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 the Claims
Pursuant to the amendment dated 04/27/2026, claim 17 has been cancelled and new claim 51 has been added. Claims 8, 13, 21-26, and 28-30 have been cancelled in a prior communication. Claims 1-7, 9-12, 14-20, 27, 31, and 51 are pending. Claims 27 and 31 stand withdrawn without traverse.
Claims 1-7, 9-12, 14-20, and 51 are under current examination.
All rejections not reiterated have been withdrawn.
Claim Objections
Claims 1, 2, and 15 are objected to because of the following informalities:
Claim 1 recites “polymeric microparticle” in line 2 and line 4. The examiner recommends amending to recite “polymeric microparticles” to improve the readability of the claim.
Claim 2 recites “The composition of claims 2”. This is ungrammatical; amending to recite “The composition of claim 2” would be remedial.
Claim 15 recites “of the in the” in line 2. This is ungrammatical, amending to delete the redundancy would be remedial.
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 5-7 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 5 recites the limitation "the biocompatible polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 1 allows for two biocompatible polymers, the first polymer in the shell and/or the second polymer in the core. As the claims are currently worded, it is unclear whether claim 5 limits one or both of the biocompatible polymers that claim 1 embraces.
Claim 6 recites the limitation "the biocompatible polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 1 allows for two biocompatible polymers, the first polymer in the shell and/or the second polymer in the core. As the claims are currently worded, it is unclear whether claim 6 limits one or both of the biocompatible polymers that claim 1 embraces.
Claim 7 recites the limitation "the non-erodible polymer" in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 1 allows for two non-erodible polymers, the first polymer in the shell and/or the second polymer in the core. As the claims are currently worded, it is unclear whether claim 7 limits one or both of the non-erodible polymers that claim 1 embraces.
Response to Arguments
Applicant's arguments filed 04/27/2026 have been fully considered but they are not persuasive. On pages 7-8, Applicant argues that claim 1 has been amended to correct antecedent basis for biocompatible polymer and non-erodible polymer. The examiner respectfully disagrees. The way the claim is worded both the first and the second polymer are biocompatible and at least one of the first and the second polymers must be non-erodible. The way the claims are currently worded, it is unclear whether claims 5-7 require the first, the second, or both polymers to be biocompatible or non-erodible, respectively.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-5, 14, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rariy et al. (US 9248195; issue date: 02/02/2016; cited in the IDS filed 07/28/2023) in view of Singh et al. (US 20150313892; publication date: 11/05/2015).
With regard to claims 1, 3 and 4, Rariy discloses an abuse-deterrent pharmaceutical composition comprising a drug likely to be abused, such as opioids, dispersed within coated spherical microparticles composed of a material that is either slowly soluble or not soluble in water, wherein the drug is slowly released after administration (abstract). The microparticles are formed from a carrier material, which may be a polymer such as ethylcellulose, i.e. a biocompatible non-erodible polymer (col 9, lines 50-57). The coating material may also be ethyl cellulose or methyl cellulose (col 11, lines 29-34). The drug subject to abuse can be, inter alia, tramadol (col 6, line 44). The focus of Rariy’s disclosure is on oral delivery; however, Rariy teaches that the in addition to oral administration, some embodiments may be administered by other routes (col 16, lines 21-25).
Thus, Rariy teaches a pharmaceutical composition comprising a population of microparticles wherein each of the microparticles comprises a polymeric core comprising a first polymer and an active agent subject to abuse, and a polymeric shell comprising a second polymer, wherein the first polymer is a biocompatible polymer and the second polymer is a biocompatible polymer and wherein the first polymer, the second polymer, or both the first polymer and the second polymer comprise a non-erodible biocompatible polymer.
Rariy does not disclose that the composition is injectable and formulated in a pharmaceutically acceptable injectable carrier.
Singh discloses a pharmaceutical composition for treating pain associated with dysmenorrhea (title) comprising the opioid, tramadol, in combination with an anticonvulsant and a NMDA antagonist (abstract) can be delivered in the form of microparticles for injection (0180). Singh discloses further that the composition is for sustained release that provides a release rate to attain the desired results (0240). The drugs may be formulated in a carrier suitable for intravenous, subcutaneous, or other suitable mode of administration (0249), which the examiner considers to fall within the scope of “pharmaceutically acceptable injectable carrier. The composition may also form a depot (e.g. claim 5).
It would have been prima facie obvious to formulate the coated particles of Rariy to contain tramadol in combination with gabapentin or pregabalin and an NMDA antagonist for injection in a pharmaceutically acceptable injectable carrier. The artisan of ordinary skill would have been motivated to do so in order to treat symptoms of dysmenorrhea in patients who prefer modes of administration other than oral, and also provide extended release of the medicine while protecting against potential recreational misuse of the drugs subject to abuse. the artisan of ordinary skill would have had reasonable expectation of success because this would merely require formulating the tramadol taught by Rariy with gabapentin and the NMDA antagonist followed by dispersing in an injectable pharmaceutical carrier.
With regard to claim 5, as noted above, Rariy teaches ethylcellulose for both the coating and the core of the microparticle.
With regard to claim 14, the examiner considers it to have been routine testing for one of ordinary skill to determine the amount of each drug to achieve the pain relief they were recognized to provide (see MPEP 2144.05).
With regard to claim 16, as noted above, Singh directs the artisan of ordinary skill to seek sustained release that provides a release rate to attain the desired results. It would have been merely optimization of the parameters described in Rariy and Singh for the artisan of ordinary skill, e.g. an individual with a Ph.D. in formulations science, to develop a polymer core/shell combination that achieves a desired release profile. For this reason, the examiner does not consider the limitation of instant claim 16 to patentably define over the cited prior art.
With regard to claim 18, the composition can be formulated for e.g. subcutaneous delivery, which would also provide local delivery. Moreover, claim 18 recites an intended use for the composition. As the composition rendered obvious by Rariy or Singh is compatible for use for this purpose, the claim does not patentably define over the prior art.
With regard to claim 19, as noted above, Rariy’s composition deters abuse of the medication.
With regard to claim 20, Singh teaches aqueous suspension for parenteral delivery (0249), which may contain suspending agents such as hydroxypropyl methyl cellulose or natural gums (i.e. dispersing agent, referred to by Singh as a “suspending agent”; 0250).
With regard to claim 51, the ethylcellulose taught by Rariy is a non-erodible, biocompatible polymer.
Claims 2, 7, 9-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rariy et al. (US 9248195; issue date: 02/02/2016; cited in the IDS filed 07/28/2023) in view of Singh et al. (US 20150313892; publication date: 11/05/2015) as applied to claims 1, 3-5, 14, 16-20 and 51 above, and further in view of Ghosh et al. (US 20120202838; publication date: 08/09/2012).
The relevant disclosure of Rariy and Singh are set forth above.
Neither reference discloses a dispersing agent in the polymer coating (second polymer) as required by instant claims 2, 9-12, and 15.
Rariy discloses that the shell may further comprise a plasticizer (col 11, line 31).
Ghosh discloses that poloxamers, such as poloxamer 407, function as plasticizers (0016, claim 20, 0068).
It would have been prima facie obvious to use poloxamer 407 (limitations of instant claims 2, 9-12) as the plasticizer in Bruna’s invention because this substance was known to serve the same purpose as the plasticizers disclosed by Bruna (see MPEP 2144.06(I)).
With regard to the limitation of instant claim 2 requiring a dispersing agent, the examiner notes that poloxamer 407 also functions as a dispersing agent (see claims 9-12) and as such this limitation is inherently met by the substance poloxamer 407 (see MPEP 2112).
With regard to the amount of dispersing agent required by instant claim 15, Ghosh discloses an example composition comprising poloxamer 407 at 6.4% of the formulation (table 4, page 16). This falls within the scope of the range required by instant claim 15 and would have given the artisan of ordinary skill a starting point to optimize plasticizing effect. The examiner does not consider the range recited in instant claim 15 to patentably define over the cited prior art as substances falling within the term “dispersing agent” (i.e. poloxamer 407) were known for use in the field within the claimed range. Absent evidence establishing criticality of the claimed range in dispersing agent to an unexpectedly superior property, this limitation is considered prima facie obvious. See MPEP 2144.05(II).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Rariy et al. (US 9248195; issue date: 02/02/2016; cited in the IDS filed 07/28/2023) in view of Singh et al. (US 20150313892; publication date: 11/05/2015) as applied to claims 1, 3-5, 14, 16-20 and 51 above, and further in view of and further in view of Lee et al. (US 20160326325; publication date: 11/10/2016).
The relevant disclosure of Rariy and Singh are forth above.
As noted above, Rariy discloses that the coating may be formed from ethyl cellulose but does not disclose the specific polymers listed in instant claims 6 and 7.
Lee discloses that polysulfone was known to function as an encapsulating (i.e. coating) agent as of the instant effective filing date.
It would have been prima facie obvious to replace the ethyl cellulose disclosed as a coating polymer with polysulfone because these two substances were known to serve the same purpose as of the instant effective filing date (see MPEP 2144.06(I)).
The examiner notes that in view of the indefiniteness rejection above, neither claim 6 nor claim 7 clearly limits the first (core) or second (shell) polymers recited in instant claim 1. Claim 6 reads on microparticles in which the first or second polymers are biocompatible and selected from polysulfone, polycaprolactone, or a combination thereof because the unclear antecedent basis of “biocompatible” is not clear. As explained in the indefiniteness rejection above, the claim is interpreted to further limit either the biocompatible first polymer or the biocompatible second polymer or both biocompatible first and second polymers. Similarly, claim 7 limits either the non-erodible first polymer or the non-erodible second polymer because claim 1 permits either the first or the second polymer to be non-erodible. As such, claim 7 reads on microparticles in which the first or second polymers are non-erodible and selected from polysulfone, poly(ethylene-co-vinyl-acetate), or polyvinyl alcohol.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 9-12, 14-16, and 18-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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