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, 5-16, 18, 20-28, in the reply filed on 08/04/2026 is acknowledged.
Claims 29, 32 and 44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/04/2026.
Applicants further elected contraceptive agent as specific drug with traverse based on burden of search not being explained, this is not persuasive because this is national stage of internation patent application which follows PCT guidance for restri8ction requirement. There is indeed burden to search all specific drug since different filed of search is required for each drug. Thus, the election of species is proper and made final.
Claims 1-3, 5-16, 22-28 read on the elected species and are under examination; claims 18, 20-21 do not read on the elected species and are withdrawn from consideration.
claims 1-3, 5-16, 18, 20-29, 32 and 44 are pending; 1-3, 5-16, 22-28 are under examination.
Priority
Acknowledge is made that this application is national stage of internation patent application PCT/US2023/022560, filed on 05/17/2023; which claims priority from US provisional application 63/342983, filed on 05/17/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/28/2024 and 08/18/2026 is being considered by the examiner.
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.
Claim 23 is 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 23 recites the limitation "the water-soluble polymer" in 23. There is insufficient antecedent basis for this limitation in the claim.
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, 5-16, 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Prausnitz et al. (US20200238065) in view of Nguyen et al. (US20220096371).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Prausnitz et al. teaches separable microneedle arrays and microneedle patches are provided that may achieve sustained release of drug. The microneedle arrays may include one or more features that facilitate separation of the microneedles, such as a bubble structure. The microneedle arrays may include an effervescent material (abstract). A separable microneedle patch, as described herein, may be briefly and painlessly applied to skin to break off embedded biodegradable microneedles in the skin for slow-release of a drug, such as a contraceptive hormone. The microneedle arrays described herein may include a feature, such as an internal air bubble or an effervescent material, which facilitates the separation of the microneedles from the devices after insertion in the skin, after which the remaining portion of the device may be removed and discarded. The remaining portion of the device may be non-sharps waste. The detached microneedles may biodegrade in the skin for a sustained release and systemic delivery of a substance of interest ([0009-0010]). In some embodiments, the microneedle array for administering a substance of interest into a patient's biological tissue includes: a base substrate having a microneedle side and an opposing back side; and two or more solid microneedles extending from the base substrate, wherein at least a tip end portion of each microneedle comprises a substance of interest, wherein a bubble structure is disposed, at least partially, in each of the two or more solid microneedles, and the two or more solid microneedles are configured to penetrate into the patient's biological tissue under compression and then to fracture at the bubble structure, e.g., by a shear force applied to the array. A primary funnel portion may be disposed between and connect the base substrate and the microneedles. The bubble structure may be at least partially included in the primary funnel portion. For example, the bubble structure may be disposed at an interface of the base substrate (or the primary funnel portion, if present) and a base end of each microneedle ([0012]). In some embodiments, the microneedle array for administering a substance of interest into a patient's biological tissue includes: a base substrate having a microneedle side and an opposing back side; a primary funnel portion extending from the microneedle side of the base substrate; and two or more solid microneedles extending from the primary funnel portion, wherein at least a tip end portion of each microneedle comprises a substance of interest, wherein a bubble structure is disposed at an interface of the primary funnel portion and a base end of each microneedle, and the two or more solid microneedles are configured to penetrate into the patient's biological tissue under compression and then to separate from the primary funnel portion under shear, by fracture at the bubble structure ([0013]). FIG. 19 depicts a schematic illustration of the application into skin of one embodiment of a microneedle patch having an effervescent backing ([0041]). In some embodiments, the microneedles include an active pharmaceutical ingredient or other substance of interest, and arrays of these microneedles are particularly suited for use as/in drug delivery patches, such as for application to a patient's skin. Provided herein are microneedle patches, which, in some embodiments, can be used to self-administer a drug, such as a contraceptive. In some embodiments, the microneedle patches can provide sustained drug release. For example, the microneedle patches can provided long-term contraception by encapsulating a contraceptive hormone in biodegradable microneedles for slow release. The microneedles can be made of biodegradable, bioerodible, or bioadsorbable polymers (e.g., polylactic acid and poly(lactic-co-glycolic acid)) that may encapsulate a drug, such as a contraceptive hormone (e.g., a progestin, such as levonorgestrel, etonogestrel, or nesterone) for continuous release for at least two weeks, and, in some embodiments, four weeks or longer ([0053-0054]). The microneedle patches may be well tolerated, leave little visible evidence of use, and/or maintain plasma concentrations of a drug at or greater than a human therapeutic level for at least two weeks, and, in some embodiments, at least four weeks, at least 2 months, at least 3 months, at least 4 months, at least 5 months, or at least 6 months ([0055]). The microneedle arrays include a base substrate and two or more microneedles which extend from a surface of the base substrate. Each microneedle has a proximal end attached to the base substrate directly, or indirectly via one or more funnel portions, and a distal tip end which is sharp and effective to penetrate biological tissue. The microneedle has tapered sidewalls between the proximal and distal ends. The microneedles generally may have any cross-sectional shape, e.g., circular, polygonal, etc. ([0081]). In some embodiments, the microneedle patches provided herein advantageously include one or more funnel portions between the base substrate and the microneedles themselves. The addition of a funnel portion (sometimes referred to herein as a “funnel,” a “funnel portion,” “a pedestal,” a “primary funnel portion,” a “secondary funnel portion,” or a “funnel lead-in”) imparts certain advantages in its use, its manufacture, or in both its use and manufacturing ([0093]). Fig 1-29 depicts microneedle array that includes bubble structure and backing layer with integrated pedestal (Fig. 1-29, [0023-0051]). In some embodiments, the substance of interest is a hormone. The hormone may include a contraceptive hormone, such as a progestin. Examples of contraceptive hormones include levonorgestrel, etonogestrel, and nesterone. The hormone may include glucagon-like peptide-1 (GLP-1). The hormone may include testosterone. The hormone may include an estrogen, e.g., ethinyl estradiol ([0108]). The microneedle patches may include a single substance of interest or they may include two or more substances of interest. In the latter case, the different substances may be provided together within one of the microneedles, or some microneedles in an array of microneedles contain one substance of interest while other microneedles contain another substance of interest ([0112]). Matrix materials form the bulk of the microneedles, funnel portions, including the primary funnel portion and secondary funnel portions, and optionally the base substrate. A substance of interested may be dispersed in the matrix material used to form microneedles and/or funnel portions ([0116]). In some embodiments, microneedles are formed of a matrix material that is biodegradable, bioerodible, and/or bioabsorbable, and the matrix material encapsulates a substance of interest. The substance of interest is released as the matrix material degrades, erodes, is absorbed, or a combination thereof ([0118]). In some embodiments, microneedles are formed of a water soluble matrix material that encapsulates biodegradable polymer microparticles. The biodegradable polymer microparticles, in turn, encapsulate a substance of interest. The microneedles may dissolve relatively quickly upon contacting a biological fluid, leaving the biodegradable polymer microparticles behind (e.g., within a biological tissue), which slowly degrade and release the substance of interest ([0119]). In some embodiments, the bulk of the microneedles are formed from a matrix material including poly-lactic acid, poly-lactic glycolic acid, polycaprolactone, or a combination thereof In some embodiments ([0120]). As used herein, the terms “matrix material” and “excipient” are used interchangeably when referring to any excipients that are not volatilized or otherwise removed during drying and formation of the microneedles and funnels ([0121]). Some examples of excipients include lactose, sucrose, glucose, mannitol, sorbitol, trehalose, fructose, galactose, dextrose, xylitol, maltitol, raffinose, dextran, cyclodextrin, collagen, glycine, histidine, calcium carbonate, magnesium stearate, serum albumin (human and/or animal sources), gelatin, chitosan, DNA, hylaruronic acid, polyvinylpyrrolidone, polyvinyl alcohol, polylactic acid (PLA), polyglycolic acid (PGA), polylactive co-glycolic acid (PLGA) ([0122]). In some preferred embodiments, the microneedle is made of a biodegradable matrix material that encapsulates an API, and upon insertion into a patient the whole microneedle separates and degrades slowly in the skin ([0123]). The microneedle arrays described above may be combined with one or more other components to produce a microneedle patch, such as a patch that can be manually applied to a biological tissue, e.g., the skin, of a patient ([0124]). In a preferred embodiment, the substance of interest is loaded preferentially into the microneedles and their tips, and not into the funnel portions. The substance of interest is part of a filling material that is transferred into the mold. The filling material may also include a liquid vehicle. The filling material may be in the form of a solution, slurry or suspension of particles, melt, powder or particles, or a combination of any of these forms ([0134]). The filling material may include a combination of a solvent, a substance of interest, and a matrix material ([0135]). The microneedle and funnel cavities may be completely filled, partially filled, or overfilled. After a filling step occurs, it is generally followed by a drying or curing step. The drying or curing step can be achieved by heating or reduction in pressure (e.g., to evaporate solvent), by cooling or elevation of pressure (to solidify matrix material), exposure to light (e.g., polymerization due to ultraviolet light exposure) or combinations of these. This drying or curing step may fully, substantially or only partially dry or cure the deposited material. In general, the solution transfers more of the active into the microneedle and their tips when its viscosity is low, it has high surface energy within the funnel, and is not saturated with active (i.e., active is highly soluble in the solvent). However, none of these three characteristics are required, rather they have been found typically to enable more preferential loading of the microneedles and their tips ([0136]). The microneedles will then separate from the microneedle patch upon dissolution of the funnel portion if the funnel portion includes an effervescent material. When an effervescent material is included in the funnel portion, the microneedles may separate from the microneedle patch within about 10 seconds to about 120 seconds after the microneedle patch is pressed into the patient's skin/tissue. In some embodiments, the microneedles separate from the microneedle about 40 second to about 60 seconds after the microneedle patch is pressed into the patient's skin/tissue ([0151]). A working example teaches microneedle made from PLA and PLGA, and the patch backing made from PVA ([0160-0169]).
Nguyen et al. teaches A transdermal, biodegradable microneedle system and method for treating pain in a patient. The transdermal easy-to-use biodegradable microneedle system can be fully embedded into the skin to perform a sustained and nearly zero-order release kinetics of therapeutics over a long period of time (at least 30 days) for the treatment of pain (abstract). In Fig. 1, Nguyen et al. teaches a microneedle including PLGA cap. PLGA shell and NSAID in PLGA matrix (Fig. 1). The MNs are located on a supporting array before skin-insertion ([0020]). The present disclosure provides a transdermal easy-to-use biodegradable MN system which can be fully embedded into the skin to perform a sustained and nearly zero-order release kinetics of NSAIDs over a long period of time (at least 30 days) for the treatment of musculoskeletal pains. The present disclosure also provides a method of treating pain in a patient over a long period of time (at least 30 days) with a sustained release of a daily dose of a therapeutic and avoiding a burst release of the therapeutic. The method involves applying a transdermal microneedle assembly to the patient. The transdermal microneedle assembly includes a substrate, and a plurality of microneedles coupled to the substrate, each microneedle including a core and a shell. The core includes a therapeutic, wherein the therapeutic that when released through the shell provides a sustained release of the therapeutic into the patient over a period of time greater than 30 days to provide a daily therapeutic dose to reduce pain to the patient ([0043]). FIG . 1 illustrates the MN system 10 in accordance with an embodiment of the present disclosure . The MN system 10 include a substrate 14 and a plurality of microneedles 18 extending from the substrate 14. The plu rality of microneedles 18 each include a core 22 , a shell 26 surrounding the core 22 , and a cap 30 to enclose the core 22 . The same structure may be utilized for all or less than all of the microneedles 18 ([0044]).
Microneedle design; the microneedles include a height of 600 μm and diameter at the base of 300 μm (FIG. 3). The MNs are positioned on top of a supporting PLA array (200-600 μm high). Fabrication of the MNs: ASA was mixed with PLGA inside Acetone or Ethanol and deposited on a Teflon film for drying inside a vacuum-assisted desiccator to form a solid film (with different ASA concentrations). The film can also be lyophilized for a complete removal of the solvent. A pre-fabricated silicone or Polydimethylsiloxane (PDMS) molds were employed to fabricate the MN shell, core and cap. ([0055]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Prausnitz et al. is that Prausnitz et al. do not expressly teach cap of microneedle. This deficiency in Prausnitz et al. is cured by the teachings of Nguyen 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 Prausnitz et al., as suggested by Nguyen et al., and produce the instant invention.
Regarding claim 1,3, , Prausnitz et al. teaches a microneedle patch comparing a backing layer and the microneedle extending from the backing layer comprising a PLA microneedle with cavity fully filled with contraceptive agent in matrix such as PLGA so the contraceptive agent in matrix is encapsulated by microneedle. Since the cavity is fully filled with contraceptive agent in matrix, the contraceptive agent in matrix is considered core, and the microneedle with cavity is considered as shell. In arguendo that this is not microneedle with core-shell structure, under guidance from Nguyen et al. teaching microneedle with core -shell structure as known and suitable structure for transdermal patch, it is obvious for one of ordinary skill in the art to include a cap for microneedle in Prausnitz et al. and produce instant claimed invention with reasonable expectation of success. Prausnitz et al. further teaches microneedle being inserted unto skin (tissue) and separate from backing layer, the microneedle (shell) is PLA which is biodegradable and delayer s the release of drug for an extended period.
Regarding claim 2, since microneedle shell is made from PLA, when PLA is degraded overtime, the drug is released.
Regarding claims 5-6, Prausnitz et al. teaches backing layer made form PVA, a water-soluble polymer.
Regarding claim 7, Prausnitz et al. teaches backing layer comprising effervescent material.
Regarding claims 8-9, Prausnitz et al. teaches filling material comprising solvent, drug and matrix PLGA into cavity of microneedle, after removing solvent, the drug is dispersed into PLGA matrix as core.
Regarding claims 10-11, Prausnitz et al. teaches microneedle on the pedestal of backing layer (pedestal is integrated part of backing layer), since prior art teaches a microneedle cap which towards patch backing layer, pedestal is between backing layer and the each of cap potion of the microneedle.
Regarding claims 12-13, Prausnitz et al. teaches the bubble structure may be disposed at an interface of the base substrate (or the primary funnel portion, if present) and a base end of each microneedle and prior art teaches base end of microneedle is cap. Prausnitz et al. further teaches fracture of microneedle at the bubble structure (air pocket).
Regarding claims 14, Prausnitz et al. teaches hydrophilic PVA backing layer and prior art teaches PLA or PLGA cap potion of microneedle, and the interface of cap potion and backing layer is weak and susceptible to fracture is inherent property of prior art product. Since prior art teaches the same product, the same product is expected to have the same property.
Regarding claims 15-16, Prausnitz et al. teaches the microneedles may separate from the microneedle patch within about 10 seconds to about 120 seconds after the microneedle patch is pressed into the patient's skin/tissue; and extended release (continuously release) from 4 week to 6 months.
Regarding claim 22, Prausnitz et al. teaches one compound of interest in matrix material for microneedle (shell), thus, shell portion comprises the same drug as in core potion.
Regarding claims 23-24 and 27-28, as discussed in the above for claims 1-3, 5-16, prior art teaches a microneedle patch comprising a backing layer with array of pedestal, am array of microneedle extending from each of pedestals and the microneedle composing a core potion which a contraceptive agent dispersed in PLGA polymer; and the core potion is encapsulated (enclosed) by a shell of PLA and cap of biodegradable polymer. The microneedle is inserted into skin (tissue) and separated from pedestal and release effective amount of contraceptive agent via diffusion (by degradation of PLA) of shell portion over extended period such as 4 weeks to 6 months.
Regarding claim 25, Prausnitz et al. teaches PLA encompassing PLLA as common one (also one of three choice) for shell, prior art teaches PLGA for cap, since PLA is alternative biodegradable polymer to PLGA, it si obvious to replace PLA for PLGA for cap potion.
Regarding claim 26, Prausnitz et al. teaches PVA, a water soluble polymer, for backing layer.
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, 5-16, 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11730937 in view of Prausnitz et al. (US20200238065) in view of Nguyen et al. (US20220096371). The reference patent teaches microneedle array comprising base substrate (backing layer) comprising funnel potion (pedestal as evidenced by Prausnitz et al.), microneedle extending from funnel potion (pedestal) comprising contraceptive agent (claim 17), and silent about core/shell with cap for microneedle, in view of Nguyen et al. teaching core/shell with cap structure for microneedle, 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, 5-16, 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-51 of copending Application No. 18229388 in view of Prausnitz et al. (US20200238065) in view of Nguyen et al. (US20220096371). The reference application teaches microneedle array comprising base substrate (backing layer) comprising funnel potion (pedestal as evidenced by Prausnitz et al.), microneedle extending from funnel potion (pedestal) comprising contraceptive agent (claim 28), and silent about core/shell with cap for microneedle, in view of Nguyen et al. teaching core/shell with cap structure for microneedle, it is obvious for one of ordinary skill in the art to produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Claims 1-3, 5-16, 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24, 29-30, 33-35 and 40-42 of copending Application No. 18841936 in view of Prausnitz et al. (US20200238065) in view of Nguyen et al. (US20220096371). The reference application teaches microneedle array comprising backing layer and microneedle comprising contraceptive agent (claim 12), and silent about pedestal, core/shell with cap for microneedle, in view of Prausnitz et al. teaching pedestal between backing layer and microneedle from PLA; Nguyen et al. teaching core/shell with cap structure from PLGA for microneedle, it is obvious for one of ordinary skill in the art to produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
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.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights