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 .
Response to Arguments
Applicant's arguments, filed August 18, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Specification
Applicants amended the specification filed August 18, 2026, the issues identified in the Office Action mailed May 28, 2026 have been fully resolved. Therefore, the specification received on August 18, 2026 are acceptable and the amendments are entered.
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.
Claims 13, 20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 9,056,131, 2015; “Teranishi 2015”) in view of Poellinger et al. (Radiology, 2011; cited on PTO-892).
Regarding claims 13 and 20, Teranishi 2015 discloses a cyclodextrin-bonded indocyanine compound represented by chemical formula 19
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(columns 39-40), which reads on the compound of Formula I of instant claims and elected species. Regarding claims 13 and 25, Teranishi 2015 discloses that the composition can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (column 22, lines 7-10; column 22, lines 29-32). Regarding claim 26, Teranishi 2015 discloses that the compound can be topically administered to a body (column 1, lines 45-47).
Teranishi 2015 does not disclose contrast imaging of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (instant claim 1). Teranishi 2015 does not disclose that the contrast imaging is positive imaging in which the near-infrared fluorescence emitted from the cancer tissue is stronger than that emitted from the surrounding normal tissue (instant claim 27).
Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Teranishi 2015 for contrast imaging of breast cancer wherein the near-infrared fluorescence is stronger in cancer tissue than in surrounding normal tissue. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, a person of ordinary skill in the art would have been motivated to utilize the improved indocyanine compound of Teranishi 2015 for enhanced breast cancer detection by contrast imaging (positive imaging) in order to achieve superior tumor visualization. Teranishi 2015 teaches the identical indocyanine compound of instant claims. Teranishi 2015 and Poellinger teach the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis via positive contrast imaging. Therefore, the use of the indocyanine compound of Teranishi 2015 for diagnosing breast cancer is merely applying a known compound to a known application. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi 2015 and Poellinger as applied to claims 13, 20, and 25-27 above, and further in view of Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Teranishi 2015 and Poellinger are discussed above.
Neither Teranishi 2015 nor Poellinger discloses that the compound is present as a chloride salt.
Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Teranishi 2015 and Poellinger by forming a chloride salt in order to prepare more efficacious pharmaceutical compounds. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Further, a person of ordinary skill in the art would have been motivated to select appropriate salts according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 13, 20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 9,844,606, 2017; “Teranishi 2017”) in view of Poellinger et al. (Radiology, 2011; cited on PTO-892).
Regarding claims 13 and 20, Teranishi 2017 discloses a cyclodextrin-bonded indocyanine compound represented by chemical formula 19
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336
522
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(columns 77-78), which reads on the compound of Formula I of instant claims and elected species. Teranishi 2017 discloses a method of detecting a visualized image in a living body by near-infrared fluorescence, comprising administering to the body a composition comprising water and the compound (column 76, claim 76). Regarding claims 13 and 25, Teranishi 2017 discloses that this method is applicable to an identification of a sentinel lymph node in a cancer such as breast cancer (column 22, lines 7-10; column 24, lines 54-58). Regarding claim 26, Teranishi 2017 discloses that the compound can be topically administered to a body (column 1, lines 64-66).
Teranishi 2017 does not disclose contrast imaging of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (instant claim 1). Teranishi 2017 does not disclose that the contrast imaging is positive imaging in which the near-infrared fluorescence emitted from the cancer tissue is stronger than that emitted from the surrounding normal tissue (instant claim 27).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Teranishi 2017 for contrast imaging of breast cancer wherein the near-infrared fluorescence is stronger in cancer tissue than in surrounding normal tissue. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, a person of ordinary skill in the art would have been motivated to utilize the improved indocyanine compound of Teranishi 2017 for enhanced breast cancer detection by contrast imaging (positive imaging) in order to achieve superior tumor visualization. Teranishi 2017 teaches the identical indocyanine compound of instant claims. Teranishi 2017 and Poellinger teach the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis via positive contrast imaging. Therefore, the use of the indocyanine compound of Teranishi 2017 for diagnosing breast cancer is merely applying a known compound to a known application. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi 2017 and Poellinger as applied to claims 13, 20, and 25-27 above, and further in view of Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Teranishi 2017 and Poellinger are discussed above.
Neither Teranishi 2017 nor Poellinger discloses that the compound is present as a chloride salt.
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Teranishi 2017 by forming a chloride salt in order to prepare more efficacious pharmaceutical compounds. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Further, a person of ordinary skill in the art would have been motivated to select appropriate salts according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 13, 20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 10,086,090, 2018; “Teranishi 2018”) in view of Poellinger et al. (Radiology, 2011; cited on PTO-892).
Regarding claims 13 and 20, Teranishi 2018 discloses a cyclodextrin-bonded indocyanine compound represented by chemical formula 19
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407
638
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(columns 55-56), which reads on the compound of Formula I of instant claims and elected species. Regarding claims 13 and 25, Teranishi 2018 discloses that the composition can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (column 22, lines 1-5; column 22, lines 24-28). Regarding claim 26, Teranishi 2018 discloses that the compound can be topically administered to a body (column 1, lines 60-62).
Teranishi 2018 does not disclose contrast imaging of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (instant claim 1). Teranishi 2018 does not disclose that the contrast imaging is positive imaging in which the near-infrared fluorescence emitted from the cancer tissue is stronger than that emitted from the surrounding normal tissue (instant claim 27).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Teranishi 2018 for contrast imaging of breast cancer wherein the near-infrared fluorescence is stronger in cancer tissue than in surrounding normal tissue. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, a person of ordinary skill in the art would have been motivated to utilize the improved indocyanine compound of Teranishi 2018 for enhanced breast cancer detection by contrast imaging (positive imaging) in order to achieve superior tumor visualization. Teranishi 2018 teaches the identical indocyanine compound of instant claim. Teranishi 2018 and Poellinger teach the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis via positive contrast imaging. Therefore, the use of the indocyanine compound of Teranishi 2018 for diagnosing breast cancer is merely applying a known compound to a known application. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi 2018 and Poellinger as applied to claims 13, 20, and 25-27 above, and further in view of Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Teranishi 2018 and Poellinger are discussed above.
Neither Teranishi 2018 nor Poellinger discloses that the compound is present as a chloride salt.
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Teranishi 2018 by forming a chloride salt in order to prepare more efficacious pharmaceutical compounds. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Further, a person of ordinary skill in the art would have been motivated to select appropriate salts according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 13, 20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 10,350,310, 2019; “Teranishi 2019”) in view of Poellinger et al. (Radiology, 2011; cited on PTO-892).
Regarding claims 13 and 20, Teranishi 2019 discloses a cyclodextrin-bonded indocyanine compound represented by chemical formula 19
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331
629
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(columns 41-42), which reads on the compound of Formula I of instant claims and elected species. Regarding claims 13 and 25, Teranishi 2019 discloses that the composition can be applied to medical operations and medical diagnosis in which near-infrared fluorescence emitted by administration of the compound to a body such as breast and it is applicable to an identification of a sentinel lymph node in a cancer such as breast cancer (column 24, lines 7-11; column 22, lines 30-34). Regarding claim 26, Teranishi 2019 discloses that the compound can be topically administered to a body (column 1, lines 64-66).
Teranishi 2019 does not disclose contrast imaging of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (instant claim 1). Teranishi 2019 does not disclose that the contrast imaging is positive imaging in which the near-infrared fluorescence emitted from the cancer tissue is stronger than that emitted from the surrounding normal tissue (instant claim 27).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Teranishi 2019 for contrast imaging of breast cancer wherein the near-infrared fluorescence is stronger in cancer tissue than in surrounding normal tissue. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, a person of ordinary skill in the art would have been motivated to utilize the improved indocyanine compound of Teranishi 2019 for enhanced breast cancer detection by contrast imaging (positive imaging) in order to achieve superior tumor visualization. Teranishi 2019 teaches the identical indocyanine compound of instant claim. Teranishi 2019 and Poellinger teach the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis. Therefore, the use of the indocyanine compound of Teranishi 2019 for diagnosing breast cancer is merely applying a known compound to a known application. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi 2019 and Poellinger as applied to claims 13, 20, and 25-27 above, and further in view of Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Teranishi 2019 and Poellinger are discussed above.
Neither Teranishi 2019 nor Poellinger discloses that the compound is present as a chloride salt.
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Teranishi 2019 by forming a chloride salt in order to prepare more efficacious pharmaceutical compounds. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Further, a person of ordinary skill in the art would have been motivated to select appropriate salts according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
Claims 13, 20, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Teranishi et al. (US 2019 0262477; “Teranishi”) in view of Poellinger et al. (Radiology, 2011; cited on PTO-892).
Regarding claims 13 and 20, Teranishi discloses a cyclodextrin-bonded indocyanine compound represented by chemical formula 19
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301
549
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(page 21), which reads on the compound of Formula I of instant claims and elected species. Regarding claims 13 and 25, Teranishi discloses that the composition can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Regarding claim 26, Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
Teranishi does not disclose contrast imaging of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (instant claim 1). Teranishi does not disclose that the contrast imaging is positive imaging in which the near-infrared fluorescence emitted from the cancer tissue is stronger than that emitted from the surrounding normal tissue (instant claim 27).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to use the compound of Teranishi for contrast imaging of breast cancer wherein the near-infrared fluorescence is stronger in cancer tissue than in surrounding normal tissue. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, a person of ordinary skill in the art would have been motivated to utilize the improved indocyanine compound of Teranishi for enhanced breast cancer detection by contrast imaging (positive imaging) in order to achieve superior tumor visualization. Teranishi teaches the identical indocyanine compound of instant claim. Teranishi and Poellinger teach the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis. Therefore, the use of the indocyanine compound of Teranishi for diagnosing breast cancer is merely applying a known compound to a known application. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Teranishi and Poellinger as applied to claims 13, 20, and 25-27 above, and further in view of Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Teranishi and Poellinger are discussed above.
Neither Teranishi nor Poellinger discloses that the compound is present as a chloride salt.
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the compound of Teranishi by forming a chloride salt in order to prepare more efficacious pharmaceutical compounds. A person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Further, a person of ordinary skill in the art would have been motivated to select appropriate salts according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success.
While a new ground of rejection is set forth above, the previously applied references are still used on the new ground of rejection.
Applicant argues that the cited references do not disclose or suggest the ability to perform specific contrast imaging of the cancer tissue itself, through positive or negative imaging as demonstrated in the present application. Applicant argues that the cited references do not disclose either imaging of the specific cancers recited in claim 13 or topical administration and contrast imaging effect for breast cancer.
This argument is unpersuasive. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. As discussed above, the references teach the identical indocyanine compound instantly claimed, and the use of a near-infrared fluorescent indocyanine compound for breast cancer diagnosis. Therefore, the use of the indocyanine compound for diagnosing breast cancer is merely applying a known compound to a known application. Particularly, Poellinger teaches contrast imaging (positive imaging) for breast cancer diagnosis. Further, the physiological and optical response such as fluorescence intensity differences that naturally occur when administering a known compound or its derivative are merely inherent properties of that substance. It is well-known that the signal difference between tumor tissue and surrounding normal tissue is due to enhanced permeability and retention effect, clearance, pharmacokinetics, cellular uptake and binding, and microenvironment and aggregation. No references teach away from imaging the tumor using near-infrared fluorescence technology, nor do they contain any disclosures or technical discouragements that would lead a POSITA away from utilizing these known techniques.
The fact that Applicant subsequently named this naturally occurring and already known phenomenon “positive imaging” or certified it with experimental data when a POSITA administers the same known material according to the prior art does not impart patentability to a method of using a known compound. As discussed above, the cited references teach topical administration. Further, selecting or modifying a specific administration method amounts to routine optimization within the skill of a POSITA. A POSITA would have been motivated to optimize its administration method according to the specific requirements of the intended application in order to best achieve optimum treatment efficacy. The cited references teach breast cancer, which is an elected species and included as a species within the Markush group recited in claim 13. Since the elected species (breast cancer and formula I) is subject to an unovercomeable rejection, Applicant’s request to rejoin the non-elected species (other cancer types and formula II) is denied. Further, simply listing target organs where tumor marking is already known amounts to a routine selection. A POSITA would have been motivated to apply the compound for various cancer types in order to expand the applications of the compounds.
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 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. US 9,056,131 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”), Poellinger et al. (Radiology, 2011; cited on PTO-892), and Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Claim 3 of the ‘131 recites a cyclodextrin-bonded indocyanine compound represented by formula 11
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489
861
media_image6.png
Greyscale
, which reads on the compound of Formula I of instant claims when R is -OCH3 and s is 3.
Claims of the ‘131 do not recite contrast imaging (positive imaging) of the cancer based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘131 do not recite breast cancer, topical administration, and chloride salt.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine a specific administration route (topical administration) and a specific compound form (chloride salt) for effective breast cancer imaging with the compound of the ‘131 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method and salt according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘131, which is an identical compound as claimed, together with the known method of administration and salt form for the known application of breast cancer imaging in order to expand the applications of the compound.
Claims 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 15, and 88 of U.S. Patent No. US 9,844,606 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”), Poellinger et al. (Radiology, 2011; cited on PTO-892), and Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
Claim 15 of the ‘606 recites a cyclodextrin-bonded indocyanine compound represented by formula 19
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336
522
media_image2.png
Greyscale
, which reads on the compound of Formula I of instant claims. Claims 1 and 2 of the ‘606 recite a method of diagnosing a body part such as breast by near-infrared fluorescence. Claim 88 of the ‘606 recites that the method can provide marking of tumor.
Claims of the ‘606 do not recite contrast imaging (positive imaging) of the cancer (breast cancer) based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘606 do not recite breast cancer, topical administration, and chloride salt.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine a specific administration route (topical administration) and a specific compound form (chloride salt) for effective breast cancer imaging with the compound of the ‘606 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method and salt according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘606, which is an identical compound as claimed, together with the known method of administration and salt form for the known application of breast cancer imaging in order to expand the applications of the compound.
Claims 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10,086,090 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”), Poellinger et al. (Radiology, 2011; cited on PTO-892), and Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
claim 1 of the ‘090 recites a cyclodextrin-bonded indocyanine compound represented by formula 19
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407
638
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Greyscale
, which reads on the compound of Formula I of instant claims.
Claims of the ‘090 do not recite contrast imaging (positive imaging) of the cancer (breast cancer) based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘090 do not recite breast cancer, topical administration, and chloride salt.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine a specific administration route (topical administration) and a specific compound form (chloride salt) for effective breast cancer imaging with the compound of the ‘090 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method and salt according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘090, which is an identical compound as claimed, together with the known method of administration and salt form for the known application of breast cancer imaging in order to expand the applications of the compound.
Claims 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. US 10,350,310 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”), Poellinger et al. (Radiology, 2011; cited on PTO-892), and Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
claim 5 of the ‘310 recites a cyclodextrin-bonded indocyanine compound represented by formula 20
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274
669
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Greyscale
, which reads on the compound of Formula I of instant claims except the difference in the spatial orientation and attachment geometry of the cyclodextrin units relative to the central fluorophore. They are regioisomeric variants or positional isomers (isomerization equilibrium) representing different connectivity patterns of the same functional components. Compounds which are positional isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See MPEP § 2144.09.
Claims of the ‘310 do not recite contrast imaging (positive imaging) of the cancer (breast cancer) based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘310 do not recite breast cancer, topical administration, and chloride salt.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to combine a specific administration route (topical administration) and a specific compound form (chloride salt) for effective breast cancer imaging with the compound of the ‘310 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method and salt according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘310, which is an identical compound as claimed, together with the known method of administration and salt form for the known application of breast cancer imaging in order to expand the applications of the compound.
Claims 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. US 11,344,632 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”), Poellinger et al. (Radiology, 2011; cited on PTO-892), and Paulekuhn et al. (Journal of medicinal chemistry, 2007; cited on PTO-892).
claim 10 of the ‘632 recites a cyclodextrin-bonded indocyanine compound represented by formula 19
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301
549
media_image5.png
Greyscale
, which reads on the compound of Formula I of instant claims.
Claims of the ‘632 do not recite contrast imaging (positive imaging) of the cancer (breast cancer) based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘632 do not recite breast cancer, topical administration, and chloride salt.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
As discussed above, Paulekuhn discloses that salt formation is a well-known technique to modify and optimize the physical chemical properties of an ionizable compound (page 6665, column 1, ¶ 1). Paulekuhn discloses that properties such as solubility and stability can be influenced by using a variety of pharmaceutically acceptable counterions and that modifying these physical chemical properties may also lead to changes in biological effects such as pharmacodynamics and pharmacokinetics, including bioavailability and toxicity profile (page 6665, column 1, ¶ 1). Paulekuhn discloses that chloride ions are the most frequently utilized anionic counterions for the formation of salts as active pharmaceutical ingredients (abstract).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to combine a specific administration route (topical administration) and a specific compound form (chloride salt) for effective breast cancer imaging with the compound of the ‘632 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Paulekuhn teaches that chloride can be used in order to form a salt and enhance the stability, solubility, and bioavailability of pharmaceutical compounds. Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method and salt according to the specific requirements of the intended application through salt screening. Choosing a specific salt is a matter of routine optimization for a person skilled in the art, as taught by Paulekuhn. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘632, which is an identical compound as claimed, together with the known method of administration and salt form for the known application of breast cancer imaging in order to expand the applications of the compound.
Claims 13, 20, 25-27, and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12,509,587 in view of Teranishi et al. (US 2019 0262477; cited on PTO-892; “Teranishi”) and Poellinger et al. (Radiology, 2011; cited on PTO-892).
claim 1 of the ‘587 recites a crystal of 3-(3-{[3-(cyclomaltoheptaos-21-O-yl)propyl]amino}-3-oxopropyl)-2-{(1E)-2-[(3E)-3-{(2E)-2-[3-(3-{[3-(cyclomaltoheptaos-21-O-yl)propyl]amino}-3-oxopropyl)-1,1-dimethyl-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-methoxycyclohex-1-en-1-yl]ethen-1-yl}-1,1-dimethyl-1H-benzo[e]indol-3-ium chloride, which reads on the compound of formula (I) of instant claims present as a chloride salt.
Claims of the ‘587 do not recite contrast imaging (positive imaging) of the cancer (breast cancer) based on a difference between the near-infrared fluorescence emitted from the cancer tissue and the near-infrared fluorescence emitted from the surrounding normal tissue (stronger fluorescence in cancer tissue). Claims of the ‘587 do not recite breast cancer and topical administration.
As discussed above, Teranishi discloses that the composition comprising the cyclodextrin-bonded indocyanine compound can be applied to medical operations and medical diagnoses in which near-infrared fluorescence is emitted by administering the compound to a body part, such as breast and it is applicable to the identification of a sentinel lymph node in a cancer such as breast cancer (page 11, ¶ 105; page 12 ¶ 106). Teranishi discloses that the compound can be topically administered to a body (page 1, ¶ 2).
As discussed above, Poellinger discloses fluorescence near-infrared imaging using indocyanine green for breast cancer detection (abstract). Poellinger discloses that fluorescence exhibits a difference between tumors and surrounding breast tissue, with fluorescence from the cancer tissue being stronger than that from the surrounding tissue (abstract; Figures 2 and 5).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to combine a specific administration route (topical administration) for effective breast cancer imaging with the compound of the ‘587 to reach the claimed method. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Teranishi teaches that the compound can be used for breast cancer imaging via topical administration and Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. Further, functional limitations that merely recite a desired result, outcome, or mechanism of action, such as “the near-infrared fluorescence emitted from the cancer tissue is stronger than that from the surrounding tissue,” do not distinguish a claimed product or process from the prior art if the underlying structure or method step is otherwise identical or obvious. Reciting a functional property inherently possessed by an obvious compound fails to confer patentability. Inherent functional characteristics or predictable properties do not confer patentability on an otherwise obvious chemical entity. Discovering a previously unknown mechanism or biological pathway does not transform a known chemical entity into a patentable new composition. Accordingly, the functional limitations of instant claims 13 and 27 are unpatentable. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." 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. See MPEP § 2112. Further, a person of ordinary skill in the art would have been motivated to select an appropriate administration method according to the specific requirements of the intended application. Such optimization is a routine practice that would be obvious for a person of ordinary skill in the art to employ with a reasonable expectation of success. Accordingly, a person of ordinary skill in the art would have been motivated to utilize the compound of the ‘587, which is an identical compound as claimed, together with the known method of administration for the known application of breast cancer imaging in order to expand the applications of the compound.
While a new ground of rejection is set forth above, the previously applied references are still used for the new ground of rejection.
Applicant argues that neither the reference claims nor Teranishi teaches or suggests the discrimination step of amended claims such as discriminating a cancer tissue from surrounding normal tissue on the basis of a fluorescence intensity difference.
This argument is unpersuasive. As discussed above, the combination of the referenced claims and the cited references render the claimed method obvious. Specifically, Poellinger teaches that such an indocyanine compound can be used for contrast imaging of breast cancer with stronger fluorescence in tumor tissue than surrounding normal tissue. The administration of a known compound to target tissues inherently results in observable physiological and optical responses such as differential fluorescence intensity due to varying tissue permeability. The inherent property, mechanism, or operational outcome of a known compound or method does not impart patentability to an otherwise unpatentable claim.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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, Michael G 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.
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.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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