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 .
Claims Status
The Amendment filed on 27Mar2025 is acknowledged in which claims 2-10 and 23-42 are canceled by Applicant.
Claim(s) 1 and 11-22 is/are currently pending and presented for examination on the merits.
Claim Objections
Claim(s) 1 (and dependent claims 11-22) is/are objected to because of the following informalities: “humor” in line 7 should be “humoral”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 11-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0206332 A1 (hereinafter “US332”).
Regarding instant claim(s) 1, 11, US332 teaches a method of treating a gastrin-associated tumor or cancer in a subject, comprising administering to the subject an effective amount of a composition that comprises (i) a first agent that induces and/or provides an active and/or a passive humoral immune response against a gastrin peptide and/or a CCK-B receptor; and (ii) a second agent that induces and/or provides a cellular immune response against the gastrin-associated tumor or cancer. [e.g., claim 16]. US332 further teaches a “therapeutic agent” means an agent used to “treat, inhibit, prevent, mitigate the effects of, reduce the severity of, reduce the likelihood of developing, slow the progression of, and/or cure, a disease or disorder such as but not limited to gastrin-associated tumor…” [e.g., ¶ 0102]. US332 further teaches the phrase “treatment” refers to “therapeutic and prophylactic treatment…Those in need of treatment include…those prone to have or predisposed to having a condition, disease, or disorder…” [e.g., ¶ 0103], meaning the method applies to subject “at risk” of developing gastrin-associated cancers and/or precancerous lesions thereof.
Regarding instant claim(s) 12, US332 further teaches the agent of group (i) consists of a gastrin peptide [e.g., claim 17].
Regarding instant claim(s) 13, US332 further teaches the gastrin peptide is selected from the group consisting of EGPWLEEEEE (SEQ ID NO: 1), EGPWLEEEE (SEQ IDNO: 2), EGPWLEEEEEAY (SEQ ID NO: 3), and EGPWLEEEEEAYGWMDF (SEQ ID NO: 4) [e.g., claim 18].
Regarding instant claim(s) 14, US332 further teaches the gastrin peptide is conjugated to an immunogenic carrier, optionally via a linker [e.g., claim 19].
Regarding instant claim(s) 15, US332 further teaches the immunogenic carrier is selected from the group consisting of diphtheria toxoid, tetanus toxoid, keyhole limpet hemocyanin, and bovine serum albumin [e.g., claim 20].
Regarding instant claim(s) 16, US332 further teaches the linker comprises a E-maleimido caproic acid N-hydroxysuccinamide ester [e.g., claim 21].
Regarding instant claim(s) 17, US332 further teaches the linker and the gastrin peptide are separated by an amino acid spacer, optionally wherein the amino acid spacer is between I and IO amino acids in length, further optionally wherein the amino acid spacer is 7 amino acids in length [e.g., claim 22].
Regarding instant claim(s) 18, US332 further teaches the composition further comprises an adjuvant, optionally an oil-based adjuvant [e.g., claim 23].
Regarding instant claim(s) 19, US332 further teaches the gastrin-associated tumor and/or cancer is pancreatic cancer [e.g., claim 27].
Regarding instant claim(s) 20, US332 further teaches the composition induces a reduction in and/or prevents the development of fibrosis associated with the pancreatic cancer [e.g., claim 28]. US332 teaches that “tumor” refers to “…all pre-cancerous and cancerous cells and tissues the initiation, progression, growth, maintenance, of metastasis of which is directly or indirectly influenced by autocrine and/or paracrine action of gastrin…” [e.g., ¶ 0104], and teaches PanIN precancerous lesions [e.g., ¶ 0003, 0005].
Regarding instant claim(s) 21, US332 further teaches the composition is administered in a dose selected from the group consisting of about 50 μg to about 1000 μg, about 50 μg to about 500 μg, about 100 μg to about 1000 μg, about 200 μg to about 1000 μg, and about 250 μg to about 500 μg, and optionally wherein the dose is repeated once, twice, or three times, optionally wherein the second dose is administered 1 week after the first dose and the third dose, if administered, is administered 1 or 2 weeks after the second dose [e.g., claim 29].
Regarding instant claim(s) 22, US332 teaches method for preventing, reducing, and/or eliminating formation of fibrosis associated with a tumor and/or a cancer, the method comprising contacting cells of the tumor and/or the cancer with an agent that directly or indirectly inhibits one or more biological activities of gastrin in the tumor and/or cancer [e.g., claim 84].
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.
Claim(s) 1, 11-19, and 21-22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5, 9-11 of U.S. Patent No. 11,583,576 B2 (hereinafter “US576”), in view of US 2020/0206332 A1 (hereinafter “US332”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 11-14, US576 claim 1 teaches A method for treating and/or preventing and/or inhibiting development of a tumor and/or a cancer associated with gastrin signaling in a subject, the method comprising administering to the subject a first composition comprising an effective amount of a first agent that induces a humoral immune response against a gastrin polypeptide and a second composition that comprises a second agent that induces and/or provides a cellular immune response against the gastrin-associated tumor or cancer, wherein the first agent comprises a gastrin peptide consisting of an amino acid sequence selected from the group consisting of SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3 conjugated to a immunogenic carrier via a linker. US332 is the PG Pub of US576 and teaches a “therapeutic agent” means an agent used to “treat, inhibit, prevent, mitigate the effects of, reduce the severity of, reduce the likelihood of developing, slow the progression of, and/or cure, a disease or disorder such as but not limited to gastrin-associated tumor…” [e.g., ¶ 0102]. US332 further teaches the phrase “treatment” refers to “therapeutic and prophylactic treatment…Those in need of treatment include…those prone to have or predisposed to having a condition, disease, or disorder…” [e.g., ¶ 0103], meaning the method applies to subject “at risk” of developing gastrin-associated cancers and/or precancerous lesions thereof.
Regarding instant claim(s) 15, US576 claim 2 teaches the immunogenic carrier is selected from the group consisting of diphtheria toxoid, tetanus toxoid, keyhole limpet hemocyanin, and bovine serum albumin.
Regarding instant claim(s) 16, US576 claim 3 teaches wherein the linker comprises a E-maleimido caproic acid N-hydroxysuccinamide ester.
Regarding instant claim(s) 17, US576 claim 4 teaches he linker and the gastrin peptide are separated by an amino acid spacer, optionally wherein the amino acid spacer is between 1 and 10 amino acids in length, further optionally wherein the amino acid spacer is 7 amino acids in length.
Regarding instant claim(s) 18, US576 claim 5 teaches the method further comprises administering to the subject an adjuvant, optionally an oil-based adjuvant.
Regarding instant claim(s) 19, US576 claim 9 teaches he gastrin-associated tumor and/or cancer is pancreatic cancer.
Regarding instant claim(s) 21, US576 claim 11 teaches the first composition, the second composition, or both is administered in a dose selected from the group consisting of about 50 pg to about 1000 µg, about 50 µg to about 500 µg, about 100 µg to about 1000 µg, about 200 µg to about 1000 µg, and about 250 µg to about 500 µg, and optionally wherein the dose is repeated once, twice, or three times, optionally wherein the second dose is administered 1 week after the first dose and the third dose, if administered, is administered 1 or 2 weeks after the second dose.
Regarding instant claim(s) 22, US576 claim 10 teaches wherein the administering induces a reduction in and/or prevents the development of fibrosis associated with the pancreatic cancer. Further, the PG Publication of US576 is US332 which further teaches a method for preventing, reducing, and/or eliminating formation of fibrosis associated with a tumor and/or a cancer, the method comprising contacting cells of the tumor and/or the cancer with an agent that directly or indirectly inhibits one or more biological activities of gastrin in the tumor and/or cancer [e.g., claim 84].
Claim(s) 1 and 11-22 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-9, 16 of U.S. Patent No. 12,150,978 B2 (hereinafter “US978”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 11-13, US978 claim 1 teaches A method for preventing initiation of a pancreatic tumor or cancer in a subject, the method comprising: (a) providing a subject at risk for developing a pancreatic tumor or cancer; and (b) administering to the subject a composition comprising a gastrin immunogen comprising a gastrin peptide comprising, consisting essentially of, or consisting of an amino acid sequence selected from the group consisting of EGPWLEEEEE (SEQ ID NO: 1), EGPWLEEEE (SEQ ID NO: 2), EGPWLEEEEEAY (SEQ ID NO: 3), and EGPWLEEEEEAYGWMDF (SEQ ID NO: 4), wherein the gastrin immunogen induces an anti-gastrin humoral and/or cellular immune response in the subject sufficient to prevent initiation or progression of the pancreatic tumor or cancer in the subject.
Regarding instant claim(s) 14, US978 claim 2 teaches the gastrin peptide is conjugated to an immunogenic carrier, optionally via a linker.
Regarding instant claim(s) 15, US978 claim 3 teaches the immunogenic carrier is selected from the group consisting of diphtheria toxoid, tetanus toxoid, keyhole limpet hemocyanin, and bovine serum albumin.
Regarding instant claim(s) 16, US978 claim 4 teaches the linker comprises a ɛ-maleimido caproic acid N-hydroxysuccinamide ester.
Regarding instant claim(s) 17, US978 claim 5 teaches the linker and the gastrin peptide are separated by an amino acid spacer, optionally wherein the amino acid spacer is between 1 and 10 amino acids in length, further optionally wherein the amino acid spacer is 7 amino acids in length.
Regarding instant claim(s) 18, US978 claim 6 teaches the composition further comprises an adjuvant, optionally an oil-based adjuvant.
Regarding instant claim(s) 19, US978 claim 7 teaches the composition induces a reduction in and/or prevents the development of fibrosis associated with the pancreatic cancer.
Regarding instant claim(s) 20, US978 claim 9 teaches A method for inhibiting development of a pancreatic intraepithelial neoplasia (PanINs) in a subject, the method comprising: (a) providing a subject at risk for developing a PanINs; and (b) administering to the subject a composition comprising a gastrin immunogen, wherein the gastrin immunogen comprises a gastrin peptide that comprises, consists essentially of, or consists of an amino acid sequence selected from the group consisting of EGPWLEEEEE (SEQ ID NO: 1), EGPWLEEEE (SEQ ID NO: 2), EGPWLEEEEEAY (SEQ ID NO: 3), and EGPWLEEEEEAYGWMDF (SEQ ID NO: 4), wherein the gastrin immunogen inhibits development of the PanINs in the subject.
Regarding instant claim(s) 21, US978 claim 8 teaches he composition is administered in a dose selected from the group consisting of about 50 µg to about 1000 µg, about 50 µg to about 500 µg, about 100 µg to about 1000 µg, about 200 µg to about 1000 µg, and about 250 µg to about 500 µg, and optionally herein the dose is repeated once, twice, or three times, optionally wherein the second dose is administered 1 week after the first dose and the third dose, if administered, is administered 1 or 2 weeks after the second dose.
Regarding instant claim(s) 22, US978 claim 16 teaches a method for preventing formation of fibrosis associated with a tumor and/or a cancer, the method comprising contacting cells of the tumor and/or the cancer with a composition that comprises, consists essentially of, or consists of an agent that directly or indirectly inhibits one or more biological activities of gastrin in the tumor and/or cancer.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643