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 .
The most recent claim set, filed on Nov. 9, 2023, having claims 30-49, is examined on the merits below.
Priority
The application claims priority to provisional application 63/114.060, filed Nov. 16, 2020; as such the earliest possible priority is Nov. 16, 2020.
Information Disclosure Statement
The information disclosure statement filed May 12, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
(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.
Claim(s) 30, 31, and 33-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khan et al. (Scientific Reports, 2017, cited in IDS filed on May 12, 2023).
The claims are directed to methods of administering a therapeutically effective amount of a composition that includes a molecular weight fraction of a conditioned medium produced by culturing amnion-derived multipotent cells (ST266). Please note that it is understood that applicants intend to claim only the composition that is known as ST266, as they recite the manner in which ST266 is made (from a conditioned medium produced by culturing amnion-derived multipotent cells); use only ST266 in the claims after reciting the method of making it and labeling the composition as ST266 and, in the specification at para. [0004], they indicate that ST266 is commensurate in scope (equal to) the collected conditioned medium produced by cultured amnion-derived multipotent cells. (“Applicant has discovered and developed a conditioned medium produced by culturing amnion-derived cellular cytokine solution (ACCS), also referred to as ST266…”). A wherein clause in the claim indicate the weight fraction of the ST266 includes a <30 kDa, <50 kDa, 30-50 kDa, >30 kDa, or a >50 kDa molecular weight fraction. A second wherein clause indicates that the therapeutically effective amount stimulates Schwann cell proliferation, promotes neuroprotection, reduces demyelination, reduces retinal ganglion cell (RGC) loss reduces optic nerve inflammation or combinations of these.
With respect to claim 30, Khan et al. teach that intranasal delivery of ST266 prevent neuronal damage and preserves function in a mouse MS model. (Title, Abstract). Khan et al. teach that intranasal administration of ST266 prevented RGC death. (Abstract)
Khan et al. teach that ST266 stimulates Schwann cell proliferation and reduces RGC death in vitro. (Abstract, pg. 2, 2nd full para.) Khan et al. teach administration of the entire ST266 product (not a specific molecular weight fraction); however, the claims indicate that the composition comprises the claimed molecular weight fractions. Therefore, as the entirety of the ST266 composition was administered, the claimed weight fractions (and additional weight fractions) were administered and the claims use of comprising, which is open-ended, allows for additional elements (in this case, the rest of the ST266 composition) to be present.
With respect to claim 31, Khan et al. teach intranasal administration. (Title, Abstract).
With respect to claims 33-35, Khan et al. teach that ST266 (in its entirety) was administered intranasally and prevented RGC death (“reduces RGC loss”), as well as stimulating Schwann cell proliferation. (Abstract, pg. 2, 2nd full para.). As explained above, the use of the transition phrase “comprising” allows for other components to be present; as such administration of the entire composition of ST266 (which includes the <50 kDa molecular weight fraction) meets the claim limitation.
With respect to claim 36 and 37, Khan et al. teach intranasal administration of ST266 reduced optic nerve inflammation. (Abstract, pg. 5, “Therapeutic ST266 Administration Reduces Neuronal Damage and Reverses Dysfunction in EAE Optic Neuritis”). As explained above, the use of the transition phrase “comprising” allows for other components to be present; as such administration of the entire composition of ST266 (which includes the <50 kDa molecular weight fraction) meets the claim limitation.
With respect to claims 38-40, Khan et al. teach intranasal administration of ST266 promotes neuroprotection. (pg. 5, “Multiple Pathways Involved in ST266 Mediated Neuroprotection”). As explained above, the use of the transition phrase “comprising” allows for other components to be present; as such administration of the entire composition of ST266 (which includes the < 30 kDa, <50 kDa and > 50 kDa molecular weight fractions) meets the claim limitation.
With respect to claims 41-48, Khan et al. teach intranasal administration of ST266 reduces demyelination of the spinal cord. (Abstract, pg. 3, “Evaluation of Optic Nerve Inflammation and Demyelination”, “Evaluation of Spinal Cord Inflammation and Demyelination”; pg. 5, “Therapeutic ST266 Administration Reduces Neuronal Damage and Reverses Dysfunction in EAE Optic Neuritis”). As explained above, the use of the transition phrase “comprising” allows for other components to be present; as such administration of the entire composition of ST266 (which includes the < 30 kDa, <50 kDa and > 50 kDa molecular weight fractions) meets the claim limitation.
With respect to claim 49, Khan et al. teach that intranasal administration of ST266 stimulations Schwann cell proliferation, reduces optic nerve inflammation, promotes neuroprotection, and reduces demyelination. (Abstract, entire document) As explained above, the use of the transition phrase “comprising” allows for other components to be present; as such administration of the entire composition of ST266 (which includes the > 50 kDa molecular weight fraction) meets the claim limitation.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Khan et al. (Scientific Reports, 2017, cited in IDS filed on May 12, 2023), as applied to claims 30, 31, and 33-49 above, and further in view of Rahimpour et al. (J Heart Lung Trans, 2017).
Khan et al. teaches only intranasal administration, not systemic administration that is intravenous or intraperitoneal.
Rahimpour et al. teach that ST266 can be administered intraperitoneally to treat emphysema in mice. (Abstract).
It would have been obvious for one of ordinary skill in the art at the time of the invention to employ intraperitoneal administration in the method taught by Khan et al. because it would have been obvious to try different routes of administration, including systemic administration through intraperitoneal or intravenous administration as the person of ordinary skill would be choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. Substituting this administration route would have led to a reasonable expectation of success because Rahimpour et al. teach that systemic (intraperitoneal) administration of ST266 is possible for therapeutic treatment and it would have been obvious to try additional treatment methods (systemic intravenous or intraperitoneal, in place of intranasal) to determine if such administration could still target the neural system of the subject in question.
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634