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 .
Priority
This application is a 371 of PCT/US2022/052180 filed 12/07/2022.
PCT/US2022/052180 has PRO of 63286593 filed 12/07/2021.
Accordingly, claims 1-42 are afforded the effective filing date of 12/07/2021.
Information Disclosure Statement
The first information disclosure statement (IDS) submitted on 06/12/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-38 in the reply filed on 06/08/2026 is acknowledged.
Claims 39-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/08/2026.
Status of the Claims
Claims 1-42 are pending in this instant application, of which claims 39-42 are withdrawn at this time being drawn to a nonelected group/invention.
Claims 1-38 are examined herein on the merits for patentability.
Claim Objections
Claim 11 is objected to because of the following informalities: please add an “of” after “particle”. Appropriate correction is required.
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 16-25 and 30 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.
Regarding claims 16 and 19-22, the recitations of “the solid particles in a physiological environment release one or more biomolecules at a controlled release rate…” render said claims 16 and 19-22 indefinite because claims 16 and 19-22 are directly or indirectly dependent from claim 1, yet the solid particles of claim 1 does not contain “one or more biomolecules.” Thus it is not clear how one or more molecules can be released from the solid particle of claims 16 and 19-22 at the controlled rate as claimed in claims 16 and 19-22 when the solid particle of claim 1 does not contain one or more biomolecules. Clarification in by amendment in said claims are required.
Regarding claim 19, the parenthetical recitation “(e.g., 2 ppm/hour)” is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 19, the phrase "for example" (“e.g.”) as recited as “e.g., 2 ppm/hour” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 21, the parenthetical recitation “(e.g., about 38 ppm over 24 hours)” is indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 21, the phrase "for example" (“e.g.”) as recited as “e.g., about 38 ppm over 24 hours” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 24, the parenthetical recitations “(e.g., no more than about 37%)” and “(e.g., about 48 hours)” are indefinite because it is unclear if the text within the parenthesis are alternative limitations of the claims or merely descriptors of other elements of the claims. It is noted that [p]arenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125).
Regarding claim 24, the phrase "for example" (“e.g.”) as recited as “e.g., no more than about 37%” and “e.g., about 48 hours” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 19, 21, and 24: a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
claim 19 recites the broad recitation “about 1.5-2 ppm/hour,” and the claim also recites “e.g., 2 ppm/hour,” which is the narrower statement of the range/limitation.
claim 21 recites the broad recitation “about 37-38 ppm over 24 hours,” and the claim also recites “e.g., about 38 ppm over 24 hours,” which is the narrower statement of the range/limitation.
claim 24 recites the broad recitation “no more than about 40%,” and the claim also recites “e.g., no more than about 37%,” which is the narrower statement of the range/limitation.
claim 24 recites the broad recitation “about 50 hours,” and the claim also recites “e.g., about 48 hours,” which is the narrower statement of the range/limitation.
The claim(s) 19, 21, and 24 are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 30, the recitation of “the macromolecule or small molecule” renders claim 30 indefinite because claim 30 is dependent from claim 27, yet claim 27 is not drawn to macromolecule or small molecule and thus, is not clear what the macromolecule or small molecule is claim 30 referencing to, as there is lack antecedent basis for macromolecule or small molecule in claim 27.
Regarding claims 23-25, the recitations of “total protein is released from the solid particle” render said claims 23-25 indefinite because 23-25 are directly or indirectly dependent from claim 1, yet the solid particles of claim 1 does not contain a protein. Thus, it is not clear how the total protein content as claimed in claims 23-25 can be released from the solid particles when the solid particle of claim 1 does not contain a protein. Clarification in by amendment in said claims are required.
As a result, claims 16-25 and 30 do not clearly set forth the metes and bounds of patent protection desired.
Claim Interpretation
Claims 32 and 33 are structured as a product-by-process. Thus, claims 32 and 33 will be interpreted and examined for art rejections purposes (102 and 103 rejections) as product-by-process type claims. MPEP §2113 (I) states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Thus, while the structure implied by the process steps should be consider when assessing patentability of product-by-process claims over the prior art; however, burden of proof is placed upon Applicant to show that the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
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, 2, 6-25, 32-33 and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al (Circulation Research, 22 November 2021, 129: Abstract only, 2 pages).
The product-by-process Claim Interpretation applies here.
Regarding claims 1, 2, 7, 8, 32-33, and 37, Wang teaches solid decellularized cardiac tissue extracellular matrix (dECM) microparticles (pages 1-2).
Regarding claim 6, Wang teaches the cardiac tissue is human (fetal hearts) (page 1).
Regarding claims 9-11, as discussed above, Wang teaches structurally the same solid particle as recited in claim 1. Thus, the claimed elastic modulus characteristics/properties as recited in claims 9-11 are inherently present in the structurally same solid particle of Wang. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 12-13, it is noted the that limitations of “when exposed to or immersed in an aqueous environment, swell up to about 50-90% as compared to dECM particles or a hydrogel in a non-aqueous environment” and “when exposed to or immersed in an aqueous environment, swell up to about 70% as compared to dECM particles or a hydrogel in a non-aqueous environment” as recited in in claims 12 and 13, respectively, are conditional clauses and thus, have not been given patentable weight because conditional limitation merely describe the intended use/function of the solid particle, and how the solid particle is used and “when” it is used is conditional and does not need to be perform. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPHJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, non-limiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Thus, conditional limitations that are not recited as structure that is capable of or configured to perform the conditional function render the conditional limitation as “optional” and not truly “conditional”. As such, in view of the above analysis, the claimed solid particle only require the structural limitation of decellularized cardiac tissue extracellular matrix, this structural limitation has been structurally by Wang supra. As discussed above, Wang teaches structurally the same solid particle as recited in claim 1. Thus, the claimed sweilling characteristics/properties as recited in claims 12-13 are inherently present in the structurally same solid particle of Wang. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 14-15, as discussed above, Wang teaches structurally the same solid particle as recited in claim 1. Thus, the claimed characteristics/properties of being resistant to complete enzymatic degradation as recited in claims 14-15 are inherently present in the structurally same solid particle of Wang. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 16-25, Wang teaches the solid particle contains proteins, said solid particle prolonged release of the proteins and has decreased degradation rate (pages 1-2). As discussed above, Wang teaches structurally the same solid particle as recited in claim 1. Thus, the claimed controlled release rates as recited in claims 16-22 and the release rates as recited in claims 23-25 are inherent to the structurally same solid particle of Wang. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
As a result, the aforementioned teachings from Wang are anticipatory to claims 1, 2, 6-25, 32-33 and 37 of the instant invention.
Claim(s) 1-3, 5-25, 32-35, and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13), and as evidenced by Bejleri et al (Adv Healthcare Mater., 2019, 8(1801217): 1-29).
The product-by-process Claim Interpretation applies here.
Regarding claims 1, 2, 6-8, 32-33, and 37, Kappler teaches bio-functional human cardiac extracellular matrix (hcECM) microparticles (Abstract; pages 1-12).
Regarding claim 3, Kappler teaches the microparticles have median particle diameter of 66 µm or 57 µm (Abstract; pages 6-9).
Regarding claim 5, Kappler teaches the microparticles are spherical (pages 4 and 6).
Regarding claims 9-11, as discussed above, Kappler teaches structurally the same solid particle as recited in claim 1. Thus, the claimed elastic modulus characteristics/properties as recited in claims 9-11 are inherently present in the structurally same solid particle of Kappler. Furthermore, as evidenced by Bejleri, cardiac ECM particles have elastic modulus as low as 4 kPa (Bejleri: pages 12 and 16). It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 12-13, it is noted the that limitations of “when exposed to or immersed in an aqueous environment, swell up to about 50-90% as compared to dECM particles or a hydrogel in a non-aqueous environment” and “when exposed to or immersed in an aqueous environment, swell up to about 70% as compared to dECM particles or a hydrogel in a non-aqueous environment” as recited in in claims 12 and 13, respectively, are conditional clauses and thus, have not been given patentable weight because conditional limitation merely describe the intended use/function of the solid particle, and how the solid particle is used and “when” it is used is conditional and does not need to be perform. See MPHJ Tech. Invs., LLC v. Ricoh Ams. Corp., 847 F.3d 1363, 1379 (Fed. Cir. 2017). In MPHJ, Judge O’Malley opined that “a “wherein” clause invoking certain protocols “when” a certain application was used is a “conditional, non-limiting, non-specific clause that [did] not narrow the claim.” Id. at 1379. Thus, conditional limitations that are not recited as structure that is capable of or configured to perform the conditional function render the conditional limitation as “optional” and not truly “conditional”. As such, in view of the above analysis, the claimed solid particle only require the structural limitation of decellularized cardiac tissue extracellular matrix, this structural limitation has been structurally by Kappler supra. As discussed above, Wang teaches structurally the same solid particle as recited in claim 1. Thus, the claimed swelling characteristics/properties as recited in claims 12-13 are inherently present in the structurally same solid particle of Kappler. Furthermore, as evidenced by Bejleri, cardiac dECM particles forms hydrogel and swells when exposed of aqueous environment (Bejleri: Abstract; pages 1, 6, 9, and 11-18). It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 14-15, as discussed above, Kappler teaches structurally the same solid particle as recited in claim 1. Thus, the claimed characteristics/properties of being resistant to complete enzymatic degradation as recited in claims 14-15 are inherently present in the structurally same solid particle of Kappler. Furthermore, as evidenced by Bejleri, cardiac dECM particles exhibit prolonged degradation (Bejleri: pages 12 and 15). It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 16-25, Kappler teaches the microparticles contain proteins (pages 1-3, 8-9 and 11-12). As discussed above, Kappler teaches structurally the same solid particle as recited in claim 1. Thus, the claimed controlled release rates as recited in claims 16-22 and the release rates as recited in claims 23-25 are inherent to the structurally same solid particle of Kappler. Furthermore, as evidenced by Bejleri, cardiac dECM particles provide extended release of active ingredients and proteins (Bejleri: pages 11-12). It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 34 and 35, Kappler teaches a hydrogel containing the biofunctional cardiac ECM microparticles (Abstract; pages 1-2, 4-5 and 10-12).
As a result, the aforementioned teachings from Kappler (and as evidenced by Bejleri) are anticipatory to claims 1-3, 5-25, 32-35, and 37 of the instant invention.
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.
Claim(s) 1-25, 32-35, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13), as evidenced by Bejleri et al (Adv Healthcare Mater., 2019, 8(1801217): 1-29).
The product-by-process Claim Interpretation applies here.
The solid particle of claims 1-3, 5-25, 32-35, and 37 are discussed above from the disclosures of Kappler (and as evidenced by Bejleri), said discussion being incorporated herein in its entirety.
Regarding claim 4, Kappler teaches the median particle diameter of the hcECM microparticles is from 20 µm to 182 µm (Abstract; page 6). It would have been obvious to one of ordinary skill in the art to optimize the diameter of the microparticle of Kappler to a diameter of “about 20 µm,” and achieve the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Kappler teaches the microparticles have median particle diameter from 20 µm to 182 µm, which is a range that encompassed the claimed diameter of “about 20 µm.” Thus, absent some demonstration of unexpected results showing criticality from the claimed diameter, the optimization of the diameter of the solid particle would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 26-31 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13) in view of Christman et al (US 2020/0276360).
Regarding claims 26 and 38, Kappler teaches bio-functional human cardiac extracellular matrix (hcECM) microparticles (Abstract; pages 1-12).
However, Kappler does not teach the biomolecule that is chemically conjugated to the extracellular matrix of claims 26 and 38.
Regarding the biomolecule that is chemically conjugated to the extracellular matrix of claims 26 and 38, Christman teaches cardiac extracellular matrix particles, wherein a biomolecule is covalently linked to the extracellular matrix (Abstract; [0004]-[0095] and [0110]).
It would have been obvious to one of ordinary skill in the art to covalently link a biomolecule to the extracellular matrix of the cardiac extracellular matrix microparticles of Kappler, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Christman provided the guidance to do so by teaching that the cardiac ECM particles of Kappler can be combined with a biomolecule by covalently linking the biomolecule to the extracellular matrix so as to provide a extracellular-matrix (ECM)-based product for cardiac therapy (Christman: Abstract; [0004]-[0095] and [0110]). Given that Kappler is also drawn to using the cardiac extracellular matrix (hcECM) microparticles for cardiac therapy (Kappler: Abstract; pages 10-12), an ordinary artisan would looked to modifying the microparticles of Kappler such that a biomolecule is covalently linked to the extracellular matrix so as to provide a desired extracellular-matrix (ECM)-based product for cardiac therapy, and achieve applicant’s claimed invention with reasonable expectation of success.
Regarding claims 27-31, Christman teaches suitable biomolecules include peptides, proteins, nucleic acids, polynucleotides, oligonucleotides, DNA, RNA, drugs, nutrients, survival-promoting additives, proteoglycans, and/or glycosaminoglycans ([0037], [0077], [0101]).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 26-31 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13) in view of Atala et al (US 2016/0199179 A1).
Regarding claims 26 and 38, Kappler teaches bio-functional human cardiac extracellular matrix (hcECM) microparticles (Abstract; pages 1-12).
However, Kappler does not teach the biomolecule that is chemically conjugated to the extracellular matrix of claims 26 and 38.
Regarding the biomolecule that is chemically conjugated to the extracellular matrix of claims 26 and 38, Atala teaches cardiac extracellular matrix particles, wherein a biomolecule is conjugated to the extracellular matrix or the surface of the particles (Abstract; [0006]-[0016], [0094]-[0102], [0114]-[0140], [0173]-[0176]; Examples 1-2).
It would have been obvious to one of ordinary skill in the art to conjugate a biomolecule to the extracellular matrix of the cardiac extracellular matrix microparticles of Kappler, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Attala provided the guidance to do so by teaching that the cardiac ECM particles of Kappler can be combined with a biomolecule by conjugating the biomolecule to the extracellular matrix or the surface of the particles so as to provide a extracellular-matrix (ECM)-based product that provide controlled release of the biomolecule for cardiac therapy (Atala: Abstract; [0006]-[0016], [0094]-[0102], [0114]-[0140], [0173]-[0176]; Examples 1-2). Given that Kappler is also drawn to using the cardiac extracellular matrix (hcECM) microparticles for cardiac therapy (Kappler: Abstract; pages 10-12), an ordinary artisan would looked to modifying the microparticles of Kappler such that a biomolecule is conjugated to the extracellular matrix so as to provide a desired extracellular-matrix (ECM)-based product for cardiac therapy, and achieve applicant’s claimed invention with reasonable expectation of success.
Regarding claims 27-31, Attala teaches the biomolecule includes proteins, growth factors, antibodies, nucleic acids molecules, drugs, drug-loaded nanoparticles carbohydrates, and heparin ([0014], [0116]-[0137]; Examples 1-2).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13) in view of Schmuck et al (US 2018/0353646 A1).
Regarding claim 36, Kappler teaches bio-functional human cardiac extracellular matrix (hcECM) microparticles (Abstract; pages 1-12).
However, Kappler does not teach the microparticles is seeded in a biodegradable bioscaffold to form a patch of claim 36.
Regarding the patch of claim 36, Schmuck teaches a cardiac patch containing a biodegradable scaffold seed with cardiac ECM particles, wherein the cardiac patch is used for cardiac repair and regeneration (Abstract; [0010]-[0056]; Examples 1-3; claims 1-8).
It would have been obvious to one of ordinary skill in the art incorporate cardiac ECM microparticles of Kappler as the ECM in the cardiac patch of Schmuck and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Schmuck indicated that cardiac ECM can be seeded in the scaffold to so as provide a cardiac patch that is useful for cardiac repair and regeneration (Schmuck: Abstract; [0010]-[0056]; Examples 1-3; claims 1-8). Kappler indicated that the cardiac extracellular matrix (hcECM) microparticles is also useful for regenerative therapy (Kappler: page 1). Thus, an ordinary artisan would have looked to providing a cardiac patch containing a biodegradable scaffold seed with cardiac extracellular matrix (hcECM) microparticles, per guidance from Schmuck, so as provide a cardiac patch that is useful for cardiac repair and regeneration, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kappler et al (J Mater Sci: Mater Med., 2016, 27(120): 1-13) in view of Bejleri et al (Adv Healthcare Mater., 2019, 8(1801217): 1-29).
Regarding claim 36, Kappler teaches bio-functional human cardiac extracellular matrix (hcECM) microparticles (Abstract; pages 1-12).
However, Kappler does not teach the microparticles is seeded in a biodegradable bioscaffold to form a patch of claim 36.
Regarding the patch of claim 36, Bejleri teaches a cardiac patch containing a biodegradable scaffold seed with cardiac ECM particles, wherein the cardiac patch is used for cardiac repair and regeneration (pages 1, 6-13 and 15-25).
It would have been obvious to one of ordinary skill in the art incorporate cardiac ECM microparticles of Kappler as the ECM in the cardiac patch of Bejleri and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Bejleri indicated that cardiac ECM can be seeded in the scaffold to so as provide a cardiac patch that is useful for cardiac repair and regeneration (Bejleri: pages 1, 6-13 and 15-25). Kappler indicated that the cardiac extracellular matrix (hcECM) microparticles is also useful for regenerative therapy (Kappler: page 1). Thus, an ordinary artisan would have looked to providing a cardiac patch containing a biodegradable scaffold seed with cardiac extracellular matrix (hcECM) microparticles, per guidance from Bejleri, so as provide a cardiac patch that is useful for cardiac repair and regeneration, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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