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 .
Acknowledgement of Receipt
Applicant’s Response, filed 6/24/2025, in reply to the Office Action mailed 3/24/2025, is acknowledged and has been entered. Claims 1-12 are pending, of which claims 5-7 are withdrawn from consideration at this time as being drawn to a non-elected invention. Claims 1-4 and 8-12 encompass upon the elected invention and are examined herein on the merits for patentability.
Response to Arguments
Applicant’s arguments have been fully considered. Any rejection not reiterated herein has been withdrawn. The Examiner’s response to Applicant’s arguments is incorporated below.
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 1-4 and 8-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-15 of U.S. Patent No. 11,957,314, for reasons set forth in the previous Office Action.
Response to arguments
It is noted that Applicant is willing to provide a terminal disclaimer in the event that any allowable claims remain subject to the non-statutory double patenting rejection. However, a terminal disclaimer has not been received; the rejection is maintained at this time.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 9 -11 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 2011/0017217) in view of Reeder (US 2014/03562930), for reasons set forth in the previous Office Action.
Claim(s) 1-4 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 2011/0017217) in view of Reeder (US 2014/03562930), in further view of Soltesz (US 5,254,107), for reasons set forth in the previous Office Action.
Claim(s) 1-4 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Wood (US 2011/0017217) in view of Reeder (US 2014/03562930), in further view of Farkas et al. (2015/0374309), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that the claimed method does not involve identifying the location of a medical device within the body, and notes that instead the claimed method requires an output of fluorescence such that the features of the tissue are revealed and then displaying the collected fluorescence so that the features are visible. Applicant asserts that the prior art does not disclose the use of a fluorophore embedded medical device to reveal and visualize tissue during an operation and that Wood is utterly devoid of any disclosure that the medical device can be used to transilluminate tissue to reveal the characteristics of the tissue and then make those characteristics visible to a user.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted that the claims include the limitation exciting the medical device with an amount of near infrared radiation so that the body will emit fluorescence at a level that is sufficient to pass through the amount of tissue in the surgical site and to reveal any features of the amount of tissue; detecting the fluorescence emitted by the body; and displaying the fluorescence emitted by the body so that the features of the amount of tissue are visible. It is respectfully considered the recitation of “revealing any features of the amount of tissue” and displaying fluorescence so that “features of an amount of tissue are visible” broadly includes any features of the tissue. See MPEP 2111. During patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the “broadest reasonable interpretation” standard: The Patent and Trademark Office (“PTO”) determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction “in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must “conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description.” 37 CFR 1.75(d)(1). In the instant case, in consultation with the instant specification, which does not place limitations on the definition of the claimed features of the tissue which are to be visualized, it is respectfully submitted that given the broadest reasonable interpretation of the claims, at least the location of the tissue is a “feature” of the tissue that is visualized.
Applicant further argues that with respect to claim 2, the Examiner relied on Paragraph [0031] of Wood as disclosing the claimed level of penetration of fluorescence. Applicant asserts that in the cited portion of Wood, however, the reference describes that a device positioned less than 3 cm beneath the surface of the skin can be located and that the claimed invention requires transillumination with the medical device beneath the tissue to reveal tissue features and then display those tissue features. Wood discloses finding a medical device, not using the medical device to reveal and display tissue features. Claim 3, however, recites the display of the fluorescent return from the device in combination with the visual spectrum. Wood does not disclose any combination of the fluorescent image with the visual spectrum. With respect to claim 4, Applicant notes that the claim recites that the step of exciting the medical device “includes modulation of at least one of an intensity, an angle of incidence, and a duty cycle of a source of near infrared radiation.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted fluorescence is detected and displayed, including at the claimed depth as required by the instant claims, as such at least a feature of the tissue is visualized, for which at least location is interpreted to be a “feature” of the tissue, as set forth above. With regard to claims 3 and 4, Wood recites visualizing fluorescence emitted by said dye in response to said excitation light at paragraph 0013 which is interpreted to encompass the visual spectrum. Regarding claim 4, Wood recites choice of intensity at paragraph 0039, and further that the design of laser diodes tunable to different near infrared frequencies is discussed at paragraph 0033; accordingly, at least modulation of intensity is addressed.
Applicant further argues that Soltesz does not remedy the shortcomings of Wood and Reeder.
The Examiner’s response to arguments directed to the combined teachings of Wood and Reeder is applied as above. Soltesz is included to address PTFE to be a suitable polymer/plastic for preparing a medical catheter.
Applicant further argues that Farkas does not disclose additional limitations of claim 12. Applicant asserts that the Examiner did not identify any of the expressly recited steps in Farkas and that instead the Examiner pointed to an approach in Farkas for characterizing melanomas with multiple wavelengths of incident light. Applicant asserts that while Farkas discloses assigning coordinates to the illuminated tissue, it does not receive brightness values for each coordinate, assign relative tissue depth values, assign tissue density values, or create a virtual image with those metrics that is then added to an image of the surgical field. Farkas only considers the overall depth of the melanoma, and does not assign the specific values of the claimed invention to each coordinate or create a virtual image as recited in claim 12.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted that Farkas readily teaches that in vivo tissue characterization disclosed herein employ illumination of tissue with hyperspectral, polarized light and spatial measurements of the intensity, spectrum and polarization of light remitted by the tissue in response to the illumination to locate and characterize anomalies in the tissue (paragraph 0081); it is noted that intensity is interpreted to correspond to brightness as claimed. FIG. 3 is a schematic representation of a cross sectional view of a tissue sample showing different depths of illuminating light penetration at different illumination wavelengths. Farkas also teaches producing maps of the distribution of tissue features from the surface to depths (paragraph 0077); and further a computer is used in connection with the acquisition and processing of acquired data to generate an enhanced map, or multi-dimensional data base, of the structural characteristics of the tissue being measured (paragraph 0075), which is interpreted to correspond to a virtual image as claimed. Accordingly, brightness values for each coordinate, relative tissue depth values, tissue density values, and virtual image limitations are addressed. Applicant’s arguments have been fully considered but the rejections are maintained.
Conclusion
No claims are allowed at this time.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH H SCHLIENTZ whose telephone number is (571)272-9928. The examiner can normally be reached Monday-Friday, 8:30am - 12:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HARTLEY can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618