DETAILED ACTION
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
The instant application is a continuation-in-part of application 15/547,069 (now US 11,326,210) filed 28 July 2017 which is the national stage entry of PCT/IB2016/050495 filed 1 February 2016. Acknowledgement is made of the Applicant’s claim of domestic priority to provisional US application 62/110,153 filed 30 January 2015.
Election/Restrictions
Applicant’s election without traverse of Group I towards a method of treatment in the reply filed on 20 January 2026 is acknowledged. The Applicant has corrected a typographical error in the remaining claims, thus no claims are withdrawn. Acknowledgement is made of the Applicant’s election of the following species of compound of claim 1.
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Status of the Claims
Claims 1-16 are pending.
Claims 1-16 are rejected.
Claim Objections
Claim 5, 9, and 13 are objected to because of the following informalities: The term “fluromethyl” is misspelled. Claims 5 are 13 are missing a period at the end of the claim. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: The structures in claim 1 are largely unreadable and should be corrected.
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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-AlIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Instant claim 1 recites a method for “treating or preventing condition in a subject” The generic term "condition" encompass a potentially large groups of diseases; there is no disclosure of this term that would permit the determination of which compounds are within the scope of these compounds or which properties, if any, are required to satisfy the limitation, etc. A review of the disclosure identified no reduction to practice of treating any and all conditions with the claimed structures. The disclosure contains insufficient written description to demonstrate applicant was in possession of the genera of "conditions" to be treated by the claimed compounds; furthermore, the description does not place the public in possession of any of these generic groups of compounds. As such, claims 1-16 are rejected as lacking written description.
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inhibiting the androgen signaling pathway, does not reasonably provide enablement for “treating or preventing condition in a subject” or for the “treatment or prevention of cancer” or the alternative diseases listed in instant claims 6 and 14. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The specification does not reasonably provide enablement for prevention of any “condition” or, in particular, cancer and for treatment of any and all cancers in a patient by administration of the compounds of instant claim 1. The skilled artisan cannot envision the prevention of cancer in all patients, for example, and the instant specification provides no evidence or data to support prevention. Prevention involves "attacking" the underlying cause of the cancer; i.e., disrupting the mechanisms which give rise to it. The skilled artisan is aware that the causes of cancer were not fully known at the time of the invention herein. For purposes of enablement, the specification must provide reasonable detail in order for those skilled in the art to carry out the invention. In this case, the specification must disclose a means of preventing cancer regardless of the underlying causes thereof. The teachings of the specification do not enable a person of ordinary kill in the art to make and use the claimed composition for cancer prevention. Moreover, "[p]atent protection is granted only in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Genentech Inc. v. Novo Nordisk AIS, 108 F.3d at 1366, 42 USPQ2d at 1005 (Fed. Cir.), cert. denied, 118 S. Ct. 397 (1997), ("Tossing out the mere germ of an idea does not constitute an enabling disclosure").
Reasonable guidance with respect to preventing cancer relies on quantitative analysis from defined populations which have been successfully pre-screened and are predisposed to particular types of cancer. This type of data might be derived from widespread genetic analysis, clusters, or family histories. The essential element towards the validation of a preventive therapeutic is the ability to test the drug on subjects monitored in advance of clinical disease and link those results with subsequent histological confirmation of the presence or absence of disease. This irrefutable link between antecedent drug and subsequent knowledge of the prevention of the disease is the essence of a valid preventive agent. The instant application does not provide any data suggesting or proving that the claimed composition can prevent cancer in patients. In the absence of data suggesting that the claimed method could be used to prevent and treat every form and type of cancer, claims 6 and 14 are not fully enabled. Similarly, since the term “condition” in claim 1 is not defined, claims 1-16 are also not enabled.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation ( United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). These factors include the following:
Scope or breadth of the claims
The claims are broader in scope than the enabling disclosure. The specification does not provide evidence or data that the instant composition can reasonably prevent any disease, let alone cancer. As no data is provided, the specification cannot be relied upon to show enablement of the claimed composition for preventing cancer.
Nature of the invention
The nature of the invention is directed to a method of treating or preventing “condition” in a subject and also a method of treating or preventing cancer, along with other diseases, by administering a compound recited in claim 1.
Relative level of skill possessed by one of ordinary skill in the art
The relative level of skill possessed by one of ordinary skill in the art of medical research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess an Ph.D. in a scientific discipline such as organic synthetic chemistry, polymer chemistry, medicinal chemistry, biochemistry, pharmacology, biology or the like.
State of, or the amount of knowledge in, the prior art
It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved," and physiological activity relating to the treatment or prevention of cancer is generally considered to be an unpredictable factor. Unpredictability in treating and preventing cancer generally is established by the following references:
1) ACS (2009) teaches that cancers are caused by a multitude of sources such as cigarette smoke, UV rays from the sun, food, lack of nutrition and exercise, and infectious diseases (pg 1). While risk factors can be reduced or avoided, cancer as a whole cannot be prevented (pg 1).
2) Sausville et al. (Cancer Res. 2006, 66, 7, 3351-3354) teaches that mouse models of cancer have consistently been used to qualify new anticancer drugs for study in human clinical trials (abstract). It is further noted that their value in predicting clinical results remains poor and, as such, said data can be useful although not absolutely predictive of behavior in the clinic (abstract). Accordingly, Sausville casts doubt on the ability of mouse models to accurately predict anti-cancer behavior in humans.
3) Suggitt et al. (Clin. Can. Res. 2005, 11, 971-981) casts doubts on the predictability of cancer treatment models by suggesting that the number of anticancer agents that fail in the clinic far outweighs those considered effective based on preclinical models (abstract).
4) Yusuf et al. (Curr. Cancer Drug Tar. 2003, 3, 1-19) teaches that paclitaxel, which is suitable for treating several types of cancer, has been met with increasing resistance (abstract). For example, it was noted that the presence of a particular type of gene (MDR-1) causes said resistance and as such treatment with paclitaxel would not be effective (pg 2, col 2). To date, reversal of paclitaxel has yielded disappointing results indicating that either alternative treatments are needed or agents that can reverse the resistance need to be discovered (pg 11, conclusion).
Level or degree of predictability, or a lack thereof, in the art
The art teaches that many different pathways, molecular targets, and stimuli contribute to the prevalence of cancer. Moreover, it is shown that cancer cannot be prevented but merely treated and the risk factors reduced. In addition, it is shown that known anti-cancer drugs may treat some forms of cancer but not necessarily all forms, such as the case with paclitaxel and emerging resistance. As such, the art teaches that many unrelated pathways contribute to general inflammation rendering preventing inflammation as a whole as nearly impossible.
Amount of guidance or direction provided by the inventor
The Applicant was required to provide in the specification additional guidance and direction with respect to the use of the claimed subject matter in order for the application to be enabled with respect to the full scope of the claimed invention. However, the Applicant has not provided guidance on how to use their claimed invention to prevent cancer or to simply treat all forms thereof. Moreover, Applicant has also not provided guidance on how to use their invention for the treatment or prevention of “condition.”
Presence or absence of working examples
The specification fails to provide scientific data and working embodiments with respect to all forms of cancer that will work in this invention. The specification does provide data for the inhibition of the androgen signaling pathway (see Figure 3) but provides no further explanation of said inhibition or details on treating other diseases. No additional compounds or cell lines are tested nor is any data provided with in vivo testing results.
Quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure
One of ordinary skill in the art would have to conduct a myriad number of experiments comprising picking and choosing different cancer cell lines, administering the claimed invention in all its embodiments, and testing for efficacy. The art teaches that cancer is unpreventable and that not all cancer drugs can treat all forms of cancer. Cancer is a complicated disease with many known causes and mechanisms. Therefore, in view of the Wands factors discussed above, to prevent cancer or to treat it by using the claimed compound a person of skill in the art would have to engage in undue experimentation, with no assurance of success. Similarly, without further definition or guidance, the skilled artisan would have to engage in undue experimentation to determine how to treat or prevent “condition” in a subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-9, and 11-12 of copending Application No. 17/672,693 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘693 application is a method of treating or preventing cancer in a subject by administering an agent that includes some of the agents in the instant claims including, but not limited to, the trifluoro compound on page 10 of the ‘693 patent which mirrors the same compound on page 5 of the instant claims. The modifications to the composition in the method of ‘693 track with the dependent claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 17/679,073 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘073 application is a method of treating or preventing cancer in a subject by administering an agent that includes some of the agents in the instant claims including, but not limited to, the cyclopropyl compound in the first row of claim 1 of the ‘073 patent which mirrors the same compound on page 5 of the instant claims. The modifications to the composition in the method of ‘073 track with the dependent claims of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613