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 the Claims
Claims 21-40 are pending in the application.
Allowable Subject Matter
Claims 21-40 are considered allowable over the prior art of record, subject to the double patenting rejection(s) presented below.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach or fairly suggest the present claims of Applicants. The closest prior art of record is Millot (US 6171289 A).
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As to independent claims 21, 28, and 35, Millot teaches (claim 35) an ostomy system (Abstract), comprising an ostomy appliance (device 1 Fig.1; Col.3,ll.19-38), the ostomy appliance comprising (claims 21,28) an electrode assembly for an ostomy or medical device (Abstract, Fig.2-3)), the electrode assembly comprising:, a substrate (first adhesive layer 11), with a distal side, a proximal side, and a center point opening 8 [Fig.2-3; Col.3,ll.31-38]; Fig.3 [Col.3,ll.35-36] configured to be skin facing when the ostomy appliance is for attachment of the base plate 5 to a skin surface of a user [Col.2,ll.21-23]; the adhesive layer 11 having a stomal opening 8 [passage 8, Fig.2-3 Col.3,ll.23-24];
a plurality of electrodes [one or more sets of electrodes as multiple pairs of 1st, 2nd, 3rd, electrodes 17 as: 1st 17; 2nd 17; 3rd 17; etc., with corresponding grounding electrode 1st 18, 2nd 18, 3rd 18, etc.; as: 1st 17/18; 2nd 17/18; 3rd 17/18, etc. Col.3, line 41] arranged on a distal side (upper) of the substrate first adhesive layer 11 Fig.3; the plurality of electrodes comprising:
a first electrode 17 [as first 17 (as at least one electrode Col.3, line 41; Fig.2-3; Col.3,ll.41-50] located at least in part in a first region of the base plate 5 [as a second radial distance from the stoma-receiving opening 8 and adjacent electrode 18, Fig.2-3 Col.3,ll.43-45]; and
a second electrode 17 [as second 17 (as at least one Col.3, line 41); Col.3,ll.41-50] located at least in part in a second region of the base plate 5 [as a third radial distance from the stoma-receiving opening 8 and adjacent electrode 18, Fig.2-3 Col.3,ll.43-45];
wherein:
the first electrode 17 and the second electrode 18 cooperate to form a first sensing zone (as portion of substrate/adhesive layer 11 between 1st electrode 17 and second electrode 18 Fig.2-3);
a monitor interface 19 arranged on the distal side (top Fig.2) of the substrate 11 for electrically connecting the plurality of electrodes 17, 18 with a monitor device 19 [where monitor interface as at least a portion of circuit 19 Col.3,ll.56-62]; and
a monitor device 27 (voltage comparator 27; Fig.4; Col.4,ll.54) configured to electrically couple the monitor device 27and the plurality of electrodes 17,18 of the ostomy appliance (Fig.4; Col.4,ll.54-58)
However, Millot fails to teach or fairly suggest the combination of:
the plurality of electrodes are on the proximal side of the substrate;
the first electrode and a common electrode cooperate to form a first sensing zone of the electrode assembly; and
the second electrode and a common electrode cooperate to form a second sensing zone of the electrode assembly;
the monitor interface including a first terminal element for the first electrode, a second terminal element for the second electrode, and a common terminal element for a common electrode; and a monitor device configured to removably couple with the monitor interface of the ostomy appliance.
It would not have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Millot to provide the above combination of elements and features, and one of skill would not have been motivated to do so, where Millot fails to teach or suggest the combination of the these elements and features, and does not provide any motivation to do so.
The remaining claims are considered allowable over the prior art of record as depending upon an allowable base claim.
Double Patenting
Non Statutory Obviousness Type 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-40 are rejected on the ground of nonstatutory double patenting over at least claims 1-2, 6, and 13-14 of US Patent No. 12,232,999 B2 (‘999) (Issued from parent application 18/113633).
As to Claims 21-40, claims 1-2, 6, and 13-14 of ‘999 teach or suggest the claimed leak sensing device, as follows:
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The differences between present claims and the claims of ‘999 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, the ‘999 claims teach or suggest each element of the current claims, as listed above, such that the present claims would have been obvious over the ‘999 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘999 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
No Obviousness Type Double Patenting
It is noted that the claims of issued US patents: 10,849,781 B2 (‘781) (Issued from parent application 16/112804); and 11,612,509 B2 (‘509) (Issued from parent application 17/023407) fail to teach or fairly suggest the present claims of applicants, e.g., where the claims fail to teach or fairly suggest the combination of elements as presented above for the prior art. Thus, the claims of these patents do not render obvious the present claims under Obviousness-Type Double Patenting.
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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