DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 November 2025 has been entered. Claims 1 and 4-21 are now pending. The Examiner acknowledges the amendments to claims 1, 6, 10, 11, 13-15 and 18-21.
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 .
Claim Objections
3. Claim 1 is objected to because of the following informalities: at line 5 of claim 1, “the received user-specific data” should apparently read – the received user-specific data,--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claims 8 and 14-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
6. At line 1 of claim 8, it is unclear if “user-specific data” is the same as or different than “user-specific data” recited at line 3 of claim 1. A suggested amendment to claim 8 is -- the user-specific data--.
7. Claim 14 at lines 8-9 recites “the anatomy". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
8. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 4-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite a method of providing a customized vaginal therapeutic device via receiving data, generating a model and designing the VTD.
Claim 1 merely recites the steps of "receiving user-specific data characterizing…anatomical measurements" which amounts to a practitioner obtaining data that could be printed matter; "generating an anatomical model based on the…data" which could amount to sketching a model on paper using the data; "designing the customized VTD…based on the generated anatomical model..." which could also amount to thinking about the data and defining the geometry/material composition mentally, then drawing the model on paper; and providing data characterizing the defined geometry and the defined material composition..." which also could amount to a practitioner providing data that could be on a piece of paper or printed matter.
Claim 14 recite similar steps, in addition to "updating at least one VTD model based on the user-specific data" which does not further define over a step of adjusting/updating a model that could be sketched on paper, or using pen/paper to write down different measurements/data points in a written model. Therefore, claims 1 and 14 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. This judicial exception is not integrated into a practical application because the method can be performed in the mind, in addition to being implemented with pen/paper by a practitioner.
While claims 1 and 14 do recite the additional element of a model, which is a computational model, machine learning algorithm or artificial intelligence engine, such a generating/updating step is recited as being implemented using a generic computer application (computational model, a machine-learning algorithm or artificial intelligence engine) lacking any further specification. As such, it amounts to no more than merely adding a step of “apply it” (or equivalent thereof) with respect to the computational model, algorithm or AI engine. However, such a machine learning model for image analysis is well-understood and conventional in the art as suggested by U.S. Patent No. 8,457,710 and U.S. Pub. No. 2007/0027667.
Dependent claims 4 and 21 do recite the additional element of a CAD file containing data of a 3D model, however providing a CAD file containing 3D information of a model is well-understood and conventional in the art of image processing as suggested by U.S. Patent No. 8,457,710 and U.S. Patent No. 10,687,977.
Dependent claims 5-7, 12, 13 and 15-17 merely limit the generic steps to the types of measurements/data.
Dependent claim 8 does recite the additional limitation of including a biometric sensor, however a biometric sensor is well-understood and conventional in the art of monitoring/sensing properties of internal tissues as suggested by U.S. Pub. No. 2007/0027667 and U.S. Patent No. 10,687,977.
Dependent claims 9-11 and 18-20 recite a step of fabricating the VTD according to the defined geometry/material composition, however such a step does not preclude an additional step of using pen/paper to "fabricate" or draw the VTD according to the gathered data regarding the geometry/material of the VTD.
Claim Rejections - 35 USC § 103
9. 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.
10. Claims 1 and 4-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hardart et al. (U.S. Patent No. 10,687,977) in view of Myers et al. (WO 2017/152029). Regarding claim 1, Hardart et al. (hereinafter Hardart) discloses a method of providing a customized vaginal therapeutic device (VTD) for a user (“customized pessary”) comprising:
receiving user-specific data characterizing one or more anatomical measurements of a user’s anatomy (data which forms a dataset of fill volume for each balloon in the balloon matrix - col. 5, lines 7-15; or data from the fill volumes is recorded then used to create a physical model for further manipulation – col. 5, lines and 29-41)
generating an anatomical model based on the received user-specific data, the model including one or more anatomical features of the user (volume of balloons 27-30 determines radial dimensions 127-130 of a modeled ring pessary - col. 4, lines 61-64; or data then used to create a physical model for further manipulation as described above at col. 5, lines and 29-41),
designing the customized VTD with a predetermined computational model, a machine learning algorithm and/or an artificial intelligence engine based on the generated anatomical model, the customized VTD having a defined geometry (col. 5, lines 4-6 and col. 5, lines 15-26) for the customized VTD to treat at least one ailment (urinary incontinence) of the user (“modeled ring pessary” as shown in Fig. 4B and descried above at col. 4, lines 61-64; or data which was used to create the physical model is then scanned and the resulting computational model is used for further manipulation and/or manufacturing of the pessary – col. 5, lines 29-41); and
providing data characterizing the defined geometry of the designed customized VTD (col. 4, line 67 – vol. 5, lines 1-6).
While Hardart fails to disclose explicitly that the model defines the material composition, which is further provided as data, Myers et al. (hereinafter Myers) teaches a method of providing a customized VTD, as likewise disclosed by Hardart, wherein the pessary may comprise materials of different compliance, such that one end is compliant enough to facilitate insertion into the patient and another portion less compliant to enable the pessary to resist forces related to cervical shortening [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate a model for creating a personalized VTD/pessary as taught by Hardart, to define the material composition of the VTD as suggested by Meyers, as Hardart recognizes the creation of a personalized pessary with individual dimensions/geometry for 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), which would necessitate the type of material in order to print, and Myers teaches that the pessary may be formed of different materials dependent upon the function served on each region of the pessary ([0086], [0089] and [0090]), and further that the pessary will be formed based on the model, wherein the suggested manufacturing processes (e.g., 3D printing, injection molding and additive manufacturing) would also require data defining the material composition of the pessary for its subsequent construction [0096].
Regarding claim 4, Hardart teaches the provided data comprises a CAD file containing a virtual three-dimensional model of the customized VTD (col. 4, lines 61-67 – col. 5, lines 1-6).
Regarding claim 5, Hardart teaches that the one or more anatomical measurements include data derived from a clinical assessment (col. 2, lines 3-21 and col. 5, lines 7-15).
Regarding claim 6, while Hardart discloses that the data comprises measurements of anatomical landmarks of the user’s anatomy (col. 3, lines 36-48 and col. 4, lines 35-45), Hardart does not disclose explicitly that the clinical assessment comprises a Pelvic Organs Prolapse Quantification (POP-Q). Hardart does make such obvious in light of the teaching of a calculation of dimensions of the vaginal canal for purposes of modeling a pessary to be designed (see Abstract), which is where the measurements for the POP-Q are taken.
Regarding claim 7, Hardart teaches that the one or more anatomical measurements include imaging-derived data (col. 5, lines 50-64), however Hardart does not disclose explicitly that that imaging is ultrasound. Myers teaches a method of providing a customized VTD, as likewise disclosed by Hardart, wherein the patient-specific pessary can be designed by measuring a patient’s anatomy via one or both of a transabdominal or transvaginal ultrasound [0091].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize ultrasound imaging as disclosed by Hardart, in a method for imaging vaginal tissue for modeling a customized pessary as taught by Hardart, as Hardart recognizes various imaging modalities such as CT, MRI and other imaging solutions may be utilized to measure/assess the internal tissue (col. 5, lines 50-64), and Myers teaches that transabdominal or transvaginal ultrasound facilitates design of a complementary pessary which approximates a specific patient’s cervical and vaginal dimensions ([0091]-[0092]).
Regarding claim 8, Hardart teaches that the user-specific data comprises data provided by at least one biometric sensor (col. 1, lines 19-24 and col. 5, lines 50-64).
Regarding claim 9, while Hardart teaches fabricating the customized VTD according to the defined geometry via 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), Hardart fails to disclose explicitly that the fabricating is also according to the defined material composition. Myers teaches a method of providing a customized VTD, as likewise disclosed by Hardart, wherein the pessary may comprise materials of different compliance, such that one end is compliant enough to facilitate insertion into the patient and another portion less compliant to enable the pessary to resist forces related to cervical shortening [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to fabricate the personalized VTD/pessary as taught by Hardart, according to a defined material composition as suggested by Meyers, as Hardart recognizes the creation of a personalized pessary with individual dimensions/geometry for 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), which would necessitate the type of material in order to print, and Myers teaches that the pessary may be formed of different materials dependent upon the function served on each region of the pessary ([0086], [0089] and [0090]), and further that the pessary will be formed based on the model, wherein the suggested manufacturing processes (e.g., 3D printing, injection molding and additive manufacturing) would also require data defining the material composition of the pessary for its subsequent construction [0096].
Regarding claims 10 and 11, while Hardart does not disclose explicitly that the fabricating of the customized VTD is accomplished via at least one additive manufacturing technique, or at least one non-additive manufacturing technique, Hardart makes such obvious as Hardart discloses utilizing the resulting personalized model for 3D printing ("additive manufacturing technique") and/or manufacturing which would result in a physical version of the VTD, which would be used to prepare a mold ("non-additive manufacturing technique”) used to manufacture customized pessaries (col. 4, lines 61-65 – col. 5, lines 1-6 and 36-41).
Regarding claims 12 and 13, Hardart teaches that the user-specific data includes user quality-of-life information which includes one or more performance goals of the user (achieving urinary continence) (col. 4, lines 40-45 and col. 1, lines 16-19).
Regarding claim 14, Hardart discloses a method of providing a customized vaginal therapeutic device (VTD) for a user (“customized pessary”) comprising:
receiving user-specific data including clinical information characterizing user response information (col. 1, lines 55-60; col. 5, lines 7-15 and 29-41) for a first VTD designed to treat a first user ailment (intended use);
updating at least one VTD model 102 based on the received user-specific data using a predetermined computational model (Fig. 4B and col. 4, lines 61-64; “updating” also discussed at col. 1, lines 58-60 – “New pessary designs can be created, and previously created measurements evaluated”),
the at least one VTD model defining a geometry for a second VTD to treat the first user ailment (intended use, but the at least one VTD model 102 defines a geometry for a ring pessary 102 as shown in Fig. 4A and described at col. 4, lines 61-64),
the at least one VTD model being based upon a generated model of the user’s anatomy (which is conducted by filling balloons of the device shown in Fig. 4A; it is noted that this limitation does not positively recite the generation of a model of the user’s anatomy);
designing the second VTD based on the updated at least one VTD model, the second VTD having the defined geometry (col. 5, lines 7-20 – “This dataset is entered into a function that outputs a pessary model, which is essentially a set of rules for making a customized pessary. The size of the dataset may range from the fill volume for a single balloon, to the fill volume for each balloon of the balloon matrix. For instance, FIGS. 4A and 4B depict an example in which a ring pessary is determined by the data of four balloons, whereas FIG. 9 depicts an example in which a ring pessary with a “saddle” shaped urethral support 127 may even be determined by the volume of a single balloon 27”);
and providing data characterizing the defined geometry of the designed second VTD (col. 4, line 67 – vol. 5, lines 1-6).
While Hardart fails to disclose explicitly that the at least one VTD model defines a material composition for a second VTD, which is further provided as data, Myers et al. (hereinafter Myers) teaches a method of providing a customized VTD, as likewise disclosed by Hardart, wherein the pessary may comprise materials of different compliance, such that one end is compliant enough to facilitate insertion into the patient and another portion less compliant to enable the pessary to resist forces related to cervical shortening [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to generate a model for creating a personalized VTD/pessary as taught by Hardart, to define the material composition of the VTD as suggested by Meyers, as Hardart recognizes the creation of a personalized pessary with individual dimensions/geometry for 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), which would necessitate the type of material in order to print, and Myers teaches that the pessary may be formed of different materials dependent upon the function served on each region of the pessary ([0086], [0089] and [0090]), and further that the pessary will be formed based on the model, wherein the suggested manufacturing processes (e.g., 3D printing, injection molding and additive manufacturing) would also require data defining the material composition of the pessary for its subsequent construction [0096].
While Hardart does not disclose explicitly that the defined geometry of the designed second VTD is different than a corresponding geometry of the first VTD, Myers makes such obvious as Myers discloses a step of validating that the custom-fit pessary by running a computational simulation of the pessary geometry placed within a computer model of the patient's anatomy [0091], and further that a multitude of pessaries may be provided in a range of sizes and shapes dependent upon the needs of a particular patient [0089]. In combination, these teachings would obviate the provision of another VTD with a different geometry/material composition, to ensure each patient has a custom fit.
Regarding claim 15, the clinical information comprises one or more of professional assessment information (col. 1, lines 46-60 of Hardart) and user quality-of-life information (assessing patient's comfort level due to optimal or sub-optimal fit - col. 1, lines 32-42 and col. 4, lines 35-45 of Hardart).
Regarding claim 16, while Hardart teaches that the user quality-of-life information includes symptoms related to the first user ailment while a VTD is worn by the user (col. 1, lines 32-42 and col. 4, lines 35-45), Hardart does not explicitly that that it is while a first VTD is worn. However, Hardart makes such obvious as for any user wearing a VTD, the goal of the modeling mechanism/system of Hardart is to create a customized fit to the user (col. 1, lines 52-60 and col. 5, lines 35-41) and allow the clinician to create/update new pessary designs and shapes (col. 5, lines 23-28; and col. 1, lines 58-60).
Regarding claim 17, the user quality-of-life information includes one or more performance goals of the user (achieving urinary continence) (col. 4, lines 40-45).
Regarding claim 18, while Hardart teaches fabricating the customized VTD according to the defined geometry via 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), Hardart fails to disclose explicitly that the fabricating is also according to the defined material composition. Myers teaches a method of providing a customized VTD, as likewise disclosed by Hardart, wherein the pessary may comprise materials of different compliance, such that one end is compliant enough to facilitate insertion into the patient and another portion less compliant to enable the pessary to resist forces related to cervical shortening [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to fabricate the personalized VTD/pessary as taught by Hardart, according to a defined material composition as suggested by Meyers, as Hardart recognizes the creation of a personalized pessary with individual dimensions/geometry for 3D printing (col. 4, line 67 – col. 5, lines 1-2 and 36-41), which would necessitate the type of material in order to print, and Myers teaches that the pessary may be formed of different materials dependent upon the function served on each region of the pessary ([0086], [0089] and [0090]), and further that the pessary will be formed based on the model, wherein the suggested manufacturing processes (e.g., 3D printing, injection molding and additive manufacturing) would also require data defining the material composition of the pessary for its subsequent construction [0096].
Regarding claims 19 and 20, while Hardart does not disclose explicitly that the fabricating of the customized VTD is accomplished via at least one additive manufacturing technique, or at least one non-additive manufacturing technique, Hardart makes such obvious as Hardart discloses utilizing the resulting personalized model for 3D printing ("additive manufacturing technique") and/or manufacturing which would result in a physical version of the VTD, which would be used to prepare a mold ("non-additive manufacturing technique”) used to manufacture customized pessaries (col. 4, lines 61-65 – col. 5, lines 1-6 and 36-41).
Regarding claim 21, Hardart teaches the provided data comprises a CAD file containing a virtual three-dimensional model of the designed second VTD (col. 4, lines 61-67 – col. 5, lines 1-6).
Response to Arguments
11. Applicant’s arguments filed 5 November 2025 with respect to the rejection of claims 1 and 4-21 under 35 U.S.C. 112(b) have been fully considered, however new grounds of rejection are given above (to claims 8 and 14) in light of the amendments.
12. Applicant’s arguments filed 5 November 2025 with respect to the rejection of claim 20 under 35 U.S.C. 112(d) have been fully considered and are persuasive in light of the amendments.
13. Applicant’s arguments filed 5 November 2025 with respect to the rejection of claims 1, 5 and 7-20 under 35 U.S.C. 103 citing Myers (‘029) have been fully considered and are persuasive, however new grounds of rejection are presented above in light of the amendments. The change in scope of the claim(s), while it obviated the rejection(s) to Myers, effectively broadened other portions of the claim which enabled a reading of Hardart on the instant claims.
To address the rejection under 35 U.S.C. 101, the claims merely invoke/apply a generic computer/model as a tool rather than reciting the generic computer/model as being specifically configured to implement the abstract idea, or integrating the generic computer/model into a practical application. See MPEP with respect to “ Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2); and “Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
Conclusion
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/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791