DETAILED ACTION
Claims 1-20 are pending and are addressed herein.
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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16083982.
Election/Restrictions
Applicant’s election without traverse of Group I and the species ATF6B and genetic modification of the gene encoding ATF6B in the reply filed on 02/13/2026 is acknowledged.
Claims 2-3, 5-10, 12, 14-18 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter (claims 2-3, 8-10, 12 are drawn to a non-elected species and claims 5-7, 14-18, 20 are drawn to a non-elect Invention), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/2026.
Claims 1, 4, 11, 13, 19 are under consideration as they are drawn to the elected subject matter.
Interpretation of the Claimed Invention
The title of the invention is “Mammalian cells for producing a secreted protein.” The first paragraph of the specification states, “The invention relates to the field of cell culture technology.” Page 15, beginning at line 13 states, “The term “host cells” as used herein are mammalian cell lines suitable for production of a secreted recombinant protein and may hence also be referred to as “mammalian cells”… They are adapted to serial passages in cell culture and do not include primary non-transformed cells or cells that are part of an organ structure.” (Emphasis added). It is noted that the specification does not appear to disclose any in vivo embodiments for the inventive mammalian cells, furthermore, the specification disclose a list comprising many different types of mammalian cell lines from different species which may used as the mammalian cell of the claimed invention (see Table 1). Thus, invention is interpreted as being drawn to isolated mammalian cells for producing a secreted protein.
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.
Claim 13 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.
Claim 13 is drawn to “The engineered mammalian cell of claim 1… (ii) the cell is a rodent or a human cell, preferably a CHO cell.”
First, the phrase “preferably…” in part (ii), renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Second, the phrase “the cell is… a CHO cell” also renders the claim indefinite because claim 1 recites “wherein the engineered mammalian cell is not an engineered Chinese Hamster Ovary (CHO) cell.” Thus, claim 1 explicitly excludes the CHO cells thus rendering claim 13 (which requires the cell to be a CHO cell) indefinite.
The rejection may be overcome by deleting the “preferably…” phrase from claim 13.
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, 4, 11, 13, 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,549,108. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Instant claim 1 is drawn to a mammalian cell engineered to have enhanced secretion of a recombinant therapeutic protein compared to a non-engineered control cell, said engineered mammalian cell comprising reduced expression of the host cell protein activating transcription factor 6 beta (ATF6B) (the elected species), wherein the engineered mammalian cell further comprises one or more expression cassette(s) encoding a recombinant secreted therapeutic protein; wherein the engineered mammalian cell is not an engineered Chinese Hamster Ovary (CHO) cell.
Claim 1 of the ‘108 patent is drawn to Chinese Hamster Ovary (CHO) cell engineered to have enhanced secretion of a recombinant therapeutic protein, compared to a non-engineered CHO cell, comprising reduced expression of the host cell protein activating transcription factor 6 beta (ATF6B), wherein: (a) the gene encoding the host cell protein ATF6B comprises a genetic modification that inhibits expression of said host cell protein ATF6B, or (b) the CHO cell comprises a RNA oligonucleotide that inhibits expression of the gene encoding said host cell protein ATF6B by RNA-interference, wherein said RNA oligonucleotide is not a miRNA, wherein the protein expression of ATF6B in the CHO cell is reduced compared to the same CHO cell not containing said genetic modification(s) or RNA oligonucleotide(s); and wherein the CHO cell further comprises one or more expression cassette(s) encoding a recombinant secreted therapeutic protein.
Thus, both claims encompass a mammalian cell engineered to have enhanced secretion of a recombinant therapeutic protein compared to a non-engineered control cell, said engineered mammalian cell comprising reduced expression of the host cell protein activating transcription factor 6 beta (ATF6B), wherein the engineered mammalian cell further comprises one or more expression cassette(s) encoding a recombinant secreted therapeutic protein, with the difference being that the ‘108 patent requires the mammalian cell to be a CHO cell and the instant claims explicitly exclude the cell from being a CHO cell.
However, looking to the specification for guidance with respect to the obvious variants of the claimed with respect to the types of mammalian cells that could be engineered in the context of the claimed invention, the specification states, “Non-limiting examples of mammalian cells which can be used in the meaning of this invention are also summarized in Table 1.” It is noted that Table 1 discloses over 25 different types of mammalian production cell lines – cell lines that were well known and in most cases commercially available. Thus, although the instant claims are not commensurate in scope with the claims of the ‘108 patent, it is clear that the instant specification and the specification of the ‘108 patent indicate that any of the disclosed mammalian production cell lines, which includes mammalian CHO cells as well as mammalian cells that are not CHO cells, could be used and thus are obvious variants of the claimed invention.
Instant claims 4, 11, 13 and 19 depend on claim 1.
Instant claim 4 correlates with limitations present in claim 1 of the ‘108 patent.
Instant claim 11 correlates with limitations present in claims 2 and 3 of the ‘108 patent.
Instant claim 13 correlates with limitations present in claim 6 of the ‘108 patent.
Instant claim 19 correlates with limitations present in claim 5 of the ‘108 patent.
MPEP 804 II B 1 states:
The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)… Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).
Therefore, the instant claims are an obvious variation of the invention claimed in the ‘108 patent and a non-statutory double patenting rejection is appropriate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to J. E. Angell whose telephone number is (571)272-0756. The examiner can normally be reached Monday-Friday (8:30-5:00).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J. E. Angell
Primary Examiner
Art Unit 1637
/J. E. ANGELL/Primary Examiner, Art Unit 1637