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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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 01/22/2024.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 04/29/2026 is acknowledged.
Claims 13-14 and 17-26 are being examined on the merits.
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 13-14 and 17-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating Asherman’s syndrome, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: Claim 13 recites a method of preventing Asherman’s syndrome comprising administering a pharmaceutical composition comprising isolated mitochondria as an active ingredient to a subject. There is no required administration route nor dose required for the prevention of Asherman’s syndrome. Additionally, there is no specific effective amount and no specific patient population.
For claim 13, there is no required administration route nor dose required for the prevention of Asherman’s syndrome, generally speaking of the knowledge to those skilled in the art, prevention would be difficult to achieve because Asherman’s syndrome happens when scar tissue develops generally from surgical procedures. Often, these procedures are necessary. So you can’t always prevent Asherman’s syndrome as discussed in the article by Cleveland Clinic (https://my.clevelandclinic.org/health/diseases/16561-ashermans-syndrome) and included in the file wrapper. Claim 14, addresses the administration routes however there is still no specific patient population or effective dose required and the administration route alone does not fix the issue with prevention.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The art is unpredictable as there are not many recorded successful preventative compositions for the prevention of Asherman’s syndrome let alone successful treatments.
The breadth of the claims. The scope of the claims are broad in the sense that there are no administration routes and dosage amounts that tie the administration to the activity noted in the specifications. Furthermore there is not required specific patient population such as those that would be Asherman’s syndrome patients or anyone in need of the therapy. It is also noted that there is no specific definition of the term “preventing” in the specifications, so it is given its broadest reasonable interpretation of stopping something from happening or arising (see Oxford dictionary, https://www.oed.com/dictionary/prevent_v?tab=meaning_and_use#28270689).
The amount of direction or guidance presented: The specification speaks to the treatment of Asherman’s syndrome however gives no guidance on prevention. There is no evidence that any administration of isolated mitochondria can prevent the disease. It is also not expected that any number of isolate mitochondria would be a successful treatment of the disease. Although newly amended claim 26 recites a broad range, this amount appears arbitrary and it is unclear how this range shows any efficacious treatment.
The presence or absence of working examples: The specification provides working examples for the treatment of Asherman’s syndrome in cell lines and in mice models however there appears to be no working equivalent to human treatments and preventions. The applicant describes “as a result, as shown in FIG. 25, when dead MT was injected, the fibrosis status was not reduced at all, but when live MT was injected, the fibrosis status was reduced. In addition, as shown in FIG. 26, it was confirmed that there was the fibrosis improvement effect depending on the injection dose. The injection dose was determined by quantifying the mitochondrial protein content as in Example 4.1” (see page 25). The applicant does not describe what the effective dose is. What amount is administered that achieved the results seen in the figures and what amount would be predicted to be the human equivalent?
The quantity of experimentation necessary: There may not necessarily need excessive amounts of experimentation necessary to determine if the composition can indeed prevent Asherman’s syndrome or for determining the effective amounts for effective treatment. However, the applicant has not provided this data and any examples that would enable persons skilled in the art to use the invention for preventing and effectively treating humans in need of Asherman’s syndrome. The dosages and routes of administration would indeed need to be determined and may also be different than that of what is needed to treat the symptoms.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide information sufficient to practice the claimed invention for preventing cadmium-induced toxicity in a brain and/or liver of a patient.
Examiner’s comment: It is suggested to amend the claims to recite a method of treating rather than a method of preventing Asherman’s syndrome. Additionally, amending the claims to recite specific patient populations other than the broad “subject” and to require effective dosages and/or ranges will help to overcome the rejection.
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 13, 17-20 and 22-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated CHA University Industry-Academic Cooperation (From IDS, KR20200049676A), hereinafter CHA.
Regarding claims 13, 17 and 19, CHA discloses administering (see claim 11) a pharmaceutical composition for the prevention or treatment of tendinitis comprising mitochondria as an active ingredient (see claim 1) and wherein the mitochondria are isolated from cells or tissues (see claim 2) and wherein the cells are stem cells, more specifically mesenchymal stem cells and embryonic stem cells (see claims 3 and 4).
Regarding claim 18, CHA discloses wherein the cells are somatic cells, germ cells or stem cells (see page 4, para. 5 or claim 3).
Regarding claims 20, CHA discloses that the mesenchymal stem cells may be any one selected from the group consisting of umbilical cord, cord blood, bone marrow, fat, muscle, nerve, skin, amniotic membrane and placenta (see claim 5 and page 4, para. 8).
Regarding claim 26, CHA discloses wherein the mitochondria may be included in the composition in amounts of 0.1 mg/kg (see page 5, para. 14) and this would be 0.1 ug/mL as claimed.
Regarding claims 22-25, pertaining to the limitations wherein the pharmaceutical composition reduces the expression of fibrosis factors, wherein the fibrosis factor is one or more selected from the group consisting of Colla1, Col3a1, Timp1, and Tgfp1, wherein the pharmaceutical composition increases the expression of one or more vascular endothelial cell markers selected from the group consisting of Hgf, Igfl, Angl, Vegf-A, Hifla, and Hif2a and wherein the Asherman's syndrome complication is one or more selected from the group consisting of intrauterine adhesion, leiomyoma of uterus, endometriosis, ectopic pregnancy, miscarriage, ovarian cystic tumor, menstrual disorder, infertility, sterility, pelvic adhesion, pelvic pain, and pelvic inflammatory disorder, these effects appear to be inherent to the administration of the isolated mitochondria as there was nothing done to the mitochondria except for the isolation and administration. The apparent effects are presumed to be from an effective dose which is not clear. However the Office assumes that the effective dose is within the amount claimed and thus the same administration of the same components at the claimed range would have the same effects. The patient population is not taught in the art; however the applicant merely claims administration of the isolated mitochondria to a subject for prevention of Asherman’s syndrome. Thus, any person receiving the administered composition would presumably have the claimed effect of prevention of Asherman’s syndrome.
A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. (See MPEP 707.07(f) and 2141.02 |; In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and MPEP 2111.02 Il; Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)). In this case the functional limitations have been met which is administering the isolated mitochondria and therefore the claims are anticipated.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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