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 .
Election/Restrictions
Claims 1-12, 16-17, and 19-20 are pending.
Applicant’s election without traverse of claim 17 in the reply filed on 11/14/2025 is acknowledged.
Claims 1-12, 16, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/14/2025 and made FINAL.
Claim 17 has been examined on its merits.
Claim Rejections - 35 USC § 112(b)
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 17 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.
Claims 17 recites “a molecular ratio (mM/mM) of lactate/cysteine.” Parentheses should be reserved for abbreviations otherwise it can create ambiguity because it may be unclear if the parenthetical information is a further limitation or merely an example. In the instant case, the parenthetical information has been interpreted as describing the molar ratio of lactate and cysteine when they are measured in mM concentration. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Freund et al. (International Journal of Molecular Science, 2018) in view of Ritacco et al. (Biotechnology Progress, 08/18/2022).
In regards to claim 17, Freund teaches a composition for fed batch culture of CHO cells comprising the commercial product OptiCHO medium supplemented with lactate (Abstract, p1; Adaption of Cells, p14).
It is noted that OptiCHO medium is a propriety product, and while Freund is silent as to whether this medium comprises cysteine, as taught by Ritacco, cysteine is a special nonessential amino acid in monoclonal antibody production, required for folding of CHO cell proteins, and that limitation can be fatal for CHO cell growth (p1412, column 1, bottom paragraph).
Therefore, even if the composition as taught by Freund does not comprise cysteine, a person of ordinary skill in the art would have been motivated to add cysteine because it is required for CHO cell survival and function. Furthermore, because Ritacco teaches that it is known in the art that CHO cell media can be supplemented with cysteine (p1412, column 1, bottom paragraph, through column 2, bottom paragraph), it could have been done with predictable results and a reasonable expectation of success.
In regards to the lactate/cysteine molecular ratio (mM/mM), Freund teaches a concentration of 35 mM eliminates the net production of lactic acid (which is known to inhibit cell growth and productivity) (p7, top paragraph; Fig. 2, p8).
In regards to the concentration of cysteine, Ritacco teaches that concentration below 0.1 mM or greater than 1 mM results in reduction in cell viability (p1412, column 1, bottom paragraph, through column 2, bottom paragraph).
A concentration of 35 mM lactate and a median concentration of 0.55 mM cysteine results in a lactate/cysteine ratio of 63.6:1 which appears to overlap with, or is at least close to, the range of “about 8:1 to about 50:1” lactate/cysteine (see MPEP 2144.05).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) .
Furthermore, a person of ordinary skill in the art could have arrive at a lactate/cystine ratio of 8:1 to 50:1 by routine optimization, and the disclosure does not point to a criticality in this ratio.
According to MPEP 2144.05(II)(A), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical . “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
See Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results).
Since, as above, Ritacco teaches that the concentration of cysteine can be between 0.1 mM or greater than 1 mM and because Freund teaches that supplementation with at least about 6 mM lactate decreases lactic acid (Fig 3, p8), a lactate/cysteine ratio of about 8:1 to about 50:1 by routine optimization with predictable results and a reasonable expectation of success (indeed, a concentration of 0.7 mM cysteine, which Ritacco indicates is suitable, with a concentration of 35 mM lactate, as taught by Freund results in a 50:1 lactate/cysteine ratio).
Therefore, the combined teachings of Freund and Ritacco render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631