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 .
Status of Claims
Claims 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 36, 42, 45, 48-60, and 62 are cancelled. Claims 9, 11-12, 14-15, 17-18, 20, 27, 29-30, 32, 47, and 61 are withdrawn. Claims -----1-3, 5-6, 8, 21, 23-24, 26, 33-35, 37-41, 43-44, and 46 are currently pending and under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The claims have an earliest effective filing date of 63/004,149, corresponding to application 04/02/2020.
Information Disclosure Statement
The Information Disclosure Statements filed on 01/11/2024 and 05/17/2024 have been considered.
Election/Restrictions
Claims 9, 11-12, 14-15, 17-18, 20, 27, 29-30, 32, 47, and 61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026.
Claims 47 and 61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/29/2026.
Claim Objections
Claim 1 is objected to for reciting “Table 2 and 3” in the claim. Claims 2 and 3 are objected to for reciting “Table 5” in the claim. Claims 5 and 6 are objected to for reciting “Table 4” in the claim. MPEP 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
In the instant case the binding agent numbers of Tables 2-5 could easily be incorporated into the claims to define the invention. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 1 indicates an antibody or antibody fragment that is characterized by heavy and light chain CDR sequences. There is no art-settled meaning for an amino acid sequence that is characterized by another amino acid sequence. One skilled in the art would reason that an amino acid sequence that is characterized by another amino acid could include any number of amino acid variants.
As such one skilled in the art would be unable to readily delineate the metes and bounds of the claim.
Regarding claims 8, it is noted that claim 8 recites a VHCDR1 amino acid sequence of SEQ ID NO: 81, and a VHCDR1 amino acid sequence of SEQ ID NO: 81 allows for segments of SEQ ID NO: 81. This issue may be remedied by amending claim to recite “the VHCDR1 amino acid sequence of SEQ ID NO: 81”. As such one skilled in the art would be unable to readily delineate the metes and bounds of the claim.
Claims -----2, 3, 5-6, 21, 23-24, 26, 33-35, 37-41, 43-44, and 46 are included in the rejection of the claims under 35 U.S.C. 112(b), because these claims depend either directly or indirectly from claims 1 and/or 8 but do not remedy the deficiencies of these claims with respect to 35 U.S.C. 112(b).
Conclusion
No claim is allowed.
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/J.K.D./Examiner, Art Unit 1642
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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