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 without traverse of group II and the species of intravenous administration and ureter as the organ in the reply filed on June 30, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because the quality of Figure 1 in particular is poor and the text in the shaded box is hard to read. The superscripts a and b after outpatient visit and follow-up call respectively are not defined in the drawing or anywhere in the specification. 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.
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.
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) 6 – 9 and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fushiki et al. (Mol Imaging, Biol, 2023; published online May 11, 2021; cited on IDS) in view of Nair et al. (Journal of basic and clinical pharmacy, 2016).
Fushiki et al. discloses intraoperative visualization of the ureter using NIRF (near-infrared fluorescence) visualization using the ICG (indocyanine green) derivative ASP5354 in rats and minipigs that were dosed at 0.03 or 0.3 mg/kg for rats and 0.001 or 0.01 mg/kg for minipigs (abstract). As shown in Figure 1, ASP5354 is a chloride salt and formerly known as TK-1 and this structure matches that of pudexacianinium. The right femoral vein was catharized for ASP5354 administration (p 75, col 2, ¶ 3), reading on intravenous administration.
A concentration in milligrams for the composition as in the instant claims is not disclosed.
Table 1 of Nair et al. discloses a reference body weight of 0.15 kg for rats and 40 kg for a minipig. The higher dosage for the minipigs translates to a total dose of 0.4 mg for the experiment in Fushiki et al. with a minipig having the reference weight.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to vary the total dosage based on the subject whose ureter is being visualized using intravenously administered ASP5354 and NIRF imaging. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because dosages in varying units are used and a composition containing a certain number of milligrams can be administered in varying volumes depending on the particular subject and the optimal concentration of the dye. The amount of a dye in a composition administration to a subject for imaging is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired of sufficient dye for observation purposes while limiting excess that can cause staining elsewhere.
Claim(s) 6 – 9 and 17 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 10,350,310).
Teranishi et al. discloses novel indocyanine compounds solving the problems of conventionally used indocyanine green, such as solubility in water, and a diagnostic composition including the novel indocyanine compound (whole document, e.g., abstract). The method of fluorescence imaging of an organ other than the liver by intravenous administration is also disclosed (abstract). Intravenous administration of indocyanine green (ICG) renders imaging of organs other than the liver difficult (col 3, ln 13 – 16) and the present invention solves such problems. Typical doses of ICG are 25 mg ICG for medical applications (col 2, ln 47 – 48). The compound shown across cols 41 and 42 are pudexacianinium (see Figure 1B of Kurahasi et al. of the structure of TK-1, which matches that shown in the instant application for pudexacianinium). The green pigment exhibits near infrared fluorescence, characterized by a high solubility in water or physiological saline, easy removal from a biological tissue, a low molecule association in an aqueous solution, a high near-infrared fluorescence intensity in an aqueous solution, and fluorescence imaging of an organ other than liver such as kidney, ureter, bladder, urethra, heart or lung (col 3, ln 23 – 30).
Teranishi et al. does not have an explicit example in which pudexacianinium is intravenously administered in the claimed range for imaging of an organ such as the ureter.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to intravenously administer the improved ICG compounds such as pudexacianinium disclosed by Teranishi et al. to a subject for the purpose of imaging the ureter using the emitted near-infrared fluorescence. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the improved properties of the ICG containing cyclodextrin compounds of Teranishi such as increased solubility and the ability to image organs other than the liver are explicitly disclosed by Teranishi et al. Given these improved properties, particularly the improved solubility and low molecular association, one of ordinary skill in the art would reasonably expect that the same or possibly lower amounts of pudexacianinium could be used in such imaging procedures. The amount of a dye in a composition administration to a subject for imaging is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired of sufficient dye for observation purposes while limiting excess that can cause staining elsewhere. Ranges that overlap or do not overlap but are merely closes are prima facie obvious absent evidence of criticality (see MPEP 2144.05).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. as applied to claims 6 – 9 and 17 – 18 above, and further in view of Blanchard (US 10,821,075).
Teranishi et al. is discussed above.
The chloride salt of pudexacianinium is not disclosed.
Blanchard discloses topical drug delivery systems of active pharmaceutical ingredients (APIs; whole document, e.g., abstract). The agents referenced include pharmaceutically acceptable salts (col 5, ln 51 – 52), which is defined at col 6, ln 48 – 67 and for ionizable drugs that are acidic, the corresponding negative counterions can be Cl-, Br-, etc. Indocyanine green is amongst the disclosed APIs (Table IV, col 14, at the bottom of the page; see also claim 9) and based on the known structure of ICG can be positively charged on the ring nitrogen atom and therefore pharmaceutically acceptable salts would include anions such as chloride.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use a pharmaceutically acceptable salt of the pudexacianinium such as the chloride salt. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because pharmaceutically acceptable salts are known to those of ordinary skill in the art and based on the structure of pudexacianinium, negative counterions such as chloride can be used in the preparation of such salts. The selection of the salt form is within the skill of one of ordinary skill in the art absent evidence of criticality of the particular salt form.
Claim(s) 6 – 9 and 17 – 19 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. as applied to claims 6 – 9 and 17 – 18 above, and further in view of Fushiki et al. (Mol Imaging, Biol, 2023; published online May 11, 2021; cited on IDS).
Teranishi et al. is discussed above.
The chloride salt of pudexacianinium is not disclosed.
Fushiki et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the chloride salt of pudexacianinium disclosed by Fushiki et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Fushiki et al. discloses the dosages in mg/kg for the chloride salt in rats and minipigs when pudexacianinium is used for NIRF imaging of the ureter.
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 6 – 9 and 17 – 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 13 of copending Application No. 18/710,652 in view of Teranishi et al. (US 10,350,310). The claims of US’652 recite solid or apparently liquid formulations (claims 1 and 2) that comprise pudexacianinium or a pharmaceutically acceptable salt thereof such as chloride (see claim 11); a buffer and an excipient (claim 1).
There are no methods of using the composition.
Teranishi et al. is discussed above. Forms in which the ingredients are dissolved are disclosed (e.g., col 24, ln 18) and dissolution of the cyclodextrin-bonded ICG in water did not require vibration stirring that was required for dissolution on non-cyclodextrin-bonded ICG (col 47, ln 62 – 67).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer, such as intravenously, the liquid or dissolved solid compositions of US’652 in the method of Teranishi et al. to image the ureter using NIRF imaging during a procedure. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because compositions as in US’652 are intended for use in some manner and Teranishi et al. discloses that one possible use of such formulations is to image the ureter using NIRF imaging during a procedure. The amount of a dye in a composition administration to a subject for imaging is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired of sufficient dye for observation purposes while limiting excess that can cause staining elsewhere.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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