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
This action is in response to the papers filed on 03/10/2026. Claims 1-7 and 12-24 are currently pending as per claims filed on 03/10/2026. Claims 8-11 were previously canceled as per claims filed on 02/20/2024.
Applicant’s election of Group I, which include claims 1-7, 12-15, and 21-23, drawn to a serum-free and animal component- free culture media in the reply filed on 03/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16-20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
The requirement for restriction between Groups I-III is still deemed proper and is therefore made FINAL.
Therefore, claims 1-7, 12-15, and 21-23 are subject to examination to which the following grounds of rejection are applicable.
Priority
The instant application is a 371 of PCT/US21/62668 filed on 12/09/2021, which claims priority to PRO 63/123,346 filed on 12/09/2020.
Thus, the earliest possible priority for the instant application is 12/09/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/08/2023 and 01/13/2025 were filed before the mailing date of the non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 1 recites “A serum-free and animal-component-free culture media for expansion of muscle cells for use in cultured food applications, the media comprising: a baseline serum-free and animal-component-free culture media that, in use, provides a baseline growth capability for expansion of the muscle cells for use in cultured food applications; a recombinant version of albumin, wherein the serum-free and animal-component-free culture media, in use, provides an improved growth capability for expansion of the muscle cells for use in cultured food applications, wherein the improved growth capability is at least 50% greater than the baseline growth capability.”
The limitation that “for expansion of muscle cells for use in cultured food applications” is intended use. If the prior art composition taught by primary reference is capable of performing the recited intended use, this limitation is met. See e.g. In re Schreiber, 128 F.3d 1473, 1477; 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2114
Additionally, the phrase “wherein the serum-free and animal-component-free culture media, in use, provides an improved growth capability for expansion of the muscle cells for use in cultured food applications, wherein the improved growth capability is at least 50% greater than the baseline growth capability” is inherent to the product (media) of the claim. The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
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 2, 7, 13, 22 and 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.
Claim 2 recites the phrase, “one or more optional minerals”. It is unclear what the intended meaning is for “optional minerals”. Are the minerals optional in that the applicant intends that they are not required to be added? Does the applicant intend that specific minerals are being described under an umbrella phrase of optional minerals, and therefore are not in fact optional as a component? The claim does not provide information that would alleviate the lack of clarity and therefore claim 2 is indefinite.
Claim 2 recites an “and/or” conjunction in the phrase one or more growth-stimulating and/or cell-signaling factors at a concentration of between 0.01 ng/mL and 100,000 ng/mL. It is unclear whether the “and/or” is meant solely to apply to the growth-stimulating and cell-signaling factors, or if the and/or conjunction applies to all of the components listed in Claim 2. Therefore, the metes and bounds are uncertain, which renders the claim indefinite.
Claim 7 recites, “The serum-free and animal-component-free culture media of claim
3, comprising the recombinant version of interleukin 6.” There is insufficient antecedent basis for the recitation of “the recombinant version of interleukin 6” in claim 7 as this recombinant version of interleukin 6 is not present in claim 3. Therefore, the claim as written is indefinite.
Claim 13 recites, “The serum-free and animal-component-free culture media of claim 1, comprising a basal media, L-ascorbic acid 2-phosphate, recombinant insulin, recombinant Transferrin, sodium selenite, recombinant fibroblast growth factor 2, recombinant Neuregulin 1, and recombinant transforming growth factor beta 3.” There is insufficient antecedent basis for this recitation as the serum-free and animal-component-free culture media of claim 1 is not “comprising a basal media, L-ascorbic acid 2-phosphate, recombinant insulin, recombinant Transferrin, sodium selenite, recombinant fibroblast growth factor 2, recombinant Neuregulin 1, and recombinant transforming growth factor beta 3.” It is suggested that applicant amend the claim to recite “The serum-free and animal-component-free culture media of claim 1, further comprising…”.
Claim 23 inherits this deficiency and is rejected insofar as it depends from claim 13.
Claim 22 recites “The serum-free and animal-component-free culture media of claim 1, wherein the improved growth capability is short-term growth capacity.” It is unclear what the applicants’ intended meaning for “improved growth capability in a short-term growth capacity”. By what metric is the growth capability measured? Improved growth capability compared to what alternative? What length of time does the applicant consider as “short-term”? The metes and bounds cannot be determined and therefore the claim is indefinite. Claim 23 recites the phrase “is at a lower concentration or lower concentrations than would ordinarily be present in the baseline culture media.”. It is unclear what the applicants intended meaning for “would ordinarily be present in the baseline culture media.”. What is an experimental condition deemed ordinary versus not ordinary? How would this value vary between baseline culture medias? If one baseline culture media has specific value and a second baseline culture media has a lower specific value than the first, does the applicant intend that the second can be used in the alternative? The metes and bounds cannot be determined and therefore the claim is indefinite.
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)(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.
(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 1-6, 14-15 and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pettit et al. (US 2012/0315697; hereafter “Pettit”, IDS filed 11/08/2023).
Regarding Claim 1, 14-15 and 21-22, Pettit teaches a serum-free and animal-component-free culture media (Abstract) and methods for producing supplemented cell culture media, including providing a cell culture media base (Paragraph [0015]). Pettit teaches specific examples of media that may be used including, BGJb Medium (Fitton-Jackson Modification), (Paragraph [0101]). Pettit teaches the medium may be serum free, animal free, and protein free (Paragraph [0097]). Pettit teaches the media also provides a baseline growth capability, showing that cells in media without supplementation proliferated to 3.3x105 viable cells/ml (Paragraph [0415]; Table E9). Pettit teaches the addition of a recombinant version of albumin (Paragraph [0043]). Pettit teaches enhancing the productivity of a cell that has been adapted to serum free media comprising the addition of a supplement to the serum free media (Paragraph [0175]), and the addition of a supplement comprising recombinant albumin to the culture media during one or more of the growth phase, transition phase or production phase of the culture (Paragraph [0194]). Moreover, Pettit shows their invention to be used in a method providing improved growth capability, specifically they teach “a method to increase the yield of the production phase of a cell culture system and thereby increase the productivity of a bioreactor by adding the supplement. .. invention to the cell culture system, (Paragraph [0200]); “Addition of plant derived recombinant human serum albumin ... increased the proliferation of cells” (Paragraph [0415]), and that “ the yield of the production phase is increased by about 50% .... by about 60% .... by about 70% .... by about 80% .... by about 90% .... by about 100% .... by about 200% .... by about 500% (Paragraph [0201]); the yield is increased compared to a control cell culture system to which the supplement was not added (Paragraph [0202]). The limitation that “for expansion of muscle cells for use in cultured food applications” is intended use. The prior art composition taught by primary reference is capable of performing the recited intended use and, therefore, this limitation is met. See e.g. In re Schreiber, 128 F.3d 1473, 1477; 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2114
Additionally, the phrase “wherein the serum-free and animal-component-free culture media, in use, provides an improved growth capability for expansion of the muscle cells for use in cultured food applications, wherein the improved growth capability is at least 50% greater than the baseline growth capability” is inherent to the product (media) of the claim.
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
Claims 14-15 and 21 recite limitations to the muscle cells of claim 1 (relevant portion quoted below) and claim 22 recites “wherein the improved growth capability is short-term growth capacity.” Claim 14 recites, “…wherein the muscle cells are bovine, galline, ovine, porcine, equine, murine, caprine, lapine, or piscine.” Claim 15 recites, “…wherein the muscle cells are bovine, galline, porcine, or piscine.” Claim 21 recites, “…wherein the muscle cells are muscle satellite cells”. The product, as recited in claim 1, is taught by Pettit, absent evidence to the contrary. Therefore, as discussed above, the intended use and inherent properties of the media are also taught by Pettit, absent evidence to the contrary.
Regarding Claim 2, Pettit anticipates the media of claim 1 as discussed in the 102 rejection above. Moreover, Pettit teaches the media of their invention may comprise the following components:
1. basal media (Paragraph [0097]), 2. sugars such as glucose (Paragraph [0097]) and Gibco #11965-092 which comprises dextrose at a concentration of 4.5g/L (Paragraph [0310]), 3. one or more amino acids “a solution may include ... all essential amino acids, and usually the basic set of twenty amino acids plus cystine” (Paragraph [0097]) and Gibco #11965-092 which comprises L-Cystine 2HCI at a concentration of 0.063g/L) (Paragraph [0310]), 4. one or more vitamins “a solution may include ... vitamins ... required at low concentrations” (Paragraph. [0097]); and Gibco #11965-092, where Gibco #11965-092 comprises Choline Chloride at a concentration of 0.004 g/L) (Paragraph [0310]), 5. one or more optional minerals one or more trace elements, “a solution may include ... trace elements, where trace elements are defined as inorganic compounds or naturally occurring elements that are typically required at very low concentrations, usually in the micromolar range, (Paragraph [0097]); Sodium Selenite was used at a concentration of 6.7 μg/ml, (Paragraph (0437]), 6. One or more growth-stimulating and/or cell-signaling factors, “The solution may optionally be supplemented with one or more ... hormones and other growth factors (Paragraph [0097]); growth and productivity enhancing effect of plant derived transferrin, plant derived human recombinant serum albumin, sodium selenite and ethanolamine alone and in combination with insulin was examined on cells which were seeded into DMEM/F12 .... recombinant human Insulin ... was used at a concentration of 10 μg/ml (Paragraph [0431]) and 7. One or more carrying proteins “addition of a supplement to the culture wherein the supplement comprises a mixture of recombinant albumin and a transferrin related protein” (Paragraph [0054]); the transferrin related protein is lactoferrin, (Paragraph [0060]); the lactoferrin is added to a final concentration of between about 100 mg/L and 400 mg/L, (Paragraph (0063]). Therefore, these components and their respective concentrations as taught by Pettit anticipate those recited in the instant claim 2. Regarding Claim 3, Pettit anticipates the media of claim 1 as discussed in the 102 rejection above. Moreover, Pettit teaches the media may be supplemented with ethanolamine (Paragraphs [0056], [0250], [0324]).
Regarding Claim 4 Pettit anticipates the media of claim 1 as discussed in the 102 rejection above. Moreover, Pettit teaches use of recombinant albumin at both .5 and 1 g/L (Pg. 50, Table 15).
Regarding Claim 5, Pettit anticipates the media of claim 1 as discussed in the 102 rejection above. Moreover, Pettit teaches the recombinant albumin is added to a final concentration of between about 100 mg/L and 2000 mg/L and another aspect of any of the claimed methods the recombinant albumin is added to a final concentration of between about 200 mg/Land 1000 mg/L (Paragraph [0065]). This range encompasses and therefore anticipates the 800 mg/L as recited in claim 5.
Regarding Claim 6, Pettit anticipates the media of claim 1 as discussed in the 102 rejection above. Moreover, Pettit teaches human recombinant serum albumin (Paragraph [0047]).
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 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pettit et al. (US 2012/0315697; hereafter “Pettit”, IDS filed 11/08/2023) as applied to claim 1 above, in view of Kuo et al. (Kuo, Hui-Hsuan et al. Stem cell reports, 2020; hereafter “Kuo”, IDS filed 11/08/2023).
With regards to claim 1, Pettit anticipates the media of claim 1, as iterated above in the 102 rejection, the content of which is incorporated herein, in its entirety.
Regarding Claims 12-13, Pettit teaches their media may contain sodium selenite, transferrin, and recombinant insulin (Paragraph [0431]. FGF2 (Pg. 23, Paragraph [251]), growth factors [Paragraph [0009]) which include TGFß (Paragraph [0118]). The proteins used in the media taught by Pettit are preferably recombinant from human (Paragraph [0013].
Pettit does not teach the specific use of B8 media for a baseline media as recited in instant claim 12. Pettit does not teach L-ascorbic acid 2-phosphate and Neuregulin 1 as components of the media as recited in claim 13.
Kuo cures the deficiencies of Pettit as Kuo describes the development of a media for human induced pluripotent stem cell (hIPSCs), B8 media (Summary). The components of the final product of their final version of the B8 media are seen in figure 3K, provided below and include L-ascorbic acid 2-phosphate and Neuregulin 1.
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It would have been obvious to a person of ordinary skill in the art, at the time of the invention, to have modified the media, as previously disclosed by Pettit, to include the use of a chemically defined and optimized B8 base-media, as previously disclosed by Kuo. One would have been motivated to combine these teachings as Pettit’s teachings are directed towards development of an optimized defined media comprising a base media with supplementation of components shown to enhance cell culture and productivity of the cells, and the inclusion of Kuo’s K8 base media containing additional components to enhance cell culture, such as NRG1 and Ascorbic acid 2-phosphate (which Kuo described as enhancing their media), would be expected to produce a more capable media.
There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pettit et al. (US 2012/0315697; hereafter “Pettit”, IDS filed 11/08/2023) as applied to claim 1 above, in view of Kurosaka et al. (Kurosaka, M, Cell proliferation, 2013)
With regards to claim 1, Pettit anticipates the media of claims 1 and 3, as iterated above in the 102 rejection, the content of which is incorporated herein, in its entirety.
Regarding Claims 7, Pettit does not teach the inclusion of a recombinant version of interleukin 6 in the culture media. However, Kurosaka et al. teaches supplementation of recombinant IL-6 can induce dose-dependent proliferation of satellite cells in culture (Discussion, Paragraphs 1-2).
As Pettit teaches development of cell culture media to improve the growth characteristics of cultured cells, it would have been obvious to a person of ordinary skill in the art at the time of the instant invention to have modified the media of Pettit to include a recombinant protein shown to enhance cell culture, such as recombinant IL-6 as taught by Kurosaka, to further optimize the cell media for certain cell types, such as the satellite cells as taught by Kurosaka.
There would have been reasonable expectations of success in combining these teachings as one of ordinary skill in the art would recognize to combine known elements in the art to give predictable results.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G. Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KODYE LEE ABBOTT/Examiner, Art Unit 1634
/MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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