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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 12/29/2025.
Status of the claims:
Claims 1 – 12 are pending in the application.
Claims 1 and 8 are amended.
Priority
The instant application, filed on 12/16/2022 claims priority to Provisional Application 63/040,824, filed on 06/18/2020 and to PCT US2021/037760 filed on 06/17/2021. Claims 5 – 12 of the instant application are directed to subject matter that was introduced for the first time in the PCT application, filed on 06/17/2021. The earlier Provisional Application fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for a “stem comprising a plurality of ribs between a proximal and distal lip” and a “pilot balloon” as recited in claims 5 – 12. Accordingly, claims 5 – 12 are not entitled to the benefit of the prior applications because the “ribs”, “proximal and distal lips”, and “pilot balloon”, recited in claims 5 – 12 of the instant application, are considered to be unsupported within the Provisional Application listed above. The earliest disclosure for the subject matter above and thus the effective filing date for the subject matter of claims 5 – 12 is 06/17/2021. Additionally, claims 1 – 4 are directed to subject matter that was introduced for the first time in the Provisional Application, and thus are granted an effective filing date of 06/18/2020.
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:
the generic placeholder is “a locking assembly” in claims 4 and 9, which is coupled to the functional language “to lock the stem and balloon occluder assembly from movement in at least one direction”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “locking assembly” in claims 4 and 9 will be read as a thumbscrew, washer, nut, or a plastic piece (which are the disclosed corresponding structures, as described in paragraph [0046] of the instant specification) or an equivalent structure, which is any structure that performs the identical function of the generic placeholder(s), specified in the claim, in substantially the same way.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parys et al (US 2016/0100861 A1) (previously cited).
Regarding claim 1, Parys discloses a uterine manipulator device (uterine manipulation device 100) (Title, abstract, paragraph [0116], and Figs. 1 – 12), comprising:
an elongated cannulated tube (shaft 102) comprising a proximal end and a distal end, a handle (handle 112) on the proximal end, an intrauterine balloon (balloon 106) on the distal end (paragraphs [0116 – 0120] and Figs. 1 – 4), a cervical cup (colpotomizer cup 146) on the cannulated tube (shaft 102), a stem (sleeve 148) proximal of the cup (paragraphs [0124 – 0125] and Figs. 1 – 4 and 7);
a balloon occluder (vaginal cuff 150) positioned on the stem (sleeve 148) and shaped to form an opening (paragraphs [0124], [0129], and Figs. 5 and 6),
wherein when the balloon occluder is positioned on the stem, the cervical cup (colpotomizer cup 146) is configured to move along the elongated cannulated tube (shaft 102) separately from the balloon occluder (vaginal cuff 150) (Examiner’s note: it should be understood that the preceding limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed. With that said, as stated in paragraph [0129], the vaginal occluder / cuff 150 (i.e., the balloon occluder) can be mounted about the sleeve 148, which holds the colpotomizer cup 146 (i.e., the cervical cup), thus, the vaginal cuff 150 (i.e., the balloon occluder) is movable relative to the colpotomizer cup 146 (i.e., the cervical cup) and the shaft 12 (i.e., the cannulated tube). Additionally, as stated in paragraph [0131] the colpotomizer cup 146 (i.e., the cervical cup) and the sleeve 148 (i.e., the stem) are snapped fit together such that other cup sizes can be placed thereon, thus the colpotomizer cup 146 (i.e., the cervical cup) and the sleeve 148 (i.e., the stem) are moveable relative to each other along shaft; moreover, there is nothing that would prevent the colpotomizer cup 146 (i.e., the cervical cup) from being removed from the sleeve 148 (i.e., the stem) while the vaginal cuff 150 (i.e., balloon occluder) is on the sleeve 148 (i.e., the stem). Therefore, the colpotomizer cup 146 (i.e., the cervical cup) is capable of being moved relative to the sleeve 148 (i.e., the stem) when on the colpotomizer cup 146 (i.e., the cervical cup) is on the shaft 102 (i.e., the elongated cannulated tube) and the vaginal cuff 150 (i.e., balloon occluder) is on the sleeve 148 (i.e., the stem). Thus the device of the prior art is configured as claimed).
Regarding claim 4, Parys discloses the stem (sleeve 148) further comprising a locking assembly (thumb lock 176), wherein the locking assembly is configured to lock the stem (sleeve 148) and the balloon occluder (vaginal cuff 150) from movement in at least one direction along the elongated cannulated tube (shaft 102) (paragraphs [0126 – 0128] and Fig. 4).
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.
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Parys et al (US 2016/0100861 A1) (previously cited) as applied to claim 1 above, and further in view of Pustilnik (US 2010/0168784 A1) (previously cited).
Regarding claims 2 and 3, as discussed above, Parys discloses the uterine manipulator device of claim 1.
However, Parys is silent regarding (i) [claim 2] an inflation valve and a gas passage lumen and (ii) [claim 3] wherein the balloon is torus shaped. With respect to (i), Parys discloses, in paragraph [0129], a catheter lumen 101 for inflating the balloon via saline or water.
As to the above, Pustilnik teaches an occluder balloon (balloon 300) (title, abstract, and paragraphs [0015] and [0027]) that is torus shaped (donut shaped) and an inflation valve (valve 306) with a gas passage lumen (communication line 110), wherein the gas passage lumen couples to the outer wall of the occluder balloon (balloon 300) via a port 302 (paragraphs [0026] and [0032] and Fig. 3A).
It should be understood that Parys and Pustilnik are known references in the art that teach inflatable vaginal occlusion cuffs (title, abstract, and paragraph [0116] – Parys ; title, abstract, and paragraph [0015] and [0027] – Pustilnik); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one balloon and the inflation means for another (i.e., a torus shaped balloon filled via gas), and the results of the substitution would have been predictable and resulted in the modified vaginal cuff of Parys being able to function as intended to properly occlude the flow of fluid/gas within the vagina during surgery. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the modified device of Parys and Pustilnik to incorporate the valve 306, as taught by Pustilnik, for the purpose of preventing the air from escaping the balloon during inflation (paragraph [0032] – Pustilnik).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Parys et al (US 2016/0100861 A1) (previously cited) as applied to claim 1 above, and further in view of Wu et al (US 2019/0254708 A1) (previously cited).
Regarding claim 5, as discussed above, Parys discloses the uterine manipulator device of claim 1.
However, Parys is silent regarding (i) [claim 5] wherein the stem comprises a plurality of ribs positioned between a proximal lip and distal lip over which the balloon occluder is positioned and configured to limit movement of the balloon occluder assembly.
As to the above, Wu teaches, in the same field of endeavor, a uterine manipulator device (manipulator 100) (abstract, paragraph [0032], and Fig. 1) comprising a stem (stem 55) and an occluder (occluder 19’) with an opening configured to allow for the passage of a cannulated tube (tube 13) (paragraphs [0032], [0036], and [0039], and Fig. 3F), wherein the stem (stem 55) comprises a plurality of ribs (internal grooves 37) between a proximal lip and distal lip (barbell features 35) for the purpose of preventing the migration of the occluder along the stem in the distal and proximal directions (paragraph [0037]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sleeve 148 of Parys to incorporate the ribs and lips (i.e., the internal grooves and barbell features), based on the teachings of Wu, for the purpose of preventing the migration of the occluder along the stem in the distal and proximal directions (paragraph [0037] – Wu)
Regarding claim 6, as discussed above, it would have been obvious to modify the sleeve of Parys to include the ribs and lips of Wu. Additionally, Parys teaches the vaginal occluder 150 is radially closed and is a separate element which is mounted on to sleeve 148 (paragraph [0129] and Fig. 5 – Parys), and it would be obvious for the opening on one end of the vaginal occluder 150 to allow passage of the distal tip therethrough, for the purpose of being able to mount the vaginal occluder to the sleeve 148. Therefore, the combination further makes obvious wherein the opening of the balloon occluder (vaginal occluder 150 – Parys) is configured to allow passage therethrough of the distal lip (distal barbel feature 35 – shown in Fig. 3F of Wu) of the stem (sleeve 148 – Parys).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Parys et al (US 2016/0100861 A1) (previously cited) as applied to claim 1 above, and further in view of Levine (US 5,104,377) (previously cited).
Regarding claim 7, as discussed above, Parys discloses the uterine manipulator of claim 1.
However, Parys is silent regarding (i) a pilot balloon.
As to the above, Levine teaches a balloon (proximal balloon 16) used within the uterus and vagina, wherein the balloon (proximal balloon 16) is coupled with a pilot balloon (pilot balloon 62) for the purpose of indicating the pressure of the balloon when inflated with air (proximal balloon 16) (col. 5 lines 5 – 27).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Parys to inflate the balloon with air, as air is a known element used to inflate medical balloons, as evidenced by Levine, and a person of ordinary skill in the art would have a reasonable expectation of success with said modification because the modification would be predictable and result in the balloon (vaginal cuff 150) of Parys being able to expand to occlude the vaginal canal as intended. Furthermore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Parys to further include a pilot balloon, as taught by Levine, for the purpose of providing feedback to the user by indicating the pressure of the balloon when inflated (col. 5 lines 5 – 27 – Levine).
Claims 8 – 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Parys et al (US 2016/0100861 A1) (previously cited) and in view of Wu et al (US 2019/0254708 A1) (previously cited) and Pustilnik (US 2010/0168784 A1) (previously cited).
Regarding claims 8, 10, and 12, Parys discloses a uterine manipulator device (uterine manipulation device 100) (Title, abstract, paragraph [0116], and Figs. 1 – 12), comprising:
an elongated cannulated tube (shaft 102) comprising a proximal end and a distal end, [claim 10] a handle (handle 112) on the proximal end, a stem (sleeve 148) positioned along the elongated cannulated tube (shaft 102) (paragraphs [0124], [0127 – 0129], and Figs. 1 – 7); and
a balloon occluder assembly (vaginal cuff 150), comprising:
a balloon occluder (balloon cuff 198) shaped to form an opening (opening / through passage of balloon cuff 198 – shown in Fig. 5) and formed of a single component (Fig. 5), the opening configured to allow passage therethrough of the elongated cannulated tube (shaft 102) and configured to change between an inflated state and a deflated state (paragraphs [0129] and [0138] and Figs. 5, 11, and 12), wherein a cervical cup (colpotomizer cup 146) positioned distally to the balloon occluder (vaginal cuff 150) on the elongated cannulated tube (shaft 12) (when mounted – Figs. 3, 4, and 6) and wherein when the balloon occluder is positioned on the stem, the cervical cup (colpotomizer cup 146) is configured to move along the elongated cannulated tube (shaft 102) separately from the balloon occluder (vaginal cuff 150) (Examiner’s note: it should be understood that the preceding limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed. With that said, as stated in paragraph [0129], the vaginal occluder / cuff 150 (i.e., the balloon occluder) can be mounted about the sleeve 148, which holds the colpotomizer cup 146 (i.e., the cervical cup), thus, the vaginal cuff 150 (i.e., the balloon occluder) is movable relative to the colpotomizer cup 146 (i.e., the cervical cup) and the shaft 12 (i.e., the cannulated tube). Additionally, as stated in paragraph [0131] the colpotomizer cup 146 (i.e., the cervical cup) and the sleeve 148 (i.e., the stem) are snapped fit together such that other cup sizes can be placed thereon, thus the colpotomizer cup 146 (i.e., the cervical cup) and the sleeve 148 (i.e., the stem) are moveable relative to each other along shaft; moreover, there is nothing that would prevent the colpotomizer cup 146 (i.e., the cervical cup) from being removed from the sleeve 148 (i.e., the stem) while the vaginal cuff 150 (i.e., balloon occluder) is on the sleeve 148 (i.e., the stem). Therefore, the colpotomizer cup 146 (i.e., the cervical cup) is capable of being moved relative to the sleeve 148 (i.e., the stem) when on the colpotomizer cup 146 (i.e., the cervical cup) is on the shaft 102 (i.e., the elongated cannulated tube) and the vaginal cuff 150 (i.e., balloon occluder) is on the sleeve 148 (i.e., the stem). Thus the device of the prior art is configured as claimed).
However, Parys is silent regarding (i) [claims 8 and 12] the stem comprising a plurality of ribs positioned between a proximal lip and distal lip, (ii) the balloon configured to be placed around the ribs of stem and configured to allow passage of the distal lip, (iii) [claim 8] wherein the balloon occluder is formed from a single molded component, and (iv) an inflation valve configured to change the balloon between an inflated state and a deflate stated, the inflation valve being communicatively coupled to the balloon via a gas passage lumen. With respect to (iv), Parys discloses, in paragraph [0129], a catheter lumen 101 for inflating the balloon via saline or water.
As to (i) and (ii), Wu teaches, in the same field of endeavor, a uterine manipulator device (manipulator 100) (abstract, paragraph [0032], and Fig. 1) comprising a stem (stem 55) and an occluder (occluder 19’) with an opening configured to allow for the passage of a cannulated tube (tube 13) (paragraphs [0032], [0036], and [0039], and Fig. 3F), wherein the stem (stem 55) comprises a plurality of ribs (internal grooves 37) between a proximal lip and distal lip (barbell features 35) for the purpose of preventing the migration of the occluder along the stem in the distal and proximal directions (paragraph [0037]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sleeve 148 of Parys to incorporate the ribs and lips (i.e., the internal grooves and barbell features), based on the teachings of Wu, for the purpose of preventing the migration of the occluder along the stem in the distal and proximal directions (paragraph [0037] – Wu). Additionally, with respect to (ii), Parys teaches the vaginal cuff 150 (i.e., the balloon occluder) is radially closed and is a separate element that is mounted on to sleeve 148 (paragraph [0129] and Fig. 5 – Parys), and the Examiner contends it would be obvious for the opening on one end of the vaginal cuff 150 (i.e., the balloon occluder) to be configured to allow passage of the distal tip therethrough, for the purpose of being able to mount the vaginal cuff 150 to the sleeve 148 as intended by Parys. Therefore, the combination of Parys and Wu makes obvious the limitation above.
As to (iii), Parys further teaches, in paragraph [0123] wherein the various components of the uterine manipulator (the shaft 102, the expandable balloon 106, the handle 112, and the tube 118) can be formed from one or more molded materials. The Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have the balloon occluder (balloon cuff 198) of Parys be formed from a single molded component, as the particular technique is known and recognized as part of the ordinary capabilities of one skilled in the art, and one of ordinary skill in the art would have been capable of applying this known technique to form the known device (i.e., the balloon occluder), and the results of the process would have been predictable, wherein the device would be able to function as intended.
As to (iv), Pustilnik teaches an occluder balloon (balloon 300) (title, abstract, and paragraphs [0015] and [0027]) and an inflation valve (valve 306) with a gas passage lumen (communication line 110), wherein the gas passage lumen couples to the outer wall of the occluder balloon (balloon 300) via a port 302 (paragraphs [0026] and [0032] and Fig. 3A).
It should be understood that Parys and Pustilnik are known references in the art that teach inflatable vaginal occlusion cuffs (title, abstract, and paragraph [0116] – Parys ; title, abstract, and paragraph [0015] and [0027] – Pustilnik); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one balloon for another (including the gas line and valve), and the results of the substitution would have been predictable and resulted in the modified vaginal cuff of Parys being able to function as intended to properly occlude the flow of fluid/gas within the vagina during surgery. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the modified device of Parys and Pustilnik to incorporate the valve 306, as taught by Pustilnik, for the purpose of preventing the air from escaping the balloon during inflation (paragraph [0032] – Pustilnik).
Regarding claim 9, as discussed above, it would have been obvious to modify the sleeve of Parys to include ribs and lips, as taught by Wu. Additionally, Parys discloses wherein the stem (sleeve 148 – Parys) comprises a locking assembly (thumb lock 176 – Parys) positioned proximally from the distal lip (distal barbel feature 35 of Wu) (Examiner’s note: looking at Fig. 3 the thumb lock 176 is the most proximal element on sleeve 148 – Parys), wherein the locking assembly is configured to lock the stem (sleeve 148 – Parys) and the balloon occluder assembly (vaginal occluder 150 – Parys) from movement in at least one direction along the elongated cannulated tube (shaft 102 – Parys) (paragraphs [0126] and [0128] and Fig. 3 – Parys).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Parys et al (US 2016/0100861 A1) (previously cited) in view of Wu et al (US 2019/0254708 A1) (previously cited) and Pustilnik (US 2010/0168784 A1) (previously cited), as applied to claim 8 above, and further in view of Levine (US 5,104,377) (previously cited).
Regarding claim 11, as discussed above, the combination of Parys, Wu, and Pustilnik teaches the uterine manipulator of claim 8.
However, the combination of Parys, Wu, and Pustilnik is silent regarding (i) a pilot balloon.
As to the above, Levine teaches a balloon (proximal balloon 16) used within the uterus and vagina, wherein the balloon (proximal balloon 16) is coupled with a pilot balloon (pilot balloon 62) for the purpose of indicating the pressure of the balloon when inflated with air (proximal balloon 16) (col. 5 lines 5 – 27).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Parys in view of Wu and Pustilnik to include a pilot balloon, as taught by Levine, for the purpose of providing feedback to the user by indicating the pressure of the balloon when inflated (col. 5 lines 5 – 27 – Levine).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive. More specifically:
Regarding Applicant’s argument that “Neither Parys nor any of the other cited references, alone or in combination, teach or suggest the above structural configuration. For example, it is best understood that Parys's cup and occluder are co-mounted and move together; Parys nowhere teaches that the cup is configured to move along the shaft separately from the occluder while the occluder remains mounted”, as stated in the rejection above, the claim as currently written only requires the cervical cup to be configured to be moveable along the cannulated tube separately from the balloon occluder while the balloon is on the stem, which is intended use; and 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. With that said, and as stated in the rejection of claims 1 and 8 above, the cervical cup (colpotomizer cup 146) of Parys and the stem (sleeve 148) of Parys are separable from each other and from the cannulated tube (shaft 12) of Parys, and therefore, each of the cervical cup (colpotomizer cup 146) of Parys and stem (sleeve 148), with the balloon occluder (vaginal cuff 150) attached thereto, are capable of moving along the cannulated shaft (shaft 12) of Parys without the movement of the other.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771