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
Claims 48-67 are pending in the application.
Claims 48-67 are examined on the merits.
Priority
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
The information disclosure statement(s) (IDS) submitted on 05/21/2024 and 12/02/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Claim Objections
Claim(s) 53 and 61 is/are objected to because of the following informalities:
Claim 53, “first and second conductive traces connected to the LED the first and second conductive traces configured to provide power and ground connections to the LED” should read -- first and second conductive traces connected to the LED, the first and second conductive traces configured to provide power and ground connections to the LED --.
Claim 61, “first and second conductive traces connected to the LED the first and second conductive traces configured to provide power and ground connections to the LED” should read -- first and second conductive traces connected to the LED, the first and second conductive traces configured to provide power and ground connections to the LED --.
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.
Claim(s) 48-58 and 60-66 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 3, 8-10, 12, 49, and 61-65 of U.S. Patent No. 11957545.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 8-10, 12, 49, and 61-65 of the reference patent contain a wound dressing comprising a substantially flexible substrate covered by a conformal coating; and one or more sensors supported by the substantially flexible substrate and configured to measure characteristics of a wound, the one or more sensors comprising: an optical sensor covered by a substantially non-stretchable coating, the optical sensor configured to monitor at least one of the wound or a periwound; and a light emitting diode (LED) covered by the substantially non-stretchable coating, and wherein covering the optical sensor and the LED with the substantially non- stretchable coating prevents formation of localized stress on the optical sensor and the LED.
Examiner notes that the scope of the claimed “light emitting diode (LED) encompasses “white light emitting diode (LED)”. Thus, the scope of the claimed limitations in the reference patent encompasses the claimed limitations in the instant application.
Regarding instant claim 48, claim 3 of the reference patent discloses all of the limitations of instant claim 48.
Regarding instant claim 49, claim 8 of the reference patent discloses all of the limitations of instant claim 49.
Regarding instant claim 50, claim 9 of the reference patent discloses all of the limitations of instant claim 50.
Regarding instant claim 51, claim 10 of the reference patent discloses all of the limitations of instant claim 51.
Regarding instant claim 52, claim 12 of the reference patent discloses all of the limitations of instant claim 52.
Regarding instant claim 53, claim 49 of the reference patent discloses all of the limitations of instant claim 53.
Regarding instant claim 54, claim 61 of the reference patent discloses all of the limitations of instant claim 54.
Regarding instant claim 55, claim 62 of the reference patent discloses all of the limitations of instant claim 55.
Regarding instant claim 56, claim 63 of the reference patent discloses all of the limitations of instant claim 56.
Regarding instant claim 57, claim 64 of the reference patent discloses all of the limitations of instant claim 57.
Regarding instant claim 58, claim 65 of the reference patent discloses all of the limitations of instant claim 58.
Regarding instant claim 60, claim 1 of the reference patent discloses all of the limitations of instant claim 60.
Regarding instant claim 61, claim 49 of the reference patent discloses all of the limitations of instant claim 61.
Regarding instant claim 62, claim 61 of the reference patent discloses all of the limitations of instant claim 62.
Regarding instant claim 63, claim 62 of the reference patent discloses all of the limitations of instant claim 63.
Regarding instant claim 64, claim 63 of the reference patent discloses all of the limitations of instant claim 64.
Regarding instant claim 65, claim 64 of the reference patent discloses all of the limitations of instant claim 65.
Regarding instant claim 66, claim 65 of the reference patent discloses all of the limitations of instant claim 66.
Allowable Subject Matter
Claims 48-67 contain allowable subject matter which is allowable over prior art; however, claims 48-67 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8-10, 12, 49, and 61-65 of U.S. Patent No. 11957545 (see Double Patenting section above). In order to overcome the nonstatutory double patenting rejection, Applicant's reply must include a terminal disclaimer over U.S. Patent No. 11957545.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record is Quintanar (US PGPUB 20190076298 – of record), Brownhill (US PGPUB 20190290496 – of record), Cheng (US PGPUB 20020058865 – of record), Duesterhoft (US PGPUB 20130274630), Dobriyal (US PGPUB 20180070456), and Ding (US PGPUB 20160038083 – of record).
Regarding claim 48, Quintanar discloses a wound dressing comprising: a substantially flexible substrate and one or more sensors supported by the substantially flexible substrate and configured to measure characteristics of a wound; the one or more sensors comprising: an optical sensor.
Quintanar does not disclose the one or more sensors comprising a LED.
Brownhill remedies this deficiency by teaching one or more light sources comprising a LED for the benefit of measuring optical properties of the tissue, exudate, or foreign bodies (¶0109 of Brownhill).
Quintanar/Brownhill does not disclose the LED is separated from the optical sensor by no more than approximately 10 millimeters.
Cheng remedies this deficiency by teaching arranging multiple optical sensors and multiple optical sources by having near distances and/or far distances between them (¶0113 and Fig. 2) for the benefit of allowing detection of the electromagnetic waves absorbed or scattered through different regions of the target area in different depths (¶0113 of Cheng).
Quintanar/Brownhill/Cheng does not disclose the substantially flexible substrate covered by a conformal coating.
Duesterhoft teaches to cover the substrate with epoxy (the appurtenance 120 can be fabricated from one or more composite materials, such as plastic with an overlay of epoxy: ¶0045; epoxy reads on the claimed conformal coating: ¶0265 of the instant specification).
In addition, Dobriyal teaches to apply the conformal coating such as epoxy on electronic products/systems (¶0012-0014) for the benefits of providing a barrier to air-borne contaminants from the operating environment and preventing attack from moisture, aggressive chemicals, salt sprays, etc., which may cause corrosion and leakage currents or shorting due to condensation (¶0013 of Dobriyal).
Thus, the combination of Duesterhoft and Dobriyal teaches to have a conformal coating on the substrate.
Quintanar/Brownhill/Cheng/Duesterhoft/Dobriyal does not disclose the optical sensor covered by a substantially non-stretchable coating.
Ding remedies this deficiency by teaching having a polyimide layer 57 covered electronic components on the circuit board (¶0078-0080; polyimide layer reads on the claimed non-stretchable coating: ¶0261 of the instant specification) for the benefit of protecting the electrical components from sweat and other environmental factors.
However, none of cited prior art teach or suggest the LED covered by a substantially non-stretchable coating and covering the optical sensor and the LED with the substantially non-stretchable coating prevents formation of localized stress on the optical sensor and the LED. In addition, there is no reason to combine Ding reference to teach a LED covered by a substantially non-stretchable coating since Ding only teaches to have a non-stretchable coating/layer on sensors.
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Therefore, claim 48 and its dependent claims 49-59 are deemed novel and non-obvious over the prior art of record.
Regarding claim 60, Quintanar discloses a wound dressing comprising: a substantially flexible substrate and one or more sensors supported by the substantially flexible substrate and configured to measure characteristics of a wound; the one or more sensors comprising: an optical sensor.
Quintanar does not disclose the one or more sensors comprising a LED.
Brownhill remedies this deficiency by teaching one or more light sources comprising a LED for the benefit of measuring optical properties of the tissue, exudate, or foreign bodies (¶0109 of Brownhill).
Quintanar/Brownhill does not disclose the substantially flexible substrate covered by a conformal coating.
Duesterhoft teaches to cover the substrate with epoxy (the appurtenance 120 can be fabricated from one or more composite materials, such as plastic with an overlay of epoxy: ¶0045; epoxy reads on the claimed conformal coating: ¶0265 of the instant specification).
In addition, Dobriyal teaches to apply the conformal coating such as epoxy on electronic products/systems (¶0012-0014) for the benefits of providing a barrier to air-borne contaminants from the operating environment and preventing attack from moisture, aggressive chemicals, salt sprays, etc., which may cause corrosion and leakage currents or shorting due to condensation (¶0013 of Dobriyal).
Thus, the combination of Duesterhoft and Dobriyal teaches to have a conformal coating on the substrate.
Quintanar/Brownhill/Duesterhoft/Dobriyal does not disclose the optical sensor covered by a substantially non-stretchable coating.
Ding remedies this deficiency by teaching having a polyimide layer 57 covered electronic components on the circuit board (¶0078-0080; polyimide layer reads on the claimed non-stretchable coating: ¶0261 of the instant specification) for the benefit of protecting the electrical components from sweat and other environmental factors.
However, none of cited prior art teach or suggest the LED covered by a substantially non-stretchable coating and covering the optical sensor and the LED with the substantially non-stretchable coating prevents formation of localized stress on the optical sensor and the LED. In addition, there is no reason to combine Ding reference to teach a LED covered by a substantially non-stretchable coating since Ding only teaches to have a non-stretchable coating/layer on sensors.
No other prior art was located that fairly suggested the claimed invention in whole or in part, along with the requisite motivation for combining to render the claimed invention obvious.
Therefore, claim 60 and its dependent claims 61-67 are deemed novel and non-obvious over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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/NHU Q. TRAN/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781