DETAILED ACTION
This action is in response to Applicant’s submission dated September 6, 2023, in which Applicant amended the specification.
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 references contained in the IDS dated September 6, 2023 are made of record.
Claim Rejections - 35 USC § 102
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 1-2, 5-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bevinaguddaiah, et al, Prader-Willi syndrome with Oculocutaneous Albinism: Anesthetic Implications and Management, Nat. J. Lab. Med., Vol. 3(2), pp. 13-15 (2014).
Regarding claim 1, Bevinaguddaiah, et al. teaches a method of treating a subject having a clinical condition associated with low circulating levels of testosterone (anesthetic management of a patient with Prader-Will syndrome; Abstract; see instant specification paragraph [0096], wherein Prader-Willi syndrome is a clinical condition associated with low circulating levels of testosterone), comprising: administering to the subject a therapeutically effective dose of sevoflurane (sevoflurane 1-3% with air-oxygen mixture was used for anesthetic maintenance; p. 14, left column, lines 4-5), thereby treating the clinical condition associated with low circulating levels of testosterone.
Regarding claim 2, Bevinaguddaiah, et al. teaches a method of claim 1, wherein the administration is via inhalation (sevoflurane 1-3% with air-oxygen mixture was administered with tracheal intubation; p. 13, right column, through p. 14, left column, first full paragraph).
Regarding claim 5, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose increases serum levels of testosterone in the subject from 1 day to 150 days after the administration of the therapeutically effective dose of sevoflurane, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 6, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose increases serum levels of testosterone by about 10% to about 350% within about 12 hours to about 96 hours following administration, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 7, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose increases serum levels of testosterone to about 270 ng/dL to about 1070 ng/dL within about 12 hours to about 96 hours following administration, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 8, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the administering comprises daily administration for about one day to about 10 days (sevoflurane 1-3% with air-oxygen mixture was used for anesthetic maintenance during the procedure, that is the drug was administered daily for one day; p. 14, left column, lines 4-5).
Regarding claim 9, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose is about 0.05 vol% to about 3 vol% when administered via inhalation (sevoflurane 1-3% with air-oxygen mixture was administered with tracheal intubation; p. 13, right column through p. 14 left column, first full paragraph).
Regarding claim 10, Bevinaguddaiah, et al. teaches a method of claim 9 and further regarding wherein the therapeutically effective dose is about 0.05 vol% to about 2 vol% when administered via inhalation (sevoflurane 1-3% with air-oxygen mixture was administered with tracheal intubation; p. 13, right column through p. 14 left column, first full paragraph).
Regarding claim 11, Bevinaguddaiah, et al. teaches a method of claim 9 and further regarding wherein the therapeutically effective dose is about 0.05 vol% to about 1 vol% when administered via inhalation (sevoflurane 1-3% with air-oxygen mixture was administered with tracheal intubation; p. 13, right column through p. 14 left column, first full paragraph).
Regarding claim 12, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the sevoflurane is administered via inhalation in oxygen (sevoflurane 1-3% with air-oxygen mixture was administered with tracheal intubation; p. 13, right column through p. 14 left column, first full paragraph).
Regarding claim 15, Bevinaguddaiah, et al. teaches a method of claim 1 and further regarding wherein the clinical condition associated with low circulating levels of testosterone is prolactinoma, presence of a pituitary tumor, Prader-Willi syndrome, or Kallmann’s syndrome (anesthetic management of a patient with , Prader-Willi syndrome is a clinical condition associated with low circulating levels of testosterone).
Claims 1-2, 5-10, and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Macksey, et al, Anesthetic Management in a Pediatric Patient with Noonan Syndrome, Mastocytosis, and von Willebrand Disease: A case report, AANA J., Vol. 75, No. 4, pp. 261-264 (2007).
Regarding claim 1, Macksey teaches a method of treating a subject having a clinical condition associated with low circulating levels of testosterone (anesthetic management in a patient with Noonan Syndrome; Title, Abstract; see instant specification paragraph [0095], wherein Noonan Syndrome is a clinical condition associated with low circulating levels of testosterone), comprising: administering to the subject a therapeutically effective dose of sevoflurane (inhalation induction was accomplished sevoflurane at 2% to 8%; p. 262, right column, first full paragraph), thereby treating the clinical condition associated with low circulating levels of testosterone.
Regarding claim 2, Macksey teaches the method of claim 1, further wherein the administering is via inhalation (inhalation induction was accomplished by sevoflurane at 2% to 8%; p. 262, right column, first full paragraph).
Regarding claim 5, Macksey teaches the method of claim 1, and further regarding wherein the therapeutically effective dose increases serum levels of testosterone in the subject from 1 day to 150 days after the administration of the therapeutically effective dose of sevoflurane, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 6, Macksey, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose increases serum levels of testosterone by about 10% to about 350% within about 12 hours to about 96 hours following administration, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 7, Macksey, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose increases serum levels of testosterone to about 270 ng/dL to about 1070 ng/dL within about 12 hours to about 96 hours following administration, the discovery of the previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old method new to the second inventor. Thus the claiming of a new use, new function, or previously unknown property, which is inherently present in the prior art method, does not necessarily make the limitation novel.
Regarding claim 8, Macksey, et al. teaches a method of claim 1 and further regarding wherein the administering comprises daily administration for about one day to about 10 days (inhalation induction was accomplished sevoflurane at 2% to 8%, that is the drug was administered daily for one day; p. 262, right column, first full paragraph).
Regarding claim 9, Macksey, et al. teaches a method of claim 1 and further regarding wherein the therapeutically effective dose is about 0.05 vol% to about 3 vol% when administered via inhalation (inhalation induction was accomplished sevoflurane at 2% to 8%; p. 262, right column, first full paragraph).
Regarding claim 10, Macksey, et al. teaches a method of claim 9 and further regarding wherein the therapeutically effective dose is about 0.05 vol% to about 2 vol% when administered via inhalation (inhalation induction was accomplished sevoflurane at 2% to 8%; p. 262, right column, first full paragraph).
Regarding claim 12, Macksey, et al. teaches a method of claim 1 and further regarding wherein the sevoflurane is administered via inhalation in oxygen (inhalation induction was accomplished with a 60% nitrous oxide, 40% oxygen mixture, and sevoflurane at 2% to 8%; p. 262, right column, first full paragraph).
Regarding claim 13, Macksey, et al. teaches a method of claim 1 and further regarding wherein the sevoflurane is administered via inhalation in a gas comprising about 50 vol% to about 80 vol% N2O and about 25 vol% to about 50 vol% O2 (inhalation induction was accomplished with a 60% nitrous oxide, 40% oxygen mixture, and sevoflurane at 2% to 8%; p. 262, right column, first full paragraph).
Regarding claim 14, Macksey, et al. teaches a method of claim 1 and further regarding wherein the clinical condition associated with low circulating levels of testosterone is Klinefelter’s Syndrome, Noonan Syndrome, testicular injury, or congenital anorchidism (anesthetic management in a patient with Noonan Syndrome; Title, Abstract).
Claim Rejections 35 U.S.C. § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Claims 1 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over KR 10-2016-0118844 (KAHN MEDICAL SCIENCE INSTITUTE, et al. (12 Oct. 2016) in view of Ju, et al., Intergenerational Effects of Sevoflurane in Young Adult Rats, Anesthesiology, Vol. 131, No. 5, pp. 1092-1109 (Nov. 2019).
Regarding claim 1, Khan teaches a method of treating a subject having a clinical condition associated with low circulating levels of testosterone (a method of alleviating late onset male hypogonadism; Abstract; see instant disclosure paragraph [0097], wherein late onset male hypogonadism is a clinical condition associated with low circulating levels of testosterone). Khan does not expressly disclose the method comprising administering to the subject a therapeutically effective dose of sevoflurane.
Ju; however, discloses that the administration of 6% and 2.1% sevoflurane increased serum testosterone levels in male rat models (p. 1093, right column, lines 1-12, p. 1102, left column, second full paragraph, and Fig. 5N).
It would be obvious to one of ordinary skill in the art at the time that the invention was made to modify Khan with the teaching of Ju for the purpose of using alternative drugs with serum testosterone increasing activity in the method of Khan. The motivation to do so being to use drugs known to raise serum testosterone levels in male rat models to treat diseases associated with low serum testosterone, including onset male hypogonadism, particularly since Khan teaches that compositions with such activity are useful in the treatment of the condition (Abstract, paragraphs {0045], [0102], [0104], and Table 8).
Regarding claim 16, modified Khan teaches the method of claim 1 and further regarding wherein the clinical condition associated with low circulating levels of testosterone is late-onset hypogonadism (a method of alleviating late-onset hypogonadism; Abstract, see instant disclosure paragraph [0097], wherein late onset male hypogonadism is a clinical condition associated with low circulating levels of testosterone).
The instant invention would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Claims 3 and 4 are rejected under 35 U.S.C. § 103 as being unpatentable over Bevinaguddaiah (see supra) in view of US 2018/0116997 A1 (The Regents of the University of California (03 May 2018).
Regarding claim 3, Bevinaguddaiah, et al. teaches a method of claim 2, but fails to explicitly disclose wherein the administration is via inhalation by a vaporizer.
US 2018/0116997 A1; however, discloses that anesthetics including sevoflurane (the anesthetic may be sevoflurane; paragraph [0141]) may be administered via inhalation by a vaporizer (the anesthetic compound will typically be vaporized using a vaporizer using a carrier gas; paragraph [0411]).
It would be obvious to one of ordinary skill in the art at the time that the invention was made to modify Bevinaguddaiah, et al. with the teaching of US 2018/0116997 A1 for the purpose of using known, conventional medical anesthetic equipment, i.e. a vaporizer. The motivation to do so being to use conventional techniques and equipment to safely and effectively induce and maintain anesthesia.
Regarding claim 4, Bevinaguddaiah, et al. teaches the method of claim 1, but fails to explicitly disclose wherein the administering is nasally.
US 2018/0116997 A1; however, discloses that anesthetics including sevoflurane (the anesthetic may be sevoflurane; paragraph [0141]) may be administered nasally (the compositions are delivered to the subject via a respiratory pathway, e.g., via inhalational, pulmonary, and/or intranasal delivery; paragraph [0410]).
It would be obvious to one of ordinary skill in the art at the time that the invention was made to modify Bevinaguddaiah, et al. with the teaching of US 2018/0116997 A1 for the purpose of using the conventional anesthesia administration technique, intranasal delivery. The motivation to do so being to use conventional techniques to safely and effectively induce and maintain anesthesia.
The instant invention would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932