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 .
DETAILED ACTION
Claims 1-12 are pending.
Claims 1-12 are under examination on the merits.
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. Claims 1-12 have an effective filing date of 09/30/2022, corresponding to PRO 63/377,801.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01-09-2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Notes on the Prior Art
The claims are drawn to an antibody that binds to sADAM9v2 comprising a heavy chain comprising CDR1 comprising an amino acid sequence of SEQ ID NO: 1, CDR2 comprising an amino acid sequence of SEQ ID NO: 2, and CDR3 comprising an amino acid sequence of SEQ ID NO: 3; and a light chain comprising CDR1 comprising an amino acid sequence of SEQ ID NO: 4, CDR2 comprising an amino acid sequence of SEQ ID NO: 5, and CDR3 comprising an amino acid sequence of SEQ ID NO: 6. Following a sequence search, it has been determined that the claimed antibody that binds to sADAM9v2 is a novel antibody. Furthermore the instantly claimed antibody is not an obvious variant of any art-known antibody that binds to sADAM9v2. As such the instant claims are free of the prior art.
Objection to the Drawings
The drawings are objected to, because Figure 8 is blurry and difficult to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections
35 U.S.C. 112(b)
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.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites an antibody that binds to sADAM9v2 comprising a heavy chain comprising CDR1 comprising an amino acid sequence of SEQ ID NO: 1, CDR2 comprising an amino acid sequence of SEQ ID NO: 2, and CDR3 comprising an amino acid sequence of SEQ ID NO: 3; and a light chain comprising CDR1 comprising an amino acid sequence of SEQ ID NO: 4, CDR2 comprising an amino acid sequence of SEQ ID NO: 5, and CDR3 comprising an amino acid sequence of SEQ ID NO: 6. The recitation of an amino acid sequence renders the claim indefinite, because the claim encompasses, for example, an antibody that binds to sADAM9v2, wherein said antibody comprises a heavy chain CDR1 that is a partial sequence of SEQ ID NO: 1. An amino acid sequence of SEQ ID NO: 1 encompasses an amino acid sequence that may comprise only two consecutive amino acid residues of SEQ ID NO: 1. As such the claim is indefinite, because one skilled in the art could not readily delineate the metes and bounds of the claim. Claims 2-12 are included in this rejection, because these claims either directly or indirectly depend from claim 1 but do not remedy the 112(b) issues of claim 1.
Applicant is informed that this rejection may be overcome by amending claim 1 to recite an antibody that binds to sADAM9v2 comprising a heavy chain comprising CDR1 comprising the amino acid sequence of SEQ ID NO: 1, CDR2 comprising the amino acid sequence of SEQ ID NO: 2, and CDR3 comprising the amino acid sequence of SEQ ID NO: 3; and a light chain comprising CDR1 comprising the amino acid sequence of SEQ ID NO: 4, CDR2 comprising the amino acid sequence of SEQ ID NO: 5, and CDR3 comprising the amino acid sequence of SEQ ID NO: 6.
Regarding claims 2-4, the term “preferably” and the phrase “more preferably” renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 11 is rejected under 35 U.S.C. 112(b), because claim 19 is a “use” claim. According to MPEP 2173.05(q), “[a]ttempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: ‘[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon’ was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).” Claim 11 recites the use of an antibody that binds to sADAM9v2 for manufacturing a pharmaceutical composition for treating sADAMv2-related diseases; however the claim does not recite any active, positive steps defining how this use is actually practiced and is therefore rejected under 35 U.S.C. 112(b).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642