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 .
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.
Claim Status
Applicant’s arguments and amendments dated 1/20/26 have been received and entered in the application.
Claims 5, 10, and 16-21 are currently pending and examined on the merits.
Claims 5, 10 are currently amended.
Claims 16-21 are newly added.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
Claim Rejections - 35 USC § 102
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.
Claim(s) 5 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inlow et al., US Patent No. 6,048,728 (hereinafter Inlow).
Regarding claims 5, 10, and 16-21, Inlow discloses culture media for enhanced cell growth, culture longevity, and product expression. Inlow explains that adding trace metal ions, such as iron in the form of iron choline citrate may improve culture growth and/or product expression (col 3 ln 10-16, col 11 ln 39-47). In some embodiments, the iron choline citrate may be present at about 0.1 to 10 mM (col 3 ln 10-16, col 11 ln 39-47).
With respect to the preamble of claims 5 and 10, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus or composition is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. The only structure present in the recited claims refer to a media comprising iron choline citrate at a particular concentration. The terms ”feed” and “basal” do not impart any structural differences on the claimed media. Consequently, the preambles of claims 5 and 10 are not considered in analyzing the patentability of the apparatus or composition.
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.
Claim(s) 5, 10, 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inlow.
Regarding claims 5, 10, and 16-21, Inlow discloses culture media for enhanced cell growth, culture longevity, and product expression. Inlow explains that adding trace metal ions, such as iron in the form of iron choline citrate may improve culture growth and/or product expression (col 3 ln 10-16, col 11 ln 39-47). In some embodiments, the iron choline citrate may be present at about 0.1 to 10 mM (col 3 ln 10-16, col 11 ln 39-47).
With respect to the preamble of claims 5 and 10, claim scope is not limited by language that does not limit the claim to a particular structure. That is, intended use of an apparatus or composition is insufficient to distinguish the structure of the apparatus or composition from the prior art. See MPEP §§ 2111.02 and 2111.04. Therefore, only language that clearly defines structural limitations is considered with respect to patentability analysis. The only structure present in the recited claims refer to a media comprising iron choline citrate at a particular concentration. The terms ”feed” and “basal” do not impart any structural differences on the claimed media. Consequently, the preambles of claims 5 and 10 are not considered in analyzing the patentability of the apparatus or composition.
Response to Arguments
Applicant's arguments dated have been fully considered but are not persuasive as explained in detail below.
Claim(s) 5 and 10, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inlow. Claim(s) 5, 10, 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inlow.
Applicant argues that Inlow fails to disclose the narrower claimed ranges of iron choline citrate with sufficient specificity to qualify as an anticipatory reference (Response p5-6). Applicants have not advanced any arguments explaining why Inlow fails to obviate the claims as presented.
In response, claims 5 and 10 each encompass a broad range of concentrations of iron choline citrate (0.1 mM to 5 mM and 0.4 mM to 5 mM). Inlow discloses a broad range of iron choline citrate may be present at about 0.1 to 10 mM (col 3 ln 10-16, col 11 ln 39-47). While Inlow does disclose a broader range, the overlap, amounts to significantly more than a slight overlap with the range presently claimed (See MPEP § 2131.01). Further, applicants have not alleged any unexpected results or criticality of the claimed ranges. Therefore, Inlow is deemed to read on the claims as presented.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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