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 3/20/2026 to claims 1, 3-10, and 12-19 have been entered. Claims 2, 11, and 20 are canceled. Claims 1, 3-10, and 12-19 remain pending, of which claims 1, 3-8, and 16-19 are being considered on their merits. Claims 9, 10, and 12-15 remain withdrawn from consideration. References not included with this Office action can be found in a prior action.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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 § 102 and 103
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.
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, 3-5, 7, 8, and 16-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Murhammer et al. (Biotechnol. Prog. (1990), 6, 142-148; provided in the IDS dated 4/12/2023) as evidenced by the Sigma-Aldrich product insert to TNM-FH insect media (2014).
Murhammer teaches a cell culture medium added to 50 ml spinner flasks, the medium comprising: a meroxapol (i.e. reverse Pluronic) with an average molecular weight Mp between 1000 and 8000 g/mol and a polyethylene oxide percentage between 55 and 95% (w/w) (see Table 2: “25R5” (avg. M.W. 4250), “10R5” (avg. M.W. 1950), and “10R8” (avg. M.W. 4550) with the “R” indicating reverse Pluronic and the last number digit indicating about 1/10th the percentage of the polyoxyethylene hydrophile; p145, subheading “Reverse Pluronic Polyols”), anticipating or reading on claims 1-3 and 16-18. Murhammer teaches adding 0.2% w/v of the reverse Pluronic to the cell culture medium (p145, subheading “Reverse Pluronic Polyols”, and noting that 0.2% w/v equates to 0.2 g per 100 ml or 20 g/L), anticipating or reading on claims 4 and 19. Murhammer teaches that the reverse Pluronic/meroxapol polyols are added to TNF-FH medium to grow Sf9 insect cells, wherein TNM-FH is a chemically defined medium as evidenced by the Sigma-Aldrich product insert to TNM-FH insect media (see Murhammer at the paragraph spanning both columns on p143, and the 1st page of Sigma-Aldrich), anticipating or reading on claims 5, 7, and 20. Murhammer teaches that antifoam C is only added to the cell culture medium for the sparged bioreactors and spinner flask controls (the paragraph spanning p143-144), anticipating or reading on the negative limitation of claim 8.
Regarding the peak molecular weight of claims 1, 2, 16, and 17, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same as that of the claim but does not explicitly disclose the function or property.
In this case, the prior art cell culture medium composition of Murhammer is substantially similar to the claimed composition because Murhammer’s composition comprises reverse Pluronic/meroxapol polyols having an average molecular weight that is coextensive to the claimed peak molecular weight ranges. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 102 rejection by showing the prior art product lacks the claimed function/property, and to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious. In this case, the burden is shifted to Applicant that Murhammer does not anticipate and does not render the claimed composition prima facie obvious.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Murhammer as applied to claim 1 above, and further in view of Rayner-Brandes (US 9,399,757).
The teachings of Murhammer are relied upon as set forth above.
Regarding claim 6, Murhammer does not teach a dry powder or a dry compacted medium (e.g. formulated as tablets).
Rayner-Brandes teaches dry granulated cell culture media compositions and methods of production thereof, for use in mammalian, insect, and/or plant cell culture (Abstract). Rayner-Brandes teaches that dry powdered cell culture media for later dissolution in water is advantageous over the relatively short shelf life and difficulties of shipping and storage of liquid cell culture media (Col. 1, lines 31-40), reading on claim 6. Rayner-Brandes teaches a dry granulated cell culture media formulated as a tablet (Col. 7, lines 38-50), reading on claim 6.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the cell culture media of Murhammer as a dry powder or dry compacted medium (e.g. as tablets) in view of Rayner-Brandes. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Murhammer and Rayner-Brandes are directed towards cell culture media compositions. The skilled artisan would have been motivated to do so because Rayner-Brandes teaches that dry cell culture media for later dissolution in water is predictably advantageous over the relatively short shelf life and difficulties of shipping and storage of liquid cell culture media, thus improving upon the cell culture media of Murhammer.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 5-7 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 6-7 of the reply, Applicant alleges that Murhammer is deficient by not teach the peak molecular weight range as set forth in claim 1. This is not found persuasive of error, because when the structure in the cited reference is substantially identical to the claimed structure, any claimed properties or functions are presumed to be inherent in the absence of any persuasive showing to the contrary; see M.P.E.P. § 2112. Applicant bears the burden to show that Murhammer’s meroxapol composition does not possess the claimed peak molecular weight range for the 35 U.S.C. § 102 rejection, and any allegation of inoperability of the prior art requires evidence supported by an appropriate Affidavit or Declaration, see M.P.E.P. § 716.01(c). If Applicant can show by a preponderance of evidence that Murhammer’s meroxapol composition does not possess the claimed peak molecular weight range, Applicant also bears the burden to show that the claimed composition is otherwise nonobvious over Murhammer’s meroxapol composition for the 35 U.S.C. § 103 rejection.
As Applicant has not yet established by a preponderance of evidence that Murhammer does not anticipate the composition of claim 1, Applicant’s arguments regarding unexpected results on pages 8-9 of the reply are premature and not persuasive of error. However, the allegation of unexpected results would not likely be persuasive because Applicant relies on a comparison between the disclosed meroxapols with poloxamer 188 but which cannot be reasonably considered the closest prior art, see M.P.E.P. § 716.02(e). Murhammer is likely the closest prior art by teaching a cell culture medium comprising a meroxapol with an average molecular weight Mp between 1000 and 8000 g/mol and a polyethylene oxide percentage between 55 and 95% as cited above, and there does not appear to be any significant difference between the disclosed species of meroxapols on cell density in Figs. 5-7, 9, and 10 as relied upon; see M.P.E.P. § 716.02(a). Finally, any allegation of unexpected results is not reasonably commensurate to the scope of the claims (see M.P.E.P. § 716.02(d)) and even if the allegation were persuasive they would not be reasonably commensurate to the scope of the claims/ The disclosure only appears to test a single species of mammalian cell and without any further evidence or technical argument that the single species of cell is representative of generic cells and include of microbial and prokaryotic cells.
Conclusion
No claims are allowed. No claims are free of the art.
THIS ACTION IS MADE FINAL. 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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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