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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/17/2026 has been entered.
Response to Arguments
Regarding the previous 112(b) rejections, the amendments to claims 1 and 7 are acknowledged and the 112(b) rejections and claim objection are withdrawn.
Regarding the previous 112(f) interpretation of “a feature” in claim 7, the amendment to claim 7 to further define it as “an inflator, syringe, or pump” is acknowledged and the 112(f) interpretation for claim 7 is withdrawn.
Regarding the previous 112(d) rejection, the cancellation of claim 12 is acknowledged and the 112(d) rejection is withdrawn.
Applicant’s arguments filed 07/17/2026 with respect to claim(s) 1-2, 5, and 11-13 over Cohn 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. Upon further consideration, a new ground(s) of rejection is made in view of Conti (US 20190282350).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a removal feature” in claim 5 “adapted to deform said widened retaining portion to assist in removal of said device from said bodily orifice” (functional language). The limitation describing the removal feature in claim 5 fails to include sufficient structure to perform the recited function of "removal". In the specifications, the term “removal feature” is not found. However, para. 0021 of the instant application states “The vaginal stent may further include a feature for aiding removal, such as a handle, pull string, wire or other appropriate feature that may be pulled to aid in removal from the bodily cavity, as illustrated with the pull strings in the various figures”). Therefore, the removal feature is interpreted as handle, pull string, wire or any structural equivalents thereof used to aid in the removal of the device.
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 1, 3, 5-7, 9-11, and 13 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.
Claim 1 recites “disc-shaped, cone-shaped, or flower-shaped widened retaining portion” in line 4. It is unclear to the examiner if the “disc-shaped, cone-shaped, or flower-shaped widened retaining portion” is meant to further define the widened retaining portion of line 2 or an additional, new, widened retaining portion. For examination purposes, the limitation will be interpreted as further defining “the widened retaining portion” introduced in line 2 having a disc-shape, cone-shape, or flower-shape.
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, 9, 11, and 13 are rejected under 35 U.S.C. 102(a) as being anticipated by Conti (US 20190282350).
Regarding claim 1, Conti discloses a device 40 for retaining a caliber of a bodily orifice (para. 0002) comprising:
a body 42, 44 having a widened retaining portion 42 and a stem portion 44 (Fig. 6A, para. 0071: “The vaginal insert device 40 of FIG. 6A may include an upper portion 42 and a lower stem-like, removal portion or stem 44);
at least one drainage aperture 68 in said body (Fig. 8, para. 0077: “s an embodiment of vaginal insert device 40 which includes a ventilation opening 68 at a region joining the upper portion 42 and the stem 44”, see note below in regards to intended use); and
a disc-shaped widened retaining portion (interpreted as the widened retaining portion 42 which has a disc-shape, see Fig. 7, see 112(b) rejection above;) adapted to reversibly deform at least a portion of said body to engage and bias against a wall of the bodily orifice when fully inserted into the bodily orifice (Figs. 14A-B, para. 0085),
wherein the bodily orifice comprises a vaginal cavity 18 of a human (Fig. 13, para. 0083: “In particular, in FIG. 13, vaginal insert device 40 is inserted in the vagina 18 to manage, improve, or eliminate a prolapsed uterus 30.”), wherein said at least one drainage aperture 68 is in fluid communication with an internal lumen 66 extending through said stem portion 44 through the vaginal cavity (Fig. 8, para. 0076).
Note: The limitation “at least one drainage aperture” is interpreted as functional language and intended use of the aperture. Para. 0067 of Conti discloses additional uses of the device such as “menstrual uses, collection of vaginal fluids or discharge”. Therefore, the aperture is capable of being used as a drainage aperture of vaginal fluids. This is further supported in para. 0096 of Conti which discusses openings that are used as ventilation and fluid flow (para. 0096: “The one or more openings 192 may facilitate flow of fluids and/or may assist in equalizing pressure through the vaginal insert device 100 and/or may act as an indicator for placement of the device 100”).
Regarding claim 9, Conti discloses further comprising an applicator 84 for inserting said device into said bodily orifice (Fig. 15A, para. 0086: “FIG. 15A illustrates a side-view of a pessary applicator 84 which may be used to assist in inserting, positioning, or removing a vaginal insert device 40 into a patient's vagina 18 (FIG. 14B)”).
Regarding claim 11, Conti discloses wherein said at least one drainage aperture 68 comprises an opening in said widened retaining portion 42 (Figs. 8, 10, para. 0077: “FIG. 8 further illustrates an embodiment of vaginal insert device 40 which includes a ventilation opening 68 at a region joining the upper portion 42 and the stem 44”).
Regarding claim 13, Conti discloses wherein said body comprises a material selected from the group consisting of polyetheretherketone (PEEK), polysulfone, polycarbonate, and/or any other appropriate material (para. 0075: “For example, the upper portion 42 and the stem 44 may be formed of a medical grade silicone”. The examiner notes that para. 0016 of the instant application states that “the material of the body 102 may include natural or synthetic polymeric elastomers, such as silicone”).
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.
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.
Claim(s) 3, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Conti (US 20190282350) as applied to claim 1 above, and further in view of Norred et al. (US 20130245581) [hereinafter Norred].
Regarding claim 3, Conti discloses all of the limitations set forth above in claim 1. However, Conti fails to disclose further comprising a dilating feature for enlarging said stem portion, wherein said dilating feature is selected from the group consisting of an inflatable balloon, an expanding coil, a shape memory section, a spring section and a dilating insert.
Norred in the same field of endeavor of gynecological devices (Fig. 1) teaches that it is known the art to provide a stem portion (interpreted as connecting tube 16) of the device with an inflatable balloon 18 for the purpose of creating a seal with a vaginal canal (para. 0005: “Once inserted into the uterus, the occlusion balloon can be inflated to create a seal with the vaginal canal”; see Fig. 10 for example, para. 0016).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the stem portion in Conti to be a tube comprising an inflatable balloon, as taught by Norred, in order to seal and stabilize the tubular stem portion, thereby preventing accidental movement of the stem portion while being within the vaginal canal (para. 0027: In FIG. 1,…the sealing balloon 118 is inflated near the distal end of the woman's vagina 120 to create a vacuum seal”).
Regarding claim 7, modified Conti discloses further comprising a feature for actuating said inflatable balloon comprising an inflator (para. 0016: “the sealing balloon 18 of Norred is inflated via a channel 20 inside the connecting tube by some external fluid source via an attached fluid tube 22”).
Regarding claim 10, modified Conti discloses wherein said dilating feature 18 is disposed about said stem portion 16 (see Fig. 1 of Norred).
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Conti (US 20190282350) as applied to claim 1 above, and further in view of Stal (US 20210267640).
Regarding claims 5 and 6, Conti discloses all of the limitations set forth above in claim 1. Conti further discloses that a pull string may be an alternative stem portion in the embodiment of Fig. 6B (Fig. 6B, para. 0032), wherein the stem portion is adapted to deform said widened retaining portion to assist in removal of said device from said bodily orifice (para. 0041: “the removal portion or stem 44 of an embodiment of vaginal insert device 40 can be accessed from the exterior of the vagina 18 when the vaginal insert device is inserted and assists in removal of the vaginal insert device”). However, Conti fails to disclose the pull string in combination with the stem portion.
Stal in the same field of endeavor of gynecological devices teaches that it is known in the art for a stem portion 5 to comprise a pull string as a gripping feature 52 (Fig. 1, para. 0054: a proximal end 51 of the handling element 5 may be provided with a grip 52…However, it will be appreciated that the protrusion or other grip may be of another design…for instance be formed as a ring or loop located at a proximal end of an elongate handling element 5 formed by a string or a cord or the like”)
In light of this teaching, one skilled in the art would have readily recognized that providing the stem portion of Conti with the pull string of Stal, would provide additional grip such that the user can use the stem portion to insert the widened retaining portion into the body and pull on the pull string instead of a portion of the body of the device during removal (para. 0054: “a proximal end 51 of the handling element 5 may be provided with a grip 52…which may provide additional grip, for example when the substantially inverted cup part 10 is pulled towards its substantially non-inverted, first state or for example during removal of the cup part 10 from the vagina 4.); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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