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 .
Election/Restrictions
Applicant's election with traverse of group I claims 1-12 and 15-20 in the reply filed on 6/1/2026 is acknowledged. The traversal is on the ground(s) that unity of invention does exist between groups I and II because they share a special technical feature. This is not found persuasive because the special technical feature as noted in the previous action does not make a contribution over the prior art. Applicants additionally assert there would be no search burden to search the inventions together, however search burden is not a consideration for PCT application. Undue search burden is not an issue in a lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Baumler et al. "Photo-oxidative killing of human colonic cancer cells using indocyanine green and infrared light", British Journal of Cancer, 80 (3/4), 1999, pages 360-363, cited IDS.
Baumler teaches use of indocyanine green (ICG) laser irradiation with histidine quenching of HT-29 cells in vitro to study the ability of the dye to kill human colonic cancer cells, the amount of ICG was 10-500 uM and the amount of histidine was 50 mM, the ratio of histidine to ICG was greater than 0.05.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6,8-10,12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinnefeld et al. (2010/0181535), cited IDS.
Tinnefeld teaches photostability and control of fluorescent intensity of fluorescent dyes including ICG with redux buffers including oxidizing and reducing agents such as histidine and cysteine (meeting claim 4) in aqueous solution. See entire disclosure, especially abstract, [0089],[0140] and claims. Tinnefeld is silent with respect to the ratio between dye (ICG) and reducing agents (histidine and cysteine), however the reference teaches that by setting the ratio between reducing agent, oxidizing agent to dye the time period the fluorescent dye remains in the non-fluorescing state can be regulated and photostability/ shelf life can be increased. See [0021]-[0022],[0038]-[0040],[0047]. Thus, the preparation of dye compositions having variable amount of reducing agents such as histidine and cysteine is within the level of skill of one having ordinary skill in the art at the time of the invention. One of ordinary skill would have good reason to adjust the amount of histidine/cysteine to ICG to increase non-fluorescence time and increase photostability and shelf life. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Regarding the functional limitations or properties found in claims 10,18-20 on stability over time of ICG, it follows that any property measured is the natural result that occurs from optimizing the amounts of dye and reducing agent, which as noted above is obvious when the disclosure of Tinnefeld is considered.
Claim(s) 1-12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinnefeld et al. (2010/0181535) in view of Alam et al. (2003/0060718) in view of Gabbai (WO 2007/077560).
Tinnefeld is disclosed above. Tinnefeld is silent with respect to a lyophilized product as recited in claim 11 and the use of sodium iodide which is recited in claim 8.
Alam is used for its teaching on lyophilized forms of ICG were well known before the time of the claimed invention. See [0020], example 3 and claims 46-50. Gabbai is used only for its disclosure that sodium iodide was a well-known cryoprotectant used in lyophilized compositions. See claims 1 and 23.
Since Tennefeld and Alam are related to the same general field of endeavor of dye compositions one of ordinary skill would have a high expectation of success in producing the composition of the primary reference in convenient lyophilized form with the addition of the cryoprotectant sodium iodide from Gabbai to provide stability. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding the amounts of sodium iodide recited in claim 7, Gabbai is silent on the amounts, however the preparation of dye compositions having variable amount of cryoprotectant to provide stability to the lyophilized composition is within the level of skill of one having ordinary skill in the art at the time of the invention. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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