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 .
Response to Arguments
Applicant's arguments filed 16 July 2026 have been fully considered but they are not persuasive. Applicant argues Ball does not teach the limitation central opening sized and shaped to permit visualization of the urethra and vaginal openings of typical human female anatomy through the central opening. The limitation requires that the opening accomplish this function permitting visualization of the urethra and vaginal openings of typical human female anatomy through the central opening. While Ball does include a vaginal cover, the movement of the device during placement e.g., placing the top of the device adjacent to the pubic region and then placing the cover, would allow the visualization of both openings in order to ensure accurate fit. Further, Examiner notes the above-mentioned limitation is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Ball opening is capable of performing the intended use of placement over the vaginal openings for viewing as structurally, Ball already teaches all the limitations of claim 1.
Regarding Applicant’s argument of there being no reason or motivation to modify Ball to provide a larger opening, it is noted the rejection of claim 1 stands under USC 102 and does not rely on reason or motivation to modify Ball.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the loop of Ball recited is not sized, shaped, positioned, or used to overlie anterior genital anatomy.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, the claims only recite with regard to the anterior tab, the anterior tab joined to said pair of wings at said first junction and nothing in relation to the anatomy. For these reasons, claims 1-21 remain rejected.
Examiner further notes Applicant argues that Singh would not teach the skin-adhering adhesive that attaches to labial tissue. While Singh does not adhere to the labial tissue, it is noted the limitation configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Singh device is capable of attaching toe labial tissue.
Claims 22-27 are newly added.
Claims 1-27 are examined on the merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 9-10 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ball (US 4815151).
Regarding claim 1, Ball discloses a labial device comprising:
a pair of wings (figure 2, see annotated figure below) joined at least at a first junction and defining therebetween a central opening (12) sized and shaped to permit visualization of the urethra and vaginal openings of typical human female anatomy through the central opening (col 3, lines 40-55) when the device is in contact with a genital region of female anatomy (figure 1); and
an anterior tab (26, see annotated figure below) joined to said pair of wings at said first junction and extending in a first direction away from said central opening (the tab is joined to the wings since the device is one piece).
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Regarding claim 2, Ball discloses wherein said pair of wings is further joined at a second junction opposite said first junction, said pair of forming a closed loop around said central opening (see annotated figure above, the wings are joined on anterior and posterior sides).
Regarding claim 3, Ball discloses further comprising: a posterior tab (see annotated figure above) joined to said pair of wings at said second junction, said posterior tab extending in a second direction, opposite said first direction, away from said central opening (the tab extends away as shown in figure 2).
Regarding claim 4, Ball discloses wherein said pair of wings and said anterior tab are formed as a unitary body (figures 1-2).
Regarding claim 5, Ball discloses wherein said body is curved relative to at least one plane (figure 1A, and 3).
Regarding claim 6, Ball discloses wherein said body is curved relative to at least two orthogonal planes (figures 1A and 3, curvature shown to be at angles to orthogonal planes).
Regarding claim 9, Ball discloses wherein each of said pair of wings has a front surface and a rear surface (front and rear or annotated wing above, figures 1A and 3) and defines a respective sidewall extending generally transversely to the front surface and away from the rear surface (figure 3).
Regarding claim 10, Ball discloses wherein each of said pair of wings defines an elongated tab (tab approximately near 13 in figure 3) elongated to extend beyond the typical human female labia when the device is in contact with a genital region of female anatomy (figure 1-3).
Regarding claim 22, it is noted the limitation wherein said anterior tab is sized and shaped to overlie at least a portion of at least one of the prepuce and the clitoris of typical human female anatomy when the device is in contact with the genital region is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Ball anterior tab is already sized and shaped as it is a portion of the device itself that is used to overly a portion of the female anatomy.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ball in view of Feloney (US 8202263).
Regarding claim 7, Ball discloses the body made of rubber (col 4, lines 22-25) but not wherein said body is constructed of a medical-grade silicone material.
Feloney discloses a catheter visualization device and teaches said body (104) is constructed of a medical-grade silicone material (col 2, lines 45-50).
Feloney provides a suitable surgical grade material for use in order to have desired material properties for the body (col 2, lines 45-50). It would have been obvious to a person of ordinary skill in the art at the effective filling date to substitute the rubber material of Ball with the silicone of Feloney in order to have suitable material for use on the body.
Claims 8, 11-21, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ball in view of Singh (US 2014/0303447).
Regarding claim 8, Ball discloses wherein said body defines a front surface and a rear surface(body has front and rear surface, front facing garment and rear facing the labia), but does not teach wherein a skin-adhering adhesive supported on said rear surface.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]).
Singh provides adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including adhesive to adhere the labial device onto the body and prevent movement.
Regarding claim 11, Ball discloses a body (10) defining a pair of wings (figure 2, see annotated figure below) joined at least at a first junction and defining therebetween a central opening (12) sized and shaped to permit visualization of the urethra and vaginal openings of typical human female anatomy through the central opening (col 3, lines 40-55) when the device is in contact with a genital region of female anatomy (figure 1); and
said body having a front surface and a rear surface (body has front and rear surface, front facing garment and rear facing the labia);
Ball does not disclose an adhesive supported on said rear surface of said body.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]).
Singh provides adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including adhesive to adhere the labial device onto the body and prevent movement.
Regarding claim 12, Ball further discloses an anterior tab (26, see annotated figure above) joined to said pair of wings at said first junction and extending in a first direction away from said central opening (the tab is joined to the wings since the device is one piece).
Ball discloses further comprising: a posterior tab (see annotated figure above) joined to said pair of wings at said second junction, said posterior tab extending in a second direction, opposite said first direction, away from said central opening (the tab extends away as shown in figure 2).
Regarding claim 13, Ball further discloses wherein said pair of wings is further joined at a second junction opposite said first junction, said pair of forming a closed loop around said central opening (see annotated figure above, the wings are joined on anterior and posterior sides).
Regarding claim 14, Ball further discloses wherein said body is curved relative to at least one plane (figure 1A, and 3).
Regarding claim 15, Ball further discloses said body is constructed of a pliable material (col 4, lines 22-25).
Regarding claim 16, Ball discloses wherein each of said pair of wings has a front surface and a rear surface (front and rear or annotated wing above, figures 1A and 3) and defines a respective sidewall extending generally transversely to the front surface and away from the rear surface (figure 3).
Regarding claim 17, Ball discloses wherein each of said pair of wings defines an elongated tab (tab approximately near 13 in figure 3) elongated to extend beyond the typical human female labia when the device is in contact with a genital region of female anatomy (figure 1-3).
Regarding claim 18, Ball discloses catheterization kit comprising:
a labial retention device comprising:
a body (10) defining a pair of wings (figure 2, see annotated figure below) joined at least at a first junction and defining therebetween a central opening (12) sized and shaped to permit visualization of the urethra and vaginal openings of typical human female anatomy through the central opening (col 3, lines 40-55) when the device is in contact with a genital region of female anatomy (figure 1); and
said body having a front surface and a rear surface (body has front and rear surface, front facing garment and rear facing the labia);
Ball does not teach adhesive supported on said rear surface of said body; and
a pair of gloves;
a moistened cleansing towelette; and
a skin-preserving preparation.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]);
a pair of gloves ([0063]);
a moistened cleansing towelette ([0062], [0088]); and
a skin-preserving preparation ([0062-0063]).
Singh provides multiple elements in the catheter system in a package including adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0065], [0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including multiple elements in a package for ease of use and adhesive to adhere the labial device onto the body and prevent movement.
Regarding claim 19, Ball does not disclose the kit further comprising: at least one of a urinary catheter and a skin lubricant.
Singh further teaches a catheter ([0086]) that inserted into the urethra, these urinary catheters naturally have skin lubricants in order to safely insert into the body.
Singh provides catheters for insertion into the body for urological procedures ([0005]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball with adding the catheter of Singh to provide a kit that can be inserted into the body for urological procedures.
Regarding claim 20, Ball does not disclose a package defining an internal volume, each of said labial retention device, said pair of gloves, said moistened cleaning towelette, and said skin preparation material being disposed in said internal volume of said package.
Singh further teaches package defining an internal volume ([0065, package interior), each of said labial retention device, said pair of gloves, said moistened cleaning towelette, and said skin preparation material being disposed in said internal volume of said package ([0065], components of the device can be included).
Singh provides the package to have the items of the system assembled together for use ([0065]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball with the comprehensive package in order to provide all parts of the device together.
Regarding claim 21, Ball does not teach at least one of a mirror or illumination source.
Singh further teaches an illumination source ([0064]).
Singh provides an illumination source in order to clearly observe the insertion area ([0004]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including an illumination source to monitor the site of insertion.
Regarding claim 23, Ball discloses wherein said wing defines a clinician facing front surface (away from body) and a rear surface facing body (body has front and rear surface, front facing garment and rear facing the labia), but does not teach wherein a skin-adhering adhesive supported on said rear surface, and configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]). It is noted the limitation configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Singh device is capable of attaching toe labial tissue.
Singh provides adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including adhesive to adhere the labial device onto the body and prevent movement.
Regarding claim 24-25, Ball discloses wherein a clinician facing front surface (away from body) and a rear surface facing body (body has front and rear surface, front facing garment and rear facing the labia), but does not teach wherein a skin-adhering adhesive supported on said rear surface, and configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]). It is noted the limitation configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Singh device is capable of attaching toe labial tissue.
Singh provides adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including adhesive to adhere the labial device onto the body and prevent movement.
Regarding claim 26-27, Ball discloses wherein a clinician facing front surface (away from body) and a rear surface facing body (body has front and rear surface, front facing garment and rear facing the labia), but does not teach wherein a skin-adhering adhesive supported on said rear surface, and configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position.
Singh discloses a labia spreader comprising a body with a skin-adhering adhesive (30, figure 24) supported on said rear surface ([0080]). It is noted the limitation configured to adhere labial tissue to the wing so as to retain labial tissue in a displaced position is a recitation of intended use. A recitation of the intended use of the claimed invention 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 meets the claim. In this case, the Singh device is capable of attaching toe labial tissue.
Singh provides adhesive on the rear surface in order to attach the device to the body and properly secure the spreader ([0007]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Ball by including adhesive to adhere the labial device onto the body and prevent movement.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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