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 .
Claims 1, 8, 9, 10, 26, 27, 30, 43, 84, 112, 142, 171, 193, 254, 281 and 386-400 are pending in this application.
Election/Restrictions
Applicant's election with traverse of Group XI (Claims 142 and 386-400) and of the species (cell: myoblasts), (aquatic animal: ray-finned fish) and (aquatic animal: Thunnus orientalis) in the reply filed on 04/10/2026 and the Interview of 05/07/2026 is acknowledged. The traversal is on the ground(s) that all the groups share a common special technical feature of a cell culture media comprising nervonic acid with one or more PUFA, SFA, UFA, MUFA and or sterols. See Remarks, Pg. 11. This is not found persuasive because at least currently pending Groups I, VI, IX, X, XII, XIII and XIV do not specifically require the alleged special technical feature of a cell culture media comprising nervonic acid with one or more PUFA, SFA, UFA, MUFA and/or sterols. Further, the Special Technical Feature should be set forth in the first broad Claim, which would be Claim 1.
As set forth in the prior action, the Special Technical Feature of Claim 1 is not a special technical feature as it does not make a contribution over the prior art in view of Nahmias et al. (US 2021/0395690 A1), of record, whom teaches cultured chicken cells wherein the cultured product has less than 1% saturated fat (Pg. 11, Paragraph [0133]). Fatsecret (2019), of record, evidences that Heritage Farm chicken thighs have 23% saturated fat, thus the prior art has less saturated fat when compared to farm chicken.
Claims 1, 8, 9, 10, 26, 27, 30, 43, 84, 112, 171, 193 and 254 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claim 281 is rejoined as having the same limitation scope as Claim 142. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/10/2026.
Claims 142, 281 and 386-400 were examined on their merits.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted.
Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Alternatively, Applicant may delete reference to color in the Figures, e.g. Figs. 2A, 3A, 5A, 7A, 8A, 9A, 10A, 11A, 12A, 13A, 14A, 15A, 16A, 17A, 18A, 19A, 20A, 21A, 22A, 23A, 24A, 25A, 26A, 27A, 28A, 29A, 30A, 31A, 32A, 33A an 34 and in the Brief Description of the Drawings.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The use of the terms MITOTRACKER™, GLUTAMAX™ which is a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms. Although the use of trade names and marks used in commerce (e.g., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains embedded hyperlinks and/or other forms of browser-executable code at Paragraphs [000169]-[000171] and [000322]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement.
37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 390 is objected to because of the following informalities: “dihomo-gamma-linolenic acid” is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 390 and 400 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 390 recites “Docosahexaenoic acid” and “Tetracosahexaenoic acid (Nisinic acid)” twice.
Regarding claim 400, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 142, 281, 389, 396, 397 and 398 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Tocher et al. (1995), as evidenced by Wonerow et al. (2021).
Tocher et al. teaches that cell culture media are generally devoid of fatty acids and so cells in culture generally derive all of their lipid and fatty acids from the lipid contained in the serum supplement, with FCS being the predominant serum supplement in cell culture, including fish cell culture, which is relatively rich in PUFA and for mammalian cells, FCS provides a sufficient amount and balance of n-6 and n-3 PUFA. In contrast, fish cells grown in FCS display lower percentages of n-3 PUFA and are enriched in n-6 PUFA in comparison with fish tissues (Pg. 365, Column 2, Lines 8-19).
Tocher et al. teaches culturing fish cells lines (AS, CHSE-214, EPC, TF and PLHC-1) in Fetal Calf Serum (FCS) or delipidated FCS (dFCS) for a time and under conditions that allow lipid uptake and maintain cell viability,
wherein the FCS: has a concentration of nervonic acid (24:1) of 2.8±0.4 or 0.7±0.1 wt.% and the dFCS has a concentration of nervonic acid of 0.5 wt.% (or about 2.8wt.% x 1.02 [density of FBS/BCS, see Wonerow at Pg. 4, Table 1] x 10,000 = 2.8 x 104 µg/mL);
has at least 0.1 µg/mL of one or more polyunsaturated fatty acids comprising carbon chain lengths of from 12-24 carbons, including linoleic acid, α-linoleic acid, eicosadenoic acid, dihomo-gamma-linoleic acid, mead acid, arachidonic acid, eicosapentaenoic acid, docosatetraenoic acid-6 and docosatetraenoic acid-3 (for example, eicosadienoic acid at 0.6wt/% x 1.02 x 10,000 = 6.1 x 103 µg/mL;
and one or more saturated fatty acids comprising carbon chain lengths of from 10-24 carbons, including myristic acid, pentadecylic acid, palmitic acid, margaric acid, stearic acid, arachidic acid and lignoceric acid (Pg. 369, Table 4 and Pg. 366, Column 1, Cell Lines and Media and Column 2, EFAD cultures and Incubation Conditions), and reading on Claims 142, 281, 389, 397, 398,
With regard to Claim 392, Tocher et al. teaches the dFCS comprises linoleic acid at 1.4 µg (Pg. 372, Column 1, Lines 13-15).
With regard to Claim 393, Tocher et al. teaches the dFCS comprises α-linoleic acid at 0.2 µg (Pg. 372, Column 1, Lines 13-15).
With regard to Claims 394 and 396, Tocher et al. teaches the FCS and dFCS comprises eicosapentanoic acid/EPA/20:5, n-3 (Pg. 369, Table 4).
With regard to Claim 395 and 396, Tocher et al. teaches the FCS and dFCS comprises docosapentanoic acid/DHA/22:6, n-3 (Pg. 369, Table 4).
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.
Claims 142, 281, 386, 387, 388, 389, 391, 392, 393, 394, 395, 396, 397, 398 and 399 are rejected under 35 U.S.C. § 103 as being unpatentable over Tocher et al. (1995), as evidenced by Wonerow et al. (2021).
The teachings of Tocher et al. were discussed above.
Tocher et al. did not teach a method wherein the nervonic acid is in a concentration of from 1-100 µg/mL, as required by Claim 386;
wherein the nervonic acid is in a concentration of from 10-100 µg/mL, as required by Claim 387;
wherein the nervonic acid is in a concentration of from 50-75 µg/mL, as required by Claim 388;
wherein the polyunsaturated fatty acids/PUFA are in a concentration of from 0.01-1000 µg/mL, as required by Claim 391;
wherein the linoleic acid is in a concentration of from 1-100 µg/mL, as required by Claim 392;
wherein the α-linoleic acid is in a concentration of from 1-100 µg/mL, as required by Claim 393;
wherein the EPA is in a concentration of from 1-100 µg/mL, as required by Claim 394;
wherein the DHA is in a concentration of from 1-100 µg/mL, as required by Claim 395;
or wherein the saturated fatty acids/SFA are in a concentration of from 0.01-1000 µg/mL, as required by Claim 399.
While the above cited reference does not specifically teach the claimed concentration range/amount limitations, those of ordinary skill in the art before the effective filing date would recognize the concentration or amount of a composition component as an optimizable variable dependent on the desired effect thereof. In this instance, Tocher et al. teaches that cells in culture generally derive all of their lipid and fatty acids from the lipid contained in the serum supplement, therefore the amount of lipid and fatty acids desired in the cultured cells is dependent upon the lipid profile in the media supplied to those cells.
This is an effective result based on the concentration of the serum and/or fatty acid/lipid media components as the lipid profile in the cells is dependent on the lipid profile of the supplied media. This is motivation for the ordinary artisan to practice or test the fatty acid concentration values widely to determine those that are functional and optimal and which would be inclusive or cover the instantly claimed ranges. Absent any teaching of criticality by the Applicant concerning the concentration of the claimed components, it would be prima facie obvious that the ordinary artisan would recognize these limitations are an optimizable variable which can be met as a matter of routine optimization, see the MPEP at 2144.05 Il. B. There would have been a reasonable expectation of success in making this modification because the prior art teaches the use of the same fatty acid media components and the determination of the optimal concentrations thereof by routine optimization was within the purview of those of ordinary skill in the art prior to the effective filing date.
Claims 142, 281, 386, 387, 388, 389, 390, 391, 392, 393, 394, 395, 396, 397, 398, 399 and 400 are rejected under 35 U.S.C. § 103 as being unpatentable over Tocher et al. (1995), as evidenced by Wonerow et al. (2021), as applied to Claims 142, 281, 386, 387, 388, 389, 391, 392, 393, 394, 395, 396, 397, 398 and 399 above, and further in view of Varela-Rohena et al. (WO 2019/055853 A1).
The teachings of Tocher et al. were discussed above.
Tocher et al. did not teach a method wherein the cells are cultured in a medium further comprising:
hexadecatrienoic acid, gamma linoleic acid, stearidonic acid, eicosatrienoic acid, heneicosapentaenoic acid and tetracosahexaenoic acid, as required by Claim 300;
or wherein the medium further comprises the sterol glycerophospholipid, as required by Claim 400.
Varela-Rohena et al. teaches compositions and methods for culturing cells (Title), wherein the cells may be animal cells (Paragraph [0009]),
and a cell culture medium that comprises at least one, and up to 20 lipids (Paragraph [00129]);
wherein the lipid may be a phospholipid and/or a glycerolipid (e.g. the sterol glycerophospholipid) (Paragraph [00131]);
and wherein the at least one lipid is; stearidonic acid, eicosatrienoic acid, heneicosapentaenoic acid, tetracosapentaenoic acid, gamma linoleic acid and hexadecatrienoic acid (Paragraph [00139]).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Tocher et al. of culturing fish cells in a culture medium comprising multiple fatty acids to include the lipids/fatty acids taught by Varela-Rohena et al. because it is prima facie obvious to select other fatty acids for inclusion in a cell culture medium which already contains multiple fatty acids. See the MPEP at 2144.07.
Those of ordinary skill in the art would have been motivated to make this modification in order to provide multiple fatty acids to cells in culture which may be required for viability and growth but must be provided exogenously. There would have been a reasonable expectation of success in making this modification because both references are drawn to the same field of endeavor, that is, culture media suitable for animal cells.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G 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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/PAUL C MARTIN/Examiner, Art Unit 1653 05/12/2026
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