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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/31/2026 has been entered.
Withdrawn Rejection
The rejection of claims 45-49 and 51-56, as amended or previously presented, are rejected 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. Applicant amendments and arguments are found persuasive.
Non-Statutory 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.
(1) Claims 45-49 and 52-56, as amended or previously presented, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 11,434,474. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim discloses all of the limitations of the instant claim.
Regarding claim 45, patent claim 13 discloses a method for producing a recombinant therapeutic polypeptide in a cell, the method comprising: providing a eukaryotic cell comprising a first exogenous nucleic acid encoding a first lipid metabolism modulator (LMM) comprising stearoyl CoA desaturase-1 (SCD-1), or a functional fragment or isoform thereof; and a second exogenous nucleic acid encoding the recombinant therapeutic polypeptide, wherein the recombinant therapeutic polypeptide is selected from an antibody, an antibody fragment, a hormone, a blood clotting factor, a cytokine or a protein vaccine; and (ii) culturing the cell under conditions where the first LMM and the recombinant therapeutic polypeptide are expressed, thereby producing the recombinant therapeutic polypeptide, wherein the cell further comprises a third exogenous nucleic acid encoding a second LMM comprising sterol regulatory element-binding transcription factor-1 (SREBF-1) or a functional fragment or isoform thereof, and in step (ii) the cell is cultured under conditions where the second LMM is expressed. As such, patent claim 13 discloses all of the limitations of instant claim 45, but further specifies the presence of an addition sequence encoding SCD-1. Thus patent claim 13 discloses an anticipatory species of instant claim 45.
Regarding instant claims 46-48, patent claims 13 does not expressly disclose the limitations of these claims. However, these are all function conveyed by the expression of LLM and given the method requires such expression, inherently the resultant function of such expression should occur in patent claim 13.
Regarding claim 49, patent claim 14 discloses wherein the second LMM comprises an amino acid sequence with at least 80% identity with the amino acid sequence of SREBF1 corresponding to SEQ ID Nos: 1 or 34, or a functional fragment thereof, corresponding to SEQ ID Nos: 26, 27, or 36.
Regarding claim 52, patent claim 13 does not specify that the LLM is integrated into the genome of the cell and LLM is stably expressed as claimed. However, at the time of the patent, means of inserting gene sequences to be expressed into the genome of a cell were well established in the prior art. Further one would have been motivated into introduce the LLM into the genome because it has been long established to provide more stable expression of an introduced gene than episomal introduction of a gene. As such, claim 52 is an obvious variant of patent claim 13.
Regarding claims 53-54, patent claim 13 more broadly recites a eukaryotic cell and does not recite the narrower limitations of a mammalian cell (claim 53) or a CHO cell (claim 54). However, at the time of the patent claim CHO cells were commonly used in methods producing recombinant therapeutic polypeptides because they were of human origin and provided robust expression of recombinant proteins. As such, it would have been obvious to an artisan of ordinary skill at the time of the invention to choose CHO cells from a finite number of predictable cell for expressing recombinant proteins for use in the method of patent claim 13 and predictably arrive at the limitations of claims 53-54. As such, claims 53-54 are obvious variants of patent claim 13.
Regarding claim 55, patent claim 13 does not teach that the method further comprises separating the recombinant therapeutic polypeptide from at least one cellular or medium component. However, at the time of the invention, recombinant therapeutic polypeptides were commonly isolated from the host cell producing it if expressed in the cell or isolated from the medium if it was secreted into the medium of the culture in preparation for therapeutic use/administration. As such, it would have been obvious to an artisan of ordinary skill at the time of the invention to 6solatee the recombinant therapeutic polypeptide uses predictable art-established methods in the method of patent claim 13 to predictably arrive at the limitations of instant claim 55.
Regarding claim 56, patent claim 13 does not specify that the first exogenous nucleic acid is introduced into the eukaryotic cell before the second exogenous nucleic acid in the method. However, it would have been obvious to an artisan of ordinary skill that one could choose from introducing the first exogenous nucleic acid into the cell before the second exogenous nucleic acid from a finite number of predictable combinations of sequential or concurrent nucleic acid introductions into the cell in the method of patent claim 13 to predictably arrive at the limitations of claim 56.
(2) Claims 45-48 and 52-56, as amended or previously presented, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,655,111. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims recite a species of eukaryotic cell as claimed and providing and culturing it to provide it recombinant polypeptide product as the instant claim method requires is an obvious use for the cell recited in the patent claims.
Regarding claim 45, patent claim 1 provides a cell comprising: a first exogenous nucleic acid encoding a first lipid metabolism modulator (LMM), wherein the first LMM comprises a sterol regulatory element-binding transcription factor 1 (SREBF1) or a functional fragment or isoform thereof; and an exogenous nucleic acid encoding a recombinant polypeptide, wherein the first exogenous nucleic acid is integrated into the chromosomal genome of the cell; and wherein the cell is a CHO-derived cell (i.e. a eukaryotic cell as claimed in instant claim 45). Patent claim 1 more broadly recites the a second exogenous nucleic acid encoding a recombinant polypeptide, as opposed to the narrower recitation of a recombinant therapeutic polypeptide as recites in instant claim 45. However, it would have been obvious to an artisan at the time of the inventions to choose a recombinant therapeutic polypeptide, as recited in instant claim 45, for use in the CHO cell of patent claim 1 to predictably arrive at the limitations of instant claim 45. One would choose a recombinant therapeutic polypeptide because CHO cells are commonly used for expression of therapeutic polypeptides and production of therapeutic polypeptides for clinical use is desired in the art. Patent claim 1 does not disclosed that the cell is cultured under conditions to impart expression of the LMM and therapeutic polypeptide. However, as stated above CHO cells comprising exogenous nucleic acid sequences for express of transgene product are most commonly used in method of culturing under conditions to cause expression of their transgene products. As such, it would have been obvious to an artisan of ordinary skill at the time of the invention, to used the cell of patent claim 1 in a method of expression the exogenous nucleic acids Introduced into the CHO cells to express the recombinant products introduced into the cells. As such, instant claim 45 is an obvious variant of patent claim 1.
Regarding instant claims 46-48, patent claim 1 does not expressly disclose the limitations of these claims. However, these are all function conveyed by the expression of LLM and given the method requires such expression, inherently the resultant function of such expression should occur in patent claim 1.
Regarding claim 50, patent claim 7 further discloses an additional nucleic acid encoding a second LLM comprising a SCD1. As such, instant claim 50 is an obvious variant of patent claim 7.
Regarding instant claims 52-54, patent claim 1 discloses that the first LLM is integrated into the genome and is stably expressed in CHO cells (i.e. a mammalian cell).
Regarding claim 55, patent claim 1 does not teach that the method further comprises separating the recombinant therapeutic polypeptide from at least one cellular or medium component. However, at the time of the invention, recombinant therapeutic polypeptides were commonly isolated from the host cell producing it if expressed in the cell or isolated from the medium if it was secreted into the medium of the culture in preparation for therapeutic use/administration. As such, it would have been obvious to an artisan of ordinary skill at the time of the invention to 9solatee the recombinant therapeutic polypeptide uses predictable art-established methods in the method of patent claim 1 to predictably arrive at the limitations of instant claim 55.
Regarding claim 56, patent claim 1 does not specify that the first exogenous nucleic acid is introduced into the eukaryotic cell before the second exogenous nucleic acid in the method. However, it would have been obvious to an artisan of ordinary skill that one could choose from introducing the first exogenous nucleic acid into the cell before the second exogenous nucleic acid from a finite number of predictable combinations of sequential or concurrent nucleic acid introductions into the cell in the method of patent claim 1 to predictably arrive at the limitations of claim 56.
Applicant’s Remarks Regarding Non-Statutory Double Patenting Rejections
Applicant disagrees with these rejection and requests that the rejections be held in abeyance until allowable claims are otherwise acknowledged by the Office. In response the above double patenting rejections of record are maintained.
Allowable Subject Matter
Claim 51 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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