IACT Dennis

1. U.S. Patent Law – A Brief History and Current Practice
Presented to the Inventors Association of Connecticut
October 23, 2018
Dennis J. Jakiela, Ph.D.
Patent Agent, Reg. No. 68,539 Follow:
Cantor Colburn LLP @CantorColburn

2. U.S. Patent Law – A Brief History and
Current Practice – Topics
Ø A brief history of 10 million patents.
Ø Patent filing timeline.
Ø Anatomy of a patent.
Ø Examination of patent applications – main applicable laws.

3. What the heck is a patent anyway?
Ø A legal document issued by the U.S. government that authorizes a
patent owner to prevent others from making, using, or selling his
invention for a fixed period of time.
Ø A Quid Pro Quo: Government gives a “limited monopoly” in the
claimed subject matter in exchange for a complete public disclosure
of how to make and use the invention.
Ø Benefits of patent system:
• Provides incentive for innovation (financial benefit).
• Patent portfolio has value through sale or licensing even if inventions
are not commercialized.
• New developments are made public.
• Research on improvements can begin immediately.

4. A Brief History of Patents - The First Known Patent
Ø Granted by Florence in 1491 to architect and engineer Fillippo Brunelleschi.
Ø Gave him a three-year monopoly on the manufacture of a barge with hoisting
gear used to transport marble.
Ø Brunelleschi was architect of Florence’s cathedral dome and was a formative
influence on Leonardo da Vinci.

5. Patent Law is Constitutional Law!
Authority to grant patents comes
from the U.S. Constitution at
Article I, Sec. 8, clause 8.
“The Congress shall have power…To promote the progress of
science and useful arts, by securing for limited times to authors and
inventors the exclusive right to their respective writings and
discoveries.”
A Brief History of Patents

6. Patent Act of 1790
Ø First federal patent statute of the U.S.
Ø Established 14-year term of exclusive rights
(changed to 20-year term from filing date in
1995).
Ø Foreigners ineligible for patents.

7. First US Patent

8. Patent Act of 1793
Ø Repealed Patent Act of 1790.
Ø Defined subject matter eligible for patenting that is
still in force today as Title 35 U.S. Code §101:
“any new and useful art, machine, manufacture or composition of
matter and any new and useful improvement on any art, machine,
manufacture or composition of matter.”
Ø “Art” later amended to “process”.

9. Patent Act of 1836
Ø Created US Patent Office.
Ø Instituted patent examination process.
Ø Established positions of Commissioner of
Patents and Patent Examiners.
Ø Established a library of prior art.
Ø Early example of “globalization” – Removed US
nationality and residency requirements.

10. US Patent No. 1, July 1836
Locomotive Steam-Engine for Rail and Other Roads

11. 10/24/18
Patent Act of 1952
Ø Clarified and simplified U.S. patent law.
Ø Codified the requirement of non-obviousness.
Ø Codified in United States Code (U.S.C.) Title 35

12. US Patent No. 10,000,000, June 19, 2018
Coherent Ladar Using Intra-Pixel Quadrature Detection

13. Provisional
0 12 24
Months
3630
A Patent Filing Strategy
1. File Provisional Application
Ø Inexpensive, only $280 for large entity;
Ø Not examined or published – trade secrecy still an option;
Ø Provides 12 months to access commercial value of invention and
decide whether to pursue non-provisional or foreign filing;
Ø Can file additional related provisional applications within 12 months
for further improvements.
Priority Date Provisional Expires

14. Importance of Priority Date
Ø USPTO transitioned from “first to invent” to “first-
to-file” with AIA (2013) to bring US in line with
practice in other countries.
Ø Any references or public disclosures after priority
date will not affect patentability.
Ø Can promote invention to customers after priority
date.
Ø Patent term is not measured from provisional
filing date.

15. Provisional
0 12 24
Months
3630
Priority Date Provisional Expires
PCT and/or
US Non-provisional
2. File Non-Provisional Application in US and/or PCT
(International Application).
Ø PCT serves as patent application for most countries.
(Taiwan not a PCT member.)
Ø PCT published at 18 months from priority date.
Ø $3600 filing and search fees.
Ø Provides an additional 18 months to decide which
countries to pursue patent in.
PCT Expires

16. Provisional
PCT and/or
US Non-provisional
0 12 24
Months
3630
3. National Stage Filing of PCT application in desired countries.
Ø File 30-31 months from priority date for most countries.
National
Stage

17. Pathways From Invention to Patent
Non-Final
Office Action
Applicants’
Response
Final
Office Action
Applicant’s
Response
Advisory
Action
Examiner
Interview
Allowance
Invention Prepare and File
Application
Examination
(Prosecution)
Allowance Issue
Search
Appeal to PTAB
Pre-Appeal
Conference
CAFC
SCOTUS
Allowance
Restriction
PGR
IPR
Allowance
Allowance
Divisional
Continuation

19. US Patent No. 10,022,328, July 17, 2018
Dialkyl Sulfosuccinate Compositions, Method of Making, and Method of Use
Anatomy of an Application –
Title page
Ø Title – statutory classes of invention
Ø Bibliographic Information:
Applicant, Inventors, Assignee, Application
No., File Date, Prior publication
Ø Related Application Data
Ø Abstract – for databases
Ø References Cited – Statutory duty to
disclose
Ø Representative drawing

20. Prior art sorted as:
Ø U.S. Patent Documents
Ø Foreign Patent Documents
Ø Other Publications – “Non-patent literature” (technical articles, books, product
data sheets, searches from patent offices)

21. Parts of Application – Claims
Ø Claims – Establish “metes and bounds”
of right to exclude. Analogous to a deed
which establishes the boundaries of your
property.
Ø Should be drafted first, and agreed upon
by inventors before drafting Detailed
Description.
Ø Published Patent Application – original
(desired) claims that have no legal effect.
Ø Issued Patent Application – Final claims,
usually amended, that are enforceable.
Ø Final claims the result of the patent
prosecution process, a kind of
“negotiation” with the Examiner with the
Applicant presenting amendments to
original claims in response to Examiner
rejections.

23. Ø Can be graphs, photos, drawings.
Ø Anything that helps to explain the invention.
Ø Critical for mechanical patents.
Ø Described in “Brief Description of the
Drawings” and in more detail in “Detailed
Description”.
Ø Minimize text, use numeric codes for items
that can be described in Detailed Description
Anatomy of Application – Figures

24. Anatomy of Application
Ø Cross Reference to Related Applications –
important for establishing priority claim.
Ø Background – outline problem solved by the
invention. Analogous to opening arguments in
a jury trial.
Ø Brief Description – restatement of main
(independent) claims.
Ø Brief Description of the Drawings – Figure
captions omitted from figures.

25. Anatomy of Application
Ø Detailed Description
Ø Can begin with a statement of advantages of
the invention. “Elevator pitch.”
Ø Should discuss the subject matter of all of the
claims.
Ø Includes examples section at end.
Ø Should include restatement of claims as
“embodiments” or “aspects” of the invention.

26. Anatomy of Application
Ø “Embodiments” or “aspects” of the invention.
Ø Mirrors all claims.
Ø Include all embodiments you are interested in
that you might want to claim at some point.
Unlike claims, no extra cost.
Ø Important for making amendments in some
jurisdictions, esp. European Patent Office.

27. Anatomy of Application
• Examples
• Fulfills duty to teach the public
how to practice the invention.

28. Examination of Patents
U.S.C. Title 35 – Patents
Ø § 101 Inventions Possible – Eligible subject matter
Ø § 102 Conditions for Patentability; Novelty
Ø § 103 Conditions for Patentability; Non-obvious subject
matter
Ø § 112(a) Written description and enablement
Ø § 112(b) Clarity

29. § 101 Inventions Possible
Eligible subject matter - Any new and useful:
Ø Processes;
Ø Machines (mechanical, electronic, computer hardware);
Ø (Articles of) Manufacture;
Ø Compositions of matter.
Ø Designs – ornamental designs for manufactured articles
Separate category - “design patents”,
Ø Plants – New varieties of asexually reproduced plants.
Separate category.

30. § 101 Inventions Possible
Ineligible subject matter:
Ø Laws of nature;
Ø Abstract ideas;
Ø Algorithms;
Ø Natural products;
Ø Genes;
Ø Organisms;
Ø Human organisms (AIA § 33).

31. § 101 Inventions Possible
Disputed subject matter:
Ø Software;
Ø Business methods;
Ø Genetically modified organisms;
Ø Methods of medical treatment.

32. § 101 Inventions Possible –
Genetically Modified Organisms (GMOs)
Ø Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), 5-4 Decision
Ø “The laws of nature, physical phenomena, and abstract ideas
have been held not patentable. Thus, a new mineral discovered
in the earth or a new plant found in the wild is not patentable
subject matter. Likewise, Einstein could not patent his celebrated
law that E = mc2; nor could Newton have patented the law of
gravity. Such discoveries are ‘manifestations of · · · nature, free to
all men and reserved exclusively to none.’ ” Diamond v.
Chakrabarty, 447 U.S. 303, 309 (1980) (internal citations
omitted).
Ø Although living organisms are not patentable, the SC approved a
patent on a genetically altered bacterium, i.e. a man-made
organism. “Congress intended statutory subject matter ‘include
anything under the sun that is made by man.’”

33. Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), 5-4 Decision

34. Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), 5-4 Decision
Ø Ananda Chakrabarty, a genetic engineer at General Electric working on
oil spill remediation, developed two strains of Pseudomonas bacterium
modified with plasmids imparting the ability of the bugs to eat petroleum.
Ø One strain was modified with plasmids imparting ability to degrade
camphor, octane, salicylate, and naphthalene.
Ø Another strain was modified with plasmids imparting ability to degrade
camphor, salicylate, and naphthalene and also imparting drug resistance
factor RP-1.

35. Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), 5-4 Decision
Claim 1. A bacterium from the genus Pseudomonas containing therein at least
two stable energy-generating plasmids, each of said plasmids providing a separate
hydrocarbon degradative pathway.
Claim 2. The Pseudomonas bacterium of claim 1 wherein the hydrocarbon
degradative pathways are selected from the group consisting of linear aliphatic,
cyclic aliphatic, aromatic and polynuclear aromatic.
Patent eligible!
Ø The claimed bacterium has a different structural characteristic from naturally
occurring Pseudomonas, i.e. it was genetically modified to include more plasmids
than are present in naturally occurring Pseudomonas.
Ø The claimed bacterium also has a different functional characteristic from
naturally occurring Pseudomonas, i.e. it is able to degrade at least two different
hydrocarbons, while natural Pseudomonas can only degrade one.

36. § 103 – Non-obvious Subject Matter:
InnoPharma and Lupin v. Senju and Bausch & Lomb
IPR2015-00903 (P.T.A.B. July 28, 2016)
Ø PROLENSA® is an FDA-approved treatment for post-operative
inflammation and pain in patients undergoing cataract surgery, a
$100 million market.

37. InnoPharma and Lupin v. Senju and Bausch & Lomb
Regulatory barrier to competition:
InnoPharma and Lupin filed ANDAs seeking to market exact copies of
Senju and Bausch & Lomb’s PROLENSA® ophthalmic solution
(bromfenac, 0.07 w/v %) also containing tyloxapol (0.02 w/v%)
Bromfenac, NSAID
(2-amino-3-(4-bromobenzoyl)phenylacetic acid)

38. InnoPharma and Lupin v. Senju and Bausch & Lomb
Ø Patent barrier to competition:
Other potential producers excluded by U.S. Patent No.
8,129,431 (Sawa).
Ø Plaintiffs sought to invalidate Sawa patent to remove
this barrier.
Ø Alleged that the PROLENSA® patents were obvious
over two prior art patents, U.S. 4,910,225 (Ogawa)
and U.S. 6,107,343 (Sallmann).

39. InnoPharma and Lupin v. Senju and Bausch & Lomb
Challenged claim:
Ø Claim 1. An aqueous liquid preparation consisting essentially of the
following two components,
wherein the first component is
2-amino-3-(4-bromobenzoyl)phenylacetic acid [bromfenac] or a
pharmacologically active salt thereof or a hydrate thereof . . . and
wherein the second component is tyloxapol,
wherein said liquid preparation is formulated for ophthalmic
administration, and
wherein when a quaternary ammonium compound is included in
said liquid preparation, the quaternary ammonium compound is
benzalkonium chloride.

40. InnoPharma and Lupin v. Senju and Bausch & Lomb
Ø “It is prima facie obvious to combine two compositions
each of which is taught by the prior art to be useful for
the same purpose, in order to form a third composition
for the very same purpose.” MPEP § 2144.06 (I)
Ø The selection of a know material based on its
suitability for its intended purpose support[s] a prima
facie obvious determination . . .” MPEP § 2144.07

41. InnoPharma and Lupin v. Senju and Bausch & Lomb
Ø A person of ordinary skill in the art (POSITA) would
have been motivated to swap bromfenac from Ex. 6 of
Ogawa for the diclofenac potassium of Sallmann Ex. 2.
Ø Similarly, a POSITA of would have been motivated to
swap the tyloxapol of Sallman Ex. 2 for the Polysorbate
80 of Ogawa Ex. 6.

42. InnoPharma and Lupin v. Senju and Bausch & Lomb
PTAB Opinion:
Patent upheld based on finding of unexpected results.
Ø Thermal stability of bromfenac was unexpected increased by 44%
when Polysorbate 80 is replaced by tyloxapol. (Both materials are
polyethoxylated non-ionic surfactants.)
Ø Moreover, decreasing the amount of tyloxapol relative to the amount
of polysorbate 80 in Ogawa, from 0.15 g to 0.02 g, still provides
increased thermal stability (relevant to claims 3,4, and 6).
Ø Increased stability relative to Ogawa also observed in the absence of
sodium sulfite (reducing agent).
Ø With 0.02 w/v% tyloxapol, PROLENSA® exhibits zero side effects of
burning and stinging upon contact with eye, unlike all prior art
ophthalmic NSAIDS (relevant to claims 3,4, and 6).

43. Ø Claims found inoperable because they require violating
the principle of conservation of mass.
Process Control Corp. v. HydReclaim Corp., 190 F.3d
1350, 1359 (Fed.Cir.1999)
Ø Claims to a perpetual motion machine ruled inoperable.
Newman v. Quigg, 877 F.2d 1575 (Fed.Cir.1989)
§ 112(a) – Enablement

44. 10/24/18
Cantor Colburn is
#4 U.S. Utility Patent Firm
Source: IP Watchdog, February 28, 2018.
“Top Patent Law Firms for 2017
We compiled a list of the top patent law firms that are ranked based on the
total number of U.S. utility patents that issued in 2017 where the patent firms
were listed on the front of the utility patents.”

45. Connecticut Invention Convention (CIC)
Audrey Larson received Cantor Colburn Patent Award
Ø Given to “an inventor whose invention is most ingenious and unique and likely to
have a high success of being awarded a patent.”
Ø Eighth grader at Dag Hammarskjold Middle School, Wallingford, CT in 2017.
Ø Provisional application filed August 24, 2017, non-provisional application filed June
21, 2018.
Ø The nation’s oldest continuously operated children’s invention education program.
Ø Annually, more than 17,000 students in grades K-12, from over 275 Connecticut
schools, take part in the CIC learning curriculum.
Ø Annually, up to 2,400 students advance to compete in Regional, State, National,
and Global Invention Conventions annually.
https://www.youtube.com/watch?v=Q9RrHmSbQXM

46. Answers Dennis J. Jakiela, Ph.D.
Patent Agent
Registration No. 68,359
djakiela@cantorcolburn.com
(860) 286-2929
Follow: @CantorColburn