DETAILED ACTION
Notice of 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 Claims
Claims 25, 27-29, and 32-33 are cancelled. Claims 1-24, 26 and 30-31 are pending and under examination. Claims 24, 26 and 30-31 are withdrawn. Claims 1-23 are under examination.
Priority
This application is a national stage entry of PCT/US2022/074425 filed on 8/2/2022, which claims priority from provisional applications 63/364,341 filed on 5/8/2022 and 63/228,480 filed on 8/2/2021.
Rejections Withdrawn
The rejection under USC 112(a) for scope of enablement is withdrawn per applicant’s amendments and arguments.
The rejection under USC 112(b) for “e.g.” or “for example” is withdrawn per all claims formerly indicated except for claim 22. This was due to applicant’s amendments.
The rejection under USC 112(b) for “such as” is withdrawn per applicant’s amendments.
The rejections under USC 112(b) for monomers in claim 3 is withdrawn per applicant’s amendments and arguments.
The rejection under USC 112(b) for “etc” is withdrawn per applicant’s amendment.
The rejection under USC 112(b) for “wherein following said polymerizing, the polymer particles have not been exposed to liquid or solvent during the method” is withdrawn per applicant’s amendment to claim 20.
The rejection under USC 112(b) for “atoms from coating present on the substrate are not present in the polymer particle” is withdrawn per applicant’s amendment to claim 21.
The rection under USC 102 over Karandikar and each of the rejections under USC 103 including Karandikar are withdrawn per applicant’s amendments and arguments.
As these rejections are withdrawn, applicant’s arguments to these rejections are now moot.
New Objection – As Necessitated by the Amendment to Claim 1 and Reconsideration of the Prior Art
Claim Objection
Claim 18 is objected to for being dependent on a claim that is currently rejected over the prior art. The examiner discusses what may be done below.
Claim Rejections - 35 USC § 112(b)
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 2, 3 and 22 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.
Maintained Rejection -Claim not amended
Regarding claim 22, the phrase "for example" (parentheticals with e.g. where e.g. means for example or use of “for example” or use of parentheticals following a term) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Having items in parentheticals even without using e.g. or for example, brings up the question whether they may also be exemplary of the item just before the items in the parenthetical. If deleting exemplary recitations from claims, applicant should check dependent claims to whether they still have antecedent basis for items as such deletions can remove where previous antecedent basis was provided. For the purpose of compact prosecution, the examiner will consider the claims with the broader recitations provided.
New Rejections – As Necessitated by Amendment to Claim 2
Claim 2 is indefinite for recitations of “or precursors”, although the specification mentions the word precursors as monomers/precursors in a table starting in paragraph 32, the specification does not provide a particular definition to what compounds’ precursors will encompass or does not provide for a representative number of species to define the bounds of precursors. As precursors can encompass many possible compounds that can either be reacted together or compounds that can be broken apart to provide a possible monomer, the claim does not provide the proper metes and bounds to understand what limitation precursor provides to the claims and how precursors should be read. For the purpose of compact prosecution, if the prior art provides for any reasonable compound that might be processed in some way to get to such monomers, then it will read on the limitation. Additionally, it is further noted that precursors as in the claims do not even recite “or precursors thereof” to refer to the monomer. However, this does not fully repair the issue of not defining the metes and bounds of “precursor”.
Claim 3 is rejected as being dependent on an indefinite claim. As claim 3 uses “comprises” it would still be open to addition of the precursors limitation.
New Rejection – As Necessitated by Amendment to claim 1 – “wherein” clause
Claim Rejections – 35 U.S.C. § 103
The following is a quotation of 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 of this title, 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 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(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 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-7, 9, 11-17, and 19-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tao et al (Langmuir, 2012, volume 28, pages 16580-16587).
Tao teaches condensation and polymerization of supersaturated monomer vapor (title and abstract). Tao teaches “Initiated chemical vapor deposition (iCVD) of poly(glycidyl methacrylate) from supersaturated monomer vapor is reported. Rapid film growth rates, up to 600 nm/min, were observed. Films grown from supersaturated monomer exhibited distinct surface undulations.” (abstract). Tao teaches droplet densities with rapid polymerization (abstract). Tao provides for another embodiment where undulations are not formed by first depositing a thin, crosslinked film followed by deposition of the supersaturated monomer vapors. However, it also teaches the embodiment without first depositing the thin film (see figure 3). Initiated chemical vapor deposition is provided in the Experimental Section. Tao teaches custom built deposition chamber as shown in figure 1 with a chamber pressure control (experimental section). Tao teaches “Flows of the monomer, GMA, and cross-linker (another agent), EGDA, were controlled via needle valves, and the thermal initiator, TBPO, was controlled with a mass flow controller (MKS Type 1479A). A filament array consisting of 14 parallel nickel–chromium (Omega) filaments (heated filament array) was heated to about 250 °C by a DC power supply (Gw Instek SPS 606). The substrate temperature was controlled via backside cooling using a recirculating chiller/heater unit” (Experimental section). Tao teaches “Depositions were conducted on Teflon FEP-coated, removable substrates”. FEP stands for fluorinated ethylene propylene, which is a polymer. Here, Tao also provides that silicon wafer substrates were also used to show type of substrate was not important. TBPO is provided as t-butyl peroxide in Result and Discussion. Formation of dome shaped droplets with nucleation is seen in figure 4 that was affected by deposition time. Table 1 provides for deposition rate with 32 nm/min up to 600 nm per minute. Thus, in 1 minute the deposition size will be from 32-600 nm. Tao teaches “film growth is limited by monomer adsorption onto a growing polymer film. (12,13) Experiments conducted at or beyond monomer saturation (Pm/Psat > 1) showed significantly higher deposition rates, and the deposition rate increased nearly linearly with Pm/Psat. The maximum deposition rate observed was about 600 nm/min” (iCVD deposition section).” Tao teaches “For a typical deposition, the filament was turned on, and the system was equilibrated at operating pressure for 1 h. Monomer and initiator were then fed into the reactor at 5.8 and 2.2 sccm, respectively.” (Initiated chemical vapor deposition). Tao also teaches feeding the crosslinker into the chamber.
There is no indication of using a solvent or liquid other than the condensed monomers in Tao, and thus, it would be liquid and solvent free.
Although Tao teaches much of the process and components used in the process, Tao teaches films rather than particles. Based on rates in nm/minute, particles can be achieved by Tao and be nanometers in size and higher if allowed to go multiple minutes.
One of ordinary skill in the art before the time of filing would have been capable of using the method, components and apparatus of Tao to produce dome/hemisphere shaped particles in the nm size range or above as Tao provides for deposition rates that would allow for controlling the size of the produced polymer material while showing that the condensed drops are hemisphere/dome shaped. Tao provides for addition of crosslinking agent with its monomers, and thus, see adding an additional agent to the reactor. Tao provides for a substrate with a fluorinated polymer coating, and thus, sees modified surfaces for its process. Therefore, there was a reasonable expectation of success in using the teachings of Tao and achieving such polymer particles through controlling deposition rate and the time.
Claim 8 in addition to Claims 1-7, 9, 11-17, and 19-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tao et al (Langmuir, 2012, volume 28, pages 16580-16587) and Tung et al (Nature communications, 2018, cited previously).
Tao teaches the claims as discussed above.
Tao does not directly teach sublimation of the additional agent.
Tung teaches vapor deposition of polymers on regular stationary substrates is known and
that polymer particles with sizes controllable to the nanometer scale can be produced by
chemical vapor deposition (abstract). Tung teaches that defined size and porosity are controlled
by varying the processing time (abstract). Tung teaches deposition of the polymer is directed via
a sublimation process (abstract). Tung teaches the stepwise sublimation/deposition process is a
facile approach to fabricate a polymer particle (see discussion on page 6). Tung teaches "TEM
images show the production of particle composites by incorporating metals or oxides during the
fabrication (sublimation/deposition) process" (figure 4 legend). Tung uses the
sublimation/deposition process to produce multifunctional particles and composites (page 5).
One of ordinary skill in the art before the time of filing would see the sublimation/deposition of agents/reactants in a vapor involved process for making polymer particles of Tung would have been seen useful for a vapor phase polymerization process of Tao that makes polymer particles since it creates a new and improved way to control sizes of the polymer particles being produced and to produce multifunctional particles. Thus, there was a reasonable expectation of success in combining the techniques of Tung with the techniques of Tao and achieving a process that would sublime agents in a vapor phase polymerization process to create polymer particles with agents such as drugs/actives. As Tao’s process involves the use of vaporized materials, the sublimation of the agent would put the agent into a gas phase suited for its reactor.
Claim 10 in addition to Claims 1-7, 9, 11-17, and 19-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tao et al (Langmuir, 2012, volume 28, pages 16580-16587) and Akala US 20140274929, cited previously.
Tao teaches the claims as discussed above.
Tao does not teach one of the agents as in claim 10.
Akala teaches making polymer particles (abstract). Akala teaches ethylene glycol dimethacrylate as a crosslinker for the particles (paragraphs 8 and 99). Paragraph 92 teaches hydroxyethyl methacrylate as an acrylate in the polymer (paragraph 92), which is also noted as avoiding biological recognition (paragraph 68). Akala teaches mechlorethamine (aka chlormethine) as an anti-cancer drug that can be used (paragraph 111) as well as allowing other types of therapeutic agents (paragraphs 104-108). Akala's process also involves initiator systems to make the particles (paragraph 149 and paragraphs 101-103). Akala teaches "For example, in one embodiment, a therapeutic agent might be incorporated into the particle during the copolymerization process. The particle polymer would then prevent the therapeutic agent from prematurely being absorbed by the body or encountering biological barriers, such as macrophages, or even being prematurely excreted as waste" (paragraph 104). Thus, the drug is envisioned being added in the polymerization process rather than after it. Paragraph 154 provides for an example of adding a drug to the reaction mixture to make nanosphere particles. Paragraph 169 teaches the co-initiator system decomposes to form free radicals which react with the monomers.
One of ordinary skill in the art before the time of filing would have been capable of incorporating a therapeutic agent into a polymerization process as provided by Akala. Thus, there was a reasonable expectation of success of adding an additional agent that was a therapeutic agent and obtaining polymer materials with the incorporated agent such as therapeutic agent by the combined teachings of the prior art.
Advisory Notice/Allowable Subject Matter
After reconsideration of the response and noting the art (Tao) cited above in response to applicant’s new amendments to claim 1, claim 18 was found not be motivated by the prior art for such a process. As claim 18 is dependent on claim 16, it is noted the limitation of claim 18 requires the substrate to be functionalized by an omniphobic coating that enables dropwise condensation on the substrate. Applicant’s specification shows in paragraphs 133-136, using a perfluorodecyl acrylate compound (a type of perfluorinated polymer) to form such an omniphobic coating on the substrate and then using it to provide the making of the particles. It is noted in the art that not all fluorinated polymers are capable of omniphobic coatings, but the group of perfluorinated polymers are. If these limitations from claim 16 and 18 are added to claim 1 in a proper format, then applicant will have an allowable claim barring any other issues that might occur during an amendment (e.g. new 112’s, objections or if there is a broadening amendment to any of the limitations). Applicant will also have to address the 112(b) rejections in this action. Upon noting of an allowable independent claim, Applicant may have to consider cancelling withdrawn “particle claims” at this time as these would be considered by product-by-process claims (MPEP 2113) and similar particles might be found in the prior art made by different processes. The particle claims would require different searching of the prior art than the method that had particular steps, conditions, and equipment to perform the method.
Conclusion
No claims are allowed. Claim 18 is objected to.
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 MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong 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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/MARK V STEVENS/ Primary Examiner, Art Unit 1613
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