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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 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.
Regarding claim 15, the limitations “a vulva,” “an external urethral orifice,” and “a urethra” in lines 3-4 as well as “a vaginal opening” and “a clitoris” in lines 5-6 render the claim indefinite as it is unclear whether these are the same or different than those claimed in claim 1. For examination purposes, these limitations are considered the same. Additionally, it is unclear which vestibule is being referenced in line 8, as claim 1 in line 3 includes “a vestibule between labia minora and between a vaginal opening and a clitoris of a vulva” in lines 3-4 while claim 15 includes “a vestibule of a vulva” in line 3.
Claim 16 is rejected as a dependent of claim 15.
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.
Claim(s) 1-7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne et al. (US 2013/0184778) in view of Scholz et al. (US 2014/0221907), and as evidenced by London Brown et al. (US 2014/0024615).
Regarding claim 1, St. Anne discloses a barrier device 10 (see Figs. 1 and 5, barrier device can fit over urethra 20) comprising: a patch 10 having a size and a shape, the size and shape being such that the patch is positionable on a vestibule between labia minora and between a vaginal opening and a clitoris of a vulva such that the patch overlays an external urethral orifice of a urethra and without the patch impeding access to the vaginal opening or the clitoris (see Fig. 5, patch 10 can be placed in such a position, with London Brown disclosing in par. 97 that the typical urethral opening is substantially circular with a diameter in the range of 4-5 cm, which is 0.16-0.2 inches, falling within the Fig. 3 width of St.Anne disclosed as 1 1/16 inches), the patch comprising: an upper layer 16 such that the upper layer is impervious to bacteria (see Fig. 1, upper layer 16 is impervious film material, which would block liquid and the bacteria associated with liquid); and a lower layer 14 being coextensive with the upper layer (see Fig. 1) and comprising adhesive (see Fig. 1).
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). While St. Anne does not disclose the barrier device as a urethral barrier device, as adhesively attaching to the required vestibule and preventing bacteria from entering the urethra during sexual intercourse, the barrier device is able to perform such functions. St. Anne discloses wherein the lower layer is configured for adhesively attaching the patch to the vestibule such that the patch extends over the external urethral orifice (see Figs. 1, 3, and 5, dimensions mentioned above would allow for adhesively attaching patch to vestibule such that it extends over urethral orifice), therefore functioning as a urethral barrier device, and wherein the patch is configured for preventing bacteria from entering a urethra through the external urethral orifice during sexual intercourse (see par. 11, can be used during intercourse and as mentioned above, would prevent bacteria due to impervious film material of upper layer).
St. Anne does not disclose the upper layer comprising elastomer, though St. Anne discloses the upper layer as flexible plastic film and as a backing sheet (see par. 29). Scholz discloses a backing film that is polymeric, flexible, and impermeable to the passage of liquids (see par. 80, 83) and uses elastomeric polyurethane as an example of a backing film that also has the benefit of transparency (see par. 80, 83). It would have been obvious to a person having ordinary skill in the art at the time of invention to have the upper layer comprise an elastomeric polyurethane, as disclosed by Scholz, as this would still provide the flexibility required for positioning on the body along with the benefit of transparency disclosed by Scholz. Additionally, the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious), and similarly the material disclosed by Scholz shows that elastomeric polyurethane is a known material that is suitable for the intended purpose of acting as a backing/upper layer and therefore supports a prima facie obviousness determination similar to In re Leshin.
Regarding claim 2, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and while St. Anne discloses shapes that are rectangular, oval, and triangular (see Figs. 2-4), these prior art do not disclose the shape as being substantially square.
Applicant places no criticality on the shape, as alternative shapes disclosed are “circular, ovoid, triangular, or the like” (see current Specification, page 4, lines 18-21), and therefore there is no evidence of record that establishes that changing the shape would result in a difference in function of the device. Further, a person having ordinary skill in the art, being faced with modifying the shape, would have had a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed square shape. Lastly, applicant has not disclosed that the claimed shape solves any stated problem, indicating various alternative shapes may also be used and therefore there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the rectangular shape disclosed by St. Anne to be substantially square as a matter of design choice within skill of the art and as changes in shape have been found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 3, St. Anne, Scholz, and London Brown disclose the limitations of claim 2 and St. Anne further discloses the corners of the patch are convexly arcuate (see Fig. 3).
Regarding claim 4, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and St. Anne further discloses the size is from 2.0 to 12.0 cm2 (see Fig. 3, the length is 1 ½ cm, which is 3.81 cm, and the width is 1 1/16 in, which is 2.70 cm, which would result in a surface area of 3.81 cm x 2.70 cm, which is 10.29 cm2, falling within the claims range).
Regarding claim 5, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and St. Anne further discloses the size is 10.29 cm2 (see Fig. 3, the length is 1 ½ cm, which is 3.81 cm, and the width is 1 1/16 in, which is 2.70 cm, which would result in a surface area of 3.81 cm x 2.70 cm, which is 10.29 cm2, falling within the claims range). The above cited prior art does not specifically disclose the size from 4.0 to 10.0 cm2. However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the size from 4.0 to 10.0 cm2 as applicant appears to have placed no criticality on the claimed range and since it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In this case, 10.29 cm2, disclosed by St. Anne, is considered close to the claimed range.
Regarding claim 6, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and St. Anne further discloses the upper layer is substantially impermeable to water (see Fig. 1, impervious fluid material).
Regarding claim 7, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and as explained above, disclose the upper layer comprises polyurethane (see rejection of claim 1 above, elastomeric polyurethane).
Regarding claim 14, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 and St. Anne further discloses including a cover panel 12 being reversibly attached to the lower layer for preventing inadvertent adhesion of the patch, wherein the cover panel is configured for being separated from the patch for enabling attachment of the patch to the vestibule (see par. 30).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne in view of Scholz and as evidenced by London Brown as applied to claim 1 above, and further in view of St. Anne (US 2017/0281939), hereinafter St. Anne 2.
Regarding claim 8, St. Anne, Scholz, and London Brown disclose the limitations of claim 1 but do not disclose the lower layer comprises a hydrogel adhesive.
St. Anne 2 discloses that hydrogels can be formulated to provide a more gentle adhesive in an adhesive layer (see par. 73). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the lower layer, which is the adhesive layer, be made of a hydrogel as disclosed by St. Anne 2 in order to use a more gentle adhesive that would result in more comfortability due to its gentleness.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne in view of Scholz and as evidenced by London Brown as applied to claim 1 above, and further in view of Pfister et al. (US 5,232,702) and Moscherosch et al. (US 2020/0261253).
Regarding 9, Anne, Scholz, and London Brown disclose the limitations of claim 1 but do not disclose the device further including the patch comprising a colloidal layer sandwiched between the upper layer and the lower layer, the colloidal layer comprising a medicant, such that the medicant is delivered through the lower layer to one or both of the vestibule and the urethra.
Pfister discloses a patch comprising a colloidal layer 54 sandwiched between an upper layer 52 that is a backing layer and a lower layer in the form of an adhesive layer 58 (see Fig. 4; col. 9, lines 1-12), the colloidal layer including drugs such an antimicrobials that travel to the skin via the adhesive layer (see col. 8, lines 41-44 and col. 9, lines 4-8). Mosherosch discloses suitable odor control additives in a barrier device for the vaginal area, the odor control additives including antimicrobials (see Abstract, par. 103). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a colloidal layer with antimicrobials sandwiched between the upper and lower, as disclosed by Pfister, in order to help control odor via antimicrobials, as disclosed by Moscherosch. Consequently, the antimicrobial, considered a medicant, would be delivered through the lower adhesive layer to the vestibule.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne in view of Scholz in view of Pfister and Moscherosch, and as evidenced by London Brown as applied to claim 9 above, and further in view of Modak et al. (US 2020/0352991).
Regarding claims 10-11, St. Anne, Scholz, London Brown, Pfister, and Moscherosch disclose the limitations of claim 9 but do not disclose the medicant comprises one or more of a beneficial microorganism, an essential oil, a polyphenol, and a flavonoid, nor do they disclose the medicant comprises witch-hazel extract.
Modak discloses an antimicrobial agent in the form of a botanical that is witch hazel extract (see claims 1, 15). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the antimicrobial agent be with hazel extract, such an antimicrobial agent in a medical device disclosed by Modak and this predictably resulting in the control of odors via antimicrobials. Witch hazel extract includes flavonoids and polyphenols.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne in view of Scholz in view of Pfister and Moscherosch, and as evidenced by London Brown as applied to claim 9 above, and further in view of Carlozzi (US 2010/0152687).
Regarding claim 10, St. Anne, Scholz, London Brown, Pfister, and Moscherosch disclose the limitations of claim 9 but do not disclose the medicant comprises one or more of a beneficial microorganism, an essential oil, a polyphenol, and a flavonoid.
Carlozzi discloses active agents comprising a mixture of a probiotic and anti-microbial (see par. 71, 94) placed in a layer of a feminine device such that the active agents interact with the skin (see Abstract, par. 5, 70-71). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have the medicant in the form of an antimicrobial be paired with a probiotic in the same layer, as disclosed by Carlozzi, in order to supply an additional active agent beneficial to the user of the device. Consequently, the medicant would include both a beneficial organism and an antimicrobial.
Regarding claim 12, St. Anne, Scholz, London Brown, Pfister, Moscherosch, and Carlozzi as described above disclose the limitations of claim 10 but do not disclose the medicant comprises one or more lactobacillus species to inoculate the urethra with the one or more lactobacillus species.
Carlozzi discloses the probiotic agents include lactic acid bacteria (see par. 102) with Moscherosch disclosing lactic acid bacteria as lactobacillus (see par. 141). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a lactic acid bacteria as Carlozzi discloses this being one of the useful probiotic agents and to specifically use lactobacillus as the lactic acid bacteria, as disclosed by Moscherosch, Moscherosch disclosing it as a well known lactic acid bacteria as well as conferring a health-benefit on a host (see par. 140).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Anne in view of Scholz in view of Pfister and Moscherosch and further in view of Carlozzi, and as evidenced by London Brown as applied to claim 12 above, and further in view of Sileika et al. (US 2023/0301816).
Regarding claim 13, St. Anne, Scholz, London Brown, Pfister, Moscherosch, and Carlozzi as described above disclose the limitations of claim 12 and further discloses the lactobacillus species is present in the colloidal layer (see rejections of claims 9-10 and 12) but do not disclose the species present as dehydrated granules.
Pfister discloses medicants/active agents being in the form of granules 56 in the colloidal layer (see Fig. 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use granules within the colloidal layer as disclosed by Pfister as this would allow for easy distribution of the active agents throughout the layer, allowing for a spread out treatment through the adhesive layer.
Sileika discloses that probiotic bacteria may be provided in dehydrated form (see par. 77, 83). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to supply the probiotic bacteria in a dehydrated form, as disclosed by Sileika, allowing it to reanimate with exposure to water vapor or moisture from the skin contacting adhesive and/or perspiration from a user’s skin, as disclosed by Sileika, predictably resulting in the treatment of the device wearer via the probiotic.
Allowable Subject Matter
Claims 15-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: prior art could not be found that discloses the required method as claimed:
While St. Anne and Scholz disclose the device of claim 1, neither St. Anne nor Scholz discloses the required positioning of the patch between the labia minora and between a vaginal opening and a clitoris such that the patch does not impede access to the vaginal opening or the clitoris. In St. Anne, the patch impedes access to the clitoris (see Fig. 5, par. 35) as the method is specifically for external physical stimulation to be applied to the clitoral region (see Abstract) and therefore one of ordinary skill in the art would not be motivated to position the patch such that it does not impede the clitoris.
Khun (US 2017/0079832) discloses a female urinary barrier system with a patch having an upper layer and a lower layer (see Fig. 10), which also does not disclose the required positioning of the patch between the labia minora and between a vaginal opening and a clitoris such that the patch does not impede access to the vaginal opening or the clitoris. In Khun, the method is specifically designed to cover the vaginal opening to provide a barrier from fecal matter (see Abstract), and therefore one of ordinary skill in the art would not be motivated to position the patch such that it does not provide a barrier to the vaginal opening, as that is its purpose.
Loock (US 2025/0107936) discloses a urethral barrier device (see Fig. 1) comprising a patch 1 with an upper and lower layer (see Fig. 2) but does not disclose the required positioning of the patch between the labia minora and between a vaginal opening and a clitoris such that the patch does not impede access to the vaginal opening or the clitoris. Loock is specifically designed to allow access to the vaginal opening but discloses covering the clitoris, and one of ordinary skill in the art would not be motivated to leave the clitoris uncovered absent hindsight.
London Brown also discloses a female urinary barrier system with a patch having an upper layer and a lower layer (see Fig. 8) but does not disclose the required positioning of the patch between the labia minora and between a vaginal opening and a clitoris such that the patch does not impede access to the vaginal opening or the clitoris. London Brown is specifically designed to allow access to the vaginal opening but discloses covering the clitoris, and one of ordinary skill in the art would not be motivated to leave the clitoris uncovered absent hindsight.
Conclusion
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781