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
This action is in response to the papers filed June 3, 2024.
Claim Amendments
Applicant’s amendment to the claims filed 06/03/2024 is acknowledged.
Claims 2-60 have been cancelled.
New claims 61-79 have been added.
Claims 1, 61-79 are pending and under examination.
Priority
The instant application 18/715,599 was filed on 05/31/2024. This application is a national stage of international application PCT/US2023/061128 filed 01/24/2023, claiming priority based on U.S. Provisional Patent Application No. 63/302,842 filed 01/25/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/22/2024, 08/23/2024 and 06/03/2025 has been considered.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or by applicant in an information disclosure statement (IDS), they have not been considered.
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.
Claim 71 is 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 71 recites that the hydrogel fibers are characterized by a “flexible dissolution rate.” Although one of ordinary skill in the art would have understood the term “dissolution rate” in describing a hydrogel material, the meaning of a “flexible dissolution rate,” as claimed, is unclear. Generally, it is unclear how a dissolution rate that is “flexible” may be discerned from a dissolution rate that is “inflexible.” The term is not defined by the claims or specification of the present application, and one of ordinary skill in the art would not have been reasonable apprised of the scope of the term.
Claim 71 further recites that the flexible dissolution rate is “about 3 minutes to more than 100 days,” i.e., 3 or more minutes. However, “3 or more minutes” is not a “dissolution rate” as claimed. A dissolution rate of a hydrogel material refers to the absolute or percent mass loss over a time interval, e.g., units % mass per minute. Accordingly, claiming a “dissolution rate” of “3 or more minutes” is indefinite, and one of ordinary skill in the art would not have been reasonable apprised of the scope of the claimed parameter.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 74 is 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 74 contains the trademark/trade name Kurobuta™ (U.S. Serial No. 78,085,133). In particular, Kurobuta™ is a brand name used for commercially-available pork. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used in the claims to identify/describe a Japanese breed of black pig called Kagoshima Berkshire and, accordingly, the identification/description is indefinite.
Claim 79 is 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 79 recites that the cell type may be “connective tissue cells of connective tissue cell precursors.” The recitation is indefinite as to the meaning and scope of “connective tissue cells of connective tissue cell precursors.” The term is not defined by the claims nor specification, and one of ordinary skill in the art would not have recognized the term as a term of art. For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Changing the limitation to “connective tissue cells or connective tissue cell precursors” would be remedial.
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.
(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, 61, 66-67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0118195 A1 to Mao et al.
Mao teaches fabrication of hydrogel fibers by an electro-stretching approach. See, Abstract; Figure 1. The hydrogel fibers are formed and cross-linked. See, par. 29, 39 67. The hydrogel fibers may be frozen and lyophilized to create a porous morphology. See, par. 76.
Accordingly, Mao anticipates a process for acquiring a scaffold comprising: forming hydrogel fibers, crosslinking the hydrogel fibers to obtain crosslinked hydrogel fibers, and lyophilizing the crosslinked hydrogel fibers to obtain crosslinked lyophilized hydrogel fibers.
Mao does not teach or fairly suggest that the scaffold is intended for a “cultivated meta product,” as stated in the preamble of claim 1.
As instructed by MPEP 2111.02, 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. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)
In this case, the preamble of claim 1 states: “[a] method of acquiring a scaffold for a cultivated meat product.” The preamble indicates that the scaffold acquired by the claimed method is intended for use in meat cultivation, but the preamble is not found to necessarily limit the manipulative actions of the claimed method, i.e., one or more of steps (a), (b) and (c), in such a way that patentably distinguishes the claimed method from that found in the prior art. Furthermore, the hydrogel fibers of the prior art reference are found to possess a structure capable of performing the intended use limitation. For these reasons, the preamble is not found to patentably distinguishes the claimed method from that found in the prior art.
Accordingly, the method of claim 1 is anticipated by the prior art reference.
Regarding dependent claim 61, Mao further teaches that the hydrogel fibers are seeded with one or more cells. See, e.g., par. 46, 51, 101-102.
Regarding dependent claim 66, Mao teaches freezing and lyophilizing the hydrogel fibers. See, par. 76. A freezing and lyophilizing process, as taught by Mao, is a process of transforming water at a first temperature from liquid state to solid state and drying at a second temperature to remove water by sublimation, as claimed.
Regarding dependent claim 67, Mao teaches a step of washing the hydrogel fibers. See, e.g., par. 71, 87.
Claims 1, 62-64, 66, 70-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kessel et al. (2020) “3D bioprinting of macroporous materials based on entangled hydrogel microstrands” Advanced Science, 7(18), 2001419, 13 pages.
Kessel discloses a process of fabricating hydrogel fibers (microstrands) comprising filling an assembly fitter with a mesh with micro-sized apertures with liquid hydrogel, allowing the liquid hydrogel to cool and solidify to obtain solid hydrogel, and extruding the solid hydrogel through the fitter assembly mess to obtain hydrogel fibers. See, Abstract; pages 2 and 10; and Figure 1:
PNG
media_image1.png
743
1319
media_image1.png
Greyscale
In one example, Gelatin Methacrylol (GelMA) bulk hydrogel was formed through thermoreversible gelation, sized into microstrands, and additionally crosslinked by controlled photoexposure in the UV-A range. See, page 10. Kessel further discloses freezing and lyophilizing the hydrogel fibers. See, page 11, left column.
Accordingly, Kessel anticipates a process for acquiring a scaffold comprising: forming hydrogel fibers, crosslinking the hydrogel fibers to obtain crosslinked hydrogel fibers, and lyophilizing the crosslinked hydrogel fibers to obtain crosslinked lyophilized hydrogel fibers.
Kessel does not teach or fairly suggest that the scaffold is intended for a “cultivated meta product,” as stated in the preamble of claim 1.
As instructed by MPEP 2111.02, 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. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)
In this case, the preamble of claim 1 states: “[a] method of acquiring a scaffold for a cultivated meat product.” The preamble indicates that the scaffold acquired by the claimed method is intended for use in meat cultivation, but the preamble is not found to necessarily limit the manipulative actions of the claimed method, i.e., one or more of steps (a), (b) and (c), in such a way that patentably distinguishes the claimed method from that found in the prior art. Furthermore, the hydrogel fibers of the prior art reference are found to possess a structure capable of performing the intended use limitation. For these reasons, the preamble is not found to patentably distinguishes the claimed method from that found in the prior art.
Accordingly, the method of claim 1 is anticipated by the prior art reference.
Regarding dependent claims 62-64, Kessel discloses a process of fabricating hydrogel fibers (microstrands) comprising filling an assembly fitter with a mesh with micro-sized apertures with liquid hydrogel, allowing the liquid hydrogel to cool and solidify to obtain solid hydrogel, and extruding the solid hydrogel through the fitter assembly mess to obtain hydrogel fibers, wherein the assembly comprises an extruder. To deconstruct bulk hydrogels into microstrands, bulk hydrogels were made inside syringes and manually pressed (pressure) through a nylon sieve (mesh). See, Abstract; pages 2 and 10; and Figure 1.
Regarding dependent claim 66, Kessel teaches freezing and lyophilizing the hydrogel fibers. See, page 11, left column. A freezing and lyophilizing process, as taught by Kessel, is a process of transforming water at a first temperature from liquid state to solid state and drying at a second temperature to remove water by sublimation, as claimed.
Regarding dependent claim 70, Kessel teaches the hydrogel is a thermoreversible hydrogel that is no a liquid a room temperature. See, page 10, Gelatin Methacrylol.
Regarding dependent claim 71, the claim recites the hydrogel fibers possess a dissolution rate from about 3 minutes to more than 100 days, which is a range equivalent to 3 or more minutes. Kessel discloses culturing the hydrogel fibers for at least 7 days. See, Figure 6. Accordingly, Kessel’s hydrogel fibers possessed a dissolution rate that enable culture of the hydrogel fibers for at least 7 days.
Regarding dependent claim 72, Kessel teaches that hydrogel fibers have a modulus of 2.7 kPa before cell culture. See, Abstract; pages 8-9, joining paragraph.
Regarding dependent claims 73-74, Kessel discloses contacting the scaffolds with C2C12 mouse immortalized myoblasts, primary articular chondrocytes isolated from the femoral cartilage of 6-month-old calves (young cow). See, page 11.
Regarding dependent claim 75, cells were expanded for 7 days and 21 days. See, Figure 6.
Regarding dependent claim 76, the cultured hydrogel fibers were harvested, and the hydrogel fibers were fabricated by extrusion through 40 and 100 micron-sized meshes. See, pages 10-11.
Regarding dependent claim 77, the culture media contains animal serum, which contains extracellular matrix protein, e.g., fibronectin. See, pages 10-11.
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.
Claims 65 and 69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0118195 A1 to Mao et al., as applied to claims 1, 61, 66-67 above.
Mao teaches suspending the hydrogel fibers in a collection bath comprising a crosslinking reagent, and then crosslinking the hydrogel fibers. See, paragraphs 39, 67, 71-73.
Mao does not teach that crosslinking is performed for at least 6 hours at a temperature from about 0 °C to 10 °C, as claimed in dependent claim 65.
"[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). See also, MPEP 2144.05.
In this case, Mao generally teaches a step of crosslinking the hydrogel fibers, as claimed in claim 65. Mao does not expressly disclose the incubation time and temperature; whereas, claim 65 recites an incubation time of 6 hours and a temperature from about 0 °C to 10 °C. However, differences in incubation time and temperature will not support the patentability of subject matter taught or fairly suggested by the prior art unless there is evidence indicating such incubation time and temperature is critical. In particular, a step of crosslinking the hydrogel fibers, as claimed, is generally taught by Mao, and there is no evidence of record that the instantly claimed incubation time and temperature is critical. Moreover, one of ordinary skill in the art would have recognized that incubation time and temperature are result-effective variables influencing the efficiency and/or degree of crosslinking, and, therefore, one of ordinary skill in the art would have been led to optimize incubation time and temperature through routine optimization. For these reasons, absent a secondary consideration, the instantly claimed incubation at a temperature from about 0 °C to 10 °C for 6 hours would have been prima facie obvious over the prior art.
For these reasons, dependent claim 65 would have been prima facie obvious over the prior art.
Regarding dependent claim 69, Mao teaches that the hydrogel fibers are frozen and lyophilized to create a porous morphology. The porosity can be easily tuned by varying the input polymer concentration, composition and crosslinking density. See, paragraphs 76, 110-111.
Mao does not teach that the pores have an average opening size of about 2-500 microns, as instantly claimed in dependent claim 69.
"[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). See also, MPEP 2144.05.
In this case, Mao generally teaches hydrogel fibers having a porous surface; whereas, claim 69 recites that the pores have an average opening size of about 2-500 microns. However, differences in average pore opening size will not support the patentability of subject matter taught or fairly suggested by the prior art unless there is evidence indicating such average pore opening size is critical. In particular, hydrogel fibers having a porous surface, as claimed, is generally taught by Mao, and there is no evidence of record that the instantly claimed average pore opening size is critical. Moreover, one of ordinary skill in the art would have recognized that the average pore opening size is a result-effective variable influencing the surface topography and cell-surface interactions, and, therefore, one of ordinary skill in the art would have been led to optimize the average pore opening size through routine optimization. Indeed, the porosity can be easily tuned by varying the input polymer concentration, composition and crosslinking density. For these reasons, absent a secondary consideration, the instantly claimed average pore opening size of about 2-500 microns, as claimed in dependent claim 69, would have been prima facie obvious over the prior art.
Claims 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Kessel et al. (2020) “3D bioprinting of macroporous materials based on entangled hydrogel microstrands” Advanced Science, 7(18), 2001419, 13 pages, as applied to claims 1, 62-64, 66, 70-77 above; in further view of Shi et al. (2015). “Microfluidic spinning of cell‐responsive grooved microfibers” Advanced Functional Materials, 25(15), 2250-2259.
Kessel does not teach a co-culture of two or more cell types, as claimed in dependent claims 78-79.
Shi is relevant prior art for teaching the fabrication of methacrylamide-modified gelatin (GelMA) hydrogel fibers via microfluidic spinning. The hydrogel fibers were used for the co-culture of two or more cell types selected from C2C12 myoblasts, human osteoblasts (hFOBs) and human umbilical vein endothelial cells (HUVECs). The GelMA hydrogel fibers were found to support cell viability and induce cell alignment. See, Abstract; pages 2254-2256; Figures 5-7.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the cell culture of Kessel by co-culturing two or more cell types selected from myoblasts, osteoblasts and endothelial cells, as taught by Shi, with a reasonable expectation of success the addition of other cell types would provide a muscle tissue construct more closely simulating its natural counterpart.
For these reasons, dependent claims 78-79 would have been prima facie obvious over the prior art.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Kessel et al. (2020) “3D bioprinting of macroporous materials based on entangled hydrogel microstrands” Advanced Science, 7(18), 2001419, 13 pages, as applied to claims 1, 62-64, 66, 70-77 above; in further view of Galante et al. (2018) “Sterilization of hydrogels for biomedical applications: A review” Journal of Biomedical Materials Research Part B: Applied Biomaterials, 106(6), 2472-2492.
Kessel does not teach the sterilization process recited in dependent claim 68.
Galante is relevant prior art for teaching the sterilization of hydrogels for biomedical applications to eliminate contaminants and reduce bioburden. Sterilization methods include radiation and alcohol-based washes. See, Abstract; pages 2475-2476; Figure 1.
Therefore, prior to the effective filing date of the instantly claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the hydrogel fibers of Kessel by further subjecting the hydrogel fibers to sterilizing radiation and alcohol-based washes, as taught by Galante, with a reasonable expectation of success in order to eliminate contaminants and reduce bioburden.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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, James D Schultz can be reached at (571)272-0763. 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.
/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
Prosecution Insights