DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on March 17, 2023 and July 30, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
3. Claims 1 and 11 are objected to because of the following informalities:
Line 4 of claim 1 and line 8 of claim 11 recite “…the fluid cavity open through an opening in the top of the body…” which appears grammatically incorrect. For the purpose of examination, the limitation will be interpreted as ---…the fluid cavity is open through an opening in the top of the body…---.
Appropriate correction is required.
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.
4. Claims 7-8 are 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.
Namely, claims 7 and 8 appear to recite subject-matter relating to the embodiment shown in Figure 7a, where “a pad body defines an opening through the pad”; however, claim 7 depends from claims 1 and 3-6, where claim 4 recites features relating to the embodiment shown in Figure 4c, in which “the pad body is foldable”. Accordingly, claims 7 and 8 require both a pad body configured to fold about a midpoint, as well as a pad body wherein the front, back, first side and second side define a pad opening through the pad – this appears contradictory.
Additionally, claim 8 makes it unclear as to whether the pad is “configured to be inserted into the fluid cavity and below the top of the body” as required by claim 5, or whether the pad is “configured to be coupled to the top of the body” as required by claim 8 – this also appears contradictory.
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.
5. Claim(s) 1, 2, 9-13 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin et al. (WO 2021/211568 A1).
6. With regard to claims 1 and 18, Martin discloses a human interface for a urinary relief system/assembly (abstract; Figs. 6a, 6c), comprising: a body (fluid collection device, 600) including a top, a bottom, a front, a back, a first side, and a second side (Fig. 6a; [0066]); a fluid cavity (chamber, 604) formed in the body (600) and defined by the bottom, the front, the back, the first side, and the second side (Fig. 6a; [0067]), the fluid cavity (604) is open through an opening in the top of the body (opening 606, not shown, between open-cell foam border, 620; [0066]; [0069]); and an outlet (aperture, 612) formed near the back of the body (600), the outlet (612) extending from the fluid cavity (604) and through the bottom (Fig. 6a), the outlet (612) located near the back and centered between the first side and the second side (Figs. 6a, 6c; [0067-0071]).
7. With regard to claim 11, Martin discloses a urinary relief system (abstract; Figs. 1, 11), comprising: a control unit (“controller”, not shown; [0094]); a storage device (fluid storage container, 14; [0041-0042]; [0044-0045]) coupled to the control unit ([0093]); a human interface device (fluid collection device, 12) coupled to the storage device (14; Fig. 1), the human interface device (12) including: a tray (600; Figs. 6a, 6c) including a top, a bottom, a front, a back, a first side, and a second side (Fig. 6a; [0066]); a fluid cavity (604) defined by the bottom, the front, the back, the first side, and the second side (Fig. 6a; [0067]), the fluid cavity is open through an opening in the top of the tray (opening 606, not shown, between open-cell foam border, 620; [0066]; [0069]); and an outlet (612) extending from the fluid cavity (604) and through the bottom and adjacent the back of the tray (600), the outlet (612) extending toward the front of the tray (Figs. 6a; [0067-0071]).
8. With regard to claim 2, Martin discloses a funnel (formed at bottom of fluid-impermeable pouch, 602) formed in the fluid cavity (604), the funnel located near the back (Figs. 6a, 6c), the outlet (612) fluidly coupled to the fluid cavity (604) through the funnel (of 602; [0066-0069]).
9. With regard to claim 9, Martin discloses that the first side (of 600) has a first curve extending toward the fluid cavity (604) along the first side from the back to the front (Figs. 6a, 6c; [0043]; [0066]), and wherein the second side has (of 600) a second curve extending toward the fluid cavity (604) along the second side from the back to the front (“rounded curve shape”; [0071]; [0087]; [0099]).
10. With regard to claim 10, Martin discloses that the top (of 600) is curved upward from the back to the front, the front being higher than the back (Figs. 6a, 6c; [0043]; [0071]).
11. With regard to claim 12, Martin discloses that the outlet (612) is centered between the first side and the second side (Figs. 6a, 6c; [0067-0071]).
12. With regard to claim 13, Martin discloses that the outlet (612) is located adjacent the first side of the tray (Figs. 6a, 6c; [0067-0068]; [0071]).
13. With regard to claim 19, Martin discloses a pad (fluid-permeable material, 610) coupled to the body (600; Fig. 6c), the pad (610) is configured to be inserted into the fluid cavity (604) and below the top of the body (600; Fig. 6c; [0068]), the pad (610) including a wing (contoured strip, 660) configured to extend over the top of the body (600; Fig. 6c; [0071]).
14. With regard to claim 20, Martin discloses a funnel (formed at bottom of fluid-impermeable pouch, 602) located near the back of the body (600; Figs. 6a, 6c), the funnel coupling the fluid cavity (604) to the outlet (612), wherein the outlet (612) extends out toward the first side of the body (600; Fig. 6a; [0066-0069]), the outlet including an outlet opening (channel, 615) toward the front of the body (600; [0067-0068]).
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.
15. Claim(s) 3, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Martin.
16. With regard to claim 3, while Martin discloses a pad (fluid-permeable material, 610) having a pad body (Figs. 6a, 6c; [0068]) and a first wing (contoured strip, 660) extending from a first portion of the pad body (610; Fig. 6c; [0071]), Martin fails to disclose, that the pad (610) has a second wing extending from a second portion of the pad body.
However, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pad disclosed by Martin, to include a second wing extending from a second portion of the pad body, similar to the first wing disclosed by Martin, in order to further assist in the grasping and removal of the pad from the device, for disposal or replacement, as suggested by Martin in paragraph [0071], and further since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
As an alternative rejection to claim 3, while in the embodiments disclosed in Figures 6a and 6c, Martin discloses a pad (open-cell foam border, 620) having a pad body (Figs. 6a, 6c; [0069]), Martin fails to disclose, within the same embodiment, a pad having a pad body, a first wing, and a second wing, the first wing extending from a first portion of the pad body and the second wing extending from a second portion of the pad body.
However, in an alternate embodiment of Figures 5A and 5B, Martin discloses a pad (“securement element”) having a pad body (lip, 522), a first wing (one or more opposing wings, 520), and a second wing (one or more opposing wings, 520), the first wing extending from a first portion of the pad body (522) and the second wing extending from a second portion of the pad body (Figs. 5A, 5B; [0062]).
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 have modified the pad disclosed by Martin in embodiments of Figures 6a and 6c, to include a first and second wing extending from the pad body, similar to that disclosed by Martin in the alternate embodiment of Figures 5a and 5b, in order to provide wings or flaps which assist in securing the fluid collection device between the legs and against the anatomy of the user, as suggested by Martin in paragraph [0062].
17. With regard to claim 15, while in the embodiments disclosed in Figures 6a and 6c, Martin discloses a pad (open-cell foam border, 620) having an oval body (Figs. 6a, 6c; [0069]), and a pad opening (606; not shown) formed therethrough ([0066]), the pad (620) configured to be coupled to the top of the tray (600; [0069]), Martin fails to disclose, within the same embodiment, a first wing extending from a first side of the pad; and a second wing extending from a second side of the pad
However, in an alternate embodiment of Figures 5A and 5B, Martin discloses a pad (“securement element”) having a pad body (lip, 522), a first wing (one or more opposing wings, 520), and a second wing (one or more opposing wings, 520), the first wing extending from a first side of the pad body (522) and the second wing extending from a second side of the pad body (Figs. 5A, 5B; [0062]).
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 have modified the pad disclosed by Martin in embodiments of Figures 6a and 6c, to include a first and second wing extending from the pad body, similar to that disclosed by Martin in the alternate embodiment of Figures 5a and 5b, in order to provide wings or flaps which assist in securing the fluid collection device between the legs and against the anatomy of the user, as suggested by Martin in paragraph [0062].
18. With regard to claim 16, while in the embodiments disclosed in Figures 6a and 6c, Martin discloses a pad (open-cell foam border, 620) having a pad front, pad back, first pad side, and second pad side (Figs. 6a, 6c; [0069]), and a pad opening (606; not shown) formed therethrough ([0066]; [0069]), Martin fails to disclose, within the same embodiment, that the pad is disposed around an outer surface of the tray and below the top of the tray.
However, in an alternate embodiment of Figures 3A and 3B, Martin discloses a pad (sheet of absorbent fabric or other material, 322) having a pad front, pad back, first pad side, and second pad side (Figs. 3a, 3b; [0056]), and a pad opening (306; for holding 318 within) formed therethrough ([0054-0055]), wherein the pad (322) is disposed around an outer surface of the tray (300) and below the top of the tray (300; Figs. 3a, 3b; [0055-0056]).
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 have modified the pad disclosed by Martin in embodiments of Figures 6a and 6c, to be disposed around an outer surface of the tray and below the top of the tray, similar to that disclosed by Martin in the alternate embodiment of Figures 3a and 3b, in order to further support and secure the device against the anatomy of the user during use, as suggested by Martin in paragraph [0056].
19. Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Martin, as applied to claim 3 above, and further in view of Powers et al. (US PGPUB 2024/0269010 A1).
20. With regard to claim 4, Martin discloses that the pad body (610) includes a first end, a mid-point, and second end, the first portion of the pad body extending from the first end to the mid-point, the second portion of the pad body extending from the mid-point to the second end (Figs. 6a, 6c; [0068]; [0071]).
However, while the pad body (610) of Martin is fully capable of being folded about the mid-point, Martin is silent in regard to the pad body being configured to fold about the mid-point.
Powers, in the same field of endeavor, discloses a minor urinary discharge capture device (abstract; Figs. 1b, 1d, 1e) comprising a pad body (absorbent pad, 100) having a first end (top end having tab, 165), a mid-point (folding portion, 160), and second end (top end having tab, 165), the first portion of the pad body (100) extending from the first end to the mid-point (160), the second portion of the pad body extending from the mid-point (160) to the second end (Fig. 1b), wherein the pad body (100) is configured to fold about the mid-point (160; Figs. 1d, 1e; [0006]; [0007]; [0022-0023]; [0025]; [0027]).
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 have modified the pad disclosed by Martin to be configured for folding about the mid-point, similar to that disclosed by Powers, in order to provide a pad that forms a receptacle in the form of a sleeve-like pouch which can easily be slid onto and securely retain a male appendage, as suggested by Powers in paragraph [0023], while further enhancing the wicking of fluid toward the outlet, as suggested by Martin in paragraph [0071].
21. With regard to claim 5, Martin, as modified by Powers above, discloses the pad of claim 4, and Martin further discloses that the pad (modified 610) is configured to be inserted into the fluid cavity (604) and below the top of the body (600; Figs. 6a, 6c).
While the pad body (modified 610 of Martin) is fully capable of being inserted so that the mid-point (160 of Powers) of the pad body (610) is adjacent the front of the body (600; Figs. 6a, 6c) and the first end and the second end (165 of Powers) of the pad body (modified 610 of Martin) is adjacent the back (Figs. 6a, 6c), Martin and Powers fail to explicitly disclose that the mid-point of the pad body is adjacent the front of the body, the first end and the second end of the pad body is adjacent the back.
Nonetheless, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the direction of insertion of the pad disclosed by Martin in view of Powers, so that the mid-point of the pad body is adjacent the front of the body and the first and second ends of the pad body are adjacent the back, in order to properly utilize the pad, where the opening of the sleeve-like pouch pad faces the same direction as the opening in the top of the body, for the male appendage to be slid into and securely retained, as suggested by Powers in paragraph [0023]. One having ordinary skill in the art would recognize that if the pad were to be inserted in the opposite direction within the fluid cavity, the pad would no longer serve its intended purpose, as its opening between each folded end would be inaccessible.
22. Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Martin, as applied to claim 16 above, and further in view of VanMiddendorp et al. (US PGPUB 2017/0281399 A1).
23. With regard to claim 17, Martin is silent in regard to a ring formed around the outer surface of the tray and below the top of the tray; and a channel defined by the top of the tray and the ring, wherein the pad is located in the channel.
However, VanMiddendorp, in the same field of endeavor, discloses an external urine collection system (100) and related methods (abstract; Figs. 1-4, 6-9), comprising: a tray (external urinary collector, 10 defining a cup, 14) with an outlet (40); and a couplable pad (sleeve, 12); wherein a ring (male connector, 52) is formed around the outer surface of the tray (10, 14) and below the top of the tray (Fig. 6; [0042-0043]); and a channel (outer seal recess, 86) defined by the top of the tray (10, 14 or leg, 82) and the ring (52), wherein the pad (12) is located in the channel (86; [0048-0049]; [0061]; Figs. 4, 8).
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 have modified the outer surface of the tray disclosed by Martin to include a ring and channel, similar to that disclosed by VanMiddendorp, in order to provide the pad with a mating feature for forming a liquid tight seal between the pad and the body, as suggested by VanMiddendorp in paragraph [0048].
Allowable Subject Matter
24. Claims 6-8 and 14 are 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 prior art of record fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure, further comprising: a first indent formed in the first side of the top of the body, the first indent configured to receive the first wing; and a second indent formed in the second side of the top of the body, the second indent configured to receive the second wing, as required by instant claim 6. Claims 7 and 8 are indicated as allowable by virtue of their dependency on claim 6.
The prior art of record fails to reasonably disclose or suggest, alone or in combination, the unique combination of claimed structure, further comprising: a pad having a linear body with a first end, a mid-point, and a second end; a first wing extending from the first end to the mid-point and extending outward from the linear body; and a second wing extending from the mid-point to the second end and extending outward from the linear body, wherein the pad is configured to be inserted into the fluid cavity, the first wing is configured to extend over the top on the first side, and the second wing is configured to extend over the top on the second side, as required by instant claim 14.
Conclusion
25. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Block (US 5,632,736) discloses a fluid voiding apparatus with pad underneath tray top.
Crowley (US 4,799,928) discloses a urological device with an inserted winged portion.
Harvie (US PGPUB 2003/0195484 A1) discloses an automatic bladder relief system.
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781