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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/05/2026 has been entered.
Response to Amendments
Applicant's amendments filed 3/05/2026 to claim 1 have been entered. Claim 6 is canceled. Claims 1-5 and 7-10 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 No claims are withdrawn from consideration at this time.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. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 and 7-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “sheet-like” in claim 1 is a relative term which renders the claim indefinite. The term “sheet-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Correction is required.
In so much that claims -5 and 7-10 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite under 35 U.S.C. § 112(b).
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 1-5 and 7 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 1-5 and 7.
Regarding claim 1-5 and 7, 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. 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 1-5 and 7, 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 claims 1 and 5, 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.
Regarding claim 1, Stibbons does not teach deriving/obtaining the tissue from intima, pericardium, or blood vessel. Regarding claim 1, Stibbons does not teach a sheet-like form.
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)
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 1-5 and 7-10 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 1-5 and 7-10. 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 claim 1, 4, 5, and 7, Matsuda 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. 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, 5, 7, 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 claims 1 and 5, 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 a sheet-like form.
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).
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.
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 and 2 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 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 a portion having a matrix structure outside the cells, the portion being selected from the group consisting of intima, pericardium, and 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 4-9 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.
On page 6 of the reply, Applicant appears to allege that Stibbons is deficient by not teaching every element of claim 1 (e.g. the “sheet-like” decellularized tissue). On page 6 of the reply, Applicant alleges that Matsuda is deficient by being directed towards methods of lyophilizing and pulverizing organs to generate a decellularized particulate composition. These arguments are not found persuasive of error for several reasons: 1) Neither Stibbons nor Matsuda are applied alone under any 35 U.S.C. § 102 rejection, but are applied together with Mitchell and the claimed invention becomes obvious when the references are considered together as a whole rather than each alone, and 2) one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Applicant’s arguments do not persuasively address what the combination of Stibbons, Matsuda, and Mitchell would (or would not) suggest to a person of ordinary skill in the art as the arguments do not address the specific rationales set forth to make the prima facie case for obviousness to combine Matsuda and Mitchell with Stibbons as set forth above
On pages 7-8 of the reply, Applicants rely on arguments traversing the above rejection under 35 U.S.C. § 103 over Stibbons, Matsuda, and Mitchell to traverse the separate 35 U.S.C. § 103 rejection over Matsuda and Mitchell. Therefore, the response set forth above to arguments also applies to this rejection.
Applicant's arguments regarding the double patenting rejections of record on page 6 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.
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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/Sean C. Barron/Primary Examiner, Art Unit 1653