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 .
Status of Claims
1. Claims 1-20 are pending and currently under consideration for patentability.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on April 3, 2024 is 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,931,165 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-19 contain additional limitations requiring a wound dressing comprising an absorbent layer, the wound contact layer having a surface area that is at least as large as the absorbent layer, the absorbent layer being configured to store the wound exudate; that the sensor is configured to output a signal usable to determine a value indicative of a physiological parameter of the patient; as well as the apparatus comprising a conformal coating comprising biocompatible material and encapsulating the elastomer substrate and the sensor, and is thus more specific, in effect making the invention of patented claims 1-19 a "species" of the "generic" invention of instant claims 1-20. It has been held that the generic invention is "anticipated" by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Allowable Subject Matter
6. Claims 1-20 are allowed over prior art. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Namely, a terminal disclaimer is required to overcome the non-obviousness type double patenting rejection, as outlined above.
The following is a statement of reasons for the indication of allowable subject matter:
It is to be noted that the allowable subject matter of the parent application (16/641,960) has been incorporated in its entirety within independent claims 1 and 13 of the instant application.
The closest prior art of record are Locke et al. (US PGPUB 2014/0005618), Duesterhoft et al. (US PGPUB 2013/0274563) and Park et al. (EP 3,060,034 A1).
Locke, while disclosing a wound monitoring or treatment apparatus (abstract; Figs. 1A-D, 3, 4; [0030]), the apparatus comprising: a wound contact layer (distribution manifold, 118; Fig. 1A) configured to be positioned over a wound ([0032-0034]; Fig. 1A); a printed circuit board (board, 127 associated with dressing, 112; Fig. 1A; [0043]) coupled to the wound contact layer (118; [0044]), the circuit board (127), comprising: a conductive pathway on a first side of the circuit board (127; “one or more conductive layers” applied to 127, “to form circuit elements that may be etched into the conductive layer”; [0043]); and a sensor (sensor, 126; “may be pressure sensor comprised of a strain gauge 131 associated with a deflector 133”; strain gauge 131 may be a component printed onto 127; [0042]) mounted on the circuit board (127), the sensor (126) being configured to monitor a physiological parameter of a patient (sensor 126 can be a pressure sensor, temperature sensor, pH sensor, humidity sensor, Volatile Organic Compounds sensor, blood sensor, or growth factors sensor; [0040]; [0042-0044]), fails to reasonably disclose or suggest, alone or in combination, an elastomer substrate incorporated in or coupled to the wound contact layer, the elastomer substrate being flexible and including a first conductive pathway formed from ink on at least part of a perimeter of a first side of the elastomer substrate, the first conductive pathway being electrically coupled to an electrical ground plane for the elastomer substrate; wherein the first conductive pathway is configured to protect the sensor against an electrostatic discharge.
Duesterhoft, while disclosing appurtenances to cavity wound dressings for use in monitoring or treating a wound (abstract; Figs. 2A, 2B, 3, 12; [0009-0010]), wherein the wound dressing (cavity wound dressing, 300) comprises a flexible wound contact layer (appurtenance, 230 having substrate, 200) and an absorbent layer configured to store the wound exudate (“gauze”; [0076]; “cavity wound dressing can also be configured to absorb excess exudate from the wound region”; [0043]); and a circuit board (series of sensor units, 220; indicator, 1030; Fig. 12; [0096]) incorporated in the wound contact layer (“the sensor units, 220 are embedded within the substrate, 200”; [0076]; [0081]; [0094]), fails to reasonably disclose or suggest, alone or in combination, an elastomer substrate incorporated in or coupled to the wound contact layer, the elastomer substrate being flexible and including a first conductive pathway formed from ink on at least part of a perimeter of a first side of the elastomer substrate, the first conductive pathway being electrically coupled to an electrical ground plane for the elastomer substrate; wherein the first conductive pathway is configured to protect the sensor against an electrostatic discharge.
Park, while disclosing an electromagnetic shield structure for electronic devices (abstract), wherein the device can be used in the context of medical applications ([0022]; [0038]); addresses the same problem of protecting printed circuits from electrostatic discharge ([0010]); and discloses a circuit board (PCB, 20) comprising a first conductive pathway (surface plating portion, 33) extending around at least part of a perimeter of a first side of the circuit board (20; Fig. 5B), the first conductive pathway being electrically coupled to an electrical ground for the circuit board ([0059]), and wherein the first conductive pathway is configured to protect the components of the circuit board (20) against an electrostatic discharge ([0060-0062]), fails to reasonably disclose or suggest, alone or in combination, an elastomer substrate incorporated in or coupled to the wound contact layer, the elastomer substrate being flexible and including a first conductive pathway formed from ink on at least part of a perimeter of a first side of the elastomer substrate, the first conductive pathway being electrically coupled to an electrical ground plane for the elastomer substrate; wherein the first conductive pathway is configured to protect the sensor against an electrostatic discharge.
These nonobvious limitations provide the claimed apparatus and method of manufacture with a novel function of providing a wound contact layer with a physiological sensor that is advantageously provided on a stretchable elastomer substrate that employs a discharge path for improved safety and tolerance to environmental conditions, such as electromagnetic radiation or electrostatic discharge in wound therapy systems, as suggested by applicant in paragraph [0125] of the Pre-Grant Publication 2024/0215906.
Conclusion
7. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Whitney (US PGPUB 2007/0211398) discloses suppressing electrostatic discharge associated with radio frequency identification tags.
Hamby et al. (US PGPUB 2013/0114174) discloses electrostatic discharge protection for electrical components.
Toth et al. (US PGPUB 2015/0335288) discloses modular physiological monitoring systems.
Seo (US PGPUB 2018/0192514) discloses wearable flexible printed circuit boards.
8. 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..
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781