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
This office action is in response to applicant’s filing on July 28, 2023.
Status of Claims
Claims 1-4 are currently pending and are the subject of this office action.
Claims 1-4 are presently under examination.
Priority
This application is a continuation of US patent application 17/027,761 filed in September 22, 2020, which is a continuation of U.S. patent application serial no. 16/830,357 filed March 26, 2020, which is a continuation of U.S. patent application serial no. 16/287,201 filed February 27, 2019 (now U.S. patent no. 10,646,459), which is a divisional of U.S. patent application serial no. 16/017,345 filed June 25, 2018 (now U.S. patent no.10, 278,960), which claims the benefit of U.S. provisional patent application serial no. 62/524,221 filed June 23, 2017.
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 1-4 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1-4 recite a method of treating prostate cancer comprising the administration of a composition comprising ozanimod or a salt thereof.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
As illustrative of the state of the art regarding the treatment of prostate cancer in general, the Examiner refers to Lauer et. al. (Expert Opinion on Drug Discovery (2015) 10:81-89).
Lauer teaches that “while metastatic prostate cancer remains and incurable tumor, remarkable progress has been made with novel drug design strategies for this incurable disease” (see Introduction on page 81).
“Androgen deprivation therapy, whether surgical or medical, remains the mainstay of treatment to this day. Prostate cancer regularly develops treatment resistance and progresses despite androgen depletion, representing the state of castration-resistant prostate cancer (CRPC)” (See page 82, left column, second paragraph). Then, Lauer teaches the major drugs for the treatment of the different types of prostate cancer, none of which includes ozanimod (see section 2 through 8).
The authors conclude: “human prostate cancer is a prevalent disease with an inherent challenge for clinicians to determine what patients will require aggressive treatment versus patients that would benefit more from active surveillance without immediate treatment (see section 10, on page 86)
This article plainly demonstrates that the art of treating prostate cancer is extremely unpredictable.
Ozanimod (RPC1063) is a known Sphingosine-1-Phospahte receptor agonist (see for example instant specification [0006]) and a search of the literature revealed no association between ozanimod or Sphingosine-1-Phospahte receptor agonists and the treatment of prostate cancer
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work”.
The specification provides no data either in vitro or in vivo showing any efficacy in treating prostate cancer comprising the administration of ozanimod or a salt thereof.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art such as the pharmaceutical art in general, and the treatment of prostate cancer, is required for practice of the claimed invention.
5. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is a high unpredictability in the art of treating prostate cancer. Based on this and in the absence of experimental evidence commensurate in scope with the claims (see: 4. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept ozanimod, will be effective in treating GERD as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single experiment that shows or suggests any efficacy in treating prostate cancer comprising the administration of ozanimod.
So, determining is ozanimod, will be effective in treating prostate cancer, will require assaying ozanimod in an assay that correlates with the treatment of prostate cancer, and then further determine their efficacy in a validated animal model.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
6. Conclusion
Accordingly, the inventions of claims 1-4 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached on Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
November 25, 2025..