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 04/18/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2024 and 08/05/2024 are being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/07/2026 is acknowledged. The applicant has not articulated any reason for the traversal of the election/restriction and so the response is considered incomplete.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/07/2026.
Claims 1-8 are being examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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. Claim 1 recites PEP and this abbreviation can have many different interpretations/meanings making the claim indefinite. The claim should spell out each word for clarification. The specifications do not define the term and therefore the limitation is indefinite.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
Claim 1-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saribas (from IDS-08/05/2024, Effects of uterus derived mesenchymal stem cells and their exosomes on asherman’s syndrome, Acta Hsitochemica, 122 (2020) 151465).
Regarding claims 1 and 3 , Saribas discloses isolating exosomes from cultured mesenchymal stem cells and administering at 25ug in 100 ul PBS to each uterine horn (see 2.5 page 3) and with the broadest reasonable interpretation this would imply purified because if the exosomes are isolated then they are found separated from everything else, hence being isolated.
Saribas discloses “We conclude that all of the histomorphologic damages of the typical Asherman’s syndrome were observed in the created Asherman’s model and those damages were then observed to be restored in the treatment groups. The expression of CD31 and VEGFR-1 in the Ash+uMSCs group was higher than in the Ash+uMSCs-Exo group; that the tissue repair process has not been completed yet. Although the process was not completed, the results were reflected in the morphological findings. The fact that the expression of CD31 and VEGFR-1 in the Ash+uMSCs Exo group was less than the Ash+uMSCs group indicates that this group has completely completed the vascularization process. As a result, exosomal administration improved the damage of Asherman’s syndrome better than the stem cell administration” (see 2nd para., page 10).
Regarding claims 2, 4-5 and 7, Saribas discloses “before setting up the experimental groups, 2 female wistar albino rats were used to establish and verify the Asherman’s syndrome rat model. Under the anesthesia, a vertical incision was made in the abdominal wall of the rats and the uterus was exposed. A small incision was made in each uterine horn at the utero-tubal junction and the horn traumatized in a standardized fashion using 18 Gauge needle inserted thirds of the way through the lumen, rotated and withdrawn four times (Fig. 1). Following trauma, the uterus was placed in the abdomen and the abdomen was closed with suture material” (see 2.1, page 2).
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 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over (from IDS-08/25/2024, WO2019118817) and Saribas (from IDS-08/05/2024, Effects of uterus derived mesenchymal stem cells and their exosomes on asherman’s syndrome, Acta Hsitochemica, 122 (2020) 151465).
Regarding claim 1, Behfar teaches a purified exosome product comprising spherical or spheroid exosomes having a diameter no greater than 300 mm (see claim 1) and teaches their administration (see lines 7-22, page 15).
Behfar teaches “FIG. 9 shows phase, immunofluorescence and graphical depiction of skeletal muscle satellite cells grown in the presence of PEP. Here, a low confluence of satellite cells demonstrated the capacity for proliferation into myoblasts, myocytes (MyoD+) and ultimately organized into functional myotubes (Actinin+). In FIG. 10, these findings are further supported by a head-to head comparison of PEP with other growth conditions such as FBS (or PRP and Platelet lysate not shown) where satellite cells cannot be coaxed to yield functional tissue. In FIG. 11, further demonstration of this paradigm was provided with in vivo testing of collagen matrices either engrafted alone or following PEP enrichment. FIG. 11 A and FIG. 11B document that in the PEP enriched conditions, there is robust evidence for skeletal muscle generation as early as two weeks with full thickness restoration of muscle content noted at eight weeks. This regenerative response was not seen in the control (collagen only) group. These data provide the rationale behind the use of a PEP enriched environment to induce regeneration of tissues enriched with progenitors such as the skin, skeletal muscle (including the pharynx/larynx, urinary and anal sphincter, and diaphragm along with those associated with the musculoskeletal system), tissues with smooth muscle including the gastrointestinal tract, vagina, bladder, uterus and other structural organs” (see pages 18-19, lines 20-30 and lines 1-4). Furthermore, Behfar teaches intrauterine administration and to the mucosal surface (see page 12, lines 27-30). Therefore, this indicates an amount of PEP which can be used for treating tissues within the mucosal lining of the uterus.
Bhefar teaches “the presence of both of these populations in PEP allows for appropriate induction of cell growth for healing, but prevents uncontrolled growth” (see lines 14-15, page 5) and teaches the delivery of PEP for either in the setting of injury or to prevent organ injury (see lines 22-23, page 21).
Behfar does not specifically teach that the subject has Asherman’s Syndrome.
Saribas discloses isolating exosomes from cultured mesenchymal stem cells and administering at 25ug in 100 ul to each uterine horn (see 2.5 page 3) and with the broadest reasonable interpretation this would imply purified because if the exosomes are isolated then they are found separated from everything else, hence being isolated.
Saribas discloses “We conclude that all of the histomorphologic damages of the typical Asherman’s syndrome were observed in the created Asherman’s model and those damages were then observed to be restored in the treatment groups. The expression of CD31 and VEGFR-1 in the Ash+uMSCs group was higher than in the Ash+uMSCs-Exo group; that the tissue repair process has not been completed yet. Although the process was not completed, the results were reflected in the morphological findings. The fact that the expression of CD31 and VEGFR-1 in the Ash+uMSCs Exo group was less than the Ash+uMSCs group indicates that this group has completely completed the vascularization process. As a result, exosomal administration improved the damage of Asherman’s syndrome better than the stem cell administration” (see 2nd para., page 10).
Regarding claims 2, 4-5 and 7, Saribas discloses “before setting up the experimental groups, 2 female wistar albino rats were used to establish and verify the Asherman’s syndrome rat model. Under the anesthesia, a vertical incision was made in the abdominal wall of the rats and the uterus was exposed. A small incision was made in each uterine horn at the utero-tubal junction and the horn traumatized in a standardized fashion using 18 Gauge needle inserted thirds of the way through the lumen, rotated and withdrawn four times (Fig. 1). Following trauma, the uterus was placed in the abdomen and the abdomen was closed with suture material” (see 2.1, page 2).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to administer the composition taught by Behfar and/or Saribas for to subjects with Asherman’s Syndrome because purified exosomes are known for treating uterine tissues. It would also have been obvious to administer the purified exosome product prior to uterine surgery or in preparation to a procedure such as in vitro fertilization, because Behfar teaches the composition of PEP allows for appropriate induction of cell growth for healing, but prevents uncontrolled growth and teaches them to be useful in preventing organ injury.
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 BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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