DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. This Office Action is in response to the amendment filed 05 August 2026, wherein claims 1-2, 36, 67, 73-74, 76, 91-92, 94, and 97 were amended and claims 19-20 were cancelled. It is noted that claim 36 was amended but has the status identifier of “previously presented”.
Claims 4-5, 7, 9-35, 37-64, 68, 70, 75, 78-81, 84-90, 93, 95-96, 98, and 100-113 are cancelled.
Claims 1-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 are under
consideration.
Objections Withdrawn
Specification
4. The objection to the disclosure for containing an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of Applicant’s amendments.
Claim Objections
5. The objections to claims 1-2 for informalities are withdrawn in view of Applicant’s amendments. The objection to claim 19 is rendered moot in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112
6. The following rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are withdrawn/rendered moot in view of Applicant’s amendments.
The rejections of claims 19-20 are rendered moot in view of Applicant’s amendments.
The rejection of claim 36 for being unclear if (1)-(14) are alternatives or all required is withdrawn in view of Applicant’s amendments.
The rejections of claim 67 for the “such as” language and it being unclear if the antibody or antigen-binding fragment is human or humanized/chimeric are withdrawn in view of Applicant’s amendments.
The rejection of 94 for being unclear if “pharmaceutically” is modifying “excipient” or every item in the list is withdrawn in view of Applicant’s amendments.
7. The rejection of claims 1-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendments.
8. The rejection of claim 36 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicant’s amendments.
9. The rejection of claims 91-92 and 97 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for isolated vectors and cells, does not reasonably provide enablement for unisolated vectors and cells, is withdrawn in view of Applicant’s amendments.
Double Patenting
10. The provisional rejection of claims 1-3, 6, 8, 19-20, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 on the grounds of nonstatutory double patenting as being unpatentable over claims 10 and 13 of copending Application No. 18/253,386 (reference application) is withdrawn in view of the abandonment of the copending application.
Objections Maintained
Specification
11. The use of the term Per. C6, which is a trade name or a mark used in commerce, remains objected to. Applicant argues that the trademark or registrations for the term has been abandoned and thus the mark is not appropriate. Examiner asserts that abandoned terms still require the mark.
Rejections Maintained
12. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
13. Claims 1-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 remain 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 remains rejected for reading on both monoclonal and polyclonal antibodies.
Claims 2-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99, which are dependent on claim 1, are similarly rejected.
Claims 73 and 76 remain rejected for the fragment thereof not having a defined numbering system due to the “or” language.
Applicant’s Arguments: Applicant argues polyclonal antibody preparations are defined in the specification as a composition that includes different antibodies, and that while an antibody molecule can be a part of the polyclonal composition, they are not polyclonal themselves and thus the molecules must have both the VH and VL. Applicant further states that the amendment to claims 73 and 76 alleviates the 112(b) issue.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
The argument that an antibody molecule can be part of a polyclonal composition but not polyclonal itself is not in commensurate in scope with the claims. Additionally, the Instant Specification at page 22 defines an antibody as polyclonal. It is improper to incorporate one embodiment of the specification into the claim when the broadest reasonable interpretation and definition section make clear the claim is broader than said embodiment. Thus, claim 1 still reads on a polyclonal antibody where the six CDRs are not all on one molecule. Examiner suggests making the antibody an antibody molecule. Regarding the amendment to claims 73 and 76, the numbering system of the fragment thereof is undefined due to the “or” language.
14. Claims 1-3, 6, 8, 36, 65-67, 69, 71-74, 76-77, 82-83, 91-92, 94, 97, and 99 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a monoclonal antibody comprising a full set of parental CDRs, does not reasonably provide enablement for any antibody molecule with fewer than all parental CDRs or mutated/truncated CDRs. 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 and use the invention commensurate in scope with these claims.
Applicant’s Arguments: Applicant argues that the amendments to claim 1 now requires all six parental CDRs.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive with respect to the issue below.
As discussed supra, claim 1 still reads on a polyclonal antibody and thus does not necessarily have all six CDRs on one monoclonal antibody. Furthermore, Applicant does not address the CDR numbering system of claim 1, as discussed in the Non-Final Office Action, pages 10-11. The cancellation of claims 19-20 does not remove Applicant’s responsibility to properly define the CDR numbering system.
New Objections
15. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites “the instant disclosure”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Art-Free Subject Matter
16. A monoclonal antibody comprising CDRH1-3 with SEQ ID NOs: 32, 35, and 5, respectively and CDRL1-3 with SEQ ID NOs: 9-11, respectively is currently free of the prior art.
Conclusion
17. No claim is allowed. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
