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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. The drawings possess the following issues:
Claims 4 and 5 require a “microprocessor.” It is unclear where in the drawings a microprocessor is identified.
Therefore, the features identified above must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 person shall be entitled to a patent unless –
(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Rogers et al. (WO 2016025438A1) (hereinafter – Rogers).
Re. Claim 1: Rogers teaches a device to measure a subdermal fluid flow parameter (Abstract: blood flow is a subdermal fluid flow parameter),
comprising:
a substrate (Paragraph 006: “Tissue-mounted electronic and photonic systems of some embodiments combine thermal actuation with colorimetric and/or electronic thermal sensing provided in array formats on soft, elastomeric substrates to achieve spatially and/or temporally resolved sensing of thermal transport properties of tissue, while minimizing adverse physical effects to the tissue”);
at least one upstream temperature sensor supported by the substrate (Fig. 1A: temperature mapping sensors surrounding a central thermal actuator (large circle in middle) as described at Paragraph 0041);
at least one downstream temperature sensor supported by the substrate (see previous citation – any sensor which lies on an opposing side of the central thermal actuator); and
a thermal actuator supported by the substrate and positioned between said upstream temperature sensor and said downstream temperature sensor (see previous citation – “central” thermal actuator);
wherein the upstream temperature sensor and the downstream temperature sensor are located on the same side of the substrate (Fig. 1A: temperature sensors and the central thermal actuator are located on the same side; Paragraph 0015: “In an embodiment, for example, at least a portion of the thermal actuators and thermal sensors are in physical contact, fluid communication, optical communication, and/or electrical communication with the surface of the tissue”).
Re. Claim 2: Rogers teaches the invention according to claim 1. Rogers further teaches the invention wherein the temperature sensors are one or more of:
diode temperature sensors,
positive temperature coefficient of resistance (PTC) sensors, negative coefficient of resistance (NTC) sensors (Rogers discloses calculating resistance-based thermal sensing in Paragraphs 0039, 0040, 00117, 00184; PTC and NTC sensors differ in whether resistance changes are positively or negatively correlated with temperature changes; thus, Rogers’ teaching of using resistance-based thermal sensing covers at least one of either PTC or NTC sensors), and
colorimetric temperature sensors (Paragraph 006: “Tissue-mounted electronic and photonic systems of some embodiments combine thermal actuation with colorimetric and/or electronic thermal sensing;” Paragraph 007-009, 0014, 0023, 00213-00214).
Re. Claim 3: Rogers teaches the invention according to claim 1. Rogers further teaches the invention further comprising a controller in electronic communication with the downstream temperature sensor, the upstream temperature sensor and the thermal actuator (Figs. 27A, 27B; Paragraph 00183-00184: custom built system of USB-interface control electronics for control and recording of epidermal device, comprising a microcontroller; alternatively or additionally – the computer shown in Fig. 27B can be considered comprising a controller which is in electronic communication with the claimed components via the USB-interface control electronics).
Re. Claim 4: Rogers teaches the invention according to claim 3. Rogers further teaches the invention further comprising a microprocessor in electronic communication with the controller configured to calculate a flow parameter from the measured upstream and downstream temperatures (see previous citation; Paragraph 00184: “To map thermal transport over time, as done for blood flow measurements, the thermal actuator receives a continuous current input (2 mA) from the Keithley 6220. Simultaneously, the sensor resistances are sampled by DMM1 , in the same fashion described for mode 1 ), but this time without sampling S10 (the central actuator). The actuator voltage is read by DMM2. The relay circuit allows isolation of the S1 0-Keithley-DMM2 circuit from the sensor array-DMM1 circuit”).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over:
Rogers et al. (WO 2016025438A1) (hereinafter – Rogers) in view of
Cusimano Reaston et al. (US 20110224503 A1) (hereinafter – CR)
Re. Claim 5: Rogers teaches the invention according to claim 4. Rogers does not appear to disclose wireless communication between the microprocessor of the USB-interface control electronics to the controller (i.e., the laptop computer shown in Fig. 27B).
CR teaches analogous art in the technology of wireless physiological sensors (Abstract). Cusimano further teaches wireless communication between a sensor interface and a controller (Figs. 1A, 1B).
It would have been obvious to one having skill in the art before the effective filing date to have modified Rogers to include wireless communication between the microprocessor of the sensor electronics of Rogers to a controller as taught by Cusimano, the motivation being that doing so increases freedom of movement while using the system.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1 and 21 of U.S. Patent No. 11160458 B2 (hereinafter – “the ‘458 patent”) in view of
Rogers et al. (WO 2016025438A1) (hereinafter – Rogers).
Re. Claim 1: Claims 1 and/or 21 of the ‘458 patent teaches a device to measure a subdermal fluid flow parameter (Claims 1 and/or 21: a device which interfaces with a skin to determine direction of blood flow),
comprising:
a substrate (Claims 1 and/or 21: “a flexible or stretchable substrate”);
at least one upstream temperature sensor supported by the substrate (Claims 1, 21: “wherein two of said thermal sensors form a matched pair on opposing sides of said central thermal actuator”);
at least one downstream temperature sensor supported by the substrate (see previous citation); and
a thermal actuator supported by the substrate and positioned between said upstream temperature sensor and said downstream temperature sensor (see previous citation).
Claims 1 and 21 of the ‘458 patent fail to teach the invention wherein the upstream temperature sensor and the downstream temperature sensor are located on the same side of the substrate.
Such an aspect is taught by Rogers (Fig. 1A: temperature sensors and the central thermal actuator are located on the same side; Paragraph 0015: “In an embodiment, for example, at least a portion of the thermal actuators and thermal sensors are in physical contact, fluid communication, optical communication, and/or electrical communication with the surface of the tissue”).
It would have been obvious to one having skill in the art before the effective filing date to have modified claims 1 and/or claim 28 of the ‘458 patent to include the temperature sensors and thermal actuators to be located on a common side, the motivation being that such placement allows the temperature sensor to sense the same surface which heat is applied via the thermal actuator, increasing the detection of thermal changes compared to a system where heat applied via a thermal actuator mounted on one side of a substrate is transferred to a differing side of a substrate where the temperature sensor is mounted.
Claims 2-5 are rejected as being dependent on rejected claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791