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 November 26, 2025.
Claims 1-15 are pending in the application. Claims 1, 4, and 6 have been amended, no new claims are added and no claims are canceled as set forth in the claim set filed 11/26/2025. Claims 1, 4 and 15 are independent claims.
The examiner acknowledges 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 1-15 are examined on the merits.
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
Maintained 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.
This rejection has been modified in light of Applicant’s arguments and amendments filed 11/26/2025.
Claim 1 and by dependence, claims 2-3 and 7-14 are vague and indefinite in the recitation of “…able of…” , since this phrase refers to a latent ability, and it is unknown whether the ability is expressed or observed in the invention.
Note, it has been held that the recitation that an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138.
Claim Rejections - 35 USC § 102
Claims 1-15 under 35 U.S.C. 102(a)(1) remain rejected 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).
This rejection has been modified in light of Applicant’s argumnts and amendmnts filed 11/26/2025.
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 8, Singelyn teaches treatment of myocardial infarction (i.e. tissue/vascular injury with a myocardial matrix hydrogel derived from ECM via administration intravenously through a catheter (p. 752, 2nd column; Figure 4). This reads on the above interpretation of iECM. As the amount injected into the subject via catheter in vivo resulted in preservation of cardiac function after myocardial infarction and increase in ejection fraction (p. 753-754, bridging paragraph), the amount of matrix at 75 microliters is determined to be an effective amount. The method of administration is transendocardial (p. 754, 1st column), therefore it contacts the vasculature.
Regarding the limitation of being able to pass through a 250 nm filter, it has been held that the recitation that an element is “capable of performing” or “able to” perform a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchinson, 69 USPQ 138. Although not explicitly stated, as evidenced by Applicant’s own declaration, particle sizes in the ECM of Singelyn, while larger, would still be able to pass through a 250 nm filter. Although Applicant’s Declaration states there would be difficulty with clogging, any portion of the ECM below that size, or liquid portions, would be “able to” pass through.
Regarding claims 2 and 3, in the instant specification, para [0050] discloses leaky vasculature has been observed in the vessels surrounding tumors and following ischemic injuries, such as myocardial infarction, therefore vascular injury with leaky vasculature is treated. Therefore, Singelyn reads on treating vascular injury which is associated with myocardial infarction and has leaky vasculature.
Regarding claim 5, although Singelyn 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 Singelyn, the same method steps yield the same predictable results.
Regarding claim 6, Singelyn teaches that the tissue treated is the heart as myocardial infarction creates infarct areas which are areas of damage (p. 760, 2nd column; p. 752, 1st column).
Regarding claim 7, Singelyn does not explicitly teach that the results of their myocardial matrix were reducing tissue infiltration of reactive oxygen species, inflammatory cytokines, growth factors, exosomes, or any proteins, particles, or molecules, by blocking or reducing vascular permeability. However, as evidenced by Wassenaar which utilizes the myocardial matrix of Singelyn via the same means of administration into a subject, the method described results in the upregulation of transport of molecules (p. 1075, 1st column; Table S4; Table S12, See Aqp7). Although not explicitly taught that this is by blocking or reducing vascular permeability, as Singelyn teaches each and every method step of the claimed invention, the same method steps obtain the same results.
Regarding claim 9, Singelyn teaches that the ECM is an injectable liquid which self assembles with injection and additionally, that the liquid is kept on ice until administration (p. 752, 1st column; p. 752, 2nd column; p. 754, 1st column). Therefore, it is interpreted that the iECM does not gel in vitro below 38 °C as ice is well below that temperature.
Regarding claim 10 and 11, Singelyn teaches that the myocardial matrix is derived from the heart/cardiac tissue (p. 752, 1st column)
Regarding claim 12, Singelyn teaches that the myocardial matrix forms ECM nanofibers in vivo (p. 752, 1st column)
Regarding claim 13, Singelyn teaches that the myocardial matrix is brought to a 6 mg/mL concentration for injection (p. 752, 2nd column). Therefore, the concentration is 1-20 mg iECM per mL of the composition.
Regarding claim 14, although Singelyn does not explicitly state that the vascular permeability is reduced by binding to ECM in the vasculature through peptides, proteins or polysaccharides, Singelyn does teach that many protein components of native ECM are in their myocardial matrix product and that their matrix binds to the walls of the heart after injection (p. 759, 1st column; Figure 5). Therefore, it is interpreted that the matrix has bound itself to the ECM through peptides, proteins or polysaccharides. Furthermore, ECM binding is an inherent characteristic of the ECM obtained, therefore, as the ECM product of Singelyn is indistinguishable from the product claimed, the same characteristics are also present.
Regarding claim 15, Singelyn teaches that aliquots were taken and decellularized ECM is milled into a fine powder (Figure 1). As the ECM is taken out of the SDS solution and then milled and lyophilized, it is interpreted that this separates soluable fraction from insoluable fraction and therefore, the process is fractionated.
Therefore, the invention would have been anticipated by one of ordinary skill in the art at the time of the effective filing date.
In response to Applicant’s arguments, Declaration and amendments filed 11/26/2025,
The declaration under 37 CFR 1.132 filed 11/26/2025 is insufficient to overcome the 102 rejection as set forth in the last Office action because: While Applicant shows differences in products made by different methods, both the present invention and Singelyn, the claims are directed to a method of use. Additionally, while the Christman Declaration states that due to clogging the ECM could not be “effectively filtered” the ECM of Singelyn still maintains the ability to pass through a 250 nm filter at least partially as seen in the provided figure 14 where particles under 250nm are present in Singelyn’s ECM.
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive. As Applicant’s remarks are based solely on the argument above, they are not persuasive in overcoming the 102 rejection concerning Singelyn.
Conclusion
No claims are allowed.
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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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634