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 .
Status of Claims
This Action is in response to the amendment filed on December 1, 2025.
As directed by the amendment: Claims 1, 11, 25, and 31 were amended. Claim 10 was canceled. Thus, claims 1, 6, 8-9, 11-25, and 30-31 are pending and currently under consideration for patentability under 37 CFR 1.104.
Claim Interpretation
It is noted that while features of an apparatus may be recited either structurally or functionally, “Apparatus claims cover what a device is, not what a device does,” and a “‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim,” see MPEP 2114(II). In the instant case, the claims recite functional language or intended uses of the device (such as “arranged to draw tissue of the vaginal wall into the apertures to deliver the microtrauma” in claim 1, and “arranged, in use, to draw tissue of the vaginal wall into and through the apertures such that the tissue elongates at least partly within the holes to deliver microtrauma that stimulates angiogenesis … characterized by an array of lesions on the vaginal wall that persist after delivery of the negative pressure mechanical microtrauma therapy” in claim 31). In these instances where the claims recite functional language, as long as the prior art discloses the structural limitations and is able to perform the claimed function(s), it will be considered to read on the claimed function(s).
Furthermore, once a prior art product appearing to be substantially identical in structure is made the basis of a rejection, a prima facie case of anticipation or obviousness has been established. (MPEP 2112.01(I)). The burden of production then shifts to the Applicant to prove that the prior art does not necessarily or inherently possess the characteristics of the claimed product (See MPEP 2112(V), 2112.01(I)).
Claim Interpretation - 35 USC § 112(f)
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 tamper resistance device” in claim 22. The corresponding structure in the specification is a sensor arranged to read a unique identifier (see page 16, lines 23-27 of the Specification filed January 11, 2022), or may comprise a tamper proof cap, seal or foil that is broken/removed when a flexible lead is connected for the first time (see page 16, line 32 through page 17, line 4 of the Specification filed January 11, 2022).
“actuator/controller module is arranged to: sense the tamper resistance device and to [determine] if the disposable parts are being used for the first time based on the tamper resistance device, and prevent activation of the vacuum pump if disposable parts are determined to have been reused” in claim 22. The corresponding structure in the specification is an actuator/controller configured to read and record a unique identifier in a memory, and then compare subsequently read unique identifiers to those read during previous uses in order to determine if a flexible lead/treatment module is being used or being connected for the first time (See page 16, lines 27-30 of the Specification filed January 11, 2022), or the actuator/controller is arranged to sense the presence or condition of the tamper resistance device to determine whether the flexible lead is being reused via a sensor provided at the connection point (See page 17, lines 2-4 of the Specification filed January 11, 2022).
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“actuating and/or controlling means including the vacuum pump for the microtrauma module” in claim 19. The recitation of the vacuum pump is sufficient structure to perform actuating and/or controlling of the microtrauma module.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 1 and 22 are objected to because of the following informalities:
Claim 1, line 3 recites “the wall of the vagina” and Examiner suggests --a wall of the vagina-- because this is the first recitation of a wall of the vagina, and because this would match the similar language used in line 3 of independent claim 31 (“a wall of the vagina”).
Claim 22, line 3 recites “the actuator/controller module” and Examiner suggests --the actuation/controller module-- to use consistent language with the previously recited “actuation/controller module” (see claim 21, line 3).
Claim 22, line 4 recites “detem1ine” which appears to be a typographical error. Examiner suggests --determine--. Furthermore, it is noted that the phrase “detem1ine” was not present in the immediate prior version of claim 22, yet there are no markings provided to claim 22 to illustrate the change. Applicant is reminded to comply with 37 CFR 1.121(c)(2) by using appropriate underlining and/or strike-through in future amendments to reflect the changes made relative to the immediate prior version of the claims.
Appropriate correction is required.
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)(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.
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.
Claim 31 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wu (2020/0405572).
Regarding claim 31, Wu discloses a device (Fig. 1) to treat vaginal atrophy (“treatment of vaginal atrophy” see line 7 of [0036]) comprising a treatment module (body 12, Fig. 1) configured for insertion into the vagina (“body 12 extends longitudinally along a longitudinal axis and is sized and configured for insertion into a patient’s vagina” see lines 8-10 of [0023]), at least part of the treatment module (12) having an elongate shape (the entire treatment module 12 has an elongated, elliptical shape as seen in Fig. 1) and an outer surface (outer surface 14, Fig. 1) configured to abut a wall of the vagina when inserted (“fits against walls of the vaginal canal during use … able to compress and/or bend to follow the contours of the walls of the vaginal canal” see para. [0023]), the treatment module (12) having a microtrauma module (the microtrauma module is considered to be collectively the outer apertures formed by channels 22, and the chamber 20, Fig. 1) configured to deliver negative pressure (from suction generated in chamber 20, see Fig. 1, and the last sentence of [0027]) mechanical microtrauma therapy to the wall of the vagina when inserted (“maintaining sufficient negative pressure over a sufficient time or repeatedly applying sufficient negative pressure to cause micro-trauma of the vaginal tissue along the length of the vaginal wall to be regenerated” see para. [0013]), wherein the microtrauma module comprises a plurality of apertures (the apertures formed by the external openings of channels 22, Fig. 1. Note, the first sentence of [0024] states the channels 22 fluidly couple the inner chamber 20 to the outer surface 14, lines 6-11 of [0027] state that air is pulled inwardly through the channels 22, and lines 18-20 of [0026] clarify that the channels have openings) formed by holes extending from the part of the outer surface of the treatment module (the channels 22 themselves are considered the “holes” extending from the outer surface 14, Fig. 1) configured to abut the wall of the vagina when inserted (the outer apertures formed by channels 22 abut the vaginal wall, “channels 22 contact the vaginal wall” see the third sentence of [0024]), the apertures being arrayed over at least the part of the outer surface (14) of the treatment module (12, see Fig. 1, the apertures are arrayed over at least the elongated part of 14) and configured to deliver the negative pressure therapy to the wall of the vagina in contact with the apertures (“modulating the atmospheric pressure within the chamber 20 affects the atmospheric pressure within the vagina via the channels 22. Further, when used to induce micro-traumas along vaginal tissue, such micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see lines 4-9 of [0024] and note that the apertures are the external opening(s) of channels 22), wherein the apertures are in fluidic connection (via channels 22, see lines 1-6 of [0024]) with a vacuum pump (piston block 26 and chamber 20 form a vacuum pump, Fig. 1; see lines 1-6 of [0024] and see para. [0027]), the device being arranged to generate, in use, a negative pressure at the apertures (negative pressure is generated via the vacuum pump, which is fluidly coupled to the outer surface 14 via external apertures of channels 22. See lines 1-6 of [0024]) whereby the microtrauma module is arranged, in use, to draw tissue of the vaginal wall into and through the apertures such that the tissue elongates at least partly within the holes (channels 22) to deliver microtrauma that stimulates angiogenesis within the tissue of the vaginal wall to provide vaginal atrophy treatment (this is a recitation of functional language, and the Wu device is able to perform this function because Wu’s body 12 is inserted into the vaginal canal, the channels 22 are configured to contact the vaginal wall, and fluidly couple the inner vacuum chamber 20 to the outer surface 14, see lines 1-9 of [0024]. The device is configured to apply the same negative pressures as recited: ranging from 1 to 760 mmHg, with the range 1-180 mmHg inducing microtrauma and 180-600 mmHg increasing blood flow, see all of para. [0031]. Additionally, Wu states that “when inserted into the vagina for treatment, at least a portion of the body 12 forms an annular seal against the walls of the vagina, and … as negative pressure is applied, the surface 14 of the body 12 increasingly contacts vaginal tissue … by pulling the vaginal tissue inward and against the body 12” see lines 11-19 of [0023]. With the negative pressure pulling the vaginal tissue inward against the body 12 the tissue contacts the channels 22 and “micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]. Thus, Wu’s device is arranged to provide the same pressures to the same tissue of the vaginal wall. Directly contacting the tissue with the apertures and providing the same suctioning forces as disclosed by Applicant would be expected to produce the same result of the tissue elongating at least partly within the holes suctioning the tissue), wherein the microtrauma is characterized by an array of lesions on the vaginal wall (“micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]. The channels 22 are formed in an array, and thus there would be an array of lesions) that persist after delivery of the negative pressure mechanical microtrauma therapy (this is a recitation of how the body is intended to respond to the treatment. Wu’s micro-trauma causes small tears or abrasions which induces tissue repair and/or regeneration as stated in para. [0022]. Wu’s micro-traumas are formed in substantially the same manner, at the same location as disclosed by Applicant and thus would be expected to persist at least temporarily, i.e., not be instantaneously repaired).
It is maintained that Wu is arranged, in use, to generate a negative pressure at the apertures to draw tissue of the vaginal wall into and through the apertures such that the tissue elongates at least partly within the holes to deliver microtrauma that stimulates angiogenesis within the tissue of the vaginal wall to provide vaginal atrophy treatment … and the microtrauma is characterized by an array of lesions on the vaginal wall that persist after delivery of the negative pressure mechanical microtrauma therapy because Wu is a substantially identical structure and is configured to apply the same pressure range(s) as the instant invention (See MPEP 2112.01(I)). Even if it was argued that Wu is not able to perform this function, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see MPEP 2144.05(II)(A)).
As outlined above, Wu discloses the general conditions of the claim: Wu discloses an elongated treatment module (12, Fig. 1) configured to be inserted into the vaginal canal (see lines 8-10 of [0023]) to treat vaginal atrophy (see line 7 of [0036]), the treatment module having a plurality of relatively small apertures (the apertures formed by the external openings of channels 22, Fig. 1) and generating negative pressures ranging from 1 to 760 mmHg to provide micro-traumas and/or increased blood flow (see all of para. [0031]) where the apertures/channels contact the vaginal wall (see the third sentence of [0024]).
The selection of a negative pressure arranged to draw tissue of the vaginal wall into and through the apertures such that the tissue elongates at least partly within the holes to deliver microtrauma is merely routine optimization because Wu discloses applying negative pressures encompassing the disclosed range (Wu discloses pressures from 1 to 760 mmHg in para. [0031], while the instant invention discloses applying pressures from 200-600 mmHg in para. [0013] of the printed publication) and Wu discloses values approaching the disclosed range are specifically used for generating micro-trauma (180 mmHg, see the last two sentences of [0040]). Furthermore, Applicant’s own disclosure states that “[t]esting performed by the inventors has shown that [200 mmHg to 600 mmHg] provides effective VA treatment without causing excessive tissue damage” and the negative pressure of 300-450 mmHg was “found in testing carried out by the inventors to provide an optimal range for effective VA treatment” (see the last sentence of [0013] and [0014]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the negative pressure of the microtrauma therapy of Wu to be arranged to draw tissue of the vaginal wall into and through the apertures such that the tissue elongates at least partly within the holes to deliver microtrauma that stimulates angiogenesis … and the microtrauma is characterized by an array of lesions on the vaginal wall that persist after delivery of the negative pressure mechanical microtrauma therapy, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (negative pressures sufficient to draw tissue into the apertures) involves only routine skill in the art (see MPEP 2144.05(II)(A)).
Claim(s) 1, 6, 8-9, 11, 13-14, 16, and 19 are rejected under 35 U.S.C. 103 as being obvious over Wu (2020/0405572).
Regarding claim 1, Wu discloses a device (Fig. 1) to treat vaginal atrophy (“treatment of vaginal atrophy” see line 7 of [0036]) comprising a treatment module (body 12, Fig. 1) configured for insertion into the vagina (“body 12 extends longitudinally along a longitudinal axis and is sized and configured for insertion into a patient’s vagina” see lines 8-10 of [0023]), at least part of the treatment module (12) having an elongate shape (treatment module 12 has an elongated, elliptical shape as seen in Fig. 1) and an outer surface (outer surface 14, Fig. 1) configured to abut the wall of the vagina when inserted (“fits against walls of the vaginal canal during use … able to compress and/or bend to follow the contours of the walls of the vaginal canal” see para. [0023]), and the treatment module (12) having a microtrauma module (the microtrauma module is considered to be collectively the outer apertures formed by channels 22, and the chamber 20, Fig. 1) configured to deliver negative pressure (from suction generated in chamber 20, see Fig. 1, and the last sentence of [0027]) mechanical microtrauma therapy to the wall of the vagina when inserted (“maintaining sufficient negative pressure over a sufficient time or repeatedly applying sufficient negative pressure to cause micro-trauma of the vaginal tissue along the length of the vaginal wall to be regenerated” see para. [0013]), wherein said negative pressure is between 200 mmHg and 600 mmHg (Wu discloses applying negative pressures ranging from 1 to 760 mmHg. However, it is noted that Wu states that the pressure range 1-180 mmHg is used to induce the microtrauma, see all of para. [0031]), wherein the microtrauma module comprises a plurality of apertures (the apertures formed by the external openings of channels 22, Fig. 1. Note, the first sentence of [0024] states the channels 22 fluidly couple the inner chamber 20 to the outer surface 14, lines 6-11 of [0027] state that air is pulled inwardly through the channels 22, and lines 18-20 of [0026] clarify that the channels have openings) formed by holes extending from the outer surface of the treatment module (the channels 22 themselves are considered the “holes” extending from the outer surface 14, Fig. 1) configured to abut the wall of the vagina when inserted (the outer apertures formed by channels 22 are configured to abut the vaginal wall, “channels 22 contact the vaginal wall” see the third sentence of [0024]), wherein said holes can have their cross-sectional size adjusted depending on the use (“the size and shape of the channel 22 opening can vary depending on the needs of the user…” see the last eight lines of [0026]), the apertures being arrayed over at least part of the outer surface (14) of the treatment module (12, see Fig. 1, the apertures are arranged in a group that extends over at least part of the outer surface 14) and configured to deliver the negative pressure therapy to the wall of the vagina in contact with the apertures (“modulating the atmospheric pressure within the chamber 20 affects the atmospheric pressure within the vagina via the channels 22. Further, when used to induce micro-traumas along vaginal tissue, such micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see lines 4-9 of [0024] and note that the apertures are the external opening(s) of channels 22), wherein the apertures are in fluidic connection (via channels 22, see lines 1-6 of [0024]) with a vacuum pump (piston block 26 and chamber 20 form a vacuum pump, Fig. 1; see lines 1-6 of [0024] and see para. [0027]), the device being arranged to draw tissue of the vaginal wall into the apertures to deliver the microtrauma (this is a recitation of functional language, and the Wu device is able to perform this function because Wu’s body 12 is inserted into the vaginal canal, the channels 22 are configured to contact the vaginal wall, and the device is configured to apply the same negative pressures as recited: ranging from 1 to 760 mmHg, with the range 1-180 mmHg inducing microtrauma and 180-600 mmHg increasing blood flow, see all of para. [0031]. Additionally, Wu states that “when inserted into the vagina for treatment, at least a portion of the body 12 forms an annular seal against the walls of the vagina, and … as negative pressure is applied, the surface 14 of the body 12 increasingly contacts vaginal tissue … by pulling the vaginal tissue inward and against the body 12” see lines 11-19 of [0023]. With the negative pressure pulling the vaginal tissue inward against the body 12 the tissue contacts the channels 22 and “micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]. Thus, the device is arranged to draw at least a portion of the tissue into the suctioning apertures to apply microtrauma).
It is reiterated that Wu’s device is configured to apply negative pressures encompassing the claimed range of 200 mmHg and 600 mmHg (ranging from 1 to 760 mmHg, see all of para. [0031]) and the size of the holes can vary depending on the use (“the size and shape of the channel 22 opening can vary depending on the needs of the user. For example, fewer, larger channels 22 may be preferred for targeting greater micro-trauma … whereas, smaller channels 22 spread over the majority of the body 12 may be preferred for primarily increasing blood flow”” see the last eight lines of [0026]). But Wu states that the microtrauma is provided at 1-180 mmHg and Wu is silent regarding wherein said holes have a maximum cross-sectional size of greater than 1.00 mm and less than 4 mm.
However, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see MPEP 2144.05(II)(A)). As outlined above, Wu discloses the general conditions of the claim: Wu discloses an elongated treatment module (12, Fig. 1) configured to be inserted into the vaginal canal (see lines 8-10 of [0023]) to treat vaginal atrophy (see line 7 of [0036]), the treatment module having a plurality of relatively small apertures (the apertures formed by the external openings of channels 22, Fig. 1) and generating negative pressures ranging from 1 to 760 mmHg to provide micro-traumas and/or increased blood flow (see all of para. [0031]) where the apertures/channels contact the vaginal wall (see the third sentence of [0024]).
The selection of 200 mmHg to 600 mmHg is merely routine optimization because Wu discloses pressures encompassing the claimed range (1 to 760 mmHg) and values approaching the claimed range are specifically used for generating micro-trauma (180 mmHg, see the last two sentences of [0040]). Furthermore, Applicant’s own disclosure states that “[t]esting performed by the inventors has shown that [200 mmHg to 600 mmHg] provides effective VA treatment without causing excessive tissue damage” and the negative pressure of 300-450 mmHg was “found in testing carried out by the inventors to provide an optimal range for effective VA treatment” (see the last sentence of [0013] and [0014]).
The selection of a hole size of greater than 1.00 mm to less than 4 mm would have been routine optimization because Wu specifically states the size of the apertures may be adjusted for different uses, including for generating micro-trauma (see the last eight lines of [0026]). Since Wu discloses pressures encompassing the claimed range and specifically suggests varying the hole size to uses such as generating micro-trauma, a person of ordinary skill in the art would have had a reasonable expectation of success the formulate the claimed range(s).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the negative pressure of the microtrauma therapy and the hole size of Wu to use a pressure between 200 mmHg and 600 mmHg with holes having a maximum cross-sectional size of greater than 1.00 mm and less than 4 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (negative pressures between 200 mmHg to 600 mmHg used with holes having a maximum cross-sectional size of greater than 1.00 mm and less than 4 mm) involves only routine skill in the art (see MPEP 2144.05(II)(A)).
Regarding claim 6, the modified Wu device discloses in which the device is arranged to generate a pressure in the range of between 300 mmHg and 450 mmHg (“high pressures (e.g. between 180-600 mmHg) can be used to increase blood flow … applied pressure can vary depending on the intended result” see the last two sentences of [0031]) at the apertures (the pressure generated in chamber 20 is directly transmitted to the apertures via channels 22, see Fig. 1).
Regarding claim 8, the modified Wu device as currently combined discloses in which the holes (channels 22, Fig. 1) extend about a quarter of the way through the body of the device (12, see Fig. 1), and the body (12) is sized and configured to be inserted into the vagina (see lines 8-10 of [0023]) to contact the vaginal walls when suction is applied. Thus, Wu’s holes (22) extend a relatively short distance, but Wu is silent regarding the holes (22) extend: a depth of at least 1 mm; a depth of at least 1 mm and less than 6 mm; a depth of greater than 2 mm; or a depth of greater than 2 mm and less than 6 mm. However, there does not appear to be any particular criticality to these dimensions as this is merely the distance the holes extend from the exterior of the body to connect to a central vacuum pump. Furthermore, it is noted that a change in size is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04(IV)(A)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the depth of Wu’s channels (holes) to be at least 1 mm and less than 6 mm because such a range would be expected to perform suitably for a device sized and configured to be inserted into the vagina and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A).
Regarding claim 9, the modified Wu device as currently combined discloses in which the holes (22) extend a depth of at least 1 mm and less than 6 mm (see the claim 8 rejection statement above), but does not specifically disclose in which the holes extend a depth in the range between 3 mm and 4 mm. However, there does not appear to be any particular criticality to these dimensions as this is merely the distance the holes extend from the exterior of the body to connect to a central vacuum pump. Furthermore, it is noted that a change in size is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04(IV)(A)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the depth of Wu’s channels (holes) to be between 3 mm and 4 mm because such a range would be expected to perform suitably for a device sized and configured to be inserted into the vagina and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A).
Regarding claim 11, the modified Wu device as currently combined discloses in which the holes (22) have a maximum cross-sectional size of at least 1 mm and less than 4 mm (see the claim 1 rejection statement above), but does not specifically state the holes have a maximum cross-sectional size in the range between 2 mm and 3 mm.
However, it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation (see MPEP 2144.05(II)(A)). As outlined above in the claim 1 rejection statement, Wu discloses the general conditions of the claim: Wu discloses an elongated treatment module (12, Fig. 1) configured to be inserted into the vaginal canal (see lines 8-10 of [0023]), the treatment module having a plurality of relatively small apertures (the apertures formed by the external openings of channels 22, Fig. 1) and generating negative pressures ranging from 1 to 760 mmHg to provide micro-traumas and/or increased blood flow (see all of para. [0031]) where the apertures/channels contact the vaginal wall (see the third sentence of [0024]). Furthermore, the selection of a hole size in the range between 2 mm and 3 mm would have been routine optimization because Wu specifically states the size of the apertures may be adjusted for different uses, including for generating micro-trauma (see the last eight lines of [0026]). Since Wu specifically suggests varying the hole size to uses such as generating micro-trauma, a person of ordinary skill in the art would have had a reasonable expectation of success the formulate the claimed range(s).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hole size of Wu to have a maximum cross-sectional size in the range between 2 mm and 3 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (holes having a maximum cross-sectional size between 3 mm and 4 mm) involves only routine skill in the art (see MPEP 2144.05(II)(A)).
Regarding claim 13, the modified Wu device discloses in which the treatment module (12) comprises: a support member (rigid hollow core 16, Fig. 1), the support member comprising an arrangement of passageways (openings connecting chamber 20 to the channels 22, Fig. 1) that are fluidly coupled to the vacuum pump (fluidly connected to chamber 20 of the vacuum pump); an outer tip member (deformable layer 18, Fig. 1), the outer tip member (18) comprising the plurality of holes forming the apertures of the treatment module (there are holes in layer 18 corresponding to the locations of the channels 22, see Fig. 1), wherein the outer tip member (18) is arranged to fit around a distal portion of the support member (see Fig. 1, the outer tip member 18 fits around the distal portion of support member 16), the outer tip member and support member arranged to form an interlocking engagement (outer layer 18 is sleeved over the rigid hollow member 16 and directly engaged with it as seen in Fig. 1) whereby the passageways of the support member are aligned relative to the holes of the outer tip member to form a fluidic connection between them (the passageways of support member 16 and the holes of outer tip member 18 are aligned because they are the entrance and exit of the channels 22, see Fig. 1).
Regarding claim 14, the modified Wu device discloses wherein one of: a) the outer tip member (18) is formed from an elastomeric material (silicone, rubber, bendable and/or compressible polymers, polyethylene, polytetrafluorothylene, see the last 14 lines of [0023]. At least silicone is an elastomeric material), and the support member (16) is formed from a relatively rigid material (“rigid hollow core 16 is formed from a rigid polymer” see the last sentence of [0023]).
Regarding claim 16, the modified Wu device discloses in which the treatment module (12) comprises a proximal handle part (the left half of body 12 in Fig. 1 is capable of being grasped by hand because it is sized and shaped for insertion into the vagina. Thus, it reads on the broadest reasonable interpretation of a proximal handle part. Alternatively, it is noted that Figure 2 provides a rod, strap, or string 44 to have the user pull the piston block 26, see the first two sentences of [0030]. The Figure 2 embodiment is otherwise substantially identical to Figure 1 and would read on the claim 1 limitations in the same manner as stated above) and a distal treatment part (right half of body 12, Fig. 1, comprising the apertures and associated channels 22) being adapted for insertion into the vagina during use (“micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]), wherein the apertures (openings associated with channels 22, Fig. 1) are provided on the distal treatment part (see Fig. 1).
Regarding claim 19, the modified Wu device discloses in which the device comprises a remote actuation/controller module (automated pump 32, Fig. 1, is remotely connected via tube 34) operatively connectable to the treatment module (12, via tubing 34, Fig. 1) and comprising actuating and/or controlling means (automated pump 32 “with integral pressure regulator is shown communicatively coupled to proximal chamber portion 20b way of tubing 34 connected through a valve 36” and having an “electronic controller configured to adjust pressure toe a predefined or a user defined parameter” see Fig. 1 and lines 1-18 of [0028]) including the vacuum pump for the microtrauma module (automated pump 32 is connected to and part of the vacuum pump by adjusting the pressure within the vacuum pump chamber portion(s) 20, see lines 1-18 of [0028]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Lei (2015/0366747).
Regarding claim 12, the modified Wu device discloses the treatment module (12) is sized and configured to be inserted into the vagina (see lines 8-10 of [0023]), but does not specifically state a portion of the treatment module adapted for insertion into the vagina has a maximum cross-sectional size in the range between 20 mm and 30 mm.
Lei teaches a related vaginal rejuvenation apparatus (Fig. 1) in which the vaginal treatment module (applicator 3, Fig. 1; i.e., handle 21 and disposable plug components 22, 23, 25, 26, Fig. 2; see the last sentence of [0111]) is inserted to be adjacent the vaginal wall for vaginal tightening (see the first sentence of [0054]). The treatment module has a maximum cross-sectional size in the range of 25-37.5 mm (see the second sentence of [0054]), which is an optimal size for most users (see the last sentence of [0054]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment module of Wu to have a maximum diameter of about 25-37.5 mm as taught by Lei because such a diameter is shown to be suitable for most users for a treatment probe that is sized and configured to be inserted into the vagina for vaginal rejuvenation and tightening. The claimed range limitation is thus obvious because the prior art overlaps with the range, see MPEP 2144.05.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Weston et al. (2005/0203452).
Regarding claim 15, the modified Wu device is silent regarding further comprising a: a) liquid trap, the liquid trap being provided upstream of the vacuum pump and arranged to trap liquid discharge drawn through the apertures; and/or b) a hydrophobic filter, the hydrophobic filter being arranged to block contaminates drawn though the apertures from reaching the vacuum pump.
Weston teaches a related tissue suctioning device (Fig. 3A) that includes a liquid trap (collection system 243, Fig. 3A) being provided upstream of a vacuum pump (vacuum pump 231, Fig. 3A) and arranged to trap liquid discharge drawn through a suctioning aperture (collects liquid drawn by the vacuum pump through port 228, Fig. 3A; “container 243 provides a means for containing and temporarily storing the collected exudate” see para. [0039]); and a hydrophobic filter (filter 233, Fig. 3A) being arranged to block contaminates drawn through the aperture(s) (from port 228, Fig. 3A) from reaching the vacuum pump (“filter 233 may also be a hydrophobic filter that prevents any exudate from the wound from contaminating, and then being vented to atmosphere by, the vacuum pump 231” see para. [0036]). Thus, the operation of the vacuum pump is not interfered with by liquids.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wu’s vacuum pump system to include a liquid trap and/or hydrophobic filter as taught by Weston in order to prevent bodily fluid from being suctioned into the vacuum pump. This provides an expected result of improving the operation of the vacuum pump, so its operation is not interfered with by liquids.
Claims 17-18, 20-21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Bridges (2016/0242953).
Regarding claim 17, the modified Wu device discloses in which the distal treatment part comprises an aperture portion (area with the plurality of channels 22, Fig. 1) in which the apertures (external openings of channels 22) are located, the aperture portion being located distally (“a plurality of channels 22, preferably distal D to and/or at the site of the annular seal after insertion”) to a sealing portion (“at least a portion of the body 12 forms an annular seal against the walls of the vagina” see [0023]). Wu does not specifically state the treatment part comprising a proximal sealing portion in which none of the apertures are located.
Bridges teaches a related suctioning treatment module (device 302, Fig. 3) for vaginal tightening (see abstract), in which the treatment module comprises a proximal handle part (handle 306, Fig. 3) and a distal treatment part (shaft 304 and sealing cup 308, Fig. 3) being adapted for insertion into the vagina during use, wherein apertures are provided on the treatment part (suction openings 310 are provided on distal treatment part 304, see Fig. 3), and the treatment part comprises a proximal sealing portion (sealing cup 308, Fig. 3) in which none of the apertures are located (suction openings 310 are on the shaft 304, not on the sealing cup 308, see Fig. 3), and an aperture portion (the portion of shaft 304 with the suction openings 310, Fig. 3) in which the apertures (310) are located, the aperture portion being located distally to the sealing portion (308, see Fig. 3). This arrangement provides advantages that the suction assembly is “self-contained” (para. [0051]) and the sealing part is positioned to form a seal to allow the distal treatment part effectively provide suction (“The sealing cup is configured to seal a cavity opening when the shaft is inserted into the body cavity” para. [0004], see also generally para. [0042]). Furthermore, the handle provides an expected result of allowing the user to conveniently grip the device to help position it.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment module of Wu to have a proximal handle and a distal treatment part including a proximal sealing portion and an aperture portion as taught by Bridges because this allows the device to be self-contained and thus more portable, and the handle allows the device to be conveniently gripped to help the user position it properly while still forming a seal to allow the distal treatment part to effectively provide suction.
Regarding claim 18, the modified Wu device is silent regarding the distal treatment part is detachable from the proximal handle part, and in which the distal treatment part is disposable.
Bridges teaches a related suctioning treatment module (Fig. 9A-9B) for vaginal tightening (see abstract), in which the treatment module comprises a proximal handle part (706, Fig. 9A, note that this is capable of being grasped by a hand and uses the similar reference character as the other handles 106, 206, 306, etc.) and a distal treatment part (suction distribution cap 740, Fig. 9B) being adapted for insertion into the vagina during use, wherein apertures are provided on the treatment part (suction holes 744 are provided on distal treatment part 740, see Fig. 9B). Bridges has the distal treatment part (suction distribution cap 740, Fig. 9B) detachable from the proximal handle part (706, Fig. 9A), and in which the distal treatment part is disposable (“suction distribution cap 740 is configured to be separated from the shaft 704 for easy cleaning and/or disposable of the suction distribution cap 740” see para. [0069]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment module of Wu to have a detachable distal treatment part that is disposable as taught by Bridges because the detachability allows this part that is inserted into the vagina be easily cleaned and/or disposed (para. [0069]).
Regarding claim 20, the modified Wu device is silent regarding the treatment module (12, Fig. 1) is detachable from the remote actuation/controller module (32, Fig. 1) and is disposable.
Bridges teaches a related suctioning treatment module (shaft 1504 and sealing part 1508, Fig. 18C) for vaginal tightening (see abstract), in which the treatment module is detachable from (via quick connect system 1506, see Figs. 18A-18C and the first two sentences of [0083]) a remote actuation/controller module (the quick connect system 1506 detachably connects the treatment module to the suction hose 1518. As seen in Figs. 14A and Fig. 15, a suction hose such as 1118 is able to connect to a remote actuation/controller module in the form of a hand suction pump 1216 or an electric pump 1316. Thus, the quick connect system of Fig. 18A-18C would detach the treatment module from some form of remote actuation). The quick connect system (1506) allows the treatment module to be easily removed from the suction hose for cleaning, maintenance, and/or storage (see the last sentence of [0083]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the treatment module of Wu to be detachable from the remote actuation/controller module by a quick connect system as taught by Bridges because this allows the treatment module to be easily removed for cleaning, maintenance, and/or storage. Furthermore, the treatment module in the modified Wu/Bridges device is detachable and capable of being thrown away, and thus reads on the broadest reasonable interpretation of “disposable.”
Regarding claim 21, the modified Wu/Bridges device discloses in which the treatment module (12, Fig. 1 of Wu) and the actuation/controller (32, Fig. 1 of Wu) are coupled by a lead (tubing 34, Fig. 1 of Wu, as modified by Bridges to be the suction tubing 1518 with quick disconnect system 1506), wherein: the treatment module (12, Fig. 1 of Wu) is detachable from the lead (via quick disconnect system 1506 of Bridges) so that the treatment module is a disposable part (in the modified device, the treatment module 12 of Wu is now detachable and capable of being thrown away, and thus reads on the broadest reasonable interpretation of “disposable”).
The modified Wu/Bridges shows that the lead is bent into different shapes (see Fig. 1 of Wu and various figures of Bridges), but does not specifically state the lead (suction tubing) is flexible. However, it is well known in the art to use flexible pneumatic tubing, and selecting a flexible material provides an expected result that the device will be easier to handle due to the ability to bend as needed.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the tubing of Wu/Bridges to be a flexible material such as rubber or a plastic, 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, 125 USPQ 416. See MPEP 2144.07.
Regarding claim 24, the modified Wu device states the actuation/controller module (32) includes an electronic controller for the user to adjust to a predefined or user defined parameter (see para. [0028]), but is silent regarding in which the actuation/controller module (32, Fig. 1) comprises a graphical user interface.
Bridges teaches a related suctioning treatment module (device 202, Fig. 2) for vaginal tightening (see abstract), in which a remote actuation/controller module (controller 224, Fig. 2) comprises a graphical user interface (“digital display” see para. [0050]) to conveniently allow the user to control/adjust operation of the device (“controller 224 may be configured to start/stop the suction device, increase/decrease the speed/suction of the suction device, and/or to reverse the direction of air flow. In some embodiments, the controller 224 includes a display, such as, for example, a digital display, to display information to a user, such as, for example, a timer, a suction measurement, and/or any other suitable information” see the last two sentences of [0050]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electronic controller of Wu to include a graphical user interface such as a digital display as taught by Bridges so the user can see important information such as a timer, suction measurement, etc.
Regarding claim 25, the modified Wu device discloses b) the plurality of apertures (external openings associated with channels 22, Fig. 1) may be arranged in a variety of patterns (“the plurality of channels 22 can be arranged in any suitable pattern” see the first sentence of [0026]), but does not specifically state the apertures are arranged circumferentially around the outer surface of the treatment module. It is noted that claim 25 only requires “any one or more” of the listed limitations.
Bridges teaches a related suctioning treatment module (device 202, Fig. 2) for vaginal tightening (see abstract), in which the apertures (suction openings 210, Fig. 2) are arranged circumferentially (spiral suction pattern 211, see Fig. 2 and para. [0048]) around the outer surface of the treatment module (see Fig. 2). This would provide an expected result of applying the therapeutic suction to a plurality of sides of the vaginal canal thereby increasing the treatment area.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of apertures of Wu to be arranged circumferentially around the outer surface of the treatment module as taught by Bridges because Wu states that any suitable pattern may be utilized, and such a pattern taught by Bridges would be expected to apply the therapeutic suction to a plurality of sides of the vaginal canal thereby increasing the treatment area.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Bridges (2016/0242953) as applied to claim 21 above, and further in view of Lei (2015/0366747).
Regarding claim 22, the modified Wu/Bridges device is silent regarding a tamper resistance device, provided at a connection point between disposable and non-disposable parts of the device, and wherein the actuator/controller module is arranged to: sense the tamper resistance device and to [determine] if the disposable parts are being used for the first time based on the tamper resistance device, and prevent activation of the vacuum pump if the disposable parts are determined to have been reused.
Lei teaches a related vaginal rejuvenation apparatus (Fig. 1) including a tamper resistance device (identification chip 25, Fig. 2), provided at a connection point between disposable and non-disposable parts of the device (parts 22, 23, 25, and 26, Fig. 2, are disposable as part of the “disposable plug” see the last sentence of [0111]. The identification chip 25 is at a connection point between these disposable components and the non-disposable handle 21). The controller module is arranged to: sense the tamper resistance device (the equipment can recognize plug head usage based upon the ID chip, see para. [0182]. The portion(s) of the equipment that perform this recognition function are part of a controller module) and to determine if the disposable parts are being used for the first time based on the tamper resistance device (see para. [0052]), and prevent activation of the device if the disposable parts are determined to have been reused (“allowed to connect with the system for only once …The system will be prohibited to operate once beyond the restrictions” see the last two sentences of [0134] and the last two sentences of [0182]). This promotes a clean and safe treatment of the vagina because it avoids cross infection that would be caused by repeated application of the components (see the first two sentences of [0134]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wu/Bridges to include a tamper resistance device at a connection point between disposable and non-disposable parts of the device, and have the actuator/controller module arranged to: sense the tamper resistance device and determine if the disposable parts are being used for the first time based on the tamper resistance device, and prevent activation of the vacuum pump if disposable parts are determined to have been reused as taught by Lei in order to ensure that there is a clean and safe treatment of the vagina, avoiding cross infection that would be caused by repeated application of the components (see the first two sentences of [0134] of Lei).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Bridges (2016/0242953) and Lei (2015/0366747) as applied to claim 22 above, and further in view of Cao (2009/0065565).
Regarding claim 23, the modified Wu/Bridges/Lei device discloses the tamper resistance device comprises an identifier (identification chip 25 of Lei), and the device further is configured to read the identifier and the actuator/controller determines if the flexible lead is being connected for the first time based on the identifier (see para. [0134], [0182] of Lei). The modified device does not specifically state the identifier is “unique” and the device comprising a sensor arranged to read the unique identifier. However, Lei states that the use of such an identifier chip is well known (see the last sentence of [0145]).
Cao teaches a related system for preventing the reuse of a medical device that has a disposable portion (see Fig. 2 and abstract), wherein the disposable portion (probe 60, Fig. 2) includes a tamper resistance device (ID device 67, Fig. 2) comprising a unique identifier (“ID device 67 has a unique or statistically unique characteristic that is detectable by the base station 70 through the probe handle 50” see para. [0028]), the device comprising a sensor arranged to read the unique identifier (“each probe 60 is fabricated with a different capacitance and inductance and therefore, each probe 60 has a different impedance vs. frequency response and one or more cross-over frequencies. Measuring this response yields a statistically unique value of set of cross over frequencies that are used to determine if a probe 60 has already been used” see para. [0028] and see para. [0029] stating that the base station 70 keeps track of which unique codes have been used, and prevents use if the probe has already been used). This provides an expected result that the same probe will not be used twice.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the chip ID and controller module of Wu/Bridges/Lei to have the chip ID be a unique identifier for each disposable device, and to have the controller module sense the unique identifier and keep track of which unique codes have already been used as taught by Cao because the use of unique codes helps make sure that the device has not been used already.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (2020/0405572) in view of Carava (2004/0073144)
Regarding claim 30, the modified Wu device is silent regarding a timer configured to terminate treatment after a pre-defined treatment period, wherein the duration of the treatment period is between 1 and 90 minutes.
Carava teaches a related tissue suctioning device (Fig. 1A) with a timer (suction timer 208, Fig. 6) configured to terminate treatment after a pre-defined treatment period (“The user may also preselect the duration for application of the suction where the suction force is automatically turned off when the preselected period expires. This is done by activating the timer by means of timer level 12 on the suction control box 4” see para. [0040]. Thus, the treatment period is pre-defined by the placement of the timer control lever 12, Fig. 1A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Wu device to include a timer configured to terminate treatment after a pre-defined treatment period as taught by Carava because this provides an expected result of allowing the user or doctor to choose a suitable amount of suction time and prevents excessive suction to the tissue.
The modified Wu/Carava device does not specifically state that the duration of the treatment period is between 1 and 90 minutes. It is noted that this is a broad range of time, with no stated particular criticality and Carava demonstrates that one of ordinary skill in the art is able to adjust a pre-defined suction treatment range.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the duration of the treatment period to be between 1 and 90 minutes, since it has been held that where the general conditions of a claim are disclosed in the prior art (Carava discloses a user-selectable timer that allows the user to preselect a duration of suction treatment), discovering the optimum or workable ranges (a duration of 1 to 90 minutes) involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Response to Arguments
Applicant's arguments filed December 1, 2025, have been fully considered but they are not persuasive.
The Declaration of Conor Minogue under 37 CFR 1.132 filed December 1, 2025 (hereinafter “the Declaration”) has been considered, but it is insufficient to overcome the rejection of claims 1, 6, 8-9, 11-25, and 30-31. The Declaration is discussed below in the Response to Arguments.
Regarding the argument that Wu expressly teaches away from the claimed pressure range of 200-600 mmHg because Wu indicates that a low negative pressure is preferable, directly contradicting the negative pressure limitation of the claimed invention and signaling to a skilled artisan that such a modification would be undesirable or inoperative (see the last paragraph of page 12 of the Remarks, through the last paragraph of page 13), this argument is not persuasive.
First, it is noted that this is a device claim. It is reiterated that “[a]pparatus claims cover what a device is, not what a device does,” and a “‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim,” see MPEP 2114(II). Wu clearly discloses the apparatus can apply the recited negative pressure range of 200 mmHg to 600 mmHg (180 to 600 mmHg, see para. [0031]).
Second, a “teaching away” requires a reference to actually criticize, discredit, or otherwise discourage investigation into the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Furthermore, "[w]e will not read into a reference a teaching away from a process where no such language exists." DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364 (Fed. Cir. 2006).” In the instant case, there is no language in Wu that actually criticizes, discredits, or discourages the use of 200 mmHg to 600 mmHg. On the contrary, Wu discloses applying 180-600 mmHg pressures to increase blood flow (see para. [0031]). There is nothing in Wu that would suggest 1-180 mmHg is the only pressure range that can induce microtrauma.
Regarding the argument that paragraphs 6-11 of the Declaration explain that the Wu device could not be used to draw tissue inwards to create a microtrauma (see the second paragraph of page 14 of the Remarks, and paragraphs 6-11 of the Declaration), this argument is not persuasive.
Paragraph 6 of the Declaration alleges that the “manner in which the channels 22 open to the atmosphere are not described or suggested.” This is not persuasive. It is readily apparent to one of ordinary skill in the art that the channels 22 are tubular passages because the channels “fluidly couple the inner chamber to an outer surface of the body” (see the first sentence of [0024] and see the depiction of channels 22 in Figs. 1-2). “Drawing the piston block 26 proximally along the longitudinal axis decreases pressure in the distal portion 20a of chamber 20, which pulls air inward through the plurality of channels 22 and because of the annular seal, pulls the body 12 and the walls of the patient’s vagina against each other” (emphasis added, see lines 6-11 of [0027]).
Paragraph 6 of the Declaration additionally alleges that because Wu draws the vaginal wall against the body of the device, the “openings cannot therefore be located at the ends of the channel 22 because as soon as they would make the slightest contact with the vaginal wall the air flow would stop preventing further evacuation and increase in negative pressure.” This is not persuasive. First, the claims do not set out any requirement for the device to provide “further evacuation and increase in negative pressure” once the tissue contacts the apertures. Second, when tissue contacts Wu’s channel 22 openings, the tissue will still be exposed to the reduced pressure within vacuum chamber 20. The tissue will be drawn towards the reduced pressure of the vacuum chamber and thus elongate at least partially into the aperture(s). Even a small degree of elongation would read on the claim language. Third, Applicant’s argument appears to undermine how the instant invention operates. The instant invention provides negative pressure at apertures to cause adjacent tissue to contact the apertures and “be drawn through the apertures 106 so that the tissue elongates within the holes 110” (see para. [0117] of the publication). If Applicant’s apertures are able to apply negative pressure to tissue at the end of a channel/hole, why would Wu’s apertures allegedly would be inoperable? They are both applying suction to tissue through an array of holes.
Paragraph 6 of the Declaration additionally alleges that Wu’s openings could be located on the sides of the channels 22 but could not be used to draw tissue inwards to create microtrauma. This is not persuasive. There is nothing in Wu to suggest the openings are located on the sides of the channels 22, nor any evidence that the ends of the channels are closed. Thus, one of ordinary skill in the art would interpret Wu’s channels 22 to be typical channels: tubular passages with an opening at each end to “fluidly couple the inner chamber to an outer surface of the body” (see the first sentence of [0024] and see Figs. 1-2) to allow the piston to pull “air inward through the plurality of channels 22” (see lines 18-20 of [0026]).
Paragraph 7 of the Declaration alleges that Wu’s drawings only provide a limited cross-sectional view and there are no openings shown at the top of the channels 22 as would be expected in a cross-sectional view. This is not persuasive. A cross-sectional view of a tubular passage with openings at each end would look precisely as shown in Figures 1-2. The “top” view of the channel opening would not be visible. It is reiterated that there is nothing in Wu to suggest the openings are located on the sides of the channels 22, nor any evidence that the ends of the channels are closed. Thus, one of ordinary skill in the art would interpret Wu’s channels 22 to be typical channels: tubular passages with an opening at each end to “fluidly couple the inner chamber to an outer surface of the body” (see the first sentence of [0024] and see Figs. 1-2) to allow the piston to pull “air inward through the plurality of channels 22” (see lines 18-20 of [0026]).
Paragraph 8 of the Declaration alleges that the microtrauma taught by Wu arises due to tissue pressing against channels 22 as the vaginal wall is drawn against the body 12, resulting in compressive stress as distinct from the tensile stress applied in the claimed device as tissue is drawn into surface apertures. This is not persuasive. Wu similarly pulls the vaginal wall against the suctioning surface apertures. Wu states that “when inserted into the vagina for treatment, at least a portion of the body 12 forms an annular seal against the walls of the vagina, and … as negative pressure is applied, the surface 14 of the body 12 increasingly contacts vaginal tissue … by pulling the vaginal tissue inward and against the body 12” emphasis added, see lines 11-19 of [0023]. With the negative pressure pulling the vaginal tissue inward against the body 12 the tissue contacts the channels 22 and “micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]. Thus, the device is arranged to draw at least a portion of the tissue against and into the suctioning apertures to apply microtrauma in the same manner as claimed.
Paragraph 9 of the Declaration alleges that Wu is essentially different from the claimed device because Wu’s device operates to evacuate the vaginal space so as to draw the vaginal wall against the device, while the claimed invention creates an array of localized negative pressure points corresponding to each aperture. This is not persuasive. Wu also has an array of localized negative pressure points based upon the array of channels 22 that “fluidly couple the inner chamber to an outer surface of the body” (see the first sentence of [0024] and Figs. 1-2) to allow the piston to pull “air inward through the plurality of channels 22” (see lines 18-20 of [0026]).
Paragraph 10 of the Declaration alleges that even assuming there is an opening at the end of the channels 22, the operation of Wu’s device would be to stretch the tissue over the end of the channels to create microtrauma by compressing the tissue against/across the channels rather than being drawn into the channels. This is not persuasive. When the vaginal tissue contacts the open ends of the suctioning channels 22, the tissue will at least partially be drawn into the apertures of the channels due to the negative pressure produced in the vacuum chamber 20. Why would the tissue move across the channels, as alleged? It is noted that Wu is configured to apply the same pressure level(s) through an array of apertures/openings as recited, thus the tissue would be expected to act in the same manner as the claimed invention when it contacts a suctioning aperture.
Paragraph 11 of the Declaration alleges the tissue in Wu is deformed into a shape extending into the vaginal wall, which is directly opposite to the inverted dimple extending into the holes created by the presently claimed device, and the inverted dimple has been found to provide effective treatment for vaginal atrophy. This is not persuasive. First, it is unclear what is meant by the “inverted dimple” as this phrase does not appear in any of the claims or disclosure. Second, it is unclear why Applicant believes the tissue in Wu would be deformed into a shape extending into the vaginal wall. Instead, Wu states “as negative pressure is applied, the surface 14 of the body 12 increasingly contacts vaginal tissue … by pulling the vaginal tissue inward and against the body 12” see lines 11-19 of [0023]. The vaginal tissue in Wu contacts the body and the channels 22 (“micro-traumas are formed primarily at regions where the channels 22 contact the vaginal wall” see the third sentence of [0024]). The channels 22 “fluidly couple the inner chamber to an outer surface of the body” (see the first sentence of [0024] and Figs. 1-2) to allow the piston to pull “air inward through the plurality of channels 22” (see lines 18-20 of [0026]). Thus, the tissue is pulled into contact with the suctioning channels 22 and would be at least partially drawn into the apertures.
Regarding the argument that the Wu device would actually inhibit the vaginal tissue from being drawn into the apertures upon suction and the device operates in entirely opposite manner from the instant invention so a person of ordinary skill would not be motivated to modify Wu to arrive at the claimed invention (see the second paragraph of page 14 of the Remarks and paragraph 11 of the Declaration), this argument is not persuasive. How would Wu inhibit vaginal tissue from being drawn into the apertures upon suction? Wu specifically states the vaginal tissue is pulled into contact with the suctioning channels (see lines 11-19 of [0023], and lines 1-9 of [0024]), and Wu discloses negative pressure ranges encompassing the recited pressure range. How is this “entirely opposite” from the claimed invention? It appears to be the same mechanism of operation.
Regarding the argument that the Examiner’s assertion that the claimed parameters would have been achieved through routine optimization is unsupported and inconsistent with the evidence of record because Wu does not identify the claimed combination of pressure and aperture size as result-effective nor provide guidance to modify the prior art in the manner claimed (see the last paragraph of page 14 of the Remarks, through the first paragraph of page 15), this argument is not persuasive. First, Applicant’s own disclosure states that “[t]esting performed by the inventors has shown that [200 mmHg to 600 mmHg] provides effective VA treatment without causing excessive tissue damage” and the negative pressure of 300-450 mmHg was “found in testing carried out by the inventors to provide an optimal range for effective VA treatment” (see the last sentence of [0013] and [0014]). This is a strong indication that the pressure selection is a result-effective variable. Second, Wu does identify the claimed negative pressures because Wu discloses pressures from 1 to 760 mmHg (see para. [0031]), and Wu discloses values approaching the claimed range are specifically used for generating micro-trauma (180 mmHg, see the last two sentences of [0040]). Lastly, Wu provides guidance to modify the applied pressure and aperture size by stating the applied pressure can vary depending on the intended result (see the last sentence of [0031]), and the size of the channel 22 opening “can vary depending on the needs of the user. For example, fewer, larger channels 22 may be preferred for targeting greater micro-trauma…” (see para. [0026]). Thus, Wu identifies both pressure and aperture size as result-effective variables related to providing micro-trauma.
Regarding the argument that the Declaration demonstrates that changes to any one of negative pressure, hole size, and time for which the pressure is applied produce unexpected results and a person of ordinary skill in the art would not have reasonably expected the claimed ranges to yield the observed advantages (see the first paragraph of page 15 of the Remarks), this argument is not persuasive.
The burden is on Applicant to establish that the results are in fact unexpected and unobvious and of both statistical and practical significance, such as through direct and indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims (see MPEP 716.02(b)) “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected” … and “a difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘"a new property dissimilar to the known property,’" rather than producing a predictable result but to an unexpected extent” (MPEP 716.02).
Here, Applicant has not demonstrated what the expected result would be, and has not clearly defined what the “result” is, and has not compared the results to the closest prior art. Is the unexpected result just that a combination of negative pressure, hole size, and time yielded “observed advantages”? Why would this be “unexpected” when Wu already discusses providing varying degrees of negative pressure and hole sizes to provide micro-trauma to vaginal tissue? What are the “observed advantages” compared to the prior art? Additionally, the claims do not recite any particular time value. Even if the results were “really unexpected,” were they producing a difference in degree, or a difference in kind? It is reiterated that the burden is on Applicant to establish that the results are both unexpected and significant.
Regarding the argument that a summary of in-vivo negative pressure therapy studies showed that discovering the optimum pressure used with the apertures to generate force on the vaginal wall is not a simple matter of routine optimization (see the second paragraph of page 15 of the Remarks), this argument is not persuasive. Applicant appears to be arguing that because three variables were tested, this is not routine optimization. However, Wu specifically suggests varying the negative pressure value (see the last sentence of [0031]), the aperture size (see para. [0026]), and Wu indicates that the amount of time the negative pressure is maintained is a factor (“maintaining sufficient negative pressure over a sufficient time or repeatedly applying sufficient negative pressure to cause micro-trauma…” see para. [0013]). Thus, finding the optimum combination of pressure, aperture size, and time (which is not claimed) for micro-trauma would require merely routine optimization.
Regarding the argument that Lei does not cure the deficiencies of Wu, so claim 12 is not obvious (see the last three paragraphs of page 16 of the Remarks), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Lei.
Regarding the argument that the Examiner incorrectly assumes Weston’s liquid trap and hydrophobic filter would provide an expected result of improving operation of Wu’s vacuum pump, as its operation is not interfered with by liquids (see the first paragraph of page 17 of the Remarks), this argument is not persuasive. Wu would not want liquids to be drawn into the vacuum chamber 20 or any other part of the vacuum pump, as it could interfere with proper functioning of the piston and vacuum pump.
Regarding the argument that Weston does not cure the deficiencies of Wu, so claim 15 is not obvious (see the second paragraph of page 17 of the Remarks), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Weston.
Regarding the argument that Bridges does not cure the deficiencies of Wu, so claims 17, 18, 20, 21, 24, and 25 are not obvious (see the last paragraph of page 17 of the Remarks, through the second paragraph of page 18), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Bridges.
Regarding the argument that Bridges and Lei do not cure the deficiencies of Wu, so claim 22 is not obvious (see the last paragraph of page 18 of the Remarks, through the first paragraph of page 19), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Bridges and Lei.
Regarding the argument that Bridges, Lei, and Cao do not cure the deficiencies of Wu, so claim 23 is not obvious (see the last paragraph of page 19 of the Remarks, through the first paragraph of page 20), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Bridges, Lei, and Cao.
Regarding the argument that Carava does not cure the deficiencies of Wu, so claim 31 is not obvious (see the last two paragraphs of page 20 of the Remarks), this argument is not persuasive because Wu has no apparent deficiencies aside from what is taught by Carava.
Conclusion
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/CHRISTOPHER E MILLER/Examiner, Art Unit 3785