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 .
DETAILED ACTION
The preliminary amendment filed 06/17/2024, cancelled claims 4, 6, 8-9, 12-13, 15-18, 23, and 27-160, and amended claims 11 and 20.
Claims 1-3, 5, 7, 10-11, 14, 19-22, and 24-26 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Claim Interpretation
The terms “preventing”/”prevention” and “treating”/”treatment” are interpreted as follows:
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(see [00106] of the instant specification).
Claim Rejections - 35 USC § 112(b)
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 1-3, 5, 7, 10-11, 14, 19-22, and 24-25 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.
-Claims 1, 5, 7, 10, and 19 recite “a composition comprising urolithin or an urolithin,” which renders the claim in definite. It is not clear what the difference between urolithin and an urolithin is, and the specification does not further define these terms. Moreover, in regard to “urolithin,” [00202] of the instant specification provides examples of “urolithin,” wherein ellagic acid, which is not urolithin, is exemplified as a urolithin. As such, the metes and bounds of the term “urolithin” and “an urolithin” are unclear.
In view of compact prosecution, for the purpose of applying prior art, “urolithin” and “an urolithin” are interpreted as compounds having the structure:
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, wherein A, B, C, D, W, X, Y, Z are H or OH.
-Regarding claims 2, 11, and 20, it is not clear how dialysis, which is a treatment in which a machine performs the natural filtering functions of the kidneys, is a disease or condition.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 7, 10-11, 19-22, and 25-26 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2018/162651 to Rinsch (published 2018, IDS).
Regarding claims 1, 10, 19, and 26, Rinsch teaches compounds of
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, such as urolithin A, for treating or preventing a muscle related disease, disorder, or condition (pgs. 96-100, claims 1, 10, 14, 24). Since the compound is used to treat a disease, it would necessarily be administered as a composition to a subject with a muscle related disease, disorder, or condition.
Regarding claims 1-3, 10-11, 19-21, and 26, Rinsch further teaches compounds of
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, such as urolithin A, for the treatment of diabetes; acute or chronic kidney failure, which Rinsch teaches as a chronic kidney disease (pg. 36, lines 22-26), and which is a late stage of chronic kidney disease (see [0007] of the instant specification); metabolic syndrome; muscle-wasting; muscle degenerative disease; age-related decline in muscle function; ICUAW, an ICU acquired weakness characterized by muscle weakness; muscle loss; a muscle function disorder; age-related muscle wasting; and muscle fatigue (pg. 98, claim 12). See also pg. 36, lines 21-end; pg. 41, line 19; pg. 42, line 29-pg. 43, line 15; pg. 52, Representative Examples; pgs. 54-56, Examples 1-3. Since the compound is used to treat a disease, it would necessarily be administered as a composition to a subject with the above recited diseases. Since the composition is administered to treat the recited diseases, the composition is administered in an effective amount to treat the disease.
Regarding claims 5, 14, and 22, Rinsch teaches oral and enteral administration (pg. 41, lines 5-pg. 42, line 5; pg. 100, claim 29).
Regarding claims 7 and 24, Rinsch teaches the compounds administered as a dietary, nutritional/health supplement, or as a food (pg. 97, claim 6).
Regarding claims 25-26, Rinsch teaches micronized urolithin A as a preferred embodiment of Formula (I) (pg. 42, lines 29-pg. 43, line 24; pg. 45, lines 16-23).
Regarding claims 10 and 19, the instant specification teaches patients with chronic kidney disease as patients in need of improving lean mass of muscle and in need of increasing albumin reabsorption ([0009], [0011]).
Regarding claims 10 and 19, while Rinsch does not explicitly teach its methods as improving lean muscle mass or increasing albumin reabsorption, it is reasonable to assume that the methods of Rinsch, would have the same properties since it administers the same compound, urolithins and specifically urolithin A, for the same purpose (treating kidney and muscle diseases, such as chronic kidney failure/disease and muscle wasting), in the same dosage amounts (Rinsch teaches ~1000mg and from 9-18 mg/kg/day (pg. 99, claims 17-18) and the instant specification teaches 0.2-150mg/kg ([00206])); to the same patient population as that taught by the instant specification and claims. As such, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
See also MPEP 2112.02, under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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