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 .
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.
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Claim(s) 28-38 and 40-51 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 16-23 of U.S. Patent No. 11,730,937. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding Claim 28, the reference patent claims (see Clm. 16) a microneedle array for administering a contraceptive hormone into a subject's biological tissue, the microneedle array comprising:
a base substrate;
a primary funnel portion extending from the base substrate;
a plurality of secondary funnel portions extending from the primary funnel portion; and
a plurality of microneedles, each microneedle extending from a respective one of the secondary funnel portions, wherein each of the microneedles comprises a tip end portion which comprises the contraceptive hormone, wherein the microneedles are configured to (i) penetrate into the subject's skin and then to separate from the secondary funnel portions and (ii) release a prophylactically and/or therapeutically effective amount of the contraceptive hormone to the subject for a sustained period of at least 2 weeks.
As such, Claim 28 makes no contribution over Claim 16 as issued.
Regarding Claim 29, in the instant case failure by the claims to quantify the “initial burst” creates a broad claim wherein whatever initial rate release rate of the pharmaceutical comprises in the reference patent reads upon the instant claim.
Regarding Claim 30, the reference patent recites (Clm. 17) that the contraceptive hormone comprises a progestin.
Regarding Claim 31, in the instant case while the claims (16-22) of the reference patent do not positively recite that the contraceptive hormone comprises levonorgestrel, it is held that levonorgestrel is a well-known species of contraceptive that would have been obvious to utilize in association with the claimed invention of Claim 16 to obtain only a predictable and expected outcome of utilizing a well-known species in satisfaction of a broader recited genus.
Regarding Claim 32, the reference patent claims (see Clm. 18) the sustained period is at least 4 weeks.
Regarding Claim 33, the reference patent claims (see Clm. 16) the microneedle array comprises a bubble structure or effervescent material that facilitates the separation of the microneedles.
Regarding Claim 34-35, the reference patent recites (see Clm. 20) the microneedles comprise a biodegradable polymer (re: poly-lactic acid or poly-lactic glycolic acid or combinations thereof). While the reference patent fails to disclose that the contraceptive comprises levonorgestrel or disclose the ratio of the polymer matrix to the contraceptive, it is submitted that it would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a well-known contraceptive, such as levonogestrel, to satisfy the selection of a specific species to be utilized in satisfaction of the broader recited genus, wherein discovering of the optimal or workable ratio of the matrix to the contraceptive (re: the dosing ratio) needed to obtain a prophylactic or therapeutically effective is obvious and amounts to mere optimization pursuant to routine and customary experimentation and optimization to determine the optimal dosage for a result effective variable.
Regarding Claim 36, while the instant claims (see Clm. 16-23) of the reference patent fail to explicitly recite the microneedles to be conical, Examiner submits that “conical” is merely one specific shape that the ordinary artisan would have found obvious to utilize with respect to the microneedles, whereby conical needles are routine, customary, and well-known in order to provide a sharpened penetrating surface useful to piercing the stratum corneum to access the deeper tissues for drug release.
Regarding Claim 37, while the instant claims of the reference patent (see Clm. 16-23) fail to disclose the timing for separation of the microneedles to be within 60 seconds following insertion of the microneedles into the subject's skin. Examiner submits that such a specific value is obvious and nominal to the recitation in Claim 16 that the separation occurs at an “increased rate”, whereby the claim therefore establishes quick release to be a beneficial result effective variable and selection of 60 seconds (or less) to provide the initial rate increase for separation therefore constitutes a mere, obvious design choice over the issued claims of the reference patent.
Regarding Claim 38, as discussed above, it would have been obvious for one having ordinary skill in the art at the time the invention was made to encapsulate a levonorgestrel contraceptive within a PLGA matrix (see above), provide the separation of the microneedles within 60 seconds following insertion of the microneedles into the subject's skin (see above), and the microneedles are configured to release a prophylactically and/or therapeutically effective amount of the levonorgestrel to the subject for a sustained period of at least 2 week (see Clm. 16).
Regarding Claim 40, the reference patent (see Clm. 16) recites each tip end portion is formed of a composition comprising a first matrix material in which the contraceptive hormone is dispersed, wherein the first matrix material comprises poly-lactic acid, poly-lactic glycolic acid, or a combination thereof (see Clm. 20).
Regarding Claim 41, the reference patent recites (see Clm. 16 and 20) each secondary funnel portion comprises a second matrix material, wherein it would have been obvious for one having ordinary skill in the art at the time the invention was made to select a polyvinylpyrrolidone, polyvinyl alcohol, a carbohydrate, or a combination matrix with such materials be obvious, art recognized species of matrixes known and appreciated in the prior art of which construction of the second matrix material would have been obvious.
Regarding Claim 42, the reference patent recites (see Clm. 18) the sustained period is at least 4 weeks.
Regarding Claim 43-51, these method claims are held to be obviated by the functional use language recited in Claims 16-23, wherein it would have been obvious for one having ordinary skill in the art at the time the invention was made to use the apparatus in a manner consistent with the functional language to affect birth control via a sustained release microneedle array arrangement as claimed.
Claim(s) 39 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 16-23 of U.S. Patent No. 11,730,937 as applied above, and further in view of WO 2015/164840 (“Mcallister”).
Regarding Claim 39, the claims of the reference patent substantially recite the instantly claimed subject matter except that the array comprises two subsets of needles with different rate releases so a first subset will provide an immediate burst release and the second subset will provide a sustained release. However, such features are well-known to the art (see Mcallister – Pg. 11). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the array of the reference patent claims to provide for two subsets of microneedles, a first configured for immediate burst release to quickly raising blood levels to effective ranges and a second sustained release configured to maintain blood concentration over a long period of time, as disclosed by Mcallister, to ensure both quick onset of medication as well as continued therapeutically effective treatment.
Claim Objections
Claim 42 objected to under 37 CFR 1.75 as being a substantial duplicate of Claim 32. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 28, 29, 32, 34, 36, 39, 40, 41, 42, 43, 46, 47, 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”).
Regarding Claims 28, 43, and 47, Mcallister discloses a microneedle array (see e.g. 905) for use in a method of administering a contraceptive hormone (e.g. progesterone – see Pg. 15) into a subject's biological skin tissue, the microneedle array comprising:
a base substrate (910);
a primary funnel portion (925) extending from the base substrate;
a plurality of secondary funnel portions (935) extending from the primary funnel portion; and
a plurality of microneedles (930), each microneedle extending from a respective one of the secondary funnel portions, wherein each of the microneedles comprises a tip end portion which comprises the contraceptive hormone (Pg. 12; Pg. 15),
wherein the microneedles are configured to (i) penetrate into the subject's skin and then to separate from the secondary funnel portions, and (ii) release a prophylactically and/or therapeutically effective amount of the contraceptive hormone to the subject for a sustained period (Pg. 11, 26, and 41).
Mcallister discloses the invention substantially as claimed except that the microneedles are configured to provide for sustained release for “at least 2 weeks”. While Mcallister does explicitly resolve “sustained” and “extended” periods of release, Mcallister fails to quantify this period. However, Chowdhury discloses a related invention wherein active agents can be provided in a sustained/extended release via being separated from a delivery portion and remaining in the patient’s tissue (see Fig. 1), wherein sustained release can occur over “days or weeks” (Par. 47) inclusive to the delivery of contraceptives (Par. 49). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the invention of Mcallister to provide for sustained release over a period of at least two weeks, as disclosed by Chowdhury (re: “days or weeks” wherein “weeks” clearly obviates two weeks by virtue of the plural being recited), particularly in association with a contraceptive, in order to provide for sustained application of birth control.
Regarding Claims 29 and 50, Mcallister discloses the microneedle array provides an initial burst release of the contraceptive hormone (Pg. 11).
Regarding Claims 32, 42, and 46, in the instant case Examiner submits that the recitation of “weeks” by Chowdhury would also obviate “at least 4 weeks”, whereby the sustained release period is determined to be a result effective variable and determination of the optimal or workable range for a result effective variable requires only routine and customary skill in the art, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 34, Mcallister discloses the microneedles may comprise a biodegradable polymer (Pg. 16).
Regarding Claim 36, Mcallister discloses that the microneedles are conical (see Fig. 10).
Regarding Claim 39, Mcallister discloses that the microneedles can be divided into first and second subsets wherein a first subset is configured to provide an immediate bust release of therapeutic to raise blood levels of the agent (e.g. contraceptive hormone progesterone) into a prophylactic and/or therapeutic range and a second subset configured to provide for sustained release of the agent to keep the blood levels in the prophylactic or therapeutic rate for a sustained period of time (see Pg. 11).
Regarding Claim 40, Mcallister discloses each tip end portion is formed of a composition comprising a first matrix material in which the contraceptive hormone is dispersed, wherein the first matrix material comprises poly-lactic acid, poly-lactic glycolic acid, or a combination thereof (see Pg. 16-17).
Regarding Claim 41, Mcallister discloses each secondary funnel portion comprises a second matrix material, wherein the second matrix material comprises polyvinylpyrrolidone, polyvinyl alcohol, a carbohydrate, or a combination thereof (see Pg. 16-17).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”) as applied above, and further in view of U.S. Publication No. 2015/0258319 (“Simmers”) and CN 105246458 (“Bayramov”).
Regarding Claim 35, Mcallister discloses that the microneedles may comprise PLGA, but fails to disclose the ratio of PLGA to the pharmaceutical agent and that the agent particularly comprises levonorgestrel. However, Simmers discloses a related microneedle array configured to provide for sustained delivery of a hormone contraceptive wherein the contraceptive may comprise levonorgestrel (LNG) (Par. 83). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the PLGA matrix of Mcallister to comprise LNG, as disclosed by Simmers, in order to deliver a specific type of therapeutic agent to obtain birth control in a known and predictable manner wherein selection of the appropriate birth control agent is an obvious design choice based upon patient needs and clinician opinion.
Bayramov discloses a related microneedle array which like Mcallister discloses using a matrix made of PLGA wherein the PLGA can be provided in ratio by weight with the therapeutic at various values depending upon the specific agent and delivery rate, wherein exemplary ratios include 30-50 wt% therapeutic (see Clm. 7) a range which includes the instantly claimed weight percentage of 40%. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the PLGA matrix of modified Mcallister to comprise 40 wt% therapeutic agent, a value within the range disclosed by Bayramov, in order to achieve a desired delivery rate and volume for the therapeutic agent as a matter of routine experimentation and optimization to find the optimal value within the identified range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the remaining matrix of modified Mcallister to be formed of only PLGA (thereby constituting 60 wt%), thereby only achieving the expected results of selecting a known material for constructing the matrix (see Pg. 16 – Mcallister) identified by the prior art for its suitability in constructing a dissolvable microneedle matrix. It has been held that selecting a known material for an art recognized utility based upon its established suitability for such a purpose is obvious and requires only routine and customary skill in the art, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 30, 31, 44, 45, 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”) as applied above, and further in view of CN 107233297 (“Chen”)
Regarding Claims 30, 31, 44, 45, and 49, Mcallister discloses the invention substantially as claimed except that that the contraceptive hormone comprises progestin or levonorgestrel for the prophylactic/therapeutic effect of birth control. Rather Mcallister only explicitly suggests progesterone. However, Chen discloses a related microneedle array which can be used to delivery contraceptives, wherein this contraceptives can comprise progestin and levonorgestrel containing formulations (see Summary of Invention; Example 1; Clm. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Mcallister to deliver either progestin or levonorgestrel, as disclosed by Chen, in order to utilize a microneedle system to deliver alternative forms of hormonal birth control depending upon patient needs, contraindications, and responsiveness to any particular agent versus another.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”) as applied above, and further in view of U.S. Publication No. 2017/0036003 (“Wakamatsu”).
Regarding Claim 33, Mcallister discloses that the microneedle array can comprise a feature which comprises a dissolving or fracturable layer between the microneedles and the funnel structure which allows for rapid separation of the microneedles therefrom. However, Mcallister fails to characterize this layer/material as a “bubble structure” or “effervescent material”, rather only the broader fracturable or rapidly dissolving is used. However, Wakamatsu discloses a related microneedle (Fig. 4B, 4C) wherein an air bubble (124) is provided at the boundary between a funnel shaped portion (112) and a releasable microneedle tip (120) in order to assist in quick separation between the two when applied to the tissue (Par. 79, 80). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the array of Mcallister to utilize a bubble structure between the microneedle and second funnel portion, as disclosed by Wakamatsu, in order to create a mechanical area of increased weakness/dissolvability to assist in more rapid release of the microneedle projection from the second funnel.
Claim(s) 37 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”) as applied above, and further in view of U.S. Publication No. 2015/0258319 (“Simmers”) and CN 105073178 (“Ding”)
Regarding Claims 37 and 48, Mcallister, as modified in view of Chowdhury, discloses the invention substantially as claimed except that for disclosing how quickly the microneedles separate from the second funnel structure. However, Ding discloses a related microneedle array wherein the microneedles are configured to separate from the remainder of the array into the skin (Background) where emphasis is made to ensure that separation can occur easily. Ding discloses that separation can be configured to occur within a period of time of 10 seconds to 10 minutes inclusive to examples of 10 seconds, 30 seconds, and about 1 minute (all examples within the instantly claimed range). It would have been obvious for one having ordinary skill in the art at the time the invention was made to ensure that separation of the microneedles in the invention of modified Mcallister occurs within 60 seconds following insertion, as disclosed by Ding, in order to promote quick and easy separation to ensure that all of the microneedles have been released in a predictable and expected manner in order to promote the desired burst of immediate release along with the sustained released thereby improving the efficacy and repeatability of the array treatment.
Claim(s) 38 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/164840 (“Mcallister”) in view of U.S. Publication No. 2016/0243027 (“Chowdhury”) as applied above, and further in view of U.S. Publication No. 2015/0258319 (“Simmers”) and CN 105073178 (“Ding”).
Regarding Claims 38 and 51, as discussed above, Mcallister discloses that the active agent can be encapsulated in a PLGA matrix (see Pg. 16-17) at the tip of the microneedle. Mcallister, as modified, discloses the invention substantially as claimed except that that the contraceptive hormone is levonorgestrel and separation between the microneedles and the second funnel portion occurs within 60 seconds following insertion of the microneedles.
Simmers discloses a related microneedle array configured to provide for sustained delivery of a hormone contraceptive wherein the contraceptive may comprise levonorgestrel (LNG) (Par. 83). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the PLGA matrix of Mcallister to comprise LNG, as disclosed by Simmers, in order to deliver a specific type of therapeutic agent to obtain birth control in a known and predictable manner wherein selection of the appropriate birth control agent is an obvious design choice based upon patient needs and clinician opinion.
Ding discloses a related microneedle array wherein the microneedles are configured to separate from the remainder of the array into the skin (Background) where emphasis is made to ensure that separation can occur easily. Ding discloses that separation can be configured to occur within a period of time of 10 seconds to 10 minutes inclusive to examples of 10 seconds, 30 seconds, and about 1 minute (all examples within the instantly claimed range). It would have been obvious for one having ordinary skill in the art at the time the invention was made to ensure that separation of the microneedles in the invention of modified Mcallister occurs within 60 seconds following insertion, as disclosed by Ding, in order to promote quick and easy separation to ensure that all of the microneedles have been released in a predictable and expected manner in order to promote the desired burst of immediate release along with the sustained released thereby improving the efficacy and repeatability of the array treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/27/2026