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 .
Status of Application
Receipt of the Applicants remarks and amended claims filed on April 28, 2026 is acknowledged.
Claims 1, 3-5, 7-12, 16-17, and 20-29 are pending in this application.
Claims 3, 9, and 23-26 are withdrawn per the restriction requirement.
Claims 2, 6, 13-15, 18-19 have been cancelled.
Claims 1, 4, 7-8, and 11-12 have been amended.
Claims 27-29 are new.
Claims 1, 4-5, 7-8, 10-12, 16-17, and 20-22 are under examination in this application.
Withdrawn Objections/Rejections
Claim Objections
The objection to claim 8 because the claim recites the first or second poloxamer is P407 (F127) and since P407 is also known as F127, the recitation of F127 is redundant and unnecessary has been withdrawn in view of the amendment to the claim to delete the term F127 as suggested by the Examiner.
Claim Rejections - 35 USC § 112
The rejection of claim 1, 4-12, 16-17, and 20-23 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claim 1 recites the term “substantially” which is a relative term which renders the claim indefinite has been withdrawn in view of the amendment to claim to delete the term; and
claims 11-12 recite “the step of removing the water miscible solvent is performed at a temperature from about 25 ˚C to about 35 ˚C (32˚C to 34˚C)” has been withdrawn in view of the amendment to the claims to recite bath temperature.
The rejection of claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because claim 4 recites “mixing the first aqueous solution and the solvent system” and “preparing the first aqueous solvent, the second aqueous solvent and/or the solvent solution”, however, claim 1, from which 4 depends recites “providing a mixture of a first aqueous solution… with a solvent system”, thereby indication the components are mixed together and prepared has been withdrawn in view of the amendment to the claim to recite “”wherein prior to step (a) the method further includes…”.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 4-8, 16-17, and 20-23 under 35 U.S.C. 103 as being unpatentable over Geng et al. (WO 2016/004369) in view of Yang et al. (A novel mixed micelle gel with thermos-sensitive property for the local delivery of docetaxel, Journal of Controlled Release 135 (2009) 175-182) has been withdrawn in view of Applicant’s arguments regarding step (c) and the lack of motivation to contact the micelle formulation with a second aqueous solution comprising a poloxamer and/or polyamine.
The rejection of claim 10 under 35 U.S.C. 103 as being unpatentable over Geng et al. (WO 2016/004369) in view of Yang et al. (A novel mixed micelle gel with thermos-sensitive property for the local delivery of docetaxel, Journal of Controlled Release 135 (2009) 175-182) as applied to claims 1, 4-8, 16-17, and 20-23 above, and further in view of O’Driscoll (Why Rotart Evaporation is more Efficient than standard distillation, 19 July 2018) has been withdrawn in view of Applicant’s arguments regarding step (c) and the lack of motivation to contact the micelle formulation with a second aqueous solution comprising a poloxamer and/or polyamine.
Newly Applied Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-5, 7-8, 10-12, 16-7, 20-22, and 27-29 are rejected 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.
Claims 1 and 28-29 recite "the water miscible solvent is or comprises…”. Applicant has not particularly pointed out what the solvent is limited to. It is unclear what is excluded/included in the claim based on the is (comprising)/consisting of language. For purposes of prosecution in application of prior art, the claims are being examined utilizing "comprising". The claims must be limited to one transitional phrase.
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, 4-5, 7-8, 16-17, 20, 22, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Evaluation of micelles incorporated into a thermosensitive hydrogels for intratumeral delivery and controlled release of docetaxel: A dual approach for in situ treatment of tumors, Asian Journal of Pharmaceutical Sciences 12(2018) 373-382; cited on IDS dated February 28, 2024).
Xu discloses the preparation of docetaxel (DTX) loaded mixed micelles. The micelles were prepared using solvent evaporation methods. Certain amounts of docetaxel were dissolved in ethanol and added to a solution of Solutol HS15 and Pluronic F127 (poloxamer 407). The docetaxel micelles were then obtained after some processing, including evaporation of the solvents (section 2.2.1).
The micelles were then added to a solution containing Pluronic F127 to prepare hydrogels (section 2.2.3).
It is noted that docetaxel is highly hydrophobic.
It is noted that Solutol HS15 is a non-ionic surfactant.
Regarding claim 4, as noted above, the docetaxel is added to the poloxamer solution, therefore, it would have been prepared prior.
Regarding claim 5, as noted above, the first solution comprises Pluronic F127.
Regarding claim 7, as noted above, the docetaxel is dissolved in ethanol.
Regarding claim 8, as noted above, Pluronic F127 or poloxamer 407 is disclosed.
Regarding claims 16-17, the gelation state is at 37˚ C, which reads on the “about 35” an “about 32” recited in the instant claims.
Regarding claim 20, as noted above, Solutol HS 15 is disclosed, which is polyethylene glycol 12-hydroxysteaarate.
Regarding claim 22, as noted above, docetaxel is disclosed.
Regarding claim 28, the hydrogel additionally comprises P188 (section 2.2.3).
Xu, 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.
Claims 1, 4-5, 7-8, 10-12, 16-17, 20, 22, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (Evaluation of micelles incorporated into a thermosensitive hydrogels for intratumeral delivery and controlled release of docetaxel: A dual approach for in situ treatment of tumors, Asian Journal of Pharmaceutical Sciences 12(2018) 373-382; cited on IDS dated February 28, 2024) in view of O’Driscoll (Why Rotart Evaporation is more Efficient than standard distillation, 19 July 2018).
The teachings of Xu are discussed above.
The combination does not disclose the evaporation in Xu is by rotary evaporation.
O’Driscoll discloses rotary evaporation is often favored over standard distillation, with one of the main reasons being that you can achieve a faster evaporation rate with a rotavapor setup. You might be wondering why this is the case.
For an at-a-glance look, the factors that can help speed up evaporation are:
Decreased pressure within the system
Increased temperature of the solvent
Rotation of the flask
While the first two factors can be changed with both rotary evaporation and standard distillation, only rotary evaporation has the added benefit of rotating the sample.
Regarding claims 11-12, Xu discloses evaporation was performed at 40˚C, which reads on the “about 35(34) ˚C” recited in the instant claims.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used rotary evaporation in the method of Xu in order to increase the surface area of the solvent and agitation of the water bath liquid since the solvent forms a thin film around the sides of the flask, greatly increasing the surface area and speeding up evaporation.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (Evaluation of micelles incorporated into a thermosensitive hydrogels for intratumeral delivery and controlled release of docetaxel: A dual approach for in situ treatment of tumors, Asian Journal of Pharmaceutical Sciences 12(2018) 373-382; cited on IDS dated February 28, 2024) in view of Yang et al. (A novel mixed micelle gel with thermos-sensitive property for the local delivery of docetaxel, Journal of Controlled Release, 135 (2009) 175-185; cited on IDS dated February 26, 2024).
The teachings of Xu are discussed above.
Xu does not disclose the use of polyoxyethylene sorbitan monooleate.
Yang discloses the preparation of mixed micelle gels utilizing Pluronic F127 (poloxamer 407), Tween 80 (polyoxyethylene sorbitan monooleate), and docetaxel.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have substitute or incorporated additionally surfactant, including tween 80 into the micelle formulation of Xu since Yang discloses it is a suitable alternative in docetaxel micelles by increasing physical stability and drug release.
Claims 21 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (Evaluation of micelles incorporated into a thermosensitive hydrogels for intratumeral delivery and controlled release of docetaxel: A dual approach for in situ treatment of tumors, Asian Journal of Pharmaceutical Sciences 12(2018) 373-382; cited on IDS dated February 28, 2024) in view of Yang et al. (A novel mixed micelle gel with thermos-sensitive property for the local delivery of docetaxel, Journal of Controlled Release, 135 (2009) 175-185; cited on IDS dated February 26, 2024) and Sannaningannavar et al. (Ultrasonic study of thermos-acoustic parameters of the polysorbate 20, 40, 60, and 80 liquid surfactants at different temperatures, Journal of Molecular Liquids, 196 (2014) 244-248; cited on IDS dated February 26, 2024).
The teachings of Xu and Yang are discussed above.
The teachings do not disclose Tween 20.
Tween 20 and Tween 80 surfactants exhibit lyotropic liquid crystal properties at certain concentrations and temperatures when dissolved in appropriate solvents. Surfactants, such as Tween 20, 40, 60, and 80 have the tendency to undergo volume expansion with an increase in temperature.
It would have been obvious to one of ordinary skill in the art to select the tween to be included in the micelle formulation of Xu and Yang in order to take advantage of their properties. Applicant’s attention is directed to MPEP 2141.03 which discloses the person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983).
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007).
Conclusion
Due to the new grounds of rejection presented in this office action, this action is made Non-Final.
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 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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