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(s) (IDSs) submitted on 6/17/26 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Claims
Claims 1-21 are pending in the application, with claims 1 and 3-13 under consideration and claims 2 and 14-21 withdrawn. Election/Restriction
Applicant's election without traverse of claims 1 and 3-13 in the DATE Restriction Response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claims 2 and 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Allowed Subject Matter
Claims 1 and 3-8 are considered allowable over the prior art of record.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Klug (US 4846909 A). As to independent claim 1, Klug teaches a system for treating or managing urinary incontinence (male urinal device; Abstract), comprising:
a male external catheter (male urinal device ) including a sheath 12 (Fig.3-4; Col.3,ll.19-2), the sheath 12 including an interior surface (inside surface Fig.3; Col.3,ll.22-23,20; Col.4,ll.24-25) having adhesion zones of exposed adhesive 14 (Fig.3) (where adhesive is applied in a pattern, such as a bands or matrix of dots/random dispersion of adhesive on inner zone of sheath to lessen skin irritation Col.5,ll.1-9, also such as a narrow banded strip pattern of adhesive Fig.5; Col.4,ll.66-67).
However, Klug fails to teach or fairly suggest wherein: the system comprises a plurality of male external catheters of the same size; the plurality of catheters with interior surfaces having differently configured adhesion zones; and each of the plurality of male external catheters having the differently configured adhesion zones adhering to a different adhesion location on a patient’s skin. It would not have been obvious to one of skill before the effective filing date to modify the teachings of Klug to provide the above combination of elements and features, and one of skill would not have been motivated to do so, where Klug fails to teach this combination of elements and features, and does not provide any motivation to do so.
The remaining claims 3-8 are allowed as depending upon an allowed base claim.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9-13 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Klug (US 4846909 A).
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As to independent claim 9, Klug teaches a device for treating or managing urinary incontinence (male urinal device; Abstract), comprising:
a male external catheter (male urinal device ) including a sheath 12 (Fig.3-4; Col.3,ll.19-2), the sheath 12 including an interior surface (inside surface Fig.3; Col.3,ll.22-23,20; Col.4,ll.24-25) and an exterior surface (opposite interior surface; Fig.3,4), the interior surface including two zones of exposed adhesive 14 (Fig.3) separated by a zone of no exposed adhesive (where adhesive is applied in a varying pattern, such as a bands or matrix of dots/random dispersion of adhesive on inner zone of sheath to lessen skin irritation, necessarily including two zones as “including”/comprising two zones Col.5,ll.1-9, also such as a narrow banded strip pattern of adhesive Fig.5; Col.4,ll.66-67).
As to claims 10-11, X teaches wherein the zone of no exposed adhesive includes adhesive that is covered (by a release liner Col.6,ll.42; or adhesive at least partially covered by foam material Col.4,ll.17-18) OR covered by silicone (where transfer mandrel 60 is covered with silicone Col.4,ll.8,12 and then adhesive 66 coated over silicone covering Col.4,ll.15-17 and then adhesive transferred to inner surface of sheath Col.4,ll.24-25, such that at least some silicone would necessarily be present covering adhesive transferred to inner surface of sheath).
As to claim 12, X teaches wherein the zone of no exposed adhesive includes no adhesive (where adhesive is applied in a varying pattern, such as a bands or matrix of dots/random dispersion of adhesive on inner zone of sheath to lessen skin irritation, necessarily including area of no exposed adhesive as including no adhesive Col.5,ll.1-9).
As to claim 13, X teaches wherein the sheath is cylindrical (where sheath 12 Col.3,ll.19-20 formed from cylindrical mandrel Col.4,ll.5-6 forming cylindrical shape Fig.3,5); and wherein the device further comprises a funnel 24 (funnel region 24 Fig.3; Col.3,ll.65) and an interface configured to couple the device to a urine receptacle (interface as connector plug attached to stem portion 34 (Fig.3; Col.3,ll.39) of sheath to couple a catheter to a urine collection bag Col.3,ll.44-46; interface/stem portion 34 for conducting urine out of sheath Col.2,ll.47-48).
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 Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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