presentation gives a wide overview of US and European Patent Law.

1. Module III
CONTACT SEMINARS
ROUND 1
PATENTABILITY OF INVENTIONS : US and European
perspectives
SWAPNA SUNDAR
CEO, IP DOME – IP STRATEGY ADVISORS

2. 11/25/2012 2
Agenda
• US Patent Regime
1.Patentability of Inventions
2.Utility
3.Anticipation
4.Obviousness
5.Enablement
• European Patent regime
• Questions

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• US PATENT REGIME
I. Title 35 USC & Title 37 CFR
II. Patentability

4. 11/25/2012 4
Title 35 of the US Code governs
Patent law
Consists of 37 chapters (376 sections of which 149 of are
used).
Title 35 has four parts:
Part I—USPTO
Part II—Patentability of Inventions and Grant of Patents
Part III—Patents and Protection of Patent Rights
Part IV--Patent Cooperation Treaty

5. 11/25/2012 5
CFR Title 37 – Patents, TM and ©
Code of Federal Regulations is the codification of the general
and permanent rules and regulations.
CFR must have an "enabling statute‖.
USC is a codification of legislation; CFR is administrative law.
USC precedes the CFR and contains statutes enacted
by Congress.
CFR spells out in further detail how the executive
branch will interpret the law.

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7. 11/25/2012

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Patentabililty: Eligibility for grant
The Applicant must be the inventor.
Patentable subject matter (section 101)
Novel and the application for a patent on the invention must be
timely (section 102)
The invention must be non-obvious (section 103)
The invention must be sufficiently documented (section 112)

9. 11/25/2012 7
Patents issued by the USPTO
-UTILITY PATENTS
- generally permits patentee monopoly over making, using,
or selling the invention for 20 years from the date of patent
application filing, subject to the payment of maintenance
fees.
-DESIGN PATENTS
-PLANT PATENTS
-Reissue patents, defensive publication, statutory invention
registration

10. 11/25/2012 8
35 USC 101 Inventions patentable
Whoever invents or discovers
any new and useful process,
machine,
manufacture, or
composition of matter,
or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions and
requirements of this title

11. 11/25/2012 9
What is patentable – (102 & 103)
An invention must belong to one of these classes:
a. Machine (eg. Mechanism with moving parts)
b. Article of manufacture (eg. Hand tool or diagnostic kit)
c. Composition of matter (eg. Drug)
d. Process (eg. Of making nanotubes)
PROCESS defined in 35 U.S.C. 100:
- means process, art or method, and includes a new use of
a known process, machine, manufacture, composition of
matter, or material.

12. 11/25/2012 10
What is patentable Contd.
e. New use or improvement of existing invention
f. Modified living organism (eg. Transgenic rice)
g. Isolated or purified natural materials (eg. Purified proteins)
- Mathematical formulae, chemical elements, laws of
nature are not patentable.
Gene Patents are patent on a specific isolated gene
sequence, its chemical composition, the processes for
obtaining or using it, or a combination of such claims. Gene
patents are a part of the broader category of biological
patents.

13. 11/25/2012 11
Cases
Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127
(1948): Kalo got patents on packaged mutually non-inhibitory
rhizobia species for inoculation into the roots of leguminous
plants and for the process. Held unpatentable as:
―qualities of these bacteria…are manifestations of laws of
nature‖
―aggregation of species‖
ISOLATES: The first patent for a human product was granted
on March 20, 1906 for a purified form of adrenaline. It was
challenged and upheld in Parke-Davis v. Mulford [2] Judge
Hand argued that natural substances when they are purified
are more useful than the original natural substances.

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• US PATENT REGIME
I. Utility
II. Novelty
III. Non-obviousness

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Utility 35 USC 101
Invention must demonstrate identifiable benefit and use; must
express a specific, credible, and substantial utility.
• Operability whether the invention actually works or
accomplishes the utility that the inventor claims
• a beneficial use requires that the patented invention ―not be
frivolous or injurious to the well-being, good policy, or sound
morals of society‖. An invention is ‗useful‘ under section 101 if
it is capable of providing some identifiable benefit.
• practical use: in Brenner V. Manson a novel process for
making a known steroid did not satisfy the utility requirement
because the patent applicants did not show that the steroid
served any practical function.

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Utility diluted
Juicy Whip, Inc. v. Orange Bang, Inc. dealing with a juice
dispenser that arguably deceived the public into believing
that the liquid seen in the attached reservoir was that which
was being dispensed
Gambling
Toys to enhance sexual pleasure

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Novelty
Patent can be granted to an invention unless it
(a) was known or used by others in this country, or patented or
described in a printed publication in this or a foreign country,
before the invention thereof by the applicant for patent, or
(b) was patented or described in a printed publication in US or
another country or in public use/sale in this country, more than 1
year prior to the date of the application for patent in the US
(c) Was abandoned by the applicant
(d) patented in another country <12 months before US filing
(e) the invention was described in - (1) a published US prior patent
application

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(2) A patent granted before the invention or an international
application filed under the PCT in English
(f) he did not himself invent the subject matter sought to be
patented
(g)(1) during the course of an interference it is established that
the invention was made by another inventor and not
abandoned, suppressed, or concealed.
or (2) that the invention was made in this country by another
inventor who had not abandoned, suppressed, or concealed it.
Considerations:
dates of conception and reduction to practice of the invention
reasonable diligence of one who was first to conceive and last
to reduce to practice,

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Nicholson paving case
City of Elizabeth V. American Nicholson Paving: Nicholson
sought to patent a process for a system of pavement using
wooden blocks and sued the City of Elizabeth, NJ for
infringement. City claimed that he had publicly used the
system for 6 years. Court found that he had been testing it in
private conditions.
Nicholson put down a section of his new pavement on a
turnpike operated by a private corporation in which Nicholson
was a shareholder and officer in 1848 in order to test its
durability and the public's response to it. Supreme Court held
that while the public use of an invention more than one year
prior to the inventor's application for a patent normally causes
the inventor to lose his right to a patent, there is an exception
to this rule for public uses for experimental purposes.

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• ANTICIPATION
"A claim is anticipated only if each and every element as
set forth in the claim is found, either expressly or
inherently described, in a single prior art reference."

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Anticipation
Verdegaal Bros. v. Union Oil Co. of California, "When a claim
covers several compositions, either generically or as alternatives,
the claim is deemed anticipated if any of the structures or
compositions within the scope of the claim is known in the prior
art.
" Brown v. 3M (claim to a system for setting a computer clock to
an offset time to address the Year 2000 (Y2K) problem,
applicable to records with year date data in "at least one of two-
digit, three-digit, or four-digit" representations, was held
anticipated by a system that offsets year dates in only two-digit
formats.
Richardson v. Suzuki Motor Co., The elements must be arranged
as required by the claim, but identity of terminology is not
required.

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Anticipation contd.
35 U.S.C. 102 rejection over multiple references has been
held to be proper when the extra references are cited to:
(A)Prove the primary reference contains an "enabled
disclosure;" In re Donohue, claims were rejected over a
publication in view of two patents.
• The publication disclosed the claimed compound structure
• the patents taught methods of making compounds of that
general class.
The court held that the publication taught all the elements of
the claim and thus motivation to combine was not required.

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Anticipation contd.
(B) Extrinsic evidence may be used to explain but not expand
the meaning of terms used in the anticipating reference.
In re Baxter Travenol Labs. Baxter invented a blood bag system
incorporating a bag containing DEHP.
The examiner rejected the claims over a technical progress
report by Becker which taught the same blood bag system
without expressly disclosing DEHP but disclosing the
commercial blood bag system as "very similar to Travenol's."
Extrinsic evidence (depositions, declarations and patentees
admissions) showed that commercial blood bags contained
DEHP. PHOSITA would have known that "commercial blood
bags" meant bags containing DEHP.

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Anticipation contd.
(C) Show that a characteristic not disclosed in the reference is
inherent.
Continental Can Co. USA v. Monsanto Co., accommodates
situations in which the common knowledge of technologists is not
recorded in the reference.
Atlas Powder Co. v. IRECO, Inc., Two prior art references
disclosed blasting compositions containing water-in-oil emulsions
with identical ingredients to those claimed, in overlapping ranges
with the claimed composition. The only element of the claims
arguably not present in the prior art compositions was "sufficient
aeration . . . entrapped to enhance sensitivity to a substantial
degree." The Federal Circuit found that the emulsions described
in both references would inevitably and inherently have "sufficient
aeration―.

25. 11/25/2012 23
Plant Patents (161)
A plant patent is granted by the Government to an inventor
who has invented or discovered and asexually reproduced
a distinct and new variety of plant, other than a tuber
propagated plant or a plant found in an uncultivated state.
The grant, which lasts for 20 years from the date of filing
the application, protects the inventor's right to exclude
others from asexually reproducing, selling, or using the
plant so reproduced. Mutants, hybrids, and transformed
plants are comprehended; sports or mutants may be
spontaneous or induced.

26. 11/25/2012 24
Plant Patents Contd.
Hybrids may be natural, from a planned breeding program, or
somatic in source. While natural plant mutants might have
naturally occurred, they must have been discovered in a
cultivated area. Algae and macro fungi are regarded as plants,
but bacteria are not.
In Pioneer Hi-bred Intl V. J.E.M. Ag Supply : Supreme Court
upheld the validity of sexually reproduced plants as subject
matter for patent protection.
Rejecting the argument that the 1930 Plant Patent Act2 (―PPA‖)
and the 1970 Plant Variety Protection Act3 (―PVPA‖) precluded
the patenting of plants under section101

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INFRINGEMENT
A patent provides its proprietor with the right to exclude
others from utilizing the invention claimed in that patent.
Should a person utilize that invention, without the permission
of the patent proprietor, they may infringe that patent.

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Direct infringement
A person directly infringes a patent by making, using, offering
to sell, selling, or importing into the US any patented invention,
without authority, during the term of the patent.
Unlike direct infringement, which does not require knowledge
of the patent or any intent to infringe.
While the United States Patent Act does not directly distinguish
"direct" and "indirect" infringement, it has become customary to
refer to describe infringement under 35 U.S.C. § 271(a) as
direct infringement, while grouping 35 U.S.C. § 271(b) and 35
U.S.C. § 271(c) together as "indirect" ways of infringing a
patent.,

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Indirect Infringement
Accused has some knowledge and intent
35 U.S.C. § 271(b) "active inducement of infringement ―by
encouraging, aiding, or otherwise causing another person to
infringe. Inducer must be aware of the patent and intend.
35 U.S.C. § 271(c) "contributory infringement," is triggered
when a seller provides a part or component that, while not itself
infringing of any patent, has a particular use as part of some
other machine or composition that is covered by a patent.[3] If
there are other valid uses for the product.
Only occurs when there has actually been a direct infringement
of the patent. There must have been at least one instance
where the inducement or contribution resulted in the practice of
the patented art.

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Defenses
Non-infringement:to prove infringement, patentee must show
that each and every limitation of the asserted claim is present
in the accused product, either literally or equivalently. If the
patentee fails to show the presence of even a single claim
limitation, that is enough to negate an allegation of infringement
of the claim. This is known in patent law as the ―all elements
rule‖.
Attack the validity of the Patent and claims. Even if patent is
determined to be valid, the Plaintiff must prove that every
element of at least one claim was infringed.

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Defenses contd.
Safe Harbour defense: Research for "purely philosophical"
inquiry is not an infringement, but research directed to
commercial purposes is infringing. 1813 decision in
Whittemore v. Cutter, Justice Story wrote that the intent of the
legislature could not have been to punish someone who
infringes "merely for [scientific] experiments, or for the
purpose of ascertaining the sufficiency of the machine to
produce its described effects.―
Hatch-Waxman process – Where research is directed
toward obtaining approval of the Food and Drug
Administration (FDA) for introduction of a generic version of a
patented drug

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Remedies
Reasonable royalty determined by the standard practices of the
particular industry
Lost profits due to infringement
"willful" infringement could lead to punitive damages assessed
up to 3X actual damages. Legal fees can also be assessed.
Injunction and removal of an infringing product from the market.
Until the 2006 Supreme Court case of eBay v. MercExchange,
plaintiffs routinely sought, and were granted, injunctions
prohibiting infringement of their patents. After 2006, injunctions
were much harder to obtain, leaving plaintiffs to pursue
remedies only for damages.

33. 11/25/2012
• DOCTRINE OF EQUIVALENTS
holds a party liable for patent infringement even
though the infringing device or process does not fall
within the literal scope of a patent claim, but
nevertheless is equivalent to the claimed invention.

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Infringement: Doctrine of Equivalents
In the US, the doctrine is applied to individual claim
limitations, not to the invention as a whole and is limited
by prosecution history estoppel.
The difference between the limitation in the accused
device and the limitation literally recited in the patent
claim may be found to be "insubstantial on the basis of
the triple identity test:
It performs substantially the same function
In substantially the same way
To yield substantially the same result

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Prosecution history estoppel
If the patentee abandoned through an amendment to the
patent application certain literal claim coverage (e.g., by
narrowing the literal scope of the patent claim), then the
patentee is estopped from later arguing that the surrendered
coverage is insubstantially different from the literally claimed
limitation.

36. 11/25/2012 34
Warner-Jenkinson Co. v. Hilton Davis
Chem. Co. (1997)
Hilton Davis Chemical Co. had developed an "ultrafiltration"
process to purify dyes. By amendment he specified that a
solution used in the process must have a pH level between 6.0
and 9.0, to avoid overlap with prior art which specified lower
limit of 9.0; however, the plaintiff was unable to explain why the
amendment stated a lower level of 6.0. The defendant had
developed a process using a solution with a pH level of 5.0,
which was outside the range of the plaintiff's patent. Held
estopped.

37. 11/25/2012 35
Festo Corporation Vs. SMC
Festo was marketing a patented industrial device . SMC began
marketing a device that used one two-way sealing ring and a
non-magnetizable sleeve. Festo filed suit claiming
infringement under the doctrine of equivalents. Festo's claim
had been amended during prosecution for statutory compliance
and SMC claimed that prosecution history estoppel should bar
Festo .
(a) To enable a patent holder to know what he owns, and
the public to know what he does not, the inventor must
describe his work in ―full, clear, concise, and exact terms.‖
Thus, a patent's scope is not limited to its literal terms, but
embraces all equivalents to the claims described.

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Festo Corpn. Contd.
(b) Prosecution history estoppel requires that patent claims
be interpreted in light of the proceedings before the Patent and
Trademark Office (PTO). When the patentee originally claimed
the subject matter alleged to infringe but then narrowed the
claim in response to a rejection, he may not argue that the
surrendered territory comprised an unforeseen equivalent.
Were it otherwise, the inventor might avoid the PTO's
gatekeeping role and seek to recapture in an infringement
action the very subject matter surrendered as a condition of
receiving the patent.

39. 11/25/2012 37
Software/algorithm patentability: trilogy
Gottschalk v. Benson method of programming a general-
purpose digital computer using an algorithm to convert
binary-coded decimals into pure binary numbers.
Held the discovery was un-patentable since it was no
more than abstract mathematics; granting it would
preclude others from using the abstract mathematical
principles. Court‘s decision did not preclude patenting of
software, only patentability where the only useful
characteristic was an algorithm.

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Trilogy Contd.
Parker v. Flook method of calculating alarm limits by using a
"smoothing algorithm" to make the system responsive to trends
but not momentary fluctuations in process variables (such as
temperature).
Held Where a patent was sought on an implementation of a
principle (the algorithm), the implementation itself must be
inventive for a patent to issue. Since that was not so, the Court
held unpatentable.
Diamond v. Diehr A method of operating a rubber-moulding
press for precision molded compounds with the aid of a digital
computer. In this case the Court backed away from the analytic
dissection approach, and insisted that patent-eligibility must be
decided on the basis of the claim (or invention) considered as a
whole, granting the patent. Court studiously avoided stating
that Flook and Benson were overruled or limited.

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Business Methods
The Federal Circuit has not yet defined what it is that
specifically characterizes a business method claim and
separates it from other process claims. The Court has stated
that claims drawn to a method of doing business should not be
categorized as a ―business method‖ claim, instead they should
be treated like any other process claim. State Street Bank &
Trust Co. v. Signature Financial Group, 1998: The claimed
invention as a whole must accomplish a practical application. It
must produce a "useful, concrete and tangible result."
A business method may be defined as "a method of operating
any aspect of an economic enterprise". International Patent
Classification (IPC), for business methods: "G06Q" (Data
processing systems or methods, specially adapted for
administrative, commercial, financial, managerial, supervisory
or forecasting purposes).

42. 11/25/2012 40
Business Method claims
U.S. Class 705: Automated business data processing
technologies, applications related to financial data processing.
Class 434 Education and Demonstration: methods of teaching
are classified in
Class 273, Amusement Devices & games: Methods of playing
games
Class 47, Plant Husbandry: Methods of improving crop
Other process claims which may be labelled a ―business
method‖ are classified and examined according to their
technology.

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Drafting Business Method claims
- ―Jepson-type‖ claim construction
- Limit claims, drawn to a single invention
- claims have proper antecedence in the specification
- Start with broad claims and then narrow them
- Range within a range normally raises 112, 2nd paragraph
issues
Be aware of 101 issues:
• data streams per se (not patentable per se)
• non functional data (not patentable per se)
Be careful with statements of intended use; ―able‖ or ―adapted
for‖ clauses & ―whereby‖ and ―wherein‖ clauses - the limiting
effect of the language in the claim

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Bilsky: patent-eligibility of a process
Bilski v. Kappos - method of hedging the seasonal risks
of buying energy On June 28, 2010, the Court ruled] that
Bernard Bilski's patent application is an abstract idea
and is therefore unpatentable.
However, it also said that business methods are not
inherently unpatentable, and was silent on the subject of
software patents. The majority opinion also said that the
Federal Circuit's "machine or transformation" test, while
useful, is not an exclusive test for determining the
patentability of a process.

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Patenting of life
1970s A.M.Chakrabarty of GE developed a genetically
improved microorganism that was designed to break down
crude oil rapidly; Process granted but not product
In 1980, 8 years after the initial filing, the Supreme Court held
that the microorganisms were a new composition of matter, the
product of human ingenuity and not of nature‘s handiwork, and
thus a patentable subject matter. – Human intervention test
Chakrabarty and Kellogg for ‗‗Bacteria capable of dissimilation
of environmentally persistent chemical compounds,‖ in 1985.
Kenneth Hibbard, Paul Anderson, and Mellanie Barker for
‗‗Tryptophan overproducer mutants of cereal crops,‘‘in 1986.
Philip Leder and Timothy Stewart ‗‗Transgenic nonhuman
mammals‘‘ in 1988 the ‗‗Harvard Mouse,‘‘

46. 11/25/2012 44
Human cells patenting
Human cells, expressed sequence tags (ESTs), single
nucleotide polymorphisms (SNPs), and cultivation and
isolation of stem cells have also been patented.
David Golde and Shirley Quan for ‗‗Unique T-lymphocyte line
and products derived therefrom‘‘ in 1984 for cell line derived
from John Moore‘s spleen
Ann Tsukamoto, Charles Baum, Ykoh Aihara, and Irving
Weissman for ‗‗Human hematopoetic stem cell,‘‘ isolated
human bone marrow stem cells in 1991

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Test for patenting life
The relevant distinction was not between living and inanimate
things but between products of nature, whether living or not,
and human-made inventions. The tests set forth by the Court :
(A) "The laws of nature, physical phenomena and abstract
ideas" are not patentable subject matter
(B) A "non-naturally occurring manufacture or composition of
matter - a product of human ingenuity -having a distinctive
name, character, [and] use" is patentable subject matter.
(C) "[A] new mineral or Einstein's E=mc2 are 'manifestations of
nature, free to all men and reserved exclusively to none.'"
(D) Production of articles prepared by giving to raw materials
new forms, qualities, properties, or combinations whether by
hand labour or by machinery" [emphasis added] is a
"manufacture" under 35 U.S.C. 101.

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Diamond v. chakrabarty
Diamond vs. Chakrabarty:
Genetic engineer Ananda Mohan Chakrabarty, working for
General Electric, had developed a bacterium (derived from the
Pseudomonas genus) capable of breaking down crude oil,
which he proposed to use in treating oil spills. The application
for patent was turned down by the USPTO because the law
dictated that living things were not patentable. The Board of
Patent Appeals and Interferences agreed with the original
decision; however, the United States Court of Customs and
Patent Appeals overturned the case in Chakrabarty's favor,
writing that "the fact that micro-organisms are alive is without
legal significance for purposes of the patent law."

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Diamond Vs. Chakrabarty Contd.
Sidney A. Diamond, Commissioner of Patents and
Trademarks, appealed to the Supreme Court. The Supreme
Court case was argued on March 17, 1980 and decided on
June 16, 1980. In a 5–4 ruling, the court ruled in favor of
Chakrabarty, and upheld the patent, holding that: A live,
human-made micro-organism is patentable subject matter
under § 101. Respondent's micro-organism constitutes a
"manufacture" or "composition of matter" within that statute.

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Living multicellular organisms
Class 800: living multicellular organisms (nonhuman animals
and plants) and separated or severed parts thereof that have
not undergone any modification or treatment subsequent to
their separation. Genetic modification processes are included.
Mammals, method of making and using a transgenic
nonhuman animal in an in vivo test method (e.g., drug efficacy
tests, etc.) & method of using a transgenic nonhuman animal to
manufacture a protein which is then to be isolated or extracted
are contemplated.
Different types of breeding techniques are also provided for.

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Harvard Oncomouse
Inventors: Philip Leder, Timothy A. Stewart
Original Assignee: President and Fellows of Harvard College
Current U.S. Classification: 800/10; 435/6.14; 435/317.1;
536/23.5; 800/18
International Classification: C12N 100; C12Q 168; C12N 1500;
C12N 500
Patent number: 4736866
Filing date: Jun 22, 1984
Issue date: Apr 12, 1988
Two patents were issued to Harvard College covering methods
for providing a cell culture from a transgenic non-human animal
(expired Feb 11, 2009) and testing methods using transgenic
mice expressing an oncogene (expiring 2016)

52. 11/25/2012 50
Other jurisdictions
Canada
2002: Supreme Court rejected the patent in Harvard College
v. Canada, overturning a Federal Court of Appeal verdict
which ruled in favour of the patent.
2003: Canadian patent 1,341,442 CA 1341442 was granted to
Harvard College amended to omit the "composition of matter"
claims on the transgenic mice. Canadian patent law allowed
the amended claims to grant under pre-GATT rules and the
patent remains valid until 2020.
EPO
1989: refused in by an Examining EPO as EPC excludes
patentability of animals per se. 1992 granted on the ground
that varieties were unpatentable not animals per se. 2001,
hearing on objections, the patent was maintained in amended
form. 2006 revoked for failure to pay the fees and to file
translated claims.

53. 11/25/2012
3. NON-OBVIOUSNESS
• If the differences between the subject matter sought to be
patented and the prior art are such that the subject matter
as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the
art to which said subject matter pertains.

54. 11/25/2012 52
Non-obviousness
(A) Combining prior art elements according to known methods to
yield predictable results;
(B) Simple substitution to obtain predictable results;
(C) Use of known technique to improve similar devices
(D) "Obvious to try" - choosing from a finite number of identified,
predictable solutions, with a reasonable expectation of success;
(E) Known work in one field of endeavor may prompt variations
of it for use in either the same field or a different one based on
design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(F) Some teaching, suggestion, or motivation in the prior art that
would have led one of ordinary skill to modify the prior art
reference or to combine prior art reference teachings to arrive at
the claimed invention.

55. 11/25/2012 53
Structural obviousness
the motivation of PHOSITA to make a claimed compound,
expecting compounds similar in structure will have similar
properties
In re Merck & Co., Inc., 1986, claimed and prior art compounds
used in a method of treating depression expected to have similar
activity because the structural difference between the
compounds involved a known bioisosteric replacement.
In re Dillon, 1991, The tri-orthoester fuel compositions of the
prior art and the claimed tetra-orthoester fuel compositions
would have been expected to have similar properties based on
close structural and chemical similarity between the orthoesters
and the fact that both the prior art and applicant used the
orthoesters as fuel additives.

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Formulation
Unigene Labs. and Upsher-Smith Labs v. Apotex, 2011: Unigene's
reissued patent covers its Fortical calcitonin nasal spray
developed in response to Novartis's Miacalcin calcitonin nasal
spray. Content of citric acid, polysorbate 80, phenylethyl alcohol
and benzyl alcohol are claimed in Unigene's patent. Citric acid
enhances absorption. Novartis product used BZK for the purpose.
In 2006, Apotex filed an ANDA to import a generic version of
Unigene's spray. Unigene sued for infringement. Apotex‘s
obviousness defense was struck down by Fed.Cir.
The court determined that the citric acid in Unigene serves as
a substitute for BZK and that at the time of invention, it was not an
obvious substitute for BZK.

57. 11/25/2012 55
Process
"A process yielding a novel and nonobvious product may
nonetheless be obvious; conversely, a process yielding a
well-known product may yet be nonobvious." TorPharm, Inc.
v. Ranbaxy Pharmaceuticals, Inc., (Fed. Cir. 2003)
Brouwer, "highly fact-specific by design― to be assessed on a
case-by-case basis. Ochai: flexibility
Process of chemically reducing one novel, nonobvious
material to obtain another novel, nonobvious material was
held obvious because the reduction reaction was old. In re
Albertson (CCPA 1964)

58. 11/25/2012 56
In re Durden
Federal Circuit:
[A]n otherwise old process becomes a new process when a
previously unknown starting material is subjected to a
conventional manipulation to produce a product which may
also be new. But it does not necessarily mean that the whole
process has become unobvious. If the "use of an unobvious
starting material renders a process unobvious― - every step,
for example, dissolving or heating, when performed on a new
compound would result in a patentable process.
Applicant claimed the process of making the novel
carbamate products from the novel oxime starting materials

59. 11/25/2012 57
In re Kuehl
In re Kuehl, (CCPA 1973) Process of cracking hydrocarbons
using novel zeolite catalyst found to be patentable even
though catalytic cracking process was old. The obviousness of
the process of cracking hydrocarbons with ZK-22 as a catalyst
must be determined without reference to knowledge of ZK-22
and its properties.‖ PHOSITA would not only have to able to
predict the outcome of using ZK-22, but also find it obvious to
use ZK-22 which was not predictable until the invention.

60. 11/25/2012 58
Method of use
Obviousness-type double patenting applies
Applicants are barred from obtaining multiple patents
covering the same invention by the doctrine of double
patenting. There are two types of double patenting:
statutory double patenting, which prohibits a later patent
from covering the identical invention, and obviousness-type
double patenting, which prevents a later patent from
covering a slight variation of an earlier patented invention.

61. 11/25/2012 59
Sun Pharma V. Eli Lilly
Eli Lilly‘s Patent No. 4,808,614 related to Gemzar – which
claims both gemcitabine itself, a method of using it to treat viral
infections, as well as discloses using gemcitabine to treat
cancer. Patent No. 5,464,826 claims a method of treating
cancer comprising administering a therapeutically effective
amount of gemcitabine.
The applications leading to both the '614 (exp. 2010) and '826
(exp. 2012) patents were filed on the same day, December 4,
1984. The '614 was a continuation-in-part of application No.
473,883 which did not disclose using gemcitabine to treat
cancer.
Obviousness-type of double patenting

62. 11/25/2012 60
Process in biotechnology and chemistry
Proteins which are the product of biotechnological processes
are often known and naturally occurring and therefore product
claims can be subject to rejection during prosecution.
Thus process claims can protect the biotechnology product as
well as the process where the product is not patentable for
obviousness. A process will prevent a foreign competitor from
importing the product into US. Based on in re Durden, PTO
routinely rejected claims to process for cultivating a patented
transformed host cell to produce an unpatentable product.
PTO rejected process claims with genetically engineered
starting materials.

63. 11/25/2012 61
THE BIOTECHNOLOGY PROCESS PATENT ACT,
1995
Divided section 103 into three subsections.
Section 103(b) now provides that the applicant can elect for
patent to proceed under a biotechnological
process using or resulting in a composition of matter that is
novel under
section 102 and nonobvious under section 103(a). Claims to
the process and the composition of matter should be
contained in either the same application for patent or in
separate applications having the same filing date; and the
compositions of matter, and the process at the time it was
invented should be owned by the same person or subject to
an obligation for assignment to the same person.

64. 11/25/2012 62
Contd.
The term ―biotechnological process‖ means -
(A) a process to genetically alter or otherwise inducing a single-
or multi-celled organism to -
(i) express and exogenous nucleotide sequence,
(ii) inhibit, eliminate, augment, or alter expression of an
endogenous nucleotide
sequence, or
(iii) express a specific physiological characteristic not naturally
associated with
said organism;
(B) cell fusion procedures yielding a cell line that expresses a
specific protein, such as a monoclonal antibody; and
(C) a method of using a product produced by a process defined
by subparagraph (A) or (B), or a combination of subparagraphs
(A) and (B).

65. 11/25/2012 63
PHOSITA
PHOSITA is a legal fiction defined in the Patent Act of
the United States, based on
- educational level of the inventor;
- type of problems encountered in the art;
- prior art solutions to those problems;
- rapidity with which innovations are made;
- sophistication of the technology; and
-educational level of active workers in the field

66. 11/25/2012 64
Obviousness: KSR V. Teleflex
Teleflex, Inc. sued KSR International, claiming that KSR
products infringed Teleflex's patent on connecting an adjustable
vehicle control pedal to an electronic throttle control. KSR
argued that the combination of the two elements was obvious,
and the claim was therefore not patentable.
The district court ruled in favour of KSR. Federal Circuit
reversed in January 2005.
On April 30, 2007, the Supreme Court reversed the judgment of
the Federal Circuit, holding that the disputed claim 4 of the
patent was obvious.
Federal Circuit had rigidly applied the "teaching-suggestion-
motivation" (TSM) test.

67. 11/25/2012 65
Obviousness: TSM Test
Winner Int'l Royalty Corp. v. Wang, (2000), there must
be a suggestion or teaching in the prior art to combine
elements shown in the prior art in order to find a patent
obvious.
Non-obviousness grant of patent requires more than
simple novelty. Thomas Jefferson's 1813 letter: changing
material to "chain, rope, or leather" was insufficient for
patentability. Patent Act of 1952, in part, to reduce the
impact of nonobviousness on patentability and to
eliminate the flash of genius test.

68. 11/25/2012 66
Graham Factors
Graham et al. v. John Deere Co. of Kansas City et al., (1966)
held that obviousness should be determined by looking at
the scope and content of the prior art;
the level of ordinary skill in the art;
the differences between the claimed invention and the prior
art; and
objective evidence of non-obviousness outlined by:
commercial success;
long-felt but unsolved needs; and
failure of others.

69. 11/25/2012 67
Graham Factors contd
Environmental Designs, Ltd. v. Union Oil Co. of Cal., (Fed.
Cir. 1983) considering scepticism or disbelief before the
invention as an indicator of non-obviousness;
Allen Archery, Inc. v. Browning Mfg. Co., (Fed. Cir. 1987)
considering copying, praise, unexpected results, and industry
acceptance as indicators of non-obviousness

70. 11/25/2012
4. ENABLEMENT
• a written description of the invention, and of the
manner and process of making and using it, in such full,
clear, concise, and exact terms as to enable any person
skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same.

71. 11/25/2012 69
In general
PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING
When it expressly anticipates or makes obvious all of the
elements of the claimed invention, the reference is presumed
to be operable. Once such a reference is found, the burden
is on applicant to provide facts rebutting the presumption of
operability. In re Sasse, (CCPA 1980)
WHAT CONSTITUTES AN "ENABLING DISCLOSURE"
DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE
DISCLOSURE IS CONTAINED IN
The level of disclosure required within a reference to make it
an "enabling disclosure" is the same no matter what type of
prior art is at issue. It does not matter whether the prior art
reference is a U.S. patent, foreign patent, a printed
publication or other. In re Moreton, (CCPA 1961).

72. 11/25/2012 70
Contd.
EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART
ENABLEMENT for anticipation. If it in sufficient detail to
enable a person of ordinary skill in the art to carry out the
claimed invention. Impax Labs. Inc. v. Aventis Pharm.Inc.,
(Fed. Cir. 2006).
REJECTIONS AND USE OF INOPERATIVE PRIOR ART
"Even if a reference discloses an inoperative device, it is prior
art for all that it teaches." Beckman Instruments v. LKB
Produkter AB, (Fed. Cir. 1989). Therefore, "a non-enabling
reference may qualify as prior art for the purpose of
determining obviousness under 35 U.S.C. 103." Symbol
Techs. Inc. v. Opticon Inc (Fed. Cir. 1991).

73. 11/25/2012 71
Further requirements (112)
Best Mode: Patent must disclose the best mode of
practising the invention including preferred materials and
methods. Failure may result in patent being declared
‗unenfoceable‘.
Duty of Candor: good faith and specifically requires that
everyone involved with a patent application must disclose
all publications that they know of which may adversely
affect the patentability of their invention through out the
pendency of the application . Within 3 months all material
information must be disclosed.

74. 11/25/2012 72
Further requirements Contd.
Oath: The inventor must swear that she understands the
patent document, the duty of candour and full disclosure
and that the named inventor is the true and first inventor.
Inventorship The requirement that the applicant for a
patent be the inventor is a characteristic of U.S. patent
law. The threshold question in determining inventorship is
who conceived the invention. Unless a person contributes
to the conception of the invention, he is not an inventor.
Conception of atleast one claim.

75. 11/25/2012 73
America Invents Act
The Leahy-Smith America Invents Act (AIA) is United
States federal legislation that was passed by Congress
and was signed into law by President Barack Obama on
September 16, 2011.
Changes to be implemented with varying dates between
Sept. 2012 -13

76. 11/25/2012 74
Substantive Changes
• Changes from "First to Invent" to "First to File" System
o "Effective Filing Date"
o Eliminates One-year Grace Period for 3rd party disclosures
o Makes changes to prior art
• Provides Derivation Proceedings
• Adds Pre-Grant Submissions
• Expands Post-Grant Proceedings
o Expands on Post-Grant Submissions
o Retains Ex Parte Reexamination
o Eliminates Inter Partes Reexamination, but…

77. 11/25/2012 75
Substantive Changes II
Adds Post-Grant Patent Review
Adds Inter Partes Review
• Adds Post-Grant Supplemental Examination
o Provides Patent Owner with an opportunity to "cure" errors in
prosecution
• Eliminates Best Mode Failure as a Defense

78. 11/25/2012
Prior Art
The Act omits the 102(g) interference and prior art provisions,
relating to an invention that was previously made in this country by
another inventor who had not abandoned, suppressed, or concealed it
oNo more patent interferences
oDerivation proceedings will be available
102(a) A person shall be entitled to a patent unless—
(1)the claimed invention was patented, described in a printed
publication, or in public use, on sale, or otherwise available to
the public before the effective filing date of the claimed
invention; or
(2) the claimed invention was described in a patent issued under
section 151, or in an application for patent published or deemed
published under section 122(b), in which the patent or
application, as the case may be, names another inventor and
was effectively filed before the effective filing date of the
claimed invention.

79. 11/25/2012 77
Prior Art Exceptions
• Exceptions from Prior Art
o Applicant's own "disclosures" within 1 year before the
"effective filing date" of a U.S. application and the
information derived therefrom.
o Includes Applicant's own publications
o Grace period is expanded in cases claiming foreign priorities
and provisional applications
o Subject matter related to a research agreement.

80. 11/25/2012 78
Post-Grant Patent Review Procedures
Summary and Timing
Procedure Request Effective Threshold
Date
Ex parte reexam Anyone In effect Substantial new question of
patentability
Inter partes Third party request based on Now – Reasonable likelihood that
reexam patents and printed 9/2012 petitioner would prevail (upon
publications enactment)
Inter partes Third party request based on Beginning Reasonable likelihood that
review patents and printed 9/2012 petitioner would prevail (upon
publications enactment)
Post-grant Third party request based on Beginning More likely than not that at least
review any ground of invalidity that with 1 challenged claim is
could be raised under patents unpatentable
paragraph (2) or (3) of § 282 filed after
(b) or showing a novel or 3/2013
unsettled legal question that
is important to other patents
Supplemental Patent owner 9/2012 Substantial new question of
examination patentability

81. 11/25/2012 79
Overview of Available Procedures

82. 11/25/2012 80
First to File
• "Effective Filing Date"
• One year grace period only good for Inventor's own disclosures
• Broader scope of patent-defeating prior art
• Derivation Proceeding- operate only when inventor alleges that
the other applicant derived invention from the inventor
• Priority based on effective filing date
o Effective March 16, 2013 (may be a rush to file for choice of
law) and it applies to any patent application that has an
"effective filing date" after the 18 month period.

83. 11/25/2012 81
Derivations
Will replace patent interference 35 U.S.C. § 291
(a) In General – when a patentee claims the same invention with an
earlier effective filing date, an owner of a patent may have relief
by civil action against him, if the former patent was derived from
the inventor of the latter patent.
(b) Filing Limitation – An action under this section may be filed only
before the end of the 1-year period beginning on the date of the
issuance of the first patent containing a claim to the allegedly derived
invention and naming an individual alleged to have derived such
invention as the inventor or joint inventor.

84. 11/25/2012 82
Pre-grant submissions (3rd party observations)
Effective date: September 16, 2012; applies to any pending
patent application at that time.
• When:
o Must be filed "before the earlier of–"
(A) Date of Notice of Allowance or
(B) the later of
(i) 6 months after publication date or
(ii) date of first Office Action (rejection)
• What: Third Party Submissions
o Citation to Printed publications (patent, non-patent, or court
decision (can likely introduce an argument under §§ 101
and 112))
o "Concise" Description of Relevance

85. 11/25/2012 83
Post-grant submissions
Expands Post-Grant Submissions
Retains Ex Parte Reexamination
Eliminates Inter Partes Rexamination, but…
Adds Post-Grant Patent Review
Adds Inter Partes Review
Adds Post-Grant Supplemental Examination
Request for Ex Parte Reexamination ( 302) Effective date: N/A
Who and When: Any person at any time
Scope: §§ 102 and 103
Threshold for Initiation: Substantial New Question of
Patentability

86. 11/25/2012 84
Post-grant submissions – II
Post-Grant Submissions ( 301)
• When (September 16, 2012)
o Any time after patent grant
• What
o Information
Prior Art consisting of patents or printed publications
(same as before) or
Written Statements made by the patent owner either before
a Federal court or the USPTO related to claim scope (new)
o Include written explanation that provides reasons why the
Prior Art or Written Statements are relevant

87. 11/25/2012 85
Post-grant proceedings
Post-Grant Review (§ 321) and Inter Partes Review ( 311)
• Effective Date (September 16, 2012).
• Post-grant review: Applies only to patents having an
effective date on or after 18 months from enactment.
• Inter partes review: Applies to any patent issuing before, on,
or after that date.
• When
o Post-grant review: petition filed within 9 months from
patent grant date of patent or from grant date of reissued
patent (§ 321(c))
o Inter partes review: petition filed after the later of either 9
months after patent grant or termination of a post-grant
review ( 311(c))

88. 11/25/2012 86
Post-Grant Review (§ 321) and Inter Partes Review ( 311)
• Scope
o Post-grant review: Can challenge any aspect of patentability
of any claim including §§ 101 and 112
o Inter partes review: Restricted to patents and printed
publications and to issues of novelty and non-obviousness
• Patent Owner's Right
o Post-grant review: Preliminary Response
o Inter partes review: Preliminary Response

89. 11/25/2012 87
Post-Grant Review (§ 321) and Inter partes review ( 311)
• Threshold for Initiation
o Post-grant Review: USPTO must consider petition
information and patent owner's preliminary response and will
initiate post-grant review if it is more likely than not that at
least one claim is unpatentable. (§ 324(a), i.e., preponderance
of evidence standard).
Threshold "may also be satisfied by a showing that the
petition raises a novel or unsettled legal question that is
important to other patents or patent applications." (§
324(b))
o Inter partes review: Same as above except that the required
showing is a reasonable likelihood that the petitioner would
prevail with respect to at least 1 of the claims challenged in
the petition.
( 314(a))

90. 11/25/2012 88
Post-Grant Review (§ 321) and Inter partes review ( 311)
• Evidentiary Standard
o Post-grant Review: The "petitioner shall have the burden of
proving a proposition of unpatentability by a preponderance
of the evidence." ( 326(e))
o Inter partes review: Same as above. ( 316(e))
• Patent Owner's Right to Amend
• Post-grant Review: Right to file motion to amend the
claims, second motion only possible if both parties agree (
326(d))
• Inter partes review: Same as above. ( 316(d))
Confidential Settlements are Allowed
Intervening Rights ( 252) Apply

91. 11/25/2012 89
Post-Grant Review (§ 321) and Inter partes review ( 311)
• Time Limit for Completion
o Post-grant Review: Proceeding should be completed within
1 year with one 6 month extension available on a showing
of "good cause." ( 326(a)(11))
o Inter partes review: Same as above. ( 316(a)(12))
• Preclusive Effect (Estoppel)
• Post-grant Review: Cannot raise issues before the USPTO,
District Court, or the ITC if the issues were previously
raised or reasonably could have been raised. ( 325(e))
• Inter partes review: Same as above. ( 315(e))

92. 11/25/2012 90
Post-Grant Review (§ 321) and Inter partes review ( 311)
• Litigation Limitations
o Post-grant Review: Cannot request review if previously filed
declaratory judgment ("DJ") action contesting the validity of the
patent ( 325(a)(1))
o Inter partes review: Same as above. ( 315(a)(1)) Except that
inter partes review cannot occur after 9 months of the filing of
the complaint by the patent owner against the petitioner. (
315(b))
o Post-grant Review: If petitioner files civil action on or after
request for review, then civil action automatically stayed unless
(i) the patent owner requests to lift the stay, (ii) the patent owner
files its own civil action or files a counterclaim, or (iii) the
petition requests to dismiss civil action.
( 325(a))
o Inter partes review: Same as above. ( 315(a))

93. 11/25/2012 91
For both types of proceedings, discovery
rules will be promulgated for:
• Setting forth standards and procedures for discovery of
relevant evidence, including that such discovery shall
be limited to:
• PGR: evidence directly related to factual assertions
advanced by either party to the proceeding.
• IPR: the deposition of witnesses submitting affidavits
or declarations; and what is otherwise necessary in
the interest of justice.
• Prescribing sanctions for abuse of discovery, abuse of
process, or any other improper use of the proceeding,
such as to harass or to cause unnecessary delay or an
unnecessary increase in the cost of the proceeding
• Providing for protective orders governing the exchange
and submission of confidential information

94. 11/25/2012 92
Supplemental Examination
Supplemental Examination ( 257)
Effective Date: September 16, 2012 – applies to any patent
issued before, on, or after that date.
• When
o Post-Grant
• What: Request by Patent Owner Only
o Consider, reconsider, or correct information believed to be
relevant to the patent
o Request must raise substantial new question of
patentability
• Effect: A mechanism for the patent owner to ward off a
potential inequitable conduct defense

95. 11/25/2012 93
Supplemental Examination (cont'd)
Supplemental Examination (§ 257)
Effective Date: 1 year after enactment date
• Key Provision
• "A patent shall not be held unenforceable on the basis of
conduct relating to information that had not been
considered, was inadequately considered, or was incorrect
in a prior examination of the patent if the information was
considered, reconsidered, or corrected during a
supplemental examination of a patent.
• Exceptions (cannot file request):
• Prior allegations (made in a PIV certification letter)
• Defense raised in a pending litigation unless Supplemental
Examination proceedings concluded prior to the date of
litigation

96. 11/25/2012
• EUROPEAN PATENT REGIME
I. European patent convention
II. Patentable inventions in European Patent systems
III. History of the Broad Definition of Patentability
IV. Final form of European Patent system Development of EPO
Practice in Relation to Software Industries

97. 11/25/2012 95
Novelty Art. 54 of EPC
(1)An invention shall be considered to be new if it does not
form part of the state of the art.
(2) The state of the art shall be held to comprise everything
made available to the public by means of a written or oral
description, by use, or in any other way, before the date of
filing of the European patent application.
(3) The content of European patent applications as filed prior
to the date referred to, and which were published on or after
that date

98. 11/25/2012 96
Contd.
(4) shall not exclude the patentability of any substance or
composition, comprised in the state of the art, for use in a
method referred to in Article 53(c), provided that its use for
any such method is not comprised in the state of the art.
(5) shall also not exclude the patentability of any substance
for any specific use in a method referred to in Article 53(c),
provided that such use is not comprised in the state of the
art.

99. 11/25/2012 97
Utility (and patentability) Art. 52
European patents shall be granted for any inventions, in all
fields of technology, provided that they are new, involve an
inventive step and are susceptible of industrial application.
Art. 57 An invention shall be considered as susceptible of
industrial application if it can be made or used in any kind of
industry, including agriculture. Profitable use.
Art. 83 Sufficiency of disclosure

100. 11/25/2012 98
Inventive Step Art. 56
An invention shall be considered as involving an inventive step
if, having regard to the state of the art, it is not obvious to a
person skilled in the art. If the state of the art also includes
documents within the meaning of Article 54, paragraph 3,
these documents shall not be considered in deciding whether
there has been an inventive step.

101. 11/25/2012 99
European Patent Convention,
5 October 1973
A multilateral treaty instituting the European Patent
Organisation and providing an autonomous legal system
according to which European patents are granted.
European patent is not a unitary right, but a group of
essentially independent nationally-enforceable, nationally-
revocable patents subject to central revocation or narrowing as
a group pursuant to two types of unified, post-grant
procedures: a time-limited opposition procedure, which can be
initiated by any person except the patent proprietor, and
limitation and revocation procedures, which can be initiated by
the patent proprietor only.

102. 11/25/2012 100
EPC and exclusions under Article
.
53 EPC
Discoveries, scientific theories, mathematical methods,
aesthetic creations, schemes, rules and methods for
performing mental acts, playing games or doing business,
programs for computers and presentations of information – as
such
The second set of exclusions, or exceptions, include
inventions contrary to "ordre public" or morality,
plant or animal varieties and essentially biological processes
for the production of plants and animals, and
methods for treatment of the human or animal body by surgery
or therapy, and diagnostic methods practised on the human or
animal body,which have been excluded for "socio-ethical
considerations and considerations of public health‖.

103. 11/25/2012 101
Software
Art. 52(2) The following in particular shall not be regarded as
inventions …
(c) schemes, rules and methods for performing mental acts,
playing games or doing business, and programs for
computers;
52(3) Paragraph 2 shall exclude the patentability of the subject-
matter or activities referred to therein only to the extent to
which a European patent application or European patent
relates to such subject-matter or activities as such.

104. 11/25/2012 102
T469/03
Claim 4 is directed to a computer-readable medium
having computer-executable instructions (i.e. a computer
program) on it to cause the computer system to perform the
claimed method.
The subject-matter of claim 4 has technical character since it
relates to a computer-readable medium, i.e. a technical
product involving a carrier. Moreover, the computer executable
instructions have the potential of achieving the above-
mentioned further technical effect of enhancing the internal
operation of the computer, which goes beyond the elementary
interaction of any hardware and software of data processing
(see T 1173/97 - Computer program product/IBM; OJ EPO
1999, 609). The computer program recorded on the medium is
therefore not considered to be a computer program as such,

105. 11/25/2012 103
Differences between US and Eu practices
First inventor to file system effective March 16, 2013 v. First
to file .
Inventor‘s own personal publications and disclosures will not
constitute prior art so long as they are published no more
than one year prior to the patent application – no such grace
period in Eu
Best mode requirement
Non-obvious v. inventive step

106. 11/25/2012
SWAPNA SUNDAR
CEO, IP Dome – IP Strategy Advisors
No. 7/8 Flowers Road III Lane
Purusaiwalkam, Chennai 600084
swapna@ipdome.in
THANK YOU
for your
attention