DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 7/31/26 has been entered in full. Claims 1-4, 11, 13 and 15 are amended. Claims 1-4, 6, 11, 13, 15, 25-27, 29-30, 32-33, 35, 39, 41, 51-52 and 55-56 are pending.
Applicants’ election of Group I, claims 1-4, 6, 11, 13, 15 and 27, was previously acknowledged and treated as an election without traverse. Claims 25-26, 29-30, 32-33, 35, 39, 41, 51-52 and 55-56 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The election of SEQ ID NO: 8 as the species of GPCR was also previously acknowledged and reads on each claim in the elected group.
Claims 1-4, 6, 11, 13, 15 and 27 are under consideration.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (5/1/26).
The objection to the drawings at pages 2-3 is withdrawn in view of the replacement sheets filed on 7/31/26.
The objection to the specification at page 3 is withdrawn in view of the substitute specification filed on 7/31/26.
The objections to claims 1-4, 6, 11, 13, 15 and 27 at page 3 is withdrawn in view of the amendments to the claims.
The rejection of claims 1-4, 6, 11, 13, 15 and 27 at page 4 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter is withdrawn in view of the amendments to the claims.
The rejection of claims 1, 6 and 27 at page 10 under 35 U.S.C. 102(a)(1) as being anticipated by Tian et al, WO 2018/098262, is withdrawn in view of the amendments to the claims.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(a), written description
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 1-2, 4, 6, 11, 13, 15 and 27 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 written description requirement. The claim(s) contains 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was set forth at pages 4-9 of the previous Office action.
At page 9 of the 7/31/26, Applicants argue that the rejection should be withdrawn because claim 1 has been amended to limit the inhibitory molecule of independent claim 1 to “a nanobody comprising an amino acid sequence having at least 80% identity with SEQ ID NO: 2 or SEQ ID NO: 3” (page 9). Applicants argue that as such the claims no longer encompass inhibitory molecules “that are proteins other than nanobodies” and instead are limited “to inhibitory nanobodies having at least 80% identity with nanobodies that are acknowledged by the Examiner to be supported in the application as filed, and which “bind [and] inhibit the cpFp in a basal state” (page 9).
Applicants’ arguments have been fully considered but are not found persuasive. While it is acknowledged that rejection of record indicated that a GEFI of claim 1 having an inhibitory molecule that is “a nanobody that is Nb39 (SEQ ID NO: 2) or Nb80 (SEQ ID NO: 3)” meets the written description provision (page 9 of the 5/1/26 Office action), the rejection did not indicate that a GEFI of claim having an inhibitory molecule that has at least 80% identity to SEQ ID NO: 2 or 3, as now claimed, meets the provision. A variant with this scope was not previously recited in the claims and thus is newly considered here. Variants with at least 80% identity include those with changes in up to 20% of the amino acid sequence. The nanobody Nb39 is a sequence of 124 amino acids, and the nanobody Nb80 is a sequence of 120 amino acids, and thus variants with up to 20% changes include those with up to 24 amino acid changes. Nb39 and Nb80 are nanobodies having a “single monomeric variable antibody domain” as described in the instant specification (¶ 55, published application), which thus comprises three CDRs in total. While the instant specification does not teach the identity of the CDRs in Nb39 or Nb80, the relevant prior art (Tu et al, 2020. Immunology. 161: 53-65) teaches that “The CDR3 is the most polymorphic region of IgGs and the main contributor to antigen binding. The CDR3 loop in VHHs of dromedary is loner than the loop in VHs from humans or mice (average of 14 or 13 amino acids, respectively). Longer loop size increase the paratope size and consequently help compensate for the diversity loss that occurs when light chains are not absent” (page 61) and that 18 is the average length (page 58). Variants with up to 24 amino acid changes include those in which the entirety of the CDR3 of Nb39 or Nb80 is changed by substitution mutation. Likewise, variants with up to 10% changes, as encompassed by dependent claim 2, include those with up to 12 amino acid changes, which is still a majority of the amino acids of CDR3. The instant specification does not provide any description of inhibitory nanobodies that retain the required binding characteristics but with different CDR3s from those of Nb39 or Nb80. As such, the rejection of record is maintained over the claims as amended.
Note that claim 3 is not included in this rejection, because as amended, it is limited to a GEFI comprising a nanobody that comprises an amino acid sequence having at least 95% identity with SEQ ID NO: 2 or 3. A variant with up to 5% changes to SEQ ID NO: 2 or 3 is limited to six amino acid changes across the sequence, which is less than a majority of the CDR3 of Nb39 or Nb80.
New Claim Objections
Claims 1-4, 6, 11, 13, 15 and 27 are objected to for the following informalities:
Claim 1 has been amended to add a third concluding “wherein clause”. In view of this, the “and” joining the first and second clause should be moved to between the second and third clause. Furthermore, the term “inhibitory molecule” in the new clause is missing an article (compare with line 4). As such, the word “and” should be deleted on line 5, and the new clause on line 7 should be begin, “and wherein the inhibitory molecule”
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Conclusion
Claim 3 is 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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