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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 15, 2025 has been entered.
Disposition of Claims
Claims 1-9 are pending.
Claims 1 & 4-9 are rejected.
Claims 2-3 are objected to.
Response to Arguments
Applicant’s arguments, see Page 3, filed December 15, 2025, with respect to the rejections under 35 U.S.C. § 112(b) of Claims 1-9 have been fully considered and are persuasive in light of amendments to the claims.
The rejections under 35 U.S.C. § 112(b) of Claims 1-9 have been withdrawn.
Applicant’s arguments, see Pages 3-6, filed December 15, 2025, with respect to the rejections under 35 U.S.C. § 103 of Claims 1 & 4-9 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
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 4-5, 7 & 9 are rejected under 35 U.S.C. 103 as being unpatentable over Shachrur (WO 2020/212923) in view of Voegele et al. (hereinafter "Voegele") (US 2011/0105850).
Regarding Claim 1, Shachrur discloses a speculum (Fig. 1A, 10; Page 2, Para. 8) comprising:
a speculum sheath (Fig. 1A, 12; Page 2, Para. 8) formed with
one or more fluid flow lumens (Fig. 2A, 20; Page 2, Para. 9) in fluid communication with a pump and controller unit for introducing pressurized fluid into a vagina (Fig. 2A, 24; Page 2, Para. 9),
a pressure sensor lumen (Fig. 2A, 26; Page 2, Para. 9) in fluid communication with said pump and controller unit for measuring fluid pressure in the vagina (Page 2, Para. 9), and
a viewing lumen (Fig. 2A, 30; Page 2, Para. 9) in which is disposed a viewing device (Fig. 3A, 18; Page 2, Para. 9).
Shachrur fails to explicitly discloses a vaginal interface element that comprises flexible folds and is configured for pressing and sealing against labia minora and/or labia majora of the vagina, said flexible folds being compressible in an axial direction along a longitudinal axis of said speculum sheath, and wherein said flexible folds of said vaginal interface element comprises one or more pressure relief exit ports.
However, Voegele teaches a speculum assembly (Fig. 23E, a speculum assembly comprising 1300 and 2100; [0199]) comprising:
a speculum (Fig. 23E, 2100; [0199]);
a speculum sheath (Fig. 23E, 1310; [0193]); and
a vaginal interface element (Fig. 23E, 1330; [0193]) for pressing and sealing against labia minora and/or labia major of the vagina ([0201]) comprising:
flexible folds (Fig. 23E, 1332; [0199]);
said flexible folds being compressible along a longitudinal axis of said speculum sheath ([0199]), and
wherein said flexible folds said vaginal interface element comprises one or more pressure relief exit ports (Figs. 7 & 23A-C, 1331 is attached to a port (not labeled) on 1332; [0199]).
The advantage of the compressible vaginal interface element is to accommodate anatomical variations between patients' vaginas (Voegele; [0201]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the speculum as disclosed by Shachrur, to include the compressible vaginal interface element taught by Voegele, to accommodate anatomical variations between patients' vaginas (Voegele; [0201]).
Regarding Claim 4, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 1. Voegele further teaches wherein said folds are asymmetric with respect to a longitudinal central axis of said vaginal interface element (see Fig. 23A).
Regarding Claim 5, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 1. Voegele further teaches wherein said folds are not perpendicular with respect to a longitudinal central axis of said vaginal interface element (see Fig. 23A).
Regarding Claim 7, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 1. Shachrur further discloses image capturing optics (Fig. 3A, 18 comprises a camera, an LED and a lens; Page 3, Para. 1).
Regarding Claim 9, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 7. Shachrur further discloses wherein said image capturing optics is operative to capture images at different focal planes in the vagina or a cervix (Fig. 3A, 10, which includes the camera, LED and lens, is inserted into the vaginal cavity and thus capable of capturing images at different focal planes; Page 3, Para. 1).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shachrur (WO 2020/212923) in view of Voegele et al. (hereinafter "Voegele") (US 2011/0105850) as applied to Claim 1 above, and further in view of Shibuya (US 2012/0123209).
Regarding Claim 6, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 1. Shachrur further teaches wherein a distal portion of said speculum sheath comprises a window (Fig. 2A, 31; Page 2, Para. 9).
Shachrur, as previously modified by Voegele, fails to explicitly disclose wherein the distal portion of said speculum sheath comprises a window seal, and an air outlet through which pressurized air can flow distal to said window, and wherein said window and said window seal are proximal to the distal end of said speculum sheath and proximal to said air outlet.
However, Shibuya teaches a speculum sheath (Fig. 1, 10; [0040]) comprising:
a distal portion (Fig. 1, 42; [0049]); and
wherein the distal portion of said speculum sheath further comprises:
a window (Fig. 2, 46; [0053]);
a window seal (Fig. 2, 10, which comprises 48, is inserted into a body lumen and thus must be sealed from the body lumen; [0041]); and
an air outlet (Fig. 2, 54; [0053]) through which pressurized air can flow distal to said window ([0063]);
and wherein said window and said window seal are proximal to said air outlet (54 is raised distally from 46; see Fig. 2).
The advantage of the distal air outlet is to prevent visual interruption of the window (Shibuya; [0068]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the distal portion of the speculum sheath as disclosed by Shachrur, as previously modified by Voegele, to include the distal air outlet taught by Shibuya, to prevent visual interruption of the window (Shibuya; [0068]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Shachrur (WO 2020/212923) in view of Voegele et al. (hereinafter "Voegele") (US 2011/0105850) as applied to Claim 7 above, and further in view of Liang et al. (hereinafter "Liang") (US 2015/0293877).
Regarding Claim 8, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 7. Shachrur further discloses wherein said image capturing optics comprises a camera (Page 3, Para. 1), an LED (Page 3, Para. 1) and one or more lenses (Page 3, Para. 1), and said image capturing optics operative to capture images at different focal planes (Fig. 3A, 10, which includes the camera, LED and lens, is inserted into the vaginal cavity and thus capable of capturing images at different focal planes; Page 3, Para. 1).
Shachrur, as previously modified by Voegele, fails to explicitly disclose wherein said image capturing optics comprises an auto-focus module.
However, Liang teaches a speculum sheath (Fig. 1a, 100; [0013]) comprising:
image capturing optics (Fig. 1c, 110; [0013]);
wherein said image capturing optics further comprises:
a camera (an image sensor; [0013]),
an auto-focus module (an auto focusing mechanism; [0013] & [0030]);
an LED (Fig. 1c, 116; [0013]); and
one or more lenses (Fig. 1c, 114; [0013]).
The advantage of the auto focus mechanism is to ensure the camera is always in focus (Liang; [0030]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the image capturing optics as disclosed by Shachrur, as previously modified by Voegele, to include the auto focus mechanism taught by Liang, to ensure the camera is always in focus (Liang; [0030]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 & 4-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-10 of copending Application No. 18/252,225 in view of Voegele et al. (hereinafter "Voegele") (US 2011/0105850), Shibuya (US 2012/0123209) and Liang et al. (hereinafter "Liang") (US 2015/0293877).
The claims of ‘225 disclose all the limitations of the instant claims except for said vaginal interface element is configured for sealing against labia minora and/or labia majora of the vagina; said flexible folds being compressible in an axial direction along a longitudinal axis of said speculum sheath; wherein said flexible folds of said vaginal interface element comprises one or more pressure relief exit ports; wherein said folds are asymmetric with respect to a longitudinal central axis of said vaginal interface element; wherein said folds are not perpendicular with respect to a longitudinal central axis of said vaginal interface element; wherein a distal portion of said speculum sheath comprises a window, sealed by a window seal, and an air outlet through which pressurized air can flow distal to said window, and wherein said window and said window seal are proximal to the distal end of said speculum sheath and proximal to said air outlet; wherein the speculum further comprises image capturing optics; and wherein said image capturing optics comprises a camera, an auto-focus module, an LED and one or more lenses, said image capturing optics operative to capture images at different focal planes in the vagina or a cervix.
Regarding Claims 1 & 4-9, Voegele discloses a speculum assembly (Fig. 23E, a speculum assembly comprising 1300 and 2100; [0199]) comprising:
a speculum (Fig. 23E, 2100; [0199]);
a speculum sheath (Fig. 23E, 1310; [0193]); and
a vaginal interface element (Fig. 23E, 1330; [0193]) for pressing and sealing against labia minora and/or labia major of the vagina ([0201]) comprising:
flexible folds (Fig. 23E, 1332; [0199]);
said flexible folds being compressible along a longitudinal axis of said speculum sheath ([0199]), and
wherein said flexible folds said vaginal interface element comprises one or more pressure relief exit ports (Figs. 7 & 23A-C, 1331 is attached to a port (not labeled) on 1332; [0199]);
wherein said folds are asymmetric with respect to a longitudinal central axis of said vaginal interface element (see Fig. 23A); and
wherein said folds are not perpendicular with respect to a longitudinal central axis of said vaginal interface element (see Fig. 23A).
The advantage of the compressible folds of said vaginal interface element is to accommodate anatomical variations between patients' vaginas (Voegele; [0201]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the flexible folds of said vaginal interface element as disclosed by ‘225, to be compressible as Voegele, to accommodate anatomical variations between patients' vaginas (Voegele; [0201]).
Regarding Claims 1 & 4-9, Shibuya discloses a speculum sheath (Fig. 1, 10; [0040]) comprising:
a distal end (Fig. 1, 42; [0049]); and
wherein the distal portion of said speculum sheath further comprises:
a window (Fig. 2, 46; [0053]);
a window seal (Fig. 2, 10, which comprises 48, is inserted into a body lumen and thus must be sealed from the body lumen; [0041]); and
an air outlet (Fig. 2, 54; [0053]) through which pressurized air can flow distal to said window ([0063]);
and wherein said window and said window seal are proximal to said air outlet (54 is raised distally from 46; see Fig. 2).
The advantage of the distal air outlet is to prevent visual interruption of the window (Shibuya; [0068]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the distal end of the speculum sheath as disclosed by ‘225, to include the distal air outlet taught by Shibuya, to prevent visual interruption of the window (Shibuya; [0068]).
Regarding Claims 1 & 4-9, Liang discloses a speculum sheath (Fig. 1a, 100; [0013]) comprising:
image capturing optics (Fig. 1c, 110; [0013]);
wherein said image capturing optics further comprises:
a camera (an image sensor; [0013]),
an auto-focus module (an auto focusing mechanism; [0013] & [0030]);
an LED (Fig. 1c, 116; [0013]); and
one or more lenses (Fig. 1c, 114; [0013]).
The advantage of the image capturing optics with an auto focus mechanism is to ensure the camera is always in focus (Liang; [0030]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the speculum as disclosed by ‘225, to include the image capturing optics with an auto focus mechanism taught by Liang, to ensure the camera is always in focus (Liang; [0030]).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 2-3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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:
Regarding Claim 2, Shachrur, as previously modified by Voegele, teaches the speculum according to Claim 1. Shachrur, as previously modified by Voegele, fails to explicitly disclose wherein said vaginal interface element comprises an air inlet septum, separate from the one or more pressure relief exit ports, through which pressurized air enters from said pump and controller unit and said air inlet septum sealing said vaginal interface element when no air is introduced therethrough.
Specifically, as detailed above, Voegele teaches the vaginal interface element including the compressible flexible folds with a pressure relief exit port disposed thereon. Voegele, however, fails to disclose, teach or suggest another air inlet septum (i.e., port) on the vaginal interface element and further modifying said vaginal interface element to add additional port(s) would be improper hindsight. Even if, arguendo, adding additional ports to the vaginal interface element of Voegele would not be improper hindsight, Voegele does not disclose, teach or suggest a pump or a control unit and thus attaching said pump and control unit of Shachrur to the additional port(s) of modified Voegele would not be obvious.
Additionally, all other prior art of record, alone or in combination, fail to disclose, teach or suggest the speculum claimed herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795