DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Formal Matters
Claims 1-12 and 14-20 are pending. Claims 14 and 16 are withdrawn. Claims 1-12, 15 and 17-20 are the subject of this Office Action.
2. Claim Rejections - 35 USC § 112(a) – scope of enablement
Claims 1-5, 7-12, 15 and 17-20 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for H3B-6527, FGF-401 and BLU-554, does not reasonably provide enablement for the genus of inhibitors or suppressors of tyrosine kinase activity which bind to Cys552 in the ATP-binding region specific for FGFR4. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404, the factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
The breadth of the claims is excessive with regard to claiming any and all inhibitors or suppressors of tyrosine kinase activity which bind to Cys552 in the ATP-binding region specific for FGFR4. The genus potentially includes nucleic acids, proteins, including antibodies, as well as small organic and inorganic compounds. Applicants have only provided guidance and working examples of H3B-6527, FGF-401 and BLU-554 which do not clearly define other types of molecules in the genus.
Furthermore, it is not predictable to one of ordinary skill in the art how to make other members of the genus, including small organic molecules, given only H3B-6527, FGF-401 and BLU-554.
These factors lead the Examiner to hold that undue experimentation is necessary to practice the invention as claimed.
3. Claim Rejections - 35 USC § 112(a) – written description
A. Claims 1-8, 11, 12 and 15 remain rejected and claim 9 is also rejected for the reasons already of record on pages 2-5 of the Office Action dated 2/5/26. Claim 9 does not recite specific sequences and should have been included in the rejection.
Regardless, Applicants have amended the claims to recite “antigen-binding fragment”. This does help to remedy the situation, and may even be sufficient to overcome the rejection if more support is provided. Regardless of the amendment, the issue is based on the phrase “derived from”. The claims recite an H chain V region of either SEQ ID NO:16, 20, 24, 26, 30, 32, 34, 36, 38, 40, 42 or 44 and an L chain V region of either SEQ ID NO:18, 22, 28 and 46. While it does appear from the claims that a number of representative species are identified by SEQ ID NO, sequence comparisons among all of the regions has not been performed in order to determine if the genus is well-represented. In other words, given all of the distinct VH and VL sequences, would one of ordinary skill in the art know which residues can/cannot be amended in order to retain function?...or do the changes only represent a small portion of the genus, leading to a genus that is not adequately described?
Further arguments from Applicants, along with sequence alignments or other sequence comparison information, may be helpful in making such a determination.
B. Claims 1-5, 7-12, 15 and 17-20 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
These are genus claims. Other than inhibiting or suppressing tyrosine kinase activity by binding to Cys552 in the ATP-binding region specific for FGFR4, the specification and claims do not indicate what distinguishing attributes are shared by the members of the genus. Thus, the scope of the claims includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between/among genus members is permitted. The specification and claims do not provide any guidance as to what changes should be made. Structural features that could distinguish compounds in the genus from others in the nucleic acid, protein, or small molecule class are missing from the disclosure. No common structural attributes identify the members of the genus.
The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed. Since the disclosure fails to describe the common attributes or characteristics that identify members of the genus, and because the genus is highly variant, H3B-6527, FGF-401 and BLU-554, alone, are insufficient to describe the genus. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus. Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
4. Claim Rejections - 35 USC § 103
All rejections are withdrawn in view of Applicants’ amendments and arguments.
5. Nonstatutory Double Patenting
Claims 1-5, 7-12, 15 and 17-20 remain rejected over coepending application 17/599,820 in view of Kanzaki et al. for the reasons of record on pages 9-10 of the Office Action dated 2/5/26. The copending application claims the use of levatinib, which is known to act by binding Cys552 in the ATP-binding region specific for FGFR4. The rejection is being held in abeyance.
6. Conclusion
No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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