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 23,26,32,34-39,41,42,44,45,49 and 50 are pending in the application. Claims 27,40,43 and 46-48 are cancelled and claim 50 newly added in the amendment filed 4/21/26.
Any objections and/or rejections from previous office actions that have not been reiterated in this office action are obviated.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode
contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35,36 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claims 35,36 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement as stated in the office action
mailed 10/23/25.
Applicant asserts that the specification clearly discloses that the TBR can be 2.75 to 15 2-24 hours after administration, 7.6 being included in the range of 2.75 to 15 as well as 7.6 to 15 being within the range 2.75 to 15 10-24 hours, and four hours are each within the range 2-24 for any dye disclosed therein. Moreover, paragraph [0228] states that any TBR discussed above, i.e. any single TBR or range thereof (which include 7.6 and 7.6-15), can be present at the following intervals, 2-24 hours, 4-10 hours, 12-24 hours, 15-18 hours and 18-24 hours. Also, as previously presented, paragraph [0141] of the specification explicitly states, “Ranges provided herein are understood to be shorthand for all of the values within the range.”
The Examiner asserts that although the specification states the TBRs stated above by Applicant, the specification does not describe that the imaging agent of claim 23 ZW-800-1 provides for the target cell to background ratio is greater than 7.6 five to ten hours after administration, the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration or the target cell to background ratio four hours after administration is 7.6.
Although the 7.6 being included in the range of 2.75 to 15 as well as 7.6 to 15 being within the range 2.75 to 15 10-24 hours, the specification does not describe which combination of the dyes, linkers and/or targeting moieties explicitly describes the target cell to background ratio is greater than 7.6 five to ten hours after administration, the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration or the target cell to background ratio four hours after administration is 7.6. The specification merely states generally that the TBR can be 2.75 to 15 2-24 hours after administration, 7.6 being included in the range of 2.75 to 15 as well as 7.6 to 15 being within the range 2.75 to 15 10-24 hours, and four hours are each within the range 2-24.
New Grounds of Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 50 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 50, the phrase "such that" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41,42,44 and 45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 41,42,44 and 45 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The instant claims 41,42,44 and 45 comprise an optional linking group between the imaging agent and the targeting vector while the instant claim 37 to which the instant claims 41,42,44 and 45 depend requires a PEG linking group. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The dependent claims fall therewith.
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) 23,26,34-36,49 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (Nature Biotechnol. 2013, 31, 148-154) in view of de Valk et al. (Clin. Cancer Res. 2020, 26, 3990-3998).
Choi et al. (Nature Biotechnol. 2013, 31, 148-154) discloses image-guided surgery of tumor
tissue with the zwitterionic near-infrared (NIR) fluorophore imaging agent cRGD-ZW100-1 (Figure 1)
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wherein the cRGD-ZW800-1 encompasses generating an imaging agent dye of the instant claim 23.
It is respectfully pointed out that instant claims 23 and 50 are product-by-process limitations. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed Cir. 1985). See MPEP 2113.
The ZW800-1 encompasses the ZW800-1 of the instant claims.
The phenoxy moiety of cRGD-ZW100-1 encompasses the phenoxy moiety of the instant claims, has the same properties and is capable of the same functions, such as a.) configured to stabilize the imaging agent dye in an acidic environment or a target cell causing the imaging agent to fluoresce and configured to cause the imaging agent dye to metabolize in blood external to the target cell rendering the imaging agent non-fluorescent, b.) a ratio of the signal detected from the imaging agent relative to a background is at least two times greater than a ratio of a signal relative to a background detected from an imaging agent that does not have the labile linker and c.) increasing a target cell to background ratio after administration of the imaging agent dye more than target cell to background ratio of an imaging agent dye without a labile linker.
The cRGD encompasses the cRGD of the instant claims.
The cRGD-ZW100-1 is used for image-guided surgery upon intravenous administration into mice
(human melanoma cell) tumor model systems (abstract; p150, Tumor targeting and image-guided surgery) that encompasses the administration of the imaging agent for the methods of imaging tumor cells and treating cancer of the instant claims.
The mice were irradiated and imaged (Figure 3a,b) that encompasses the irradiating and imaging of the methods of imaging tumor cells and treating cancer of the instant claims.
The TBR is examined 4 hours after administration (p150, Tumor targeting and image-guided surgery; Figure 3) that encompasses irradiating and detecting a signal from the imaging agent 2-4 hours after administration of the instant claims.
The first-in-human clinical trials of ZW800-1 are in process and the ZW800-1-targeted small
molecules will have reasonable human dosing (p152, right column) and therefore, the use in a human is envisioned and encompasses the human subject of the instant claim 27.
The cRGD-ZW100-1 NIR fluorophore exhibits low background and has a TBR of 17.2 ± 1.2 (mean ± s.d.) 4 hours after administration that encompasses increasing the tumor-to-background ratio of an imaging agent dye and at least two hours after administration of the instant claims.
The instant invention of the instant claims uses the identical imaging agent cRGD-ZW100-1 of Choi et al. for analogous methods of imaging and treating but does not include any different method steps, any different conditions or any different imaging techniques to explain the observed results.
The cRGD-ZW100-1 encompasses the cRGD-ZW100-1 of the instant claims, has the same
properties and is capable of the same functions, such as a target cell to background ratio is greater than 7.6 five to ten hours after administration of the imaging agent, and wherein the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration and a target cell to background ratio four hours after administration is 7.6.
Also, 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).
Choi et al. does not disclose a dose of about 0.25 mg to about 5.0 mg, the administration 18 hours prior to surgery displays the highest TBR, or the target cell to background ratio four hours after administration is 7.6.
de Valk et al. (Clin. Cancer Res. 2020, 26, 3990-3998) discloses cRGD-ZW800-1
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used for the intraoperative visualization of colon cancer provides imaging with improved tumor-to-background ratio having the structure (abstract; p3990, right column, last paragraph; Figure 6).
The cRGD-ZW800-1 used for the intraoperative visualization of colon cancer (abstract; p3991,
Translational Relevance) is administered via intravenous bolus of cRGD-ZW800-1 to human patients 2 to
4 hours prior to surgery (title; p3993, cRGD-ZW800-1 injection time window).
The doses 0.005, 0.015 and 0.05 mg/kg 2 to 4 hours prior to surgery showed a mean TBR of 1.4,4.0 and 4.1, respectively (p3993, cRGD-ZW800-1 injection time window; Supplemental Table 1).
The dose 0.05 mg/kg 18 hours prior to surgery displays the highest TBR of 6.2 and the longer intervals between injection and imaging improved the tumor-to-target background ratio (abstract; p3993, cRGD-ZW800-1 injection time window; Figure 1). Background was specifically reduced for cRGD-ZW800-1 and therefore, leading to a much higher TBR (p3335, left column, first paragraph).
Intraoperative colon tumor imaging was performed and images are shown in Figure 1 (p3991,
Intraoperative NIR imaging of colon tumors).
The surgical procedures are stated in Table S1.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a dose of about 0.25 mg to about 5.0 mg of cRGD-ZW800-1 to a human subject as de Valk et al. discloses examined doses (0.05 mg/kg ≈ 3.1 mg in a 62 kg average weight human) that provide for the advantage of improved tumor-to-background ratio.
de Valk et al. further teaches of
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(Fig. 2B) that
encompasses the Fig. 19 of the instant claims which shows
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cRGD-ZW00-1 TBR at 18 hours. Therefore, it would have been predictable to one of ordinary skill in the art that the cRGD-ZW00-1 of Choi et al., de Valk et al. and cRGD-ZW00-1 of the instant claims have the same properties and are capable of the same functions, such as the target cell to background ratio four hours after administration is 7.6 with a reasonable expectation of success.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the cRGD-ZW100-1 of Choi et al. may observe a peak target-to-background ratio 18-24 hours after administration as de Valk et al. teaches that administration of the identical cRGD-ZW100-1 of Choi et al. and of the instant claims 18 hours prior to surgery displays the highest TBR and the longer intervals between injection and imaging improved the tumor-to-target background ratio for imaging.
Choi et al. does not explicitly disclose a target to background ratio is greater than 7.6 five to ten hours after administration or the target cell to background ratio is 7.6 to 15 ten to twenty-four hours
after administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the TBR of cRGD-ZW100-1 of Choi et al. may observe a target to background ratio is greater than 7.6 five to ten hours after administration as de Valk et al. further teaches of
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(Fig. 2B) that encompasses the Fig. 19 of the instant claims which shows
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cRGD-ZW00-1 TBR at 18 hours. Therefore, it would have been predictable to one of ordinary skill in the art that the cRGD-ZW00-1 of Choi et al., de Valk et al. and cRGD-ZW00-1 of the instant claims have the same properties and are capable of the same functions, such as a target to background ratio is greater than 7.6 five to ten hours after administration or the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration with a reasonable expectation of success.
The instant invention uses the identical compound cRGD-ZW100-1 of Choi et al. for analogous
methods of imaging and treating and does not include any different method steps, any different
conditions or any different imaging techniques to explain the observed results.
Also, 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 assertions with regards to Frangioni, Hyun, Njiojob, Bao, and Mukkamala are moot as they are not included in the instant rejection.
Applicant asserts that Claim 23 is clearly directed to a method of imaging, comprising, among other things, the step of generating an imaging agent dye by conjugating a targeting vector to a charged balanced imaging agent via introduction of a labile linker, where the labile linker has certain advantageous and unexpected functional properties. Neither Choi nor Frangioni disclose this method step or any synthesis scheme. This step is assumed by the Examiner. Such an assumption is only proper if the prior art device would necessarily perform the claimed method in its normal and usual operation.
The methods of the instant claims merely comprise administration of the imaging agent dyes and imaging of the imaging agent dyes.
The instant invention uses the identical compound cRGD-ZW100-1 of Choi et al. for analogous
methods of imaging and treating as Choi et al. comprises the administration and imaging of the analogous imaging agent dyes. The instant claims do not include any different method steps, any different conditions or any different imaging techniques to explain the observed results.
Therefore, the Examiner’s assertions are proper wherein the imaging agent dyes are used in their normal and usual operation of imaging and/or treating tumor cells.
The arguments of counsel cannot take the place of evidence in the record. Examples of attorney
statements are not evidence and must be supported by an appropriate affidavit or declaration include statements regarding unexpected results. MPEP § 716.01 (c).
Applicant asserts that the particular dose of 2.5 mg to 5 mg is neither disclosed nor contemplated by Choi or Frangioni, and there is no evidence in the prior art to suggest the claimed unexpected properties of the labile linker would have been observed in the prior art at the same dosages and in a human subject. It is noted that the Court found nonobviousness can be shown when a claimed invention is shown to have unexpectedly superior properties when compared to the prior art, in particular, where the prior art is applicants own similar compounds, but the newly claimed compounds
provide superior effects, such as with respect to potency and toxicity at certain dosing.
The reference of de Valk et al. was used to teach of the dose of cRGD-ZW800-1 0.05 mg/kg ≈ 3.1 mg in a 62 kg average weight human that provide for the advantage of improved tumor-to-background ratio.
The cRGD-ZW800-1 of Choi and/or de Valk is not only a similar compound to the cRGD-ZW800-1 of the instant claims but has an identical structure to the cRGD-ZW800-1 of the instant claims. The phenoxy group of the cRGD-ZW800-1 of Choi and/or de Valk is analogous to the phenoxy group of the instant claims, has the same properties and is capable of the same functions as stated above.
Applicant asserts that the present application is similar to Example 10 in that the authors of the prior art (one of which is a listed inventor of the present application) did not consider the improved and superior properties (i.e., the claimed TBR) of the compound when used in the claimed imaging method and administered at the claimed dosing. There is no disclosure in the cited art which suggests the authors understood or even contemplated the claimed method with respect to generating the imaging agent dye by introducing the labile linker so as to induce the claimed effects, such as the relatively high TBR as compared to the prior art and at the claimed dose.
The reference of de Valk et al. teaches of
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(Fig. 2B) that encompasses the Fig. 19 of the instant claims which shows
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cRGD-ZW00-1 TBR at 18 hours.
Therefore, it would have been predictable to one of ordinary skill in the art that the cRGD-ZW00-1 of Choi et al., de Valk et al. and cRGD-ZW00-1 of the instant claims have the same properties and are capable of the same functions, such as a target to background ratio is greater than 7.6 five to ten hours after administration or the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration with a reasonable expectation of success.
Claim(s) 23 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (Nature Biotechnol. 2013, 31, 148-154) in view of Mulder et al. (Am. J. Nucl. Med. Mol. Imaging. 2018;8(5):282-291).
Choi et al. (Nature Biotechnol. 2013, 31, 148-154) discloses that stated above.
Mulder et al. (Am. J. Nucl. Med. Mol. Imaging. 2018;8(5):282-291) discloses a dual labeled
cRGD-based PET/optical tracer for pre-operative and intraoperative treatment of colorectal cancer (title; p289, Conclusion).
The dual labeled tracer comprises cRGD-ZW800-1-Forte-[89Zr]ZrDFO:
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that is injected into mice bearing orthotopic human colorectal tumors for tumor detection with NIRF imaging (abstract; Figures 1-3; p285, Fluorescence Imaging).
PET/CT permitted clear visualization of the colorectal tumors at 4 and 24 h and allows for image-guided treatment intraoperatively (abstract; p286, PET/CT) which encompasses the radioisotope for PET of the instant claim 32.
The injection and imaging encompasses the administration and detection in the method of imaging tumor cells of the instant claim 23.
Imaging at 4 hours after administration encompasses administering, irradiating and detecting a signal 4 hours after administration of the instant claim 23.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the cRGD-ZW100-1 of Choi et al. with a [89Zr]ZrDFO such as that of Mulder et al. for the advantage of dual labeled cRGD-based PET/optical tracer for pre-operative and
intraoperative treatment that predictably provides improved identification of primary tumor margins from a variety of tumors as well as identification of occult intra-abdominal metastases (Mulder et al. p289, right column, first full paragraph).
Response to Arguments
Applicant’s assertions with regards to Choi et al. is stated above.
The Examiner’s response with regards to Choi et al. is stated above.
The reference of Mulder et al. does teach of the cRGD-ZW100-1 that encompasses the cRGD-ZW100-1 of the instant claims, has the same properties and is capable of the same functions but was used to teach of a dual labeled cRGD-based PET/optical tracer for pre-operative and intraoperative treatment that predictably provides improved identification of primary tumor margins from a variety of tumors as well as identification of occult intra-abdominal metastases.
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 23,26,35,36,49 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,2,6 and 7 of U.S. Patent No. 10,201,621B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method of imaging of U.S. Patent No. 10,201,621 encompasses the method of imaging tissue or cells of the instant claims.
The imaging agents of U.S. Patent No. 10,201,621B2 comprise an analogous dye and targeting ligand cRGD of the instant claims.
The methods of imaging of U.S. Patent No. 10,201,621B2 and of the instant claims comprise contacting a tissue or cells with the imaging agent, irradiating and detecting an optical signal.
The imaging agent dyes of U.S. Patent No. 10,201,621B2 comprise encompass the imaging agent dyes of the instant claims, have the same properties and are capable of the same functions, such as a target cell to background ratio is greater than 7.6 five to ten hours after administration of the imaging agent, and wherein the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration and a target cell to background ratio four hours after administration is 7.6.
The phenoxy moieties of the imaging agent dyes of U.S. Patent No. 10,201,621B2 and of the imaging agents of the instant claims have the same properties and are capable of the same functions, such as a.) configured to stabilize the imaging agent dye in an acidic environment or a target cell causing the imaging agent to fluoresce and configured to cause the imaging agent dye to metabolize in blood external to the target cell rendering the imaging agent non-fluorescent, b.) a ratio of the signal detected from the imaging agent relative to a background is at least two times greater than a ratio of a signal relative to a background detected from an imaging agent that does not have the labile linker and c.) increasing a target cell to background ratio after administration of the imaging agent dye more than target cell to background ratio of an imaging agent dye without a labile linker.
Also, 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 23,26,35,36,49 and 50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 9,023,611B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the method imaging tissue or cells of the U.S. Patent No. 9,023,611B2 encompasses the method of imaging tissue or cells of the instant claims.
The imaging agents of U.S. Patent No. 9,023,611B2 comprise an analogous dye and targeting ligands, not excluding the targeting ligands of the instant claims.
The methods of imaging of U.S. Patent No. 9,023,611B2 and of the instant claims comprise contacting a tissue or cells with the imaging agent, irradiating and detecting an optical signal.
The imaging agent dyes of U.S. Patent No. 9,023,611B2 encompass the imaging agent dyes of the instant claims, have the same properties and are capable of the same functions, such as a target cell to background ratio is greater than 7.6 five to ten hours after administration of the imaging agent, and wherein the target cell to background ratio is 7.6 to 15 ten to twenty-four hours after administration and a target cell to background ratio four hours after administration is 7.6.
The phenoxy moieties of the imaging agent dyes of U.S. Patent No. 9,023,611B2 and of the imaging agents of the instant claims have the same properties and are capable of the same functions, such as a.) configured to stabilize the imaging agent dye in an acidic environment or a target cell causing the imaging agent to fluoresce and configured to cause the imaging agent dye to metabolize in blood external to the target cell rendering the imaging agent non-fluorescent, b.) a ratio of the signal detected from the imaging agent relative to a background is at least two times greater than a ratio of a signal relative to a background detected from an imaging agent that does not have the labile linker and c.) increasing a target cell to background ratio after administration of the imaging agent dye more than target cell to background ratio of an imaging agent dye without a labile linker.
Also, 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 23,26,32,34-39,41,42,44,45,49 and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,6-8,10,12-14,22-25,30 and 32 of copending Application No. 18/641,149 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the imaging agent dyes of copending Application No. 18/641,149 comprising an L linking group, such as PEG bound to the charge balanced imaging agent through an ester group and having the structures of cRGD-ZW800-1, FAP-ZW800-1, KUE-ZW800-1, Bombesin-ZW800-1, cRGD-ZW830-1, FAP-ZW830-1, KUE-ZW830-1, and Bombesin-ZW830-1 encompass the imaging agent dyes of the instant claims, optionally comprising an L linking group, such as PEG bound to the charge balanced imaging agent through an ester group. The imaging agents of the instant claims and the imaging agents of copending Application No. 18/641,149 are used for the method of imaging and for the method of treating cancer by administration of the imaging agent dyes to a human, irradiating the cells, detecting/diagnosing cancer and/or administering a treatment.
The imaging agent dyes of copending Application No. 18/641,149 encompass the imaging agent
dyes of the instant claims, have the same properties and are capable of the same functions, such as a target cell to background ratio is greater than 7.6 five to ten hours after administration of the imaging agent, and wherein the target cell to background ratio is 7.6 to 15 ten to twenty-four hours
after administration and a target cell to background ratio four hours after administration is 7.6.
The phenoxy moieties of the imaging agent dyes of copending Application No. 18/641,149 and of the imaging agents of the instant claims have the same properties and are capable of the same functions, such as a.) configured to stabilize the imaging agent dye in an acidic environment or a target cell causing the imaging agent to fluoresce and configured to cause the imaging agent dye to metabolize in blood external to the target cell rendering the imaging agent non-fluorescent, b.) a ratio of the signal detected from the imaging agent relative to a background is at least two times greater than a ratio of a signal relative to a background detected from an imaging agent that does not have the labile linker and c.) increasing a target cell to background ratio after administration of the imaging agent dye more than target cell to background ratio of an imaging agent dye without a labile linker.
Also, 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant believes amended the claims in a manner that they believe overcomes the rejections. The Applicant will file Terminal Disclaimers to obviate any maintained rejections once it is clear the double patenting rejections are the only remaining rejections.
The new double patenting rejections are disclosed above and therefore, the rejections are maintained.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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