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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 03/13/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/13/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/01/2026 is acknowledged.
Upon secondary consideration, the claims are being rejoined and being fully examined for patentability as searching did not prove to be burdensome for the examiner.
Claims 21-40 are being examined on the merits.
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.
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 21-24, 26-29, 34-35, 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et. al. (from IDS, Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis, Journal of Translational Medicine, Vol. 13, No. 49, 01 February 2015, 14 pages).
Regarding claims 21, 27, Zhang discloses administering rats with exosomes from induced pluripotent stem cell-derived mesenchymal stem cells (see page 3, right column 2nd para.) and administering to rats would also be administering to cells as rats are made of cells. Zhang teaches the structural components of the invention which is administering exosomes from induced-pluripotent stem-cell derived mesenchymal stem cells to cells and so the instant invention is anticipated even if the preamble is not specifically disclosed (a method for regulating ILK signaling pathway in a cell).
Regarding claims 22, 28, 34, 37, Zhang discloses passaging cells every 5-7 days and harvesting cells at passage 4 (see methods 1st-2nd para., page 2).
Regarding claims 23-24, 29, 35, and 38, Zhang discloses treating exosomes with fibroblasts at 100 ug/mL exosomes (see page 4, right column, 2nd para.), and Zhang discloses culturing HUVEC cells with 50 or 100 ug/mL of hiPSC-MSC-Exos and cultured for 4, 6 and 18 hours (see page 4, right column, para. 3).
Regarding claim 26, wherein ILK pathway activity of the cell is restored, the prior art discloses the same administration of the exact same component to cells which is required for the claimed effect and therefore the activity is inherent to the administration of the exosomes to cells.
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.
Claims 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et. al. (from IDS, Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis, Journal of Translational Medicine, Vol. 13, No. 49, 01 February 2015, 14 pages).
Regarding claims 21, 27, Zhang discloses administering rats with exosomes from induced pluripotent stem cell-derived mesenchymal stem cells (see page 3, right column 2nd para.) and administering to rats would also be administering to cells as rats are made of cells. Zhang teaches the structural components of the invention which is administering exosomes from induced-pluripotent stem-cell derived mesenchymal stem cells to cells and so the instant invention is anticipated even if the preamble is not specifically disclosed (a method for regulating ILK signaling pathway in a cell).
Regarding claims 22, 28, 34, 37, Zhang discloses passaging cells every 5-7 days and harvesting cells at passage 4 (see methods 1st-2nd para., page 2).
Regarding claims 23-24, 29, 35, and 38, Zhang discloses treating exosomes with fibroblasts at 100 ug/mL exosomes (see page 4, right column, 2nd para.), and Zhang discloses culturing HUVEC cells with 50 or 100 ug/mL of hiPSC-MSC-Exos and cultured for 4, 6 and 18 hours (see page 4, right column, para. 3).
Regarding claim 26, wherein ILK pathway activity of the cell is restored, the prior art discloses the same administration of the exact same component to cells which is required for the claimed effect and therefore the activity is inherent to the administration of the exosomes to cells.
Zhang does not specifically teach that the exosomes are administered to the patient at intervals of about 1 day to 7 days, however determining administration to be at intervals of about 1 to 7 days is common and conventional in the art and well within the purview of any skilled artisan. Furthermore, one would want to make sure the patient was getting continued treatment as the treatment is not noted as being a one-and-done curative type of treatment.
Regarding claim 33, pertaining to the diseases being abnormal or pathological angiogenesis, Zhang teaches “Our in vitro experimental results confirmed that hiPSC-MSC-Exos can increase proliferation, migration, and tube formation of HUVECs in a dose dependent manner. These data indicate that the formation of nascent and mature vessels during cutaneous wound healing may be due to the pro-angiogenic effect of hiPSCMSC-Exos.”
“We demonstrated that hiPSC-MSC-Exos exert beneficial effects on granulation tissue formation and angiogenesis, which are two critical phases of the wound-healing process, and that hiPSC-MSC-Exos facilitated a significant therapeutic effect during cutaneous wound healing. (see last para. before conclusion, and conclusion page 14).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the exosomes for ILK related pathway diseases such as abnormalities or pathologies with angiogenesis-related diseases, because that is what Zhang teaches them to be useful for, especially during wound repair.
There would have been a reasonable expectation of success in arriving at the instant invention given the prior art as the prior art teaches the structural components and limitations of the instant application. The activity noted from the instant application appears to be within the same effective amount taught in the prior art. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). In the instant case it appears to be a mechanism of action specifically to ILK pathways.
Conclusion
Currently no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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