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 .
Claim Status
Claims 1-148 and 161 are cancelled. New claim 169 is added. Claims 149-160 and 162-169 are pending. Claims 149-158 and 163-168 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5/14/25.
Claims 159-160, 162 and 169 are currently under consideration for patentability under 37 CFR 1.104.
Terminal Disclaimer
The terminal disclaimer filed on 10/22/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Application 18/654,304 and U.S. Patent 12,016,910 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Interview with Applicant
The Examiner contacted Applicant on 1/8/26 to propose an Examiner’s Amendment to overcome the outstanding issues. Applicant requested mailing of an Office Action detailing the issues. See attached Interview Summary.
Compliance with 37 CFR §§ 1.821—1.825
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). The amendments filed 10/22/25 place the application in compliance with the requirements of 37 C.F.R. §§ 1.821-1.825.
Objections Withdrawn
The objection to the abstract of the disclosure because the abstract contains acronyms and/or abbreviations that should be spelled out upon first occurrence is withdrawn in light of Applicant’s amendments thereto.
The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code on page 37, 42, 63, 67, 75, 80, 124, 125, and 137 is withdrawn in light of Applicant’s amendments thereto.
The objection to claim 159 because of the following informalities: the term “BIRC5” contains an acronym and/or abbreviation that should be spelled out upon first occurrence is withdrawn in light of Applicant’s amendments thereto.
Claim Rejections Withdrawn
The rejection of claims 159-160 and 162 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 161 is rendered moot by cancellation of the claim.
The rejection of claims 159-160 and 162 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 is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 161 is rendered moot by cancellation of the claim.
The rejection of claims 159-160 and 162 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Winther et al (US 2015/0329617 A1; filed 3/13/02; published 11/19/15) is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 161 is rendered moot by cancellation of the claim.
The rejection of claims 159-160 and 162 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 is withdrawn in light of Applicant’s amendments thereto. The rejection of claim 161 is rendered moot by cancellation of the claim.
The rejection of claims 159-160 and 162 under 35 U.S.C. 102(a)(2) as being anticipated by Chene et al (US 12,016,910 B2; filed 4/11/19; published 6/25/24) is withdrawn in light of Applicant’s arguments thereto. The rejection of claim 161 is rendered moot by cancellation of the claim.
The provisional rejection of claims 159-160 and 162 on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/654,304 (reference application) is withdrawn in light of the Terminal Disclaimer filed 10/22/25. The rejection of claim 161 is rendered moot by cancellation of the claim.
The rejection of claims 159-160 and 162 on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,016,910 is withdrawn in light of the Terminal Disclaimer filed 10/22/25. The rejection of claim 161 is rendered moot by cancellation of the claim.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The provisional rejection of claims 159-160, 162 and 169 on the ground of nonstatutory double patenting as being unpatentable over claims 27, 30, and 34 of copending Application No. 18/852,118 (reference application) is maintained. The rejection of claim 161 is rendered moot by cancellation of the claim.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are directed to ameliorating, reducing, preventing, and/or treating an adrenal cancer or for reducing or preventing reoccurrence in a subject comprising administering a peptide comprising an epitope of BIRC5, an immunogenic compound comprising the peptide, a nanoparticle loaded with the peptide, a cell loaded with the peptide, or a pharmaceutical composition comprising the peptide, immunogenic compound, nanoparticle, or cell. The adrenal cancer can be pheochromocytoma or ACC. The peptide can comprise an amino acid sequence set forth in any one of SEQ ID NO:287-289, or consists of an amino acid sequence as set forth in SEQ ID NO:289.
The copending application claims an antigenic peptide comprising SEQ ID NO:32 in combination with other antigenic peptides, or a pharmaceutical composition thereof (see e.g. claim 27, 30, and 34). Copending SEQ ID NO:32 is identical to instant SEQ ID NO:289. The copending application claims also are directed to a method for preventing and/or treating cancer or initiating or prolonging an anti-tumor response comprising administering the claimed peptide (see e.g. claims 27, 30, and 34). Given that the composition comprises the structure required by the instant claims, the recited peptide would inherently prevent adrenal cancer, including pheochromocytoma and ACC, upon administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s Arguments
Applicant argues:
1. Applicant argues that the present application has an earlier patent term filing date than the reference application, and therefore should be withdrawn when it is the only rejection remaining.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
1. MPEP 1490 states that “if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.” However, the double patenting rejection is not the only rejection remaining, and therefore the rejection is maintained.
It is strongly advised that Applicants file any Terminal Disclaimer by using eTerminalDisclaimer (http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp) in EFS-Web. The new eTerminal Disclaimer provides applicants with many advantages and promotes greater efficiency in the patent examination process. This web-based eTerminal Disclaimer can be filled out completely online through web-screens and no EFS-Web fillable forms are required. eTerminal Disclaimers are auto-processed and approved immediately upon submission if the request meets all of the requirements. This is especially important for a Terminal Disclaimer filed after final.
Fees must be paid immediately which will then provide users more financial flexibility. A paper filed Terminal Disclaimer requires a fee but does not guarantee a Terminal Disclaimer approval. Each eTerminal Disclaimer filed requires a single terminal disclaimer fee, but can include up to 50 “reference applications” and 50 “prior patents”.
See http://www.uspto.gov/patents/process/file/efs/guidance/eTD-QSG.pdf for instructions. For assistance with filing an eTerminal Disclaimer, or to suggest improvements, please call the Patent Electronic Business Center at 866-217-9197 (toll free) or send an email to EBC@uspto.gov.
New Claim Rejections
Claim Rejections - 35 USC § 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 159-160, 162, and 169 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 159 recites subparts (i)-(v), but it is unclear if the named components must be administered to the subject together, or if the listed subparts are alternatives that are administered individually. It is recommended that Applicant amend the claim to add a conjunction such as “or” or “and” to clarify the listing of subparts.
Claim 159 recites four compositions in subpart (v), but it is unclear if each component is present in the composition, or if each component is an alternative that would be present separate from the other components in the list. It is recommended that Applicant amend the claim to add a conjunction such as “or” or “and” to clarify the required components of the composition.
Claim 169 recites administration of the nanoparticle of part (iii) and the pharmaceutical composition of part (v). It is unclear if these administrations are both required and administered separately, if they are alternatives, or if they are referencing the same administration.
Claims depending from the rejected claims do not remedy the deficiency and therefore are also rejected.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREA MCCOLLUM whose telephone number is (571)272-4002. The examiner can normally be reached 9:00 AM to 6:00 PM EST.
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, VANESSA FORD can be reached at (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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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/BRIAN GANGLE/Primary Examiner, Art Unit 1645