DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of the species where the method is a method of providing an active pharmaceutical ingredient to a subject in need of treatment of infertility or hormone replacement in the reply filed on June 12, 2026 is acknowledged.
The restriction is deemed proper and therefore made FINAL.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 14-16 and 21 is are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 14-16 recite or require “a degree of crosslinking of the polymer matrix is substantially proportional to a degree of swelling”. Eichenbaum et al. illustrate the variability of the impact of crosslinking within a single polymer that is loaded via solution immersion with a drug (see Macromolecules 1999 32:4867-4878 - IDS). Here a single set of polymers with different degrees of crosslinking exhibit very different swelling abilities based upon the pH of the treatment aqueous solution (see figure 2). At pH values of 4 and below the swelling is not proportional to the crosslink density whereas at values beyond this threshold, a proportional relationship emerges (see figure 2). In the instant specification, there is no general guidance for selecting the solvent-polymer pairings as well as the supporting conditions that are necessary to achieve the claimed functional relationship of crosslinking to polymer swellings.
Claim 21 recites the polymer matrix to be prepared from dual cure resin by exposure to sequential UV light and heat. While the disclosure has one example of a polymer that is cured via the two recited mechanisms that also swells as required, it does not provide general guidance for combinations of active pharmaceutical, solvent, and polymer that yield the degree of swelling that is required while employing a polymer matrix that is UV light and heat cured/curable, sequentially. Various predictive models of polymer swelling in solvents that apply with varying levels of accuracy in real world systems are known, but the applicant does not make reference to any of them as governing their claimed method (see Nandi et al. Macromolecules 2005 38:4447-4455 – see IDS and Durning et al. Journal of Chemical Physics 1993 98(5): 4275-4293 – see IDS). The disclosure names two polymer categories and two particular polymers as envisioned polymers for the claimed medical device. The examples employ one silicone-polyurethane polymer and explore acetone, methanol, chloroform, and isopropyl acetate for their ability to induce swelling and loading of two different model drugs or a dye and the nature of the relationship between parameters (e.g., loading solution concentration and percent loaded) (see pages 24 and 35-37). Characterization of the acetone and methanol influence on the polymer and its uptake of model compounds was conducted, but outcomes do not apply to polymers significantly different in chemical structure from the tested silicone (see page 33 and examples 8-18).
As a result, the disclosure is missing a structure-function correlation that provides for the determination of particular embodiments, beyond the few examples of component combinations, that have the claimed swelling functionality in accordance with the claims (see MPEP 2163(II)(3)(a)(ii)). Consequently, the artisan of ordinary skill would have deemed the applicant in possession of the invention as claimed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 8-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 19 recite “providing a medical device comprising a polymer matrix and API, wherein the API is loaded into the polymer matrix by exposing the polymer matrix to a loading solution with the API”. Due to the description of the device with the phrasing “is loaded”, it is unclear if this recitation is a product-by-process describing a product employed in the active process step later recited in the claim or if the recitation is an additional active step of producing the medical device, in spite of the discussion of the API (active pharmaceutical ingredient) loading process in past tense.
Claim 14 recites “wherein a degree of crosslinking of the polymer matrix…defines an accessibility of a micro space within the polymer matrix”. The meaning of “micro space” is not clear or elaborated upon in the specification such that the feature is identifiable. It is also unclear what entity is to have “access” to the “micro space” or not, dependent on crosslinking. In addition, there is no previous requirement that the polymer matrix be crosslinked, thus the addition of limitations concerning crosslinking yields an incomplete delineation of the claim scope. Further, the relationship between swelling and crosslink density is situationally dependent. Eichenbaum et al. illustrate this phenomenon (see Macromolecules 1999 32:4867-4878 - IDS). Here a single set of polymers with different degrees of crosslinking exhibit very different swelling abilities based upon the pH of the treatment aqueous solution (see figure 2). At pH values of 4 and below the swelling is not proportional to the crosslink density, whereas at values beyond this threshold, a proportional relationship emerges (see figure 2). Thus the scope of required polymers, solvents, and qualifying treatment conditions are not clear for the claimed method.
Claim 15 recites “the degree of swelling is substantially directly proportional to the degree of API loading” in the device. The basis for the degree of loading is not provided. If it is presumed to refer to the proportion of feed API contacted with the polymer matrix for loading, a resulting device could be obtained due to exposure to two different load solution concentrations where the matrix is permitted to swell for different periods of time. It is not clear of the structure of these devices would actually differ, thus the scope of devices that are embraced by this recited functionality is not clear.
Claim 19 recites “interactions between the API and “swelling of a polymer matrix…a surface area…another API…a polymeric membrane…and an initial loaded concentration of API”. It is not clear how the API ‘interacts’ with “swelling” or what is meant by the API ‘interacting’ with a surface area or with an initial loaded concentration of itself. Thus the scope of devices whose release kinetics are controlled by these recited interactions is unclear as is the method administering them. For the sake of compact prosecution and the application of prior art, methods that fulfill the recited structural limitations of these devices and are administered by the recited method will be deemed sufficient to meet these limitations.
Claims that are rejected, but are not elaborated upon, are also indefinite because they depend from an indefinite claim and do not add clarity.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 12-13, and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites the same range of days over which the release kinetics are recited to occur as is recited in the parent claim. Thus the scope is the same as the parent claim.
Claim 12 recites a series of optional durations over which “substantially sustained release” occurs. Since none of the recited durations are required and the parent claim already recites “substantially sustained release”, the scope of the claim is no different than that of its parent.
The claims 13 and 16 appear to recite governing parameters that control physical phenomena in polymer matrices such as swelling and mass transport as well as their time dependent increases (e.g., swelling and diffusion distance into polymer - increase with time) (see Hseih et al. Journal of Pharmaceutical Sciences 1983 72(1):17-22 – see IDS; Horne et al. Journal of Drug Delivery Science and Technology 2017 41:410-418, and Vesely Macromolecular Symposia 1999 138:215-223 – see IDS). They do not add limitations because all possible polymer matrices and polymer medical devices of claim 1 meet a criteria recited in each of the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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, 5-6, 8-9, 13, 18-19, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. (US PGPub No 2006/0134161) in view of Duijkers et al. (Human Reproduction 2018 33(11):2131–2140).
Halliday et al. teach linear polyurethane polymers employed to generate a controlled/sustained release medical device, where a drug of interest is loaded via post-fabrication swelling (see paragraphs 1-4, 12, and 20; instant claims 1, 13-16, and 19). Suppositories and pessaries for vaginal use are envisioned as devices and female sex hormones are envisioned drugs (see paragraphs 20 and 23; instant claim 6). Particular envisioned and exemplified drugs include the female sex hormone, progesterone which is a hydrophobic drug, as well as hydrophilic drugs such as clindamycin phosphate (see table 19, instant claim 6 and 23). They go on to detail that the polymer swells in water as well as in other solvents to varying degrees (see paragraph 12 and table19; instant claim 1 and 19). An example of pessaries details post-fabrication swell loading of progesterone or other more hydrophilic compounds into a polymer with a solution of the drug (see paragraph 124-130). The progesterone loaded polymer matrix swells to 200 to 300% in an alcohol/water solvent (see tables 19 and 21 and figure 10; instant claims 1 and 19). The exposure to the loading solution occurs over 16 to 24 hours (see table 19; instant claim 26). Halliday et al. further teach purifying (pre-extracting) the polymer matrix prior to loading (see paragraphs 29 and 124, tables 14 and 17; instant claim 18). Analysis of the release rate of progesterone for the device showed a release of about 30% at 8 hours for the A03033 sample which swelled to 230% during loading (see figure 10; instant claims 1 and 19). Halliday et al. do not explicitly detail administering the device to a patient population in need of infertility treatment.
Duijkers et al. teach administering vaginal pessaries that release progesterone to treat infertility in female human patients (see abstract and page 2132 second column second-third full paragraphs; instant claims 6 and 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the device of Halliday et al. to human patients in need of female sex hormones because it is obvious to use a device for its intended purpose. Specifically, it would have been obvious to administer the progesterone releasing pessary to female patients in need of infertility treatment in light of Duijkers et al. who teach this administration route as useful for such treatments. The A03033 pessary of Halliday et al. would be expected to continue releasing its progesterone and extrapolation of its rate of release yields a duration of about one day (see instant claims 1 and 19). Therefore claims 1, 5-6, 8-9, 13, 18-19, 23, and 26 are obvious over Halliday et al. in view of Duijkers et al.
Claim 1-2, 5-6, 8-9, 13, 18-19, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Duijkers et al. as applied to claims 1, 5-6, 8-9, 13, 18-19, 23, and 26 above, and further in view of Muldoon et al. (US PGPub No. 2005/0042292).
Halliday et al. in view of Duijkers et al. render obvious the limitations of instant claims 1, 5-6, 8-9, 13, 18-19, 23, and 26. While vaginal pessaries are detailed, ring shapes are not explicitly detailed for the administered device.
Muldoon et al. teach that intravaginal rings and pessaries are known intravaginal designs for polymer drug delivery (see abstract and paragraph 2; instant claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the device of Halliday et al. in view of Duijkers et al. as a ring instead of pessary as a known alternative shape for intravaginal drug delivery devices. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26 are obvious over Halliday et al. in view of Duijkers et al. and Muldoon et al.
Claim 1-2, 4-6, 8-13, 18-20, 23, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Duijkers et al. and Muldoon et al. as applied to claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26 above, and further in view of Arps et al. (US PGPub No. 2016/0310644).
Halliday et al. in view of Duijkers et al. and Muldoon et al. render obvious the limitations of instant claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26 where the device is an intravaginal ring. The addition of a rate controlling membrane is not detailed.
Arps et al. teach that the application of a rate controlling membrane to a drug loaded polymeric intravaginal ring permits control of the rate of release of the drug over days to years (see paragraph 39; instant claim 4). Such membranes may be added after the ring is loaded (see paragraphs 43 and 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a rate controlling membrane to the intravaginal ring of Halliday et al. in view of Duijkers et al. and Muldoon et al., in light of Arps et al. This modification would have been obvious as the application of the same technique to a similar device in order to yield the same improvement. The range of durations attainable from such features overlap with those instantly claimed, thereby render the claimed ranges obvious (see instant claims 10-12, 20, and 27). “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)” (see MPEP 2144.05). Therefore claims 1-2, 4-6, 8-13, 18-20, 23, and 26-27 are obvious over Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al.
Claim 1-2, 4-6, 8-13, 18-20, 23, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al. as applied to claims 1-2, 4-6, 8-13, 18-20, 23, and 26-27 above, and further in view of Shi at al. (US PGPub No. 2013/0017243).
Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al. render obvious the limitations of instant claims 1-2, 4-6, 8-13, 18-20, 23, and 26-27, where the intravaginal ring includes a rate limiting membrane. The details for how the membrane is modified to alter the release duration is not explicitly stated.
Shi et al. teach that rate limiting membranes can be altered in thickness to control the rate of release of an underlying active compound (see paragraph 24). Specifically, a thicker membrane yields slower release or longer duration of release (see paragraph 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the duration of release of the device of Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al. in light of Shi et al. as a matter of routine optimization because it is a result effective variable. Therefore claims 1-2, 4-6, 8-13, 18-20, 23, and 26-27 are obvious over Halliday et al. in view of Duijkers et al., Muldoon et al., Arps et al., and Shi et al.
Claim 1-6, 8-13, 18-20, 23, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al. or over Halliday et al. in view of Duijkers et al., Muldoon et al., Arps et al., and Shi et al. as applied to claims 1-2, 4-6, 8-13, 18-20, 23, and 26-28 above, and further in view of Kiser et al. (US PGPub No. 2014/0209100).
Halliday et al. in view of Duijkers et al., Muldoon et al., and Arps et al. as well as Halliday et al. in view of Duijkers et al., Muldoon et al., Arps et al., and Shi et al. render obvious the limitations of instant claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26, where the device is an intravaginal ring with a rate controlling membrane. Rate altering additives are not explicitly detailed.
Kiser et al. teach an intravaginal ring form drug delivery structured as a drug containing core and rate limiting membrane (see abstract). They additionally teach the utility of adding excipients in the drug core that modify the release of the drug (see paragraph 36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a rate altering excipient to the intravaginal ring of the modified Halliday et al. teachings. This modification would have been obvious as the application of the same technique to a similar device in order to yield the same improvement. Therefore claims 1-6, 8-13, 18-20, 23, and 26-27 are obvious over Halliday et al. in view of Duijkers et al., Muldoon et al., Arps et al., and Kiser et al. or over Halliday et al. in view of Duijkers et al., Muldoon et al., Arps et al., Shi et al. and Kiser et al.
Claim 1-2, 5-6, 8-9, 13, 18-19, 23, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Duijkers et al. and Muldoon et al. as applied to claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26 above, and further in view of Benhabbour et al. (US PGPub No. 2019/0091141 – see IDS).
Halliday et al. in view of Duijkers et al. and Muldoon et al. render obvious the limitations of instant claims 1-2, 5-6, 8-9, 13, 18-19, 23, and 26, where the device is an intravaginal ring. Details of the design for the ring are not provided.
Benhabbour et al. teach of the benefit of added geometric complexity with printed unit cells in drug delivering intravaginal rings that permit control of delivery via the loading capacity, diffusion rate, and surface area (see paragraphs 8-9). They detail that the drug may be loaded prior to or after fabrication (see paragraphs 64). Geometries of the unit cell they detail include cylinders and hexagons (honeycomb) (see paragraph 64 and figures 3C-3D; instant claim 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the intravaginal ring of Halliday et al. in view of Duijkers et al. and Muldoon et al. with the geometries taught by Benhabbour et al. This modification would have been obvious as the application of the same technique to a similar device in order to yield the same improvement. Therefore claims 1-2, 5-6, 8-9, 13, 18-19, 23, 26, and 28 are obvious over Halliday et al. in view of Duijkers et al., Muldoon et al., and Benhabbour et al.
Claims 1, 5-6, 8-9, 13, 17-20, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Halliday et al. in view of Chollet et al. (US PGPub No. 2007/0264309) as evidenced by Ward et al. (WO 2012/065998).
Halliday et al. teach linear polyurethane polymers employed to generate a controlled/sustained release medical device, where a drug of interest is loaded via post-fabrication swelling (see paragraphs 1-4, 12, and 20; instant claims 1, 13-16, and 19). Suppositories and pessaries for vaginal use are envisioned as devices and female sex hormones are envisioned drugs (see paragraphs 20 and 23; instant claim 6). Particular envisioned and exemplified drugs include the female sex hormone, progesterone which is a hydrophobic drug, as well as hydrophilic drugs such as clindamycin phosphate (see table 19, instant claim 6 and 23). They go on to detail that the polymer swells in water as well as in other solvents to varying degrees (see paragraph 12 and table19; instant claim 1 and 19). An example of pessaries details post-fabrication swell loading of progesterone or other more hydrophilic compounds into a polymer with a solution of the drug (see paragraph 124-130). The progesterone loaded polymer matrix swells to 200 to 300% in an alcohol/water solvent (see tables 19 and 21 and figure 10; instant claims 1 and 19). The exposure to the loading solution occurs over 16 to 24 hours (see table 19; instant claim 26). Halliday et al. further teach purifying (pre-extracting) the polymer matrix prior to loading (see paragraphs 29 and 124, tables 14 and 17; instant claim 18). Analysis of the release rate of progesterone for the device showed a release of about 30% at 8 hours for the A03033 sample which swelled to 230% during loading (see figure 10; instant claims 1 and 19). Halliday et al. do not explicitly detail administering the device to a patient population in need of hormone replacement.
Chollet et al. teach of the effectiveness of hormone replacement of progesterone and estriol via a vaginal suppository in menopausal women (see abstract and example 5; instant claim 25). Estriol is an estrogen female sex hormone that can be considered hydrophilic (see paragraph 35; Ward et al. page 6 lines 28-30; instant claim 24)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the device of Halliday et al. to patients in need of female sex hormones because it is obvious to use a device for its intended purpose. Specifically, it would have been obvious the administer progesterone with the added inclusion of estriol via suppository to female patients in need of hormone replacement treatment in light of Chollet et al. who teach their topical vaginal application and utility for such treatments. The A03033 pessary of Halliday et al. would be expected to continue releasing its progesterone and extrapolation of its rate of release yields a duration of about one day (see instant claims 1 and 19). Therefore claims 1, 5-6, 8-9, 13, 17-20, and 23-26 are obvious over Halliday et al. in view of Chollet et al. as evidenced by Ward et al.
Claims 1, 5-6, 8-9, 13-19, 22, 24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Embrey et al. (US Patent No. 5,017,382) in view of Uhland et al. (US PGPub No. 2014/0088346).
Embrey et al teach the provision of solid polymer devices for controlled/sustained drug delivery envisioned in the form of a swellable hydrogel (vaginal) pessary (see abstract and column 5 lines 5-14). The devices deliver prostaglandin, a compound envisioned for treating cervical incompetence prior to artificial insemination (infertility) (see column 6 lines 6-10 and 17-19; instant claims 6, 8, and 24). The polymer of the device is crosslinked and preferably swells to 200 to 500%, when exposed to a loading solution of prostaglandin to yield a device that releases over 24 hours (see column 7 lines 55-column 8 line 4; instant claims 1, 13-1619, and 26). Swelling/loading solvents are envisioned to include chloroform as well as water (see column 7 lines 32-48; instant claims 22 and 24). An example loads a prostaglandin over 24 hours via a solution comprising chloroform, where the polymer matrix swells to 384% (see example 11; instant claims 1 and 19). A release half life of 95 hours is detailed (see example 11; instant claims 1 and 19). A human female patient in need of infertility treatment is not explicitly taught as the patient population.
Uhland et al. teach the local (vaginal) delivery of prostaglandin to human female patients with infertility, prior to artificial insemination (see paragraphs 7, 88, and 107).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the exemplary pessary of Embrey et al. with a suitable prostaglandin to a human patient in need of infertility treatment. This choice would have been obvious in light of Uhland et al,. who teach of this patient population benefiting from the local release of prostaglandin in order to address infertility. In addition, it is obvious to use a device for its intended purpose, thus administration for local prostaglandin release would have been obvious. Therefore claims 1, 5-6, 8-9, 13-19, 22, 24, and 26 are obvious over Embrey et al. in view of Uhland et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
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