The (Sometimes) Rocky Road of Patent Prosecution

1. The (Sometimes) Rocky Road of Patent Prosecution David W. Ladner And Chirag Patel

2. Chemistry/Pharmaceuticals • Patentable Subject Matter • Compounds (the molecule) • Sequences (Not Found in Nature) • Compositions (the actual product) • Methods of Use • Method of Preparation • Intermediates • Apparatuses • Diagnostic Kits • Secondary Uses • Novel Crystalline Forms/Polymorphs NAPP 2015 Nuts and Bolts

3. Chemical Patent Prosecution • Essentials in preparation • The Claims • How Broad can you go? • How many can you afford? • How much support do you have? • Experimental Examples • Data • Do you know the prior art? • How many Inventions? • No “Profanity”!!

4. Checklist • How big is the genus, e.g., • The largest, general, all encompassing chemical structure (formula)? • Can you support it? • Have a fall back position(s). • What is the utility? • Can you support it? • US and ex-US? • Equivalents?

5. The Dilemma • File early to get early priority Or • File later to get longer exclusivity during the actual product lifetime, with likely better enablement

6. Chemistry/Pharmaceuticals • Provisional application(s) are common. • Use of PCT applications to delay major costs • Bolster initial (offensive) protection with follow-on (often defensive) filings. • “Patent of Selection”

7. What to Expect • Inventor will likely want broader scope than can be easily supported • Inventor may have only considered narrow scope for some groups • Inventor may have overlooked some “obvious” groups

8. “The Cloud”

9. A compound of Formula (I) wherein R1 is H, halo, amino, dialkylamino, phenyl or nitro; R2 is H, lower alkyl or phenyl; R3 is H or lower alkyl; R4 is H, halo, lower alkyl or CN; R5 is H or lower alkyl optionally substituted with phenyl; and X is O or S.

10. Checklist • Some R combinations may be unstable • Some R combinations could result in loss of novelty • Some compounds may be beyond the realm of ability of a PHOSITA to make • Some will be never be made • Some will not likely have utility • Disclosure can discourage others from patenting within your genus, but • It could also hurt the Inventor in follow-on filings

11. Electrical/Software/Business Methods • Patentable Subject Matter • Apparatus (circuits, devices, modules) • Process (operations) • System (network, ) • Methods of Use • Method of Manufacturing • Business methods (?) • Software (?) • Computer readable media (?) • Assembly/kit NAPP 2015 Nuts and Bolts

12. Electrical/Software/Business Methods • Provisional application(s) are common. • Allows time for prior art search • Enablement? • Use of PCT applications to delay major costs • Bolster initial (offensive) protection with follow-on (often defensive) filings.

13. Electrical/Software/Business Methods • Importance of detailed and varied implementations • If only one embodiment is disclosed, court is likely to (although not supposed to) read limitations from that embodiment into broad claim terms (see Gen. Am. Trans. Corp. v. Cryo-Trans, Inc., CAFC, 1996).

14. Electrical/Software/Business Methods • Examples of technical effect that may allow avoiding rejections under 101 • Image processing • Speech recognition • Encryption/decryption • modulation/demodulation • Higher speed • Economical use of memory • Low energy use

15. Electrical/Software/Business Methods • Avoiding covered business method (CBM) review: • Have at least some claims that are not directed to performing data processing or other operation used in the practice, administration, or management of a financial product or service.” • Recite a “technological feature” in the claim to fall into the “technological invention” exception. • Avoid monetary, financial terms in the specification and claims.

16. Electrical/Software/Business Methods • Functional Claiming (“Configured to,”“operable to,”“adapted to,” etc.): • Covers all devices that are capable of the recited function • Irrespective of the structure of the device • Example: A processor “configured to” [do A, B, C] would cover future devices using any processor. • However, the underlying structure should be adequately disclosed in the specification to avoid written description rejections under 35 USC 112(a)

17. Electrical/Software/Business Methods • Computer readable media (CRM) Claims: • Cause software encoded on media (CD, server, etc.,) to infringe the claim • Have a good description of CRM in the specification • Disclaim non-transitory media (waveforms) from CRM in the specification to avoid 101 rejection • Valid after Alice? Undecided (although, over half a million active US patents have CRM claims)

18. Electrical/Software/Business Methods • PGR Proofing your application • Include large number of claims, make it expensive to challenge under PGR • Submit/include secondary evidence (commercial success, etc.,) as part of specification • Conduct thorough prior art search and submit IDS • Include claims with overlapping scope

19. Electrical/Software/Business Methods • means plus function: • Use of the terms such as “circuits,”“modules,” etc., may be interpreted as means plus function claim (if you intend to do so, OK, but in that case include sufficient implementations in the specification). • To avoid MPF interpretation  Provide clear and unambiguous description of operation • Example claim limitation: “a soft start circuit that provides a signal instructing said drive circuit to discontinue said drive signal when said magnitude of said oscillation signal is greater than a magnitude of said frequency variation signal.”  The word “circuit” in combination with a clear and unambiguous description of the circuit’s operation = avoid means-plus function construction. See Power Integrations v. Fairchild Semiconductor (Fed. Cir., March, 2013).

20. Typical Prosecution Sequence • File non-provisional • File IDS, Assignments, Declaration • First Action Interview Pilot Program • Patent Prosecution Highway • Get Restriction Requirement • First Office Action rejections • 101 (rare in Chemistry, possible in biotech) • 112 (enablement, written description) • 102/103 • Amend and argue: Consider First Action Interview PP • Final Office action, may be some allowances, still some rejections • Amend Response after final Interview • Allowance or Appeal or Abandon • RCE, Divisionals, Continuations

21. Patent Prosecution Highway • 20 participating offices, including EPO, Japan, China, Canada, UK, Australia, etc. • Within and outside the framework of PCT • Example PCT work products: • the written opinion of the International Searching Authority, • the written opinion of the International Preliminary Examining Authority, or • the international preliminary examination report issued within the framework of the PCT • May have to revise claims to conform with the allowable claims in corresponding jurisdiction • Applicants can generally obtain a final action more quickly before participating Offices

22. First Action Interview Pilot Program • Available in all areas, less than 3/20 claims, non-PRV, non-reissue, or national phase appl. • If the applicants follows the process, non-discretionary on part of Examiner • Must file a request electronically before first office action • Single invention and must elect without traverse • After the search, the Examiner sends a Pre-Interview Communication that includes citations to prior art references from the prior art search (similar to a search report) and an identification of any rejections and/or objections, if at least one claim is not allowable. • Applicant can request to not have a first action interview with the examiner, or schedule the interview and file a proposed amendment or remarks, within one month/thirty days. • If no interview  First Action Interview Office Action entered (30 days to respond) • If agreement on all claims  Notice of Allowance. • If no agreement on all claims  First Action Interview Office Action entered (30 days to respond) • Success rate: 41.4% allowance rate (2011 PTO statistics)

23. First Office Action Rejections • No Need to Panic • Read the rejection over carefully –look for hints in how to respond • Examiner may in fact be correct in some cases, but often these can be fixed • If you don’t understand, give examiner a call (interview) • Consult with inventor to strategize

24. 101 Rejections • Rare in Chemistry, however • Diagnostic methods, e.g., if mere mental processes • Naturally occurring gene and protein sequences • Quite common in computer software/business methods • Surviving Alice based rejections: • Force the Examiner to support “abstract idea” argument • Provide “significantly more” than “abstract idea.” • Show technical effect to avoid 101 rejections (example: improving functioning of computer, increasing effi • Use example of claims allowed in recent decisions (amend to be in line).

25. 112 Written Description Rejections Recurring Errors in claim language: • No antecedent basis • “and” instead of “or”; (vice versa in Markush groups • Wrong claim dependency • Method claim not perfected: Example “4. A method of using a compound of formula (I) for the treatment of diabetes.”

26. 112 Enablement Rejections Frequently cited by Examiner: • No enablement for claimed method of using. • Inadequate specific examples to support claim, or breadth of claim. • Lacking data or references for claimed utility. • Red Flags: “Heterocyclo-”; “Polymorphs”, “Prodrugs” ; “Cancer”; “Cure”; “Prevent”.

27. In re Wands (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

28. Responding to 112 Rejections • Amend/clarify claim language. • Use specification to indicate support for terms/description. • Provide data to show “possession of the invention”. • Provide literature references to link data to end use utility. • Caution: beware of the “112/103 squeeze”. • Narrow to cover that which is enabled.

29. 102 Rejections • A prior art compound fits in a generic claim • A method is disclosed, e.g., disclosed use for colon cancer, but not skin cancer. • Examiner uses an “inherency” argument: i.e., even though a limitation or feature of a claim was not disclosed or even recognized in the art, it anticipates the claim if it was inherent in the disclosure.

30. 1. A compound of Formula (I) wherein R1 is H, halo, amino, dialkylamino, phenyl or nitro; R2 is H, lower alkyl or phenyl; R3 is H or lower alkyl; R4 is H, halo, lower alkyl or CN; R5 is H or lower alkyl optionally substituted with phenyl; and X is O or S. Examiner finds a reference disclosing Compound I:

31. Reference #1 discloses Can you fix this? How? wherein R1 is H, halo, amino, dialkylamino, phenyl or nitro; R2 is H, lower alkyl or phenyl; R3 is H or lower alkyl; R4 is H, halo, lower alkyl or CN; R5 is H or lower alkyl optionally substituted with phenyl; and X is O or S.

32. Responding to 102 Rejections • Can you use “Consisting of” instead of “Comprising”? • Does it matter if the disclosed compound was not enabled? • Probably not, but I’d like to see a challenge • Your method of use claim has a long list of disease indications • If examiner finds any that are disclosed, you will have to amend • Arguing against inherency

33. Inherency Example: Prior art described a detection of urinary tract infections in which the DNA came from samples isolated from cells that were released in the urinary tract. However….the described technique might have inadvertently (and unknowingly) isolated and detected DNA from outside the urinary tract. Is this an Inherency problem?

34. Inherency Example, continued

35. 103 Rejections • A broad disclosure in one or more references suggests your compound class. • Structural similar compounds are known • One or more references teach or suggest that your compounds, while novel, would likely be useful for the intended use. • All the features/limitations of your claim are present in a combination of references, and it would be obvious for a PHOSITA to combine them.

36. Overcoming 103 Rejections Graham v John Deere 1) determine the scope and content of the prior art, (2) determine the differences between the prior art and the claimed invention, and (3) determine the level of ordinary skill in the pertinent art. A court or the PTO may also use secondary considerations such as commercial success, long-felt but unmet needs, and failure by others as objective indications of nonobviousness. • Post KSR – is everything obvious?

37. Overcoming 103 Rejections • Has examiner used impermissible hindsight or made unsubstantiated assertions? • Are all the limitations taught by the art? • Would a PHOSITA really have been motivated by the teachings with an expectation of success? • Are your compounds really taught, suggested? • Do your compounds do what is taught by the prior art? • Do you have surprising/unexpected results? Long felt need?

38. Reference #2 discloses wherein R8 is H, halo, phenyl; R9 is H or lower alkyl; R10 is H or lower alkyl; and Ar is phenyl and heterocyclyl. “Heterocyclyl” defined as 5- and 6-membered heterocyclic ring radicals containing from 1 to 3 hetero atoms selected form O, S and N. There are no actual examples where Ar is thienyl or furyl (X = O or S; Is this a problem? Maybe, but depending on other factors, may not need to change anything. wherein R1 is H, halo, amino, dialkylamino, phenyl or nitro; R2 is H, lower alkyl or phenyl; R3 is H or lower alkyl; R4 is H, halo, lower alkyl or CN; R5 is H or lower alkyl optionally substituted with phenyl; and X is O or S.

39. Overcoming 103 Rejections • Example: Prior art teaches a substituent R, Where R can be alkyl. “Alkyl” defined as straight branched, or cyclic C1-C8 groups. • Prior art discloses the n-propyl (C3) analog. • Examiner contends that cyclopropyl analog, although novel, is suggested, taught and obvious in light of the reference. • Rebuttal?

40. Overcoming 103 Rejections • Rebutting prima facie obviousness rejections • In medicinal chemistry, the replacement of one group with another can have significant effects on biological activity. • Cyclopropyl shown to be superior to n-propyl • Surprising results include, efficacy, lower toxicity, ease of formulating, longer half-life etc. Also might be able to show that • Method of making is not enabled by prior art • Prior art examples teach away from your compound.

41. Overcoming 103 Rejections • Is the prior art reference from Non-analogous art? • Is the problem to be solved different • If not, would it be “Reasonably pertinent”? • Would it “logically commend itself” to a PHOSITA? • If found to be non analogous, a reference cannot be used in a rejection. • This argument is worth considering, but not a high success rate in winning.

42. Overcoming 103 Rejections Examiner: Range of values (time, temperature) are a mere optimization over ranges taught by the art. Consider: • Your ranges define intrinsic properties not taught by the prior art (e.g., boiling point of a distillate). • Your range overlaps but is not wholly defined by the prior art for an important reason.

43. Interviews with Examiner • Call to schedule; trivial matters may be decided on the spot • Be prepared. • Agenda with items to be discussed, email, fax • References (new IDS). • Listen for hints and suggestions. • Consult with inventor before making major concessions. • An oral agreement is not worth the paper it is printed on.

44. Interviews with Examiner (cont’d) • Consider including the inventor on the Examiner interview, but prepare them beforehand • Request that supervisor examiner is present • Consider WebEx interview (each Examiner is equipped with WebEx) • Consider live interview • Video conferencing is available at each satellite office • Be open to Examiner’s Amendment (have blessing from clients beforehand, if possible)

45. Final Office Actions • Panic might be appropriate…but there is hope. • Perhaps a trivial amendment will make it all better. • INTERVIEW if you haven’t already • Response after final is possible, but limited • Come up with stronger arguments, new amendments; set up for possible appeal. • File RCE, especially if new amendments were not entered. • Lather, rinse, repeat • APPEAL if the case is strong enough and economics so dictate.

46. Appeals • Pre-Appeal Brief Request for Review • When to file – After two rejections • File with Notice of Appeal and fee ($800/400/200) • Use when Examiner has clear error or omission • Only five (5) pages of arguments • Review team: Examiner, SPE and another SPE (from different art unit with limited review time, therefore, odds are stacked against Applicant) • 2010 study found that 56% of the time Examiner affirmed

47. Appeals (continued) • Typical Process: *Image from www.uspto.gov

48. Appeals (continued) • Appeal Brief • Expensive (forwarding fee $2K/1K/.5k) • Long review time (2-3 years) • Forces the Examiner to defend her/his arguments (it’s a lot of work on Examiner’s part as well) • Consider in case of junior examiners • decided by a panel of three Administrative Patent Judges

49. Appeals (continued) • Appeal Brief Practice Tips • Appeal when you have strong conviction • Pick one or two of your strongest arguments • Argue claims with strongest arguments first • Argue at least one strong narrow dependent claim • Typically, rely on strong technical arguments v. legal arguments • Provide good summary of claimed subject matter for all claims that are argued • Can not use new affidavit, new evidence, etc., that was not argued during prosecution • Clearly point to examiner errors (I like to rebut each paragraph of the office action by referring to them)

50. Appeals (continued) • Reply Brief • Due two-months after the Examiner’s Answer • Not mandatory – However, recommended almost always (do not let the Examiner get the last word) • If the Examiner repeats old arguments, point that out • Summarize arguments from Appeal Brief if necessary (the Board may just review the Reply Brief) but make sure to rebut each argument from the Reply Brief • Do not raise new arguments or enter new evidence