DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 10/22/2025.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-4, 6-8 and 11-20 have been amended. No claims were cancelled or newly added. Accordingly, claims 1-20 remain pending in the application and are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejections of claims 18-20 under 35 USC 101/112 (use claims) moot. Specifically, the claims have been amended such that the claims are no longer use claims. Thus, said rejections have been withdrawn.
Applicant’s amendment renders the rejections of claims 2-4, 6-8, 11 and 13-20 under 35 USC 112(b) moot. Specifically, the claims have been amended such that the various indefinite issues have been remedied. Thus, said rejections have been withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 and 9-20 stand rejected under 35 U.S.C. 103 as being unpatentable over Ron et al. (US 2011/0280922 A1, Nov. 17, 2011, hereafter as “Ron”) in view of Loxley et al. (US 2013/0209539 A1, Aug. 13, 2013, hereafter as “Loxley”) and as evidenced by Evatane® 33-25 Technical Data Sheet (2020).
The instant claims are drawn to an intravaginal ring comprising: a core comprising a first ethylene-vinyl acetate copolymer having a vinyl acetate content from 26 to 40 wt%, and an estrogenic steroid, and a sheath comprising a second ethylene-vinyl acetate copolymer having a vinyl acetate content from 20 to 40 wt%, and at least 10 wt% of a progestational steroid based on the weight of the sheath, and wherein the sheath is the outer layer of the intravaginal ring; a method of making and use thereof.
Regarding instant claims 1, 9 and 11 Ron teaches an intravaginal drug delivery ring-shaped device (abstract; Figures). Ron teaches said devices contain ethylene vinyl acetate (EVA) having vinyl acetate in amounts of about 4-80%, about 4-50%, about 15-40% ([0014] and [0103]). Ron also teaches the particular EVA polymer, Evatane® 33.25 ([0101]) which contains 33% vinyl acetate content as evidenced by the Evatane® 33-25 Technical Data Sheet. Ron further teaches that drug release is determined by the vinyl acetate content of the polymeric substance ([0103]). Ron teaches delivering a pharmaceutically effective amount of one or more contraceptive agents intravaginally for about 1 month, about 3 months, or about 6 months or more ([0063]). Ron defines the term “contraceptive agents” as “one or more hormonal steroids (e.g., estrogenic steroids and/or progestational steroids) that prevent or reduce the likelihood of pregnancy” ([0043]). Ron further teaches contraceptive agents including progestins (e.g., etonogestrel, progesterone, levo-norgestrel, dl-norgestrel, norethindrone) and estrogens (e.g., ethinyl estradiol) can be located in separate segments of the device ([0044], [0045] and [0083] Fig. 1B). Ron teaches amounts of active agent being about 0.1 to 50 parts my weight (%), preferably about 10 and about 30 parts by weight (%) ([0095]).
Ron is silent to a sheath comprising a second ethylene-vinyl acetate copolymer having a vinyl acetate content from 20-40 wt% and at least 10 wt% of a progestational steroid based on the weight of the sheath, wherein the sheath is the outer layer of the intravaginal ring.
Loxley, in the analogous art of drug delivery devices, teaches a device, particularly, an intravaginal ring, that is composed of a core, wherein the core is substantially or completely covered by a sheath, wherein the sheath comprises ethylene vinyl acetate copolymer, wherein the core and/or sheath is loaded with active agents (abstract; [0080] and [0083]). Loxley defines “substantially” to mean “at least 90% of the core surface” ([0042]). Loxley teaches that the sheath is made of EVA, wherein the vinyl acetate content is from 15-30%, preferably, 28% ([0056]). Loxley further teaches that the sheath thickness is from 5-500 microns, particularly from 25-250 microns, and more particularly from 50-200 microns ([0064]) and that the thickness and the vinyl acetate content can either or both be modified to modify/control the release rate characteristics of the active agents ([0065]-[0066]). Loxley teaches the particular active agents, hormones ([0043] and [0068]). It is noted that the sheath in Loxley is the outer layer of the intravaginal ring as there are no additional outer layers required.
Ron and Loxley are drawn to hormone-releasing intravaginal rings, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sheath comprising ethylene-vinyl acetate and a hormone, the sheath covering the implant of Ron as suggested by Loxley with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Loxley teaches that said ethylene-vinyl acetate sheath can contain an active agent such as a hormone and said sheath effectively modifies the release rate characteristics of the active agents. A skilled artisan would have a reasonable expectation of success because said sheath is suitable for drug delivering devices including intravaginal rings. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to also include the particular hormone, a progestational steroid, in the sheath with a reasonable expectation of success because Ron teaches the particular combination of the well-known contraceptive combination of a progestational steroid and an estrogenic steroid and placement of the active agents in the core and/or sheath would be dependent on the desired release profile of said active agents. In terms of the amount of progestational steroid, Ron teaches amounts of active agent being about 0.1 to 50 parts by weight (%), preferably about 10 and about 30 parts by weight (%) ([0095]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of progestational steroid by way of routine experimentation with a reasonable expectation of success. MPEP states,
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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."
A skilled artisan would have been motivated to do so because Ron teaches the general amounts of active agent and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claims 2 and 3, Ron and Loxley teach the elements discussed above including amounts of active agent being about 0.1 to 50 parts my weight (%), preferably about 10 and about 30 parts by weight (%) (Ron at [0095]).
Ron is silent to “wherein the sheath comprises at least 15 wt% of the progestational steroid” (instant claim 2) and “wherein the sheath comprises 40 wt% or less of the progestational steroid” (instant claim 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of progestational steroid by way of routine experimentation with a reasonable expectation of success. MPEP 2144.05 states,
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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."
A skilled artisan would have been motivated to do so because Ron teaches the general amounts of active agent and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 4, the references teach the elements discussed above. Ron further teaches that the active agent may be dissolved or distributed (Examples) and Loxley further teaches that the sheath may comprise one or more active pharmaceutical ingredients dissolved or dispersed therein (abstract; [0022] and [0067]). It is noted that Loxley defines “dispersed” to mean one or more active pharmaceutical ingredients form a dispersion in the core polymer or sheath polymer, so that they form aggregates or powders (i.e., particles) that are suspended in and surrounded by a continuous phase ([0022]).
Regarding instant claim 5, the references teach the elements discussed above. Ron further teaches that the active agent may be dissolved or distributed (Examples) and Loxley further teaches that the core may comprise one or more active pharmaceutical ingredients dissolved or dispersed therein (abstract; [0021] and [0067]). It is noted that Loxley defines “dissolved” to mean one or more active pharmaceutical ingredients form a solution (e.g., supersaturated, saturated or non-saturated) in the core polymer or the sheath polymer, so that they are distributed in the core polymer or the sheath polymer forming a homogeneous phase ([0021]). Loxley also defines “saturated” as a solution containing a concentration of the active pharmaceutical ingredient that is equal to the saturation concentration at a given temperature and “non-saturated” as a solution containing a concentration of the active pharmaceutical ingredient that is lower than the saturation concentration at a given temperature (e.g., room temperature) ([0021], [0023] and [0025])). Loxley further teaches that the saturation concentration of the active ingredient can be determined by methods well-known in the art ([0025]-[0031]).
Regarding instant claim 6, the references teach the elements discussed above. Ron further teaches that the active agent may be dissolved or distributed (Examples) and Loxley further teaches that the core may comprise one or more active pharmaceutical ingredients dissolved or dispersed therein (abstract; [0022] and [0067]). It is noted that Loxley defines “dispersed” to mean one or more active pharmaceutical ingredients form a dispersion in the core polymer or sheath polymer, so that they form aggregates or powders (i.e., particles) that are suspended in and surrounded by a continuous phase ([0022]).
Regarding instant claim 7, the references teach the elements discussed above including amounts of active agent being about 0.1 to 50 parts my weight (%), preferably about 10 and about 30 parts by weight (%) (Ron at [0095]).
Ron is silent to “wherein the core comprising at least 10 wt% of the estrogenic steroid”.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of estrogenic steroid by way of routine experimentation with a reasonable expectation of success. MPEP states,
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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."
A skilled artisan would have been motivated to do so because Ron teaches the general amounts of active agent and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 10, the references teach the elements discussed above including the sheath is made of EVA, wherein the vinyl acetate content is from 15-30%, preferably, 28% (Loxley at [0056]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of vinyl acetate in the EVA of the sheath by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Loxley teaches an effective vinyl acetate amount in the sheath is from 15-30%, preferably, 28% and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 12, the references teach the elements discussed above including the particular progestins, etonogestrel, progesterone, levo-norgestrel, dl-norgestrel, and norethindrone (Ron at [0045]).
Regarding instant claim 13, the references teach the elements discussed above including that the sheath thickness is from 5-500 microns (0.005-0.5 mm), particularly from 25-250 microns (0.025-0.25 mm), and more particularly from 50-200 microns (0.05-0.20 mm) (Loxley at [0064]) and that the thickness and the vinyl acetate content can either or both be modified to modify/control the release rate characteristics of the active agents ([0065]-[0066]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the thickness of the sheath by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Loxley teaches sheath thicknesses from 5-500 microns (0.005-0.5 mm) are suitable for same purpose and that said thickness can be altered in order to modify/control the release rate characteristics of the active agents to the desired release rate.
Regarding instant claim 14, the references teach the elements discussed above including the cross-sectional diameter of the intravaginal device (the core) being from 0.5-12 mm (Ron at [0019]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the cross-sectional diameter of the core by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Ron teaches a general cross-sectional diameter range of 0.5-12 mm being suitable and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 15, the references teach the elements discussed above including the outer diameter of the intravaginal ring ranging from 40-80 mm (Ron at [0019]) or 50-60 mm, more particularly 52-56 mm (Loxley at [0078]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the outer diameter of the intravaginal ring by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Ron teaches a general outer diameter range of 40-80 mm and Loxley teaches a general outer diameter range of 50-60 mm as being suitable for the same purpose and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 16, the references teach the elements discussed above. Ron additionally teaches extrusion, cutting into pieces of the required length, and joining the ends together ([0054], [0055] and [0110]). Loxley also teaches a similar process involving co-extrusion, cutting into pieces of the required length, and joining the ends together ([0100] and [0101]).
Regarding instant claim 17, the references teach the elements discussed above. Loxley further teaches a curing phase may be carried out in order to allow the particles of the active ingredients to migrate to the outer surface, which can occur on coaxial polymer strands alone or after the coaxial polymer strands are bonded to get the ring, said curing occurs by controlling temperature from 5°C to 60°C and relative humidity from 10% to 80% ([0094]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the curing temperature by way of routine experimentation with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Loxley teaches a general curing range of 5°C to 60°C as being suitable for the same purpose and it is the normal desire of scientists or artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values.
Regarding instant claim 18, the references teach the elements discussed above. Ron additionally teaches substantially zero-order kinetics ([0076] and [0077]) as well as delivering appropriate amounts of the active agent effective to achieve a treatment over 3 days, 1 week, 1 month, or more ([0073]). It is noted that the instant specification states that in order to provide the desired zero order release profiled of the estrogenic steroid it is preferred that the core comprises an ethylene-vinyl acetate copolymer with a vinyl acetate content from 26 to 40%, preferably 26 wt%, 33 wt%, or 40 wt% (page 10, lines 26-29). As discussed above, Ron teaches that the devices contain ethylene vinyl acetate (EVA) having vinyl acetate in amounts of about 4-80%, about 4-50%, about 15-40% ([0014] and [0103]). Ron also teaches the particular EVA polymer, Evatane® 33.25 ([0101]) which contains 33% vinyl acetate content as evidenced by the Evatane® 33-25 Technical Data Sheet. Ron further teaches that drug release is determined by the vinyl acetate content of the polymeric substance ([0103]). Accordingly, Ron teaches the structure (EVA in the core in the amount of 33%) that is described in the instant specification that gives rise to the function of zero-order release of the estrogenic steroid.
Regarding instant claim 19, the references teach the elements discussed above. Ron additionally teaches, in a particular embodiment, an intravaginal ring releases 100 micrograms per day of estradiol ([0165]).
Regarding instant claim 20, the references teach the elements discussed above. Ron additionally teaches, in a particular embodiment, an intravaginal ring releases 6 mg per day of progesterone (i.e., a progestin/progestogen) ([0165]).
Thus, the combined teachings of Ron and Loxley render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 10/22/2025, regarding the 103 over Ron and Loxley have been fully considered but they are not persuasive.
Applicant argues that does not teach the structure of claim 1 and asserts that Ron teaches away from the claimed structure. Applicant asserts that Ron does not disclose a drug delivery system comprising a core and a sheath in which both the core and the sheath comprise a drug. Applicant further asserts that Ron states at [0050] that the terms “segment” and “unitary segment” specifically exclude systems that comprise a core or reservoir and an inner and/or outer layer of material, such as a skin, wall, membrane, coating or polymeric layer(s). Applicant states that in view of Ron’s express exclusion, a person skilled in the art would not be motivated by Ron to add any sheath, let alone a drug-loaded sheath to Ron’s unitary segment design. Remarks, pages 5-6.
In response, it is respectfully submitted that the examiner agrees that Ron does not teach a drug delivery system comprising a core and a sheath. As discussed in the rejection, Loxley is relied upon for the feature of a sheath. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). With respect to the assertion that Ron teaches away from the claimed invention, paragraph [0050] of Ron states, “The terms "segment" and "unitary segment" specifically exclude, in some embodiments, vaginal rings or portions thereof, segments, or forms that comprise a core or reservoir and an inner and/or outer layer of material, such as a skin, wall, membrane, coating, or polymeric layer or layers” (emphasis added). MPEP 2123 states that references are relevant for all they contain and preferred embodiments do not constitute a teaching away from a broader disclosure. The paragraph that Applicant relies on as an express exclusion is not accurate. Said paragraph states that in some embodiments, that an outer layer is excluded. However, such a teaching does not exclude coverings for all embodiments. Thus, for these reasons, Applicant’s argument is found unpersuasive.
Applicant also argues Loxley describes a ring comprising a polyurethane core and an EVA sheath [0006] and states generally that one or more active agents may be dissolved or dispersed in the core and/or the sheath [0012]; however, the function of Loxley’s device requires that the core to be a swellable material to release the active ingredient, and even though the sheath aims at regulating drug release, it is essential that the core swells [0008]. Remarks, pages 6-7.
In response, it is respectfully submitted that the rejection does not rely on the core material taught by Loxley as Ron teaches a core comprising EVA. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is also noted that Ron teaches EVA and polyurethane as suitable segment/core materials ([0053] and [0097]). Accordingly, Ron effectively teaches that said polymers are interchangeable/equivalents and suitable for the same purpose (MPEP 2144.06 and 2144.07). Thus, Applicant’s argument is not persuasive.
Applicant also argues that Loxley does not disclose any system with a sheath containing at least 10wt% of a progestational steroid. Applicant asserts that Loxley explains at [0047] that a progestational steroid is very soluble in the PU core and that the amount of steroid is kept below saturation to prevent crystallization over time. Applicant also asserts that Loxley teaches that the core comprises a progestational steroid in a concentration from 0.2 wt% to 1.0 wt% which is far lower than required by claim 1 ([0049]-[0050]). Remarks, page 7.
In response, it is respectfully submitted that the examiner agrees that Loxley teaches embodiments having a core that comprises a progestational steroid in a concentration from 0.2 wt% to 1.0 wt% ([0049]-[0050]), however Loxley is not relied upon for this teaching. The instant claims require a sheath comprising at least 10wt% of a progestational steroid. The amount of progestational steroid in the core taught by Loxley is irrelevant to the claimed invention and the rejection. It is further noted that Loxley teaches that the core and/or sheath can be loaded with active agents including progestins (abstract; claims 1 and 8). References are relevant for all they contain and preferred embodiments do not constitute a teaching away from a broader disclosure (MPEP 2123). Similarly, applicant’s arguments pertaining to the PU core are irrelevant as Loxley is not relied upon for its teaching of a PU core as the claims do not require a PU core. Rather, the claims require a core comprising EVA which is taught by Ron. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In terms of the particular amount of at least 10 wt% of a progestational steroid, the instant rejection explains that Ron teaches amounts of active agent being about 0.1 to 50 parts by weight (%) (which overlaps with the teachings of Loxley), preferably about 10 and about 30 parts by weight (%) ([0095]). Depending on the desired release profile, a skilled artisan would have been able to optimize the amount of progestational steroid by way of routine experimentation. It is the normal desire of scientists/artisans to improve upon what is already generally known and determine where in a disclosed range is the optimum values (MPEP 2144.05). For these reasons, Applicant’s argument is not persuasive.
Applicant argues that in the claimed invention, a high amount of progestational steroid is loaded in the sheath to ensure the steroid is incorporated as crystals which yields prolonged release of said steroid. Remarks, page 7.
In response, it is respectfully submitted that the independent claims do not require that the progestational steroid is in form of crystals, thus, applicant is arguing limitations that are not in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 17 recites, “wherein said method further comprises a cooling step in which the provided fiber is cooled to a temperature of about 20°C in order to provide crystals of at least the progestational steroid in sheath”. However, as explained in the rejection Loxley teaches the same method step. Thus, one of ordinary skill in the art would reasonably expect the same method to yield the same result, i.e., crystals. For these reasons, Applicant’s argument is unpersuasive.
Applicant also argues that Loxley teaches that the active agents are in the core rather than the sheath and that it is preferred that the sheath conations no active ingredient. Applicant notes that while Loxley generally observes that a sheath may comprise one or more actives, Loxley does not disclose a single embodiment in which the sheath contains an active. Remarks, pages 7-8.
In response, it is respectfully submitted that Loxley teaches that the core and/or sheath can be loaded with active agents including progestins (abstract; claims 1 and 8). References are relevant for all they contain and preferred embodiments do not constitute a teaching away from a broader disclosure (MPEP 2123). Applicant’s argument is not persuasive.
Thus, for the above reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
Claim 8 stands rejected under 35 U.S.C. 103 as being unpatentable over Ron et al. (US 2011/0280922 A1, Nov. 17, 2011, hereafter as “Ron”) in view of Loxley et al. (US 2013/0209539 A1, Aug. 13, 2013, hereafter as “Loxley”) and as evidenced by Evatane® 33-25 Technical Data Sheet (2020), as applied to claims 1 and 4 above, and further in view of Baker et al. (USPN 3,923,939 A, Dec. 2, 1975, hereafter as “Baker”).
The claimed invention is described above.
Ron and Loxley teach the elements discussed above.
Ron and Loxley are silent to the progestational steroid particles having a particle size of between 3-40 microns or between 8-24 microns or between 10-24 microns (instant claim 8).
Baker teaches a drug delivery device comprising ethylene vinyl acetate as the polymer matrix and a drug incorporated therein (abstract). In a particular embodiment, Baker teaches progesterone (i.e., a progestational steroid) having a particle size of 5-10 microns loaded into an ethylene vinyl acetate copolymer matrix is effective in locally delivering sustained release of progesterone (Example 1).
The references are all drawn to hormone-releasing drug delivery devices comprising an ethylene-vinyl acetate matrix, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include progestational steroid particles having a particle size of between 5-10 microns into the invention of Ron/Loxley as suggested by Baker with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Baker teaches that said particle size of a progestational steroid incorporated into an ethylene vinyl acetate matrix effectively delivers locally sustained release of said progestational steroid.
Thus, the combined teachings of Ron, Loxley and Baker render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 10/22/2025, regarding the 103 rejection over Ron, Loxley and Baker have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 103 rejection over Ron and Loxley. No further arguments regarding claim 8 are presented. Remarks, pages 5-8.
For the same reasons as discussed above, Applicant' s arguments are not persuasive.
Thus, said rejection is maintained.
Conclusion
All claims have been rejected; no claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617