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 .
Status of the Claims
Applicant’s preliminary submission filed 12 May 2026 has been entered. Claims 2-4, 6-8, and 19 are pending. Claims 2-4 and 6-8 have been amended, while claims 1, 5, and 9-18 have been cancelled without prejudice or disclaimer and claim 19 has been newly added. Therefore, prosecution on the merits commences for claims 2-4, 6-8, and 19. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 3-4, 9, and 14
The cancellation of claims 9 and 14 renders the objections of those claims moot. For the remaining claims, Applicant’s amendments to each of instant claims 3-4 obviate the objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 5, 10, and 15 under 35 USC 112(b)
The cancellation of claims 5, 10, and 15 renders the rejections of those claims moot. Therefore, the rejections are withdrawn.
RE: Rejection of claims 1-4, 8-9, 13-14, and 18 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Qin et al
The cancellation of claims 9, 13-14, and 18 renders the rejection moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 2 requiring the pharmaceutical composition to comprise chorion membrane extract-derived extracellular vesicles at a concentration of 1x1010 to 1x1012 particles per well of a 24 well-plate obviate the rejection of record, as it is a newly presented limitation that has not been considered.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-6, 8-11, 13-16, and 18 under 35 USC 103 over Qin et al
The cancellation of claims 5, 9, 13-14, and 18 renders the rejection moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 2 requiring the pharmaceutical composition to comprise chorion membrane extract-derived extracellular vesicles at a concentration of 1x1010 to 1x1012 particles per well of a 24 well-plate obviate the rejection of record, as it is a newly presented limitation that has not been considered.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-18 under 35 USC 103 over Qin et al in view of Song et al
The cancellation of claims 5, 9, 13-14, and 18 renders the rejection moot for those claims. For the remaining claims, Applicant’s amendments to independent claim 2 requiring the pharmaceutical composition to comprise chorion membrane extract-derived extracellular vesicles at a concentration of 1x1010 to 1x1012 particles per well of a 24 well-plate obviate the rejection of record, as it is a newly presented limitation that has not been considered.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as written:
Applicant has traversed the rejection, asserting on Page 6 of the Remarks filed 12 May 2026 that the claimed treatment method exhibits the advantages of a significantly increased ALP activity, and better osteogenesis-promoting effects when compared to amnion membrane extract and a mixed amnion/chorion extract. In response, the Examiner respectfully reminds Applicant that when submitting evidence asserted to establish unobvious results, there is a burden on Applicant to indicate how the examples asserted to represent the claimed invention are considered to relate to the examples intended to represent the prior art and, particularly, to indicate how those latter examples do represent the closest prior art. The evidence relied upon should also be reasonably commensurate in scope with the subject matter claimed and illustrate the claimed subject matter relative to the prior art subject matter. See MPEP § 2145. It should also be established that the differences in the results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP § 716.02(b). In the instant case, Applicant has failed to indicate how the alleged unexpected results differ from the closest prior art.
Applicant has further traversed the rejection, asserting in Pages 6-7 that a person of ordinary skill would not have had a reasonable expectation of success in combining Song et al with a reference that teaches a chorion extracellular vesicle composition. In response, the Examiner respectfully submits that Song et al disclose a pharmaceutical composition that comprises an extract from postnatal tissues, including chorion membranes. Therefore, the ordinary artisan would have recognized that chorion membrane-derived extracellular vesicles can also be utilized with the HA/bTCP scaffolds of Song et al.
New Grounds of Rejection
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 2-4, 6, 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2019/0000886 A1) in view of Traweger et al (US 2019/0328792 A1) as evidenced by ThermoFisher Scientific (Useful Numbers for Cell Culture, 2015).
Ross is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Traweger et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claims 2-4: Ross discloses methods and pharmaceutical compositions for enhancing osteochondral tissue, so that osteochondral defects may be repaired by the body and/or prevented or lessened (Abstract).
As such, Ross discloses a method of treating osteoporosis in a subject, wherein a membrane-enclosed vesicle composition is administered to the subject (Paragraphs [0027], [0086]). Ross further discloses that the membrane-enclosed vesicle composition is a pharmaceutical composition comprising membrane-enclosed vesicles, including exosomes derived from chorion membrane mesenchymal stem cells (Paragraphs [0076]-[0077], [0079]-[0080], [0084], [0088], [0091], [0094], [0101]).
Ross further discloses that the membrane-enclosed vesicle composition is administered to the subject in a therapeutically effective amount (Paragraphs [0033]-[0038], [0097]).
Ross does not disclose that the therapeutically effective amount of the membrane-enclosed vesicles is 1x1010 to 1x1012 particles per well of a 24 well-plate, as required by instant claim 2.
Traweger et al, however, disclose pharmaceutical compositions comprising mesenchymal stem cell-derived extracellular vesicles for the treatment of bone defects, including osteoporosis (Abstract; Paragraphs [0007]-[0008], [0023], [0041]-[0042], [0083], [0139], [0160]-[0170], [0177], [0228]). Traweger et al further disclose that the extracellular vesicles are present in the pharmaceutical composition at a concentration between about 1×109 to about 1×1012 particles per mL (Paragraphs [0205], [0207], [0217], [0299]).
It is of note that the working volume of a 24-well plate is 1 mL, as evidenced by Page 1 of the ThermoFisher Scientific reference.
Therefore, it would have been prima facie obvious to have modified the treatment method of Ross such that the pharmaceutical composition comprises between about 1×1010 to about 1×1012 particles per mL of exosomes, as detailed in Traweger et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to administer a therapeutically effective amount of exosomes in order to induce bone formation, and would have had a reasonable expectation of success given that the disclosures of Ross and Traweger et al are both concerned with the treatment of osteoporosis with MSC-derived extracellular vesicles. See MPEP § 2143(I)(G).
Consequently, Ross as modified by Traweger et al as evidenced by ThermoFisher Scientific render obvious a method of treating osteoporosis (claim 3), wherein a pharmaceutical composition comprising between about 1×1010 to about 1×1012 particles per mL of chorion membrane mesenchymal stem cell-derived exosomes (claim 4) to a subject in need thereof. As the working volume of a 24-well plate is 1 mL, this therefore renders obvious the method of instant claim 2. See MPEP § 2144.05.
Regarding claim 6: Following the discussion of claim 2, Ross further discloses that the exosomes have a diameter of about 100 nm to 150 nm (Paragraphs [0069], [0077], [0092], [0101]). This therefore reads on the method of the instant claim.
Regarding claim 8: Following the discussion of claim 2, Ross further discloses that the pharmaceutical composition is a formulated as a solid dosage form, a cream, an aqueous mixture, or a lyophilized aqueous mixture (Paragraph [0102]). This therefore reads on the method of the instant claim.
Regarding claim 19: Following the discussion of claim 2, Traweger et al further disclose that the extracellular vesicles allows for the differentiation of MSCs into osteoblasts (Paragraphs [0228], [0393]). This therefore renders obvious the method of the instant claim for the same reasons as discussed in the rejection of claim 2.
Claims 2-4, 6-8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ross (US 2019/0000886 A1) in view of Traweger et al (US 2019/0328792 A1) as evidenced by ThermoFisher Scientific (Useful Numbers for Cell Culture, 2015), and further in view of Song et al (WO 2017/222111 A1, as translated by Espacenet, of record).
The discussion of Ross in view of Traweger et al as evidenced by ThermoFisher Scientific regarding claim 2 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Ross in view of Traweger et al as evidenced by ThermoFisher Scientific render obvious claims 2-4, 6, 8, and 19. Song et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 7: As aforementioned in the discussion of claim 2 above, Ross as modified by Traweger et al as evidenced by ThermoFisher Scientific render obvious a method of treating osteoporosis, wherein a pharmaceutical composition comprising between about 1×1010 to about 1×1012 particles per mL of chorion membrane mesenchymal stem cell-derived exosomes to a subject in need thereof.
The combination of Ross and Traweger et al fail to teach that the pharmaceutical composition is mixed and used with a hydroxyapatite/β-tricalcium phosphate (HA/bTCP) scaffold, as required by instant claim 7.
Song et al, however, disclose a pharmaceutical composition for the prevention or treatment of osteoporosis comprising an extract from postnatal tissue, including from the chorion membrane (Pages 1-3, 7). Song et al further disclose that the pharmaceutical composition can also comprise a HA/bTCP support (Pages 3-4).
Therefore, it would have been prima facie obvious to have modified the treatment method of Ross as modified by Traweger et al as evidenced by ThermoFisher Scientific such that the pharmaceutical composition further comprises a HA/bTCP scaffold, as detailed in Song et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to include the HA/bTCP scaffold, as it allows for an increased bone regeneration efficiency when combined with the pharmaceutical composition (Song et al: Page 4), and would have had a reasonable expectation of success given that the disclosures of Ross, Traweger et al, and Song et al are all concerned with the treatment of osteoporosis via the administration of a pharmaceutical composition comprising a chorion membrane extract. See MPEP § 2143(I)(G).
Consequently, Ross as modified by Traweger et al and Song et al render obvious a treatment method wherein the pharmaceutical composition comprises chorion membrane mesenchymal stem cell-derived exosomes and a HA/bTCP scaffold. This therefore renders obvious the method of the instant claim.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
Prosecution Insights