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 .
Response to Amendment
Upon review, the finality of the previous Office Action is withdrawn. The allowability of claims 28-31 is withdrawn. Applicant’s after-final amendment (12/22/2025) has been entered.
102 Rejections Withdrawn
The rejection of claims 16-18, 20 and 23-27 under 35 USC 102(a)(1), outlined in the previous Office Action, is withdrawn and reformulated below. (Previously allowed claims 28, 29 and 31 have also been rejected under 35 USC 102(a)(1).)
Claim Rejections - 35 USC § 102, NEW
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 16-18, 20 and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2012/001065 A2, cited in the IDS.
The reference teaches a method for preventing skin tumor formation, or inhibiting the development of an existing skin tumor (i.e. treating an existing solid tumor), by administering a composition containing an α2 adrenergic receptor agonist (abstract). Amitraz, clonidine, detomidine, dexmedetomidine, epinephrine, guanfacine, lofexidine, medetomidine, methoxamine, naphazoline, norepinephrine, oxymetazoline, romifidine, tizanidine, xylazine, and xylometazoline are explicitly taught as suitable α2 adrenergic receptor agonists (Table 1, page 6-7; page 7, [0028]). The composition may be formulated for administration via a variety of routes including transdermal, subcutaneous or intramuscular (i.e. systemic methods of administration) (page 13, [0060]). An additional treatment for preventing the formation of a skin tumor, or inhibiting the progression of an existing skin tumor, may also be administered such as chemotherapy, surgery and radiation (page 10, [0044]-[0046]). The cancer may be inter alia a squamous cell carcinoma, a melanoma or a sarcoma (page 28, claim 12).
With respect to claim 20, as is well known in the medicinal arts, the blood/brain barrier is generally considered to exclude hydrophilic compounds such as, for instance, epinephrine.
Claims 28, 29 and 31 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2012/001065 A2, cited in the IDS.
The reference teaches a method for preventing skin tumor formation, or inhibiting the development of an existing skin tumor, by administering a composition containing an α2 adrenergic receptor agonist (abstract). The reference also teaches a method of inducing the death or inhibiting the growth a skin tumor cell by administering a composition containing an α2 adrenergic receptor agonist (page 2, [0011]; page 10, [0048]; page). (It is noted that the death of skin tumor cells will intrinsically reduce the volume and/or weight of the skin tumor.) Amitraz, clonidine, detomidine, dexmedetomidine, epinephrine, guanfacine, lofexidine, medetomidine, methoxamine, naphazoline, norepinephrine, oxymetazoline, romifidine, tizanidine, xylazine, and xylometazoline are explicitly taught as suitable α2 adrenergic receptor agonists (Table 1, page 6-7; page 7, [0028]).
With respect to claim 31, as is well known in the medicinal arts, the blood/brain barrier is generally considered to exclude hydrophilic compounds such as, for instance, epinephrine (an α2 adrenergic receptor agonist).
Claim Rejections - 35 USC § 103, MAINTAINED
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 21 remains rejected under 35 U.S.C. 103 as being unpatentable over WO 2012/001065 A2, cited in the IDS.
WO 2012/001065 A2, has been outlined above (102 rejection). Dosage guidance is given for a topical formulation (0.1 g/cm2 of skin surface area to about 5 g/cm2 of skin surface area) (page 17, [0082]).
Inventor teaches a method for the treatment of a blood or solid cancer comprising administering an alpha-2 adrenergic receptor agonist (amitraz, apraclonidine, etc., or an antibody, an antibody fragment, etc.) in a systematic dosage of from about 0.0001 mg/kg body weight to about 100 mg/kg of body weight.
One of ordinary skill (a highly skilled individual such as a clinical oncologist), before the effective filing date of the instant invention, would have found it obvious to determine the effective systemic dosage of the alpha-2 adrenergic receptor agonist in the treatment of cancer guided by ordinary clinical considerations (alpha-2 adrenergic receptor agonist choice and efficacy, cancer type, patient tolerance, etc.). One of ordinary skill would have been motivated to optimize a systemic dosage, a results-effective variable, with respect to mg/kg of body weight, and with a reasonable expectation of success - given the dosage guidance in the cited art and the fact that the reference explicitly teaches that the composition may be formulated for systemic administration.
Claim Objections Withdrawn
The objection to claims 19 and 22 is withdrawn. (Claim 22 has been canceled by inventor’s amendment.)
Allowable Subject Matter
Claim 19 is allowed. Claim 30 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 1/14/2026