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 .
Claims and Previous Objections/Rejections Status
Claims 12,15-18 and 21-25 are pending in the application. Claims 13,14 and 19 are cancelled and claims 23-25 newly added in the amendment filed 11/7/25.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Maintained Rejections
The claims 12,15-18 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2,4,6,7,10 and 11 of U.S. Patent No. 10,405,753B2 as stated in the office action mailed 7/7/25.
New Grounds of Rejection
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.
Claim(s) 12,15-18 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over
ThermoFisher Scientific DyLight®800, free acid certificate of analysis 2/24/12 and DyLightTM dyes, Free acid safety data sheet (10/9/14 and version:1 9/10) in view of Bogyo et al. (US 2018/0002375A1) and Hillman (US 2009/0252682A1) and in further view of Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) and Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066).
ThermoFisher Scientific DyLight®800, free acid certificate of analysis 2/24/12 discloses DyLight® 800 having SPECIFICATIONS: ABSORPTION MAXIMUM: 777 ± 4 nm PURITY: (HPLC) ≥ 90%
RESULTS: ABSORPTION MAXIMUM: 777 nm PURITY: 98%.
DyLightTM dyes, Free acid safety data sheet (10/9/14 and version:1 9/10) discloses that DyLightTM
dyes, free acid are solids that are to be kept in the original container or an approved alternative made
from a compatible material, kept tightly closed when not in use (p5, Physical state).
The product is stable (p5, Chemical Stability). Transport within user’s premises: always transport in closed containers that are upright and secure (p8, Special precautions for user).
The structure of the DyLight®800 free acid comprises
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and encompasses the fluorescent dye compound of the instant claims.
ThermoFisher Scientific and DyLightTM dyes do not disclose DyLight®800 free acid in an injectable unit dosage form for visualization of tissue of a patient via intravenous or parenteral administration and/or a pharmaceutically acceptable carrier.
Kovar et al. (US 7,597,878B2) discloses the cyanine NIR dye compounds comprising
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(abstract; column 3 lines 20-30 and column 4, lines 1-10; column 5, lines 32+; column 11, line 1; column 13).
The dye compounds are nontoxic to the subject and is capable of being formulated in a nontoxic composition (column 34, lines 37-42).
The dye compounds may be formulated as a composition via the addition of a conventional pharmaceutical carrier, such as a sterile aqueous solution (column 34, lines 13-19; column 36, lines 9-12).
The sterile aqueous solution encompasses the sterile liquid composition and the water pharmaceutically acceptable carrier of the instant claims.
The dye compounds may be administered via intravenous, injection, parenterally, etc. (column 34; lines 3-6 and 43-57).
Bogyo et al. (US 2018/0002375A1) discloses that NIR fluorophores, such as IRDye 800CW and DyLight series dyes, such as DyLight®800 are particularly well suited for in vivo imaging applications (p11, [0138-0139]).
Hillman (US 2009/0252682A1) discloses that DyLight dyes, IRDye800, etc. are used as optical contrast substances that can be injected into a subject (p4, [0043-0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the DyLight®800 free acid as a sterile and non-toxic injectable unit dosage form in an aqueous pharmaceutically acceptable carrier for NIR visualization of tissue in a patient with a reasonable expectation of success as Kovar et al. teaches of formulating an injectable sterile aqueous composition comprising a nontoxic dye compound having an analogous structure to that of DyLight®800 free acid for NIR imaging, Bogyo et al. teaches that IRDye 800CW and DyLight®800 are particularly well suited for in vivo imaging applications and Hillman teaches that DyLight dyes and IRDye800 are used as optical contrast substances that can be injected into a subject. Therefore, it would have been predictable to one of ordinary skill in the art to substitute one known NIR cyanine dye for another known NIR cyanine dye having an analogous core structure in a pharmaceutically acceptable carrier to yield an injectable NIR contrast agent.
ThermoFisher Scientific and DyLightTM dyes do not disclose a non-toxic formulation and the formulated doses for parenteral administration of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg.
Kovar et al. further discloses that the cyanine NIR dye compounds are formulated into compositions containing an effective amount of the dye with the pharmaceutical carrier and are administered in doses effective to achieve the desired optical imaging (column 34, lines 6-13 and 20-25).
Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) discloses the toxicity study of IRDye 800CW carboxylate intravenously administered at dose levels of 1,5, and 20 mg/kg (abstract; p584, Safety Study; p593, left column) as any agent used in human clinical investigation must undergo rigorous toxicity testing (p584, left column, second paragraph). No toxic effects were observed among any of the subjects (p586, Clinical Observations).
Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066) discloses that DyLight®800 has similar fluorescence properties to IRDye 800CW (p1063, DAC imaging of cutaneous siRNA uptake in vivo).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a non-toxic injectable DyLight®800 free acid aqueous formulation with doses from 0.1-4 mg/kg body weight or 20 mg as Marshall et al. teaches of the toxicity study of the comparable IRDye 800CW carboxylate dye at dose levels of 1,5, and 20 mg/kg. Therefore, it would have been predictable to one of ordinary skill in the art to examine the toxicity dosages of the comparable DyLight®800 dye to yield a formulation comprising an effective amount of the dye to achieve the desired optical imaging without toxicity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to begin with the lowest dose of DyLight®800 free acid for administration to a patient for imaging to determine the dosage that is non-toxic to do no harm to the patient while providing an effective imaging agent.
Furthermore, it is obvious to vary and/or optimize the amount of DyLight®800 free acid provided in the composition, according to the guidance provided by Kovar et al. and Marshall et al. to provide a composition having the desired properties such as the desired optical imaging. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The DyLight®800 free acid of ThermoFisher Scientific DyLight®800, free acid certificate has the same properties and is capable of the same functions, such as being formulated as a sterile and non-toxic injectable unit dosage form in a pharmaceutically acceptable carrier which is administered intravenously in an amount of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg for
visualization of ureter of a patient via NIR.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Response to Arguments
Applicant's arguments filed 11/7/25 have been fully considered but they are not persuasive.
Applicant asserts that the compound of formula (III), herein referred to as "IS-001," represents a significant advance in surgical safety by enabling effective ureter visualization during hysterectomy procedures. Administered systemically, IS-001 offers surgeons a reliable tool to avoid inadvertent ureteral injury-a complication that commonly occurs without intraoperative recognition and can have devastating consequences for patients. Historically, visualizing the ureter required frequent, localized application of dyes such as ICG, which is both time-consuming and technically complex. With IS-001, avoidance of ureteral injury is greatly simplified, directly enhancing surgical efficiency and effectiveness, improving patient outcomes. Ureteral injury is a serious complication of gynecological and colorectal surgery that frequently goes unrecognized intraoperatively.
The statement of enhancing surgical efficiency and effectiveness, improving patient outcomes is a subjective statement and does not provide quantitative data.
The DyLight®800 free acid stated above has the same properties and is capable of the same functions, such as being formulated as a sterile and non-toxic injectable unit dosage form in a pharmaceutically acceptable carrier which is administered intravenously to a patient for effective ureter visualization during hysterectomy procedures with enhanced surgical efficiency and effectiveness, improving patient outcomes.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant asserts that IS-001 is distinguished by its ease of use: a low dose, intravenously administered to the patient before the surgical procedure, achieves vivid ureteral visualization under near-infrared fluorescence (NIFR) within minutes. The dye then travels to the bladder for excretion without the need for any special intervention. In contrast, as is with ICG, the FDA approved cyanine dye, a ureteral catheter is cystoscopically inserted into the mid ureters and ICG is injected retrograde into the lumen of each ureter. The ureteral catheters are clamped to minimize leakage of ICG, and secured to a Foley catheter so they can be accessed throughout the procedure, where under NIRF, the ICG injected ureter will fluoresce green.
The instant claims are not drawn to a method of ureteral visualization during a surgical procedure without the need for any special intervention.
The statement of vivid ureteral visualization under near-infrared fluorescence (NIFR) within minutes is subjective and does not provide any quantitative data.
The DyLight®800 free acid stated above has the same properties and is capable of the same functions, such as being formulated as a low dose sterile and non-toxic injectable unit dosage form in a pharmaceutically acceptable carrier which is administered intravenously to a patient for effective ureter visualization during hysterectomy procedures.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant asserts that another key advantage of IS-001, is that it cannot be seen by the naked eye and so does not interfere with visualization of normal tissue, as is the case with blue dyes and fluorescein. This allows physicians to perform the required surgery while, only when needed, visualize the ureter in order to avoid iatrogenic ureteral injuries. Currently, IS-001 is in Phase 2 of clinical development.
The DyLight®800 free acid stated above has the same properties and is capable of the same functions, such as not being seen by the naked eye and so does not interfere with visualization of normal tissue.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant asserts that in the study published by Farnam et al. (Journal of Biomedical Optics 24(6), 066004 (June 2019), submitted herewith) clinical safety and efficacy of a real-time ureter visualization was evaluated at several concentrations. The study showed that IS-001 is safe, renally excreted, and allowed for enhanced ureter visualization when imaged with a clinically approved near-infrared sensitive endoscope. This is a first-in-human study showing that IS-001 is safe and effective during surgery for improved ureter visualization.
The statement that IS-001 is safe and effective during surgery for improved ureter visualization is subjective and does not provide any quantitative data.
The DyLight®800 free acid stated above has the same properties and is capable of the same functions, such as being safe and effective during surgery for improved ureter visualization.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim patentable and does not render the old composition patentably new to the discoverer. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Applicant asserts that as shown in Farnam et al., fluorescent ureter visualization was observed in all subjects following IV infusion of IS-001 when imaged with the da Vinci® Surgical System's Firefly® fluorescent imaging at all tested doses (10 mg, 20 mg, and 40 mg; see Fig. 2 of Farnam et al.). In Farnam et al., 8 women 39 to 58 years of age and 53 to 95 kg body weight, received a single dose of 10 mg, 8 women 33 to 51 years of age and 61 to 100 kg body weight, received a single dose of 20 mg, and 8 women 43 to 59 years of age and 52 to 122 kg body weight, received a single dose of 40 mg IS-001. Accordingly, the dosages of Farnam et al. range from about 0.1 mg/kg to about 0.77 mg/kg, showing that the claimed injectable unit dosage form is effective as low as 0.1 mg/kg.
The instant claims are not commensurate in scope as the low dose of the disclosure and in Farnam et al. is 0.1mg/kg to 0.77 mg/kg and does not include dosages from 0.8 mg/kg up to 4 mg/kg.
Applicant asserts that the references of DyLight®800 and DyLight 2014 were used to teach that the DyLight®800 free acid was known in the prior art before the effective filing date of the claimed invention. Even if the compound of formula (III) was known as a dye, there was no motivation to select DyLight®800 out of countless known commercially available dyes, for use in an injectable unit dosage
form.
The reference of Bogyo et al. was used to teach that NIR fluorophores, such as IRDye 800CW and DyLight series dyes, such as DyLight®800 are particularly well suited for in vivo imaging applications.
The reference of Hillman was used to teach that DyLight dyes, IRDye800, etc. are used as optical
contrast substances that can be injected into a subject
The reference of Ra et al. was used to teach that DyLight®800 has similar fluorescence properties to IRDye 800CW.
It would have been obvious and predictable to one of ordinary skill in the art to substitute one well known NIR cyanine dye IRDye 800CW for another known NIR cyanine dye DyLight®800 free acid having an analogous core structure and similar fluorescence properties in a pharmaceutically acceptable carrier to yield an injectable NIR contrast agent.
Applicant asserts that Kovar et al. was used to teach of formulating a nontoxic and injectable composition comprising a nontoxic dye compound having an analogous structure to that of DyLight®800 free acid in a sterile aqueous carrier for NIR imaging. However, one of skill in the art would not look to Kovar for a teaching to use unconjugated DyLight®800 free acid alone for administration/visualization. Kovar is directed to ICG, and derivatives thereof, but does not teach DyLight®800 free acid, alone or as a conjugate.
The reference of Kovar et al. was not used to teach of DyLight®800 free acid but was used to teach of used to teach that cyanine NIR dye compounds comprising a core structure analogous to that of DyLight®800 free acid are formulated into sterile non-toxic injectable aqueous compositions having an effective amount of the dye to achieve the desired optical imaging.
Applicant’s assertions with regards to Chiappini et al. are moot as it is not used in the instant rejection.
Applicant’s assertions with regards to Cheung are moot as it is not used in the instant rejection.
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 12,15-18 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10,15,18 and 20 of U.S. Patent No. 10,513,611B2 in view of Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) and Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066).
U.S. Patent No. 10,513,611B2 discloses the compound
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that encompasses the NIR fluorescent dye compound of the instant claims.
U.S. Patent No. 10,513,611B2 does not disclose the dose for parenteral administration of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg.
Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) is stated above.
Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066) is stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a non-toxic injectable aqueous formulation of the compound of U.S. Patent No. 10,513,611B2 with doses from 0.1-4 mg/kg body weight or 20 mg as Marshall et al. teaches of the toxicity study of the comparable IRDye 800CW carboxylate dye at dose levels of 1,5, and 20 mg/kg. Therefore, it would have been predictable to one of ordinary skill in the art to examine the toxicity dosages of the comparable dye compound to yield a formulation comprising an effective amount of the dye to achieve the desired optical imaging without toxicity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to begin with the lowest dose of the compound of U.S. Patent No. 10,513,611B2 for administration to a patient for imaging to determine the dosage that is non-toxic to do no harm to the patient while providing an effective imaging agent.
Furthermore, it is obvious to vary and/or optimize the amount of the compound of U.S. Patent No. 10,513,611B2 provided in the composition, according to the guidance provided by Marshall et al. to provide a composition having the desired properties such as the desired optical imaging. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The compound of U.S. Patent No. 10,513,611B2 has the same properties and is capable of the same functions, such as being formulated as a sterile and non-toxic injectable unit dosage form in a pharmaceutically acceptable carrier which is administered intravenously in an amount of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg for visualization of tissues of a patient via NIR.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim
patentable and does not render the old composition patentably new to the discoverer. In re Best, 562
F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claims 12,15-18 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9,13,15,17,18,23 and 24 of U.S. Patent No. 10,053,580B2 in view of Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) and Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066).
U.S. Patent No. 10,053,580B2 discloses the method of preparing the compounds
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that encompasses the NIR fluorescent dye compound of the instant claims.
U.S. Patent No. 10,053,580B2 does not disclose the dose for parenteral administration of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg.
Marshall et al. (Mol. Imaging Biol. 2010, 12:583-594) is stated above.
Ra et al. (J. Invest. Derm. 2011, 131, 1061-1066) is stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a non-toxic injectable aqueous formulation of the compound of U.S. Patent No. 10,053,580B2 with doses from 0.1-4 mg/kg body weight or 20 mg as Marshall et al. teaches of the toxicity study of the comparable IRDye 800CW carboxylate dye at dose levels of 1,5, and 20 mg/kg. Therefore, it would have been predictable to one of ordinary skill in the art to examine the toxicity dosages of the comparable dye compound to yield a formulation comprising an effective amount of the dye to achieve the desired optical imaging without toxicity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to begin with the lowest dose of the compound of U.S. Patent No. 10,053,580B2 for administration to a patient for imaging to determine the dosage that is non-toxic to do no harm to the patient while providing an effective imaging agent.
Furthermore, it is obvious to vary and/or optimize the amount of the compound of U.S. Patent No. 10,053,580B2 provided in the composition, according to the guidance provided by Marshall et al. to provide a composition having the desired properties such as the desired optical imaging. It is noted that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The compound of U.S. Patent No. 10,053,580B2 has the same properties and is capable of the same functions, such as being formulated as a sterile and non-toxic injectable unit dosage form in a pharmaceutically acceptable carrier which is administered intravenously in an amount of 0.10 mg to 4 mg per kg of the patient’s body weight, 0.10 mg to 2 mg per kg of the patient’s body weight, 0.10 mg to 1 mg per kg of the patient’s body weight or 20 mg for visualization of tissues of a patient via NIR.
Products of identical chemical composition can not have mutually exclusive properties. A
chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function
or unknown property which is inherently present in the prior art does not necessarily make the claim
patentable and does not render the old composition patentably new to the discoverer. In re Best, 562
F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA JEAN PERREIRA whose telephone number is (571)272-1354. The examiner can normally be reached M9-3, T9-3, W9-3, Th9-2, F9-2.
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/MELISSA J PERREIRA/Examiner, Art Unit 1618
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