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 .
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.
Claim Status
Claims 1, 123, 128-151 are currently pending and examined on the merits.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Applicant purports to incorporate by reference unpublished US application Nos. 63/279,617, 63/279,642, 63/279,644, 63/159,403, 63/279,631, 63/300,557, 63/164,397, 63/164,387, 63/314,171, 63/314,191.
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Enablement
Claims 140-151 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 enablement requirement. The specification, while being enabling for methods of culturing non-human animal cells in a culture media comprising between 2% and 20% by weight of a non-human animal platelet lysate, does not reasonably provide enablement for growing a cell-based meat product from the non-human animal cells. The specification contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” See MPEP § 2164. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill:
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples;
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
(A) With respect to the breadth of the claims, the claims as currently drafted encompass culturing any non-human animal cell in a culture media comprising between 2% and 20% of a non-human platelet lysate (PL). The instant claims do not require any particular cell type (e.g., skeletal muscle), species (e.g., bovine, salmon, cricket, etc.), culture conditions (e.g., temperature, humidity, duration, etc.), media components (e.g., differentiation v. growth media), or other parameters. The claims are limited by utilizing non-human cells and PL. Consequently, the breadth of the claims is expansive.
(B) The invention is ostensibly in the field of ex vivo meat products.
(C)-(E) With respect to the state of the prior art, and predictability of the art, ex vivo cultured food products is an emerging art.
Hong et al., Current issues and technical advances in cultured meat production. Food Sci Anim Resour, 41(3) May 2021, pp. 355-372 (hereinafter Hong)., explains that cultured food products currently in development include chicken, beef, duck, and pork meat products (Biological basis underlying the cultured meat production of various livestock, Table 2). Hong explains that as of 2021 cultured meat has not yet been formally been commercialized and sold; that only prototypes have been developed (Biological basis underlying the cultured meat production of various livestock, Table 2).
Miller, R.K., A 2020 synopsis of the cell-cultured animal industry. Animal Frontiers, 10(4) Oct 2020, pp. 64-72 (hereinafter Miller)., likewise explains that cultured food products are currently in the stages of innovation and development, and that as of late 2020 viable products are likely several years away from being established (Where is the industry?, Table 2).
Genovese et al., PCT Publication No. WO 2015/066377 (hereinafter Genovese) discloses methods for producing ex vivo skeletal muscle for use as cultured meat products (Abstract). Genovese discloses genetically modifying a self-renewing animal cell line with a myogenic transcription factor such as MyoG, MyoD1, MYF5 (¶ [0006]-[0008], [0062]-[0064], [0074]). The modified cell line may be induced to differentiate into myogenic lineage cells, such as by treating with E2 in the absence of doxycycline (¶ [0008], [0064]). Differentiation may further involve activating the Wnt signaling pathway and adding epigenetic modulators (¶ [0008], [0065]-[0068]). The resultant cells when further cultured in low-mitogen media further differentiate into multinucleated myotubes with contractile potential (¶ [0008], [0074]-[0078]). Genovese explains that the resultant product is suitable for use as in developing cultivated meat products, but does not disclose actually producing a cultured meat product (¶ [0004], [0009], [0054]).
Therefore, ex vivo cultured meat products is an art with a degree of unpredictability.
(F)-(G) The applicants have provided multiple working examples directed to culturing lamb or bovine myoblasts in culture media comprising bovine PL. The applicants have not provided working examples for preparing an ex vivo meat product.
(H) Undue experimentation would be required to practice the invention as claimed due to the amount of experimentation necessary because of the breadth of the claims, the state of the prior art and its lack of predictability, and the lack of guidance in the form of varied working examples in the specification.
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to claims 140-151, in view of the applicant’s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 140-151 would not be enabled by the written disclosure. Therefore, claims 140-151 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to use make and/or use the invention commensurate with the scope presented.
Claim Rejections - 35 USC § 112(a)/1st paragraph
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.
Written Description
Claims 140-151 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163.
The specification as originally filed indicates that in some embodiments cell-based meat products are grown using the disclosed culture media (p31 ¶1). However, the specification contains no description as to how a cell based meat product may be actually produced; the specification appears to be prophetic rather than providing means by which the cell-based product may be produced. While the specification purports to incorporate unpublished US applications, each of these applications are likewise directed to limited aspects of the process of producing a cell-based meat product (e.g., producing microcarriers for the culture of myoblasts) (See p31 ¶1-p32 ¶1). Therefore, it is not clear that, at the time of filing, applicants had full possession of the claimed invention.
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 140-148 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 140 as presented contains the limitation “growing a cell-based meat product from the non-human animal cells in the bioreactor”. Claim 140 contains no further guidance as to how the non-human animal cells may be grown into a meat product (e.g., differentiation media components, culture duration, cell types, etc.). Culture parameters are considered to be critical method steps for achieving a particular output. Claims 141-148, do not rectify the deficiencies noted in claim 140. For examination purposes, claim 140 is consequently interpreted as comprising “growing the non-human animal cells in the bioreactor”.
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.
Claim(s) 1, 123, 128, 143 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alden et al., (2007) Porcine platelet lysate as a supplement for animal culture. Cytotechnology, 55(1): pp. 3-8 (hereinafter Alden).
Regarding claims 1, 123,128, Alden discloses culture media supplements comprising porcine platelet lysates (PPL) (Abstract). Alden discloses culturing each of Vero (African green monkey), Chinese hamster ovary (CHO) and human hybridoma cells (39.5) in Dulbecco’s Modified Eagle’s Media (DMEM) supplemented with penicillin/streptomycin, L-glutamine, and 5-10% PPL (Cell culture). Alden discloses that PPL is a viable alternative to fetal bovine serum for the culture of various cell types (Conclusions).
Therefore, every limitation of claims 1, 123, 128, and 143 is present in Alden, and the subject matter is anticipated.
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.
Claim(s) 1, 123, 128-132, 134-140, 143, 146-147 , 150-151 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberli et al., US Publication No. 2021/0244770 (hereinafter Eberli) and further in view of Alden.
Regarding claims 1, 132, 140, Eberli discloses methods of culturing skeletal muscle derived precursor cells (MPCs) in a xeno-free culture media for (Abstract). Eberli explains that cell proliferation is medium-dependent and that addition of growth factors alone may not be sufficient to sustain cell expansion ([0015]). Eberli discloses that human PLs are a possible substitute for fetal bovine serum (FBS) in the culture of certain cell types ([0014]).
Regarding claim 123, the PLs are preferably present between 7-12% ([0027]).
Regarding claims 129-131, 143, 147, 151 in a preferred embodiment the media is DMEM/F-12 supplemented with 2-20 ng/mL, human epidermal growth factor (EGF), 0.5-2 ng/mL human basic fibroblast growth factor (bFGF), 5-20 µg/mL insulin, and 0.2-0.8 g/mL dexamethasone ([0028]).
Regarding claims 132, 140, Eberli explains that MPCs may be produced in a bioreactor ([0061]).
Eberli does not disclose that the platelet lysate or the cells is derived from a non-human animal.
Alden discloses culture media supplements comprising porcine platelet lysates (PPL) (Abstract). Alden discloses culturing each of Vero (African green monkey), Chinese hamster ovary (CHO) and human hybridoma cells (39.5) in Dulbecco’s Modified Eagle’s Media (DMEM) supplemented with penicillin/streptomycin, L-glutamine, and 5-10% PPL (Cell culture). Alden discloses that PPL is a viable alternative to fetal bovine serum for the culture of various animal cell types (Conclusions).
Regarding claims 134-139, 146, 150, Alden does not explicitly disclose that the non-human animal cells arise from certain animal species. However, Alden explains that animal platelet lysates (porcine and bovine) may be highly useful for the “culture of animal-derived cells”. Therefore, there is a suggestion present in Alden that animal-derived platelet lysates may be utilized with a variety of animal species as would be evident to one of ordinary skill in the art.
As both Eberli and Alden are directed to methods of culturing cells in media comprising PLs it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that one known species of PL could be substituted for another, with a reasonable expectation that cells could be successfully cultured therein. Similarly, a skilled artisan would understand that one known species of cells could be substituted for another, with a reasonable expectation that the cells could successfully be cultured.
Claim(s) 141-142, 144-146, 148-149 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberli and Alden as applied to claims 1, 123, 128-132, 134-140, 143, 146-147 , 150-151 above, and further in view of Lee et al., (2019) Effect of Hierarchical Scaffold Consisting of Aligned dECM Nanofibers and Poly(lactide-co-glycolide) Struts on the Orientation and Maturation of Human Muscle Progenitor Cells. ACS Applied Materials & Interfaces, 11(43): 39449-39458 (hereinafter Lee).
Regarding claims 141-142, 144-146, 148-149, the combination does not disclose that the culture media further comprises scaffolds with an average diameter of less than 1 mm.
Lee discloses methods of making scaffolds and culturing MPCs thereon (Abstract). Lee discloses modifying decellularized skeletal muscle tissue methacrylate (dECM-MA) and electrospinning to produce nanofibers (Preparation and characterization of dECM-MA, Fabrication of electrospun dECM-MA nanofibers). Lee discloses that the diameter of the dECM-MA fibers may be modified between less than 1 to greater than 3 µm (Fabrication of electrospun dECM-MA nanofibers, Fig. 3(c)). Lee discloses seeding hMPCs on the scaffolds (In vitro biological properties of multiscale composite scaffolds). The seeded cells demonstrate myogenic differentiation potential in the absence of myogenic differentiation media (In vitro biological properties of multiscale composite scaffolds, Conclusions). Lee concludes that the disclosed scaffold demonstrate “great promise for developing functional skeletal muscle tissue” (Conclusions).
As both Lee and Eberli are directed to methods of culturing MPCs it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to utilize the scaffolds of Lee in the methods of Eberli to more efficaciously develop functional skeletal muscle tissue as suggested by Lee.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632