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 .
DETAILED ACTION
Claims 1, 5, 7, 8, 10-16, 20-25 and 29 are pending in a Response of 02/10/2026. Claims 13-16 and 20-25 and 29 have been withdrawn.
According to MPEP 714 and 37 CRF 1.121(c), the status of claims must be indicated using specific identifiers. However, Applicant improperly indicates the status of those non-elected claims as “previously presented” instead of “withdrawn”.
Consequently, claims 1, 5, 7, 8 and 10-12 are being examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/10/2026 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copies are enclosed herewith.
Withdrawn rejections:
Applicant's amendments and arguments filed 02/10/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New Grounds of Rejection --- as necessitated by amendment
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-5, 7, 8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bhamra et al. (WO2016/055786A1, IDS of 07/12/2023) in view of Guo et al., “The applications of vitamin E TPGS in drug delivery”, European Journal of Pharmaceutical Sciences, vol. 49, Issue 2, 2013-05, pp. 175-186 (IDS of 07/12/2023).
Applicant claims the below claim 1 filed on 02/10/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical anti-cancer compound research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Bhamra discloses N-pyridinyl acetamide derivatives as inhibitors of the WNT signaling pathway (title); a pharmaceutical composition for treating cancer comprising a compound of formula (I) including 2-(5-methyl-4-(2-(trifluoromethyl)pyridin-4-yl)-1H-imidazol-1-yl)-N-(5-(pyrazin-2-yl)pyridin-2-yl)acetamide (entire document including e.g., Example 9, compound no. 74 on page 102 and claims 1-14 of prior art) which reads on the claimed compound I; and the composition further comprises a pharmaceutically acceptable excipient (claim 28 of prior art) wherein the excipient includes adjuvant, diluent or carrier such as polyethylene glycol (PEG) and vegetable oil ([0210] and [0213]-[0214]), and since the composition contains semi-solid diluent/solubilizer, the composition would be present in semi-solid form (instant claim 1, in part); the said compound is present in an amount of 0.05 to 99%, or 0.1-50% ([0211]) which overlaps the instant range of about 0.1 to about 10% or about 0.5 to about 3%, and the compound can be administered in an amount of 0.01 µg per kilogram body weight (g/kg) to 100mg per kilogram body weight (mg/kg) ([0209]) which overlaps the instant range of about 0.05 to about 5 or about 0.5 mg to about 5 mg. In this respect, please see MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claims 5, 7, 8 and 10). Further the composition is in the form of e.g., creams, gels, lotions, solutions, capsules, tablets, syrups, etc. ([0212]) and for example, the composition is provided in the form of soft gelatin or hard gelatin ([0214]) (instant claim 12).
However, Bhamra does not expressly teach specific diluent of vitamin E TPGS of instant claim 1. The deficiency is cured by Guo.
Guo discloses vitamin E TPGS (D-alpha-tocopheryl polyethylene glycol 1000 succinate or vitamin E TPGS) has been used for its emulsifying, dispersing, gelling, and solubilizing effect on the drugs (abstract); for drug delivery systems, absorption enhancer, emulsifier, solubilizer, additive, permeation enhancer, stabilizer, as excipient for overcoming multidrug resistance, for increasing the oral bioavailability of anticancer drugs, as anticancer agent, synergistic effect with other anticancer drugs, etc. (see Introduction on page 176) (instant claim 1 - TPGS). As evidenced by Antares obtained from wayback machine website [https://www.tpgs.com/tpgs-technical-info/tpgs-properties (2018)], vitamin E TPGS diluent has a melting point of 37-41C and thus has semi-solid properties as supported by the instant publication at [0018].
Although Guo does not expressly teach the amount 97-99% of vitamin E TPGS, it would be optimized depending on the intended purpose, relative amount of active agent to be diluted, type of solvent and formulation, etc. When the composition contains smaller amount of the said compound and higher amount of diluent, the composition would be in semi-solid form.
It would have been obvious to modify the diluent e.g., PEG of Bharma with vitamin E TGPS of Guo in order to effectively solubilize the compound of Bharma and synergistically enhance drug delivery as taught by Guo.
In light of the foregoing, instant claims 1, 5, 7, 8 and 10-12 are obvious over Bhamra in view of Guo.
Accordingly, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that selection of TPGS semi-diluent provides unexpected results in view of [0021] and Example 4 of instant specification where PEG-based diluents yields inferior results relative to TPGS.
The Examiner responds that Guo teaches effective advantages of TPGS including solubilizing/absorbing effects on poorly water-soluble drugs, permeation enhancer, etc. and therefore combining TPGS (e.g., as a solubilizer, absorption and permeation enhancer, emulsifier and/or surface stabilizer) with the claimed compound (I) for formulating the composition would have expected enhanced properties in drug delivery (see left column on page 176 of Guo); specifically, TPGS has amphiphilic structure (hydrophilic PEG head and lipophilic vitamin E tail) and it has a low critical micelle concentration (CMC) of 0.02% w/w and a hydrophile-lipophile balance (HLB) value of 13.2, and these features have made TPGS a great surfactant for DDS (drug delivery system), and so, it has been used to increase the solubility of poor water-soluble drugs and act as an emulsifying and stabilizing agent to improve the drug loading and stability of nanocarrier thus forms stabile micelles, making it ideal for solubilizing hydrophobic drugs as taught by Guo (see. e.g., left column on page 176 of Guo), and thus, the alleged improvements are merely the expected properties of TPGS already taught in Guo, constituting predictable results from the perspective of an ordinary artisan. Further even if the results would be considered, Example 4 of instant specification requires antioxidant and but the claimed invention does not require such antioxidant and accordingly, the claimed invention is not commensurate with the tested data.
In light of the foregoing, applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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