updated with America Invents Act

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

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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3. • US PATENT REGIME
I. Title 35 USC & Title 37 CFR
II. Patentability
III. America Invents Act
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4. 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
Title 35 of the US Code governs
Patent law
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5. 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.
CFR Title 37 – Patents, TM and ©
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6. 9/25/2013
America Invents Act
Introduced in the Senate as "America Invents Act" (S. 23) by
Patrick Leahy (D–VT) and Lamar Smith (R-TX) Jan 25, 2011
Committee consideration by: Judiciary Committee
Passed the Senate on March 8, 2011 (95–5)
Passed the House on June 23, 2011 (304-117) with
amendment
Senate agreed to amendment on September 8, 2011 (89-9)
Signed into law by President Obama on September 16, 2011

7. 9/25/2013
COURTS I

8. 9/25/2013
COURTS II

9. 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)
Patentabililty: Eligibility for grant
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10. 9/25/2013
First Inventor to file
First inventor to file under Sec. 3, 125 Stat. at 285-87
S. 102(a)(2) precludes a patent if the claimed invention was
described in a patent or application naming another inventor
and ‗effectively filed before the effective filing date of the
claimed invention‘.
S. 103 states that a patent many not be obtained if the
claimed invention would have been obvious ‗before the
effective filing of the claimed invention.‘

11. 9/25/2013
The filing date is the date when a patent application is first filed
at a patent office. The priority date, "effective filing date", is the
date used to establish the novelty and/or obviousness of a
particular invention relative to other art.
The priority date may be earlier than the actual filing date. If an
application claims priority to an earlier parent application, then
its priority date may be the same as the parent.
If a patent application is an original, non-provisional patent
application, not a continuation application, and not previously
filed in another country, its filing date is usually the same as its
priority date
What is the difference between
filing date and priority date?

12. -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 (with AIA, this has become redundant)
Patents issued by the USPTO
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13. 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
35 USC 101 Inventions patentable
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14. 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.
What is patentable – (102 & 103)
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15. 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, naturally occurring.
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.
What is patentable Contd.
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16. 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.
Cases
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17. • US PATENT REGIME
I. Utility
II. Novelty
III. Non-obviousness
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18. 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.
Utility 35 USC 101
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19. 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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20. Patent can be granted to an invention 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.
Novelty
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21. 9/25/2013
Patent Rights harmonisation
ALL U.S. PATENT RIGHTS IMMEDIATELY TERMINATE if
any of the following events occurs on or after March 17, 2013,
unless the inventor has first filed a patent application:
1. the invention is on sale anywhere in the world;
2. the invention is in public use anywhere in the world;
3. the invention is described in a printed publication anywhere
in the world; or
4. the invention is otherwise available to the public anywhere
in the world.

22. 9/25/2013
New 1-Year Grace Period
A new, limited one-year grace period for public disclosures by
the owner of the invention, but not for sales or public use.
(1) A disclosure made 1 year or less before the effective filing
date shall not be prior art to the claimed invention under
subsection (a)(1) if
(A) the disclosure was made by the inventor or joint inventor or
by another who obtained the subject matter disclosed directly
or indirectly from the inventor or a joint inventor; or
(B) the subject matter disclosed had, before such
disclosure, been publicly disclosed by the inventor or a joint
inventor or another who obtained the subject matter disclosed
directly or indirectly from the inventor or a joint inventor.

23. 9/25/2013
(2) A disclosure shall not be prior art to a claimed invention
under subsection (a)(2) if the subject matter disclosed
(A) was obtained directly or indirectly from the inventor or a
joint inventor;
(B) had, been publicly disclosed by the inventor or a joint
inventor or another who obtained the subject matter disclosed
directly or indirectly from the inventor or a joint inventor; or
(C) and the claimed invention, not later than the effective
filing date of the claimed invention, were owned by the same
person or subject to an obligation of assignment to the same
person.
Of course, any public disclosure as contemplated by §102(b)
immediately terminates the inventor‘s foreign patent rights.
Contd.

24. 9/25/2013
On March 17, 2013, Alpha opens a booth at a vending
industry trade show. Alpha Company has invested a large
amount of money in developing its new and novel vending
machine. Alpha has not yet filed a patent application. The
new and novel aspects of the machine are not apparent from
looking at Alpha‘s display and Alpha does not reveal how to
make and use the invention.
a. An Alpha representative offers to sell the new vending
machine to a customer at the trade show. The machine is ‗on
sale‘ even though the offer for sale did not disclose the
invention.
b. The Alpha representative demonstrates the machine by
putting a coin in the machine and dispensing a piece of
candy. This is a ‗public use‘ of the Invention.
c. The trade show is in Bangalore, India.
Case study Alpha Co.

25. 9/25/2013
Beta Co.
Beta brings its own new vending machine. Beta Company also
has not filed a patent application for the new machine. The
machine is not yet operational and Beta is not ready to take
orders for the machine.
a. A Beta Company representative gives a presentation at
the trade show disclosing how to make and use the invention.
This is a public disclosure.
b. Beta produces a brochure that discloses how to make
and use the invention. The brochure is on Beta‘s table at the
trade show and available to the public. This is a ‗printed
publication.‘
Who loses their patent rights?

26. Dates of conception and reduction to practice of the
invention
The act of conception is achieved when the inventor has
such a definite understanding of the invention that he/she
is able to describe it in a manner that is sufficiently detailed
to permit others to carry it out. The act of reduction to
practice involves either the actual practice of the invention
or the act of filing a patent application that is sufficiently
detailed to permit others to carry it out (a ―constructive‖
reduction to practice).
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Considerations

27. 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.
Nicholson paving case
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28. • 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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29. Verdegaal Bros. v. Union Oil Co. of California, "When a claim
covers several compositions, generically or as alternatives, the
claim is deemed anticipated if any of the structures/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.
Anticipation
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30. 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.
Anticipation contd.
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31. 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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32. 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―.
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33. 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.
Plant Patents (161)
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34. 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
Plant Patents Contd.
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35. 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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36. 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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37. 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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38. 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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39. 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
Defenses contd.
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40. 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.
Remedies
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41. • 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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42. 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
Infringement: Doctrine of Equivalents
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43. 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.
Prosecution history estoppel
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44. 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.
Warner-Jenkinson Co. v. Hilton Davis
Chem. Co. (1997)
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45. 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.
Festo Corporation Vs. SMC
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46. 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.
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47. 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.
Software/algorithm patentability: trilogy
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48. 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.
Trilogy Contd.
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49. 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).
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50. 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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51. 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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52. 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.
Bilsky: patent-eligibility of a process
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53. 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,‘‘
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54. 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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55. 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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56. 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."
Diamond v. chakrabarty
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57. 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.
Diamond Vs. Chakrabarty Contd.
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58. 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.
Living multicellular organisms
9/25/2013 48

59. 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)
Harvard Oncomouse
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60. 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.
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61. 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.
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62. 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.
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63. 9/25/2013
Prior Art
§102(a)(1) precludes a patent if the invention was
patented, described in a printed publication or ―in public
use, on sale or otherwise available to the public‖ anywhere
before the inventor‘s effective filing date. ―On sale‖ means
publically on sale.
§102(a)(2) precludes a patent if the invention was described
in a U.S. patent or published U.S. patent application
effectively filed by another before the applicant‘s effective
filing date. Prior art date can be a foreign filing date; In re
Hilmer is overruled.
No comparable provision in the Pre-AIA Period.

64. 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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65. 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.
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66. 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)
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67. 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
In re Durden
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68. 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.
In re Kuehl
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69. 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.
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70. 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
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71. 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.
Process in biotechnology
and chemistry
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72. THE BIOTECHNOLOGY PROCESS PATENTACT,
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.
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73. Contd.
The term ―biotechnological process‖ means -
(A) a process to genetically alter or otherwise inducing a single-
or multi-celled organism to -
(i) express an 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).
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74. 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
PHOSITA
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75. 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.
Obviousness: KSR V. Teleflex
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76. 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.
Obviousness: TSM Test
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77. 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.
Graham Factors
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78. 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
Graham Factors contd
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79. 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.
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80. 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).
In general
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81. 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).
Contd.
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82. Best Mode: Patent must disclose the best mode of practising
the invention including preferred materials and methods.
§282 states that failure to disclose best mode shall not be
basis for invalidity or unenforceability.
EFFECTIVE: September 16, 2011.
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.
Further requirements (112)
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83. §115 requires the name and an oath or declaration of the
inventor to be filed prior to notice of allowance. The oath or
declaration must include statement of belief that inventor is
the original inventor.
§118 allows an assignee to file an application. The assignee is
deemed to be the applicant.
Corrections may be made at any time, and failure to comply
with requirements under §115 will not make a patent invalid or
unenforceable if the failure is remedied.
EFFECTIVE: For applications filed on or after Sept 16, 2012.
Further requirements Contd.
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84. 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))
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85. 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))
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86. 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
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87. 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
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88. 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
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89. • 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
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90. 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
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91. (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.
Contd.
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92. 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
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93. 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.
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94. 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.
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95. .
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‖.
EPC and exclusions under Article
53 EPC
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96. 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.
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97. 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,
T469/03
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98. 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
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99. 9/25/2013

100. THANK YOU
for your
attention
SWAPNA SUNDAR
CEO, IP Dome – IP Strategy Advisors
No. 7/8 Flowers Road III Lane
Purusaiwalkam, Chennai 600084
swapna@ipdome.in
9/25/2013