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 September 25, 2025.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/25/2025 has been entered.
Claim Amendments
Applicant’s amendment to the claims filed 09/25/2025 is acknowledged.
Claims 1-2, 5 and 11 are amended.
Claims 12-19 are cancelled.
Claims 1-11, 20-21 are pending.
Claims 1-11, 20-21 are under examination.
Priority
The instant application 17/288,041 was filed on 04/23/2021. This application is a national stage of international application PCT/US2021/019109 filed 02/22/2021, claiming priority based on U.S. Provisional 62/979,731 filed 02/21/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/06/2025, 06/10/2025 and 12/18/2025 have been considered.
Withdrawal of Prior Rejections/Objections
Rejections and/or objections not reiterated from the previous Office action mailed 04/03/2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Claim Objections
Claim 20 is objected to because of the following informalities:
In claim 20, the phrase “a porcine scaffold of claim 1” should be “the porcine scaffold of claim 1” instead because the limitation refers to a previously-recited claim element.
Appropriate action is required.
Claim Rejections - 35 USC § 112
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 1-11, 20-21 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is newly applied, necessitated by amendment.
In the amendment to the claims filed 09/25/2025, claim 1 was amended to recite the new limitation of “a process that retains the natively present hyaluronic acid in the porcine placental membrane in an amount of at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold.” Accordingly, the claim is directed to a placental extracellular matrix (ECM) comprising at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold, or, equivalently, at least about 1.2% of hyaluronic acid per gram of porcine scaffold. This limitation is found to be new matter. The specification as originally filed is not found to have disclosed the claimed range for hyaluronic acid.
In remarks filed 09/25/2025, applicant argued that written support for the new limitation may be found in in the specification as follows:
Table VIII (Example 6) presents hyaluronic acid content of 1.2%, 1.5%, and 2.2% w/w for different batches of porcine scaffold; paragraph [0066] describes quantification of hyaluronic acid per scaffold weight, aligning directly with the claimed unit (gram of porcine scaffold; paragraphs [0055] and [0010] both describe scaffold compositions including at least about 0.5% w/w hyaluronic acid that includes and supports the lower end of the newly claimed range.
Since the specification as filed does not contain paragraph numbers, the paragraph numbering is presumed to relate to the pre-grant publication of the present application, US 2023/0310707 A1.
These portions of the specification are not found to provide sufficient written support for the claimed range of “at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold.” The working examples (Example 6, Table VIII) disclose that hyaluronic acid accounted for 1.7%, 2.2%, or 1.2% of the total dry weight of the porcine scaffolds in three different pig breeds. A range for hyaluronic acid is not described. Paragraph [0066] describes a step of dividing placental membrane into pieces, which is not a disclosure of a range for hyaluronic acid. Paragraphs [0010] and [0055] describe the ranges of at least about 0.5%, 1.0%, 1.5%, 2.0% 2.5% or 50% w/w of hyaluronic acid based on the total weight of the porcine scaffold. The claimed ranged of “at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold,” i.e., at least about 1.2% of hyaluronic acid per gram of porcine scaffold, is not described.
For these reasons, absent evidence to the contrary, claim 1 is found to recite new matter. Dependent claims 2-11, 20-21 are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
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 1-11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0155678 A1 to Francis et al.; in view of Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages.
This rejection is newly applied.
Claim 1 recites a porcine scaffold comprising decellularized, porcine placental-membrane extracellular matrix. Claim 1 further recites that the decellularized, porcine placental extracellular matrix is prepared from porcine placental membrane by a process that retains the natively present hyaluronic acid in the porcine placental membrane.
Francis is relevant prior art for disclosing a placenta-derived matrix obtained by the decellularization of placenta tissue. See, e.g., paragraphs 5. The placenta tissue is derived from a mammal, such as a porcine. See, e.g., paragraphs 6, 86. The placenta tissue is a whole, complete placenta having plate, amnion and chorion. See, e.g., paragraphs 90, 155.
Francis further teaches that the placenta-derived matrix contains native hyaluronic acid. See, e.g., par. 88, 100. The placenta-derived matrix retains a substantial amount of the extracellular matrix proteins and molecules in the placenta tissue. See, e.g., paragraphs 79, 88.
Accordingly, Francis is found to teach or fairly suggest a porcine scaffold comprising decellularized, porcine placental-membrane extracellular matrix.
Claim 2 recites that the placental extracellular matrix is substantially devoid of intact cells. Francis discloses that the placenta-derived matrix comprises no viable cell. See, e.g., paragraph 79.
Claim 4 recites that the porcine scaffold is formulated as a membrane-based construct, and claim 5 recites that the placental extracellular matrix comprises at least one placental membrane, at least one amnion membrane, at least one chorion membrane, or a combination thereof. Francis discloses that the placenta tissue includes the amnion and/or chorion. See, e.g., paragraph 90.
Claim 11 recites that the porcine placental membrane is treated with a bioburden reduction step, a detergent rinse step, and a viral inactivation step, followed by dehydrating the porcine placental membrane. Francis discloses freeze-drying the placenta-derived matrix (e.g., par. 11, 13), which is a “dehydrating” process. Francis discloses treating the placenta tissue with a detergent (e.g., par. 7, 157), which reads on a “detergent rinse step.” Francis further discloses steps of cleaning, disinfecting and sterilizing the placenta tissue, by processes such as gamma irradiation, supercritical carbon dioxide, ethylene oxide, or electronic-beam (e.g., par. 25-26, 120). These steps read on a “bioburden reduction” and “viral inactivation” steps because the cleaning, disinfection and sterilization processes would remove, kill or deactivate microorganisms and other biological agents, such as viruses, present in the placenta-derived matrix. (For example, page 14 of applicant’s specification discloses that treatment with supercritical carbon dioxide, which is found in Francis, reads on a viral inactivation step).
Claim 20 recites a wound dressing comprising a porcine scaffold of claim 1. Francis discloses that the placenta-derived matrix is used as a wound treatment matrix, wherein the placenta-derived matrix is implanted to a tissue of interest. See, e.g., paragraphs 100 and 139. Accordingly, Francis teaches or fairly suggests a wound dressing comprising the placenta-derived matrix, as claimed.
Francis does not disclose that the porcine placental membrane is recovered from a full-term delivery of one or more offspring, as claimed in claim 1.
Prior to the effective filing date of the instantly claimed invention, Leonel is relevant prior art for teaching the decellularization of placentas. Leonel discloses that placentas are commonly discarded after birth, and therefore placentas do not require an invasive procedure to be harvested. See Abstract and Introduction on pages 1-2.
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 invention of Francis by harvesting the porcine placental membrane from a full-term delivery of one or more offspring, in view of the teaching of Leonel, with a reasonable expectation of success because placental tissue may be noninvasively harvested following a full-term birth of one or more offspring.
Hyaluronic acid content:
Francis teaches that the placenta-derived matrix includes native hyaluronic acid (e.g., par. 88, 100). Francis does not teach that the porcine scaffold comprises at least from about 1.2%
to about 2.2% of hyaluronic acid per gram of porcine scaffold (claim 1), comprises at least about 1.0% w/w of hyaluronic acid based on the total weight of the porcine scaffold (claim 6), or retains at least about 50% w/w of any hyaluronic acid present in native porcine placental membrane (claim 7).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, applicant’s specification quantified the amount of hyaluronic acid in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that each breed provided 1.2 % w/w or more of hyaluronic acid based on the total weight of the porcine scaffold (Example 6, pg. 31). Neither applicant’s specification nor the cited prior art disclose a manipulative action or process which would have significantly modified the amount of hyaluronic acid in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Francis discloses that a substantial amount, including at least about 50 or 99 wt %, of the extracellular matrix proteins in the placenta tissue is retained in the decellularized, placenta-derived matrix (e.g., par. 79, 88). Accordingly, based on the evidence of record, the amounts of hyaluronic acid recited by claims 1, 6-7 are found to naturally flow from the decellularization of porcine placental tissue as found in the cited prior art. For these reasons, the amounts of hyaluronic acid recited by claims 1, 6-7 are not found to patentably distinguish the claimed invention over the prior art.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Francis discloses that the decellularized placenta retains a substantial amount of the extracellular matrix proteins and molecules in the placenta tissue (e.g., par. 79, 88), and Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the hyaluronic acid content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Francis, par. 100; and Leonel, page 1, right column). For these reasons, absent evidence of criticality, the hyaluronic acid content recited by claims 1, 6-7 would have been prima facie obvious over the prior art.
dsDNA content:
Claim 3 recites that the porcine scaffold comprises up to about 1200 ng dsDNA per mg of porcine scaffold. Francis discloses that the decellularized placenta tissue comprises no more
than 10 pg, 1 μg, 500 ng, 200 ng or 100 ng DNA per mg of dry weight of the placenta-derived matrix.
Sulfated glycosaminoglycans content:
Francis discloses that the decellularized placental matrix includes mucopolysaccharides (par. 88), which are glycosaminoglycans. Francis does not disclose that the decellularized placental matrix retains at least about 45% of any sulfated glycosaminoglycans present in native porcine placental membrane, as recited by claim 8.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, applicant’s specification quantified the amount of sulfated glycosaminoglycans in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found an average of about 0.01 g of sulfated glycosaminoglycans per gram of porcine scaffold (Example 7, pg. 32-33). Neither applicant’s specification nor the cited prior art disclose a manipulative action or process which would have significantly modified the amount of sulfated glycosaminoglycans in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the claimed invention and that of the cited prior art appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Furthermore, Francis discloses that a substantial amount, including at least about 70 or 99 %, of the extracellular matrix molecules in the placenta tissue is retained in the decellularized, placenta-derived matrix (e.g., par. 79, 88). Accordingly, based on the evidence of record, the amount of sulfated glycosaminoglycans recited by claim 8 is found to naturally flow from the decellularization of porcine placental tissue as found in the cited prior art. For these reasons, the amount of sulfated glycosaminoglycans recited by claim 8 is not found to patentably distinguish the claimed invention over the prior art.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Francis discloses that the decellularized placenta retains a substantial amount of the extracellular matrix proteins and molecules in the placenta tissue (e.g., par. 79, 88), and Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the sulfated glycosaminoglycan content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Francis, par. 100; and Leonel, page 1, right column). For these reasons, absent evidence of criticality, the sulfated glycosaminoglycan content recited by claim 8 would have been prima facie obvious over the prior art.
Elastin content:
Francis discloses that the decellularized placental matrix includes elastin (par. 88, 100). Francis does not teach that the porcine scaffold retains at least about 66% of any elastin present in native porcine placental membrane, as recited by claim 9.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, applicant’s specification quantified the amount of elastin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the porcine scaffolds retain at least about 66% of the elastin content (Example 4, pg. 28-29). Neither applicant’s specification nor the cited prior art disclose a manipulative action or process which would have significantly modified the amount of elastin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Furthermore, Francis discloses that a substantial amount, including at least about 50 or 99 wt %, of the extracellular matrix proteins in the placenta tissue is retained in the decellularized, placenta-derived matrix (e.g., par. 79, 88). Accordingly, based on the evidence of record, the amount of elastin recited by claim 9 is found to naturally flow from the decellularization of porcine placental tissue as found in the cited prior art. For these reasons, the amount of elastin recited by claim 9 is not found to patentably distinguish the claimed invention over the prior art.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Francis discloses that the decellularized placenta retains a substantial amount of the extracellular matrix proteins and molecules in the placenta tissue (e.g., par. 79, 88), and Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the elastin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Francis, par. 100; and Leonel, page 1, right column). For these reasons, absent evidence of criticality, the elastin content recited by claim 9 would have been prima facie obvious over the prior art.
Fibronectin content:
Francis discloses that the decellularized placental matrix includes fibronectin (par. 88). Francis does not disclose that the porcine comprises up to about 1650 ng fibronectin per gram of porcine scaffold, as recited by claim 10.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, applicant’s specification quantified the amount of fibronectin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the fibronectin content ranged between 1,409 and 1,634 ng per gram of tissue dry weight (Example 5, pg. 29-30). Neither applicant’s specification nor the cited prior art disclose a manipulative action or process which would have significantly modified the amount of fibronectin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Furthermore, Francis discloses that a substantial amount, including at least about 50 or 99 wt %, of the extracellular matrix proteins, such as fibronectin, in the placenta tissue is retained in the decellularized, placenta-derived matrix (e.g., par. 79, 88). Accordingly, based on the evidence of record, the amount of fibronectin recited by claim 10 is found to naturally flow from the decellularization of porcine placental tissue as found in the cited prior art. For these reasons, the amount of fibronectin recited by claim 10 is not found to patentably distinguish the claimed invention over the prior art.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the claimed invention and that of the prior art appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Francis discloses that the decellularized placenta retains a substantial amount of the extracellular matrix proteins and molecules, including fibronectin, in the placenta tissue (e.g., par. 79, 88), and Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the fibronectin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Francis, par. 100; and Leonel, page 1, right column). For these reasons, absent evidence of criticality, the fibronectin content recited by claim 10 would have been prima facie obvious over the prior art.
Claim 21 is rejected under 35 U.S.C. 103 as obvious over US 2018/0155678 A1 to Francis et al.; and Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages, as applied to claims 1-11, and 20 above; in further view of Jenkins et al. (2011) “Biomechanical and Histologic Evaluation of Fenestrated and Nonfenestrated Biologic Mesh in a Porcine Model of Ventral Hernia Repair” J Am Coll Surg, 212(3):327-39, print version: NIH Public Access Author Manuscript, PMID: 21356487, PMCID: PMC3783002.
This rejection is newly applied, necessitated by amendment.
Francis does not teach the wound dressing includes a surface defining one or more fenestrations, as claimed in claim 21.
Prior to the effective filing date of the instantly claimed invention, Jenkins compares fenestrated and nonfenestrated porcine matrices for ventral hernia repair and found that fenestrations increased tissue incorporation (Abstract). Jenkins teaches that fenestrations allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations (pg. 2, first full paragraph).
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 wound dressing of Francis to include fenestrations, as taught by Jenkins, with a reasonable expectation of success in order to allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations.
Response to arguments:
Applicant’s remarks filed 09/25/2025 have been carefully considered, but the arguments are not found persuasive for the following reasons:
Applicant argues that Francis teaches away from the claimed invention by relying on digestion processes that could eliminate native hyaluronic acid. See pages 5-6 of applicant’s reply.
The argument is not found persuasive because there is no limitation in the claim excluding an enzymatic digestion step, and applicant’s specification discloses that the decellularizing step is an enzymatic digestion step. See, e.g., page 5: “According to one embodiment, the step of decellularizing porcine placental extracellular matrix includes treating the porcine placental membrane with a detergent solution, the detergent solution including at least one protease enzyme.” Further, as set forth in the rejection, Francis teaches that the ECM components are retained following decellularization. See, e.g., paragraphs 79, 88.
Applicant argues Jenkins’s fenestrations could be expected to compromise structural integrity or alter fluid retention properties in a delicate placental membrane scaffold and does not provide a reasonable expectation of success in providing fenestrations in the claimed wound dressing composition. See pages 6-7 of applicant’s reply.
The argument is not persuasive because one of ordinary skill in the art would have recognized particular advantages to introducing fenestrations, including allowing fluid and cellular traversal through the graft and also encouraging connective tissue deposition at the graft surface and through the fenestrations, as taught by Jenkins. There would have been a reasonable expectation of success in doing so because both Francis and Jenkins relate to animal-derived matrices for use in wound healing. See, e.g., paragraph 139 of Francis: “In another aspect, the invention relates to methods of using the placenta-derived matrix described herein as a tissue bulking agent, or a wound treatment matrix for open wound or a tunnel wound.”
Applicant argues that the claimed porcine scaffold exhibits improved biological and therapeutic performance when used in wound dressings, wherein the unique retention of hyaluronic acid and other ECM constituents supports enhanced moisture balance, anti-inflammatory activity, and re-epithelialization. Applicant further argues that the present application's data show that fenestrated porcine placental scaffolds provide markedly improved wound healing outcomes compared to both (i) non-fenestrated placental scaffolds and (ii) fenestrated dermal grafts such as those in Jenkins, and the biochemical profile of the claimed scaffolds unexpectedly promotes faster re-epithelialization, reduced inflammation, and enhanced tissue remodeling compared to fenestrated dermal matrices. See page 7 of applicant’s reply.
Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results. See MPEP 716.01(c).
The remainder of the arguments are addressed or otherwise moot by the new grounds of rejection set forth above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending U.S. Application No. 17/412,700 (reference to claim listing filed 10/20/2025); in view of Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been prima facie obvious over the copending claims and secondary references. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection is newly applied.
Claim 1 of the copending application recites a method of treating a wound comprising a porcine scaffold comprising decellularized, porcine placental membrane, wherein the extracellular matrix integrity is preserved, and extracellular matrix components (collagen I, collagen IV, elastin, laminin, fibronectin and hyaluronic acid) are retained.
Regarding instant claim 2, the copending claims recite a “decellularized” placental membrane, and a step (ii) of removing cellular debris.
Regarding instant claims 4-5, the copending claims recite the porcine scaffold comprises placental membrane.
Regarding instant claim 11, copending claim 1 recites that the porcine placental membrane is treated with a bioburden reduction step, a detergent rinse step and a viral inactivation step, and the placental membrane has been dehydrated.
The copending claims do not recite that the porcine placental membrane is recovered from a full-term delivery of one or more offspring, as claimed by instant claim 1.
Prior to the effective filing date of the instantly claimed invention, Leonel is relevant prior art for teaching the decellularization of placentas. Leonel discloses that placentas are commonly discarded after birth, and therefore placentas do not require an invasive procedure to be harvested. See Abstract and Introduction on pages 1-2.
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 invention of the copending claims by harvesting the porcine placental membrane from a full-term delivery of one or more offspring, in view of the teaching of Leonel, with a reasonable expectation of success because placental tissue may be noninvasively harvested following a full-term birth of one or more offspring.
Regarding instant claim 20, copending claim 1 recites that the placental membrane is used as a wound dressing. The prior art also recognized that a decellularized extracellular matrix, such as found in the copending claims, is suitable for use as a wound dressing (see, e.g., Leonel, pg. 1; and pg. 11, right column).
Hyaluronic acid content:
The copending claims do not recite that the porcine scaffold comprises at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold (instant claim 1), comprises at least about 1.0% w/w of hyaluronic acid based on the total weight of the porcine scaffold (instant claim 6), or retains any amount, or at least about 50% w/w, of the hyaluronic acid natively present in porcine placental membrane (instant claims 1 and 7).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of hyaluronic acid in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that each breed provided 1.2 % w/w or more of hyaluronic acid based on the total weight of the porcine scaffold (Example 6, pg. 31). Neither the instant claims nor the copending claims recite a manipulative step or process which would have significantly modified the amount of hyaluronic acid in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amounts of hyaluronic acid recited by instant claims 1, 6-7 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amounts of hyaluronic acid recited by instant claims 1, 6-7 are not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the hyaluronic acid content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the hyaluronic acid content recited by claims 1, 6-7 would have been prima facie obvious over the cited references.
dsDNA content:
The copending claims do not recite that the porcine scaffold comprises up to about 1200 ng dsDNA per mg of porcine scaffold, as recited by instant claim 3.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of dsDNA in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that each breed provided approximately 1000-1200 ng dsDNA per mg dry weight (Example 3, pg. 27). Neither the instant claims nor the copending claims recite a manipulative step or process which would have significantly modified the amount of dsDNA in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of dsDNA recited by instant claim 3 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of dsDNA recited by instant claim 3 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should remove cells and nucleic acids while preserving the physical structure and chemical composition of the ECM (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the dsDNA content of the porcine scaffold through routine experimentation in order to remove cells and nucleic acids (e.g., dsDNA) while preserving the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the dsDNA content recited by claim 3 would have been prima facie obvious over the cited references.
Sulfated glycosaminoglycans content:
The copending claims do not recite that the porcine scaffold retains at least about 45% of any sulfated glycosaminoglycans present in native porcine placental membrane, as recited by instant claim 8.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of sulfated glycosaminoglycans in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found an average of about 0.01 g of sulfated glycosaminoglycans per gram of porcine scaffold (Example 7, pg. 32-33). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of sulfated glycosaminoglycans in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of sulfated glycosaminoglycans recited by instant claim 8 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of sulfated glycosaminoglycans recited by instant claim 8 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the sulfated glycosaminoglycans content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the sulfated glycosaminoglycans content recited by claim 8 would have been prima facie obvious over the cited references.
Elastin content:
The copending claims do not recite that the porcine scaffold retains at least about 66% of any elastin present in native porcine placental membrane, as recited by instant claim 9.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of elastin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the porcine scaffolds retain at least about 66% of the elastin content (Example 4, pg. 28-29). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of elastin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of elastin recited by instant claim 9 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of elastin recited by instant claim 9 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the elastin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the elastin content recited by claim 9 would have been prima facie obvious over the cited references.
Fibronectin content:
The copending claims do not recite that the porcine comprises up to about 1650 ng fibronectin per gram of porcine scaffold, as recited by instant claim 10.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of fibronectin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the fibronectin content ranged between 1,409 and 1,634 ng per gram of tissue dry weight (Example 5, pg. 29-30). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of fibronectin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending application appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of fibronectin recited by instant claim 10 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of fibronectin recited by instant claim 10 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the fibronectin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the fibronectin content recited by claim 10 would have been prima facie obvious over the cited references.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/412,700; and Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages, as applied to claims 1-11, and 20 above; in further view of Jenkins et al. (2011) “Biomechanical and Histologic Evaluation of Fenestrated and Nonfenestrated Biologic Mesh in a Porcine Model of Ventral Hernia Repair” J Am Coll Surg, 212(3):327-39, print version: NIH Public Access Author Manuscript, PMID: 21356487, PMCID: PMC3783002.
This rejection is newly applied.
The copending claims do not recite a wound dressing including a surface defining one or more fenestrations, as claimed by instant claim 21.
Prior to the effective filing date of the instantly claimed invention, Jenkins compares fenestrated and nonfenestrated porcine matrices for ventral hernia repair and found that fenestrations increased tissue incorporation (Abstract). Jenkins teaches that fenestrations allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations (pg. 2, first full paragraph).
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 invention of the copending claims to include a wound dressing having a surface defining one or more fenestrations, as taught by Jenkins, with a reasonable expectation of success in order to allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations.
Claims 1-11, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending U.S. Application No. 17/311,468 (reference to claim listing filed 09/23/2025); in view of Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been prima facie obvious over the copending claims and secondary references. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection is newly applied.
Claim 1 of the copending application recite a porcine scaffold comprising decellularized, porcine placental extracellular matrix, as recited by instant claim 1.
Regarding instant claim 2, the copending claims recite a “decellularized” extracellular matrix. The specification of the copending application defines “decellularization” as the process by which all or substantially all of the intact cells and nuclei are removed from the placental membrane, leaving a placental extracellular matrix derived from the original placental membrane (pg. 6). Accordingly, the “decellularized” porcine scaffold of the copending claims is substantially devoid of cells, as recited by instant claim 2.
Regarding instant claims 4-5, the copending claims recite the porcine scaffold comprises “placental extracellular matrix”. The specification of the copending application defines “placental extracellular matrix” as the decellularized placental membrane whereby all or substantially all of the intact cells and nuclei are removed from the placental membrane, leaving a three-dimensional network consisting of extracellular macromolecules, such as collagen, elastin, glycosaminoglycans, laminin, and fibronectin, that provide both structural and biochemical support when used in the patient’s body (pg. 6-7, joining paragraph). Accordingly, the “placental extracellular matrix” of the copending claims includes decellularized placental membrane, as recited by instant claims 4-5.
Regarding instant claim 11, copending claim 10 recites that the porcine placental membrane is treated with a bioburden reduction step, a detergent rinse step, and a viral inactivation step, followed by dehydrating the porcine placental membrane.
The copending claims do not recite that the porcine placental membrane is recovered from a full-term delivery of one or more offspring, as claimed by instant claim 1.
Prior to the effective filing date of the instantly claimed invention, Leonel is relevant prior art for teaching the decellularization of placentas. Leonel discloses that placentas are commonly discarded after birth, and therefore placentas do not require an invasive procedure to be harvested. See Abstract and Introduction on pages 1-2.
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 invention of the copending claims by harvesting the porcine placental membrane from a full-term delivery of one or more offspring, in view of the teaching of Leonel, with a reasonable expectation of success because placental tissue may be noninvasively harvested following a full-term birth of one or more offspring.
Regarding instant claim 20, the prior art recognized that a decellularized extracellular matrix, such as found in the copending claims, is suitable for use as a wound dressing (see, e.g., Leonel, pg. 1; and pg. 11, right column).
Hyaluronic acid content:
The copending claims do not recite that the porcine scaffold comprises at least from about 1.2% to about 2.2% of hyaluronic acid per gram of porcine scaffold (instant claim 1), comprises at least about 1.0% w/w of hyaluronic acid based on the total weight of the porcine scaffold (instant claim 6), or retains any amount, or at least about 50% w/w, of the hyaluronic acid natively present in porcine placental membrane (instant claims 1 and 7).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of hyaluronic acid in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that each breed provided 1.2 % w/w or more of hyaluronic acid based on the total weight of the porcine scaffold (Example 6, pg. 31). Neither the instant claims nor the copending claims recite a manipulative step or process which would have significantly modified the amount of hyaluronic acid in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amounts of hyaluronic acid recited by instant claims 1, 6-7 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amounts of hyaluronic acid recited by instant claims 1, 6-7 are not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the hyaluronic acid content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the hyaluronic acid content recited by claims 1, 6-7 would have been prima facie obvious over the cited references.
dsDNA content:
The copending claims do not recite that the porcine scaffold comprises up to about 1200 ng dsDNA per mg of porcine scaffold, as recited by instant claim 3.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of dsDNA in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that each breed provided approximately 1000-1200 ng dsDNA per mg dry weight (Example 3, pg. 27). Neither the instant claims nor the copending claims recite a manipulative step or process which would have significantly modified the amount of dsDNA in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of dsDNA recited by instant claim 3 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of dsDNA recited by instant claim 3 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should remove cells and nucleic acids while preserving the physical structure and chemical composition of the ECM (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the dsDNA content of the porcine scaffold through routine experimentation in order to remove cells and nucleic acids (e.g., dsDNA) while preserving the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the dsDNA content recited by claim 3 would have been prima facie obvious over the cited references.
Sulfated glycosaminoglycans content:
The copending claims do not recite that the porcine scaffold retains at least about 45% of any sulfated glycosaminoglycans present in native porcine placental membrane, as recited by instant claim 8.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of sulfated glycosaminoglycans in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found an average of about 0.01 g of sulfated glycosaminoglycans per gram of porcine scaffold (Example 7, pg. 32-33). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of sulfated glycosaminoglycans in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of sulfated glycosaminoglycans recited by instant claim 8 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of sulfated glycosaminoglycans recited by instant claim 8 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the sulfated glycosaminoglycans content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the sulfated glycosaminoglycans content recited by claim 8 would have been prima facie obvious over the cited references.
Elastin content:
The copending claims do not recite that the porcine scaffold retains at least about 66% of any elastin present in native porcine placental membrane, as recited by instant claim 9.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of elastin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the porcine scaffolds retain at least about 66% of the elastin content (Example 4, pg. 28-29). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of elastin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of elastin recited by instant claim 9 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of elastin recited by instant claim 9 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the elastin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the elastin content recited by claim 9 would have been prima facie obvious over the cited references.
Fibronectin content:
The copending claims do not recite that the porcine comprises up to about 1650 ng fibronectin per gram of porcine scaffold, as recited by instant claim 10.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). In this case, the instant specification quantified the amount of fibronectin in placental tissue scaffolds derived from three, undisclosed breeds of pigs and found that the fibronectin content ranged between 1,409 and 1,634 ng per gram of tissue dry weight (Example 5, pg. 29-30). Neither the instant claims nor copending claims recite a manipulative step or process which would have significantly modified the amount of fibronectin in the decellularized porcine placental tissue. Rather, both the tissue scaffold of the instantly claimed invention and that of the copending application appear to be substantially the same: a porcine scaffold comprising a decellularized porcine placental extracellular matrix. Accordingly, based on the evidence of record, the amount of fibronectin recited by instant claim 10 would have naturally flowed from a porcine scaffold comprising a decellularized, porcine placental extracellular matrix, as found in the copending claims. For these reasons, the amount of fibronectin recited by instant claim 10 is not found to patentably distinguish the instantly claimed invention over the copending claims.
Alternatively, differences in concentration or amount will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or amount 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). See MPEP 2144.05. In this case, both the tissue scaffold of the instantly claimed invention and that of the copending claims appear to be substantially the same: a porcine scaffold comprising a decellularized, porcine placental extracellular matrix. Furthermore, Leonel also discloses that decellularization protocols should preserve the physical structure and chemical composition of the extracellular matrix (Abstract; pg. 1, left column). Therefore, one of ordinary skill in the art would have been led to optimize the fibronectin content of the porcine scaffold through routine experimentation in order to retain the physical structure and chemical composition of the native extracellular matrix, which is useful in therapeutic applications like wound healing (see, e.g., Leonel, page 1, right column). For these reasons, absent evidence of criticality, the fibronectin content recited by claim 10 would have been prima facie obvious over the cited references.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 17/311,468; and Leonel et al. (2018) “Decellularization of placentas: establishing a protocol” Brazilian Journal of Medical and Biological Research, 51(1): e6382, 12 pages, as applied to claims 1-11, and 20 above; in further view of Jenkins et al. (2011) “Biomechanical and Histologic Evaluation of Fenestrated and Nonfenestrated Biologic Mesh in a Porcine Model of Ventral Hernia Repair” J Am Coll Surg, 212(3):327-39, print version: NIH Public Access Author Manuscript, PMID: 21356487, PMCID: PMC3783002.
This rejection is newly applied.
The copending claims do not recite a wound dressing including a surface defining one or more fenestrations, as claimed by instant claim 21.
Prior to the effective filing date of the instantly claimed invention, Jenkins compares fenestrated and nonfenestrated porcine matrices for ventral hernia repair and found that fenestrations increased tissue incorporation (Abstract). Jenkins teaches that fenestrations allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations (pg. 2, first full paragraph).
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 invention of the copending claims to include a wound dressing having a surface defining one or more fenestrations, as taught by Jenkins, with a reasonable expectation of success in order to allow fluid and cells to traverse through the graft and also encourage connective tissue to be deposited at the graft surface and through the fenestrations.
Response to arguments:
Applicant’s remarks filed 09/25/2025 have been carefully considered, but the arguments are not found persuasive for the following reasons:
Applicant argues that the instant claimed are patentably distinct from those of the copending application because they recite additional and specific structural and compositional limitations that are absent from the copending application, such as a particular hyaluronic acid content. See page 7 of applicant’s reply.
The argument is not found persuasive because the differences between the instant claims and those of the copending application would have been prima facie obvious, as set forth in the new grounds of rejection.
The remainder of the arguments are addressed or otherwise moot by the new grounds of rejection set forth above.
Conclusion
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631