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 .
Claim Status
Claims 17-32 are pending.
Applicant’s election without traverse of the invention of group II (claims 24-25) in the reply filed on 22 June, 2026 is acknowledged.
Claims 17-23, and 26-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 24-25 are pending and are under examination in the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2022/021843, filed 27 May, 2022, which claims priority to JAPAN Application No. JP2021-090672, filed 28 May, 2021. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified untranslated copies of papers required by 37 CFR 1.55 have been filed in this application on 28 November, 2023.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
The earliest possible priority for the instant application is 28 May, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 February, 2024, 08 November, 2024, and 11 February, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The Drawings submitted on 28 November, 2023 are accepted by the Examiner.
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 24-25 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 24 recites “using an animal cell culture medium” in the fourth line of the claim and “using the first composition” in the seventh line of the claim. It is unclear whether Applicant intends the scope of claim 24 to encompass culturing animal cells in an animal cell culture medium and culturing microalgae in the first composition respectively or whether Applicant instead intends to encompass any possible manner of usage. In the case of any possible manner of usage, it is unclear what uses fall within the scope of the instant claim 24. Accordingly, a person having ordinary skill in the art would not be apprised of the scope of claim 24. It is suggested to replace the word “using” with the word “in” in each place where “using” occurs to overcome this issue.
Claim 24 recites the limitation “the microalgae” in the ninth line of the claim. There is insufficient antecedent basis for this limitation in the claim insofar as multiple antecedents exist for “the microalgae” in step (d). It is unclear whether Applicant intends claim 24 to encompass decomposing the microalgae collected in step (c), or the microalgae cultured in step (b). Accordingly, the claim is unclear and indefinite.
Claim 25 recites the limitation "the marine and/or euryhaline microalgae" in the fourth line of the claim. There is insufficient antecedent basis for this limitation in the claim insofar as the marine and/or euryhaline microalgae of claim 24 from which claim 25 depends are consumed via a step of decomposing in step (d) of claim 24. Thus, it is unclear whether claim 25 is attempting to refer back to the specific marine and/or euryhaline microalgae that are the subject of the decomposing or instead to a second marine and/or euryhaline microalgae. This issue is compounded by the multiple antecedents found in claim 24 (see above). Accordingly, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought by claim 25. It is suggested to instead refer to “a second” marine and/or euryhaline microalgae in claim 25 to avoid this issue.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 24 and 25 broadly read on a genus of methods encompassing a vast genus of marine and/or euryhaline microalgae paired with a vast genus of mammalian cells and a vast genus of media “obtained from culturing animal cells using an animal cell culture medium” having the functional property of being a recycling culture method. In addition, claims 24 and 25 broadly read on “decomposing” by any means the microalgae to produce an algal extract which can function to support the culture of mammalian cells in a medium containing the extract.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021). Further, A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
Here, the specification provides working examples which culture microalgae in “waste medium” obtained after culturing C2C12 mouse myoblast cells for 3 days in DMEM (Specification, [0084], [0088]). The specification teaches the culturing of C. littorale, C. vulgaris, and Synechococcus sp. in waste media in the preceding fashion (Specification, [0094], [0099]-[0100]). The specification goes on to teach that C. vulgaris prefers nitrates while C. littorale prefers ammonia (the waste product of mammalian cells) for their respective nitrogen sources, that this difference resulted in a much different proliferative profile for the algae species, and that “optimization of the medium components and selection of microalgae species, such as… microalgae that prefer ammonia… will be a topic for future research (Specification, [0095]). Thus, it would appear that even the instant inventors do not believe they have an effective “recycling” method at present for C. vulgaris and that more research is needed to reach such a point. Thus, the inventors have only disclosed one mammalian cell type (C2C12 mouse myoblasts), three types of algae (C. littorale, C. vulgaris, and Synechococcus sp.), and one such waste medium (DMEM from cultured C2C12 mouse myoblasts after 3 days of culture) capable of having the functional property of being a recycling culture method. For algal extract production, the specification teaches a working example wherein C. littorale cultured for 7 days in waste medium from C2C12 cells were acid treated to extract nutrients, neutralized, and added to a basal DMEM medium (Specification, [0104], [0108]). The specification then provides only a single working example where the algal extract was used in a recycling culture method wherein C2C12 cells were cultured in DMEM containing the C. littorale algal extract (Specification, Example 5). The specification teaches no mammalian cells other than C2C12 mouse myoblasts, no medium other than DMEM, no recycling method utilizing an algal extract other than C. littorale algal extract, and no method for extracting nutrients from algae other than acid extraction.
The field of recycling cell culture methods using algae, mammalian cells, and waste media from mammalian cell culture is nascent insofar as the instant inventors appear to be the primary group investigating such methods and they have only done so in the last decade (See Haraguchi, et al. Scientific reports 7.1 (2017): 41594, hereinafter “Haraguchi” and US20220340864 (Effectively filed 01 October, 2019) (hereinafter “Shimizu”)). Where they have done so, the instant inventors have mostly exemplified C2C12 cells co-cultured with C. littorale and C. littorale algal extracts (See Haraguchi and Shimizu). In addition, as far as “decomposition” is concerned, Shimizu teaches acid-based extraction to produce algal extracts (Shimizu, Abstract). Consequently, the skilled artisan in this field is relying almost entirely on the teachings of the instant inventors for guidance in practicing the instant invention and what algal species, cell types, and cell media may be used to recycle nutrients effectively in culture. Considering the relatively nascent nature of the field, and the limited disclosure of the instant specification describing only one specific example which uses C2C12 cells cultured in DMEM containing a C. littorale algal extract, it has not been reasonably conveyed to the skilled artisan that the instant inventors had possession of the entire genus of algae, mammalian cells, media, and decomposition methods 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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Haraguchi, et al. Scientific reports 7.1 (2017): 41594, hereinafter “Haraguchi”, of record on the IDS submitted 11 February, 2026 in view of US20220340864 (Effectively filed 01 October, 2019) (hereinafter “Shimizu”), and ThermoFisher DMEM Datasheet, Accessed: 13 July, 2026, hereinafter “Thermo”.
Haraguchi discloses a method of co-culturing Chlorococcum littorale with C2C12 cells in a DMEM medium (Haraguchi, Table 1; page 8, fourth para.). C. littorale is a microalgae and C2C12 cells are mouse myoblast cells (Haraguchi, page 8, para. 2-3; page 7, second full para.). The DMEM of Haraguchi necessarily contains amino acids and at least 0.02mM phosphorus as evidenced by Thermo who teaches that DMEM contains 0.9mM phosphorus and various amino acids (Thermo, whole document). In disclosing a method of co-culturing microalgae with mammalian myoblast cells in DMEM, Haraguchi discloses a method comprising preparing a first composition comprising a medium obtained from culturing animal cells using an animal cell culture medium and culturing a marine or euryhaline microalgae in the first composition (co-culturing the C. littorale microalgae and mammalian cells in DMEM). In addition, Haraguchi teaches that the method is a “symbiotic recycling system”, thus meeting the preamble of instant claim 24 which requires a “recycling culture method”.
Haraguchi does not teach collecting the microalgae, decomposing the microalgae, and culturing animal cells using an extract from the decomposed microalgae.
Shimizu teaches a production method for a composition for cell culturing which comprises subjecting algae to acid hydrolysis treatment to obtain an algae extract, and mixing the extract with a medium for cell culturing (Shimizu, Abstract). Shimizu also claims a method of culturing cells using the composition comprising an algae extract mixed into a cell culturing medium (Shimizu, claims 1 and 13). Shimizu teaches a method of culturing C2C12 mouse myoblast cells (the same cells as Haraguchi) with a medium comprising C. littorale extract (the same microalgae as Haraguchi) (Shimizu, [0251]-[0254]). Shimizu teaches that algal extracts function effectively as surrogates for nutrients during mammalian cell culture demonstrating novel cell culture systems which can reduce effects on the environment (Shimizu, [0256]). Accordingly, Shimizu teaches a method of collecting microalgae, decomposing the microalgae to produce algal extract, and culturing animal cells using a medium containing algal extract.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have combined the method of producing an algal extract and culturing mammalian cells using the same of Shimizu with the method of co-culturing mammalian cells and microalgae of Haraguchi and to have arrived at the invention claimed in instant claim 24 with predictable results because the prior art included each element claimed with the only difference being the lack of actual combination of the elements into a single reference, and a person having ordinary skill in the art could have combined the methods into a single method by merely producing an algal extract from the co-cultured algae of Haraguchi and further culturing mammalian cells according to Shimizu and each respective method merely performs the same functions as they do separately insofar as the method of Haraguchi would still recycle nutrients in the combined method and the extract of Shimizu would still provide a surrogate for nutrients for further culturing. The results of combining the methods of Haraguchi and Shimizu would have been predictable to a person having ordinary skill in the art insofar as each method uses the same cells and the same microalgae to accomplish similar nutrient cycling and replacement ends.
Additional Comments
Claim 25 is indicated as free of the prior art of record. Although Haraguchi and Shimizu render prima facie obvious claim 24, they do not teach, suggest, or motivate a person having ordinary skill in the art to prepare a second composition comprising a medium obtained from culturing the animal cells in step (e) and a second step of culturing marine and/or euryhaline microalgae using the second composition. Applicant is advised that claim 25 still possesses issues under 35 U.S.C. 112(a) (see above written description rejection).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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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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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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