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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Regarding Claims 1 and 5, the claims refer to a “urine sample port”, however, the specification consistently refers to a “urine-specimen-container” or an “access portal”. Clarification is required to prevent clarity issues.
Claim Objections
Claim 1 is objected to because of the following informalities: “the urethra opening” should be amended to claim “a urethral opening” (similar to Claim 5). Appropriate correction is required.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,585,913 B2 (hereinafter, ‘913). Although the claims at issue are not identical, they are not patentably distinct from each other as evidenced below:
Claims 1 and 5. A female urinary device and method comprising a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being surrounding and isolating a urethral opening (Claim 1 of ‘912 “a urine stream collection chamber having a urine discharge opening and a urine stream collection opening, the urine stream collection opening having an edge being configured to surround and isolate a urethral opening”; an internal web that cooperates with at least a urine sample port to providing a spillway to the discharge opening (Claim 1 of ‘912 “an internal baffle that cooperates with at least a urine sample container to provide a spillway to the urine discharge opening”, where the spillway provides urine passage to a collection tank (Claim 1 of ‘912 “where the spillway provides urine passage to a collection tank”); and a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening (Claim 1 of ‘912 “the integrated interface configured for placement of the urine stream collection opening relative to the urethra opening and for interior engagement with a vaginal opening to provide substantially simultaneous passage through the menstrual fluid passage and urine stream collection chamber for passage of menstrual and urine fluid”.
Claims 2 and 6. The female urinary device of claim 1, wherein the internal web is disposed within the urine stream collection container (Claim 2 of ‘912 “wherein the internal baffle is disposed within the urine stream collection container.”).
Claims 3 and 7. The female urinary device of claim 1, wherein the discharge opening includes a fluid conduit penetrator configured for insertion into the urine sample port (Claim 3 of ‘912 “wherein the urine discharge opening includes a fluid conduit penetrator configured for insertion into the urine sample container”).
Claims 4 and 8. The female urinary device of claim 3, wherein the female urinary device further includes a cap configured to engage and close off the fluid conduit penetrator to effect a flow of urine directly out of the spillway (Claim 4 of ‘912 “further including a cap configured to engage and close off the fluid conduit penetrator to effect a flow of urine directly out of the spillway.”).
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8 of U.S. Patent No. 11,957,321 B2 (hereinafter, ‘321). Although the claims at issue are not identical, they are not patentably distinct from each other as evidenced below:
Claim 1. A female urinary device comprising a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening (Claim 1 of ‘321 “a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening”); an internal web that cooperates with at least a urine sample port to provide a spillway to the discharge opening (Claim 1 of ‘321 “an internal baffle that cooperates with at least a urine sample container to provide a spillway to the discharge opening”), where the spillway provides urine passage to a collection tank (Claim 1 of ‘321 “ where the spillway provides urine passage to a collection tank”; and a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening (Claim 1 of ‘321 “a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening”).
Claim 2. The female urinary device of claim 1, wherein the internal web is disposed within the urine stream collection container (Claim 2 of ‘321 “wherein the internal baffle is disposed within the urine stream collection container”).
Claim 3. The female urinary device of claim 1, wherein the discharge opening includes a fluid conduit penetrator configured for insertion into the urine sample port (Claim 3 of ‘321 “wherein the discharge opening includes a fluid conduit penetrator configured for insertion into the urine sample container.”).
Claim 4. The female urinary device of claim 3, wherein the female urinary device further includes a cap configured to engage and close off the fluid conduit penetrator to effect a flow of urine directly out of the spillway (Claim 4 of ‘321 “herein the female urinary device further includes a cap configured to engage and close off the fluid conduit penetrator to effect a flow of urine directly out of the spillway”).
Claim 5. A method of discharging urine with a female urinary device, the method comprising providing a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening (Claim 5 of ‘321 “providing a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening”); providing an internal web within the urine stream collection container that cooperates with at least a urine sample port to provide the spillway to the discharge opening which provides urine passage out of the urine stream collection container (Claim 6 of ‘321 “an internal baffle within the urine stream collection container that cooperates with at least a urine sample container to provide the spillway to the discharge opening which provides urine passage out of the urine stream collection container”; and effecting alignment of the stream collection opening of the female urinary device with a urethra with a probe of the female urinary device, where the probe is configured for insertion into a vaginal opening (Claim 5 of ‘321 “ffecting alignment of the stream collection opening of the female urinary device with a urethra with a probe of the female urinary device, where the probe is configured for insertion into a vaginal opening”).
Claim 6. The method of claim 5, further comprising providing a urine flow passage through the urine stream collection container to effect discharge of urine from the urine stream collection container through one or more of the discharge opening and a spillway (Claim 5 of ‘321 “ effect discharge of urine from the urine stream collection container through one or more of the discharge opening and a spillway”).
Claim 7. The method of claim 5, further comprising providing a cap that engages with and closes off the discharge opening effecting a flow of urine through the spillway and out of the urine stream collection container (Claim 7 of ‘321 “a cap that engages with and closes off the discharge opening effecting a flow of urine through the spillway and out of the urine stream collection container).
Claim 8. The method of claim 5, wherein the alignment of the stream collection opening of the female urinary device with the urethra occurs with the female standing or sitting in a reclined position, and discharge of urine from the urine stream collection container occurs with the female standing or sitting in the reclined position (Claim 8 of ‘321 “herein the alignment of the stream collection opening of the female urinary device with the urethra occurs with the female standing or sitting in a reclined position, and discharge of urine from the urine stream collection container occurs with the female standing or sitting in the reclined position.”).
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 1-8 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. Regarding Claims 1, 2 and 5, at the time the invention was filed, the inventors did not have possession of the term “internal web”. There is no mention of a specific “internal web” in the specification of the instant application at the time of filing.
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.
Claims 1-8 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.
Regarding Claims 1 and 5, the claims state the “cooperation” between the internal web and the urine sample port provide “a spillway”. While is “spillway” is introduced in the first half of the claim, the structure of an “cooperation” between an internal web and a urine sample port to “provide” a spillway makes it unclear if the spillway is a separate component/structure or if is a functional state provided by said “cooperation” (i.e., does the stated cooperation “provide” a spillway, e.g, form the spillway or is the spillway itself a separate component/structure?). For purposes of examination the indefinite limitation has been deemed to claim where the spillway is itself a separate component.
Regarding Claims 1, 2 and 5, the claims use the term “internal web”, however, the Detailed Description of the instant application uses the terms “internal-shelf”, “baffle” or “partial petition”. While “web” may be a broad synonym, the lack of this specific term in the instant specification makes it unclear what structure the term “web” implies. For purposes of examination the indefinite limitation has been deemed to claim an “internal-shelf”, “baffle” or “partial petition”
Claim 5 recites the limitation "the spillway". There is insufficient antecedent basis for this limitation in the claim.
The term sitting in a “reclined position” in claim 8 is a relative term which renders the claim indefinite. The term “reclined position” 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. For purposes of examination the indefinite limitation has been deemed to claim any sitting position.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/107602 Al to Cunningham in view of US 6428521 B1 to Droll and GB 2520970 A to Oldham.
Regarding Claim 1, Cunningham discloses a female urinary device (Abstract) comprising inter alia:
a urine stream collection container (elongate tubular channel portion 2, FIG. 1) having a discharge opening (tubular extension 13) and a stream collection opening (concave hood portion 1 with perimeter 6), the stream collection opening being configured to surround and isolate a urethral opening (p. 16, ll. 16-18 “The hood is defined by perimeters walls which are adapted to be conformable to the shape of the user's body to engage thereon in a generally leak proof contact…”);
an internal web (upward and lower extension 17a and 17b, respectively, of septum - also known as “flow barrier” throughout the document) that cooperates with at least a urine sample port (neck aperture 25) to provide a spillway (via main tubular portion 10) to the discharge opening (tubular extension 13), where the spillway provides urine passage to a collection tank (p. 13, ll. 21-22 “…the raised flow barrier will divert more of the initial urine flow from the urethra into the collection tube.”) (p. 13, ll. 8-18 “…the collection outlet preferably incorporates… a raised flow barrier projecting into the fluid conduit… tend to divert urine flow preferentially to the collection outlet by acting as a partial barrier… also extends into the collection channel…”).
(Claim 2) wherein the internal web (upward and low extensions 17a and 17b of septum, also known as “flow barrier” throughout the document) is disposed within the urine stream collection container (elongate tubular channel portion 2 which includes tube 13, contains upward and lower extensions 17a and 17b of septum; FIG. 1);
(Claim 3) wherein the discharge opening (tubular extension 13) includes a fluid conduit penetrator (engaging portion 19) configured for engagement with the urine sample port (neck aperture 25) (p. 17, ll. 17-24 “…collection bottle attachable to the collection tube 13 by means of an engaging portion 19 on tube 13…)”;
(Claim 4) wherein the female urinary device further includes a cap (engaging portion 19) configured to engage and close off the fluid conduit penetrator (p. 17, ll. 27-29 “…a neck 22 which is adapted to engage with the engaging portion 19 for use. Engagement is by push-fit, although a threaded, bayonet or other fitting may be used.”) to effect a flow of urine directly out of the spillway (p. 17, ll. 17-24 “…collection bottle attachable to the collection tube 13 by means of an engaging portion 19 on tube 13… once this bottle is full, further urine is still able to flow along the rest of the channel means to the downward extension 14 and be voided through aperture…” via via main tubular portion 10).
Cunningham discloses the claimed invention as set forth and cited above except for expressly disclosing (Claim 1) a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening and (Claim 3) where the fluid conduit penetrator configured specifically for insertion into the urine sample port.
However, Droll teaches a female urine collection device (Abstract) that includes a urine stream container (6), where the urine stream container includes a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening (nob and neck, col. 2, ll. 35-40 “…said nob of said neck will upon insertion into the vaginal opening, comfortably and securely engage the inner sphincter muscles thereof, thus securing said device both within the vagina and upon the intra-labial region in a substantially fluid-tight manner.”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the urine stream container of Cunningham to include the probe of Droll, as Droll teaches at col. 2, ll. 35-40 that the probe would have provided comfort, security, and probably a fluid-tight seal.
Furthermore, while Cunningham does not expressly disclose where the fluid conduit penetrator configured specifically for insertion into the urine sample port, Cunningham does disclose the engagement of fluid conduit penetrator and the urine sample port via push-fit, threading, bayonets or other fittings to provide a suitable attachment between the fluid conduit penetrator and the urine sample port (p. 17, l. 17 to p. 18, l. 1). Oldham teaches a female urine collection device (Abstract) that includes a urine stream container (205), where the urine stream container includes a conduit penetrator (203) inserted into a urine sample portion (space within 202) (FIG. 3) via a threading (301). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the threading of Cunningham to be arranged in such a manner that the treading interacts in a manner that the conduit penetrator is inserted into the urine sample port for thread interaction, because Cunningham already discloses threading is a suitable manner of attachment (p. 17, l. 17 to p. 18, l. 1) and placing the conduit penetrator within the urine sample port would be one of a plurality ways a skilled artisan would connect two components.
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2005/107602 Al to Cunningham in view of US 6428521 B1 to Droll and GB 2520970 A to Oldham.
Regarding Claim 5, Cunningham discloses a method of discharging urine with a female urinary device (Abstract), the method comprising inter alia:
providing a urine stream collection container (elongate tubular channel portion 2, FIG. 1) having a discharge opening (tubular extension 13) and a stream collection opening (concave hood portion 1 with perimeter 6), the stream collection opening being configured to surround and isolate a urethral opening (p. 16, ll. 16-18 “The hood is defined by perimeters walls which are adapted to be conformable to the shape of the user's body to engage thereon in a generally leak proof contact…”);
providing an internal web (upward and lower extension 17a and 17b, respectively, of septum - also known as “flow barrier” throughout the document) within the urine stream collection container (elongate tubular channel portion 2 which includes tube 13, contains upward and lower extensions 17a and 17b of septum; FIG. 1) that cooperates with at least a urine sample port (neck aperture 25) to provide the spillway to the discharge opening (tubular extension 13) which provides urine passage out of the urine stream collection container (p. 13, ll. 21-22 “…the raised flow barrier will divert more of the initial urine flow from the urethra into the collection tube.”) (p. 13, ll. 8-18 “…the collection outlet preferably incorporates… a raised flow barrier projecting into the fluid conduit… tend to divert urine flow preferentially to the collection outlet by acting as a partial barrier… also extends into the collection channel…”).
(Claim 6) providing a urine flow passage through the urine stream collection container (elongate tubular channel portion 2) to effect discharge of urine from the urine stream collection container through one or more of the discharge opening (tubular extension 13) and a spillway (via main tubular portion 10) (p. 13, ll. 21-22 “…the raised flow barrier will divert more of the initial urine flow from the urethra into the collection tube.”) (p. 13, ll. 8-18 “…the collection outlet preferably incorporates… a raised flow barrier projecting into the fluid conduit… tend to divert urine flow preferentially to the collection outlet by acting as a partial barrier… also extends into the collection channel…”);
(Claim 7) a cap (engaging portion 19) that engages with and closes off the discharge opening effecting a flow of urine through the spillway and out of the urine stream collection container (p. 17, ll. 27-29 “…a neck 22 which is adapted to engage with the engaging portion 19 for use. Engagement is by push-fit, although a threaded, bayonet or other fitting may be used.”) to effect a flow of urine directly out of the spillway (p. 17, ll. 17-24 “…collection bottle attachable to the collection tube 13 by means of an engaging portion 19 on tube 13… once this bottle is full, further urine is still able to flow along the rest of the channel means to the downward extension 14 and be voided through aperture…” via via main tubular portion 10); and
(Claim 8) discharge of urine from the urine stream collection container occurs with the female standing or sitting in the reclined position (p. 12, ll. 14-16 “A urine sample collection container can then be arranged to be coupled to the collection outlet to be substantially vertical when the apparatus is in use by a female sitting down”).
Cunningham discloses the claimed invention as set forth and cited above except for expressly disclosing (Claim 1) effecting alignment of the stream collection opening of the female urinary device with a urethra with a probe of the female urinary device, where the probe is configured for insertion into a vaginal opening and (Claim 8) wherein the alignment of the stream collection opening of the female urinary device with the urethra occurs with the female standing or sitting in a reclined position.
However, Droll teaches a female urine collection device (Abstract) that includes a urine stream container (6), where the urine stream container includes a probe configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethra opening (nob and neck, col. 2, ll. 35-40 “…said nob of said neck will upon insertion into the vaginal opening, comfortably and securely engage the inner sphincter muscles thereof, thus securing said device both within the vagina and upon the intra-labial region in a substantially fluid-tight manner.”). Droll further teaches where the device can be employed with standing, seated, as well as reclining or prone patients (col. 2, ll. 58-64). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the urine stream container of Cunningham to include the probe of Droll, as Droll teaches at col. 2, ll. 35-40 that the probe would have provided comfort, security, and a fluid-tight seal while that can be applied sitting or standing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791