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
Applicant’s election without traverse of Group II, claims 70-72 and 74-80 in the reply filed on 17 March 2026 is acknowledged. Accordingly, claims 1, 39, 40, 87-92, and 94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 80 is objected to because of the following informalities: “loaded polymeric shell” in lines 1-2 should be recited as --- loaded shell ---. 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.
Claims 71 and 74-79 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.
Claim 71 recites a first temperature. The claim is indefinite because the scope of the claim is unclear. It is not clear what temperatures are encompassed by the recitation of “first temperature.” At best, p. 4, lines 13-15 of the instant Specification discloses wherein the first temperature is from about 50 °C to about 200 °C. However, the same paragraph also discloses wherein the first temperature is from about 60 °C to about 100 °C. Therefore it is unclear which range of temperatures is encompassed by the recitation of “first temperature” such that one of ordinary skill in the art would know when a temperature infringes on the claimed invention.
Claims 74-79 are rejected as they depend from claim 71 but do not further clarify the scope.
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 70-72 and 74-80 are rejected under 35 U.S.C. 103 as being unpatentable over McHugh et al. (US 2019/0076631 A1, 03/14/2019, IDS reference of 04/23/2024, hereinafter McHugh).
McHugh discloses core-shell microdevices suitable for biomedical application, comprising complex geometries and having fully-enclosed internal cavities containing a solid or liquid (abs, [0023]). The microdevices comprise biocompatible, biodegradable polymers and agents and/or adjuvants in the internal cavities ([0019]). The microdevice shell complex geometries include cube, cone, cylinder, ellipsoid, and sphere, with a hollow core ([0070], [0071]). Pharmaceutical agents, including therapeutic and prophylactic agents, may be loaded into the void space of the core during the process of microdevice formation ([0080], [0082], [0090]). The polymers may be micromolded to make microparticles, filled with chemical compounds (e.g. pharmaceutical agents), and a final microstructure may be created by welding the microparticles within the mold by plastic welding methods, including thermal and ultrasonic welding as well as solvent and gas based welding ([0174]). Methods of forming spherical microdevices includes having two halves, or having the polymer structure fold over itself ([0298]).
Accordingly, McHugh discloses preparing a microparticle comprising obtaining a polymeric shell having a bottom and open top with hollow core, filling with an agent and/or adjuvant, and then sealing the filled microparticle, wherein the methods of forming the microparticle includes having the shell structure fold over itself. The microdevices have fully-enclosed internal cavities. Together these would provide a method as instantly claimed. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A). Moreover, one of ordinary skill in the art would reasonably expect the process to result in a microparticle of claim 1 as instantly claimed.
Regarding claim 71, as discussed above, McHugh discloses wherein the microstructure may be created by thermal welding. Accordingly, it would have been obvious to one of ordinary skill in the art that the filled microparticles are exposed to a first temperature, i.e., heated to a first temperature.
Regarding claim 72, although McHugh does not explicitly disclose a heating temperature, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed temperature range (i.e. about 50 °C to about 200 °C) through routine experimentation based on the temperatures desired to create the final microstructure. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 74, as discussed above, McHugh discloses wherein the methods of forming the final microstructure of the microparticles include ultrasonic welding (i.e. radiation).
Regarding claims 75-76 and 78-79, as discussed above, McHugh discloses wherein the methods of forming the final microstructure of the microparticles include gas based welding (i.e. flow of heated gas). Accordingly, it would have been obvious for one of ordinary skill in the art to have included gas based welding (i.e. non-contact), since it is a known and effective welding method as taught by McHugh. As such, a heating source having a solid surface (i.e. heat gun) and placing the filled microparticles in proximity to the heat source but not touching the heat source would flow from such teaching. Moreover, regarding claim 79, although McHugh does not explicitly disclose a temperature range, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed temperature range (i.e. about 60 °C to about 200 °C) through routine experimentation based on the temperatures desired to create the final microstructure. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP § 2144.05(II)(A).
Regarding claim 77, as discussed above, McHugh discloses wherein the methods of forming the final microstructure of the microparticles include thermal welding. Accordingly, contacting the microparticles with a solid surface heating source would have been obvious.
Regarding claim 80, as discussed above, McHugh discloses wherein the methods of forming the final microstructure of the microparticles include solvent based welding. Accordingly, contacting the filled microparticles with a solvent would have been obvious.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jaklenec et al. (US 2019/0328871 A1, 10/31/2019, IDS reference of 04/23/2024), and Jaklenec et al. (US 2015/0165020 A1, 06/18/2015, IDS reference of 04/23/2024), directed to micromolded or 3-D printed microparticles filled with an active.
Chatterjee et al. (US 2004/0065969 A1, 04/08/2004), directed to microencapsulation methods comprising an agent (e.g., a drug) and a cross-linkable matrix material.
Mihov et al. (US 2017/0367992 A1, 12/28/2017), directed to drug delivery systems comprising a core comprising a bioactive agent, and a shell, and a process for manufacturing the drug systems.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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