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 .
For clarity of the record, the non-final Office Action dated 2/26/2026 was withdrawn in view of Applicant’s request for a three month suspension that accompanied the Request for Continued Examination filed on 1/21/2026. This Office Action is non-final.
Response to Amendments
Applicant's amendments filed 4/13/2026 to claim 1 have been entered. Claims 2-10, 12, and 13 are canceled. Claims 1, 11, and 14-16 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. 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overcome the 35 U.S.C. § 112(b) and 35 U.S.C. § 103 rejections of record over Linn in view of Rayner-Brandes, which are withdrawn.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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, 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rayner-Brandes et al. (WO 2015/003773; provided in the IDS dated 8/11/2020) as evidenced by Linn et al. (Eur J Pharm Sci (2012), 45(3), 336-343 with supplementary data).
In view of the indefiniteness rejections above and in the interest of compact prosecution, this rejection addresses the embodiment of culturing the cells of claim 1 in suspension.
Rayner-Brandes teaches a method for stabilizing cells in suspension cell culture production, the method comprising culturing a cell line capable of expressing proteins (e.g. CHO cells) in cell culture media wherein the cell culture media comprises a graft polymer in which N-vinyl caprolactam (VCap) and vinyl acetate (VAc) moieties are grafted on a polyethylene glycol (PEG) backbone (Example at p22 and Fig. 1 and 2; p18, lines 11-15; also see claim 13 for suspension culture), reading in-part on claim 1. Rayner-Brandes teaches that the PEG:VCap:VAc polymer comprises 0.01-99% or 10-90% by weight in the (cell culture) media component (p15, lines 4-8), reading on the ranges of claims 1 and 11. Rayner-Brandes teaches Soluplus® as an exemplary polymer in which N-vinyl caprolactam (VCap) and vinyl acetate (VAc) moieties are grafted on a polyethylene glycol (PEG) backbone (p12, lines 8-9), reading on claim 1. Rayner-Brandes teaches a cell culture medium comprises a carbon source, amino acid, vitamins, salt mixtures, and a buffer (pages 7-8), reading on claims 14 and 15. Rayner-Brandes teaches adding phenol red (i.e. a colorimetric pH indicator) (Table 1), reading on claim 16.
Regarding claim 1, Rayner-Brandes is silent regarding any PEG-VCap-Vac ratios. However, the Soluplus® as taught by Rayner-Brandes inherently meets the claimed moiety ratios of claim 1 as evidenced by Linn. See M.P.E.P. § 2112. In this case, Linn teaches that the Soluplus® compound used comprises PEG 6000:vinyl caprolactam:vinyl acetate at a ratio of 13:57:30 respectively (1st page of the supplementary data).
Regarding claim 1, It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute Soluplus® comprising PEG 6000:vinyl caprolactam:vinyl acetate at a ratio of 13:57:30 respectively for the unspecified PEG-VCap-VAc copolymer in Rayner-Brande’s methods of stabilizing cells in cell culture. A person of ordinary skill in the art would have had a reasonable expectation of success to do so and the skilled artisan would have been motivated to do so because Rayner-Brande expressly considers Soluplus® as an exemplary PEG-VCap-Vac copolymer for stabilizing cells in cell culture.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Affidavit/Declaration\
The Declaration under 37 CFR 1.132 filed 4/13/2026 is insufficient to overcome the rejection of claims 1, 11, and 14-16 based upon Rayner-Brandes as evidenced by Linn as set forth in the last Office action because:
The additional evidence proffered in the table of bullet point 14 of the Declaration lacks any measurement of statistical significance,
Any alleged differences between 0.025 g/L Kalliphor P 188 and 0.25-5 5 g/L Soluplus® as set forth in in the table of bullet point 14 of the Declaration are close enough that any practical significance is not immediately apparent (see M.P.E.P. § 716.02(b), and Applicant has only tested a single and relatively low concentration of the prior art polymer where Rayner-Brandes contemplates 10-90% polymer by weight as cited above. Note that overlapping ranges provide for a prima facie case for obviousness, see M.P.E.P. § 2144.05. As such, the Declaration only affirms that that the claimed subject matter functions as it was intended to function and this is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. See MPEP § 716.
Any alleged differences between 0.025 g/L Kalliphor P 188 and 0.25-5 5 g/L Soluplus® as set forth in in the table of bullet point 14 of the Declaration are not reasonably commensurate to the scope of the claims. While Applicant utilizes CHO cells and which are the same cells taught by Rayner-Brandes, claim 1 is generic towards the cells and does not recite any limitations towards cell viability and/or viable cell density (VCD) across any specific time range.
The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, Rayner-Brandes expressly considers suspension culturing cells with Soluplus® as evidenced by Linn, and so any alleged improvement in the properties of CHO cells as set forth in the Declaration is simply the latent and obvious outcome taught by Rayner-Brandes to utilize Soluplus® in suspension culture. Finally, although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness; See M.P.E.P. § 716.01(d). In this case, even if Applicant could properly establish unexpected results it appears unlikely such a showing by itself would overcome the strong prima facie case of obviousness over Rayner-Brandes because Rayner-Brandes expressly considers suspension culturing cells with Soluplus® as evidenced by Linn.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments on pages 3-5 of the reply have been fully considered, but not found persuasive of error for the reasons given below. Any reference to the instant Declaration is fully addressed above.
On pages 3-4 of the reply, Applicant alleges that Raynor-Brandes is deficient by not recognizing Soluplus ® as a shear protectant. This is not found persuasive because the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, Rayner-Brandes expressly considers suspension culturing cells with Soluplus® as evidenced by Linn as an alternative embodiment, and a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments (see M.P.E.P. § 2123). As such alleged improvement in the properties of CHO cells as set forth in the Declaration and on pages 4-5 of the reply is simply the latent and obvious outcome taught by Rayner-Brandes to utilize Soluplus® in suspension culture, and the preponderance of evidence has not yet shown a nexus between the merits of the claimed invention and the proffered evidence of secondary considerations; see M.P.E.P. § 716.01(b).
Conclusion
No claims are allowed. No claims are free of the art.
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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/Sean C. Barron/Primary Examiner, Art Unit 1653
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