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 .
Election/Restrictions
Claims 3 and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 15, 2025.
Applicant’s additional election without traverse of rotary evaporation is acknowledged.
Status of Application
Receipt of the Preliminary Amendment dated August 28, 2023 is acknowledged.
Claims 1, 3-12, 16-17, and 20-26 are pending in this application.
Claims 3, 9, and 23-26 are withdrawn, as noted above.
Claims 2, 13-15, 18-19 have been cancelled.
Claims 9, 16-17, and 20-24 have been amended.
Claim 26 is new.
Claims 1, 4-8, 10-12, 16-17, and 20-22 are under examination in this application.
Information Disclosure Statement
Reaccept of the Information Disclosure Statements filed on February 24, 2023; February 28, 2024; and November 5, 2024 is acknowledged.
Signed copies are attached to this office action.
Claim Objections
Claim 8 is objected to because of the following informalities: the claim recites the first or second poloxamer is P407 (F127). Since P407 is also known as F127, the recitation of F127 is redundant and unnecessary. It is suggested Applicant delete the term F127. Appropriate correction is required.
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.
Claim 1, 4-12, 16-17, and 20-23 is 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.
Regarding claim 1, the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what amount of water miscible solvent and water can remain in the sol gel composition to meet the limitation of “substantially removing”, therefore the metes and bounds of the claim are unclear.
Regarding claims 11-12, the claims recite “the step of removing the water miscible solvent is preformed at a temperature from about 25 ˚C to about 35 ˚C (32˚C to 34˚C)”. However, it is noted that evaporation temperature is measured in vapor temp, bath temp, and condenser temp, all of which vary depending in the solvent used. It is not clear what particular temperature is recited in the instant claim. Clarification is requested.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected 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. 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. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-8, 16-17, and 20-23 are rejected 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).
Geng discloses aqueous composition comprises micelles, where the micelles comprise poloxamer and encapsulating at least one hydrophobic agent thus forming hydrophobic agent-loaded poloxamer micelles (abstract).
The method of preparation includes contacting the hydrophobic agent molecules dissolved in an organic solvent such as chloroform or other organic solvents such as ethanol, methanol, for example with surfactant molecules to form micelles, at least some of which have the hydrophobic agent molecule incorporated therein. This is followed by evaporation or partial evaporation of the organic solvent and subsequent removal of surfactant molecules that are no involved in hydrophobic agent-loaded micelles (paragraph 0012).
It is noted the boiling point of ethanol is 78˚C, methanol is 65˚C, and chloroform is 61˚C.
Regarding claim 4, as noted in the 112b rejection above, the first aqueous solution and the solvent system would be mixed according the step a in claim 1, discussed above.
Regarding claim 5, as noted above, the micelles comprise a poloxamer, which is a surfactant.
Regarding claims 6-7, as noted above, the organic solvent can be ethanol or methanol.
Regarding claim 8, the poloxamer can be Poloxamer 407 (Pluronic F127) (paragraph 0017).
Regarding claim 22, examples of the hydrophobic agent include alpha-tocopherol (vitamin E), abafungin (an anti-fungal), azithromycin dihydrate (an antibiotic), tacrolimus (an immunosuppressant), testosterone (a steroid), and tamoxifen (a hormone), for example (paragraph 0075).
The resulting micelles are also not disclosed to be contained in a thermo-responsive sol-gel composition.
Yang discloses injectable thermos-sensitive mixed micelle gel (MMG).
MMG was prepared according to the “cold” method. Briefly, Pluronic F127 (PF127) and Tween 80 were added to water in glass vials, respectively, to obtain a serial solutions with a fixed concentration of PF127 (20%, w/w) and different concentration of Tween 80. The mixture was then kept at 4 °C overnight and gently mixed with the magnetic stirrers until all of the PF127 granules were completely dissolved (section 2.2).
Regarding claims 16-17, according to Figure 1, the MMG has a gel formation
temperature of about 21 ˚C.
Regarding claims 20-21, as noted above, Tween 80 was used. It is noted that Tween 80 is polyoxyethylene (20) sorbitan monooleate.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have added the micelles of Geng into the MMG of Yang in order to obtain an injectable thermos-sensitive mixed micelle gel for local delivery of hydrophobic active agents to increase their efficacy and improve therapeutic effect for treatment (Yang, abstract).
Claim 10 is rejected 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).
The teachings of Geng and Yang are discussed above.
The combination does not disclose the evaporation in Geng 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.
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 Geng 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bright (US 2021/0268271) which discloses methods, devices, and systems for gel based modulation of neural tissue, including prevention of nerve regeneration and neuroma formation. The gel can be delivered to selected target locations including the myenteric plexus (abstract).
The hydrogel can include, for example, a neurolytic active agent; and a biodegradable polymer. The gel could include a biodegradable or bioerodable polymeric injectable hydrogel (paragraph 0028).
The gel is disclosed to be thermosensitive (paragraph 0263).
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