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
To expedite the compact prosecution, the Examiner is pursuing the claims dated 27 September 2024. in which applicant discloses claims 1-20.
Therefore, claims 1-20 are pending in the application.
Election/Restrictions
Applicant elects, without traverse, the invention directed to a method for producing a cultured meat food product, classified in C12N 5/0062 (identified in the Restriction Requirement as Group II) in the reply filed on 06/08/2026 is acknowledged. Claims 11-20 are directed to the elected invention.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 11-20 are under current examination.
Priority
This application was filed 09/27/2024 is a divisional of 16631217 filed 01/15/2020, now U.S. Patent # 12123025 and having 1 RCE-type filing therein 16631217 is a national stage entry of PCT/IL2018/050776 filed 07/15/2018 and claims priority from provisional application 62532998, filed 07/15/2017.
Thus, the earliest possible priority for the instant application is 07/15/2017.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 09/27/2024 is objected to because the abstract is not sufficiently assisting readers in deciding whether this invention is producing edible composition using “a specific cell type” or “a plurality of non-human cell types” Therefore, submitted abstract is considered non-compliant because it need to consulting the full patent text for details.
MPEP § 608.01(b)(I)(C) states that “the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.”
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Title Objection
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01
The following title is suggested:
“Cultured Bovine Meat Compositions”
Claim Rejections - 35 USC § 112(b)
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.
Claim 11 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 11 recites “wherein incubation is preformed to reach % coverage of the plurality of cells of least 10% of the area or the volume of the scaffold,”
The term “% coverage” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what control is used for comparison in determining the % coverage of the plurality of cells, this claim limitation does not define the control. MPEP 2145 states that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).” SPEC discloses coverage % refers to the area or volume of a porous scaffold that is in contact with cells or myotubes [080], which is also discloses in claim 13. The rejection may be obviated by amending the claim 11 to recite: “coverage %.”
Claim Rejections - 35 USC § 112(a)
(Scope of Enablement)
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 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while enabling an edible cultured meat composition at a particular condition as recited in claim 11, does not reasonably provide enablement for preparing an edible cultured meat composition with a plurality of any non-human cell types. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some “experimentation.” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (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; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The office has analyzed the specification in direct accordance to the factors outlined in In re Wands. MPEP 2164.04 states: "[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection." These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform "undue experimentation" to make and/or use the invention and therefore, Applicant's claims are not enabled commensurate with the scope of the invention.
Furthermore, MPEP 2164.03 as set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112, first paragraph requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.).
THE BREADTH OF THE CLAIMS
The breadth of the claims encompasses a genus of an edible meat composition. As discussed supra, the specification fails to enable the genus of an edible composition with a plurality of non-human cell types. The specification only discloses the culture of non-human specifically bovine cells [034], [037], [039], [094-096], [0120-0127], [0148-0150].
Independent claim 12-15 and 19 encompasses a genus of an edible composition comprising a three-dimensional porous scaffold comprising vegetable protein; myotubes; a plurality of non-human cell types comprising (i) myoblasts or progenitor cells thereof; (ii) the myoblasts progenitor cells are satellite cell.; (iii) the fibroblasts and smooth muscle cells or progenitor cells thereof are extracellular matrix (ECM)-secreting cells thereof.
independent claim 16 encompasses a genus of plurality of cell types comprising myoblasts, extracellular matrix (ECM)-secreting cells, and endothelial cells.
Independent claim 17 encompasses a genus of plurality of cell types comprising satellite cells, ECM-secreting cells, and endothelial cells.
THE NATURE OF THE INVENTION
The nature of the invention is directed to, inter alia, compositions of cultured meat and methods of producing the same.
ACTUAL REDUCTION TO PRACTICE
The applicant didn’t reduce to practice the production of an edible meat composition; and for the cell culture only bovine EC, bovine satellite cells and smooth muscle cells proliferated. Thus, the proliferation of a plurality of non-human cell types was not taught to prepare the edible cultured meat composition.
In [0120] Applicant evidences a single non-human cell type (i.e., Bovine model) where cultured with a specific ration, where Applicant discovered that using a tri-culture of myoblast progenitor cells (bovine satellite cells, BSC); ECM-secreting cells (smooth muscle cells, SMC); and endothelial cells (bovine endothelial cells, BEC) comprising a significant number of endothelial cells (BSC:SMC:BEC at a ratio of 2:1:5, respectively, Fig. 28 [0155]). Applicant reduced to practice a method an edible meat composition interfered with the differentiation of the BSC to myotubes, whereas a low number of endothelial cells in the tri-culture (BSC:SMC:BEC at a ratio of 2:1:1, respectively, Fig. 28 [0155]) resulted in significant differentiation of BSC to myotubes, and thus to the desired food product of the present invention.
The specification doesn’t differentiate the genus of an edible composition from any non-human cell types. Therefore, those skilled in the art of making the instant broadly claimed invention need a particular cell type (i.e., bovine cell) with specific tri-culture of BSC:SMC:BEC ratio composition to produce the edible meat.
THE STATE OF THE PRIOR ART
In the prior art (Lab-Grown Meat: 53 Hazards Identified by Fao-Who; 2023) distinguishes potential hazards in the four stages of cell-based food production: cell procurement, cell growth and production, cell harvesting and food processing. The results show that there are 53 potential sources of hazards can lead to problems and negative health consequences. These include contamination with heavy metals, microplastics and nano-plastics, allergens such as additives to improve the taste and texture of these products, chemical contaminants, toxic components, antibiotics, and prions. The applicant has not provided any evidence that the claimed method would be able to prevent potential sources of hazards and adverse health consequences caused by any and all situations.
Setapretly, Tanne et al. (BMJ. 2008 Jan 26;336(7637):176; cited in PTO892) discloses the US Food and Drug Administration (FDA) has approved the use of meat and milk from cloned cattle, pigs, and goats and from the off spring of clones of any species traditionally used as food. It said that such meat and milk was “as safe to eat as food from conventionally bred animals.” However, there was “insufficient information . . . to reach a conclusion on the safety of food from clones of other animal species, such as sheep,” the FDA said, and it recommended that food from clones of animals other than cattle, pigs, and goats was not introduced into the food supply.
Therefore, the prior art does not provide any guidance for the plurality of non-human cell types comprising an edible composition. It is only teaching the use of meat and milk from cloned cattle, pigs, and goats and the applicant has not provided any evidence that the claimed method would be able to produce the meat from cloned cattle, pigs, and goats.
Since the prior art at the effective filing date of the present application did not provide guidance for the plurality of non-human cell types comprising an edible composition, it is incumbent upon the instant specification to do so. The physiological art is recognized as unpredictable (MPEP 2164.03).
THE LEVEL OF ORDINARY SKILL IN THE ART
Since the prior art at the effective filing date of the present application did not provide guidance for the plurality of non-human cell types comprising an edible composition, it is incumbent upon the instant specification to do so. In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to make and use the instant broadly claimed invention. Therefore, an ordinary artisan in this art needs specialized knowledge of the complex nature of the meat composition (e.g., myofibrils, sarcomere, myosin, actin, troponin, tropomyosin, moisture, fat).
THE LEVEL OF PREDICTABILITY IN THE ART
While the use of meat and milk from cloned cattle, pigs, and goats are well established and it recommended that food from clones of animals other than cattle, pigs, and goats was not introduced into the food supply. Thus, it is unpredictable to preparing an edible cultured meat composition with a plurality of any non-human cell types. The predictability of an edible cultured meat composition using any non-human cell types encompassed by the instant claim would be low given that there doesn’t appear to a link between any non-human cell types and the claimed conditions.
THE AMOUNT OF GUIDANCE AND WORKING EXAMPLES DISCUSSION
Applicant’s specification teaches a specific way to prepare edible composition by comprising a significant number of bovine cells (BSC:SMC:BEC at a ratio of 2:1:5, respectively [0155]) interfered with the proliferation of a plurality of non-human cell types, whereas a low number of endothelial cells in the tri-culture (BSC:SMC:BEC at a ratio of 2:1:1, respectively [0155]) resulted desired food product of the present invention with a specific way. There is a nexus between edible meat composition and a significant number of bovine cells, but not to the full scope of the claimed invention. The applicant's full claim scope is an edible composition comprising a plurality of any non-human cell types. Applicant haven’t fully enabled the invention commensurate in scope with the claims. Therefore, POSITA can prepare an edible cultured meat composition with a plurality of bovine cell types as disclosed in specification.
Thus, the specification and the prior art provide sufficient teachings only for the enablement for prepare an edible cultured meat composition with a plurality of bovine cell types.
CONCLUSION
Since both the instant specification and the prior art at the effective filing date of the present application enabling the edible cultured meat composition at a particular conditions do not reasonably provide enablement to prepare an edible cultured with a plurality of any non-human cell types.
In conclusion, given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is required to make and use the invention beyond the scope of an edible composition comprising a specific composition of BSC:SMC:BEC and specific cell type or plurality of non-human cells are derived from a livestock mammal (i.e., Bovine).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., Natural Process) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 11 recites a method of producing meat food product comprising incubating an edible three-dimensional porous textured protein scaffold and a plurality of non-human cell types comprising myoblasts and/or progenitor cells thereof and one or more cell types selected from the group consisting of adipocytes, fibroblasts, smooth muscle cells, endothelial cells, and progenitor cells thereof, wherein the 10% of the area or the volume of the scaffold coverage by the plurality of cells thereby producing the cultured meat food product. protein scaffold, and myoblasts and/or progenitor cells are considered a product of nature. Furthermore, the Bovine satellite cells cell is cultivated with bovine ECs to produce (i.e., naturally produced in vivo) the meat and methods of producing the same. This edible meat production is considered a process of nature. A three-part inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101 for process claims that involve laws of nature. See Subject Matter Eligibility Guidance. This inquiry comprises answering:
Step 1: Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
Step 2A:
Prong one: Does the claim recite or involve one or more judicial exceptions? Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. ; and
Prong two: Whether the additional elements integrate the exception into a practical application? Does the additional element apply, rely or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception?
Step 2B: Does the claim as a whole recite something significantly different than the judicial exception(s)?
Step 1: The claim is directed to a method of producing meat food product comprising incubating an edible three-dimensional porous textured protein scaffold and a plurality of non-human cell types comprising myoblasts and/or progenitor cells. In [0120] Applicant evidences a single non-human cell type (i.e., Bovine model) where cultured with a specific ration, where Applicant discovered that using a tri-culture of myoblast progenitor cells (bovine satellite cells, BSC); ECM-secreting cells (smooth muscle cells, SMC); and endothelial cells (bovine endothelial cells, BEC) comprising a significant number of endothelial cells (BSC:SMC:BEC at a ratio of 2:1:5, respectively, Fig. 28 [0155]). Applicant reduced to practice a method an edible meat composition interfered with the differentiation of the BSC to myotubes, whereas a low number of endothelial cells in the tri-culture (BSC:SMC:BEC at a ratio of 2:1:1, respectively, Fig. 28 [0155]) resulted in significant differentiation of BSC to myotubes, and thus to the desired food product of the present invention. Therefore, the claimed invention is directed to “process,” one of the four statutory patent-eligible subject matter (Step 1: YES).
Step 2A, Prong 1: the elements for claim 1 is substantially producing the meat that does not change the structure of myoblast progenitor cells (bovine satellite cells, BSC); ECM-secreting cells (smooth muscle cells, SMC); and endothelial cells (bovine endothelial cells, BEC). Its structure is identical to the naturally process BSC, ECM, SMC and BEC cells to produce the edible meat. Furthermore, claim 11, does not add additional elements besides the process of nature. With respect to step 2A prong one, the claimed invention recites a composition of neural cells that contains feeder cells (i.e. vascular component cells and perivascular cells) to produce the neural bundle. Instant claims incorporate the process of claim 1, which result in edible meat comprising the composition of myoblasts and/or progenitor cells. However, these processes are insufficient to distinguish the claimed edible meat from the naturally occurring process of meat. There is no indication or evidence in the specification that the claimed cell differs physically, structurally, or functionally from naturally-occurring meat. Thus, the claimed process does not have markedly different characteristics from what occurs in nature and is “naturally occurring process” recited the judicial exceptions. Accordingly, the claim is directed to an exception (Step 2A, prong 1: YES).
Step 2A, Prong 2: of the analysis, the claimed invention further claims the composition comprising the protein scaffold and a plurality of non-human cell types to produce the meat. Claim 12, describes the differentiation of the myoblasts or progenitor cells thereof into myotubes. Claim 13 describes the coverage % of the myotubes on protein scaffold. Claims 14-16 describes the cell type and claims 17-20 composition of cell type. In the art, Ostrovidov et al. (Tissue Eng Part B Rev. 2014 Feb 20;20(5):403–436; cited in PTO892) suggest that the combination of myoblast progenitor cells, smooth muscle cells, and endothelial cells represents the core natural composite needed to build true structured meat (see Fig. 1-2 of Ostrovidov). Therefore, producing meat food product comprising incubating an edible three-dimensional porous textured protein scaffold and a plurality of non-human cell types comprising myoblasts and/or progenitor cells is a natural process. Accordingly, additional elements composition, like claims 12-20 does not render the naturally occurring process. Thus, the additional limitations do not impose a meaningful limitation on the judicial exception (Step 2A, prong 2: NO).
Step 2B, instant claims as a whole do not recite something significantly different than the judicial exception, as the meat composition. Therefore, based on the applicant's specifications, the prior art and the naturally occurring processes (i.e., producing) of the meat comprising 3D porous textured protein scaffold and a plurality of non-human cell types comprising myoblasts and/or progenitor cells. The claimed composition of the meat does not amount to significantly more than the judicial exception (Step 2B: YES).
In light of the above considerations and cited guidance, the claims are thus drawn to patent ineligible subject matter. Therefore, claims 11-20 are rejected as being directed to a judicial reception under 35 U.S.C. 101.
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 11-12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levenberg et al., (Nature biotechnology, 23(7), pp.879-884, 2005; cited in IDS filed 10/11/2024; hereinafter “Levenberg”).
With respect to claim 11, 15-16, Levenberg teaches the induction of endothelial vessel networks in engineered skeletal muscle tissue constructs, using a three-dimensional (3D) multiculture system consisting of myoblasts, embryonic fibroblasts (ECM-secreting cells) and endothelial cells co-seeded on highly porous, biodegradable polymer scaffolds. Levenberg further teaches that addition of embryonic fibroblasts to cultures, together with myoblasts and endothelial cells, strongly promotes vascularization of the engineered muscle. (abstract, p. 879 last ¶ on 2nd col.; p. 879 last ¶ 1st col., and p. 880 1st ¶ on 1st and 2nd col.). The quantitative analysis of endothelial vessels in muscle constructs, in vitro shows that at least 10% area coverage with plurality of the cells (Fig. 2b). Therefore, POSITA would have anticipated that Levenberg developed a 3D coculture system in which mouse myoblasts were mixed with human embryonic endothelial cells (hES cell -derived endothelial cells) or with human umbilical vein endothelial cells (HUVECs) and seeded on highly porous, 3D biodegradable polymer scaffolds.
With respect to claim 12, Levenberg teaches that the method further comprises inducing differentiation of the myoblasts or progenitor cells thereof into myotubes (p. 880 right-hand col. 2nd ¶, Fig. 3a).
Accordingly, Levenberg anticipates the instant claims 11-12, and 15-16.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 11-12, 15-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nahimias et al. (CN109714962A, published 05/03/2019, cited in IDS filed 10/11/2024 (attached the English translation); hereinafter “Nahimis”), in view of Levenberg et al (Nature Biotechnology, cited in IDS filed 10/11/2024; hereinafter “Levenberg”).
Regarding claim 11-12, 15-16, and 19, Nahimias teaches an edible meat (claims 68-83) composition comprising: a. an edible hollow-fiber scaffold comprising vegetable protein (i.e. soyabean or pea) (claims 77-80, pp. 37); The non-human cell types could select from the group consisting of progenitor cell (pp. 56, sec. 3.1) of a myoblast (Fig. 5c) is a satellite cell (clause 28, 63, 76 and 91). Further, Nahimias teaches the three-dimensional multiculture system comprising of non-human myoblasts that are differentiated into embryonic fibroblasts (i.e. ECM-secreting cells) and endothelial cells (pp. 28, clause 28, 63, 76 and 91) co-seeded on protein substrate (pp. 4).
Nahimias proves that cell growth under the perfusion, tissue organization and characteristic of the appropriate vascular connectivity with the distribution as shown in FIG. 11A to FIG. 11C. Therefore, POSITA would have recognized that the incubation coverage % depends on proliferation rate and optimize the 10% of the area or the volume of the scaffold with plurality of cells, thereby producing the cultured meat food product. Further, the choice of the coverage % of the plurality of cells 10% of the area or the volume of the scaffold would be routine optimization. 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144(II)(A).
Regarding claim 12, Nahimias is silent to the myoblasts or progenitor cells thereof into myotubes. However, such was known in the prior art.
With respect to claim 12, Levenberg teaches a composition of engineered skeletal muscle tissue constructs that are a three-dimensional multiculture system comprising of mouse myoblasts that are differentiated into myotubes (p. 880 right-hand col. 2nd ¶, Fig. 3a), human embryonic fibroblasts (ECM-secreting cells) and endothelial cells co-seeded on highly porous, biodegradable polymer scaffolds (abstract, page 879, column 2, second paragraph and page 880, bottom of column 1 to top of column 2).
Accordingly, it would have been obvious to produce the edible composition of Nahimias and choose the specific myotube as taught by Levenberg with a reasonable expectation of success. One of ordinary skill would have been motivated to do so because it will assist to organize into tubular structures in between the myoblasts and throughout the construct, forming vessel networks within the engineered muscle tissue in vitro (pp. 879, left column) when myoblasts and endothelial cells are cultured on the scaffolds.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MASUDUR RAHMAN/Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
Prosecution Insights