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 .
Restriction/Election
Applicant’s election without traverse of Group I (Claims 1-10) in the reply filed on May 13,2026 is acknowledged. Claims 11-12,14-20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 13, 2026. After conducing a search, the examiner has decided to rejoin the species because they have similar functions.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tesar (WO 2018106782)
Tesar discloses a method for accelerating cellular maturation of a cell, the method comprising impairing the activity of developmental transcription condensates at an intermediate stage of cell lineage for the cell (Tesar, Abstract, Paragraphs 23,112,115,184-185, and 204) as in instant Claim 1. Tesar discloses wherein the cell is an oligodendrocyte (Paragraph 44) as in instant Claim 2. Tesar discloses wherein the method accelerates oligodendrocyte maturation (Paragraph 58 of Tesar) as in instant Claim 9, Tesar discloses wherein the method enhances myelination (Abstract, Paragraphs 58 and 311) as in instant Claim 10.
The reference anticipates the claim limitations
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao “MicroRNA-Mediated Control of Oligodendrocyte Differentiation” Neuron 2010 March 11: 65(5): 612-626
Zhao discloses a method for accelerating cellular maturation of a cell, the method comprising impairing the activity of developmental transcriptional condensates at an intermediate stage of a cell lineage for the cell (Abstract of Zhao) as in instant Claim 1. Zhao discloses wherein the cell is oligodendrocyte (Abstract of Zhao) as in instant Claim 2. Zhao discloses wherein the developmental transcriptional condensates are regulated by Sox6 (Abstract of Zhao) as in instant Claim 3, Zhao discloses wherein the method comprises delivering to the cell an agent to decrease expression of endogenous Sox6 (Abstract of Zhao) as in instant Claim 4. Zhao discloses wherein the agent is a micro RNA (Abstract of Zhao) as in instant Claim 5. Zhao discloses contacting the cell with a delivery vehicle (Page 4, last 3 paragraphs of Zhao) as in instant Claim 6, Zhao discloses wherein the cell is contacted in vitro or in-vivo (Page 4, last 3 paragraphs of Zhao) as in instant Claim 8, Zhao discloses wherein the method accelerates oligodendrocyte maturation (Page 4-Page 5) as in instant Claim 9. Zhao discloses wherein the method enhances myelination (Pages 7-9) as in instant Claim 10.
The reference anticipates the claim limitations.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao “MicroRNA-Mediated Control of Oligodendrocyte Differentiation” Neuron 2010 March 11: 65(5): 612-626 in view of Tesar (WO 2018106782)
Zhao applies as above to teach claims 1-6 and 8-10. Zhao teaches vectors that can be used to deliver the agents to the cells. Zhao does not teach the specific delivery vectors recited in claim 7. However, Tesar teaches that recombinant genetic engineering agents/constructs can be delivered to cells using delivery vehicles such as AAV vectors, an adenovirus vector, or a lentivirus vector (Paragraph 22 of Tesar). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the delivery agents taught by Tesar. An artisan would have been motivated to have used such delivery agents because they can successfully deliver such agents to cells under in-vitro, in-vivo, and ex-vivo conditions (Paragraphs 21-23 and 29-30 of Tesar). Because such agents can deliver genetic engineering constructs to the cells under in vitro, in vivo, and ex vivo conditions, there would have been a high expectation for success (Paragraphs 15-19, 22, 30 of Tesar) as in instant Claims 1, 6-8.
Dependent Claims taught by Zhao
Zhao teaches wherein the cell is an oligodendrocyte (Abstract of Zhao) as in instant Claim 2. Zhao teaches wherein the developmental transcriptional condensates are regulated by Sox6 (Abstract of Zhao) as in instant Claim 3, Zhao teaches wherein the method comprises delivering to the cell an agent to decrease expression of endogenous Sox6 (Abstract of Zhao) as in instant Claim 4. Zhao teaches wherein the agent is a micro RNA (Abstract of Zhao) as in instant Claim 5. Zhao discloses contacting the cell with a delivery vehicle (Page 4, last 3 paragraphs of Zhao) as in instant Claim 6, Zhao teaches that the cell is contacted in vitro, in vivo (Page 4) as in instant Claim 8, Zhao teaches wherein the method accelerates oligodendrocyte maturation (Page 4-Page 5) as in instant Claim 9. Zhao teaches wherein the method enhances myelination (Pages 7-9) as in instant Claim 10.
Dependent Claims taught by Tesar
Tesar teaches wherein the cell is an oligodendrocyte (Paragraph 44) as in instant Claim 2. Tesar teaches wherein the agent is an antisense oligonucleotide (ASO), a siRNA, A CRISPER interference agent (Cas effector enzyme and guide RNA), NgAO, or microRNA (Paragraphs 15-19 of Tesar) as in instant Claim 5. Tesar teaches the cell with a delivery vehicle (Paragraphs 22-23 of Tesar) as in instant Claim 6. Tesar teaches wherein the delivery vehicle is an AAV vector, an adenoviral vector, or a lentivirus vector (Paragraph 22) as in instant Claim 7. Tesar teaches wherein the cell is contacted in vitro, in vivo, or ex vivo (Paragraph 30 of Tesar) as in instant Claim 8, Tesar teaches wherein the method accelerates oligodendrocyte maturation (Paragraph 58 of Tesar) as in instant Claim 9, Tesar teaches wherein the method enhances myelination (Abstract, Paragraphs 58 and 311) as in instant Claim 10.
Zhao teaches vectors used to deliver its agents to cells such as oligodendrocyte cells. Zhao does not teach using delivery vehicles such as AAV vectors, adenoviral vectors, or a lentivirus vector; these delivery vehicles are taught by Tesar. An artisan would have been motivated to have used the teachings of Tesar because vehicles such AAV vectors, adenoviral vectors, or lentivirus vectors are able to successfully deliver such agents to cells under in-vivo, in-vitro, and ex-vivo conditions. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicant’s invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yield predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Col. V. Teleflex Inc. 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have practical knowledge in genetic engineering. Therefore, the level of ordinary skill in this art is high.
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 1-2,5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,3-7 of U.S. Patent No.10,982,216. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 10,982,216 are species of the instant set of claims. For example, claim 1 of Patent 10,982,216 recites, “a method for generating a cell that enhances functional myelin production (a sign of cell maturation acceleration), the method comprising delivering to the cell an antisense oligonucleotide ASO or a polynucleotide encoding said ASO, (1) wherein said ASO decreases expression level of an endogenous PLP1 gene (capable of impairing the activity of developmental transcriptional condensates at an intermediate stage of cell lineage), (2) wherein the cell produces functional myelin, or is a progenitor that produces or differentiates into the cell that produces functional myelin, and (3) wherein the endogenous PLP1 gene is a deleterious disease-causing mutant PLP1 gene. Thus claim 1 of Patent 10,982,216 discloses limitations present in the instant claim 1. Instant claim 2 corresponds to claim 1 of Patent 10,082,216. Instant claim 5 corresponds to claim 1 and 4 of Patent 10,982,216. Instant claims 6-7 correspond to claim 5 of Patent 10,982,216. Instant claim 8 corresponds to claims 6-7 of Patent 10,982,216. Instant claim 9 corresponds to claim 1 of Patent 10,982,216. Instant claim 10 corresponds to claim 3 of Patent 10,982,216.
Claims 1-2,5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-6 of U.S. Patent No.12,612,636. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 12,612,636 are species of the instant set of claims. Claim 1 of Patent 12,612,636 recites, “A method of sufficiently restoring functional myelin production in a cell in a subject, wherein the subject has insufficient myelination, the method comprising delivering to the cell in the subject an RNAi construct, or a polynucleotide encoding said RNAi construct, to decrease expression level of an endogenous PLP1 gene (this impairs the activity of the developmental transcriptional condensate at an intermediate stage of cell lineage), thereby sufficiently restoring functional myelin production by the cell (this would accelerate cell maturation by facilitating differentiation of stem cells into differentiated cells able to produce myelin), or by a differentiated progeny of the cell, wherein the endogenous PLP1 gene is a deleterious-disease causing mutant PLP1 gene.” Claim 1 of Patent 12,612,636 recites limitations present in instant claim 1. Instant claim 2 corresponds to claim 6 of Patent 12,612,636. Instant claim 5 corresponds to claims 3-4 of Patent 12,612,636. Instant claims 6-7 correspond to claim 5 of Patent 12,612,636. Instant claim 8 corresponds to claim 1 of Patent 12,612,636. Instant claim 9 corresponds to claim 1 of Patent 12,612,636. Instant claim 10 corresponds to claim 1 of Patent 12,612,636.
Claims 1-2,5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-8 of copending Application No. 19/638,220. Claim 1 of Application 19/638,220 recites, “A method of generating a cell that enhances functional myelin production, the method comprising delivering to the cell an antisense oligonucleotide or a polynucleotide encoding said ASO, to decrease expression level of an endogenous PLP1 gene (impairs the activity of developmental transcriptional condensates at an intermediate stage of cell linage), wherein the cell produces functional myelin, or is a progenitor that produces or differentiates into the cell that produces functional myelin (this method causes oligodendrocytes to mature and produce myelin). Thus, claim 1 of Application 19/638,220 teaches the limitations present in instant claim 1. Instant claim 2 corresponds to claim 8 of Application 19/638,220. Instant claim 5 corresponds to claims 3-4 of Application 19/638,220. Instant claim 6-7 correspond to claim 5 of Application 19/638,220. Instant claim 8 corresponds to claims 6-7 of Application 19/638,220. Instant claim 9 corresponds to claim 1 of Application 19/638,220. Instant claim 10 corresponds to claim 1 of Application 19/638,220. This is a provisional nonstatutory double patenting rejection.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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