DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of group I in the reply filed on 02/27/2026 is acknowledged. The traversal is on the ground(s) that “group II was improperly classified under A61F2240/0001 which only applied to designing or manufacturing processes "of prostheses classified in groups A61F 2/00 - A61F 2/26 or A61F 2/82 or A61F 9/00 or A61F 11/00 or subgroups thereof." However, the claims of Group I are not classified by the Examiner in any of the enumerated groups "A61F 2/00 - A61F 2/26 or A61F 2/82 or A61F 9/00 or A61F 11/00 or subgroups thereof." Instead, the Examiner asserts that the claims of Group I are classified in A61F6/08. As such, it appears that the claims of Group II are mis-classified”. This is not found persuasive because the invention of group I is drawn to a pessary, and thus, can be classified under A61F6/08 which specifically pertains to pessary devices. Group II is drawn to a method of manufacturing a pessary, and the classification A61F2240/0001 pertains to designing or manufacturing processes "of prostheses classified in groups A61F 2/00 - A61F 2/26 which includes A61F2/00 (Devices providing patency to, or preventing collapsing of, tubular structures of the body), and A61F2/0004 (anti-incontinence devices or support slings against pelvic prolapse). Pessaries are utilized to prevent the collapse of a vagina (a tubular structure of the body), and are used as anti-incontinence devices or support slings against pelvic prolapse. Thus, the classification A61F2240/0001 pertains to designing or manufacturing processes of devices which include pessaries classified under both A61F2/00 and A61F2/0004, and the classification of group II in A61F2240/0001 is not improper as Applicant argues.
The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 14-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the pessary body selected from a ring, ring with support, shelf, Shaatz, Risser, Smith, tandem cube, cup, oval, Hodge, Hodge with knob, Hodge with support, Gehrung, dish, dish with support and donut as recited in claim 2, an anchor that is disposed beneath the outwardly facing surface of the body of the pessary device as recited in claim 7, the anchor comprises an enlarged bulbous section, t-shaped section or disc, or comprises barbs located on said anchoring section as recited in claim 8, and a pessary body selected from a Shaatz, tandem cube and donut as recited in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2, 4, and 11 are objected to because of the following informalities:
Claim 1 recites the limitation “to facilitate breaking of a seal between the body of the pessary device and a vaginal cavity wall”. This limitation should be amended to include configured to language.
Claim 2 recites multiple pessary shapes without reciting “a” or “an” prior to the shape. These limitations should be amended to recite “a” or “an” to properly present the limitations.
Claim 4 recites the limitation “the supporting web” in line 3. This limitation should be amended to recite “the substantially V-shaped supporting web to maintain consistency in the claims.
Claim 11 recites multiple pessary shapes without reciting “a” or “an” prior to the shape. These limitations should be amended to recite “a” or “an” to properly present the limitations.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the deformation" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a deformation”.
Claim 1 recites the limitation "the base" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the body”.
Claim 3 recites the limitation “the distance” in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a distance”.
Claim 3 recites the limitation “preferably” in line 4 with respect to the distance. This limitation renders the claim indefinite as it is unclear if the limitations following the term “preferably” are required by the claim, or are merely a preferred embodiment. For the purpose of examination, Examiner will interpret the limitations following “preferably” as optional, and the prior art need not disclose the limitations to read on the claim.
The term “substantially V-shaped” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as “V-Shaped”.
Claim 4 recites the limitation “preferably” in line 3 with respect to the shape of the supporting web. This limitation renders the claim indefinite as it is unclear if the limitations following the term “preferably” are required by the claim, or are merely a preferred embodiment. For the purpose of examination, Examiner will interpret the limitations following “preferably” as optional, and the prior art need not disclose the limitations to read on the claim.
The term “substantially triangular web” in claim 4 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, Examiner will interpret this limitation as “triangular”.
Claim 4 recites the limitation “a substantially V-shaped supporting web extending between the two ends, the supporting web preferably comprising a substantially triangular web extending between the two ends”. This limitation renders the claim indefinite as it is unclear as to if the supporting web is a V-shaped supporting web, or triangular supporting web because these two shapes are distinct from one another. For the purpose of examination, given the recitation of triangular supporting web is being interpreted as an optional limitation, Examiner will interpret this limitation as the supporting web is a V-shaped supporting web.
Claim 5 recites the limitation "the centre" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “a centre”.
Claim 9 recites the limitation “a harder Shore rating” in line 2, and multiple recitations to “a Shore hardness” in lines 3 and 4. These limitation render the claim indefinite because there are multiple different levels or scales of Shore hardness (Shore 000, Shore 00, Shore A, Shore D) and it is unclear as to which scale of Shore rating Applicant is referring to. Additionally Applicant’s specification does not provide a description of which Shore rating applicant is referring to. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim 9 recites the limitation “preferably” in line 2, and “more preferably” in lines 3 and 4 with respect to the Shore rating of the body of the pessary device and finger-pull. This limitation renders the claim indefinite as it is unclear if the limitations following the term “preferably” and “more preferably” are required by the claim, or are merely a preferred embodiment. For the purpose of examination, Examiner will interpret the limitations following “preferably” and “more preferably” as optional, and the prior art need not disclose the limitations to read on the claim.
Claim 12 recites the limitation “preferably” in line 2 with respect to the material of the body. This limitation renders the claim indefinite as it is unclear if the limitations following the term “preferably” are required by the claim, or are merely a preferred embodiment. For the purpose of examination, Examiner will interpret the limitations following “preferably” as optional, and the prior art need not disclose the limitations to read on the claim.
Claims 2, 6-8, 10-11, and 13 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim, and thus, containing the same offending limitations.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sham et al. (WO 2022/147611 A1) (hereinafter Sham).
In regards to claim 1, Sham discloses a pessary device (3000a; see [00221]; see figure 30b) comprising:
a body (body of 3000a; see figure 30b); and
a finger-pull (3010; see [00221]; see figure 30b) disposed on and extending from the body and adapted to receive at least one finger of a user to facilitate removal of the pessary device (see [00221]), said finger-pull comprising a loop (loop of 3010; see figure 30b) extending from an outwardly facing surface of the body, in use, and an opposed anchoring section (base of 3010; see figure 30b) connected or integral with the outwardly facing surface (see figure 30b),
wherein the anchoring section (base of 3010) is disposed at or towards an edge of the outwardly facing surface (see figure 30b) aiding in the deformation of the base during removal of the pessary device to facilitate breaking of a seal between the body of the pessary device and a vaginal cavity wall (3010 facilitates the removal of 3000a (see [00221]) and thus, aids in the deformation of the body to break the seal between the pessary and the vaginal wall as claimed).
In regards to claim 2, Sham discloses the invention as discussed above.
Sham further discloses wherein the body comprises a pessary body selected from a ring, ring with support, shelf, Shaatz, Gellhorn, Risser, Smith, cube, tandem cube, cup, oval, Hodge, Hodge with knob, Hodge with support, Gehrung, dish, dish with support and donut (see [00221]; the body of 3000a is selected from a ring, a ring with support, and when utilized without the support 3020, is in the shape of a donut pessary).
In regards to claim 5, Sham as now modified discloses the invention as discussed above.
Sham does not disclose wherein the loop (loop of 3010) is disposed at an angle towards the centre of the pessary device from the edge of the outwardly facing surface (see figure 30b).
In regards to claim 11, Sham discloses the invention as discussed above.
Sham further discloses wherein the body comprises a pessary body selected from a Shaatz, Gellhorn, cube, tandem cube and donut (see [00221]; the body of 3000a when utilized without the support 3020, is in the shape of a donut pessary).
In regards to claim 12, Sham discloses the invention as discussed above.
Sham further discloses wherein the body of the pessary device is a unitary piece of material (see figure 30b that the body of 3000a is a unitary piece of material), preferably formed from silicone.
In regards to claim 13, Sham discloses the invention as discussed above.
Sham further discloses wherein the body and finger-pull are formed from silicone (see [00276-00278] in reference to the devices described in the disclosure (and thus, 3000a and associated structures) may be formed from silicone).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sham.
In regards to claim 3, Sham discloses the invention as discussed above.
Sham further discloses wherein the anchoring section (base of 3010) includes two ends of the loop connected or integral with the edge of the outwardly facing surface (see figure 30b).
Sham does not disclose the distance between the two ends of the loop being less than a diameter of the loop, preferably wherein the distance between the two ends is about half the diameter of the loop.
However, Sham discloses a second embodiment of a pessary device (Gellhorn style pessary device; see [00226]; see figure 35) comprising an analogous finger-pull (3540; see [00226]; see figure 35) which forms a loop (3540 forms a loop) and an anchoring section comprising two ends of the loop (two portions of 3540 which are connected to 3530; see figure 35); wherein the distance between the two ends of the loop being less than a diameter of the loop (see figure 35) for the purpose of allowing the finger pull to extend to an elastic limit and aid in removal of the pessary device (See [00226]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distance between the two ends of anchoring section as disclosed by the first embodiment of the finger pull of Sham and to have formed the distance between the two ends of anchoring section as less than a diameter of the loop of the finger pull as taught by second embodiment of the finger pull of Sham in order to have provided an improved finger pull that would add the benefit of allowing the finger pull to extend to an elastic limit and aid in removal of the pessary device (See [00226]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sham in view of Morhenn (US 4,031,886 A).
In regards to claim 4, Sham as now modified discloses the invention as discussed above.
Sham does not disclose wherein the anchoring section further comprises a substantially V-shaped supporting web extending between the two ends, the supporting web preferably comprising a substantially triangular web extending between the two ends.
However, Morhenn teaches an analogous pessary device (10; see [col 2 ln 54]; see figure 1) which comprises an analogous finger pull (15; see [col 3 ln 10]; see figure 4; see [col 3 ln 40-45] that 15 comprises 18 which aids in a finger gripping the device for insertion and removal, thus 15 is a finger pull); wherein the finger pull comprises a supporting web (18; see [col 3 ln 40]; see figure 4) for the purpose of providing a drip for the finger or fingernail of the wearer during the insertion or removal of the pessary device (see [col 3 ln 40-45]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchoring section of the finger pull as disclosed by Sham as now modified and to have included the supporting web as taught by Morhenn in order to have provided an improved finger pull that would add the benefit of providing a drip for the finger or fingernail of the wearer during the insertion or removal of the pessary device (see [col 3 ln 40-45]).
With respect to the limitation of the shape of the supporting web being substantially V-shaped. Morhenn discloses that the web or wall is circular based on the finger pull being semi-circular (see [col 3 ln 32-45]). Thus, when included into the V-Shaped anchoring section of Sham as now modified, the supporting web would be substantially V-shaped as claimed.
Additionally, such a shape of the supporting web would have been obvious to one of ordinary skill in the art since it has been held that a change in the shape of a structure was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape of the structure was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (see MPEP 2144.04 IV B). In the instant case, Applicant has not has not disclosed that the claimed configuration provides an advantage, is used for a particular purpose, or solves a stated problem, contrarily stating “the supporting web preferably comprising a substantially triangular or V-shaped web extending between the two ends” (see Specification [0016]) which establishes the shape of the supporting web is a design choice obvious to one of ordinary skill in the art. Thus, the shape of the supporting web is considered a mere design choice which fails to patentably distinguish over the prior art of Sham as now modified by Morhenn.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sham in view of Abbott et al. (US 2009/0311305 A1) (hereinafter Abbott).
In regards to claim 6, Sham discloses the invention as discussed above.
Sham further discloses wherein said anchoring section (base of 3010) is connected to the outwardly facing surface of the body of the pessary device (see figure 30b)
Sham does not explicitly disclose the connection is by bonding to the edge of the outwardly facing surface or anchoring beneath the outwardly facing surface.
However, Abbott teaches an analogous device (10; see [0018]; see figure 1) to be inserted within a vagina (see figure 3) comprising an analogous finger pull (22; see [0018]; see figure 1) which comprises an analogous loop (24; see [0018]; see figure 2) and anchoring section (30; see [0018]; see figure 2); wherein said anchoring section (30) is connected to the outwardly facing surface of the body of the device (see figure 1) by anchoring beneath the outwardly facing surface (see figure 1) for the purpose of snapping the anchoring section to the outwardly facing surface of the body of the device (See [0018]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anchoring section as disclosed by Sham and to have included the spherical distal end of the anchoring section for anchoring the finger pull to beneath the outwardly facing surface of the body of the pessary device as taught by Abbott in order to have provided an improved finger pull that would add the benefit of providing a snap connection of the anchoring section to the outwardly facing surface of the body of the device (See [0018]).
In regards to claim 7, Sham as now modified by Abbott discloses the invention as discussed above.
Sham as now modified by Abbott further discloses wherein said anchoring section (base of 3010 of Sham as now modified by Abbott) of said finger-pull (3010 of Sham) further comprises an anchor (30 of Abbott) that is disposed beneath the outwardly facing surface of the body of the pessary device (30 of Abbott included onto the base of 3010 of Sham is disposed beneath the outwardly facing surface of the body of 3000a similar to Abbott figure 1).
In regards to claim 8, Sham as now modified by Abbott discloses the invention as discussed above.
Sham as now modified by Abbott further discloses wherein the anchor (30 of Abbott) comprises an enlarged bulbous section (see Abbott figure 2), t-shaped section or disc, or comprises barbs located on said anchoring section.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sham in view of Leyendecker et al. (US 2016/0317270 A1) (hereinafter Leyendecker).
In regards to claim 9, Sham discloses the invention as discussed above.
Sham further discloses the pessary device may be formed from silicone (see [00276-00278] in reference to the devices described in the disclosure (and thus, 3000a and associated structures) may be formed from silicone).
Sham does not disclose wherein said finger-pull is formed from a material having a harder Shore rating than the body of the pessary device, preferably wherein the Shore hardness of the body is from about 25-35, more preferably about 30,and the Shore hardness of the finger-pull is about 60 -70, more preferably about 70.
However, Leyendecker teaches an analogous pessary device (12; see [0029]; see figure 1) comprising an analogous body (22; see [0032]; see figure 2) which is formed from an analogous silicone material (see [0034]), and finger pull (34; see [0035]; see figure 2; 34 is capable of receiving a tip or fingernail of the user’s finger to aid in insertion and removal of the pessary device, and thus, is considered a finger pull) extending from the body (22; see figure 2); said finger pull comprising a loop extending from an outwardly facing surface of the body (22; see figure 2) and an opposed anchoring section (32; see [0033]; see figure 2) connected or integral with the outwardly facing surface (see figure 2); wherein said finger-pull (34) is formed from a material having a harder Shore rating than the body (22) of the pessary device (12; see [0034] and [0040] that 32 (and therefore 34 being an exposed portion of 32) is formed from a higher durometer material (ABS) than the material (silicone) of 38 which forms 22) for the purpose of providing firmness and stability to the body of the pessary device (see [0033]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the material of the finger pull as disclosed by Sham and to have formed the finger pull from the higher durometer as taught by Leyendecker in order to have provided an improved finger pull that would add the benefit of providing firmness and stability to the body of the pessary device (see [0033]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sham in view of Kaseki et al. (US 2004/0084054 A1) (hereinafter Kaseki).
In regards to claim 10, Sham discloses the invention as discussed above.
Sham further discloses that the pessary device can be formed from a variety of colors and/or be patterned for a specific design (see [00237]).
Sham does not explicitly disclose wherein said loop is formed of a material of a different colour to said body of the pessary device.
However, Kaseki teaches an analogous pessary device (10b; see [0090]; see figure 11) comprising an analogous body (12; see [0090]; see figure 11), and finger pull (13; see [0090]; see figure 11; 13 is capable of receiving a user’s finger to aid in insertion and removal of the device and thus, is considered a finger pull) comprising a loop (see figure 11); wherein said loop is formed of a material of a different colour to said body of the pessary device (see [0068]) for the purpose of providing identifying colors that allow for the finger pull and body of the pessary device to be differentiated from one another (See [0068]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the loop of the finger pull as disclosed by Sham and to have formed the loop of the finger pull from a material of a different colour to said body of the pessary device as taught by Kaseki in order to have provided an improved pessary device that would add the benefit of providing identifying colors that allow for the finger pull and body of the pessary device to be differentiated from one another (See [0068]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786