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 .
Status of Claims
Claims 1-20 are pending in the instant application.
Information Disclosure Statement
Applicant has submitted no Information Disclosure Statement (IDS) with this application. Applicant is reminded per 37 CFR 1.56, “Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability …”
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
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 1-20 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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the invention:
The invention is drawn to a method of treating a skin condition comprising applying a skin cream containing YEL002 to the skin condition.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to the treatment of any skin condition. This can cover an array of skin conditions, both presently known, and conditions discovered years from now that are later classified as skin conditions. Further, as the method is drawn to the administration of a cream comprising YEL002, this allows for a myriad of additional compositional ingredients, including those with a therapeutic benefit. This could encompass numerous compositions, provided YEL002 is included as a component.
State of the prior art:
The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F. 2d 833, 839, 166, USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
At Page 7, Paragraph 0018 of the instant specification, Applicant discloses exemplary embodiments of skin creams suitable for use according to the instantly claimed invention.
Beginning at Page 8, Paragraph 0021 of the instant specification, Applicant states, “With use, the skin cream described herein has been shown and/or is believed to protect the skin against ionizing radiation, UV, chemical carcinogens, chemical warfare agents, radioactive iodine and cigarette smoke. Notably, the skin cream described herein has also been shown to heal psoriasis, keratosis, eczema, inflammation, of the face and toes, acne, precancerous skin lesions, sunburn, scars, discolored skin patches, to stop itching from insect and tick bites, and help prevent skin cancer.” Further, at Paragraph 0021, Applicant reports “initial results with use of the cream described herein show improvement for ten patients from keratosis, three patients from psoriasis, two patients from eczema, one patient from inflammation of the face, three patients from inflammation of the toes, five patients from skin wrinkling, one patient from sunburn, two patients from scarring, three patients from discolored patches, one patient from precancerous lesions, and three patients from itching due to insect and tick bites.”
No data has been provided, however, demonstrating the veracity of these statements. Further, Applicant has not disclosed the methods by which the cream was administered, nor has the Applicant disclosed any details on how the efficacy of the administration of the cream was evaluated. The evidence provided in the instant disclosure is anecdotal and/or speculative, and does not instruct a person having ordinary skill in the art in a manner to understand how to use the instantly claimed invention.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As referenced above, a person having ordinary skill in the art would need not only to identify suitable protocols for evaluating the efficacy of administering a cream comprising YEL002 for the treatment of a skin condition, but then also to employ these metrics, with no assurance of success.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
The specification fails to provide enough support for the broadly claimed method of treating a skin condition.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of the claimed method of treating a skin condition, with no assurance of success.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schiestl et. al. (US 9,045,474 B2; hereinafter referred to as Schiestl).
At Column 4, Line 55, Schiestl teaches YEL002 as the compound having the formula IA. At Column 13, Line 63, Schiestl teaches that Formula IA is also described as Yel002 or Rad2.
At Column 2, Lines 21-25, Schiestl teaches a compound effective for mitigating tissue damage. At Column 5, Lines 30-31, Schiestl teaches the tissue damage can be induced by radiation of any kind.
At Column 33, Lines 22-26, Schiestl states, “Mitigation effects of Yel001 and Yel002 on radiation-induced cancer of the proliferating hematopoietic cells are translatable into other radiation (or UV)-induced cancer models of proliferating tissues such as skin and intestinal lining.
At Column 17, Third Paragraph, Schiestl teaches the composition of various embodiments of the invention is suitable for formulation for topical administration.
The broadest reasonable interpretation of a skin condition, as instantly recited at Claim 1 would include the treatment of skin cancer. Schiestl’s treatment of a composition suitable for formulation for topical administration including Yel002 for the treatment of skin cancer therefore anticipates instant Claim 1.
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.
Claim 1 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,045,474 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and U.S. Patent No. ‘474 are both drawn to the treatment of a skin condition comprising administration of Yel002.
Claim 1 of U.S. Patent No. ‘474 is drawn to administration of a compound of Formula IA as a method of mitigating tissue damage. As noted above, Formula IA in U.S. Patent ‘474 is YEL002 (see Column 13, Line 63 of U.S. Patent No. ‘474). Claim 2 of U.S. Patent No. ‘474 is drawn to administration of the compound in a pharmaceutical composition. As noted above, compositions taught by U.S. Patent No. ‘474 are suitable for formulation for topical administration (see Column 17, Third Paragraph of U.S. Patent No. ‘474).
The broadest reasonable interpretation of treatment of a skin condition, as instantly claimed at instant Claim 1, would include mitigation of tissue damage, wherein the tissue is skin tissue. Therefore, instant Claim 1 and Claims 1-2 of U.S. Patent No. ‘474 are not patentably distinct, as both sets of claims are drawn to administration of YEL002 as a method for the treatment of a skin condition.
Conclusion
Claims 1-20 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624