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 .
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.
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Claims 27-29, 32, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of Hunt et al. (U.S. Patent No. 12,186,165 B2). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patented case of Hunt recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case in view of McKenna.
Instant Claims
Claims of Patent No. US 12,186,165 B2
27
16
28
16
29
16
32
16
38
17
Claims 39 and 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of Hunt et al. (U.S. Patent No. 12,186,165 B2) in view of McKenna (Publication No. US 2011/0242532 A1). The prior art reference of Hunt teaches an method comprising: emitting a first electromagnetic radiation into the first optical fiber, detecting a second electromagnetic radiation gathered by a second optical fiber, detecting a saturation level of the dressing based on a variation between the first and second electromagnetic radiation, determine that the saturation level of the dressing satisfies a threshold, and provide an indication that the dressing should be replaced (see claim 20 of Hunt). Hunt does not teach the plurality of optical fibers comprising a first set of optical fibers and a second set of optical fibers.
However, McKenna teaches the plurality of optical fibers comprising a first set of optical fibers (light emission biodegradable waveguides 16 in structure 120; Paragraph 0036; Figure 7) and a second set of optical fibers (light receptor biodegradable waveguides 16 in structure 122; Paragraph 0036; Figure 7).
Hunt and McKenna are both considered to be analogous to the claimed invention because they are in the same field of wound dressing with optical fibers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunt to incorporate the teachings of McKenna and have the plurality of optical fibers with the first optical fiber and the second optical fiber of Hunt to be a first set and a second set of optical fibers, respectively, as taught by McKenna. This allows for the observation of a substantial area of the patient tissue by using multiple sets of waveguides (McKenna; Paragraph 0035).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patented case of Hunt in view of McKenna recite the claim limitations required in the current application. The table below shows the mapping of the overlapping claims between the current application and the patented case in view of McKenna.
Instant Claims
Claims of Patent No. US 12,186,165 B2 in view of McKenna (Publication No. US 2011/0242532 A1)
39
20
42
20
Claim Objections
Claims 36, 39, and 45 are objected to because of the following informalities:
Claim 36, line 2: “an angle” should read “a first angle”;
Claim 36, line 4: “an angle” should read “a second angle”;
Claim 39, lines 14-15: “a threshold” should read “the threshold”;
Claim 45, line 2: “an angle” should read “a first angle”;
Claim 45, line 4: “an angle” should read “a second angle”. Appropriate correction is required.
Allowable Subject Matter
Claims 27-46 are rejected under non-statutory double patenting and objected, as recited above, but would be allowable if the rejected claims under non-statutory double patenting and the claim objections are overcome.
REASONS FOR INDICATING ALLOWABLE SUBJECT MATTER
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, alone or in combination, fails to disclose all of the structural and functional limitation s as described in the claims.
The invention is drawn to an apparatus and a method of tissue monitoring or treatment with a dressing, a plurality of optical fibers having a first set of the plurality of optical fibers and a second set of the plurality of optical fibers, an emitter, a detector, and an electronic processing circuitry. The electronic processing circuitry is to detect a saturation level of the dressing based on the variation between the first and second electromagnetic radiations, determine if the saturation level satisfies a threshold, and provide an indication that the dressing should be replaced. The closest prior art are McKenna (Publication No. US 2011/0242532 A1), Ganapathy et al. (Publication No. US 2006/0173253 A1), and Blott et al. (Publication No. US 2011/0213319 A1), with none of the references disclosing the required claim limitations of “…detect a saturation level of the dressing based on a variation between at least one property of the first electromagnetic radiation and at least one property of the second electromagnetic radiation; determine that the saturation level of the dressing satisfies a threshold; and in response to determining that the saturation level of the dressing satisfies the threshold, provide an indication that the dressing should be replaced…”, required by independent claims 27 and 39.
Instead, McKenna discusses an apparatus and a method of tissue monitoring or treatment (system 10 for tissue monitoring; Figure 2; Paragraph 0024) with a dressing (bandage 14; Figure 2; Paragraph 0020), a plurality of optical fibers (plurality of biodegradable waveguide 16; Figure 7; Paragraph 0034) having a first set of the plurality of optical fibers (light emission biodegradable waveguides 16 in structure 120; Paragraph 0036; Figure 7) and a second set of the plurality of optical fibers (light receptor biodegradable waveguides 16 in structure 122; Paragraph 0036; Figure 7), an emitter (emitter 20 emits a light/first electromagnetic radiation into the first set of optical fibers 120; Figure 2 and 7; Paragraph 0020-0021), a detector (detector 26 detects a second electromagnetic radiation by the second set of optical fiber 122, where the second electromagnetic radiation results from the light being passed into the bandage 14 and reflected from the tissue of the patient; Paragraph 0020-0021; Figure 2), and an electronic processing circuitry (monitor 18; Figure 2; Paragraph 0023). McKenna does not teach the electronic processing circuitry is to detect a saturation level of the dressing based on the variation between the first and second electromagnetic radiations, determine if the saturation level satisfies a threshold, and provide an indication that the dressing should be replaced.
Ganapathy instead discusses an apparatus and a method of tissue monitoring or treatment with a dressing (foam dressing 50; Paragraph 0058; Figure 6), a plurality of optical fibers (optic fibers 62; Paragraph 0058; Figure 6), an emitter (LED; Figure 6; Paragraph 0058), a detector (photodetector; Figure 6; Paragraph 0058-0059), and an electronic processing circuitry (microprocessor 36; Paragraph 0049). Ganapathy does not teach the plurality of optical fibers having a first set of the plurality of optical fibers and a second set of the plurality of optical fibers, the electronic processing circuitry is to detect a saturation level of the dressing based on the variation between the first and second electromagnetic radiations, determine if the saturation level satisfies a threshold, and provide an indication that the dressing should be replaced.
Blott instead discusses an apparatus and a method of tissue monitoring or treatment with a dressing (dressing 2; Paragraph 0449; Figure 1), a plurality of optical fibers (optical fibres; Paragraph 0203 and 0218-0219). Blott does not teach the plurality of optical fibers having a first set of the plurality of optical fibers and a second set of the plurality of optical fibers, and an electronic processing circuitry is to detect a saturation level of the dressing based on the variation between the first and second electromagnetic radiations, determine if the saturation level satisfies a threshold, and provide an indication that the dressing should be replaced.
The closest is the disclosure of McKenna, however, the prior art, alone or in combination, does not provide a reasoning or teaching to have the electronic processing circuitry is to detect a saturation level of the dressing based on the variation between the first and second electromagnetic radiations, determine if the saturation level satisfies a threshold, and provide an indication that the dressing should be replaced, since it would require additional programming of the processor with the optical fibers to determine the saturation parameter.
Conclusion
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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