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 .
This Office action is a second Non-Final Office action.
Election/Restrictions
Applicant has elected with traverse the species of: (A) aCDR-H1 of sequence SEQ ID NO: 77; (B) a CDR-H2 of sequence SEQ ID NO: 91; (C) aCDR-H3 of sequence SEQ ID NO: 108; (D) a CDR-LI of sequence SEQ ID NO: 125; (E) a CDR-L2 of sequence SEQ ID NO: 142; (F) a CDR-L3 of sequence SEQ ID NO: 157; (G) a heavy chain variable region of sequence SEQ ID NO: 172; (H) a light chain variable region of sequence SEQ ID NO: 189; and (I) an epitope target corresponding to residues 92-106 of sequence SEQ ID NO: 212 in the reply filed on 8 July 2025.
Applicant has indicated Claims 1-3 and 38-42 as readable on the elected species.
Claims 4-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim at this time.
Claims 1-3 and 38-42 are examined upon their merits.
Claim Objections
In the interest of compact prosecution withdrawn claim 10 recites SEQ ID NO: 1112 for the CDR-H3, which should be SEQ ID NO: 112.
Improper Markush Rejection (Withdrawn)
Applicant’s arguments are persuasive to overcome the rejection of Claims 1, 38 and 41 on the basis that it contains an improper Markush grouping of alternatives. The rejection is withdrawn.
Claim Rejections - 35 USC § 112(b) (Withdrawn)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
As currently amended to recite human GFAP rather than UCH L1, the rejection of Claims 39-41 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 USC § 112(a) (New)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain 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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain 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, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 38-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement, because the specification, while being enabling for the 19 discrete antibodies (named GFAP-1 through GFAP-19 in the disclosure; see Table 9), does not reasonably provide enablement for mixing and matching the 14 CDR-H1, 17 CRD-H2, 18 CDR-H3, 17 CDR-L1, 14 CDR-L2 and 16 CDR-L3 sequences to yield millions of antibody combinations. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
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.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be “given their broadest reasonable interpretation consistent with the specification.” See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
As such, the broadest reasonable interpretation of the antibody or antigen-binding invention of Claim 1 is that it can comprise mixing and matching CDR sequences. For example, CDR-H1 can be selected from any one of SEQ ID NOs: 77-90, CDR-H2 can be selected from any one of SEQ ID NOs: 91-107, CDR-H3 can be selected from any one of SEQ ID NOs: 108-124, CDR-L1 can be selected from any one of SEQ ID NOs:125-141, CDR-L2 can be selected from any one of SEQ ID NOs: 142-156, CDR-L3 can be selected from any one of SEQ ID NOs: 157-171. Claim 38 similarly reads upon mixing and matching 16 heavy chains and 17 light chains. In contrast to what is claimed, Table 9 demonstrates 19 discrete anti-GFAP antibodies (named GFAP-1 through GFAP-19) with defined SEQ ID NOs for each of the six CDRs, which would mean defined heavy and light chain sequences as well. The claims encompass, for example, an antibody comprising SEQ ID Nos.: 77, 92, 108, 125, 143 and 159, which is not specifically disclosed as one of GFAP antibodies 1-19.
In AMGEN INC. ET AL. v. SANOFI ET AL. (No. 21-757, decided May 18, 2023), the Supreme Court held that Amgen was not enabled for “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors]” (872 F. 3d 1367, 1372) even though Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. The case law applies to the instant claims because the claims encompass a vast array of antibodies that (1) bind GFAP and (2) meet the functional requirements recited in instant claims 39-40 (having specific dissociation constants) and claim 41 (binding specific epitopes within the GFAP protein).
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentech, Inc, v. Novo Nordisk, 42 USPQ 2d 1001, (CAFC 1997), the court held that:
"[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art", "[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement".
The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the invention commensurate in scope with the breadth of the claims, without first making a substantial inventive contribution. The mixing and matching of CDRs combinations yields millions of antibodies; and then one would have to screen them all for GFAP binding. Even further a person having ordinary skill would have to screen these for the functional dissociation constant (KD) properties recited by instant claims 39-40; would have to test what GFAP epitopes these antibodies bind, in accordance with instant claim 41; and further, would have to test these antibodies in the method of detecting GFAP in a human subject, as required by instant claim 42. This amount of further experimentation goes well beyond what is considered routine in the art and constitutes undue further experimentation.
Therefore, Claims 1 and 38-42 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Allowable Subject Matter
Claims 2 and 3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1 and 38-42 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STACEY N MACFARLANE/ Examiner, Art Unit 1675