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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 15, 2026 has been entered.
Status of Application
Receipt of the Amended Claims and Applicant’s remarks filed on May 15, 2026 is acknowledged.
Claims 1-22 are pending in this application.
Claims 21-22 are new.
No claims have been amended.
All pending claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 1-22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement in view of Applicant’s arguments that any excess amount of the gallate compound in relation to the amount of water insoluble compound is effective in increasing the solubility of the compound.
Claim Rejections - 35 USC § 112
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention because claim 13 recites “or a paclitaxel derivative or other taxane compound” and it is unclear what “other taxane compounds” would encompass has been withdrawn in view of the arguments regarding the breadth of the claim and a review of the prior arts disclosure of taxane compounds.
Maintained Rejections
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.
Claims 1, 3-9, 13-15, and 19-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (CN102552245).
Yu discloses a composition for inhibiting proliferation of tumor cells comprising active components, namely epigallocatechin gallate (a gallate containing compound) and taxol (generic for paclitaxel, a water insoluble drug), wherein the mol ratio of the epigallocatechin gallate to the taxol is 200:1 to 8:1. The recitation of “wherein the amount of the gallate containing compound is effective in increasing the solubility of the water-insoluble drug in an aqueous medium”, is considered a necessary effect of the composition. Since the composition is disclosed by Yu, it would necessarily have the disclosed property.
Regarding claims 3-6, as noted above, the mol ratio of the epigallocatechin gallate to the taxol is 200:1 to 8:1.
Regarding claim 7, the recitation of “where the gallate containing compound is present in an amount effective in increasing the cellular uptake of the water-insoluble drug”, is considered a necessary effect of the composition. Since the composition is disclosed by Yu, it would necessarily have the disclosed property.
Regarding claims 8-9 and 20, as noted above, the gallate containing compound is disclosed as epigallocatechin gallate.
Regarding claims 13-15, paclitaxel is disclosed as taxol which is used for treating cancer (paragraph 0001).
Regarding claim 19 and 21, the formulation can be prepared in a saline, buffer liquid, and water (paragraph 0018), for example. As noted above, the mol ratio of the epigallocatechin gallate to the taxol is 200:1 to 8:1, therefore, the gallate containing compound is present in an amount effective in increasing the solubility of the drug in the aqueous solvent by at least 10 percent, by at least 100 percent, or by at least 200 percent, compared to an otherwise identical composition that does not include the gallate containing compound.
Yu, therefore, anticipates the rejected claims.
Claim Rejections - 35 USC § 103
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.
Claims 1-9, 13-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (CN102552245) in view of Using Medications: Topical medications, April 13, 2011).
The teachings of Yu are discussed above.
While, Yu discloses composition can be formulated for topical administration (paragraph 0018). He does not disclose the composition is in the form of a cream, paste, or gel.
Using medication discloses topical formulations include creams, gels, and pastes.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have formulated the composition in any acceptable topical formulation.
Claims 1, 3-9, 13-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (CN102552245)in view of Verweij et al. (Paclitaxel and docetaxel: Not simply two of a kind, Annals of Oncology 5; 495-505, 1994).
The teachings of Yu are discussed above.
Yu does not disclose the use of docetaxel.
Verweij discloses paclitaxel and docetaxel share major parts of their structures and mechanisms of action.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have substituted docetaxel for paclitaxel in the formulation of Yu since they are disclosed as sharing major parts of their structures, therefore the skilled artisan would expect the drugs could be formulated in similar platforms and obtain the same or similar benefits of said formulation.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues the rejections over 35 USC § 102 and 35 USC § 103 together, therefore, the Examiner will respond to arguments together.
Applicant argues:
*The Office Action once again fails to demonstrate that Yu et al. discloses a "drug preparation" comprising each and every element of claim 1, including a drug preparation comprising "a gallate containing compound and a water-insoluble drug," where the gallate containing compound is present in the preparation "in an amount by weight equal to or greater than the amount by weight of the water-insoluble drug," and where "the amount of the gallate containing compound is effective in increasing the solubility of the water-insoluble drug in an aqueous medium."
As noted in the rejection above, Yu discloses a composition for inhibiting proliferation of tumor cells comprising active components, namely epigallocatechin gallate (a gallate containing compound) and taxol (generic for paclitaxel, a water insoluble drug), wherein the mol ratio of the epigallocatechin gallate to the taxol is 200:1 to 8:1.
The claims structurally recite a composition comprising a gallate containing compound (epigallocatechin in Yu) and a water-insoluble drug (taxol in Yu) in an amount by weight equal to or greater than the amount by weight of the water-insoluble drug (200:1 to 8:1 in Yu).
In arguments presented in this application, Applicant has repeatedly argued a sufficient amount of gallate containing compound to the water insoluble drug are effective for increasing the water solubility of the drugs and said sufficient amount is an amount by weight that is equal to or greater than the amount of the drug. According to Yu, the gallate containing compound to drug is present in the amount of 200:1 to 8:1, therefore, according the disclosure in the specification and arugments presented, the composition would necessarily have to also have the cited functional property. It is additionally noted epigallocatechin and taxol are recited in dependent claims of the instant application. The recited ratio of gallate containing compound to drug is also claimed in the instant claims. Since the prior art meets all the structural limitations of the instant claims, it would necessarily also have to meet the functional properties recited in the instant claims. The prior art of Yu need not recite the functional property since a composition and its properties cannot be separated. Applicant’s attention is directed to MPEP 2112.01 which recites “where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”
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 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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,896,742. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a composition comprising a gallate containing compound and a water-insoluble active agent, wherein the gallate containing compound is present in an amount by weight equal to or greater than the water insoluble drug. Dependent claims recite identical Markush groups for each component. The instant claims additionally recite the combination of gallate containing compound and water insoluble compound is “effective for increasing the solubility of the water insoluble drug in an aqueous medium” and “effective in increasing the dermal uptake of the drug”. However, the instant application alleges that this property is a functional effect of the ratio of the combination. Therefore, the skilled artisan would have a reasonable expectation that the patented claims and the instant claims would have the same effect.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,241,520. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a composition comprising a gallate containing compound and a water-insoluble active agent, wherein the gallate containing compound is present in an amount by weight equal to or greater than the water insoluble drug. Dependent claims recite identical Markush groups for each component. The instant claims additionally recite the combination of gallate containing compound and water insoluble compound is “effective for increasing the solubility of the water insoluble drug in an aqueous medium” and “effective in increasing the dermal uptake of the drug”. However, the instant specification alleges that this property is a functional effect of the ratio of the combination. Therefore, the skilled artisan would have a reasonable expectation that the patented claims and the instant claims would have the same effect.
It is noted that there are numerous applications and issued patents with the same assignee, and one or both inventors. Applicant is requested to identify any additional Obviousness Double Patenting of which he/she may be aware.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*In making a double patenting rejection, the Office Action was required to "first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences," and then to "determine whether those differences render the claims patentably distinct using an anticipation analysis and/or an obviousness analysis."
As noted above, the instant claims and the patented claims recite the same structural elements. The claims differ only in the functional properties recited. Since Applicant has argued the properties are a result of the structural elements, the applications are not patentably distinct from each other.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 5:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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