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 .
Amendment after Non-final office action filed on June 9, 2026 is acknowledged.
Claims 52 and 67 have been cancelled.
Claims 50-51, 53-66 and 68-69 are pending in this application.
Claims 55-56, 58 and 61 are rejoined herein.
Claims 50-51, 53-66 and 68-69 are examined on the merits in this office action.
Withdrawn Objections and Rejections
Objection to the drawings is hereby withdrawn in view of Applicant filing replacement sheet on June 9, 2026.
Objections to claim 50 are hereby withdrawn in view of Applicant’s amendments to the claim.
Objection to claim 67 is hereby withdrawn in view of Applicant’s cancellation of the claim.
Rejections of claims 50-54, 57, 59-60 and 62-69 under 35 U.S.C. 112(b), are hereby withdrawn in view of Applicant’s amendment to the claims.
Rejection of claims 50-54, 57, 59-60, 62-64 and 68 under 35 U.S.C. 102(a)(1) as being anticipated by Ruoslahti grant X81XWH-12-1-0173 (September 2014, pp. 1-8, filed with IDS), is hereby withdrawn in view of Applicant’s amendment to the claims and Applicant’s persuasive arguments.
Rejection of claims 50-54, 57, 59-60, 62-65 and 68 under 35 U.S.C.103 as being obvious over Ruoslahti grant X81XWH-12-1-0173 (September 2014, pp. 1-8, filed with IDS) in view of Smith et al (US Patent No. 4966848, cited in the previous office action) or Peers et al (US Patent No. 5837218, cited in the previous office action) or Smith et al (US Patent No. 5223421, cited in the previous office action), is hereby withdrawn in view of Applicant’s amendment to the claims and Applicant’s persuasive arguments.
Rejection of claims 50-54, 57, 59-60 and 62-69 under 35 U.S.C.103 as being obvious over Ruoslahti grant X81XWH-12-1-0173 (September 2014, pp. 1-8, filed with IDS) in view of Smith et al (US Patent No. 4966848, cited in the previous office action) or Peers et al (US Patent No. 5837218, cited in the previous office action) or Smith et al (US Patent No. 5223421, cited in the previous office action), as applied to claims above, further in view of Ruoslahti et al (US Patent No. 8367621, filed with IDS), is hereby withdrawn in view of Applicant’s amendment to the claims and Applicant’s persuasive arguments.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
New Rejections
U.S.C. 112(b)
14. 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.
15. Claim 68 is 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.
16. Claim 68 recites, “The composition of claim 50, wherein the composition further comprises…” Instant claim 68 is dependent on claim 50. Claim 50 recites, “A method comprising contacting activated…” Claim 50 is drawn to a method invention. Instant claim 68 is drawn to a composition. Therefore, the metes and bounds of the claim is unclear.
U.S.C. 112(d)
17. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
18. Claim 68 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
19. Claim 68 recites, “The composition of claim 50, wherein the composition further comprises…” Instant claim 68 is dependent on claim 50. Claim 50 recites, “A method comprising contacting activated…” Claim 50 is drawn to a method invention. Instant claim 68 is drawn to a composition. Therefore, claim 68 does not further limit instant claim 50.
DOUBLE PATENTING
20. 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.
21. Claims 50, 53-56, 58-59, 61-62, 64, 66 and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 25, 28, 30-31, 33 and 35 of copending Application No. 18/866119 (US 2025/0352654) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
22. Instant claims are drawn to:
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528
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124
572
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.
23. Copending claims are drawn to:
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190
598
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58
578
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154
590
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112
600
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114
554
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.
24. Instant claims and copending claims share the same peptide sequence, e.g., SEQ ID NO: 1 (CRVLRSGSC) and a method of inflammatory immune response. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
25. Claims 50-51, 53-54, 57, 59-60, 62-66 and 68-69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 11-15, 21-22 and 26-29 of copending Application No. 19/231345 (US 2025/0345388) (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
26. Instant claims are drawn to:
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528
594
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290
580
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124
572
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.
27. Copending claims are drawn to:
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94
406
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124
404
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244
422
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108
410
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272
420
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. Furthermore, as evidenced by copending specification, cancer is selected from the group consisting of brain cancer, renal cancer,…breast cancer…and melanoma (see paragraph [0006]). Therefore, treating breast cancer is at once envisaged.
28. Instant claims and copending claims share the same peptide sequence, e.g., SEQ ID NO: 1 (CRVLRSGSC) and a method of treating cancer. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
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 JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/29/2026