DETAILED ACTION
In the Response filed 4/1/26, Applicant withdrew claims 4-5. Claim 1 was previously cancelled. Currently, claims 2-21 are pending (with claims 4-5 being withdrawn).
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 Species C in the reply filed on 4/1/26 is acknowledged.
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/1/26.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p) because they include written descriptions of the figures when only reference characters, sheet numbers and/or view numbers are permitted (see i.e. figures 1-2, 4A-4B, 7A-7B, 8A, 9A-9C, 9E, 10A-10C, 11B-11C). Appropriate revision is required.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "the device" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 14 and 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Specifically, Claims 14 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 14 and 20 each include limitations that positively recite part of the human body in combination with the device, as for example: in claim 14, the limitation reciting “…the central axis…is generally aligned with a long axis of the cervical canal…” of the claim encompasses a human being; and in claim 20, the limitations reciting: “…sites of contact…trace a path that is generally convex toward…the vaginal wall…”, “…the path…extends towards an external opening of the vagina…”,”…the path reaches nearer to an external opening of the vagina…”.”…the path extends a distance parallel to the central axis of the cervical canal…” of the claim encompass a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claims 14 and 20 have been rejected under 35 USC 101. It is suggested that the claims be amended as follows in order to overcome these rejections: claim 14 should be amended to recite: “…the central axis…is configured to be generally aligned with a long axis of the cervical canal…”; claim 20 should be amended to recite: “…sites of contact…trace a path that is configured to be generally convex toward…the vaginal wall…”, “…the path… is configured to extend towards an external opening of the vagina…”,”…the path is configured to reach nearer to an external opening of the vagina…”.”…the path is configured to extend a distance parallel to the central axis of the cervical canal…”.
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) 2-3, 6-10, 12, 15-18 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabbay (US 4381771).
Regarding claim 2, Gabbay discloses a cervical cap (female contraceptive, cervical cover, including a dome-like main portion which is shaped to cover the cervix, Abstract; referred to as “a cervical cap which permits vaginal discharge while at the same time serving as an effective contraceptive by preventing travel of semen to the uterus” – col 9 lines 14-25), comprising: a body having an upper surface and a lower surface (cover 1 having upper and lower surfaces as shown in figs 1-3); a central concave indentation in the upper surface of the body (concave indentation defined by the dome shaped section 3 at the center of the device as shown in figs 2-3), the concave indentation defined by a rim (uppermost edge of the device where the collar 2 is provided as shown in fig 3) and configured to be positioned over an ectocervix of a cervix (as shown in fig 4); a convex exterior surface (outer surface shown in figs 1-3) configured to extend outward from the rim and toward a vaginal wall and to extend downward from the rim and away from a vaginal fornix when the central concave indentation is positioned over the ectocervix (as shown in fig 4); wherein the convex exterior surface extends along a majority of a height of the cervical cap (shown in fig 3), the height being defined as a minimum distance between the upper surface and the lower surface (height is interpreted as being measured from the lower surface at cusps 4,5 to the top edge of the device at the top of the collar 2 at the upper surface; see fig 3).
Regarding claim 3, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the convex exterior surface comprises one or more protruding features (the outer surface of the device takes on a convex form from which the collar 2 extends as shown in fig 4) configured to contact a vaginal wall when the central concave indentation is positioned over the ectocervix (when pressure is introduced into the collar the outer wall 9 will expand and the inner wall will remain substantially unchanged to hold the cover in place by exerting pressure on the walls of the vagina, col. 5, In 14-22; see fig 4).
Regarding claim 6, Gabbay discloses the device as claimed (see rejection of claim 3) and Gabbay also discloses that the one or more protruding features (collar 2) are configured to not contact the vaginal wall along any continuous and closed paths that encircle a vaginal canal of the vagina when the central concave indentation is positioned over the ectocervix; and wherein the one or more protruding features are configured to not intersect every path along the vaginal wall which travels from a lower edge of the vaginal wall to an uppermost wall of the vaginal fornix when the central concave indentation is positioned over the ectocervix (as shown in fig 4, at least part of the collar elements are not directly contacting vaginal or cervical tissue when in position over the ectocervix).
Regarding claim 7, Gabbay discloses the device as claimed (see rejection of claim 6) and Gabbay also discloses that the one or more protruding features (collar 2) are configured to at least partially define a channel configured to allow fluid to travel from a space between an external os of the cervix and the cervical cap to a lower region of the vaginal canal when the central concave indentation is positioned over the ectocervix (channel extending from space 13 through lips 4, 5 - menstrual fluid fills space 13 and will put pressure on the base 14 of the dome to cause lip 4 to be biased away from lip 5 to let the menstrual fluid pass out of the device, Fig. 3, col. 5, In 67-col. 6, In 2).
Regarding claim 8, Gabbay discloses the device as claimed (see rejection of claim 6) and Gabbay also discloses that the one or more protruding features (collar 2) have a helical shape (as shown in fig 2, the collar 2 curves around the central, empty region of the device at a consistent angle and thus is interpreted as having a helical shape).
Regarding claim 9, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the device is configured to lack continuous contact with tissue along any path that intersects every path along tissue that travels from a vaginal opening of the vagina to a cervical canal of the cervix, when the central concave indentation is positioned over the ectocervix (as shown in fig 4, at least part of the collar element 2 and part of the dome shaped element 3 are not directly contacting vaginal or cervical tissue when in position over the ectocervix and thus lack continuous contact).
Regarding claim 10, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the device is configured to form a space within the central concave indentation that is continuous with an external os of the cervix and continuous with a first end of a channel to allow fluid from the external os to travel in a first direction toward a second end of the channel and out to a lower vaginal side of the cervical cap when the central concave indentation is positioned over the ectocervix (the device defines a channel extending from space 13 through lips 4, 5 where the space is continuous with an external os of the cervix and continuous with a first end of a channel as shown in fig 4,4A; menstrual fluid fills space 13 and will put pressure on the base 14 of the dome to cause lip 4 to be biased away from lip 5 to define a channel therebetween and let the menstrual fluid pass out of the valve in a first direction toward a second end of the channel and out to a lower vaginal side of the cervical cap, Fig. 3-4A, col. 5, In 67-col. 6, In 2).
Regarding claim 12, Gabbay discloses the device as claimed (see rejection of claim 10) and Gabbay also discloses that the device is further configured to lack any movable part configured to open, close, or partially obstruct a port, a passageway, or the channel (menstrual fluid fills space 13 and will put pressure on the base 14 of the dome to cause lip 4 to be biased away from lip 5 to let the menstrual fluid pass out of the device, Fig. 3, col. 5, In 67-col. 6, In 2 – thus, movement of menstrual fluid controls opening and/or closing of lips 4 and 5 but there is no specific structural feature of the device or “movable part” of the device which provides this function).
Regarding claim 15, Gabbay discloses the device as claimed (see rejection of claim 10) and Gabbay also discloses that the device is configured to provide greater resistance to fluid flow through the channel from the second end than to fluid flow through the channel from the first end to the second end, when the central concave indentation is positioned over the ectocervix (the lips of the device are configured to allow fluid to be released but resist fluid flow in the opposite direction to thereby prevent semen from entering – col 6 lines 25-27).
Regarding claim 16, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the device includes micropillars, nanopillars, or microstructures (extensions 54, Fig. 16, col. 9, In 1-13; lips having a length of 2-5 cm, col. 6, In 13-15 and extension 54 is approximately 1/8 the length of the lips, Fig. 16; to scale of a 2 cm lip, extension 54 is .25 cm or 2500 micron and thickness is <1000 micron) configured to damage, or prevent migration or proliferation of, one or more of sperm, microorganisms, viruses, fungi, or their byproducts (a series of small extensions 54 greatly increases the travel path of any ascending sperm, Fig. 16; col. 9, In 1-13).
Regarding claim 17, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the device comprises a valve (the lips form a one-way valve – abstract).
Regarding claim 18, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the convex exterior surface comprises localized flat, straight, or concave regions or localized flat, straight, or concave surface features (as shown in figs 3 and 4, the convex exterior surface of the dome shaped section 3 includes localized regions that are flat, straight, or concave beneath the collar 2).
Regarding claim 21, Gabbay discloses a method of using a cervical cap (female contraceptive, cervical cover, including a dome-like main portion which is shaped to cover the cervix, Abstract; referred to as “a cervical cap which permits vaginal discharge while at the same time serving as an effective contraceptive by preventing travel of semen to the uterus” – col 9 lines 14-25; the device is shown being used in fig 4), the method comprising: providing a cervical cap (it is inherent that the cervical cap device is “provided” in order to be used as shown in fig 4); the cervical cap comprising: a body having an upper surface and a lower surface (cover 1 having upper and lower surfaces as shown in figs 1-3); a central concave indentation in the upper surface of the body (concave indentation defined by the dome shaped section 3 at the center of the device as shown in figs 2-3), the concave indentation defined by a rim (uppermost edge of the device where the collar 2 is provided as shown in fig 3) and configured to be positioned over an ectocervix of a cervix (as shown in fig 4); a generally convex exterior surface (outer surface shown in figs 1-3) configured to extend outward from the rim and toward a vaginal wall and downward from the rim away from a vaginal fornix (as shown in fig 4); inserting the cervical cap into a vaginal canal of the vagina (as shown in fig 4); and positioning the cervical cap such that the central concave indentation is seated over the ectocervix (as shown in fig 4), and the generally convex exterior surface engages a portion of the vaginal wall (when pressure is introduced into the collar the outer wall 9 will expand and the inner wall will remain substantially unchanged to hold the cover in place by exerting pressure on the walls of the vagina, col. 5, In 14-22; see fig 4) and spans a majority of a height of the cervical cap (shown in fig 3), the height being defined as a minimum distance between the upper surface and the lower surface (height is interpreted as being measured from the lower surface at cusps 4,5 to the top edge of the device at the top of the collar 2 at the upper surface; see fig 3).
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.
Claims 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gabbay (US 4381771) in view of Greenberg (US 2616421).
Regarding claim 11, Gabbay discloses the device as claimed (see rejection of claim 10) but does not disclose that the channel is always open.
Greenberg, however, teaches a cervical cap device comprising a dome region (11) and a channel that is always open (the inner surface of the cap has a spiral thread formed therein and an internally threaded circular opening - col 2 lines 7-14; fig 2 – as shown in fig 2, the spiral threading along the inner surface defines an interior channel extending vertically through the center of the dome 11; the interior channel is interpreted as remaining open at all times in order to receive a sperm chamber 12 as shown in fig 2 or to permit passage through the device for the collection of samples used in studies of exfoliative cytology of the cervix and uterus, such as in the study of cancer when the sperm chamber is not used – col 9 lines 29-37). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the channel in the device of Gabbay so that the channel is always open, as taught by Greenberg, in order to permit access through the device for collection of samples used in studies of exfoliative cytology of the cervix and uterus, such as in the study of cancer, if desired or necessary.
Regarding claims 13-14, Gabbay discloses the device as claimed (see rejection of claim 10) and Gabbay also discloses that the cervical cap includes a central axis of the central concave indentation that is generally aligned with a long axis of the cervical canal when the central concave indentation is positioned over the ectocervix (as shown in fig 4).
Gabbay does not, however, explicitly disclose that the channel follows a curved or winding path around the cervical cap, specifically, around at least a portion of a central axis of the central concave indentation; and wherein the curved or winding path winds around material of which the cervical cap is comprised.
Greenberg, however, teaches a cervical cap device comprising a dome region (11) and an open channel that winds around material of which the cervical cap is comprised about at least a portion of a central axis of the dome region (the inner surface of the cap has a spiral thread formed therein and an internally threaded circular opening - col 2 lines 7-14; fig 2 – as shown in fig 2, the spiral threading along the inner surface defines an interior channel extending vertically through the center of the dome 11 which is interpreted as having a configuration that winds around the central axis of the dome 11 due to the spiral shape of the internal threading). Greenberg teaches that the cervical cap is attached to the cervix uteri with the aid of the internally threaded surface of the cap (col 2 lines 52-54). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the channel in the device of Gabbay so that the channel follows a curved or winding path around the cervical cap, specifically, around at least a portion of a central axis of the central concave indentation; and wherein the curved or winding path winds around material of which the cervical cap is comprised as taught by Greenberg in order to aid in attachment of the device.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gabbay (US 4381771).
Regarding claim 19, Gabbay discloses the device as claimed (see rejection of claim 2) and Gabbay also discloses that the size of the device will depend on the particular size, shape and irregularities of the cervix and the vagina (col 4 lines 17-19). Gabbay does not, however, explicitly disclose that the convex exterior surface extends along more than 75% of the height of the cervical cap. However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the convex exterior surface so that it is dimensioned, specifically, to extend along more than 75% of the height of the cervical cap in order to best meet the size, shape and irregularities of the cervix/vagina of a given user and, furthermore, because such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Regarding claim 20, Gabbay discloses a cervical cap configured to fit within a vagina of a female (female contraceptive, cervical cover, including a dome-like main portion which is shaped to cover the cervix, Abstract; referred to as “a cervical cap which permits vaginal discharge while at the same time serving as an effective contraceptive by preventing travel of semen to the uterus” – col 9 lines 14-25; the device fits within the vagina as shown in fig 4), comprising:
a central portion comprising a concave region (concave region defined by the dome shaped section 3 at the center of the cover 1 as shown in figs 2-3) configured to be positioned over an external os of a cervix and configured to cover the external os (as shown in fig 4); an outer portion extending outwardly from the central portion (outer surface shown in figs 1-3 which includes collar 2), the outer portion comprising an exterior surface configured to contact at least a portion of a vaginal wall of the vagina (when pressure is introduced into the collar the outer wall 9 will expand and the inner wall will remain substantially unchanged to hold the cover in place by exerting pressure on the walls of the vagina, col. 5, In 14-22; see fig 4); wherein sites of contact between the exterior surface and the portion of the vaginal wall trace a path that is generally convex toward the portion of the vaginal wall and within a plane containing a central axis of a cervical canal of the cervix (the outer surface of the device takes on a convex form from which the collar extends and makes contact at areas on the vaginal wall as shown in fig 4; this shape is convex relative to a central axis since the device extends outwardly from the center of the device and the central axis is aligned with the central axis of the cervical canal as shown in fig 4), when the concave region is positioned to fit over the external os and to cover the external os (as shown in fig 4); wherein the path extends outwardly from the central axis as it extends toward an external opening of the vagina, when the concave region is positioned to fit over the external os and to cover the external os (the device extends outwardly from the central axis including the outer surface in the area of dome shaped section 3 that is nearest to lips 4,5 which is the region that extends towards the external opening of the vagina during use as shown in fig 4); wherein the path reaches nearer to an external opening of the vagina than the concave region reaches, when the concave region is positioned to fit over the external os and to cover the external os (the exterior surface of dome shaped region 3 is closer to the external opening of the vagina than the inner, central portion of the dome shaped portion during use as shown in fig 4).
Gabbay does not, however, explicitly disclose that the path extends a distance parallel to the central axis of the cervical canal that exceeds 60% of a height of the device measured along the central axis, when the concave region is positioned to fit over the external os and to cover part or all of the external os.
Gabbay does, however, disclose that the size of the device will depend on the particular size, shape and irregularities of the cervix and the vagina (col 4 lines 17-19). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the exterior surface so that it is dimensioned to have sites of contact with the vaginal wall that trace a path that extends a distance parallel to the central axis of the cervical canal that, specifically, is sized to exceed 60% of a height of the device measured along the central axis, when the concave region is positioned to fit over the external os, and to cover part or all of the external os, in order to best meet the size, shape and irregularities of the cervix/vagina of a given user and, furthermore, because such a modification would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art and where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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