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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 14, 2025 has been entered. By way of this reply, Applicant has amended claim 1 and introduced new claims 21-22.
Claims 1-2, 5-6, 8, 11-15 and 17-22 are pending in the application and therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated April 14, 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-6, 8, 11-15 and 17-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims recite a method of treating a subject, the method comprising administering a composition to the subject, wherein the composition comprises at least one extracellular matrix (ECM). The claims as written encompass a method of treatment with any ECM material derived from tissue chosen from spleen and lung, and retaining native bioactive components of the tissue.
According to Applicant's specification, the ECM is a is a complex structural material found within tissues that surround and support cells, and comprises multiple types of structural proteins, growth factors, cytokines, and proteoglycans (para. 010 and 025). Applicant's specification at para. 0012 states that the ECM material may comprises any or all of these components. However, Applicant's recited examples state only "a particulate material according to the present disclosure" without specifying the composition of the material.
Pharmaceutical therapies in the absence of in vivo clinical data are unpredictable for the following reasons; (1) the protein may be inactivated before producing an effect, i.e. such as proteolytic degradation, immunological inactivation or due to an inherently short half-life of the protein; (2) the protein may not reach the target area because, i.e. the protein may not be able to cross the mucosa or the protein may be adsorbed by fluids, cells and tissues where the protein has no effect; and (3) other functional properties, known or unknown, may make the protein unsuitable for in vivo therapeutic use, i.e. such as adverse side effects prohibitive to the use of such treatment. See page 1338, footnote 7 of Ex parte Aggarwal, 23 USPQ2d 1334 (PTO Bd. Pat App. & Inter. 1992).
It is not readily apparent as to what components of the recited ECM may be used to perform the claimed method. While the "particulate material according to the present disclosure” appears to have some in vitro antiviral properties, the scope of the claim is far broader, encompassing any or all components of the ECM. Applicant presents no data as to which components of ECM may be used to perform the claimed method.
The claims also recite the properties of "directly contact[ing] the virus and inactivat[ing] at least a portion of a virus population of the subject, thereby reducing the viral load of the subject." However, Applicant's specification lacks any in vivo studies which demonstrate that the ECM is capable of coming into direct contact with a virus within a subject. There is no evidence to suggest that the claimed ECM is capable of performing the claimed function in the context of treating a subject that is infected with a virus. No guidance is given in the specification as to how this method may be performed, especially given the scope of viruses encompassed by the claims. There is no evidence to suggest that the claimed ECM is capable of performing the claimed function in the context of treating a subject that is infected with a virus. (For example, see Mok et al., Pharmaceutics. 2023 Mar 12;15(3):925 at page 18, second paragraph, cited previously.) An ex vivo culture assay cannot accurately replicate in vivo conditions for the purposes of viral inactivation.
Applicant's example in the specification relies upon in vitro cell culture tests to extrapolate broad antiviral activity for an in vivo treatment of a subject with a viral infection, which may be any enveloped virus, including SARS-CoV-2. As of the effective filing date of April 22, 2020, no treatment for SARS-CoV-2 infection was recognized by the FDA.
The examples performed in Applicant's specification describe only viral inactivation based upon administration of the claimed ECM to viral aliquot in serum-free media. The argument that an in vitro cell culture assay accurately replicates an in vivo treatment is unlikely, especially given the dosages described in the specification of 1 gram of material to 1 milliliter of viral sample. Such a treatment would require multiple kilograms of material, as the human body has about 5 liters of blood alone. This contrasts with the exemplary dosages cited in the specification at page 9 of 1-20 milligrams.
There is insufficient guidance and direction as well as objective evidence provided for treating the scope of diseases encompassed by the claimed method. In view of the lack of predictability of the art to which the invention pertains, undue experimentation would be required to practice the claimed method with a reasonable expectation of success, absent a specific and detailed description in Applicant's specification of how to effectively use the claimed agent and absent working examples providing evidence which is reasonably predictive that the claimed agent is effective, commensurate in scope with the claimed invention.
The guidance of the specification must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021). MPEP 2164.05. In view of the lack of working examples, the nature of the invention, the unpredictability of the art and the breadth of the claim scope, it would take undue trials and errors to practice the claimed invention.
Applicant argues that the Office has no evidence to support the assumption that the claims are not enabled, as there would have to be no virus present in the mucosa or in the bloodstream.
Applicant's arguments have been considered fully but are not found to be persuasive.
The claims are drawn to a "method of treating a subject to reduce a viral load of the subject". There is no evidence in the specification that shows that the claimed method would be successful in reducing the viral load of a living subject, as Applicant's experimental data is limited to in vitro assays. For example, according to Mok (Pharmaceutics. 2023 Mar 12;15(3):925 at page 18, second paragraph, cited previously), vitamin D is useful in cell-based assays against SARS-CoV-2, but does not provide a benefit in reducing viral titer in vivo.
Applicant has not demonstrated that the claimed compound would be able to meaningfully reduce viral load in vivo, in either the bloodstream or the mucosa. Nor has Applicant demonstrated that applying the claimed ECM would result in "directly contact[ing] the virus and inactivat[ing] at least a portion of a virus population of the subject, thereby reducing the viral load of the subject." As stated above, an ex vivo culture assay cannot accurately replicate in vivo conditions for the purposes of viral inactivation.
Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on Applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973). MPEP 2165.05. Applicant has not met this burden.
This rejection is therefore maintained and extended to include new claims 21-22.
Claims 1-2, 5-6, 8 and 11-13 were previously 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 amendments to the claim have addressed this issue, and this rejection is hereby withdrawn.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644