DETAILED ACTION
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 .
This Action is in response to the papers filed on May 04, 2026.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/04/2026 has been entered.
Claims 1-17 are pending in the application. Claim 1 has been amended, claims 16 and 17 are newly added and no claims are canceled as set forth in the claim set filed 05/04/2026. Claims 1, 4 and 15 are independent claims.
The examiner acknowledges previously receiving an executed Declaration under 37 C.F.R. § 1.132 executed by Dr. Karen Christman on November 26, 2025 (“Christman Declaration ”), and filed on November 26, 2025.
Therefore, claims 1-17 are examined on the merits. Claims 1, 4 and 15 are independent claims.
Priority
This application is a 371 of PCT/US2021/050181 filed 09/14/2021.
Acknowledgment is made of applicant’s claim for priority of provisional application 63/077,803 filed 09/14/2020.
Thus, the earliest possible priority date of the present application is September 14, 2020.
Response to arguments
Withdrawn objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112
Claims 1-15 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.
Applicant’s arguments and amendments filed 05/04/2026 are persuasive. In particular, the amendment removing the language “capable of” obviates the rejection,
Claim Rejections - 35 USC § 102
The rejection of claims 1-15 under 35 U.S.C. 102(a)(1) as being anticipated by Singelyn (Journal of the American College of Cardiology, Vol. 59, No. 8, 2012) as evidenced by Wassenaar (JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 67, NO. 9, 2016) has been withdrawn.
Applicant’s arguments and amendments filed 05/04/2026 are persuasive. In particular, the Examiner agrees that the Full MM composition of Singelyn has separate properties over that of the present invention’s SolMM as discussed in Applicant’s Remarks and Declaration.
A new rejection has been set forth to directly read on SolMM under 102 and 103. Additionally, it is noted that within the Application particular concentrations such as 16 mg/mL are utilized for effective gelation. If this is a critical parameter for gelation and there is a particular amount required to be infusible and gel at the infarct size, it is advised it is included in the independent claims. A response to Applicant’s arguments with regard to a withdrawn rejection is moot.
New rejections objections/ Rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12 and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spang (Circulation 138.Suppl_1 (2018): A10353-A10353; Applicant’s own work published Nov 2018) as evidenced by Christman (US20210379245; Applicant’s own work)
This rejection is newly set forth in light of Applicant’s arguments and amendments in the RCE filed 05/04/2026.
For the purposes of examination, infusible extracellular matrix (iECM) is interpreted as ECM which is able to be administered through a catheter intravenously.
Regarding claim 1, 4, and 16-17, Spang teaches a method of using an injectable hydrogel derived from decellularized porcine myocardium which is the soluble fraction of myocardial matrix (SolMM, the same product as the present invention) (Introduction, Methods). The delivery of SolMM was by infusion and after the administration, there was subsequent gelation in the infarct (i.e. a vasculature, contacts tissue) (Results).
Although Spang does not specifically state that SolMM has an average particle size of less than 250 nm (claim 1), as evidenced by Christman, SolMM has average particle sizes less than 100nm (Fig. 14, para. 0036).
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Regarding claim 2 and 3, Spang teaches infusing the SolMM into myocardial infarction model wherein the iECM fills the infarct site and aims to form a hydrogel after passing through the leaky vasculature (Introduction, Methods). As the ejection fraction is improved, it is determined that the leaky vasculature is treated.
Regarding claim 5, although Spang does not teach specifically that the method is for use in a tissue injury which is associated with one or more of Pulmonary Arterial Hypertension (PAH), use of a ventilator, aspiration of stomach contents, inhalation of environmental toxins, and post-infection complications from a bacterial or viral source, this is part of the intended use preamble of the claim. This limitations does not provide structure or an active method step to the method of treatment. Additionally, as each and every active step is taught by Spang, the same method steps yield the same predictable results.
Regarding claim 6, Spang teaches treating the infarct after myocardial infarction (Methods), therefore the tissue injury is part of the heart tissue.
Regarding claim 7, as Spang teaches gelation in the infarct/leaky vasculature (Methods), it is interpreted that this results in a decrease in vascular permeability.
Regarding claim 8, Spang teaches the SolMM is delivered via catheter in an infusion (Methods).
Regarding claim 9, Spang teaches the SolMM transitions to a gel form in the tissue after administration and does not gel in the blood (Methods).
Regarding claims 10-11, Spang teaches that the SolMM is made from myocardial matrix (Methods).
Regarding claim 12, Spang does not explicitly teach that the SolMM has nanofibers, however, as evidenced by Christman, the architecture of the solMM is nanofibrous (para. 0104).
Regarding claim 14, although Spang does not explicitly state that the vascular permeability is reduced by binding to ECM in the vasculature through peptides, proteins or polysaccharides, ECM binding is an inherent characteristic of the ECM obtained, therefore, as the ECM product of Spang is indistinguishable from the product claimed, the same characteristics are also present.
Regarding claim 15, Spang teaches SolMM is made from the soluble fraction which is isolated via high speed centrifugation (i.e. fractionation) (Methods).
Therefore, the invention is anticipated by Spang.
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Spang (Circulation 138.Suppl_1 (2018): A10353-A10353; Applicant’s own work) as applied to claim 1 in the 102 rejection above, and in further view of Singelyn (Journal of the American College of Cardiology, Vol. 59, No. 8, 2012)
This rejection is newly set forth in light of Applicant’s arguments and amendments in the RCE filed 05/04/2026.
For the purposes of examination, infusible extracellular matrix (iECM) is interpreted as ECM which is able to be administered through a catheter intravenously.
Regarding claim 1, Spang teaches a method of using an injectable hydrogel derived from decellularized porcine myocardium which is the soluble fraction of myocardial matrix (SolMM, the same product as the present invention) (Introduction, Methods). The delivery of SolMM was by infusion and after the administration, there was subsequent gelation in the infarct (i.e. a vasculature, contacts tissue) (Results).
However, Spang does not teach the concentration at which the iECM is administered.
Singelyn teaches a myocardial matrix product brought to a 6 mg/mL concentration for injection into a myocardial infarction (p. 752, 2ⁿᵈ column). Therefore, the concentration is 1-20 mg iECM per mL of the composition.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date for the SolMM taught by Spang to be formulated at a concentration of 6mg/mL as taught by Singelyn with a reasonable expectation of success. An artisan would be motivated to do so as Singelyn teaches myocardial matrix products to treat myocardial infarction are effective at 6mg/mL.
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date.
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 10, 11 and 12 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 applicant regards as the invention.
Claims 10, 11 and 12 are vague and indefinite because they recite the phrase "derived from" and the metes and bounds of how iECM can be "derived from" heart, brain, bladder, small intestine, cardiac tissue and still meet the intended limitation of the claim are not clear. As discussed above, it is not possible to know the metes and bounds of a "derivative" because any given starting material can have many divergent derivatives depending onthe process of derivatization.
This rejection could be overcome by substituting “obtained or isolated from..” for "derived" in the claims which implies a more direct method of acquiring the infusible extracellular matrix.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA CONNORS whose telephone number is (571)272-7010. The examiner can normally be reached Monday - Friday (9AM-5PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA LEAVITT can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
