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 .
Claim Rejections - 35 USC § 102, MAINTAINED and 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 remain rejected, and new claim 36 and 38 are also rejected, under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2012/001065 A2, cited in the IDS. Inventor’s arguments have been carefully considered but are not persuasive.
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.
Inventor argument is predicated upon the route of administration. Inventor argues, essentially, that the cited prior art teaches away from the instant systemic administration. The examiner respectfully disagrees.
As pointed out in the rejection above, the cited prior art 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]). That is, the cited prior art explicitly teaches systemic administration as a possible administration route. The examiner respectfully points out that it is well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches to a person of ordinary skill in the art. (Note the discussion at MPEP 2141.02, VI.)
Claims 28, 29 and 31 remain rejected, and new claims 37, 39 and 40 are also rejected, under 35 U.S.C. 102(a)(1) as being clearly anticipated by WO 2012/001065 A2, cited in the IDS. Inventor’s arguments have been carefully considered but are not persuasive.
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).
Inventor argument is predicated upon the route of administration. Inventor argues, essentially, that the cited prior art teaches away from the instant systemic administration. The examiner respectfully disagrees.
As pointed out in the rejection above, the cited prior art 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]). That is, the cited prior art explicitly teaches systemic administration as a possible administration route. The examiner respectfully points out that it is well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches to a person of ordinary skill in the art. (Note the discussion at MPEP 2141.02, VI.)
Inventor further argues that the cited prior art fails to teach the reduction in volume and/or weight of a solid tumor by administering the composition. The examiner respectfully disagrees.
As pointed out in the rejection above, 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). Inducing the death of skin tumor cells would intrinsically reduce the volume and/or weight of the solid tumor.
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. Inventor’s arguments have been carefully considered but are not persuasive.
WO 2012/001065 A2, has been outlined above (102 rejections). 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.
Inventor argument is predicated upon the route of administration. Inventor argues, essentially, that the cited prior art teaches away from the instant systemic administration. The examiner respectfully disagrees.
As previously pointed out, the cited prior art 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]). That is, the cited prior art explicitly teaches systemic administration as a possible administration route. The examiner respectfully points out that it is well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches to a person of ordinary skill in the art. (Note the discussion at MPEP 2141.02, VI.)
Allowable Subject Matter
Claim 19 remains allowed. Claim 30 remains 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. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art appears to be the prior art of record (102 and 103 rejections). The cited reference does not teach, show, suggest or make obvious the instant method comprising administering an α2 adrenergic receptor agonist selected from an antibody, antibody fragment, afucosylated antibody, diabody, triabody, tertrabody, nanobody and analogs thereof.
Claim 35 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. The following is a statement of reasons for the indication of allowable subject matter:
Int. J. Cancer (1991), 49, pp. 178-181 appears to be the closest prior art. The reference essentially teaches away from utilizing clonidine (an α2 adrenergic receptor agonist) as an effective treatment for leukemia because, in cellular studies, it decreases the intracellular level of cAMP – and low cAMP levels are associated with unregulated proliferation in transformed cells (page 180, column 2, text line 37).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 EDT.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 5/5/2026
Prosecution Insights