Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Claims 1-19 are pending.
Priority
This application is a DIV of 16/924,591 (PAT 11607399 ) filed on 07/09/2020 which is a DIV of 16/275,395 filed on 02/14/2019 ABN, 16/275,395 is a DIV of 15/637,979 filed on 06/29/2017 PAT 10258595, 15/637,979 is a DIV of 14/983,761 filed on 12/30/2015 ABN, 14/983,761 is a CON of 13/878,994 filed on 04/11/2013 PAT 9255066, 13/878,994 is a 371 of PCT/US2011/056148 filed on 10/13/2011, and PCT/US2011/056148 has PRO 61/392,855 10/13/2010.
Claim Rejections - 35 USC § 103
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bradner et al. (US 2014/0213620 A1; of record) in view of Tamarkin et al. (US 2008/0206159 A1; of record).
Bradner et al. discloses the treatment of basal cell carcinoma (see, for example, [0059], and the whole document) by administering compositions comprising an effective amount (see, for example, claim 79, and the rest of the document) of the compound shown above (see, for example, claim 73) as a topical treatment (see, for example, [0215] and claim 98) and further teaches that it can be formulated as a composition further comprising common elements including citric acid (see, for example, [0215]), glycols such as propylene glycol (see, for example, [0215]), adipates (see particularly [203]), oleyl alcohol (see particularly [203]), cellulose derivatives (see, for example, [0206]), butylated hydroxytoluene (see particularly [0215]), and buffers (see particularly [0206]). Bradner et al. further indicates that stability of the compositions is a significant concern (see, for example, the Figures wherein they compare the stability SAHA and SAHP in different situations; i.e. the stability of compounds that are very similar to the instant claims).
Bradner et al. does not specifically disclose the claimed composition at the claimed pH.
Tamarkin et al. discloses topical compositions beneficially comprising citric acid (see, for example, [0344], the examples, and the whole document), propylene glycol and hexylene glycol (see, for example, [0167] and the examples), diisopropyl adipate (see, for example, [0332]), hydroxypropyl cellulose (see, for example, [0284] and the examples), butylated hydroxytoluene (see particularly [0343]), and teaches that the adjustment of the pH/buffer enhances the chemical stability of the active agents (see, for example, claim 1) and that the pH should be adjusted to maintain the skin surface pH in order to prevent susceptibility to skin infections, damage, and disease by maintaining the normal skin surface pH of about 4-6.5.
It would have been obvious to one of ordinary skill in the art to treat skin cancer with the instantly claimed composition.
One of ordinary skill would have been motivated to treat skin cancer with the claimed composition comprising the compound shown above, ethanol, citric acid, propylene glycol, hexylene glycol, diisopropyl adipate, oleyl alcohol, hydroxypropyl cellulose, and butylated hydroxytoluene because these are common excipients that are well-known to those of skill in the art and have been used with topical compositions. One of ordinary skill in the art would have made and used the instant composition during the routine experimentation and optimization of the prior art compound and composition using the excipients taught by the prior art, and would have made the instant composition with a reasonable expectation of success in making an improved composition with improved properties, e.g. improved stability and minimized skin damage/issues.
One of ordinary skill in the art would have made the composition with about 0.1-5% by weight of the compound shown above because the amount of the active agent in the composition is well-understood to the skilled artisan to be a result-determinate variable that requires adjustment. Those of skill in the art would have adjusted the amount of the compound shown above, including to about 0.1-5% by weight, during routine optimization, and would have done so with a reasonable expectation of success in making an improved topical composition.
One of ordinary skill in the art would have been motivated to adjust the pH to about 4 because the prior art discloses that the pH of the composition is a result-determinate variable that requires adjustment, and that adjusting the pH of the composition to near that of healthy skin (i.e. about 4) can provide additional benefit to the patient. One of ordinary skill in the art would have adjusted the pH of the composition to about 4 during the routine optimization of the composition, and would have done so with a reasonable expectation of success in making an improved topical composition.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 9,255,066 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are generally drawn to the treatment of skin cancer comprising administering the instantly claimed composition, while the patented claims are generally drawn to the same composition. Looking to the specification of the patent for the definition of the utility of the patented composition, it is used for the treatment of basal cell carcinoma (see, for example, columns 12 and 13), therefore the instant claims are obvious in light of the patented claims.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,258,595 B2 in view of Bradner et al. (US 2014/0213620 A1; of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are generally drawn to the treatment of skin cancer comprising administering the instantly claimed composition, while the patented claims are generally drawn to the treatment of cutaneous T cell lymphoma with a more narrowly defined composition that anticipates the instant composition.
Bradner et al. discloses that the compound in both the instant and the patented claims was known to be useful for both basal cell carcinoma (see, for example, [0059], and the whole document) as well as cutaneous T-cell lymphoma (see, for example, claim 85). Therefore, one of ordinary skill in the art would have found the instant claims obvious in light of the patent claims.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11607399 B2 in view of Bradner et al. (US 2014/0213620 A1; of record). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are generally drawn to the treatment of skin cancer comprising administering the instantly claimed composition, while the patented claims are generally drawn to the treatment of basal cell carcinoma with a more narrowly defined composition that anticipates the instant composition.
Bradner et al. discloses that the compound in both the instant and the patented claims was known to be useful for both basal cell carcinoma (see, for example, [0059], and the whole document) as well as cutaneous T-cell lymphoma (see, for example, claim 85). Therefore, one of ordinary skill in the art would have found the instant claims obvious in light of the patent claims.
Examiner’s Comment
Claim 1 has the following limitation “at least one acidifying agent comprises citric acid”, which would read better as “at least one acidifying agent which comprises citric acid” (emphasis added), or something similar.
Claims 1, 15, and 16 have parenthetical statements with acronyms, e.g. “active pharmaceutical ingredient (API)” and “butylated hydroxyanisol (BHA)”. While exemplary language such as this is not, per se, forbidden, it is inappropriate to have it in used in this fashion in the claims. The limitations in the claims have adequate description, so the additional description is unnecessary. Further, the use of parenthetic statements for additional description in the claims risks indefiniteness if the scope of the two descriptors is not identical.
For clarity and compactness, the claims should be limited to only one description per compound/composition.
Conclusion
Claims 1-19 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622