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 .
Status of the Claims
Applicant’s submission filed 14 July 2026 has been entered. Claims 1-6, 10-12, 20-23, and 28-30 are pending. Claims 1, 4, 12, 21, and 28 have been amended, while claims 7-9 and 24, have been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 1-6, 10-12, 20-23, and 28-30. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 9 and 12
The cancellation of instant claim 9 renders the objection of record for that claim moot. With that, Applicant’s amendments to instant claim 12 obviate the objection of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 12 and 24 under 35 USC 112(b)
The cancellation of instant claim 24 renders the rejection of record for that claim moot. With that, Applicant’s amendments to instant claim 12 remove the parenthetical language, thus obviating the rejection of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claim 24 under 35 USC 112(d)
The cancellation of instant claim 24 renders the rejection moot for that claim. Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-12, 20-24, and 28-30 under 35 USC 103 over Phelps in view of DiSorbo et al
The cancellation of instant claims 7-9 and 24 renders the rejection moot for those claims. For the remaining claims, Applicant’s amendments to independent claims 1, 21, and 28 requiring the one or more carbohydrates and the one or more vitamins to be physically segregated from each other during storage at a temperature from about 15°C to about 30°C obviates the rejection of record, as it is a newly presented limitation.
Therefore, the rejection is withdrawn.
It is of note that Applicant has not provided any specific arguments in the Remarks filed 14 July 2026 against Phelps.
New Grounds of Rejection
Claim Objections
Claim 5 is objected to because of the following informalities:
Regarding claim 5: The instant claim is objected to for reciting “temperature-stable cell culture…” instead of “room temperature-stable cell culture…” in Lines 2-3.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of each claim, all of the “optional” limitations are not 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 1-6, 10-12, and 20-23 are 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.
Regarding claim 1: Instant claims 1 recites the limitation "the culture media or supplement composition". There is insufficient antecedent basis for this limitation in each of the claims, as there is no prior recitation of a “cell culture media or supplement composition" within claim 1. It is of note that Applicant has amended the preamble from “a room temperature-stable cell culture media or supplement composition" to “a room temperature-stable cell culture composition". Therefore, the metes and bounds of the claim cannot be determined, thus rendering the scope of the claim indefinite. See MPEP § 2173.05(e).
Instant claims 2-6, 10-12, and 20-23 are included in the rejection because they either directly depend from or incorporate the limitations of independent claim 1, thus rendering them indefinite as well. It is also of note that instant claims 5 and 20-21 recite variations of “room temperature-stable cell culture media or supplement composition".
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.
Claims 1-6, 10-12, 20-23, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Phelps (WO 2021/055579 A1, of record) in view of Phelps et al (US 2019/0292515 A1) and Mavromichalis (Feed Strategy, 2021).
Phelps is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Phelps et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Mavromichalis is considered prior art under 35 USC 102(a)(1).
Regarding claims 1, 4-5, and 11-12: Phelps discloses efficiently dissolving tablets of dry cell culture media, feeds, supplements, media subgroups, buffer concentrates, or media components useful in culturing cells, methods of manufacturing, and methods of use (Abstract).
As such, Phelps discloses that the final tableted media composition comprises amino acids, salts, buffers, trace minerals, lipids, nucleic acids, proteins, carbohydrates, and vitamins (Paragraphs [0005]-[0006], [0035], [0064], [0067], [0072], [0093], [0112]; Table 2). Phelps further discloses that the carbohydrate is glucose, fructose, or trehalose (Paragraphs [0006], [0090]; Table 2). Phelps further discloses that the vitamin is retinol, thiamine, riboflavin, niacinamide, pantothenic acid, pyridoxamine, biotin, folic acid, cobalamin, ascorbic acid, cholecalciferol, tocopherol, phylloquinone, choline, inositol, lipoic acid, or para-aminobenzoic acid (Paragraph [0006]; Table 2).
Phelps further discloses that final tableted media composition can be divided into various subgroups that are combined to form the final tableted media composition (Paragraphs [0040]-[0041], [0049], [0064], [0067], [0072], [0093], [0105], [0112], [0117]).
Phelps further discloses that the final tableted media composition and media subgroups are agglomerated and can be stored in separate containers based on the tableted media subgroups or components (Paragraphs [0007], [0065]-[0067], [0109], [0114]-[0119]). Phelps et al further disclose that the storage temperature is between about 20°C to about 25°C (Paragraphs [0063], [0093]).
Phelps further discloses that the tableted media subgroups are combined prior to being used (Paragraphs [0040]-[0041], [0054], [0065]-[0066], [0072], [0082]-[0083], [0096]-[0098]).
Phelps does not disclose that the carbohydrates and vitamins are physically segregated from each other when held in storage, as required by instant claim 1.
Phelps et al, however, disclose dry cell culture media or feeds comprising layered particles (Abstract). As such, Phelps et al disclose that the dry, powdered cell culture media can be comprised of layers of components, wherein the less stable or sensitive components are separated spatially from reactive components (Abstract; Paragraphs [0003], [0005], [0010], [0048], [0051], [0053]-[0054], [0056]-[0058]). Phelps et al further disclose that the sensitive components are vitamins, including thiamine and folic acid, and the reactive components are some sugars, including glucose (Paragraphs [0011], [0013], [0055], [0062]-[0063]).
Phelps et al further disclose that glucose may react with some amino acids or with polyamines to form undesirable Maillard reaction products that precipitate out when dissolved in solution, and such reactions may be further enhanced in the presence of one or more of the following: high-energy or ionizing radiations, thermal damage, light, environmental chemicals, long term storage, mechanical shaking, etc (Paragraph [0048]).
With that, Mavromichalis discloses that vitamins such as thiamine and folic acid are vitamins that are vulnerable to the Maillard reaction due to glucose (Pages 2-3).
Therefore, it would have been prima facie obvious to have modified the tableted media subgroups of Phelps such that the carbohydrates and vitamins are physically divided into separate media subgroups, as suggested by Phelps et al and Mavromichalis. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to separate the tableted media components to limit their reactivity and degradation in long-term storage, and would have had a reasonable expectation of success given that the disclosures of both Phelps and Phelps et al are concerned with the development of dry powder media formulations. See MPEP § 2143(I)(G).
Consequently, Phelps as modified by Phelps et al and Mavromichalis render obvious a final tableted media composition comprising a tableted base cell culture media of amino acids, salts, buffers, trace minerals, lipids, nucleic acids, and proteins, and two physically separated tableted media subgroups of carbohydrates – which include glucose (claim 11) – and vitamins – which include thiamine and folic acid (claim 12). As the tableted base cell culture media and tableted media subgroups are physically separated in different containers (claim 4) when held at a temperature of 20°C to about 25°C, and then combined into the final tableted media composition prior to being used (claim 5), this therefore renders obvious the composition of instant claim 1.
Regarding claims 2-3: Following the discussion of claim 1, Phelps further discloses that the tableted media is stable at about 20°C to about 25°C (claim 2) for about 3-24 months (claim 3) (Paragraphs [0063], [0066], [0095]). This therefore reads on the composition of the instant claims. See MPEP § 2131.03.
Regarding claim 5: Following the discussion of claim 4, Phelps further discloses that the tableted media subgroups are combined prior to being used (Paragraphs [0040]-[0041], [0054], [0065]-[0066], [0072], [0082]-[0083], [0096]-[0098]). This therefore reads on the composition of the instant claim.
Regarding claims 6 and 10: Following the discussion of claim 4, Phelps further discloses that the tableted media subgroups are held in different containers while in powder – or granulated – form (Paragraphs [0036], [0041], [0114]-[0117]). This therefore renders obvious the compositions of the instant claims, wherein the powdered base medium and media subgroups are each situated in separate containers (claim 6). It is of note that the holding of the carbohydrate and vitamin subgroups in separate containers from the powdered base medium will necessarily reduce their interaction with the powdered base medium, as they are not in contact with the powdered base medium (claim 10). See MPEP § 2112.
Regarding claim 20: Following the discussion of claim 1, Phelps further discloses that the final tableted media composition is for the culture of mammalian cells (Paragraphs [0064], [0072], [0080], [0086], [0099], [0101]). This therefore reads on the composition of the instant claim.
Regarding claim 21: Following the discussion of claim 1, Phelps further discloses a method of making the final tableted media composition, wherein the tableted base cell culture media comprising the amino acids, salts, buffers, trace minerals, lipids, nucleic acids, and proteins is formulated as an agglomerated powder, packaged in a separate container, and admixed with agglomerated powders of the media subgroups that are held in separate containers during storage at about 20°C to about 25°C prior to use (Paragraphs [0007]-[0008], [0011], [0014], [0034]-[0036], [0040]-[0041], [0054], [0063], [0065]-[0067], [0072], [0082]-[0083], [0095]-[0098], [0109], [0114]-[0119]). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claim 22: Following the discussion of claim 21, Phelps further discloses the formation of a vitamin concentrate (Paragraphs [0046], [0087]). This therefore reads on the method of the instant claim.
Regarding claim 23: Following the discussion of claim 22, Phelps further discloses that a solvent is utilized to solubilize a tableted media subgroup – including a vitamin concentrate – and allows for the combination of the final tableted media composition (Paragraphs [0054], [0096]-[0098], [0107]-[0109]). This therefore reads on the method of the instant claim.
Regarding claim 28: Following the discussion of claim 1, Phelps further discloses that the tableted media subgroups are comprised within a kit, wherein the kit comprises the each of the tableted media subgroups kit in separate containers such as pouches or drums (Paragraphs [0010], [0116]-[0118]). This therefore renders obvious the kit of the instant claim for the same reasons as discussed in the rejection of instant claim 1.
Regarding claims 29-30: Following the discussion of claim 28, Phelps further discloses that the tableted media is for the in vitro culture of mammalian cells (claim 29), particularly CHO cells or HEK293 cells (claim 30) (Paragraphs [0064], [0068], [0072], [0080], [0086], [0099], [0101]). This therefore reads on the kit of the instant claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (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, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights