DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendments of claims 1, 3-5, 9, and 12 are acknowledged by the Examiner
Applicant’s cancelation of claims 2, 7-8, and 11 are acknowledged by the Examiner.
Applicant’s addition of new claims 27-29 are acknowledged by the Examiner.
Applicant’s cancelations of claims 2, 7-8, and 11 has rendered the previous drawing objections moot. Therefore, the previous claim drawing objections are withdrawn.
Applicant’s amendments of claims 1 and 4, and the cancelations of claims 2 and 11 have overcome the previous claim objections. Therefore, the previous claim objections are withdrawn.
Applicant’s amendments of claims 1, 3-5, 9, and 12 have overcome the previous claim rejections under 35 U.S.C. 112(b). Therefore, the previous claim rejections under 35 U.S.C. 112(b) are withdrawn.
Claims 1, 3-6, 9-10, and 12-29 are currently pending in the application, with claims 14-26 being withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 09/28/2026 with respect to the finality of the restriction/election requirement have been fully considered but they are not persuasive.
As discussed in the previous non-final rejection, 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). Additionally, as discussed in the restriction/election requirement, Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed can be made by another and materially different process which does not utilize the production step of forming the pessary body around the anchoring section. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification (i.e. the classifications of a61f6/08 and a61f2240/0001); (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter (i.e. invention I is drawn to a pessary, and invention II is drawn to a method of manufacturing); (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries; i.e. searching for a generic pessary, and searching for a specific method of manufacturing); (d) the prior art applicable to one invention would not likely be applicable to another invention (i.e. a generic pessary with a pull tab which reads on claim 1, would not likely read on the specific method of manufacturing the device of claim 14); (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Thus, the restriction is proper and will not be withdrawn.
In regards to Applicant’s arguments that Sham does not have a finger-pull aiding in a deformation of the body during removal of the pessary device to facilitate breaking of a seal between the body of the pessary device and a vaginal cavity wall”, Examiner respectfully disagrees. Sham explicitly discloses in [00221] “a “pull-tab” is provided to improve their usability by allowing the pull-tab to be employed in the insertion and/or removal of the first and second Ring Pessaries 3000A and 3000B respectively”. Thus, a user may insert their finger within 3010, pull on 3010 to remove the pessary as claimed.
In regards to Applicant’s argument that Sham does not teach or suggest a pessary device comprising a Gellhorn or a cube pessary body as claimed, Examiner respectfully disagrees. Sham discloses all of the previously presented limitations of claim 1 as discussed in the non-final rejection. With respect to the new limitations of “wherein the body comprises a pessary body selected from a Gellhorn or a cube pessary body”, Sham teaches a second embodiment of the pessary body (body of 3100A; see [00223]; see figure 31a) which makes obvious the simple substitution of the ring-shaped pessary body (body of 3000A) seen in figure 30b for the Gellhorn pessary body seen in figure 30a.
In regards to Applicant’s arguments that the Examiner has acknowledged that “Sham does not disclose wherein the loop is disposed at an angle towards the centre of the pessary device from the edge of the outwardly facing surface”, Examiner respectfully disagrees and asserts that no such statement was made. Examiner explicitly states that Sham anticipates the limitation as seen in figure 30b where it can clearly be seen that 3010 is disposed and extends toward the center of the pessary device as claimed.
In regards to Applicant’s arguments against the modification of Sham in view of claim 3, and to do so would likely render the device of 30b unsatisfactory for its intended purpose, Examiner respectfully disagrees. First, Examiner notes that Sham states the benefit of the second embodiment of the pull tab seen in figure 35 is “for the purpose of allowing the finger pull to extend to an elastic limit and aid in removal of the pessary device (See [00226])”. Thus, providing a teaching of a benefit for the modification of the first embodiment of the pull tab 3010 of 3000a. With respect to the arguments that the modification would likely render the device of 30b unsatisfactory for its intended purpose, the modification of 3010 to be the shape of 3540 would not hinder the ability of 3010 to aid in the removal of the pessary device as the benefit explicitly states “for the purpose of allowing the finger pull to extend to an elastic limit and aid in removal of the pessary device (See [00226])” (i.e. the shape will explicitly benefit and aid in the removal functionality provided by 3010).
With respect to Applicant’s arguments that if the ends of 3010 (positioned on a first side of the body of the pessary device), were brought together as suggested by Examiner, the notch 3040 (positioned on the opposite side of the body of the pessary device) would be filled by the ends of the finger pull. Examiner reproduces figure 30b below to show that Applicant’s argument is unfounded, and the modification would not fill 3040 as suggested by Applicant.
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It is for at least these reasons that Applicant’s arguments are not persuasive, and the reference of Sham will continue to be relied upon as a primary reference. However, due to the amendments of claim 1, the scope of the claims has changed, which results in the new grounds of rejection presented below.
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 distance between the two ends being about half the diameter of the loop as recited in claim 27 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide antecedent basis for the limitations of the “Shore A hardness” as recited in claim 9. Examiner notes that the specific Shore level is not recited in the originally filed specification and thus, is new matter. Therefore, the specification should not be amended to include the specific Shore levels as this would constitute new matter as well.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites the limitation “a Shore A hardness of the body” and “a Shore A hardness of the finger-pull”. The specific Shore levels were not described in the originally filed specification and thus, are new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 5, 9, 12-13, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over 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 configured 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 a deformation of the body 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).
Sham further discloses wherein the body comprises a pessary body selected from a ring pessary (see [00221]). Sham does not disclose wherein the body comprises a pessary body selected from a Gellhorn or a cube pessary body.
However, Sham teaches a second embodiment of the pessary device (3100A; see [00223]; see figure 31b); comprising an analogous body (body of 3100A; see figure 31b) and finger-pull (3120; see [00223]; see figure 3100a; 3120 is capable of being pulled by a finger and thus, is considered a finger-pull) disposed on and extending from the body (see figure 31b); wherein the body comprises a pessary body selected from a Gellhorn (see [00223]) or a cube pessary body.
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 ring pessary body of the first embodiment of the pessary device as disclosed by Sham and to have substituted the ring pessary body for the Gellhorn pessary body as taught by the second embodiment of the pessary device of Sham that would add the benefit of providing a pessary body that provides more supportive capabilities than a ring pessary and is suited for third-degree prolapse situations.
Furthermore, such a modification is held to be obvious since it has been held that “(w)here a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509 (BPAI, 2007) (citing KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1396 (2007) (see MPEP 2143 I B). Accordingly, Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results. In the instant case a substitution of the ring pessary body of the first embodiment of the pessary device for the Gellhorn pessary body of the second embodiment of the pessary device yields the predictable results of providing a pessary device for the support of pelvic organs affected by conditions such as pelvic organ prolapse.
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 a distance between the two ends of the loop being less than a 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]).
Further such a modification 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 disclosed that the claimed configuration of the distance between the two ends of the loop (i.e. the shape of the loop) provides an advantage, is used for a particular purpose, or solves a stated problem, contrarily stating “The anchoring section preferably includes two ends of the loop, the distance between the two ends of the loop being less than a diameter of the loop” (see Specification [0027]) thereby disclosing the use of a loop with two ends and therefore, the distance between said ends is not more than a preferential design choice which would be obvious to one of ordinary skill in the art. Thus, the limitation met by the modification is considered a mere design choice which fails to patentably distinguish over the prior art of Sham.
In regards to claim 5, Sham discloses the invention as discussed above.
Sham does not disclose wherein the loop (loop of 3010) is disposed at an angle towards a centre of the pessary device from the edge of the outwardly facing surface (see figure 30b).
In regards to claim 9, Sham discloses the invention as discussed above.
Sham further discloses a Shore A hardness of the finger-pull is about 60 -70 (“Optionally, the outer surface (i.e. 3010 and the outer surface 3010 is positioned on) which contact the user may be smooth with low friction to human skin, smooth with minimal friction to human skin (low friction also referred to as “slippery”; see [00277]); see [00274] in reference to creating said slippery surface “a micro-layer (spray coated for example) of high durometer medical grade silicone, for example 70-90 durometer, to create the "slippery" surface”; silicone, being an elastomer/rubber is measured in a Shore A using durometers; thus, 3010 is considered to have a Shore A hardness of 70 durometer).
Sham does not explicitly disclose a shore A hardness of the body is from about 25-35.
However, Sham teaches wherein a Shore A hardness of the body (body of 3000a) is 20 (Accordingly, an USTD, cup, plug, cushion etc. may with medical grade silicone be clear and formed from an initial sticky soft silicone, e.g. 20 durometers; see [0274]) and that lower durometers allow the device to be soft and sticky, while higher durometers create smoother surfaces which may enhance retention of the device or provide resistance to chemicals that may or may not be used by the user (See [00274-00275]).Thus, the Shore A hardness of the body is considered to be a result effective variable in that changing the hardness affects the ability of body to be retained against the user’s body and provide resistance to chemicals that may or may not be used by the user. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Shore A hardness of the body of the pessary device of Sham as it involves only adjusting the property of a component disclosed to require adjustment.
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 Shore A hardness of the body of the pessary device of Sham by forming the body from a material with a Shore A hardness of 25-35 as a matter of routine optimization since 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” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ensuring the body of the pessary device was soft enough to aid in retaining the device, while also ensuring the body of the pessary has resistance to chemicals that may or may not be used by the user (See [00275]).
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).
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).
In regards to claim 27, Sham discloses the invention as discussed above.
Sham further discloses wherein the distance between the two ends is about half the diameter of the loop (see figure 35 that the upper portions of the two ends (i.e. the portion of the ends which transition to the wider section of the loop) have a distance between them which is about half the diameter of the loop).
In regards to claim 29, Sham discloses the invention as discussed above.
Sham further discloses wherein the body of the pessary device is formed from silicone ([00276-00278] in reference to the devices described in the disclosure (and thus, 3000a and associated structures) may be formed from silicone).
Claim(s) 4 and 28 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 discloses the invention as discussed above.
Sham does not disclose wherein the anchoring section further comprises a V-shaped supporting 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 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 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 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.
In regards to claim 28, Sham as now modified by Morhenn discloses the invention as discussed above.
Sham as now modified by Morhenn further discloses wherein the supporting web (18 of Morhenn) comprising a triangular web extending between the two ends (see Morhenn figures 3 and 4 that the shape of 18 corresponds to the shape of 16 and 17; see Sham figure 35 that the ends of 3540 form a triangular shape between them; thus, when the supporting web (18 of Morhenn) is included onto the modified pull tab (3010 modified to be the shape of 3540 of Sham), the supporting web, positioned between the two ends of the pull tab which form a triangular shape, comprises a triangular web as claimed).
Claim(s) 6 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]).
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
