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 .
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.
Election/Restrictions – Groups
Applicant’s election of Group I, claims 1-3, 5, 7-8, 10, 12-13, 16, 19, 23, 27-28, 37, 45, and 47, in the reply filed on 14 July 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)); the examiner notes that the election without traverse applies only to the group election.
Claims 21, 26, 30-31, 39-40, and 54-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 July 2026.
Election/Restrictions – Species
In applicant’s response on 14 July 2026 (hereafter referred to as applicant’s response), applicant made an initial election of the solid composition, and then a secondary election of a dispersion.
As an initial matter, it is the examiner’s position that the election of a solid composition is non-responsive because the claims are drawn to different solid compositions that would have lacked a common technical feature. Reasoning in support of this position was presented on pages 6-7 of the office action mailed on 21 May 2026 and does not appear to have been rebutted by applicant. As such, the examiner has proceeded with the understanding that applicant has elected a dispersion.
As such, applicant's election with traverse of the species of a dispersion in the reply filed on 14 July 2026 is acknowledged. As best understood by the examiner, this traversal appears to be on the grounds that other solid forms have been recited by the claims. However, this is not persuasive because nothing in applicant’s arguments appear to explain why the different solid forms recited by the claims have a common technical feature. Additionally, nothing in applicant’s arguments appear to rebut the positions taken on pages 6-7 of the office action mailed on 21 May 2026.
As such, the species election requirement is still deemed proper and is therefore made FINAL.
Claims 30-31, 37, 39-40, 45, and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected specie (namely that of the rod of microneedle), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 14 July 2026.
Note Regarding Nomenclature
As best understood by the examiner, glecaprevir is also known as ABT-493, and pibrentasvir is also known as ABT-530. In support of this position, the examiner cites Ren et al. (WO 2018/028634 A1). Ren et al. (hereafter referred to as Ren) teaches the following on page 19, relevant text reproduced below with annotation by the examiner.
PNG
media_image1.png
150
778
media_image1.png
Greyscale
As such, the examiner understands that ABT-530 is pibrentasvir and ABT-493 is glecaprevir. The examiner has used these terms interchangeably in the office action.
Multiple Dependent Claims – Claim Objection
Claim 28 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from another multiple dependent claim. Specifically claim 28 is a multiple dependent claim, and depends from claim 27, which is a multiple dependent claim. See MPEP § 608.01(n), specifically 608.01(n)(B)(4). Accordingly, the claim has not been further treated on the merits.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 19 and 23 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 19 recites the following:
PNG
media_image2.png
188
736
media_image2.png
Greyscale
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. See MPEP 2173.05(d) as well as MPEP 2173.05(c). In this case, it is unclear whether part (i) of claim 1 is drawn to the broader range of 10 nm to 2500 nm, or to narrower ranges such as 50 nm to 1500 nm.
For the purposes of examination under prior art, the examiner will examine the claims with the understanding that the broader ranges are limiting.
Similar issues apply to claim 23; the examiner has interpreted the claim with the understanding that the broadest range is limiting.
Claim Interpretation
Claim 1 recites “vit-E-PEG-succinate.” This is an abbreviation for Vitamin E polyethylene glycol succinate, or Vitamin E PEG succinate. It is also known as tocopheryl PEG succinate or tocopherol PEG succinate.
Claim 1 recites various terms in parentheses. The terms in parentheses are abbreviations for the name of the chemical preceding the term in parentheses. For example, claim 1 recites “polyvinyl alcohol (PVA).” In this case, the claim is defining “PVA” as an abbreviation for polyvinyl alcohol.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1-3, 5, 7-8, 10, 12-13, 16, 19, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US 2017/0333460 A1).
Hong et al. (hereafter referred to as Hong) is drawn to long-acting pharmaceutical compositions for treatment of hepatitis C, as of Hong, title and abstract. Hong teaches a parenteral formulation in paragraph 0002, which is administered by injection, as of Hong, paragraph 0040. Hong teaches microparticles, as of Hong, paragraph 0060.
As to claim 1, the claim requires glecaprevir and pibrentasvir. Hong teaches the following in paragraph 0100, reproduced in part below with annotation by the examiner.
PNG
media_image3.png
501
825
media_image3.png
Greyscale
As best understood by the examiner, ABT-493 reads on glecaprevir and ABT-530 reads on pibrentasvir.
As to claim 1, the claim requires a first excipient. Hong teaches polyvinyl alcohol and polyvinyl pyrrolidone in paragraph 0057. Hong also teaches polyvinyl pyrrolidone in paragraph 0053.
As to claim 1, the claim requires a second excipient. Hong teaches polysorbate 80 in paragraph 0053.
As to claim 1, Hong appears to teach all of the claim requirements, albeit not in a single embodiment. As such, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 2, the skilled artisan would have been motivated to have formulated compositions of glecaprevir and pibrentasvir in view of paragraph 0100 of Hong.
As to claim 3, Hong teaches polyvinyl pyrrolidone (i.e. PVP) and polysorbate 80 in paragraph 0053.
As to claim 5, this claim is rejected for essentially the same reason that claim 3 is rejected.
As to claim 7, because Hong teaches glecaprevir and pibrentasvir on a list in paragraph 0100, the skilled artisan would have been motivated to have made a composition of glecaprevir in the absence of pibrentasvir. A reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component; see MPEP 2123.
As to claim 8, Hong teaches polyvinyl pyrrolidone (i.e. PVP) and polysorbate 80 in paragraph 0053.
As to claim 10, Hong teaches poloxamer and PEG in paragraphs 0174-0175.
As to claim 12, Hong teaches glecaprevir and pibrentasvir on the list in paragraph 0100.
As to claim 13, Hong teaches polyvinyl pyrrolidone (i.e. PVP) and polysorbate 80 in paragraph 0053.
As to claim 16, Hong teaches the following amounts of active and inactive ingredients, as of Hong, page 16, left column, relevant text reproduced below.
PNG
media_image4.png
296
510
media_image4.png
Greyscale
These amounts of ingredients appear to differ from the claimed amounts. Nevertheless, generally, differences in concentration between the prior art and claimed invention will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Additionally, where 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). In this case, the general conditions of a dispersion (i.e. suspension) of particles comprising anti-hepatitis C drugs such as glecaprevir pibrentasvir, along with excipients, intended for long-acting parenteral administration, has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable ranges of amounts and concentrations of these ingredients via routine experimentation.
As to claim 19, Hong teaches the following, in paragraph 0060, relevant text reproduced below.
PNG
media_image5.png
252
504
media_image5.png
Greyscale
The examiner notes that 1 μm is 1000 nm. As such, Hong teaches a size range of 1000 nm to 5000 nm as of the last full sentence reproduced above. This overlaps with the size range of 10 nm to 2500 nm. Hong also teaches a size range of 50 nm to 100,000 nm in the first sentence; this also overlaps with the claimed range. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 23, the examiner notes that this is an independent claim that appears to have the same requirements as claim 1 other than the differences of claim 1 reciting an aqueous dispersion, as well as an optional limitation regarding the amount of active agent. Hong teaches a sterile suspension in paragraph 0070; this is understood to read on the required dispersion.
As to claim 27, Hong teaches a pharmaceutical composition in paragraph 0070. Hong also teaches a pharmaceutically acceptable carrier in paragraph 0079.
Claim(s) 1-3, 5, 7-8, 10, 12-13, 16, 19, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (US 2017/0333460 A1) in view of Rannard et al. (US 2019/0269662 A1).
Hong is drawn to a long-acting parenteral dosage form for administering a drug for treating hepatitis C. See the rejection above over Hong by itself.
For the purposes of this rejection, the examiner understands that Hong is deficient because Hong does not teach various excipients recited by instant claim 1 including but not limited to hydroxypropyl methylcellulose (HPMC) and tocopherol PEG succinate (i.e. Vitamin E PEG succinate). Also, Hong is silent as to the polydispersity index required by claim 19.
Rannard et al. (hereafter referred to as Rannard) is drawn to a solid dispersion for the delivery of maraviroc, which comprises various excipients, as of Rannard, title and abstract. The composition of Rannard is long-acting and is intended for injection, as of Rannard, paragraph 0374; Rannard also teaches the use of various excipients; see e.g. Rannard, page 15 right column, relevant tables reproduced in part below.
PNG
media_image6.png
270
520
media_image6.png
Greyscale
PNG
media_image7.png
204
518
media_image7.png
Greyscale
As such, Rannard teaches polymers and surfactants used in dispersions for administering a long acting injection of an active agent.
Rannard differs from the claimed invention because the active agent of Rannard differs from the required glecaprevir and/or pibrentasvir. For that matter, the active agent of Rannard is intended to treat HIV/AIDS, whereas the claimed active agents are for treating hepatitis C.
It would have been prima facie obvious for one of ordinary skill in the art to have used the dosage form of Rannard to have delivered the active agents of Hong. Rannard is drawn to a dosage form intended to deliver active agents parenterally and/or by injection in a long-acting manner. Hong desires that drugs intended to treat hepatitis C be administered in a long-acting manner, as of Hong, at least paragraph 0037 as well as elsewhere in the reference. As such, the skilled artisan would have been motivated to have used the dosage form of Rannard to have predictably administered the active agents of Hong parenterally in a long-acting manner with a reasonable expectation of success.
As to claim 1, the claim requires microparticles. Rannard teaches nanoparticles. Nevertheless, the particle size of Rannard, paragraphs 0022-0023, appears to overlap with the particle size of the particles required by instant claim 19. As such, the composition of Rannard is understood to read on the required microparticles.
As to claim 1, the claim requires glecaprevir and/or pibrentasvir. Hong is understood to teach this; see the rejection above over Hong by itself.
As to claim 1, the claim requires various excipients. These appear to have been taught by Rannard, as of the above-reproduced tables.
As to claim 2, Hong is understood to teach the requirements of this claim.
As to claim 3, Rannard teaches polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), and polysorbate 20 (referred to by its trade name of Tween 20) as of the above-reproduced tables.
As to claim 5, Rannard teaches polyvinyl alcohol (PVA) and vitamin E PEG succinate (referred to by its abbreviation of TGPS, which stands for tocopherol PEG succinate, wherein tocopherol is vitamin E) as of the above-reproduced tables.
As to claim 7, this feature has been taught by Hong; see the rejection above over Hong by itself.
As to claim 8, Rannard teaches polyvinyl pyrrolidone (PVP), and polysorbate 20 (referred to by its trade name of Tween 20) as of the above-reproduced tables.
As to claim 10, Rannard teaches polyvinyl alcohol (PVA), vitamin E PEG succinate (referred to by its abbreviation of TGPS, which stands for tocopherol PEG succinate, wherein tocopherol is vitamin E), and polysorbate 20 (referred to by its trade name of Tween 20) as of the above-reproduced tables.
As to claim 12, this feature appears to have been taught by Hong. See the rejection above over Hong by itself.
As to claim 13, Rannard teaches polyvinyl pyrrolidone (PVP), and polysorbate 20 (referred to by its trade name of Tween 20) as of the above-reproduced tables.
As to claim 16, Rannard teaches the following formulations in paragraph 0317, relevant text reproduced below.
PNG
media_image8.png
194
498
media_image8.png
Greyscale
The amounts of the drug, polymer (i.e. first excipient), and surfactant (i.e. second excipient) in Rannard appear to overlap with what is required by the instant claims. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). While the active agent in Rannard differs from that of the instantly claimed invention, upon substitution of the active agent of Hong in place of that of Rannard, the resultant compositions would have had amounts of ingredients that overlap with the claimed amounts.
As to claim 19, Rannard teaches the following on the table on page 16, relevant text reproduced below.
PNG
media_image9.png
534
738
media_image9.png
Greyscale
The above particle sizes and polydispersity indexes appear to overlap with those which are claimed. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 23, the examiner notes that this is an independent claim that appears to have the same requirements as claim 1 other than the differences of claim 1 reciting an aqueous dispersion, as well as an optional limitation regarding the amount of active agent. Rannard teaches a dispersion in paragraph 0052.
As to claim 27, Rannard teaches a pharmaceutical composition with excipients, as of paragraph 0043.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights