DETAILED ACTION
This Office action is based on the amendments filed February 18, 2026 for application 18/577,751. Claims 1 and 24-26 have been amended; claims 1-5, 8, 10-13, 19, 24-26, 48-50, and 52 are currently pending.
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 . 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.
Response to Arguments
Applicant’s arguments filed February 18, 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-5, 8, 12, 13, 19, 24, 26, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Ragheb (US 4,932,422) in view of Nakamura et al. (US 4,004,582).
Regarding claim 1, Ragheb (‘422) discloses an intracervical contraceptive device (cervical security valve 8) comprising a housing (open cylindrical body 10) having an outer surface, the housing (10) defining a conduit passing from a first proximal end (top 16) to a second distal end (bottom 18) of the housing (10), wherein the housing (10) comprises a one-way valve (flap member 12 is configured to only open downward) within the conduit, the one-way valve (12) allowing fluid to pass from the first proximal end (16) to the second distal end (18) (Figs. 1-2 & 10; column 2, lines 4-15 & 35-56).
However, Ragheb (‘422) fails to expressly teach that the intracervical contraceptive device and the outer surface are conformal.
Nakamura discloses an analogous intracervical conformal contraceptive device (intracervical contraceptive device ICD 10) comprising a housing (stem 12 + sleeve 34) having a conformal outer surface (sleeve 34) and defining a conduit (hollow bore 14) passing from a first proximal end (inner end 16) to a second distal end (outer end 22) of the housing (12+34) (Fig. 2; column 2, lines 41-43; column 3, lines 1-4 & 28-39).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intracervical contraceptive device taught by Ragheb (‘422) to have a conformal outer surface as taught by Nakamura for the purpose of providing a tight fit between the device and the walls of the cervical canal that is sufficient to prevent spermatozoa from passing between the device and the walls of the cervical canal.
Regarding claim 2, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Ragheb (‘422) further discloses that the housing (10) is substantially tubular (cylindrical) (Figs. 1-2; column 2, line 5).
Regarding claim 3, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Nakamura further discloses that the housing (12+34) is substantially spindle-shaped (barrel shape) (Fig. 2; column 3, lines 28-39).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the housing of the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura to be substantially spindle-shaped as further taught by Nakamura since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing an intracervical contraceptive device. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 4, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Nakamura further discloses that the device (10) has a length of no more than 3 cm (about 13 mm = 1.3 cm) (column 3, lines 20-22).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura to have a length of no more than 3 cm as further taught by Nakamura since it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding claim 5, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Ragheb (‘422) further discloses that the device (10) has a diameter of no more than 12 mm (small size has a diameter of 5 mm and medium size has a diameter of 10 mm) (column 3, lines 1-4).
Regarding claim 8, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Ragheb (‘422) further discloses that the housing (10) comprises a polymer (polyethylene) (column 3, lines 4-5).
Regarding claims 12 and 13, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Nakamura further discloses that the housing (12+34) comprises a silicone or a hydrogel (column 4, lines 24-26 & 37-38).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the housing of the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura to comprise a silicone or a hydrogel as further taught by Nakamura since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 19, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Nakamura further discloses a spermicidal agent (pharmaceutical agent adapted to prevent spermatozoa from accomplishing their fertilization function) positioned in the housing (12+34) (column 4, lines 24-31).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura to comprise a spermicidal agent positioned in the housing as further taught by Nakamura for the purpose of preventing spermatozoa from accomplishing their fertilization function.
Regarding claim 24, the combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, and Nakamura further discloses that the housing (12+34) comprises a flange (arms 18+20) at the first proximal end (16) of the device (10) (Figs. 1 & 4; column 2, lines 35-41; column 3, lines 8-17).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura such that the housing comprises a flange at the first proximal end of the device as further taught by Nakamura for the purpose of preventing inadvertent expulsion of the device.
Regarding claim 26, Ragheb (‘422) discloses a method comprising inserting into a cervix of a subject, a device (cervical security valve 8) comprising a housing (open cylindrical body 10) having an outer surface and defining a conduit passing from a first end (top 16) to a second end (bottom 18) of the housing (10), the housing (10) comprising a one-way valve (flap member 12 is configured to only open downward) within the conduit such that the one-way valve (12) is positioned to allow fluid to exit the vagina (Figs. 1-2 & 10; column 2, lines 4-15 & 35-56).
However, Ragheb (‘422) fails to expressly teach that the outer surface of the housing is conformal.
Nakamura discloses a method comprising inserting into a cervix of a subject a device (intracervical contraceptive device ICD 10) comprising a housing (stem 12 + sleeve 34) having a conformal outer surface (sleeve 34) and defining a conduit (hollow bore 14) passing from a first end (inner end 16) to a second end (outer end 22) of the housing (12+34) (Fig. 2; column 2, lines 41-43; column 3, lines 1-4 & 28-39).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by Ragheb (‘422) such that the outer surface of the housing is conformal as taught by Nakamura for the purpose of providing a tight fit between the device and the walls of the cervical canal that is sufficient to prevent spermatozoa from passing between the device and the walls of the cervical canal.
Regarding claim 48, the combination of Ragheb (‘422) and Nakamura discloses the method substantially as claimed, as described above, and Ragheb (‘422) further discloses that the housing 10) comprises a retention mechanism (wire hooks 20) (Figs. 1-2; column 2, lines 4-7 & 21-29).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ragheb (‘422) in view of Nakamura as applied to claim 1 above, and in further view of Hallinen et al. (US 2006/0016451).
The combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, but fails to teach that the housing comprises a polycarbonate or a polyurethane.
Hallinen discloses an intracervical device (intracervical system) comprising a housing (capsule 8) made of polycarbonate or a polyurethane (¶ 00029-0030 & 0033).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura such that the housing comprises a polycarbonate or a polyurethane as taught by Hallinen since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ragheb (‘422) in view of Nakamura as applied to claim 1 above, and in further view of Silber (US 3,312,215).
The combination of Ragheb (‘422) and Nakamura discloses the invention substantially as claimed, as described above, but fails to teach that the housing comprises a flange at the second distal end of the device.
Silber discloses an intracervical device (uterocervical cannula) comprising a housing (stem S + collar member C) defining a conduit from a first proximal end (portions 13a+13b) to a second distal end (portions 18a+18b), wherein the housing (S+C) comprises a flange (collar member C) at the second distal end (18a+18b) of the device (Figs. 2, 7, & 26; column 6, lines 20-39).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intracervical conformal contraceptive device taught by the combination of Ragheb (‘422) and Nakamura such that the housing comprises a flange at the second distal end of the device as taught by Silber for the purpose of preventing movement of the device towards the uterus.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Ragheb (‘422) in view of Nakamura as applied to claims 26 and 48 above, and in further view of Waterbury (US 2,422,377).
The combination of Ragheb (‘422) and Nakamura discloses the method substantially as claimed, as described above, but fails to teach that the retention mechanism comprises one or more circumferential vanes.
Waterbury discloses a method comprising inserting into a cervix of a subject a device (pessary) comprising a housing (stem 11) having a retention mechanism, wherein the retention mechanism comprises one or more circumferential vanes (disks 26) (Figs. 1-2; column 2, lines 18-23; column 3, lines 56-75; column 4, lines 1-12).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by the combination of Ragheb (‘422) and Nakamura such that the retention mechanism comprises one or more circumferential vanes as taught by Waterbury for the purpose of assisting in retaining the device in proper position and also serving to prevent the entrance of foreign substances into the cavity of the uterus.
Claims 50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Ragheb (‘422) in view of Nakamura as applied to claims 26 and 48 above, and in further view of Ragheb (US 10,159,597).
The combination of Ragheb (‘422) and Nakamura discloses the method substantially as claimed, as described above, but fails to teach that the retention mechanism comprises one or more ridges or that the housing has a textured surface.
Ragheb (‘597) discloses a method comprising inserting into a cervix of a subject a device (birth control assembly 10) comprising a housing (tube 12) having a retention mechanism, wherein the retention mechanism comprises one or more ridges (rings 22) which provide the housing with a textured surface (Figs. 1 & 5; column 2, lines 21-27).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by the combination of Ragheb (‘422) and Nakamura such that the retention mechanism comprises one or more ridges thus providing the housing with a textured surface as taught by Ragheb (‘497) for the purpose of frictionally engage the cervix to facilitate retaining the housing in the cervix.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786