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 invention group I, claims 1-3, in the reply filed on 02/06/2026 is acknowledged.
Claims 4-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/06/2026.
Claims 1-16 are pending, claims 1-3 are under examination.
Priority
Acknowledge is made that this application is a Continuation-In-Part of application Ser. No. 16/771,196, dated Jun. 9, 2020, which is national stag of international patent application PCT/KR2018/010324, filed on Sep. 5, 2018; which claims priority from Korean Applications No. 10-2017-0113669 filed on Sep. 6, 2017, and No. 10-2018-0031979, filed on Mar. 20, 2018.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/08/2024 is being considered by the examiner.
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 of this title, 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 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 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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Cardona et al. (US20190175507).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Cardona et al. teaches microparticles suitable of oral administration
of active agents to a subject in need thereof (abstract). The microparticles are discrete, self-sustaining bodies, each comprising a cured or crosslinked polymer matrix and a delivery enhancing moiety. Exemplary polymers that can be used include polyvinyl alcohol, poly (ethylene glycol), polylactic acid, poly-L-lactic acid, polycaprolactone,
polyglycolic acid, poly(lactic-co-glycolic acid), polyhydroxyalkanoate (page 2, [0028]). The active ingredient includes moxidectin (page 4, [0042]). Embodiments of the invention are also concerned with methods of producing polymer microparticles with
active agents uniformly distributed throughout the polymer matrix and of isolating the microparticles containing the encapsulated agents which conform to a uniform, desirable size via coacervation (page 4, [0043]). The particle size is from 1 um to 1000um, and microparticle can be controlled release (page 6, [0058]). The particle is spherical in one embodiment (page 7, [0065]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Cardona et al. is that Cardona et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Regarding claims 1, Cardona et al. teaches microparticle comprising moxidectin uniformly distributed throughout the polymer PLA with particle size 1 um to 1000um and the particle is spherical.
Regarding the ratio of polymer to moxidectin and the extended release from 3-6 months are adjust parameter, and one artisan in the art would have been motivated to optimize those parameters to have claimed weight ratio of polymer to moxidectin to 9:1 and the extended release from 3-6 months so that the effect of drug maintaining 3 to 6 months, in the absence of showing critical range. MPEP 2144.05.
Regarding claims 2-3, these are considered as product by process. Please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (US5733566) in view of Theberge et al. (US20100226947).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Lewis teaches An injectable controlled-release composition comprising:
microparticles, wherein said microparticles comprise a biodegradable polymeric matrix, wherein said composition comprises an antiparasitic agent within said matrix, and
wherein release of said agent is essentially dependent upon diffusion from, leaching from or erosion of the matrix or by a combination of these mechanisms. In one embodiment, the polymer is PLGA or PLA (polylactide), and the active agent is moxidectin and loaded with 1-75% by weight based on polymer. The particle size is from 1 to 250um (column 17-18, claims 1, 10-12, 17-19). The invention provides durations of action ranging from less than a week to several months depending upon the type of microsphere selected. In a preferred embodiment, the microspheres are designed to afford antiparasitic effect in animals over a period of a few days to one year, and preferably 30 to 270 days. The duration of action can be easily controlled by manipulation of the polymer composition, polymer : drug ratio and microsphere size. The bloodstream level of agent can also be controlled by varying these parameters (column 12, line 50-59). The microparticle has spherical shape (column 7, line 25-31). The microparticles are prepared according to some known methods (column 9, line 5 to 65). In example 3, polylactide is used in microparticle (column 16, example 3).
Theberge et al. teaches articles of manufacture having a formulation distributed therein, wherein the formulation comprises an active agent which manifests a desirable property when released from the articles of manufacture (abstract). The active agent is in the form of microparticle in one embodiment. The active ingredient may be uniformly or a nonuniformly distributed within the microparticles. When the active ingredient is uniformly distributed in the microparticle, the concentration of active ingredient in the microparticle is steady as the microparticle disintegrates, whereas when the active ingredient is not uniformly distributed within the microparticle, the concentration of the active ingredient in the microparticle varies as the microparticle disintegrates. In
other time release situations, the concentration of the active ingredient increases towards the center of the microparticle to compensate for reduced surface area as the microparticle disintegrates and thus tend to counteract the reduction of the rate of release of the active ingredient owing to the reduction of the surface area of the particle (as the particle shrinks due to erosion, its surface area diminishes) (page 10, [0095-0099).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Lewis is that Lewis do not expressly teach active agent uniformly distributed in the PLA. This deficiency in Lewis is cured by the teachings of Theberge et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Lewis, as suggested by Theberge et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have active agent uniformly distributed in the PLA in the microparticle because this is known and conventional formulation for microparticle comprising active agent as suggested by Theberge et al. Since there is no inventive step involved to follow the known and conventional formulation for microparticle, it is obvious for one of ordinary skill in the art to have active agent uniformly distributed in the PLA in the microparticle and produce instant claimed invention with reasonable expectation of success.
Regarding claims 1-3, prior arts teach microparticle comprising moxidectin uniformly distributed throughout the polymer PLA with particle size 1 um to 250um and the particle is spherical.
Regarding the ratio of polymer to moxidectin and the extended release from 3-6 months, Lewis teaches active agent moxidectin loaded with 1-75% by weight based on polymer, when moxidectin is loaded with about 11.1%, the ratio is 9:1; Lewis teaches extended release from 30 to 270 days (1 to 9 months), encompassing claimed 3 to 6 months, thus, the effect of drugs remains 3 to 6 months.
Regarding claims 2-3, these are considered as product by process. Please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11931461. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference Patent teaches microparticle comprising moxidectin in PLGA, which is obvious variant of PLA, Thus, it is obvious for one of ordinary skill in the art to produce applicant’s claimed invention with reasonable expectation of success.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18856012 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference Patent teaches microparticle comprising moxidectin in PLA, the ratio of PLA to moxidectin and sustained release over 3 months.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18856000 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference Patent teaches microparticle comprising moxidectin in PLA and the ratio of PLA to moxidectin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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, 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.
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.
/JIANFENG SONG/Primary Examiner, Art Unit 1613