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 .
Claim Objections
Claim 10 is objected to because of the following informalities: punctuation and grammatical errors. 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.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 17/635,207 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because application no. ‘207 anticipates the claimed subject matter in the instant claims. Claim 1 recites a treatment support apparatus for photoimmunotherapy comprising: an excitation light source configured to irradiate a drug containing a fluorescent substance and an antibody, which bines to a cancer cell, with excitation light in a specific waveband (encompassed by excitation light source in claim 1 of ‘207); a storage configured to store an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (encompassed by storage in claim 1 of ‘207); a controller configured to retrieve the irradiation time and the irradiation intensity stored in the storage, and control the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved from the storage (encompassed by controller in claim 1 of ‘207); a fluorescence detector configured to detect fluorescence emitted by the fluorescent substance due to excitation by the excitation light (encompassed by fluorescence detector in claim 1 of ‘207); and an image generator configured to generate a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the fluorescence from the fluorescence substance detected by the fluorescence detector (encompassed by image generator in claim 1 of ‘207); wherein the excitation light radiated with the irradiation time and the irradiation intensity by the excitation light source has energy that excites the fluorescence substance but does not kill the cancer cell (encompassed by excitation light in claim 1 of ‘207). Claim 2 is encompassed by claim 2 of ‘207. Claim 3 is encompassed by claim 3 of ‘207. Claim 4 is encompassed by claim 4 of ‘207. Claim 5 is encompassed by claim 5 of ‘207. Claim 6 is encompassed by claim 6 of ‘207. Claim 7 is encompassed by claim 7 of ‘207. Claim 8 is encompassed by claim 8 of ‘207. Claim 9 is encompassed by claim 9 of ‘207. Claim 10 recites a treatment support apparatus for photoimmunotherapy comprising: an excitation light source configured to irradiate a drug containing a fluorescent substance and an antibody, which bines to a cancer cell, with excitation light in a specific waveband (encompassed by excitation light source in claim 10 of ‘207); a storage configured to store an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (encompassed by storage in claim 10 of ‘207); a controller configured to retrieve the irradiation time and the irradiation intensity stored in the storage, and control the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved from the storage (encompassed by controller in claim 10 of ‘207); a fluorescence detector configured to detect fluorescence emitted by the fluorescent substance due to excitation by the excitation light (encompassed by fluorescence detector in claim 10 of ‘207); and a distribution information output configured to output information about a distribution state of the fluorescence emitted by the fluorescent substance based on the fluorescence detected by the fluorescence detector (encompassed by image generator in claim 10 of ‘207); wherein the excitation light radiated with the irradiation time and the irradiation intensity by the excitation light source has energy that excites the fluorescence substance but does not kill the cancer cell (encompassed by excitation light in claim 10 of ‘207). Claim 11 recites an image generation method comprising: irradiating a drug containing fluorescent substance and an antibody, which binds to a cancer cell, with excitation light in a specific waveband (encompassed by irradiating in claim 11 of ‘207); storing an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (encompassed by storing in claim 11 of ‘207); retrieving the irradiation time and the irradiation intensity stored (encompassed by retrieving in claim 11 of ‘207); controlling the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved (encompassed by controlling in claim 11 of ‘207); detecting fluorescence emitted by the fluorescent substance due to excitation by the excitation light (encompassed by detecting in claim 11 of ‘207); and generating a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the detected fluorescence emitted by the fluorescence substance of the drug due to the excitation by the excitation light (encompassed by detecting in claim 11 of ‘207); wherein the excitation light radiated with the irradiation time and the irradiation intensity has energy that excites the fluorescent substance but does not kill the cancer cell (encompassed by excitation light in claim 11 of ‘‘207).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6 and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (US 6,214,033).
Li et al. discloses a treatment support apparatus for photoimmunotherapy comprising: an excitation light source (21; 31; 51a; 51b) configured to irradiate a drug containing a fluorescent substance and an antibody, which bines to a cancer cell, with excitation light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); a storage configured to store an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (55; col. 16, lines 56-63); a controller configured to retrieve the irradiation time and the irradiation intensity stored in the storage (7; col. 6, lines 47-54; col. 10, lines 19-24), and control the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved from the storage (7; col. 6, lines 47-54; col. 10, lines 19-24); a fluorescence detector configured to detect fluorescence emitted by the fluorescent substance due to excitation by the excitation light (25; 35; 36; col. 2, lines 7-27; col. 7, lines 13-15); and an image generator (26; 35; 36) configured to generate a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the fluorescence from the fluorescence substance detected by the fluorescence detector; wherein the excitation light radiated with the irradiation time and the irradiation intensity by the excitation light source has energy that excites the fluorescence substance but does not kill the cancer cell (col. 2, lines 7-19; col. 8, lines 4-19).
With respect to claims 2-5, Li et al. discloses controlling the integrated energy (col. 17, line 66 to col. 18, line 32).
With respect to claims 6 and 8-9, Li et al. discloses controlling a limit to an irradiation intensity, an irradiation time, and a number of times of irradiation of the excitation light (col. 18, lines 23-32 and 39-57).
With respect to claim 10, Li et al. discloses a treatment support apparatus for photoimmunotherapy comprising: an excitation light source (21; 31; 51a; 51b) configured to irradiate a drug containing a fluorescent substance and an antibody, which binds to a cancer cell, with excitation light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); a storage configured to store an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (55; col. 16, lines 56-63); a controller configured to retrieve the irradiation time and the irradiation intensity stored in the storage (7; col. 6, lines 47-54; col. 10, lines 19-24), and control the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved from the storage (7; col. 6, lines 47-54; col. 10, lines 19-24); a fluorescence detector configured to detect fluorescence emitted by the fluorescent substance due to excitation by the excitation light (25; 35; 36; col. 2, lines 7-27; col. 7, lines 13-15); and a distribution information output (26; 35; 36) configured to output information about a distribution state of the fluorescence emitted by the fluorescent substance based on the fluorescence detected from the fluorescence detector; wherein the excitation light radiated with the irradiation time and the irradiation intensity by the excitation light source has energy that excites the fluorescence substance but does not kill the cancer cell (col. 2, lines 7-19; col. 8, lines 4-19).
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(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 6,214,033) in view of Wu et al. (US 2013/0053699).
Li et al. discloses the subject matter substantially as claimed except for comprising a visible light detector and an image synthesizer configured to generate a composite image. However, Wu et al. teaches in the same field of endeavor comprising detecting white light image and synthesizing a composite image to superimpose the white light image and the fluorescent image ([0017]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with the composite image as taught by Wu et al. as superimposing white light and fluorescent images are well known in the art.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 6,214,033) in view of Kobayashi et al. (US 2012/0010558).
Li et al. discloses an image generation method comprising: irradiating a fluorescent substance of a drug administered into a body of a subject with excitation light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); storing an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (55; col. 16, lines 56-63); retrieving the irradiation time and the irradiation intensity stored (7; col. 6, lines 47-54; col. 10, lines 19-24); controlling the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved (7; col. 6, lines 47-54; col. 10, lines 19-24); detecting fluorescence emitted by the fluorescent substance due to excitation by the excitation light (col. 2, lines 7-27, col. 7, lines 13-15); and generating a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the detected fluorescence emitted by the fluorescence substance of the drug due to the excitation by the excitation light (col. 2, lines 7-27; col. 8, lines 4-19); wherein the excitation light radiated with the irradiation time and the irradiation intensity has energy that excites the fluorescent substance but does not kill the cancer cell (col. 2, lines 7-19; col. 8, lines 4-19). Li et al. does not teach the drug containing a fluorescent substance and an antibody. However, Kobayashi et al. teaches in the same field of endeavor a fluorescent substance and an antibody to specifically bind to the cell surface protein ([0069]; [0156]). Ther3efore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with the fluorescent substance and an antibody as taught by Kobayashi et al. as it is a well known substance for fluorescence imaging of cancer cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PETER LUONG/ Primary Examiner, Art Unit 3797
Prosecution Insights