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 .
This Office action is in response to communications filed February 6, 2026.
Election/Restrictions
1. Applicant’s election without traverse of Group I, claims 2-17, in the reply filed on February 6, 2026 is acknowledged. Claims 19-21, which were previously a part of nonelected Group II, are now considered as being within elected Group I to be examined herein, as claim 19 has been amended to depend from independent claim 2. Claims 18, 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
2. Claims 2-17, 19-21 and 24 are pending and currently under consideration for patentability.
Claim 24 is newly presented as of the February 6, 2026 claim amendment.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on October 3, 2023, December 18, 2023, January 31, 2025 and February 6, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Double Patenting
4. 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.
5. Claims 2-17, 19-21 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,806,266. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-26 contain additional limitations requiring a fluid permeable support disposed at least partially within the fluid impermeable casing, wherein the fluid reservoir is defined between the fluid permeable support and the fluid impermeable casing; and a tube having a first end in fluid communication with the fluid reservoir and extending behind at least the portion of the fluid permeable support and the portion of the fluid permeable membrane and extending through the fluid outlet to a second, fluid discharge end, and is thus more specific, in effect making the invention of patented claims 1-26 a "species" of the "generic" invention of instant claims 2-17, 19-21 and 24. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
6. Claims 2-17, 19-21 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,324,765. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-30 contain additional limitations requiring an outlet in fluid communication with the interior volume of the fluid collection device; and a generally tube disposed in the interior volume of the fluid collection device and in fluid communication with the outlet, wherein the elongated member is separate and distinct from the elongated tube, and is thus more specific, in effect making the invention of patented claims 1-30 a "species" of the "generic" invention of instant claims 2-17, 19-21 and 24. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim Objections
7. Claim 2 is objected to because of the following informalities:
Lines 5-6 of claim 2 recite “…separate from the fluid impermeable layer, and the fluid permeable body, wherein…”; however, the first comma appears to be inappropriate and hinders the interpretation of the claim. Accordingly, this limitation should read as ---…separate from the fluid impermeable layer[[---
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.
8. Claims 12 and 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.
The term “about” in claims 12 and 13 is a relative term which renders the claim indefinite. The term “about” 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. Accordingly, the angle of curvature (claim 12) and radius of curvature (claim 13) are rendered indefinite by the use of the term “about”; and for the purpose of examination, the angle of curvature and radius of curvature will be treated with a reasonable degree of error (i.e., +/- 100 and +/- 2 inches, respectively).
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.
9. Claim(s) 2-4, 6-14, 16, 17, 19-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kuntz (US 4,747,166) in view of Rushlander et al. (US PGPUB 2007/0137718 A1).
10. With regard to claim 2, Kuntz discloses a fluid collection apparatus (fluid aspiration system, 10; abstract; Figs. 1, 2, 3), comprising: a fluid impermeable layer (lower backing layer, 36a) at least partially defining a sump (hollow bore, 22a; see Fig. 2), a chamber (within 36a, occupied by core of urine absorptive material, 34), a fluid outlet (tubing connector, 24), and an opening (for reception of urine, defined by upper facing layer, 28 and peripheral cushioning ring, 26) between the sump (26a) and the fluid outlet (24; col. 3, lines 35-57); a fluid permeable body (34) disposed at least partially within the chamber (Figs. 1-3; col. 3, line 58 – col. 4, line 32); and a tube (18a) including an extended perforated end portion (30), separate from the fluid impermeable layer (36a) and the fluid permeable body (34; col. 3, line 58 – col. 4, line 17).
However, Kuntz is silent in regard to a shape-retaining element separate from the fluid impermeable layer and the fluid permeable body, wherein the fluid impermeable layer and the fluid permeable body are configurable from a first configuration to a second configuration prior to use of the fluid collection apparatus by shaping the shape-retaining element, wherein the first configuration exhibits a straight shape and the second configuration exhibits a curved shape.
Rushlander, in the analogous field of medical device tubing ([0003]), discloses bendable position-retaining tubing (20; abstract; Figs. 1-2), comprising a cylindrical conduit (22) and a shape-retaining element (flexible wire, 26), wherein the cylindrical conduit (22) is configurable from a first configuration (Fig. 1) to a second configuration (Fig. 2) prior to use of the fluid collection apparatus by shaping the shape-retaining element (26; “after an external manual force, F”), wherein the first configuration exhibits a straight shape (Fig. 1) and the second configuration exhibits a curved shape (Fig. 2; [0053-0054]).
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 extended perforated end of the tube disclosed by Kuntz to incorporate a shape-retaining element, similar to that disclosed by Rushlander, in order to provide a bendable position-retaining and/or repositionable, yet shape-retaining, tubing; allowing the fluid collection device to be positioned and repositioned without returning to its original shape, as suggested by Rushlander in paragraphs [0002] and [0053].
11. With regard to claim 3, while Kuntz discloses that the top surface of the fluid impermeable layer (36) may include a peripheral cushioning ring (26) surrounding the opening (defined by 26, 28) positioned to contact a vaginal region of an individual (Figs. 1-3; col. 3, lines 45-57), Kuntz and Rushlander fail to explicitly disclose that the top surface of the fluid impermeable layer is positioned to contact a vaginal region of an individual.
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 fluid impermeable layer disclosed by Kuntz in view of Rushlander to either form the peripheral cushioning ring integrally with the fluid impermeable layer, or omit the peripheral cushioning ring entirely, since an embodiment omitting the peripheral cushioning ring is not precluded and would result in the top surface of the fluid impermeable layer is positioned to contact a vaginal region of an individual; and one having ordinary skill in the art would recognize that by positioning the top surface of the fluid impermeable layer to contact a vaginal region of an individual, leakage will be prevented while also maintaining a stronger seal for suction during use.
12. With regard to claim 4, Kuntz discloses that the opening (defined by 28, 26) defined by the fluid impermeable layer (36) is elongated (see Fig. 1).
13, With regard to claim 6, Kuntz discloses that the permeable body (34) includes a tubular shape (24 having central bore, 22 takes on a rectangular tube shape; Figs. 1, 4; col. 3, line 58 – col. 4, line 32).
14. With regard to claim 7, Kuntz discloses that the sump (22a) is sized such that the reservoir (within 36) forms a portion of a passageway (central bore, 22 and extended perforated end of the tube, 30 as modified above) for fluid through the fluid permeable body (Figs. 1-3; col. 3, line 58 – col. 4, line 32).
15. With regard to claims 8 and 9, while the apparatus disclosed by Kuntz as modified by Rushlander above discloses the shape-retaining element of claim 2, the combination is silent in regard to the shape-retaining element being imbedded in the fluid impermeable layer (claim 8), or attached to an outer surface of the fluid impermeable layer (claim 9).
However, Rushlander discloses that shape-retaining bending of the tube (22; Figs. 1, 2) is imparted by imbedding, or externally inserting, the shape-retaining element (26) into an overmolded second polymer (24) forming a corrugated external wall of the final tubing product ([0053]).
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 shape-retaining element disclosed by Kuntz in view of Rushlander to be imbedded in, or externally inserted into, the fluid impermeable layer, similar to the external wall of the tubing disclosed by Rushlander, in order to provide the fluid collection apparatus with physical characteristics that allow it to retain a nonlinear shape without returning to its original position, as suggested by Rushlander in paragraphs [0002] and [0053].
16. With regard to claim 10, the apparatus disclosed by Kuntz as modified by Rushlander above discloses the shape-retaining element of claim 2, and Kuntz further discloses that the shape-retaining element (30 as modified by 26 of Rushlander) is disposed between the fluid impermeable layer (36) and the fluid permeable body (34; Figs. 1, 2; col. 3, line 58 – col. 4, line 16).
17. With regard to claim 11, the apparatus disclosed by Kuntz as modified by Rushlander above discloses the shape-retaining element of claim 2, and Kuntz further discloses that the shape-retaining element (modified 30) includes a spine that divides an inner volume of the permeable body (34) into two or more chambers (first chamber of fluid within perforated tube, and second chamber of fluid within 34 flowing exterior to the perforated tube but within 22; Figs. 1-3; col. 3, lines 60-65).
18. With regard to claims 12 and 13, while the inclusion of the shape-retaining element (26 of Rushlander) in Kuntz allows for the fluid impermeable layer (36) to take on any desired angle/radius of curvature ([0053] of Rushlander), Kuntz and Rushlander are silent in regard to the fluid impermeable layer including an angle of curvature of about 600; or that the fluid impermeable layer includes a radius of curvature between about 6 inches and about 10 inches.
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 desired angle and radius of curvature of the fluid impermeable layer disclosed by Kuntz in view of Rushlander to be about 600 and between about 6 inches and about 10 inches, respectively, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.In re Aller, 105 USPQ 233. Further, one having ordinary skill in the art would recognize that by determining an optimal angle/radius of curvature will allow for a snug fit to the user, while also ensuring proper seal for vacuum.
19. With regard to claim 14, Kuntz discloses that the fluid permeable body (34) includes a membrane strut (upper facing layer, 28a-c) that extends across the opening (Figs. 1-4; col. 4, lines 11-16 and lines 35-47).
20. With regard to claims 16, 17 and 24, the apparatus disclosed by Kuntz as modified by Rushlander above discloses the shape-retaining element of claim 2, and Kuntz further discloses a tube (vacuum tube, 18) having a first end (30 as modified by Rushlander) in fluid communication with the sump (22a; Figs. 1, 2) and extending behind at least the portion of the fluid permeable body (34) and extending through the fluid outlet (24) to a second, fluid discharge end (Figs. 1, 2; col. 3, line 35 – col. 4, line 15); wherein the tube (at 30) includes a reinforced spine (second flexible wire, 26a; see Figs. 3, 4 and [0055] of Rushlander); and wherein the shape-retaining element (26 of Rushlander) forms part of the tube (as seen by 26 forming part of tube 22 of Rushlander).
21. With regard to claims 18-20, Kuntz further discloses a discharge line (18) fluidically coupled to an external receptacle (urine collection vessel, 14; Fig. 1); and a vacuum source (vacuum pump, 16) coupled to the external receptacle (14; Fig. 1); wherein the external receptacle (14) includes a sealed container (col. 3, lines 35-55).
22. Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Rushlander, as applied to claim 2 above, and further in view of Sanchez (US 8,287,508).
23. With regard to claim 5, Kuntz and Rushlander are silent in regard to the permeable body including a porous glass tubular container defining frits.
However, within the same field of endeavor, Sanchez discloses using moisture-wicking article wrapped over openings in an elongated urine collecting container for drawing urine from a region surrounding a urethral opening (abstract; Figs. 1-3) wherein a permeable body is provided including a porous glass tubular container defining frits (col. 3, lines 38-44; col. 6, lines 38-40).
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 permeable body disclosed by Kuntz in view of Rushlander to include a porous glass tubular container defining frits, similar to that disclosed by Sanchez, in order to take advantage of the known moisture-wicking functionality of such material, as suggested by Sanchez in column 6, lines 38-40.
24. Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kuntz in view of Rushlander, as applied to claim 17 above, and further in view of Keane (US 3,349,768).
25. With regard to claim 15, Kuntz and Rushlander are silent in regard to the first end of the tube comprising a beveled intake.
However, within the same field of endeavor, Keane discloses a portable urinal provided with suction means for use in micturition (abstract; Figs. 1-3), wherein a tube (5) is provided, extending behind a permeable body (through ducts, 2 of suction head, 1) and into a cavity (3), and the first end of the tube (3) comprises a beveled intake (see Fig. 2; col. 2, lines 18-23).
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 first end of the tube disclosed by Kuntz in view of Rushlander to include a beveled intake, similar to that disclosed by Keane, in order to prevent any possibility of the end of the tube being closed against the wall of the cavity, as suggested by Keane in column 2, lines 18-23.
Conclusion
26. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lawrence et al. (US 5,678,564) discloses a liquid removal system.
Martin (US 4,631,061) discloses an automatic urine detecting, collecting and storing device.
Mombrinie (US 7,901,389) discloses a liquid removal apparatus for surgical procedures.
Tsai et al. (US 8,303,554) discloses an aspiration system and body interface device.
27. 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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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