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 .
Claims 1, 4-14, 16, 18-21, 24, 27 and 49 are presented for examination.
Applicants’ drawings filed April 20, 2023 have been received and entered.
Applicants’ information disclosure statements filed November 26, 2024 and November 11, 2025 have been received and entered.
Applicants’ election filed November 11, 2025 in response to the restriction requirement of September 19, 2025 has been received and entered. The applicants elected the invention described in claims 1, 4-14, 16, 18-21, 24, 27 and 49 (Group I) without traverse.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claims 20 and 49 are objected to as being dependent upon a rejected base claim.
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 8-11 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad terms: a mitochondrial disease, disorder, or condition, a metabolic disease, a neurodegenerative disease, cancer, a motor neuron disease, a cardiovascular disease, a neurobehavioral or psychiatric disease, and an autoimmune disease. The mere fact that Applicant may have discovered one type of mitochondrial disease, disorder, or condition treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of metabolic disease, disorder, or condition treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of neurodegenerative disease treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of cancer treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of motor neuron disease, treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of cardiovascular disease, treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of neurobehavioral or psychiatric disease treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The mere fact that Applicant may have discovered one type of autoimmune treated with administration of a 15-PGDH inhibitor is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 8-11 and 19 are not allowed.
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 12, 13, 18 and 19 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 12 is rendered indefinite by the phrase “the level of PGE2 in the tissue is increased to a level substantially similar to a level present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition”. The claim does not disclose what are the PGE2 levels present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition.
Claim 13 is rendered indefinite by the phrase “the level of PGE2 in the tissue is increased to a level within 50% of a level present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition”. The claim does not disclose what are the PGE2 levels within 50% present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition.
Claim 18 is rendered indefinite by the phrase “the decreased level of a PGE2 metabolite in the tissue that is substantially similar to a level present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition”. The claim does not disclose what are the decreased PGE2 levels present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition.
Claim 19 is rendered indefinite by the phrase “the level of PGE2 metabolite in the tissue that is substantially similar to a level present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition”. The claim does not disclose what are the PGE2 metabolite levels present in the same tissue of a subject not having the mitochondrial disease, disorder, or condition.
Claims 12, 13, 18 and 19 are not allowed.
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(s) 1, 4-7, 14, 16, 21 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al., “Inhibition of the prostaglandin-degrading enzyme 15-PGDH potentiates tissue regeneration”, Science, Vol. 348, Issue No. 6240, pages 1223 and aaa2340-1 to aaa2340-8 (Reference #250 of PTO-1449).
Zhang et al. teaches accelerated tissue regeneration with an inhibitor of 15-PGDH, SW033291 (a small molecule compound)(see the abstract). Note the types of tissues accelerated are bone (bone marrow transplant), liver (after hepatic surgery), and colon (prevents ulcerative colitis). Clearly, the administration of an inhibitor of 15-PGDH increases mitochondrial biogenesis and/or mitochondrial function in a tissue of a subject.
As to the modulating or more energy biomarkers, normalizing one or more energy biomarkers, and enhancing one or more energy biomarkers, a product of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 709, 15 USPQ 2d 1655, 1658 (Fed. Cir. 1990)). In the instant application, the aforesaid inhibitor of 15-PGDH modulates, normalizes, and enhances one or more biomarkers is anticipated by Zhang et al. since the active agent (inhibitor of 15-PGDH) possesses the same identical chemical structure and function.
As to the reducing or blocking15-PGDH expression and/or reducing or blocking enzymatic activity, a product of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (see In re Spada, 911 F.2d 705, 709, 15 USPQ 2d 1655, 1658 (Fed. Cir. 1990)). In the instant application, the aforesaid inhibitor of 15-PGDH reduced or blocks 15-PGDH expression and/or reduces or blocks enzymatic activity of 15-PGDH is anticipated by Zhang et al. since the active agent (inhibitor of 15-PGDH) possesses the same identical chemical structure and function.
Clearly, the cited reference anticipates the applicants’ instant invention; therefore, applicants’ instant invention is unpatentable.
Claims 1, 4-7, 14, 16, 21 and 27 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629