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 .
Claim Objections
Claim 18,22 objected to because of the following informalities: Claim 18 states “wherein casing comprises” and should read wherein the casing comprises.
Claim 22 states “portion is concave a proximal face of the shield portion”. Based on the instant specification paragraph 48, the language should read portion is concave and a proximal face of the shield portion.
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)(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) 1-9,15,17-18,20,25-26,30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kight et al. US 2019/0350767.
Regarding claim 1, Kight discloses a tampon insertion device for inserting a tampon from a tampon applicator into a vaginal canal (abstract), the tampon applicator having a barrel (Fig. 7-9 (44)) for containing the tampon (42) and a plunger for expelling the tampon from a distal end of the barrel (plunger (46)), the device comprising:(a) a casing (12) having a distal end , a proximal end, and an interior (para. 0044); (b) an actuator (26) located in the interior of the casing (see figure 3), the actuator adapted for movement within the interior of the casing (para. 0046); and(c) a handle (24) having a passageway extending through a portion thereof (rail guide (33) with undersides (35) see figure 5)), the handle connected to the actuator (para. 0046), wherein the passageway is sized and configured to receive the casing therethrough (para. 0048, where rail guide connects with the top wall of the casing), with a portion of the casing positioned within the passageway such that movement of the handle with respect to the casing causes a corresponding movement of the actuator within the casing (para. 0042 0048); wherein the casing is adapted for releasably mounting the tampon applicator barrel to the device such that movement of the handle in the direction of the distal end of the casing causes the tampon to be expelled from the distal end of the tampon applicator barrel while retaining the applicator barrel mounted to the device (para. 0050).
Regarding claim 2, Kight discloses the tampon insertion device of claim 1, wherein the casing is adapted for releasably mounting the tampon applicator barrel to the device such that the distal end of the barrel is spaced away from the distal end of, and external to, the casing (see figure 6).
Regarding claim 3, Kight discloses the tampon insertion device of claim 2, wherein, the interior of the casing is adapted to receive and releasably retain a portion of the applicator barrel therein, with the applicator plunger positioned within the interior of the casing (see figure 8 and 9).
Regarding claim 4, Kight discloses the tampon insertion device of any one of claim 1,wherein the casing is hollow and elongate, has an open distal end, and has a longitudinal axis (para. 0044), and further wherein the casing is positioned within the passageway of the handle such that the handle is linearly movable along the exterior of the casing parallel to the longitudinal axis of the casing with the casing passing through the passageway of the handle (abstract, para. 0040, 0042).
Regarding claim 5, Kight discloses the tampon insertion device of claim 4, wherein said actuator and said handle are linearly movable along an actuation plane that includes the longitudinal axis of the casing in order to expel a tampon from the applicator barrel (para. 0042).
Regarding claim 6, Kight discloses the tampon insertion device of claim 4, wherein the casing further includes an open bottom through which the tampon applicator can be inserted into the interior of the casing (open bottom (20), para. 0044).
Regarding claim 7, Kight discloses the tampon insertion device of claim 6, wherein the actuator is coupled to the handle through the open bottom of the casing (see figure 4).
Regarding claim 8, Kight discloses the tampon insertion device of claim 7, wherein the actuator comprises a drive member positioned within the casing (distal face (27), see figure 4).
Regarding claim 9, Kight discloses the tampon insertion device of claim 7, wherein the drive member is connected to and extends upwardly away from the passageway of the handle into the casing (figure 4). The examiner notes that as the defined drive member extends “vertically” (as seen in the figure) away from the passageway, it is interpreted as extending upwardly away from the passageway, where “upward” is based on the orientation of the device.
Regarding claim 15, Kight discloses the tampon insertion device of claim 1,wherein the casing further comprises a clamp portion adapted to retain a portion of the tampon applicator barrel in the casing such that the distal end of the barrel is spaced away from the distal end of, and external to, the casing with a proximal end of the plunger adjacent the actuator (clamp portion 22, see para. 0045).
Regarding claim 17, Kight discloses the tampon insertion device of claim 1,wherein the casing further comprises at least one groove located in an interior wall of the casing and extending along an arcuate path, wherein the at least one groove is adapted for receiving a flange on the applicator (see annotated figure below).
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Regarding claim 18, Kight discloses the tampon insertion device of claim 17, wherein casing comprises a plurality of grooves located in an interior wall of the casing and extending along an arcuate path, wherein each of the grooves is adapted for receiving one or more flanges on the applicator (see annotated figure under rejection of claim 17).
Regarding claim 20, Kight discloses the tampon insertion device of claim 1,further comprising an enlarged shield portion extending away from the distal end of the casing (flange portion (36)).
Regarding claim 25, Kight discloses the tampon insertion device of claim 1,wherein the handle further comprises an arm extending upwardly away from the passageway (See annotated figure below). The examiner notes that the passageway was interpreted as the underside rails, best seen in figure 5. As seen in the second annotated figure below, the defined arm extends both below and above the rails to form a bottom face of the handle. Thus, said arm, at least partially, extends upwardly from the passageway.
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Regarding claim 26, Kight discloses the tampon insertion device of claim 25, wherein the handle further comprises a handle loop for facilitating manipulation of the device, the handle loop adapted to the receive the user's hand therethrough (see annotated figure under rejection of claim 25, see figure 10 for user’s hand fitting through the loop).
Regarding claim 30, Kight discloses a method of inserting a tampon into a user's vaginal canal, comprising the steps of:(a) providing a tampon insertion device of any preceding claim 1 (figure 1,9),with a tampon located within a tampon applicator barrel with the barrel mounted to the device (figure 9, tampon (42) within barrel (44); (b) inserting the distal portion of the applicator barrel into the vaginal canal (figure 10); (c) sliding the handle of the insertion device distally with respect to the casing and towards the vagina such that the plunger expels the tampon from the opening in the distal end of the barrel and into the vaginal canal (figure 10, para. 0051, see also claim 13).
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) 22,23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kight.
Regarding claim 22, Kight discloses the tampon insertion device of claim 20, wherein the shield portion flares laterally and distally away from the distal end of the casing such that a distal face of the shield portion is concave and a proximal face of the shield portion is outwardly flared.
The examiner notes that while the distal face of the defined shield of claim 20 (flange 36) is seen to flare laterally, said distal face does not concave. Further, the proximal face is not outwardly flared.
The examiner notes however, that a different embodiment of the shield is seen in figures 13-19. As seen in said figures and as detailed in para. 0059, the flange portion (536) is outwardly flared (trumpeted), best seen in figures 14 and 16a. The examiner notes that as seen in said figures the flanges flares laterally and distally away from the distal end of the casing, where the flaring exhibits a concave shape for the distal face of the shield. Further, as seen in said figures, the proximal face of said flange is also outwardly flared due to said “trumpeting” configuration exhibited. Therefore, as Kight teaches that the flange (536) is a suitable embodiment for a flange on a tampon application device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the flange (536 of figure 14) as the flange of the embodiment seen in figure 1. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results (aiding in proper insertion) and thus a prima facie case of obviousness exists.
Regarding claim 23, Kight discloses the tampon insertion device of claim 20, but fails to teach wherein the shield portion includes a string capture slot extending downwardly and proximally from an edge of the shield portion.
The examiner notes however, that a different embodiment of the shield is seen in figures 13-19. As seen in said figures and as detailed in para. 0056, the device comprises a string capture slot (560) for removal assistance (para. 0065). Therefore, as Kight teaches that such applicators may have a string capture slot to aid in the removal of the tampon, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the embodiment of figure 1 with a string capture slot as a means to aid in tampon removal. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (that being removal of the tampon) and thus a prima facie case of obviousness exists.
The examiner notes however, that said string capture slot is not located on the shield portion and thus does not extend downwardly and proximally from an edge of the shield portion. As seen in the figures, the slot does extend down and proximal but on the casing. However, per paragraph 0066, the string capture slot, although located on the casing, “could be located elsewhere on the device”. Per MPEP Section 2144.04 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.). Therefore, as Kight teaches that the string capture slot maybe be located in other locations on the device beside the casing as seen in figure 13-19, and per the MPEP rearrangement of parts provides and obviousness rationale so long as shifting the position would not modify the operation of the device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the string capture slot on the shield portion. Thus, while said rearrangement, Kight reads to the claimed invention
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kight in view of Yun et al. WO 2022231077, hereafter Yun.
Regarding claim 27, Kight discloses the tampon insertion device of claim 26, but fails to specifically teach that the device further comprises an elastic member attached to the arm such that the handle loop is formed by the elastic member and a proximal face of the arm. Kight however, does disclose that “the handle can be configured in a variety of alternative ways intended to improve the ergonomics of device manipulation and/or actuation” (para. 0054), and may have modified ergonomics (para. 0055).
Yun teaches a sanitary plug device and is thus considered analogous to the claimed invention. Yun teaches the device comprises an insertion guide (120), where the plug body is pushed out by a pusher member (140). Further, a handle (122) is formed to facilitate gripping of the guide, where the handle may be formed or coated in silicone resin or rubber to allow for firm handling. The examiner notes that both silicone resin and rubber are elastic. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a silicone or rubber formation or coating on the handle of Kight as a means to allow for firmer handling of the device. Doing so would merely involve combining prior art elements according to known methods to yield predictable results (handling the device) and thus a prima facie case of obviousness exists. The examiner notes therefore, the resin or rubber is interpreted as an elastic member attached to the arm. As the handle loops forms part of the holding surface, said loop would also comprise the formation or coating and thus the formation or coating forms at least a portion of both the loop and the arm, and thus reads to the claimed limitation.
Allowable Subject Matter
Claim10,11 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Cha et al. KR 102393455 B1, hereafter Cha.
Cha teaches a menstrual cup applicator, comprising a casing (110) having a distal end , a proximal end, and an interior (see figure 3a); (b) an actuator (140) located in the interior of the casing (see figure 3a), the actuator adapted for movement within the interior of the casing (para. 0021,0025); and(c) a handle (220) having a passageway extending through a portion thereof (see figure 1)), the handle connected to the actuator (para. 0024, through rotation axis 130), wherein the passageway is sized and configured to receive the casing therethrough (figure 1), with a portion of the casing positioned within the passageway such that movement of the handle with respect to the casing causes a corresponding movement of the actuator within the casing (0024). Further per claim 11 the tampon insertion device of claim 1, wherein the actuator is spring-biased in the proximal direction (where 140 of Cha is a spring).
The examiner notes however that Cha fails to read to the entirety of claim 1 and thus cannot read to claim 11. Cha teaches a menstrual cup being delivered, where the entire cup is inserted into a user through the spring action. This differs from a tampon applicator, specifically the applicator of the instant application, where the actuator of the instant application depresses a plunger of a tampon application housing to insert the tampon, where the tampon housing remains in the casing of the device. It would not have been obvious to provide a housing for the menstrual cup that would only dispense the cup into the user and not the housing as this is not of the spring of Cha operates, and it is unclear is an additional housing within the casing would fit or allow the device to function as intended. Further, in view of Kight as the primary reference (as applied to claim 1 above), modifying it to use the spring as the actuator would not allow the device to function as intended as the device of Kight relies on a slidable handle to push an actuator causing a tampon plunger to depress. Further the handle directly connects to the actuator through a notch. Replacing the actuator with a spring would not function with the slidable handle as sliding the spring distally would not bias the spring (as the spring is expanding not contracting) and thus not likely be able to provide sufficient force to push the plunger. Additionally, it would be unknown how to attach the handle of Kight directly to the spring, as compared to the actuator the prior art uses. Therefore, alone or in combination with Kight, Cha fails to read to the claimed invention.
Claim 12 fails to be read to by Cha or Kight for the same reasons as claim 11.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-9,15-22,25-26,30 rejected on the ground of nonstatutory double patenting as being unpatentable over claim1,3,5-6,11 of U.S. Patent No. US 11191677, hereafter 677. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Application Claim
Corresponding Claim of 677
1
1
2
1
3
1
4
1
5
1
6
1
7
1
8
1
9
1
11
N/A
12
N/A
15
1
17
5
18
5
20
3
22
3
23
See obvious type double patenting below
25
6
26
6
27
See obvious type double patenting below
30
11
The examiner notes that claim 1 of 677, although different (more specific) than the instant application claims, in that claim 1 of 677 requires a clamp, claim 1 of 677 requires all of the limitations of the instant application and thus the double patenting rejection is applied.
Claim 23 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. “677” above in view of Conroy et al. US 2012/0226216
677 fails to teach the string slot in the claims. Although 677 teaches said slot in the disclosure, this cannot be applied to double patenting. Conroy is used to teach this limitation. Conroy teaches that a withdrawal string is placed within a slot (9) (para. 0043) to keep the withdrawal means outside the body (para. 0010). Therefore, as a means to ease withdrawal (by ensuring the withdrawal means remains outside the body), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a string slot on the device of 677.
Claim 27 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. “677” above in view of Yun.
Yun teaches a sanitary plug device and is thus considered analogous to the claimed invention. Yun teaches the device comprises an insertion guide (120), where the plug body is pushed out by a pusher member (140). Further, a handle (122) is formed to facilitate gripping of the guide, where the handle may be formed or coated in silicone resin or rubber to allow for firm handling. The examiner notes that both silicone resin and rubber are elastic. Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a silicone or rubber formation or coating on the handle of 677 as a means to allow for firmer handling of the device.
The examiner notes that claims 11 and 12 are not subject to the double patenting rejection.
Conclusion
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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