DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 6/25/2026 to claims 1, 4, 5, and 7 have been entered. Claim 6 is canceled. Claim 11 has been added. Claims 1-5 and 7-11 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action.
The instant amendments to claims 1 and 5 have overcome the 35 U.S.C. § 112(b) and 35 U.S.C. § 103 rejections of record, which are withdrawn. New grounds of rejection are set forth below necessitated by the instant amendments.
Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 are rejected under 35 U.S.C. 103 as unpatentable over Stibbons et al. (US 2015/0190548; provided in the IDS dated 12/13/2019) in view of Matsuda et al. (WO 2014/181886; provided in the IDS dated 12/13/2019) and Mitchell et al. (US 2002/0115208).
US 2016/0051731 A1 (provided in the IDS dated 12/13/2019) is the national stage entry of WO 2014/181886 and is treated as an accurate translation of the teachings of Matsuda from Japanese into English. Therefore, the teachings of Matsuda as translated in US 2016/0051731 A1 will used to make the rejection but are afforded the publication date of the published WIPO application of 11/13/2014 as prior art. The basis of citing a foreign language document as a reference while at the same time citing a known English language version of the same document with a later publication date as a convenient translation can be found in MPEP 901.05, subheading II.
Stibbons teaches decellularized tissues obtained by decellularizing biologically derived tissue, and also describe methods for decellularization, wherein decellularized tissues are produced through a treatment using DNase after a treatment using 0.1% or 0.075% SDS (see Paragraphs [0091]-[0100], Tables 1 and 2), reading in-part on claims 1-4.
Regarding claim 1-4, Stibbons is silent about a ratio of the amount of endothermic heat per dry mass of the decellularized tissue. Regarding claims 1 and 5, Stibbons is silent about mass ratio of the amount of DNA per dry mass of the decellularized tissue. Stibbons also does not teach the product-by-process limitations towards treating the tissue with high hydrostatic pressure (see M.P.E.P. § 2113). However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established absent any showing to the contrary. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the function/property is the endothermic heat per dry mass ratios of the decellularized tissue of claims 1-4, and the DNA per dry mass of the decellularized tissue and the mass ratio of an amount of DNA per dry mass of the decellularized tissue of claim 1, the decellularized tissue composition of Stibbons is substantially similar to the claimed composition because they are made by a substantially similar process as compared to the disclosed invention, i.e. treating tissue with SDS and DNAse. The decellularized tissues described by Stibbons are produced using a substantially similar method as the method for preparing decellularized tissue set forth in Example 4 of the instant specification. Therefore, the burden to establish non-obviousness over Stibbons is shifted back to Applicant. Similarly, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any non-obvious structural characteristics to the claimed product as compared to the composition taught by Stibbons.
Regarding claim 1, Stibbons does not teach deriving/obtaining the tissue as a sheet from intima, pericardium, or blood vessel.
Matsuda teaches a particulate decellularized tissue composition, made by treating heart tissue at high hydrostatic pressures and with a nuclease (¶0101). Matsuda teaches tissue sources selected from the group in-part consisting of heart (which inherently comprises pericardium) and blood vessels (and being the narrower embodiment of a source of intima) (¶0096), reading on claim 1.
Mitchell teaches a decellularized tissue construct (Abstract). Mitchell teaches the decellularized tissue construct may be formed into any desired three-dimensional shape including formulated as a sheet (¶0081), reading on claim 1.
Regarding claim 1, a person of ordinary skill in the art would have had a reasonable expectation of success in substituting the intestine of Stibbons with the intima, pericardium, or blood vessel of Matsuda because all of these tissue sources are explicitly taught as being useful for THE SAME PURPOSE as sources of tissue for decellularization. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the decellularized tissue of Stibbons into a sheet in view of Mitchell. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Stibbons and Mitchell are directed towards decellularized tissue compositions. The skilled artisan would have been motivated to do so because combining the prior art elements according to known methods would predictably yield the decellularized tissue of Stibbons formulated as a sheet; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982). Claim 1 is a product-process claim and which are not limited to the manipulations of the recited steps, only the structure implied by the steps; see M.P.E.P. § 2113. As such, the combination of Mitchell and Matsuda with Stibbons would yield a substantially identical sheet as claimed and so the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claim imparts any non-obvious structural characteristics to the claimed product as compared to the composition taught by the combination of Mitchell and Matsuda and Stibbons.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claims 1-4 are rejected under 35 U.S.C. 103 as unpatentable over Matsuda et al. (WO 2014/181886; provided in the IDS dated 12/13/2019) in view of Mitchell et al. (US 2002/0115208).
US 2016/0051731 A1 (provided in the IDS dated 12/13/2019) is the national stage entry of WO 2014/181886 and is treated as an accurate translation of the teachings of Matsuda from Japanese into English. Therefore, the teachings of Matsuda as translated in US 2016/0051731 A1 will used to make the rejection but are afforded the publication date of the published WIPO application of 11/13/2014 as prior art. The basis of citing a foreign language document as a reference while at the same time citing a known English language version of the same document with a later publication date as a convenient translation can be found in MPEP 901.05, subheading II.
Matsuda teaches a particulate decellularized tissue composition, made by treating the tissue at high hydrostatic pressures comprising 3,000-10,000 atm (i.e. about 304-1,013 MPa) and with a nuclease (¶0101), reading on claims 1-4. Matsuda teaches tissue sources selected from the group in-part consisting of heart (which inherently comprises pericardium) and blood vessels (and being the narrower embodiment of a source of intima) (¶0096), reading on claim 1.
Regarding claims 1 and 4, Matsuda is silent about a ratio of the amount of endothermic heat per dry mass of the decellularized tissue. Regarding claims 1 and 4, Matsuda is silent about mass ratio of the amount of DNA per dry mass of the decellularized tissue. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established absent any showing to the contrary. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the function/property is the endothermic heat per dry mass ratios of the decellularized tissue of claims 1 and 4, and the DNA per dry mass of the decellularized tissue and the mass ratio of an amount of DNA per dry mass of the decellularized tissue of claim 1, the decellularized tissue composition of Matsuda is substantially similar to the claimed composition because they are made by a substantially similar process as compared to the disclosed invention, i.e. treating tissue with a combination of a nuclease and high hydrostatic pressure.The decellularized tissues described by Matsuda are produced using a substantially similar method as the method for preparing decellularized tissue set forth in Example 1 of the instant specification.Therefore, the burden to establish both novelty and non-obviousness over Matsuda is shifted back to Applicant.
Regarding claim 1, Matsuda does not teach a single embodiment of the tissue selected from the group consisting of from intima, pericardium, and blood vessel. However, It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the heart tissue of Matsuda with intima, pericardium, or blood vessel of Matsuda. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because the skilled artisan would have been motivated to do so because Matsuda expressly considers heart tissue as equivalent for the other sources of tissue in decellularized tissue compositions. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Regarding claim 1, Matsuda does not teach obtaining the tissue as sheets.
Mitchell teaches a decellularized tissue construct (Abstract). Mitchell teaches the decellularized tissue construct may be formed into any desired three-dimensional shape including formulated as a sheet (¶0081), reading on claim 1.
Regarding claim 1, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further formulate the decellularized tissue of Matsuda into a sheet in view of Mitchell. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Matsuda and Mitchell are directed towards decellularized tissue compositions. The skilled artisan would have been motivated to do so because combining the prior art elements according to known methods would predictably yield the decellularized tissue of Matsuda formulated as a sheet; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982). Claim 1 is a product-process claim and which are not limited to the manipulations of the recited steps, only the structure implied by the steps; see M.P.E.P. § 2113. As such, the combination of Mitchell and Matsuda would yield a substantially identical sheet as claimed and so the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claim imparts any non-obvious structural characteristics to the claimed product as compared to the composition taught by the combination of Mitchell and Matsuda.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the invention was filed.
Claims 1, 4, 5, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Santoro et al. (J Biomed Mater Res Part B: Appl Biomater (2016), 104B: 345–356; Reference U).
Santoro teaches a method of decellularizing pig pericardium, the method comprising dissecting parietal pericardial tissue from the left ventricle as sheets, and decellularizing said tissue with a first composition comprising SDS and a second composition comprising deoxyribonuclease-I (i.e. DNAse I) (page 346, 1st paragraph under Materials and Methods in the left column, and “Uniaxial tensile lading tests” (sic) for the pericardial tissue as sheets), anticipating or reading on the composition of claims 1-4 and the methods of claims 7 and 11.
Regarding claims 1, 4, 5, and 7, Santoro is silent about a ratio of the amount of endothermic heat per dry mass of the decellularized tissue. Regarding claims 1, 4, 5, and 7, Santoro is silent about mass ratio of the amount of DNA per dry mass of the decellularized tissue. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established absent any showing to the contrary. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the function/properties are the 1) endothermic heat per dry mass ratios of the decellularized tissue, 2) the DNA per dry mass of the decellularized tissue, and 3) the mass ratio of an amount of DNA per dry mass of the decellularized tissue of claim 1, 4, 5, and 7. However, the decellularized tissue composition of Santoro is substantially similar to the claimed composition because it is made by a substantially similar process as compared to the disclosed invention, i.e. decellularizing the pericardial sheet tissue with a combination of SDS and DNAse. The decellularized tissues described and made by Santoro are produced using a substantially similar method as the method for preparing decellularized tissue set forth in Example 4 of the instant specification. Therefore, the burden to establish non-obviousness over Santoro is shifted back to Applicant.Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Funamoto et al. (Biomaterials (2010), 31, 3590–3595; Reference V).
Funamoto teaches a method of decellularizing pig aortic blood vessels, the method comprising obtaining aortic blood vessels from pig heart, cutting the isolated aortic blood vessels into 1 x 0.2 cm pieces (e.g. intact cylindrical sheets), and decellularizing the cut aortic blood vessels with a combination of high hydrostatic pressure (HHP), treatment with a first composition comprising DNAse I, and a second composition comprising SDS (page 3591, subheadings 2.1-2.3), anticipating or reading on the composition of claims 1-4 and the methods of claims 5 and 7-11.
Regarding claims 1, 4, 5, and 7, Funamoto is silent about a ratio of the amount of endothermic heat per dry mass of the decellularized tissue. Regarding claims 1, 4, 5, and 7, Funamoto is silent about mass ratio of the amount of DNA per dry mass of the decellularized tissue. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established absent any showing to the contrary. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the function/properties are the 1) endothermic heat per dry mass ratios of the decellularized tissue, 2) the DNA per dry mass of the decellularized tissue, and 3) the mass ratio of an amount of DNA per dry mass of the decellularized tissue of claim 1, 4, 5, and 7. However, the decellularized tissue composition of Funamoto is substantially similar to the claimed composition because it is made by a substantially similar process as compared to the disclosed invention, i.e. decellularizing the pericardial sheet tissue with a combination of hydrostatic pressure and treatment with SDS and DNAse. The decellularized tissues described and made by Funamoto are produced using a substantially similar method as the method for preparing decellularized tissue set forth in Example 4 of the instant specification. Therefore, the burden to establish non-obviousness over Santoro is shifted back to Applicant.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 7 of copending Application No. 16/713,772 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive in scope of the a decellularized tissue composition subjected to high hydrostatic pressure having a ratio of an amount of endothermic heat per dry mass of the decellularized tissue relative to that of the living-body derived tissue before decellularization is 0.77 or more, as measured by differential scanning calorimetry and wherein a portion from which the living body tissue has been derived is selected from the group consisting of a sheet of intima, sheet of pericardium, and a sheet of blood vessel. Claim 2 of the ‘772 reference application maps to claim 4 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments on pages 5-11 of the reply have been fully considered, but not found persuasive of error for the reasons given below. Applicant’s specific arguments traversing the rejections of record begin on page 6 of the reply.
Applicant’s arguments on pages 6-10 of the reply are not found persuasive over the modified grounds of rejection over 1) claims 1-4 Stibbons in view of Matsuda and Mitchell, and 2) claims 1-4 Matsuda in view of Mitchell both under 35 U.S.C. § 103. Briefly restated, a new rationale is added to the obviousness rejections to address the instant amendments to tissue sheets obtained from intima, pericardium, or blood vessels.
Applicant's arguments regarding the double patenting rejections of record on page 10 of the reply are acknowledged, but not found persuasive of error. The guidance given in M.P.E.P. § 804 subsection I, B, is clear that provisional double patenting rejections should continue to be made by the examiner in each application as long as there are conflicting claims in more than one application, unless the provisional double patenting rejections are the only rejections remaining in at least one of the applications. Or, until such time as a claim amendment in either the instant or copending cases would otherwise compel reconsideration of the nonstatutory double patenting rejections. In this case, Application 16/909,111 remains pending before the Office.
Conclusion
No claims are allowed. No claims are free of the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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