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 April 22, 2026.
Claim Amendments
Applicant’s amendment to the claims filed 04/22/2026 is acknowledged.
Claims 1 and 20 are amended
Claims 12-19 have been 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.
Withdrawal of Prior Rejections/Objections
Rejections and/or objections not reiterated from the previous Office action mailed 01/30/2026 are hereby withdrawn.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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
This rejection is newly applied, necessitated by amendment.
Claim 8 recites the porcine scaffold retains at least about 45% of any sulfated glycosaminoglycans present in native porcine placental membrane. However, claim 1, upon which claim 8 depends, previously recited the porcine scaffold retains at least about 45% sulfated glycosaminoglycans present in native porcine placental membrane. Accordingly, claim 8 is in improper dependent form for failing to further limit the subject matter of claim 1, upon which it depends
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
This rejection is newly applied, necessitated by amendment.
Claim 9 recites the porcine scaffold retains at least about 66% of any elastin present in native porcine placental membrane. However, claim 1, upon which claim 9 depends, previously recited the porcine scaffold retains at least about 66% of elastin present in native porcine placental membrane. Accordingly, claim 9 is in improper dependent form for failing to further limit the subject matter of claim 1, upon which it depends
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 04/22/2026, claim 1 was amended to recite the new limitation that the porcine scaffold is prepared by a process that retains natively present extracellular matrix components, including “at least about 1.2% of hyaluronic acid based on total dry weight 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, i.e., “at least about 1.2% of hyaluronic acid based on total dry weight of porcine scaffold.” The Examiner has not identified sufficient written support for this new limitation.
In remarks filed 04/22/2026, applicant argued that written support for the new limitation may be found in in the specification as follows:
Claim 1 is currently amended to recite about 1.2% of hyaluronic acid based on the total dry weight of porcine scaffold. The specification discloses hyaluronic acid content values of 1.2%, 1.5% [sic], and 2.2% w/w (Example 6, Table VIII), thereby providing explicit support for "at least about 1.2% w/w hyaluronic acid."
However, Example 6 describes obtaining the amounts 1.7%, 2.2% and 1.2% hyaluronic acid of the total dry weight of the porcine scaffolds from Breed 1, Breed 2 and Breed 3, respectively. The claimed range “at least about 1.2% of hyaluronic acid based on total dry weight of porcine scaffold” describes a range of about 1.2% or greater of hyaluronic acid based on total dry weight of porcine scaffold. Accordingly, the present claims broadly embrace amounts of hyaluronic acid significantly greater than 1.2%, or even 2.2%, based on total dry weight of porcine scaffold because the phrase “at least about” specifies an open-ended numerical range. Moreover, the term “about” would include values less than 1.2%, which 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, necessitated by amendment.
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, wherein the porcine scaffold retains a substantial amount of the extracellular matrix proteins and molecules in the native placenta tissue.
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 about 1.2%
of hyaluronic acid based on total dry weight 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 claims 1 and 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 claims 1 and 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 claims 1 and 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 claims 1 and 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 claims 1 and 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 claims 1 and 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 04/22/2026 have been carefully considered, but the arguments are not found persuasive for the following reasons:
Applicant argues that Francis and Leonel do not quantify the hyaluronic acid content in the resulting scaffolds nor disclose the retention percentages for sulfated glycosaminoglycans or elastin. Page 5 of remarks.
The argument is not persuasive because 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). "[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).
Applicant argues that the claims as amended foreclose the possibility that the claimed levels of extracellular matrix components may be optimized through routine experimentation because hyaluronic acid, sulfated glycosaminoglycans and elastin are allegedly known to respond differently to decellularization conditions, and, therefore, achieving the claimed retention profile requires balancing competing biochemical effects rather than adjusting a single parameter. Page 5 of remarks.
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).
In this case, there is no objective evidence that hyaluronic acid, sulfated glycosaminoglycans and elastin are known to respond differently to decellularization conditions, or that optimizing one parameter would necessarily foreclose optimizing another parameter. There is nothing in In re Aller foreclosing the possibility of optimizing more than a single parameter, even when changes in one parameter may result in changes in another parameter. Regardless, in this case, there is no objective evidence supporting applicant’s argument.
Applicant is further reminded that the claim 1 recites no particular decellularization conditions. Rather, decellularization is recited broadly and generically in claim 1. Accordingly, since no differences in decellularization conditions are claimed, differences in decellularization conditions will not support a basis for nonobviousness in the present claims.
Applicant alleges that the prior art consistently recognizes that decellularization processes tend to remove cellular material at the expense of extracellular matrix integrity and often result in loss of glycosaminoglycans and hyaluronic acid. Therefore, Applicant concludes there would have been no reasonable expectation of success that one could achieve effective decellularization while simultaneously retaining hyaluronic acid, sulfated glycosaminoglycans and elastin at the claimed levels. Page 5 of remarks.
The argument is not persuasive because there is no objective evidence that the prior art consistently recognizes that decellularization processes tend to remove cellular material at the expense of extracellular matrix integrity and often result in loss of glycosaminoglycans and hyaluronic acid. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
On the contrary, Francis states that the porcine scaffold retains a substantial amount of the extracellular matrix proteins and molecules in the placenta tissue. See, e.g., paragraphs 79, 88. Accordingly, for these reasons, and those stated in the rejection above, there would have been a reasonable expectation of success in obtained the claimed porcine scaffold.
With respect to dependent claim 21, 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. Page 7 of remarks
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.”
In sum, there is a lack of evidence or scientific reasoning to support the assumption that fenestrations would significantly degrade the structural integrity or chemical composition of a placental matrix when fenestrations have been previously and successfully introduced in dermal matrices, as found in Jenkins. A “fenestration” refers to a “perforation” or “hole” in a structure, and the claim broadly recites “one or more fenestrations,” which means the claimed scaffold may have a single, small perforation or hole. The argument fails to identify a single reason why a single, small perforation or hole, or even a plurality thereof, would have been expected to render a scaffold inoperable for wound dressing solely because the scaffold was derived from placental tissue rather than dermal tissue.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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