DETAILED ACTION
This action is in reply to papers filed 11/7/2024. Claims 1-11 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the as-filed specification of this application.
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 and 11 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.
The metes and bounds of claims 1 and 11 are unclear. Claim 1 is drawn to collecting stem cells from animal tissue. However, the steps in the body of the claim require no such step. Thus, the metes and bounds of the claim are unclear. Similarly, while the preamble of claim 11 is drawn to producing cultured meat, the steps contained therein do not require the production of cultured meat. Indeed, all that is required of the claim is for the collected stem cells of claim to include differentiation to construct an artificial tissue. However, the construction of an artificial tissue is clearly not synonymous with production of a cultured meat. That is, there is no nexus between the preamble and the body of the claim. Moreover, no step contained in claim 11 derives a cultured meat.
Clarification is requested.
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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakano et al. (JP2012201616A, Published 10/22/2012; see translation attached).
Claim interpretation: Instant claim 1 is drawn to a method for collecting stem cells from animal tissue. This limitation is interpreted as an intended use. Per MPEP 2111.02 (II), if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
In this regard, the preamble of the claim fails to imbue any structural limitation onto the claim.
Regarding claim 1, Nakano discloses immersing animal tissue in a solution containing peracetic acid, hydrogen peroxide and acetic acid (Pg. 2, para. 9). Nakona teaches since peracetic acid acts as an oxidizing agent, peracetic acid cleaves the bond between type II collagen and proteoglycan present in the cartilage matrix of animal tissues, such as cartilage tissue, or is prone to extract proteoglycans. Thus, it is considered that the proteoglycan acts to move to the peracetic acid solution. Furthermore, lipid components and the like contained in the animal tissue also move from the animal tissue to the peracetic acid solution and are removed from the animal tissue (see Pg. 2).
Accordingly, Nakano anticipates the claimed invention.
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(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Stout et al. (PgPub US20220228121A1,Filed 6/1/2020), Phebus et al. (PgPub US20030047087A1, Published 3/13/2003), Christensen, T (PgPub US20090246193A1, Published 4/5/2011 ) and Lynch (WO1998033889A1, Published 8/6/1998).
Stout et al. teach bovine (as in claim 5) adipose-derived (as in claim 6) stem cells (as in claim 4) (Pg. 4,para. 34; Pg. 18,para. 95; Pg. 20, para. 118) that are suitable for use in a cultured meat product (as in claim 10) (Pg. 4,para. 36). Stout describes screening natural compounds that have demonstrated potential utility as food-safe antimicrobials for utility in commercial production of cultured meat (Pg. 45,para. 445-447).
However, Stout fails to teach a washing solution comprising acetic acid, peracetic acid and hydrogen peroxide (as further in claim 1).
Before the effective filing date of the claimed invention, Phebus et al. taught commercially available antimicrobial compositions include Spor-Klens™, a mixture of hydrogen peroxide, peracetic acid, and acetic acid (as in claim 1) (Pg. 3, para. 29). Phebus teaches the peracetic acid comprising solution is contacted with a food product for a period of from about 10 seconds to 5 minutes (as in claim 3) (see Phebus at claim 13).
And although Phebus teaches a solution comprising acetic acid, peracetic acid and hydrogen peroxide, Phebus fails to teach the concentration of each of acetic acid, peracetic acid and hydrogen peroxide (as in claim 2).
Before the effective filing date of the claimed invention, Christensen taught contacting microorganisms with, inter alia, a chemical additive sufficient to inactivate the microorganisms. Christensen teaches the chemical additive may be comprised of hydrogen peroxide (H2O2), acetic acid (AcA), peracetic acid (PAA), and trifluoroacetic acid (TFA), and mixtures thereof. One particularly preferred chemical additive that may be used is commercially available SPORECLENZ® sterilant which is a mixture of acetic acid, hydrogen peroxide, and peracetic acid (Pg. para. 30-32). Christensen teaches the chemical additive may be used in an inactivation enhancing effective amount of at least about 0.001 vol. % and greater, That is, a range of at least about 0.001 vol. % and greater, up to about 2.0 vol. % will typically be needed in order to achieve an inactivation enhancing effect (as in claim 2) (Pg. 4, para. 33).
However, none of Stout et al., nor Phebus et al. nor Christensen taught the adipocytes were cultured into cell clusters (as in claim 7).
Before the effective filing date of the claimed invention, Lynch taught primary adipocytes were obtained from fat pads of cows. Lynch teaches by about six days in culture, whereby the media is changed daily (as in claim 9) (Pg. 10-11), nearly all of the cells migrated through the basement membrane and organize into three dimensional clusters of adipocytes (as in claim 7 and claim 8) that appear very similar to developing adipose tissue in vivo (Pg. 12-13). Specifically, the cells initially form intensive ramifications and then later organize into spherical clusters that are the approximate size and shape of primitive organs. Primitive organs are early spherical clusters of fat cells found during development wherever adipose tissue eventually develops. Also, the adipocytes so cultured remain in a post-mitotic state. This can be important for transplant purposes since a dividing fat cell population might cause the inappropriate formation of lipomas or fat cell tumors or masses (Pg. 7-8).
When taken with the teachings of Stout et al., wherein Stout teaches screening anti-microbial compounds suitable for use in cultured meat, one of ordinary skill in the art would have found it prima facie obvious to use the commercially available Spor-Klens solution as an anti-microbial solution for the cultured meat of Stout because such can be used in a food product. Moreover, the skilled artisan would have looked to the teachings of Christensen in order to provide for a concentration of additives that would be effective in inactivation of microorganisms. Finally, the skilled artisan would have found it prima facie obvious to culture the adipocytes in clusters because Lynch teaches such cells remain in a post-mitotic state and do not form lipomas or tumors.
Thus, the modification would have been prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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