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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Status of the Claims
Claims 1, 5-6, 8, 10, 15, 18-20, 23, 26, 53, and 58 are pending.
Claim 1 is newly amended.
Claims 1, 5-6, 8, 10, 15, 18-20, 23, 26, 53, and 58 have been examined on their merits.
Response to Arguments
Applicant argues that the claims are enabled therefore, the scope of enablement under 35 USC 112(a) should be withdrawn (Remarks, p5-9).
Specifically, Applicant argues that, in reference to Fig. 2d, the Y-axis refers to the percent of initial values (Remarks, p5). Applicant argues that at room temperature, at saturation, the concentration of dissolved oxygen in water is 20.95% (Remarks, p5-6). Thus, Applicant argues that the inflection point at which copper is lost (which appears to be about 18.75% of the initial value) in solution results in a percentage that is less than the claimed amount of at least 8% as in claim 1 as newly amended (Remarks, p6).
Applicant also argues that it would be apparent to a person of skill in the art from the disclosure of the present specification that, given that copper filterability can be time-dependent, a way to retain copper would be to speed up filtration, for example, by increasing filtration capacity (whereby a larger volume could be filtered in a relatively shorter time), which could involve increasing filter size, filtration rate, or both (Remarks, p7). Applicant argues that persons of skill in the relevant art would be sufficiently versed in methods of increasing filtration rate or capacity, or filter size, that they would understand that the inventors possessed, and enabled, this aspect of the claimed subject matter sufficiently (Remarks, p7).
Applicant’s arguments, see p5-8, filed 11/25/2025, with respect to the rejection of the instant claims 1, 5-6, 8, 10, 15, 18-20, 23, 26, 53, and 58 under 35 USC 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, new grounds of rejections are made under 35 USC 102 and 35 USC 103 (as discussed in detail below), in order to address Hira et al. (US20210403971A1, priority to PCT on 11/01/2019) and Bardo (BioProcess International, 2004).
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
Upon further consideration, the rejection of the claims under 35 USC 112(a) is withdrawn in order to address the disclosure of Hira et al. (US20210403971A1, priority to PCT on 11/01/2019) and Bardo (BioProcess International, 2004).
Claim Objections
Claim 1 is objected to for the following informalities: claim 1 uses periods to separate subsections (i.e., “a. oxygenating” and “b. increasing”). A claim should be a single sentence. Thus, “a) oxygenating” and “b) increasing” would be ameliorative. Appropriate correction is required.
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 53 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 53 recites the limitation “a method of claim 1”. The claim is indefinite because it is unclear if the claim requires all of the steps of claim 1 (in which case, the clause should read “the method of claim 1”), or if the completion of any substep of claim 1 is sufficient to satisfy the limitation.
For compact prosecution, and giving the term its broadest reasonable interpretation, the claim has been interpreted as referring to any substep in claim 1. Appropriate clarification is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-6, 15, 18-20, 23, 53, and 58 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hira et al. (US20210403971A1, priority to 11/01/2019).
In regards to claims 1, 5, and 58, Hira discloses a method for preparing a medium (solution) (claims 1, 2, and 4) wherein the concentration of copper does not substantially change before and after filtration (claims 8 and 9) (thus, preventing copper loss).
Hira discloses that the method comprises dissolving oxygen (dO2) into the medium (claim 13).
As noted by Applicant, the atmospheric oxygen level is 20.95%. Thus, at saturation the concentration of dissolved oxygen in water would be 20.95%
Specifically, Hira discloses that “The results are shown in FIG. 2. While the copper concentration of the medium prepared under the conditions of the dissolved oxygen concentration in the prepared medium of 0% after the filtration was 1.4 ng/mL, the copper concentrations of the media prepared under the conditions of the dissolved oxygen concentrations of 20%, 40% and 100% (atmospheric saturation state) after the filtration were 8.5, 12.0 and 10.9 ng/mL, respectively (paragraph [0140]), and continuing, “From the above results, it was shown that the copper concentration in a medium after filter filtration decreases when the dissolved oxygen concentration becomes lower than 40% during the preparation of the medium” (paragraph [0141]).
Thus, the actual percentage of dO2 in water that prevents loss of copper in a solution during filtration, as disclosed by Hira is at least 8.38% (40% x 20.95 dO2 at atmospheric saturation = 8.38% dO2), which overlaps with the claimed range of at least 8%.
In regards to the timings, Hira discloses that during the preparation of the medium, the medium is stirred in the presence of oxygen (thus, dissolved oxygen) for a range of 10 minutes to 10 days (paragraph [0060]) which overlaps with the range of at least 10 minutes before commencing the filtering as in claim 1.
Hira discloses that the solvent component of the solution (e.g., water) can have a volume of 10 to 10,000 L (claim 14). Thus, the total volume of the solution itself would have a total volume that overlaps with the claimed range of 1,000 to 25,000 L as in claim 1 (or the range of 2,000 to 5,000 as in claim 58).
Hira discloses that the comprises copper (II) (claim 4). It is noted that copper (II) is well-known to be soluble.
Hira discloses that the medium comprises cysteine (claim 5).
As above, Hira discloses that the concentration of copper does not substantially change before and after filtration (claims 8 and 9).
Hira discloses that the filtration is a step in the preparation of preparing the medium (claim 8). Hira discloses that the medium can be used for the culturing of cells (claim 22), and therefore, the filtering would occur before cell culture.
Hira discloses that the oxygen levels can be maintained by oxygenating the solution (e.g., sparging) (claim 1).
In regards to claim 6, Hira discloses that the gas containing oxygen can be air (atmosphere) (paragraph [0057, 0141]).
In regards to claim 15, Hira discloses that the filtering is sterile (paragraph [0067]).
In regards to claims 18-20 and 23, Hira discloses that the cysteine can be provided as cysteine derivative (paragraph [0014]). Hira also discloses that the media can comprise cystine (paragraph [0014]) specifically. It is well known in the art that cystine is formed by the oxidation of two cysteine molecules, which links which links their sulfhydryl groups together to form a disulfide bond, and therefore, is both a cysteine derivative and a molecule that lacks a sulfhydryl group.
In regards to claim 53, Hira discloses that cells expressing a desired polypeptide and be cultured in the media and that the polypeptide can be collected (claims 22 and 27).
Therefore, Hira anticipates the invention as claimed.
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.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hira et al. (US20210403971A1, priority to 11/01/2019) in view of Bardo (BioProcess International, 2004).
Hira anticipates claim 1 as discussed above.
In regards to claims 8 and 10, in an embodiment Hira teaches that media was prepared over 240 minutes and filtered after introducing the raw materials (paragraph [0139]).
While it is unclear what the specific timing of the filtering or the filtering rate is, a person of ordinary skill in the art could have arrived at a timing of completing filtering within 24 hours of adding copper (II) to the solution or a rate of at least 0.5% by routine optimization, and the disclosure does not point to a criticality in these timings.
In regards to routine optimization, 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).
Indeed, as taught by Bardo, it was known in the art that production-scale filters, can filter at least 3000L over 325 minutes (5.41 hours, which would result in a timing of less than 24 hours; and a rate of 9.27L/min (0.3%/min) which is at least close to a rate of 0.5%) (BioProcess International, Table 1, p4). Moreover, as explicitly admitted by Applicant, “Persons of skill in the relevant art would be sufficiently versed in methods of increasing filtration rate or capacity” (Remarks filed 11/25/2025, p7).
Therefore, a person of ordinary skill in the art could have arrived at a timing a timing of completing filtering within 24 hours of adding copper (II) to the solution or a rate of at least 0.5% by routine optimization with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Hira and Bardo renders the invention unpatentable as claimed.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Hira et al. (US20210403971A1, priority to 11/01/2019) in view of Rakshit et al. (Chem Sci, 2018).
Hira anticipates claim 1 as discussed above.
In regards to claim 26, Hira does not explicitly teach that the copper is in the form of a copper (II) chelate.
However, Rakshit teaches that copper ions are essential for biological function yet are severely detrimental when present in excess (Abstract, p7916). To this end, Rakshit teaches a copper chelator that allows for the selective removal of copper (II) ions that would be available only under pathophysiological metal overload and oxidative stress conditions and provides access to effective removal of the aberrant redox-cycling copper pool without affecting the essential non-redox cycling copper (I) labile pool. Therefore, a person or ordinary skill in the art would have been motivated to provide a copper (II) chelate because it would remove toxic copper (II) ions without affecting copper (I). Moreover, because Rakshit demonstrates that a copper chelate can effectively be added to culture media (Results and discussion, p7918), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Hira and Rakshit renders the invention unpatentable as claimed.
Conclusion
No claims are allowed.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631