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 .
Status of Claims
As directed by the amendment filed on 16 January 2025: claim(s) 2 & 19 have been amended, claim(s) 1 have been cancelled, claim(s) 2-21 have been added. Thus, claims 2-21 are presently pending.
Claim Objections
Claim 6 is objected to because of the following informalities:
“the at least one valve is extends from a portion of the at least one extender” should be --the at least one valve [[is]] extends from a portion of the at least one extender--.
Appropriate correction is required.
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 extender must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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.
Claims 2, 5-8, and 18-19 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. The “at least one extender” is not described in the instant Specification. It is unclear whether the “at least one extender” is the same as the “bladder” or another element of the invention.
The remaining claim(s) is/are rejected due to dependency upon a rejected claim.
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) 2-9, 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US 20180228642 A1) in view of Hansen et al. (US 20100137821 A1).
Regarding Claim 2, Davis discloses a fluid collection assembly ("urine collection device 10" [0052]; FIG. 1), comprising:
a fluid impermeable barrier defining a chamber ("a cavity defined by the external covering 20" [0052]; FIG. 1), at least one opening ("longitudinally extending fenestration 30 is disposed in a portion of the external covering 20" [0052]; FIG. 3), and at least one fluid outlet ("tube 32 for removing the urine from the device 10" [0053]; FIG. 2), the fluid impermeable barrier including at least one proximal surface defining the at least one opening and at least one distal surface opposite the proximal surface ([0052-0054]; FIG. 1);
at least one porous material disposed in the chamber ("one or more fluid collection layers that evacuate, draw through or absorb the voided urine" [0056]); and
at least one inflation device ("one or more bellows" [0064]) including:
at least one extender ("shape retaining element" [0062]) extending from the fluid impermeable barrier ("shape retaining element is provided in the center of the device 10, and the tube 32 is provided next to the shape retaining element, outside of the device 10" [0066]; FIG. 7); and
configured to selectively permit at least one inflation fluid to flow into and out of the at least one extender to switch the at least one extender between the first state and at least the second state ("Air flow could inflate or deflate bellows or segments that would conform the device 10 to the anatomy of the user" [0064]).
Davis fails to specify at least one valve, the at least one valve including a two-way valve. However, Hansen teaches “an sealed chamber for use with an appliance for irrigation and/or drainage” ([0050]) comprising at least one valve ("valve" [0053]), the at least one valve including a two-way valve ("it is possible to connect an inflation device, such as a pump, inflate the substance and remove the device, without the substance escaping out of the valve. By pushing the valves sides together, it is possible to empty the inflated substances through the same connection" [0053]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Davis to incorporate the teachings of Hansen to suitably inflate and deflate the device via the same valve ([0053]).
Regarding Claims 3-5, 7-9, 14-15, & 17, Davis discloses the fluid impermeable barrier (20) exhibits a generally cylindrical shape ("cylindrical body as shown in the embodiments of FIGS. 1-7" [0097]; FIG. 1); the at least one porous material includes a wicking material that exhibits substantially no absorption of bodily fluids ("one or both of these layers are moisture wicking layers that evacuate the discharged fluid away from the body (e.g. by wicking or capillary effect)" [0056]); the at least one extender is positioned external to the chamber and coupled to the at least one distal surface of the fluid impermeable barrier ("shape retaining element is provided in the center of the device 10, and the tube 32 is provided next to the shape retaining element, outside of the device 10, and so on" [0066]; "shape retaining element 90 provided in the form of a core integrated into the backing" [0099]); the at least one extender includes one or more walls defining at least one interior region, the at least one extender configured to switch between a first state and at least a second state, wherein a volume of the at least one interior region is greater when the bladder is in the second state than when the bladder is in the first state ("Air flow could inflate or deflate bellows or segments that would conform the device 10 to the anatomy of the user" [0064-0065]; FIG. 11D); the inflation device includes a single extender ("a shape retaining element" [0062]) and the at least one extender defines a single interior region ([0064]; FIG. 11D); switching the bladder between the first state and the second state changes a curvature of at least a portion of the fluid impermeable barrier ("Air flow could inflate or deflate bellows or segments that would conform the device 10 to the anatomy of the user" [0064]); the fluid impermeable barrier includes at least one lateral surface extending between the at least one proximal surface and the at least one distal surface (see FIG. 1), and wherein the at least one inflation device is not adjacent to the at least one lateral surface or the at least one proximal surface ("shape retaining element is provided in the center of the device 10" [0066]); the fluid impermeable barrier includes at least one lateral surface extending between the at least one proximal surface and the at least one distal surface (see FIG. 1), and wherein the at least one inflation device is adjacent to the at least one lateral surface ("shape retaining element 90 is incorporated into the external covering 20" [0099]); at least a portion of the at least one extender extends into the chamber ("shape retaining element is provided in the center of the device 10" [0066]).
Regarding Claim 6, Davis fails to specify the at least one valve extends from a portion of the at least one extender opposite the at least one distal surface of the fluid impermeable barrier. However, Hansen teaches the at least one valve extends from a portion of the at least one extender opposite the at least one distal surface of the fluid impermeable barrier ("wall (3) of the appliance extends into a collecting bag (4) with a valve for removal of effluent" [0069]). Therefore, it would have been obvious to modify the device of Davis to incorporate the teachings of Hansen to suitably inflate and deflate the device via the same valve ([0053]).
Regarding Claim 16, Davis/Hansen fails to specify the at least one inflation device includes a plurality of inflation devices adjacent to the at least one distal surface. However, the court has 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). Therefore, it would be obvious to modify Davis/Hansen to arrive at the claimed invention by duplicating the extender to suitably “conform the device 10 to the anatomy of the user” ([0064]).
Regarding Claim 18, Davis/Hansen fails to specify a maximum width of the fluid collection assembly is unchanged when switching the at least one extender between the first state and the second state. However, Davis discloses the device is bent “into a shape having a curvature 32a conforming to the anatomical contours of a typical user” ([0062]). The court has held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984). In this case, a device having the claimed relative dimensions would not perform differently than the prior art device. Therefore, it would be obvious to modify Davis/Hansen to arrive at the claimed invention by making a maximum width of the fluid collection assembly is unchanged when switching the at least one extender between the first state and the second state “to limit discomfort to the user” ([0057]).
Regarding Claim 19, Davis discloses a system, comprising: a fluid collection assembly ("urine collection device 10" [0052]; FIG. 1) including:
a fluid impermeable barrier defining a chamber ("a cavity defined by the external covering 20" [0052]; FIG. 1), at least one opening ("longitudinally extending fenestration 30 is disposed in a portion of the external covering 20" [0052]; FIG. 3), and at least one fluid outlet ("tube 32 for removing the urine from the device 10" [0053]; FIG. 2), the fluid impermeable barrier including at least one proximal surface defining the at least one opening and at least one distal surface opposite the proximal surface ([0052-0054]; FIG. 1);
at least one porous material disposed in the chamber ("one or more fluid collection layers that evacuate, draw through or absorb the voided urine" [0056]); and
at least one inflation device ("one or more bellows" [0064]) including:
at least one extender ("shape retaining element" [0062]) extending from the fluid impermeable barrier ("shape retaining element is provided in the center of the device 10, and the tube 32 is provided next to the shape retaining element, outside of the device 10" [0066]; FIG. 7); and
configured to selectively permit at least one inflation fluid to flow into and out of the extender to switch the extender between the first state and at least the second state ("Air flow could inflate or deflate bellows or segments that would conform the device 10 to the anatomy of the user" [0064]), and
a fluid storage container ("fluid collection reservoir 204" [0079]; FIG. 32); and a vacuum source ("air pump or vacuum source 210" [0107]; FIG. 32); wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other via one or more conduits ("discharge tube line 202 coupled to the tube 32 of the collection device 10 and disposed between the tube 32 and external collection reservoir 204" [0107]; FIG. 32).
Davis fails to specify at least one valve, the at least one valve including a two-way valve. However, Hansen teaches “an sealed chamber for use with an appliance for irrigation and/or drainage” ([0050]) comprising at least one valve ("valve" [0053]), the at least one valve including a two-way valve ("it is possible to connect an inflation device, such as a pump, inflate the substance and remove the device, without the substance escaping out of the valve. By pushing the valves sides together, it is possible to empty the inflated substances through the same connection" [0053]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Davis to incorporate the teachings of Hansen to suitably inflate and deflate the device via the same valve ([0053]).
Regarding Claim 20, Davis fails to specify at least one pump in fluid communication with the at least one valve, the at least one pump configured to provide at least one inflation fluid to switch the bladder from the first state to the second state. However, Hansen teaches at least one pump in fluid communication with the at least one valve, the at least one pump configured to provide at least one inflation fluid to switch the bladder from the first state to the second state ("connect an inflation device, such as a pump" [0053]). Therefore, it would have been obvious to modify the device of Davis to incorporate the teachings of Hansen to suitably inflate and deflate the device ([0053]).
Allowable Subject Matter
Claims 10-13, & 21 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:
Regarding Claims 10-13, none of the cited references discloses or suggests the at least one inflation device includes a first region adjacent to the at least one distal surface of the fluid impermeable barrier and a second region opposite the first region, and wherein an expansion rate of the first region is less than an expansion rate of the second region; the at least one inflation device includes at least one additional layer attached to at least a portion of the first region; at least a portion of the first region exhibits a thickness that is greater than an opposing portion of the second region; at least a portion of the first region is directly attached to the fluid impermeable barrier. Kassman (US 6569083 B1) teaches an inflatable condom wherein “the thickness of the microtubules 6 may be varied around their perimeter with the result that thinner regions of the microtubules will expand under inflation more than relatively thicker regions of the microtubules” (col. 9 ln. 12-16). It would not have been obvious to combine Kassman due to their differing fields of endeavor. Kassman further does not specify a maximum width of the fluid collection assembly is unchanged when switching the at least one extender between the first state and the second state. Niazi (US 20180289934 A1) and Plata (US 20110306825 A1) both teach a inflatable balloon that affects the curvature of the device ([0006] & [0028] respectively). However, neither teaches a fluid impermeable barrier layer nor are in the same urine/liquid disposal field as the instant invention and the cited references. Therefore, it would not have been obvious to combine teachings of Niazi and Plata with the cited references.
Regarding Claim 21, none of the cited references discloses or suggests one or more sensors configured to detect contact between the fluid collection assembly and a patient, the one or more sensors communicably coupled to a control electric circuitry, the control electric circuitry configured to control the pump responsive to receiving one or more signal from the one or more sensors. Harvie (US 20050119630 A1) teaches “an automatic or semi-automatic bladder relief system” comprising “an inflatable urine collection means that may be deflated after use” (Abstract). However, Harvie’s device does not include contact sensors and requires manual inflation ("inflated by the user prior to urination by activation of the Air Pump" [0136]). Hu et al. (US 20100174250 A1) teaches a fluid collection assembly ([0073]) comprising pressure sensors "pressure sensors, volume indicators and the like to help the user to consistently apply the same degree of inflation" ([0078]). However, Hu does not specify that the sensors are configured to detect contact between the fluid collection assembly and an patient.
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.
Claims 2, 4-5, 7, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12156792 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 12156792 discloses the limitations of instant claims as follows:
Instant Application Claims
U.S. Patent No. US 12156792 B2 Claims
2, 4-5, 7, 9
1
16
11
19
16
20
17
21
18
Claims 2 & 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 18 of U.S. Patent No. US 12048643 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 12156792 discloses the limitations of instant claims as follows:
Instant Application Claims
U.S. Patent No. US 12156792 B2 Claims
2
1
19
18
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights