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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/07/2026 has been entered.
Status of claims
The amendment filed on 04/10/2026 is acknowledged. Claims 5-7, 16, and 17 have been canceled and claims 1-3 and 9 have been withdrawn. Claims 4, 8, and 10-15 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 04/10/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 112(b) rejection of claims 10-12 and 17, 35 U.S.C. 102(a)(1) rejections of claims 4-7 over Ott et al. (US 2009/0202977 A1) and of claims 4 and 8 over Christman et al. (US 2011/0189140 A1), and 35 U.S.C. 103(a) rejections of claims 4-8 and 13-16 over Ott et al. (US 2009/020977 A1) and Christman et al. (US 2011/0189140 A1) and of claims 4-8, 13, 15, and 16 over Christman et al. (US 2011/0189140 A1) and Ott et al. (US 2009/020977 A1) from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitates the following new ground of rejection.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 4-8 and 13-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ott et al. (US 2009/020977 A1) in view of Christman et al. (US 2011/0189140 A1).
Ott et al. teach a method of preparing a scaffold comprising cardiac extracellular matrix (ECM) (the instant claim 4) (abstract and paragraph 16, 86, 90, and 92);
wherein the decellularized cardiac ECM is prepared, at 5 °C, by
decellularizing isolated heart tissue by decellularization with sodium dodecyl sulfate (SDS) in water (i.e., solution, the claimed 1st decellularizing solution) using pump for recirculation (the limitation of stirring in the instant claim 4 is not define in the instant claims and is not define in the instant specification and is given the broadest reasonable interpretation as moving and non-stagnated solution); followed by
decellularization with Triton-X 100 (octylphenoxypolyethoxyethanol) using pump for recirculation (the limitation of stirring in the instant claims 4 and 10-12 as discussed above) for better removal of nuclei or contractile filament and removal of SDS (paragraph 51, 52, 69, 74, 75, 104, and 106) and
SDS decellularization protocol #3 using 1% SDS (the same claimed concentration in the instant claim 4) for ≥ 6 hours and
Triton X decellularization protocol #4 using 5% Triton X-100 and 0.1% NH3OH (the claimed 2nd decellularizing solution and the same claimed concentrations in the instant claim 4) for ≥ 6 hours (the instant claim 4);
using 1% SDS followed by 1% Triton X-100 to remove the SDS (paragraph 69);
wherein the decellularized cardiac ECM is dehydrated (the claimed drying in the instant claim 4) (paragraph 85).
Ott et al. also teach in decellularization protocol #2 washed heart being decellularized with 0.05% trypsin (implying 0.05% Trypsin in a medium while a cellular disruption medium including PBS buffer according to paragraph 23) for 30 min (the claimed gelating step in the instant claims 13 and 14) (paragraph 61-62) and at 4-40 °C (paragraph 25), thus including the claimed 37 °C in the instant claim 14;
decellularization removing all of the cellular components, i.e., 100% (very close to the claimed 95-99.9% in the instant claim 4) (paragraph 16).
Ott et al. do not specify combining 0.1% NH3OH with 1% Triton X-100 (the claimed 2nd decellularizing) following the protocol of decellularization using 1% SDS (the claimed 1st decellularization in the instant claim 4) the same concentration of Triton-X 100 (5% vs the claimed 1% in the instant claim 15).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in protocols 3 and 4 and paragraph 69 and 74 to combine protocol 3 decellularization using 1% SDS (the claimed 1st decellularization solution) and protocol 4 decellularization using 5% Triton X-100 together with 0.1% NH3OH and adjusting from 5% in protocol 4 to 1% Triton X-100 (the claimed 2nd decellularizing solution) based on the teaching of using 1% SDS decellularization followed by using 1% Triton X-100 decellularizing for better decellularizing results in paragraph 69, 74, and 75. Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Please refer to MPEP 2141 I.:
“[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 415-16, 82 USPQ2d at 1395.
“[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.).
Ott et al. do not specify the same length of 1st decellularization stirring time (≥ 6 hours vs the claimed 12-36 hours in the instant claim 4) and the same length of 2nd decellularization stirring time (≥ 6 hours vs the claimed 3-24, 4-12, 5-8, and 6 hours in the instant claims 4 and 10-12).
A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of length of 1st decellularization stirring time is 12-36 hours and the range of length of 1st decellularization stirring time taught in the prior art is ≥ 6 hours and therefor, overlaps with the claimed range.
The claimed range of length of 2nd decellularization stirring time is 3-24, 4-12, 5-8, and 6 hours and the range of length of 2nd decellularization stirring time taught in the prior art is ≥ 6 hours and therefor, overlaps with the claimed range.
Ott et al. do not specify the concentration of decellularized cardiac ECM in the scaffold in the instant claim 8.
This deficiency is cured by Christman et al. who teach methods of preparing cardiomyocyte scaffold with absorbed substantially decellularized cardiac extracellular matrix (ECM) comprising < 1% native cells by weight (abstract and paragraph 33, 46, and 64); wherein decellularized cardiac extracellular matrix is prepared by decellularizing isolated heart tissue (paragraph 38) by decellularization with sodium dodecyl sulfate (SDS) and PBS solution followed by lyophilizing and forming a gel for in situ formation of scaffold with the decellularized cardiac ECM concentration of 2-8 mg/mL, especially 7 mg/mL (paragraph 41, 42, and 64 and example 1); and exemplified in example 4 decellularizing cardiac tissue by stirring in 1% SDS until decellularized followed by stirring in 1% Triton X-100. Christman et al. teach gel or solution form of heart extracellular matrix being digested and solubilized with pepsin or trypsin (paragraph 40, 54, and 105) and forming gel after approximately 15-20 minutes at 37 °C (paragraph 50).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Ott et al. and Christman et al. to specify the concentration of decellularized cardiac ECM in the scaffold taught by Ott et al. being 2-8 mg/mL, especially 7 mg/mL. Incorporating 2-8 mg/mL, especially 7 mg/mL, decellularized cardiac ECM in a scaffold was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 04/10/2026, have been fully considered but they are moot in view of new ground of rejections.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
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