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 .
DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-11, drawn to a method for culturing cells, comprising culturing separated cells by using a composition comprising a chlorella extract.
Group II, claim 12 , drawn to a method for preparing cultured meat, comprising culturing separated cells by using a composition comprising chlorella extract.
Group III, claim 13, drawn to a medium composition for cell culture comprising chlorella extract.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-III lack unity of invention because even though the inventions of these groups require the technical feature of a chlorella extract capable being used to culture cells, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ng “Chlorella vulgaris Extract as a Serum Replacement That Enhances Mammalian Cell Growth and Protein Expression” Frontiers in Bioengineering and Biotechnology September 2020, Volume 8. Ng teaches using a Chlorella vulgaris extract to culture cells (Abstract of Ng).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Jeffrey Sharp on January 5,2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 12-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 4 is objected to because of the following informalities: The chlorella species listed in claim 4 need to be italicized. Appropriate correction is required.
Claim 7 is objected to because of the following informalities. “the composition further comprise” should be –the composition further comprises--.
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 1-4,7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ng “Chlorella vulgaris Extract as a Serum Replacement that Enhances Mammalian Cell Growth and Protein Expression” Frontiers of Bioengineering and Biotechnology, September 2020, Volume 8. Ng was disclosed by applicant in IDS dated October 5, 2023.
Ng teaches a method for culturing cells, comprising culturing separated cells by using a composition comprising a chlorella extract (Ng--Page 9, Figure 7 and its description) as in instant Claim 1. Ng discloses wherein the chlorella extract is comprised at a concentration of 23.0 g/L or less (Page 9 and Figure 7 and description) as in instant Claim 2. Ng discloses wherein the chlorella extract is comprised at a concentration of 0.4 g/L to 10 g/L (Page 9 and Figure 7 and description) as in instant Claim 3. Ng discloses that the chlorella extract is obtained from Chlorella vulgaris (Abstract of Ng) as in instant Claim 4. Ng discloses wherein the composition comprise serum (Page 9, Figure 7) as in instant Claim 7. Ng discloses wherein the serum is FBS (fetal bovine serum) (Page 9, Figure 7) as in instant Claim 8. Ng discloses wherein the serum is comprised in an amount of .5 parts by volume to 15 parts by volume based on 100 parts by volume of a total volume of the composition (Page 9, Figure 7) as in instant Claim 9. Ng discloses wherein the serum is comprised at a weight of 1000:1 to 1:1 relative to the chlorella extract (serum: chlorella extract) (Page 9, Figure 7) as in instant Claim 10.
The reference anticipates the claim limitations.
Claims 1-2,4-5,7-8, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azlan et al. “Chlorella vulgaris Modulates Genes and Muscle-Specific microRNAs Expression to Promote Myoblast Differentiation in Culture” Hindawi, Evidence-Based Complementary and Alternative Medicine, Volume 2019.
Azlan discloses culturing separated cells by using a composition comprising a chlorella extract (Abstract; Pages 2-3, 2.1 Cell Culture Section and 2.2. Preparation of Chlorella vulgaris for Cell Treatment) as in instant Claim 1. Azlan discloses wherein the chlorella extract is comprised at a concentration of less than 23.0 g/L (Page 3, Section 2.2 Preparation of Chlorella vulgaris for Cell Treatment) as in instant Claim 2. Azlan discloses wherein the chlorella extract is obtained from Chlorella vulgaris (Page 3, Section 2.2. Preparation of Chlorella vulgaris for Cell Treatment) as in instant Claim 4. Azlan teaches wherein the cell is a myoblast (a myogenic stem cell) (Page 3, 2.2. Preparation of Chlorella vulgaris for Cell Treatment) as in instant Claim 5. Azlan teaches that the composition comprise serum (FBS) (Page 2; 2.1 Cell Culture and Page 3 and 2.2 Preparation of Chlorella vulgaris for Cell Treatment) as in instant Claims 7-8. The method of Azlan produces muscle cells which can be considered a type of meat (Pages 4-5, Results Section) as in instant Claim 11.
The reference anticipates the claim limitation.
Claims 1,7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumamoto (USPT 4,468,460)
Kumamoto discloses culturing separated cells by using a composition comprising chlorella extract (Abstract of Kumamoto) as in instant Claim 1. Kumamoto discloses wherein the composition comprises serum (Column 2, lines 56-66 of Kumamoto) as in instant Claim 7. Kumamoto discloses that the serum is fetal bovine serum (Column 3, Example of Kumamoto) as in instant Claim 8. Kumamoto discloses wherein the serum is comprised in an amount of 0.5 parts by volume to 15 parts by volume based on 100 parts by volume of total volume composition (Column 3, Example of Kumamoto) as in instant Claim 9. Kumamoto discloses wherein the serum is comprised at a weight ratio of 1000:1 to 1:1 relative to the chlorella extract (serum:chlorella extract) (Column 3, Example of Kumamoto) as in instant Claim 10.
The reference anticipates the claim limitations.
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)(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 1,4-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shimizu (US 20220340864)
Shimizu discloses culturing separated cells by using a composition comprising chlorella extract (Page 9, Examples 3 and 4, and Figures 7-8) as in instant Claim 1. Shimizu discloses that the chlorellae is Chlorella vulgaris (Page, Examples 3 and 4) as in instant Claim 4. Shimizu discloses that the cell is a muscle cell (Page 9, Examples 3 and 4) as in instant Claim 5. Shimizu discloses that the cell is a bovine-derived cell (Page 9, Examples 3 and 4) as in instant Claim 6. Shimizu discloses that the culture medium comprises FBS serum (Page 9; Examples 3-4 and Figures 7-8) as in instant Claims 7-8. Shimizu disclose wherein the serum is comprised in an amount of 0.5 parts by volume to 15 parts by volume based on 100 parts by volume of total volume of the composition (Figure 7-8) as in instant Claim 9. Shimizu discloses wherein the serum is comprised at a weight ratio of 1000:1 to 1:1 relative to the chlorella extract (serum: chlorella extract) (Figure 7-8) as in instant Claim 10. The muscle cells cultured that are mentioned in Examples 3-4 and Figures 7-8 would be considered a type of meat as in instant Claim 11.
The reference anticipates the claim limitations.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu (US 20220340864).
Shimizu applies as above to teach claims 1,4-11. Shimizu does not teach the specific concentration of Chlorella extract recited in claims 2-3; Shimizu teaches a greater concentration of Chlorella extract. MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed concentration is critical. Absent such evidence, it would have been obvious to an artisan of ordinary skill at the time of effective filing Shimizu to try a finite number of different concentrations of the Chlorella extract to predictably arrive at the claimed concentration through routine optimization. An artisan would have a reasonable expectation of success in optimizing the concentrations because determining the concentrations of medium components such as algal extract was long established in the art as demonstrated by Shimizu. Thus, Shimizu renders obvious the instantly claimed concentrations in claims 2 and 3.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638