DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 12/18/2025 to claims 1, 24, 25, 29, and 31 have been entered. Claims and 2-23, 26-28, and 30 are canceled. Claims 1, 24, 25, 29, and 31 remain pending, of which claims 1 and 31 are being considered on their merits. Claims 24, 25, and 29 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
The instant amendments to claim 1 have overcome the 35 U.S.C. § 101 and 102 rejections of record, which are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Objections
Claim 1 is objected to because of the following informalities: 1) “surviving” when read in light of the specification is likely a typo for “survivin” (i.e. see GeneCards entry for BRIC5). 2) The status identifier for claims 24, 25, and 29 is only partially correct and so non-compliant under 37 C.F.R. § 1.121. While these claims have been amended in the instant reply, these claims also remain withdrawn from consideration. These claims should indicate “withdrawn” status in addition to their status regarding current or prior amendments. Appropriate correction in the next reply is required.
Claim Rejections - 35 USC § 112
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 1 and 31 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 1 has been amended to recite “idiotype of b cell lymphoma or multiple myeloma”, because it is entirely unclear which tumor antigens are and are not encompassed by the claimed phrase as the plain meaning of “idiotype” in this context would be directed towards the unique antigenicity of the antigen-binding site of any given antibody and could not be reasonably construed as a species of “tumor antigen” as claimed. Correction is required.
In so much that claim 31 depends from claim 31 and does not resolve the point of confusion, this claim must be rejected with claim 1 as indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner (US 2017/0196951; provided in the IDS dated 4/26/2022) in view of Baylink et al (US 2014/0134143) and Li et al. (Cell Research (2011), 21, 196-204) and as evidenced by Qu et al. (Mol Cell Biochem (2008), 313, 45-52).
Wagner teaches a composition comprising fibroblasts transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), and pax-5 (claim 9), reading on those embodiments of the tumor antigens for claim 1. Wagner further teaches methods of treating cancer by administering a fibroblast composition transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), pax-5 (claims 1, 8, and 9), reading in-part on claim 1.
Regarding claim 31, Wagner is silent regarding if the fibroblasts express CXCR4. However, Qu teaches a composition comprising fibroblasts transfected with a plasmid encoding for hTERT and which then overexpress CXCR4 as compared to control (i.e. non-hTERT) fibroblasts (p46, subheading “Cells”; p49, paragraph starting “Since CXCL12 was shown…” and Fig. 6). As both Qu and Wagner are directed towards a fibroblast composition transfected with hTERT, Wagner’s fibroblasts therefore inherently express CXCR4 and so Wagner as evidenced by Qu reads on claim 31. See M.P.E.P. § 2112.
Regarding claim 1, Wagner does not teach the product-by-process limitation towards the dedifferentiation of the fibroblasts towards any generic final stem cell type; this rejection addresses the embodiment of induced pluripotent stem cells (i.e. iPSCs) as a species of final cell type made from dedifferentiated fibroblasts.
Baylink teaches methods of treating cancer by administering induced pluripotent stem cells (i.e. iPSCs) to subjects thereof (claims 59 and 61), reading in-part on claims 6, 13, and 20.
Li teaches a method of generating iPSCs from mouse fibroblasts (i.e. dedifferentiation of the fibroblasts to iPSCs), the method comprising transfecting the fibroblasts with Oct4, Klf4, Sox2 and c-Myc and contacting the fibroblasts with a GSK-3 inhibitor, CHIR99021 to enhance the dedifferentiation/reprogramming process (p197, subheading “Generation of iPSCs with Oct4 and chemical combinations”), reading in-part on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further dedifferentiate the fibroblasts of Wanger into iPSCs according to the methods of Li and in view of Baylink. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wagner and Li are directed towards fibroblast compositions, and because Li teaches detailed methods of dedifferentiating/reprogramming fibroblasts to iPSCs. The skilled artisan would have been motivated to do so because Baylink teaches that the dedifferentiated cell type, iPSCs, are useful in methods of treating cancer in subjects thereof, and so the dedifferentiation of Wagner’s fibroblasts comprising the tumor antigens to iPSCs would be predictably advantageous to treat subjects for cancer in view of Baylink as Wagner also teaches treating subjects suffering from cancer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner (US 2017/0196951; provided in the IDS dated 4/26/2022) in view of Baylink et al (US 2014/0134143) and Taranger et al. (Molecular Biology of the Cell (2005), 16, 5719-5735) and as evidenced by Qu et al. (Mol Cell Biochem (2008), 313, 45-52).
Wagner teaches a composition comprising fibroblasts transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), and pax-5 (claim 9), reading on those embodiments of the tumor antigens for claim 1. Wagner further teaches methods of treating cancer by administering a fibroblast composition transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), pax-5 (claims 1, 8, and 9), reading in-part on claim 1.
Regarding claim 31, Wagner is silent regarding if the fibroblasts express CXCR4. However, Qu teaches a composition comprising fibroblasts transfected with a plasmid encoding for hTERT and which then overexpress CXCR4 as compared to control (i.e. non-hTERT) fibroblasts (p46, subheading “Cells”; p49, paragraph starting “Since CXCL12 was shown…” and Fig. 6). As both Qu and Wagner are directed towards a fibroblast composition transfected with hTERT, Wagner’s fibroblasts therefore inherently express CXCR4 and so Wagner as evidenced by Qu reads on claim 31. See M.P.E.P. § 2112.
Regarding claim 1, Wagner does not teach the product-by-process limitation towards the dedifferentiation of the fibroblasts towards any generic final stem cell type; this rejection addresses the embodiment of induced pluripotent stem cells (i.e. iPSCs) as a species of final cell type made from dedifferentiated fibroblasts.
Baylink teaches methods of treating cancer by administering induced pluripotent stem cells (i.e. iPSCs) to subjects thereof (claims 59 and 61), reading in-part on claim 1.
Taranger teaches a method of generating a pluripotent cell phenotype from fibroblasts (i.e. dedifferentiation of the fibroblasts to iPSCs), the method comprising contacting the fibroblasts with an extract of NCCIT germ cells (i.e. a species of pluripotent stem cells, see p5720, paragraph starting “Teratetracarcinomas are a …”) (p5720, subheading “Cell Extracts” and noting that Taranger does not separate any nuclear or cytoplasmic fraction, and so the extract of Taranger necessarily comprises the cytoplasm of the NCCIT cells; p5720, subheading “SLO-mediated Permeabilization and Cell Extract Treatment” for treatment of 2933T fibroblasts with the NCCIT germ cell extract; Table 1 and paragraph spanning p5721-5722 for expression of stem cell genes), reading in-part on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further dedifferentiate the fibroblasts of Wanger into cells having a pluripotent cell phenotype (i.e. induced pluripotent stem cell-like cells) according to the methods of Taranger and in view of Baylink. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wagner and Taranger are directed towards fibroblast compositions, and because Taranger teaches detailed methods of dedifferentiating/reprogramming fibroblasts to induced pluripotent stem cell-like cells. The skilled artisan would have been motivated to do so because Baylink teaches that the dedifferentiated cell type, induced pluripotent stem cell-like cells, are useful in methods of treating cancer in subjects thereof, and so the dedifferentiation of Wagner’s fibroblasts comprising the tumor antigens to induced pluripotent stem cell-like cells would be predictably advantageous to treat subjects for cancer in view of Baylink as Wagner also teaches treating subjects suffering from cancer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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.
Claims 1 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of co-pending Application No. 17/755,278 in view of Wagner (US 2017/0196951; provided in the IDS dated 4/26/2022), Baylink et al (US 2014/0134143), and Li et al. (Cell Research (2011), 21, 196-204) and as evidenced by Qu et al. (Mol Cell Biochem (2008), 313, 45-52).
This is a provisional nonstatutory double patenting rejection.
Claim 23 of the co-pending ‘278 application, which depends from claim 1, recites a dedifferentiated fibroblast composition and is directed in-part towards methods of treating cancer, reading in-part on instant claim 1.
Regarding instant claim 1, the co-pending ‘278 application does not claim at least two or more of the recited exogenous tumor antigens.
Wagner teaches a composition comprising fibroblasts transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), and pax-5 (claim 9), reading on those embodiments of the tumor antigens for claim 1. Wagner further teaches methods of treating cancer by administering a fibroblast composition transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), pax-5 (claims 1, 8, and 9), reading in-part on claim 1.
Regarding claim 31, Wagner is silent regarding if the fibroblasts express CXCR4. However, Qu teaches a composition comprising fibroblasts transfected with a plasmid encoding for hTERT and which then overexpress CXCR4 as compared to control (i.e. non-hTERT) fibroblasts (p46, subheading “Cells”; p49, paragraph starting “Since CXCL12 was shown…” and Fig. 6). As both Qu and Wagner are directed towards a fibroblast composition transfected with hTERT, Wagner’s fibroblasts therefore inherently express CXCR4 and so Wagner as evidenced by Qu reads on claim 31. See M.P.E.P. § 2112.
Baylink teaches methods of treating cancer by administering induced pluripotent stem cells (i.e. iPSCs) to subjects thereof (claims 59 and 61), reading in-part on claim 1.
Li teaches a method of generating iPSCs from mouse fibroblasts (i.e. dedifferentiation of the fibroblasts to iPSCs), the method comprising transfecting the fibroblasts with Oct4, Klf4, Sox2 and c-Myc and contacting the fibroblasts with a GSK-3 inhibitor, CHIR99021 to enhance the dedifferentiation/reprogramming process (p197, subheading “Generation of iPSCs with Oct4 and chemical combinations”), reading in-part on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the tumor antigens to the dedifferentiated fibroblasts of the co-pending ‘278 application in view of Li. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wagner and Li are directed towards fibroblast compositions, and because Li teaches detailed methods of dedifferentiating/reprogramming fibroblasts to iPSCs (e.g. a species of cell type made by dedifferentiating fibroblasts. The skilled artisan would have been motivated to do so because Baylink teaches that the dedifferentiated cell type, iPSCs, are useful in methods of treating cancer in subjects thereof, and so the dedifferentiation of the co-pending ‘278 application’s fibroblasts comprising the tumor antigens of Wagner to iPSCs according to Li would be predictably advantageous to treat subjects for cancer in view of Baylink as the co-pending ‘278 application is directed towards treating subjects suffering from cancer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 23 of co-pending Application No. 17/755,278 in view of Wagner (US 2017/0196951; provided in the IDS dated 4/26/2022), Baylink et al (US 2014/0134143), and Taranger et al. (Molecular Biology of the Cell (2005), 16, 5719-5735) and as evidenced by Qu et al. (Mol Cell Biochem (2008), 313, 45-52).
This is a provisional nonstatutory double patenting rejection.
Claim 23 of the co-pending ‘278 application, which depends from claim 1, recites a dedifferentiated fibroblast composition and is directed in-part towards methods of treating cancer, reading in-part on instant claim 1.
Regarding instant claim 1, the co-pending ‘278 application does not claim at least two or more of the recited exogenous tumor antigens.
Wagner teaches a composition comprising fibroblasts transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), and pax-5 (claim 9), reading on those embodiments of the tumor antigens for claim 1. Wagner further teaches methods of treating cancer by administering a fibroblast composition transfected with hTERT, HER2/neu, LCK, n-myc (i.e. MYCN), pax-5 (claims 1, 8, and 9), reading in-part on claim 1.
Regarding claim 31, Wagner is silent regarding if the fibroblasts express CXCR4. However, Qu teaches a composition comprising fibroblasts transfected with a plasmid encoding for hTERT and which then overexpress CXCR4 as compared to control (i.e. non-hTERT) fibroblasts (p46, subheading “Cells”; p49, paragraph starting “Since CXCL12 was shown…” and Fig. 6). As both Qu and Wagner are directed towards a fibroblast composition transfected with hTERT, Wagner’s fibroblasts therefore inherently express CXCR4 and so Wagner as evidenced by Qu reads on claim 31. See M.P.E.P. § 2112.
Baylink teaches methods of treating cancer by administering induced pluripotent stem cells (i.e. iPSCs) to subjects thereof (claims 59 and 61), reading in-part on claim 1.
Taranger teaches a method of generating a pluripotent cell phenotype from fibroblasts (i.e. dedifferentiation of the fibroblasts to iPSCs), the method comprising contacting the fibroblasts with an extract of NCCIT germ cells (i.e. a species of pluripotent stem cells, see p5720, paragraph starting “Teratetracarcinomas are a …”) (p5720, subheading “Cell Extracts” and noting that Taranger does not separate any nuclear or cytoplasmic fraction, and so the extract of Taranger necessarily comprises the cytoplasm of the NCCIT cells; p5720, subheading “SLO-mediated Permeabilization and Cell Extract Treatment” for treatment of 2933T fibroblasts with the NCCIT germ cell extract; Table 1 and paragraph spanning p5721-5722 for expression of stem cell genes), reading in-part on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the tumor antigens to the dedifferentiated fibroblasts of the co-pending ‘278 application in view of Taranger. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Wagner and Taranger are directed towards fibroblast compositions, and because Taranger teaches detailed methods of dedifferentiating/reprogramming fibroblasts to iPSCs (e.g. a species of cell type made by dedifferentiating fibroblasts. The skilled artisan would have been motivated to do so because Baylink teaches that the dedifferentiated cell type, iPSCs, are useful in methods of treating cancer in subjects thereof, and so the dedifferentiation of the co-pending ‘278 application’s fibroblasts comprising the tumor antigens of Wagner to iPSCs according to Taranger would be predictably advantageous to treat subjects for cancer in view of Baylink as the co-pending ‘278 application is directed towards treating subjects suffering from cancer.
Response to Arguments
Applicant's arguments on pages 5-11 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 8-10 of the reply, Applicant alleges that Wagner is deficient by not teaching every element of claim 1. This is not found persuasive because Wagner is not applied alone, but in-combination with Baylink and either Li and Taranger and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone. Applicant’s arguments do not address the examiner’s specific rationale of record to further dedifferentiate the fibroblasts of Wagner into iPSCs in view of Baylink and either Li or Taranger
Conclusion
No claims are allowed. No claims are free of the art.
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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653