DETAILED ACTION
Continued Examination Under 37 C.F.R. § 1.114
A request for continued examination under 37 C.F.R. § 1.114, including the fee set forth in 37 C.F.R. § 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. § 1.114, and the fee set forth in 37 C.F.R. § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 C.F.R. § 1.114. Applicant’s submission filed on January 08, 2026 has been entered.
Status of Claims
Claims 1-8 and 10-21 are pending and currently under consideration. Claims 1, 7 and 10-11 have been amended; new claim 21 have been added; and claim 9 has been cancelled. This Office Action is in response to the request for continued examination filed on January 08, 2026. 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 Office Action: Non-Final.
Withdrawn Claim Objections & Rejections
The objection to claim 20 (at par. 3-4 of the 09/08/2025 Office action) is withdrawn in light of applicant’s 01/08/2026 amendments. Applicant’s 09/08/2025 remarks at p. 5, par. 9, cont. on p. 6, are acknowledged.
The rejection of claims 1-20 under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite (at par. 5-7 of the 09/08/2025 Office action), is withdrawn in light of applicant’s 01/08/2026 amendments. Applicant’s 09/08/2025 remarks at p. 6, par. 1-3, are acknowledged.
The rejection of claims 1-3, 5-8, 12-13, 15-16 and 20 under 35 U.S.C. § 102 (a)(1) by KARP (US 2011/0021965 A1) (at par. 8-27 of the 09/08/2025 Office action), is withdrawn in light of applicant’s 01/08/2026 amendments, in particular, the amendment to independent claim 1 reciting, “wherein the plurality of microstructures comprises a second therapeutic agent having a composition that is different from the first therapeutic agent.” Applicant’s 09/08/2025 remarks at p. 6, par. 4, to p. 7, par. 1, acknowledged, but are moot.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 21 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 pre-AIA , that applicant regards as the invention.
Claim 21 is drawn to:
21. ([…]) A vaginal drug delivery device comprising:
a flexible having a shape selected from the group consisting of: a tablet, a ring, a capsule, and combinations thereof;
a first therapeutic agent embedded in the base, the first therapeutic agent comprising a drug selected from the group consisting of: estrogen, progesterone, and estradiol; and
a plurality of microstructures protruding from the base, wherein the microstructures each comprise a proximal end, a distal end, a body and a tip, wherein the plurality of microstructures comprises a second therapeutic agent selected from the group consisting of: an antibacterial agent, an antifungal agent, and an antimicrobial agent.
wherein the recitation “a flexible having” is indefinite as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements appear to be a “base” for “a flexible base.” Further in this regard, claim 21 is indefinite in the recitation, “the base” for “a first therapeutic agent embedded in the base” There is insufficient antecedent basis for this limitation in the claim as no “base” is previously recited in the claim. See MPEP § 2173.05(e).
Further clarification is required.
Claim Rejections – 35 U.S.C. § 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 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 pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-8 and 11-20 are rejected under 35 U.S.C. § 103 as being unpatentable over KARP (US 2011/0021965 A1, Publ. Jan. 27, 2011; hereinafter, “Karp”; of record).
Karp is directed to:
ADHESIVE ARTICLES
ABSTRACT
An adhesive article includes a biocompatible and at least partially biodegradable substrate having a surface; and a plurality of protrusions extending from the surface. The protrusions include a biocompatible and at least partially biodegradable material, and have an average height of less than approximately 1,000 micrometers.
Karp, title & abstract. In this regard, Karp teaches “adhesive article 20 for adhesion to a biological tissue surface including a biocompatible and biodegradable substrate 22, and a plurality of protrusions 24 extending from the substrate,” wherein “substrate 20 includes a material that is flexible and conformable”:
[0092] FIG. 1 shows an adhesive article 20 for adhesion to a biological tissue surface including a biocompatible and biodegradable substrate 22, and a plurality of protrusions 24 extending from the substrate. As shown, adhesive article 20 further includes a surface modification 26 on substrate 22 and protrusions 24 that enhances adhesion of the article to an applied surface. For example, surface modification can provide adhesive article 20 with a wet adhesive strength (e.g., in water or to a wet applied surface) that is greater than a dry adhesive strength (e.g., in air or to an applied surface free of water). In some embodiments, adhesive article 20 is substantially free of surface modification 26. As described more below, adhesive article 20 can be used in a variety of applications, such as medical applications (e.g., to join tissue and/ or to deliver pharmaceutical compounds).
[0093] Substrate 20 can include ( e.g., be formed solely of) a biocompatible and biodegradable material, such as those that breakdown to product(s) that are biocompatible and/or bioabsorbable. In some embodiments, substrate 20 and/or adhesive article 20 is degradable in vivo within the range of from approximately 1 day to approximately 1 year (e.g., less than approximately 60 days). In some embodiments, substrate 20 includes a material that is flexible and conformable. […].
[…]
[0099] Protrusions 24 can include (e.g., be formed solely of) the same composition(s) as included in substrate 22, but in other embodiments, the protrusions can include one or more different compositions to create multi-component adhesive articles. As an example, protrusions 24 can include a composition that is stiffer or harder than a composition include in substrate 22. The stiffer composition can allow protrusions 24 to more easily penetrate an application site ( e.g., tissue), thereby increasing contact area and adhesion. At the same time, the less stiff composition allows substrate 22 to be flexible and easily conformable to the application surface. As another example, article 20 can include protrusions including a first composition, a thin ( e.g., approximately 1 micrometer to approximately 100 micrometers, or approximately 0.5 micrometer to approximately 5 micrometers) layer beneath the protrusions including the first composition, and a substrate including a second composition different from the first composition ( e.g., to provide different stiffness). In some embodiments, protrusions 24 and substrate 22 can include compositions with different degradation rates, which can affect delivery of a pharmaceutical compound, if applicable. For example, one portion of an adhesive article can biodegrade quickly to provide a bolus delivery of a drug, and another portion of the adhesive article can biodegrade relatively slowly to provide an extended release of the drug. Such compositions and/or the geometry of protrusions 24 can be anisotropic. In certain embodiments, protrusions 24 have lower degradation rates than substrate 22 so the protrusions do not degrade quickly, e.g., due to their smaller dimensions and/or compositions.
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(Karp, par. [0092]-[0093] & [0099], Fig. 1), and further teaches embodiments featuring “surface modification 26,” wherein “biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20”:
[0106] Alternatively or additionally to surface modification 26, in some embodiments, biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20, for example, using covalent and/or non-covalent interactions. Exemplary non-covalent interactions include hydrogen bonds, electrostatic interactions, hydrophobic interactions, and van der Waals interactions. The biomolecules can be used, for example, to recruit cells to a wound site and/or to promote a selected metabolic and/or proliferative behavior in cells that are at the site and/or seeded in substrate 22 and/or an adherent layer on adhesive article 20 (described below). Examples of biomolecules include growth factors or ligands such as, without limitation, transforming growth factor beta (TGF-β), acidic fibroblast growth factor, basic fibroblast growth factor, epidermal growth factor, insulin growth factor I and II (IGF-I and II), vascular endothelial-derived growth factor, bone morphogenetic proteins, platelet-derived growth factor, heparin-binding growth factor, hematopoetic growth factor, and peptide growth factor. In certain embodiments, integrins and cell adhesion sequences (e.g., the RGD sequence) are attached to substrate 22 and/or the adherent layer on adhesive article 20 to facilitate cell adhesion. Extracellular matrix components, e.g., collagen, fibronectin, laminin, elastin, etc., can also be combined with substrate 22 and/or an adherent layer on adhesive article 20 to manipulate cell recruitment, migration, and metabolism, and the degradation and mechanical properties of the material. In some embodiments, proteoglycans and glycosaminoglycans are covalently or non-covalently attached to substrate 22 and/or an adherent layer of adhesive article 20.
(Karp, par. [0106]).
Regarding independent claim 1 and the requirements:
1. ([…]) A vaginal drug delivery device comprising:
a flexible base
a first therapeutic agent embedded in the base; and
a plurality of microstructures protruding from the base, wherein the microstructures each comprise a proximal end, a distal end, a body and a tip, wherein the plurality of microstructures comprises a second therapeutic agent having a composition that is different from the first therapeutic agent.
Karp clearly teaches “adhesive article 20 for adhesion to a biological tissue surface including a biocompatible and biodegradable substrate 22, and a plurality of protrusions 24 extending from the substrate” (Karp, par. [0092], Fig. 1) wherein “substrate 20 includes a material that is flexible and conformable” (Karp, par. [0093]) featuring “surface modification 26,” wherein “biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20” (Karp, par. [0106]), WHEREBY it is noted:
“biocompatible and biodegradable substrate 22” (Karp, par. [0092], Fig. 1),” wherein “substrate 20 includes a material that is flexible and conformable” (Karp, par. [0093]), particularly, “substrate 22,” which is “flexible and easily conformable to the application surface” (Karp par. [0099]), relates to the requirement of claim 1 for “a flexible base”;
“surface modification 26, in some embodiments, biomolecules and/or bioactive agents are incorporated into substrate 22” (Karp, par. [0106]) relates to the requirements of claim 1 for “a first therapeutic agent embedded in the the base”;
“a plurality of protrusions 24 extending from the substrate” (Karp, par. [0092], Fig. 1) relates to the requirements of claim 1 for “a plurality of microstructures protruding from the base, wherein the microstructures each comprise a proximal end, a distal end, a body and a tip.”
However, Karp DOES NOT TEACH a specific exemplary embodiment, “wherein the plurality of microstructures comprises a second therapeutic agent having a composition that is different from the first therapeutic agent” as required by claim 1, or the requirements of claim 17 for “one or more layers of a third therapeutic agent”:
17. ([…]) The vaginal drug delivery device of claim 10, wherein at least a portion of the device is coated with one or more layers of a third therapeutic agent.
which are well within the purview of the ordinarily skilled artisan, in light of Karp’s broader disclosure. In this respect, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Karp teaches that “the protrusions can include one or more different compositions to create multi-component adhesive articles,” and “a substrate including a second composition different from the first composition”:
[0099] Protrusions 24 can include (e.g., be formed solely of) the same composition(s) as included in substrate 22, but in other embodiments, the protrusions can include one or more different compositions to create multi-component adhesive articles. As an example, protrusions 24 can include a composition that is stiffer or harder than a composition include in substrate 22. The stiffer composition can allow protrusions 24 to more easily penetrate an application site (e.g., tissue), thereby increasing contact area and adhesion. At the same time, the less stiff composition allows substrate 22 to be flexible and easily conformable to the application surface. As another example, article 20 can include protrusions including a first composition, a thin (e.g., approximately 1 micrometer to approximately 100 micrometers, or approximately 0.5 micrometer to approximately 5 micrometers) layer beneath the protrusions including the first composition, and a substrate including a second composition different from the first composition (e.g., to provide different stiffness). In some embodiments, protrusions 24 and substrate 22 can include compositions with different degradation rates, which can affect delivery of a pharmaceutical compound, if applicable. For example, one portion of an adhesive article can biodegrade quickly to provide a bolus delivery of a drug, and another portion of the adhesive article can biodegrade relatively slowly to provide an extended release of the drug. Such compositions and/or the geometry of protrusions 24 can be anisotropic. In certain embodiments, protrusions 24 have lower degradation rates than substrate 22 so the protrusions do not degrade quickly, e.g., due to their smaller dimensions and/or compositions.
(Karp, par. [0099]), and “biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20”
[0106] Alternatively or additionally to surface modification 26, in some embodiments, biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20, for example, using covalent and/or non-covalent interactions. […].
(Karp, par. [0106]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange the disclosed above cited components of Karp in order to arrive at protrusions and a substrate including one or more different compositions (Karp, par. [0099]), wherein the different compositions contain biomolecules and/or bioactive agents (Karp, par. [0106]) that differ for one or more different compositions, thereby meeting the requirement of claim 1 for “wherein the plurality of microstructures comprises a second therapeutic agent having a composition that is different from the first therapeutic agent [in the flexible base],” and claim 17 for “one or more layers of a third therapeutic agent.”
It is noted that the preamble recitation for a “vaginal drug delivery device” is interpreted as a recitation of intended use. In this regard, it is noted that a recitation of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim, see MPEP § 2103 (I)(C). In this respect, Karp teaches “adhesive article 20” (Karp, par. [0092], Fig. 1) meeting the structural requirements of claim 1, as discussed above; further, Karp teaches that “[n]umerous other applications are possible,” for which “adhesive article 20” can be used “to attach devices (e.g., a drug delivery device) to mucus membrane ( e.g, mouth, gut, anus, nostrils, vagina, etc)” (Karp, par. [0128]), whereby Karp teaches a device that would appear to be suitable for the intended use recited in claim 1.
Thus, Karp renders claims 1 and 17 obvious.
Regarding claim 2 and the requirements:
2. ([…]) The vaginal drug delivery device of claim 1, wherein the microstructures are selected from the group consisting of microneedles, microblades, microanchors, microfishscale, micropillars, microhairs and combinations thereof.
Karp teaches “Adhesion force” versus “Height of pillar (µm),” wherein “FIG. 7C depicts adhesion trends of protrusions having various configurations and dimensional parameters,” particularly “Adhesion force” versus “Height of pillar (µm)” (Karp, par. [0077], Fig. 7C), which read on “micropillars” of claim 2.
Thus, Karp renders claim 2 obvious.
Regarding claim 3 and the requirements:
3. ([…]) The vaginal drug delivery device of claim 1, wherein the microstructures each comprises a length ranging from about 250 to 1000 μm.
Karp teaches: “The protrusions include a biocompatible and at least partially biodegradable material, and have an average height of less than approximately 1,000 micrometers.” Karp, abstract. In this regard, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
Thus, Karp renders claim 3 obvious.
Regarding claim 4 and the requirements:
4. ([…]) The vaginal drug delivery device of claim 1, wherein the microstructures each comprises a cross sectional diameter ranging from about 80 to 600 μm at the proximal end.
Karp teaches protrusion width dimensions:
[0019] The protrusions can have an average height of from approximately 0.2 μm to approximately 10 μm.
[0020] The protrusions can have an average tip width of from approximately 0.05 μm to approximately 10 μm. […].
[0021] The protrusions can have an average base width of from approximately 0.05 μm to approximately 10 μm. […].
Karp, par. [0019]-[0021]. However, to the extent that Karp DOES NOT EXPRESSLY TEACH “a cross sectional diameter ranging from about 80 to 600 μm at the proximal end” per the requirements of claim 4, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. In this respect, Karp also teaches “an average height of less than approximately 1,000 micrometers” (Karp, abstract), and that “[t]he protrusions can have an average height to base width ratio of from approximately 0.1: 1 to approximately 500: 1” (Karp, par. [0023]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange the disclosed above cited components of Karp in order to arrive at a device with protrusions up to 1,000 micrometers (Karp, abstract), and an average height to base width ratio of from approximately 0.1: 1 to approximately 500: 1 (Karp, par. [0023]) for overlapping base widths ranging from about 100 (i.e., 0.1 to 1 or 1,000 µm to 100 µm) to 2 micrometers (i.e., 500:1 or 1000 to 2 µm). In this respect, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” It is further noted, “[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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and also MPEP § 2144.05(II)(A). In the instant case, the dimensional parameters of the protrusions are clearly a result-effective variable, for which Karp teaches that “[t]he arrangement and dimensional parameters (e.g., tip width to pitch ratio, or tip width to base width ratio) of the protrusions can be controlled and optimized to enhance adhesion” (Karp, par. [0007]). Therefore, it would have been customary for an artisan of ordinary skill to select appropriate base width ratios of approximately 0.1:1 to approximately 500: 1” (Karp, par. [0023]) in optimizing the for the controlled and enhanced adhesion (Karp, par. [0007]) in order to meet the requirements of claim 4 for a “cross sectional diameter ranging from about 80 to 600 μm at the proximal end.”
Thus, Karp renders claim 4 obvious.
Regarding claims 5-6 and the requirements:
5. ([…]) The vaginal drug delivery device of claim 1, wherein the base is biodegradable.
6. ([…]) The vaginal drug delivery device of claim 1, wherein the plurality of microstructures are biodegradable.
Karp teaches “[a]n adhesive article” with a “biocompatible and at least partially biodegradable substrate having a surface” and “protrusions include[ing] a biocompatible and at least partially biodegradable material” (Karp, abstract).
Thus, Karp renders claims 5-6 obvious.
Regarding claim 7 and the requirements:
7. ([…]) The vaginal drug delivery device of claim 1, wherein the base has a shape selected from the group consisting of: a tablet, a film, a ring, a capsule, and combinations thereof.
Karp teaches that “[t]he adhesive article can be in the form of a tape” (Karp, par. [0033]), which is a “film” of claim 7.
Thus, Karp renders claim 7 obvious.
Regarding claim 8 and the requirements:
8. ([…]) The vaginal drug delivery device of claim 1, wherein the device is made from polymers selected from the group consisting of: Polyesters comprising Poly(glycolic acid), Poly(lactic acid), Poly(lactic-glycolic acid) and Poly(caprolactone) (PCL); Polysaccharides comprising chitosan, dextran, alginate, hyaluronic acid; Polyanhydrides; Polyorthoesters; Polyurethanes and combinations thereof.
Karp teaches: “[t]he substrate and/or the protrusions can include a material selected from the group consisting of poly(glycerol sebacate) (PGS), poly(glycerol sebacate acrylate) (PGSA), poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polyglycolide (PGA), polylactic acid (PLA), and/or poly-3-hydroxybutyrate (PHB), polyurethane, parylene-C, keratin, carbon nanotubes, poly(anhydride), and chitosan” (Karp, par. [0018]}, which reads on at least “Polyesters” of claims 8.
Thus, Karp renders claim 8 obvious.
Regarding claim 11 and the requirements:
11. ([…]) The vaginal drug delivery device of claim 1, wherein the second therapeutic agent comprises a drug selected from the group consisting of: an antibacterial agent, an antifungal agent, an antimicrobial agent, and combinations thereof.
Karp teaches that “[t]he substrate and/or the protrusions can include a biomolecule or a pharmaceutical compound,” inter alia, “antibiotics” (Karp, par. [0028]), which reasonably encompasses an “antibacterial agent” of claim 11. To the extent Karp DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof, the incorporation of “antibiotics” into Karp’s device would be obvious per Karp’s broader disclosure. See MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.
Thus, Karp renders claim 11 obvious.
Regarding claims 12-13, it is noted that the requirements:
12. The vaginal drug delivery device of claim 1, wherein the device has a degradation rate of about 4 days to 9 months after insertion.
13. The vaginal drug delivery device of claim 1, wherein the device has a drug release rate of about 5-20 μg per day.
are functional requirements. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claim 1, which achieve the resulting release effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended release effect of a composition that meets the structural requirements of claim 1. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claim 1 will achieve the intended result of the functional requirements and fall within the boundaries of the claims.
Thus, Karp renders claims 12-13 obvious.
Regarding claim 14 and the requirements:
14. ([…]) The vaginal drug delivery device of claim 1, wherein the body is curved along its length between the proximal end and the distal end.
Karp teaches that “protrusions 24 can have a variety of shapes and sizes” including “protrusions having the shape of a cone with a pointed tip (FIG. 2A)” wherein “the angle (8) between the surface of substrate 22 and the side of a protrusion 26 can range from approximately 0° to approximately 180°”:
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Karp, par. [0095], Fig. 2A. However, to the extent that Karp DOES NOT EXPRESSLY TEACH an embodiment meeting the requirements of claim 14, “wherein the body is curved along its length between the proximal end and the distal end,” such a shape would be obvious per Karp’s broader disclosure. In this regard, the dimensional parameters of the protrusions are clearly a result-effective variable, for which Karp teaches that “[t]he arrangement and dimensional parameters (e.g., tip width to pitch ratio, or tip width to base width ratio) of the protrusions can be controlled and optimized to enhance adhesion.” Karp, par. [0007]. Therefore, it would have been customary for an artisan of ordinary skill to select appropriate average height to base width ratios (Karp, par. [0023)]), by varying “the angle (8) between the surface of substrate 22 and the side of a protrusion 26 can range from approximately 0° to approximately 180°” (Karp, par. [0095], Fig. 2A) for controlling and enhancing adhesion (Karp, par. [0007]) in order to arrive at a curve per the requirements of claim 14.
Thus, Karp renders claim 14 obvious.
Regarding claims 15-16 and the requirements:
15. ([…]) The vaginal drug delivery device of claim 1, wherein the body connects the proximal end and the distal end without any curvature along its length.
16. ([…]) The vaginal drug delivery device of claim 1, wherein the tip is selected from the group consisting of: a cube, a rectangle, a sphere, a cone, a pyramid, a cylinder, a tube, a ring, a tetrahedron, a hexagon, an octagon, or any irregular shapes.
Karp teaches that “protrusions 24 can have a variety of shapes and sizes” including “a round cylinder (FIG. 2B)”:
[0095] Similar to substrate 22, protrusions 24 can have a variety of shapes and sizes. As some examples, FIGS. 2A-2E show protrusions having the shape of a cone with a pointed tip (FIG. 2A), the shape of a round cylinder (FIG. 2B), the shape of a frustrum of a cone (FIG. 2C), the shape of a prism having a polygonal cross section (FIG. 2D), and the shape of a truncated, four-sided pyramid (FIG. 2E). The cross section of the polygonal prism can be regular or irregular, and can have three, four, five, six or more sides. Other shapes for protrusions 24 include regular or irregular pyramids having three sides, five sides, or six or more sides. The pyramids ( e.g., FIG. 2E) can have pointed tips (e.g., as in FIG. 2A) or truncated, flat tips (e.g., as in FIGS. 2B and 2C). Referring to FIG. 2A, the angle (8) between the surface of substrate 22 and the side of a protrusion 26 can range from approximately 0° to approximately 180°. Adhesive article 20 can include protrusions 24 of the same shape or different shapes, in any combination, depending on the intended application (e.g., desired degree of adhesiveness).
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(Karp, par. [0095]), which respectively reads on the instant microstructures, “wherein the body connects the proximal end and the distal end without any curvature along its length” of claim 15, and at least a “cylinder” of claim 16.
Thus, Karp renders claims 15-16 obvious.
Regarding claim 18 and the requirements:
18. ([…]) The vaginal drug delivery device of claim 17, wherein each microstructure is formed of a solid structure.
Karp teaches “Fabrication of Adhesive Articles” (Karp, par. [0113]-[0123]), wherein “the material(s) (e.g., PGSA polymer) for protrusions 24 and substrate 22 is filled into cavities 44 and placed on template 42” and processed to obtain “uncoated adhesive article 20”:
[0114] FIG. 5 shows an embodiment of a method 40 for fabricating adhesive article 20. As shown, a template 42 (e.g., a silicon template) is prepared using, for example, a combination of photolithography followed by reactive ion etching (RIE). Template 42 includes a plurality of mold cavities 44 having the shape(s), patterning(s) and dimensions of protrusions 24, or shapes that give rise to protrusions 24. Next, the material(s) (e.g., PGSA polymer) for protrusions 24 and substrate 22 is filled into cavities 44 and placed on template 42. In some embodiments, no high vacuums are used to fill cavities 44, but in other embodiments, vacuums and/or temperature variations are used to fill the cavities. Then, the material(s) for protrusions 24 and substrate is cured, for example, using ultraviolet radiation in minutes at room temperature. The cured material(s) is then separated from template 42 to provide an uncoated adhesive article 20.
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(Karp, par. [0114], Fig. 5), whereby “protrusions 24” obtained from material “filled into cavities 44” meet the requirements for the instant device, “wherein each microstructure is formed of a solid structure” per claim 18.
Thus, Karp renders claim 18 obvious.
Regarding claim 19 and the requirements:
19. ([…]) The vaginal drug delivery device of claim 18, wherein the first therapeutic agent is released from portions of the base surrounding the plurality of microstructures.
Karp teaches that “[i]n some embodiments, protrusions 24 and substrate 22 can include compositions with different degradation rates, which can affect delivery of a pharmaceutical compound, if applicable,” e.g., “one portion of an adhesive article can biodegrade quickly to provide a bolus delivery of a drug, and another portion of the adhesive article can biodegrade relatively slowly to provide an extended release of the drug” (Karp, par. [0099]), which meets the requirements of claim 19 for “wherein the first therapeutic agent is released from portions of the base surrounding the plurality of microstructures.”
Thus, Karp renders claim 19 obvious.
Regarding claim 20 and the requirements:
20. ([…]) The vaginal drug delivery device of claim 19, wherein at least portion of the device is coated with one or more layers of an adhesive material.
Karp teaches: “Chemically, in some embodiments, the adhesive articles include a thin, tissue reactive, biocompatible surface coating,” particularly, “coating the adhesive articles with, for example, a thin layer of oxidized dextran can significantly increased the interfacial adhesion strength on porcine intestine tissue in vitro and in the rat abdominal subfascial in vivo environment.” Karp, par. [0007].
Thus, Karp renders claim 20 obvious.
Claims 10 and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over KARP (US 2011/0021965 A1, Publ. Jan. 27, 2011; hereinafter, “Karp”; of record), as applied to claims 1-8 and 11-20, above, and further in view of UHLAND (US 9,017,310 B2, Issued Apr. 28, 2015; on 01/09/2026 IDS; hereinafter, Uhland”).
The teachings of Karp, as set forth above, are hereby incorporated.
Regarding claim 10, Karp DOES NOT EXPRESSLY TEACH the requirements of claim 10 for estrogen, progesterone or estradiol:
10. ([…]) The vaginal drug delivery device of claim 1, wherein the first therapeutic agent comprises a drug selected from the group consisting of: estrogen, progesterone, and estradiol.
which is well within the purview of the ordinarily skilled artisan.
Uhland, for instance, is directed to:
TRANSMUCOSAL DRUG DELIVERY DEVICE AND METHOD INCLUDING MICRO NEEDLES
ABSTRACT
Devices and methods for transmucosal drug delivery are provided. A device includes a housing configured for intralumenal deployment into a human or animal subject; a drug-dispensing portion which contains at least one drug; and a plurality of microneedles extending, or being extendable from, the housing, the plurality of microneedles being configured to disrupt at least one region of a mucosal barrier adjacent the housing at a selected time after being intralumenally deployed in the human or animal subject. The device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the plurality of microneedles.
(Uhland, title & abstract), wherein “[t]he drug delivery device may be placed within a lumen of the subject, such as within the vagina of a female subject” (Uhland, col. 14, ln. 4-6). In this regard, Uhland discloses suitable drugs (Uhland, col. 11, ln. 5-30), inter alia, “estradiol, progesterone” (Uhland, col. 11, ln. 11).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to manufacture Karp’s “adhesive article 20” (Karp, par. [0092], Fig. 1) for delivery of “estradiol, progesterone” per Uhland (Uhland, col. 11, ln. 11). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of suitable drugs, namely “estradiol, progesterone” (Uhland, col. 11, ln. 11) for a device placed in the vagina of a female subject (Karp, par. [0128]; Uhland, col. 14, ln. 4-6).
Thus, the prior art renders claim 10 obvious.
Regarding independent claim 21 and the requirements:
21. ([…]) A vaginal drug delivery device comprising:
a flexible having a shape selected from the group consisting of: a tablet, a ring, a capsule, and combinations thereof;
a first therapeutic agent embedded in the base, the first therapeutic agent comprising a drug selected from the group consisting of: estrogen, progesterone, and estradiol; and
a plurality of microstructures protruding from the base, wherein the microstructures each comprise a proximal end, a distal end, a body and a tip, wherein the plurality of microstructures comprises a second therapeutic agent selected from the group consisting of: an antibacterial agent, an antifungal agent, and an antimicrobial agent.
Karp clearly teaches “adhesive article 20 for adhesion to a biological tissue surface including a biocompatible and biodegradable substrate 22, and a plurality of protrusions 24 extending from the substrate” (Karp, par. [0092], Fig. 1) wherein “substrate 20 includes a material that is flexible and conformable” (Karp, par. [0093]) featuring “surface modification 26,” wherein “biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20” (Karp, par. [0106]), WHEREBY it is noted:
“biocompatible and biodegradable substrate 22” (Karp, par. [0092], Fig. 1),” wherein “substrate 20 includes a material that is flexible and conformable” (Karp, par. [0093]), particularly, “substrate 22,” which is “flexible and easily conformable to the application surface” (Karp par. [0099]) and may be in the “shape of a round cylinder (FIG. 2B),” relates to the requirement of claim 21 for “a flexible having a shape selected from the group consisting of: a tablet, […], a capsule, and combinations thereof” (see MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference.);
“surface modification 26, in some embodiments, biomolecules and/or bioactive agents are incorporated into substrate 22” (Karp, par. [0106]) relates to the requirements of claim 21 for “a first therapeutic agent embedded in the the base”;
“a plurality of protrusions 24 extending from the substrate” (Karp, par. [0092], Fig. 1) relates to the requirements of claim 21 for “a plurality of microstructures protruding from the base, wherein the microstructures each comprise a proximal end, a distal end, a body and a tip.”
However, to the extent that Karp DOES NOT TEACH the particular configuration required by claim 21 for “the first therapeutic agent [embedded in the base] comprising a drug selected from the group consisting of: estrogen, progesterone, and estradiol” and “a second therapeutic [in the microstructures] agent selected from the group consisting of: an antibacterial agent, an antifungal agent, and an antimicrobial agent,” it would be obvious for one of ordinary skill to arrive at such a device for similar reasons, as discussed above for claims 1 and 10-11, absent evidence to the contrary.
Thus, the prior art renders claim 21 obvious.
Response to Arguments
Applicants’ arguments, filed on January 08, 2026 (hereinafter, referred to as “Remarks”), have been fully considered, but they are not persuasive.
Applicant argues:
Specifically, Applicant submits that Karp does not teach or suggest a device having first and second therapeutic agents wherein the first and second therapeutic agents are positioned in different portions of the device. In contrast, Karp teaches portions having compositions that are “stiffer or harder” than other portions (Karp, [0099]), however nowhere does Karp teach that the different compositions may provide different therapeutic agents. In further contrast Karp teaches “one portion of an adhesive article can biodegrade quickly to provide a bolus delivery of a drug, and another portion of the adhesive article can biodegrade relatively slowly to provide an extended release of the drug” (Karp, par. [0099], emphasis added). Karp is referring in this section to achieving different release profiles of the same drug in the device of evidenced by Karp using the article "the" to refer back to the earlier referenced drug. Nowhere does Karp teach or suggest that the device may have separate portions having different therapeutic agents.
For at least these reasons, Applicant submits that amended claim 1 is patentable over Karp. Claims 2-8 and 10-20 all depend directly or indirectly from amended claim 1, and are therefore patentable over Karp through their dependency on amended claim 1. In view of the above, Applicant respectfully requests reconsideration and withdrawal of the Examiner's rejections.
01/08/2026 Remarks, p. 7, par. 6, cont. on p. 8, to p. 8, par. 1.
In response: Karp appears to contemplate “biomolecules and/or bioactive agents [that] are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20”
[0106] Alternatively or additionally to surface modification 26, in some embodiments, biomolecules and/or bioactive agents are incorporated into substrate 22, protrusions 24, and/or an adherent layer on adhesive article 20, for example, using covalent and/or non-covalent interactions. […].
(Karp, par. [0106]), as well as protrusions that “can include one or more different compositions to create multi-component adhesive articles,” and “a substrate including a second composition different from the first composition” for “protrusions 24 and substrate 22 can include compositions with different degradation rates, which can affect delivery of a pharmaceutical compound, if applicable”:
[0099] Protrusions 24 can include (e.g., be formed solely of) the same composition(s) as included in substrate 22, but in other embodiments, the protrusions can include one or more different compositions to create multi-component adhesive articles. As an example, protrusions 24 can include a composition that is stiffer or harder than a composition include in substrate 22. The stiffer composition can allow protrusions 24 to more easily penetrate an application site (e.g., tissue), thereby increasing contact area and adhesion. At the same time, the less stiff composition allows substrate 22 to be flexible and easily conformable to the application surface. As another example, article 20 can include protrusions including a first composition, a thin (e.g., approximately 1 micrometer to approximately 100 micrometers, or approximately 0.5 micrometer to approximately 5 micrometers) layer beneath the protrusions including the first composition, and a substrate including a second composition different from the first composition (e.g., to provide different stiffness). In some embodiments, protrusions 24 and substrate 22 can include compositions with different degradation rates, which can affect delivery of a pharmaceutical compound, if applicable. For example, one portion of an adhesive article can biodegrade quickly to provide a bolus delivery of a drug, and another portion of the adhesive article can biodegrade relatively slowly to provide an extended release of the drug. Such compositions and/or the geometry of protrusions 24 can be anisotropic. In certain embodiments, protrusions 24 have lower degradation rates than substrate 22 so the protrusions do not degrade quickly, e.g., due to their smaller dimensions and/or compositions.
(Karp, par. [0099]), whereby it would be obvious to rearrange Karp’s device to release different drugs from protrusions 24 and substrate 22, absent evidence to the contrary, for instance, evidence of unexpected results from a particular drug configuration, as in claim 21. In the absence of such evidence, the configurations of claims 1 and 21 would appear to be obvious.
Conclusion
Claims 1-8 and 10-21 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611