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
This application has PRO 63/391,389 (07/22/2022)
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-30, in the reply filed on 2/19/26 is acknowledged.
Applicant also elected the species of eliglustat stated as reading on claims 1-30.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
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.
Claims 1-30 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 has the language “A method of treating a human papillomavirus (HPV)-related cancer” which is ambiguous as to whether the cancer need by caused by HPV or not. The specification provides examples of cancers, but does not clarify whether HPV causation is required. One of skill in the art would find the claim scope ambiguous as to whether treating a cancer such as head and neck cancer not caused by HPV by administering a GCS inhibitor would be within the scope of the claims. Therefore, the claim and those that depend therefrom are indefinite. Similarly, claim 26 has “HPV-associated disease” which is also not sufficiently defined.
For purposes of examination, the scope of cancers treated is interpreted as the examples in the specification regardless of origin.
Claims 3-7, 28-29 refer to “risk type” of HPV without providing a sufficient definition such that one of skill in the art would be able to unambiguously determine what the claim is referring to. Thus, the claims are indefinite.
Claims 12-14 uses the language “said protein is p16” or “E6 or E7 gene” without providing a sufficient definition such that one of skill in the art would be able to unambiguously determine what the claim is referring to without making assumptions regarding the claim scope. Thus, the claims are indefinite.
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.
(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, 8, 9, 18, 21, 22, 25, 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ranes et al. (British Journal of Cancer (2001) 84(8), 1107–1114).
Ranes teaches N -butyldeoxynojirimycin (aka miglustat) reduces growth and ganglioside content of mouse brain tumors (title, abstract) through administration of the inhibitor via chow (p. 1109) which anticipates claims 1, 8, 9, 18, 21, 22, 25, 26.
Claims 1, 8, 9, 18, 21, 22, 24-26, 30 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Guo et al. (US20250177367, at least earliest EFD of 2022-05-05).
Guo teaches treating cancer in a patient by administering the inhibitor eliglustat (claim 85). Guo teaches topical and intravenous administration ([0135])
Claim Rejections - 35 USC § 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 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.
Claims 1-26, 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Iglesias et al. (Cancer Chemother Pharmacol (2014) 74:809–817) in view of Zhao et al. (Clin Cancer Res; 24(11) June 1, 2018, p. 2700-2709), Roh et al. (Mol Cancer Ther (2015) 14 (8): 1907–1915).
Iglesias teaches administration of PDMP (an inhibitor of ceramide glycosylation) to cervical cancer cells had antiproliferative effects (abstract). Iglesias teaches that the effect of therapeutics depends on the type of HPV (p. 810: identifying HPV16 and 18 as MDR).
Iglesias does not teach treating a patient.
Zhao teaches miglustat (NB-DNJ) as being effective in treating HNSCC in HPV-positive cells (Abstract, p. 2707).
Roh teaches pharmacologic inhibition of GCS with agents such as PPMP sensitizes head and neck cancers to cisplatin (abstract).
One of ordinary skill in the art following the teaching of Iglesias regarding treating cervical cancer with a GCS would have considered the teaching of Zhao and Roh in the same field of endeavor and found the success with GCS inhibitors in treating cancer including HPV-related ones. In view of the success of each of the prior art references, one of ordinary skill in the art would have had a reasonable expectation of success in utilizing a GCS inhibitor, including miglustat, to treat cervical cancer caused by HPV16 or other HPV-related cancers and arrive at the claimed invention. Regarding claims further comprising detecting markers from a sample and diagnosis, one of ordinary skill in the art would have considered diagnosing a patient using known methods in the art including those as claimed.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Iglesias et al. (Cancer Chemother Pharmacol (2014) 74:809–817) in view of Zhao et al. (Clin Cancer Res; 24(11) June 1, 2018, p. 2700-2709), Roh et al. (Mol Cancer Ther (2015) 14 (8): 1907–1915) as applied to claims 1-26, 28-30 above and further in view of Hampson et al. (US20180161328).
Regarding claims 27, Iglesias does not teach treating a wart, however, Hampson teaches the treatment of cancer or proliferative disorders, warts, due to HPV (abstract). One of ordinary skill in the art following the combined teaching would have known that the treatment of the proliferative disorders related to HPV would include warts as demonstrated by Hampson and apply the combined teaching to arrive at the claimed invention with a reasonable expectation of success.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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