DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-15 are pending in this application.
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 .
Priority
This application is a 35 USC 111(a) filing that is a continuation in part of US application No. 17/014,803 filed on 8 Sep. 2020 (now US 11,801,315 A1), which is a continuation of US application No. 16/083,747 filed on 10 Sep. 2018 (now US 10,765,763 A1), which is a 35 US 371 National Stage filing of international application No. PCT/US2017/021623 filed on 9 Mar 2017 and claims benefit under 35 USC 119(e) to US provisional application Nos. 62/445,555 and 62/305,769 filed on 12 Jan. 2017 and 9 Mar. 2016, respectively.
Information Disclosure Statement
An information disclosure statement (IDS) has not been filed for the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0079635 A1; published 20 Mar. 2014; see attached 892).
Wang et al. teach molecular probes for detecting lipid composition and method of detecting myelin in a subject including administering to the subject a molecular probe that includes a fluorescent trans stilbene derivative and detecting the amount or distribution of the molecular probe in a tissue of interest of the subject (see title and abstract). Wang et al. teach molecular probes of formula
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wherein R10 and R11 and/or R12 and R13 may be linked to form a cyclic ring wherein the ring is aryl or heteroaryl ([0005]-[0006]) and wherein the molecular probe includes a radiolabel including at least one of 125I or 18F ([0007]). Aryl groups include naphthyl ([0036]). Wang et al. teach compounds 7
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([0166]), 125I-9
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([0156]),
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, and
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([0096]). The first two compounds read on compounds of formula (I)
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wherein R1=H or Me (lower alkyl); R2=H; R3=NR’R’’, R’=R’’=H or 125I (radiolabel); and R4=R5=R6=R7=R9=H. Wang et al. teach ring 18F-fluorination. Wang et al. teach ring fluorination
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([0096]). Wang et al. teach fluoroalkylation:
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([0087]) and
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(0098]). Wang et al. teach radiolabeling CIC with C-11 and conducting whole body microPET studies in wild-type rats ([0201]). Wang et al. teach a method of detecting a myelin related disorder including the steps of labeling myelin in vivo in the animal’s brain tissue wherein the myelination disorder includes multiple sclerosis ([0065], [0132]-[0133], [0135]-[0136]). Wang et al. teach autoradiography in mice using [125I]9. The results indicate that the autoradiographic visualization was consistent with histological staining of myelinated regions ([0165]). Wang et al. teach comparing myelinated regions of the brain in normal tissues of control populations to those of suspected animal. Myelin may be virtually absent in lesioned areas ([0135]). Wang et al. teach parenteral administration ([0128]). Wang et al. teach that the chelating group can have the following formula
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([0112]). The molecular probe can be coupled to a near infrared probe ([0118]).
Wang et al. do not exemplify a method of detecting myelin in vivo in a subject’s tissue the method comprising (i) administering to the subject a radioligand having formula (I).
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the method of Wang et al. (method of detecting myelin in vitro in a subject’s tissue, the method comprising (i) administering to the subject’s tissue [125I]-9, and (ii) detecting the location and distribution of the radioligand that is bound to and/or labels myelin in the tissue) by intravenously administering the [125I]-9 and so that the method detects myelin in vivo in a subject’s tissue as taught by Wang et al. because it would have been expected to advantageously enable in vivo diagnosis of myelin related disorders such as multiple sclerosis (MS) and/or monitoring of myelin changes. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Wang et al. by further comparing the detected distribution and/or amount of the radioligand to a control wherein a decreased distribution and/or amount of the radioligand compared to control is indicative of a decrease in myelination of the presence of myelination disorder such as MS as taught by Wang et al. because comparing would have been expected to enable a relative determination of the degree of demyelination enabling a diagnosis of the demyelination disorder.
Wang et al. do not further teach a compound of instant formula (I) wherein at least one of R4 and R5 is radiolabel such as 18F or a radioligand having the formula
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or the compound
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or exemplify a method of detecting myelin wherein the radioligand is detected by PET.
However, it would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Wang et al. so that compound 7 further comprises a ring [18F]fluorine to arrive at
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and then administer that compound to a subject to detect in vivo the location, distribution and/or amount of that compound is bound to or labels myelin by PET in tissue as taught by Wang et al. because the modifying and administering would have been expected to enable in vivo PET detection of myelin related disorders and/or PET monitoring myelin changes.
Wang et al. do not further exemplify the claimed method wherein the radioligand further comprises a chelating group or near infrared group.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Wang et al. so that the radioligand further comprises a chelating group or near infrared group as taught by Wang et al. because the chelating group would have been expected to enable MRI or radiometal detection of myelin changes and the NIR label would have been expected to enable NIR detection of myelin changes.
Wang et al. do not further disclose a radioligand of formula
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or formula
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.
It would have been obvious to a person of ordinary skill in art before the effective filing date to modify Wang et al. so that the corresponding R10 and R11 of the above compounds 7 and [125I]9 are attached to form a naphthyl or quinolinyl and optionally so that the naphthyl compound 7 derivative contains a 18F-fluoroalkyl (pentyl) amine as taught by Wang et al. because the attaching would have been expected to enable an equivalent homologue derivative capable of detecting (de/re)myelination and because the 18F-fluoroalkylation would have been expected to enable PET detection the (de/re)myelination. Homologs are prima facie obvious due to a general expectation of similar properties. See In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2014/0079635 A1; published 20 Mar. 2014; see attached 892), in view of Briard et al. (J. Med. Chem.; published 2009; see attached 892).
Wang et al. teach as discussed above.
Wang et al. do not further teach a compound of instant formula (I) wherein R3 is radiolabeled acetyl group or compound having the formula
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.
Briard et al. teach single step high yield radiosynthesis and evaluation of a sensitive 18F-laebeled ligand for imaging brain peripheral benzodiazepine receptors with PET (see title). Briard et a. teach [18F]9
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(scheme 1). Briard et al. teach that [18F]9 was produced easily through a single and highly efficient step, the reaction of [18F] fluoride ion with the corresponding bromo precursor 8 (see abstract):
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(scheme 1). Fluorine-18 emits a low-energy positron during decay and this permits high spatial resolution of modern PET cameras (see pg. 689). [18F]9 was easily prepared in a single step from the bromo precursor 8 and cyclotron-produced NCA [18F]fluoride ion under conditions previously established. Almost quantitative incorporation of [18F]fluoride ion was achieved experimentally (pg. 692). The single step high-yield radiosynthesis of [18F]9 is a significant advantage over the radiosyntheses of the other two evaluated 18F-labeled BR radioligands known from the aryloxyanilide class (see pg. 693).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Wang et al. so that the obvious naphthyl/quinolinyl derivative contains an 18F acetyl group attached to the amine as taught by Wang et al. and Briard et al. because the obvious 18F acetamide would have been expected to advantageously enable an 18F-label obtained in single step high yield synthesis and a PET imaging method devoid of defluorination.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,382,991 B2, in view of Wang et al. (US 2014/0079635 A1; published 20 Mar. 2014; see attached 892), and Briard et al. (J. Med. Chem.; published 2009; see attached 892).
Claims 1-10 of U.S. Patent No. 11,382,991 B2 claim a method of detecting myelin, the method comprising (i) administering to the animal a molecular probe of formula
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and (ii) detecting the molecular probe in the animal using an in vivo imaging modality to determine the myelinated regions of the animal the molecular probe comprising a radiolabel including 125I and 18F or chelating group or a NIR group and imaging modality comprising PET and the molecular probe comprising a formula selected from
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and
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.
Claims 1-10 of U.S. Patent No. 11,382,991 B2 do not claim a method wherein the molecular probe has one or more formulae and/ or compounds:
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,
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. Wang et al. do not further claim a method comprising comparing the detected distribution and/or amount of the radioligand to a control, wherein a decreased distribution and/or amount of the radioligand compared to control is indicative of a decrease in myelination of the tissue and the presence of myelination related disorder such as multiple sclerosis.
Wang et al. teach as discussed above.
Briard et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-10 of U.S. Patent No. 11,382,991 B2 by further comparing the detected distribution and/or amount of the radioligand to a control wherein a decreased distribution and/or amount of the radioligand compared to control is indicative of a decrease in myelination of the presence of myelination disorder such as MS as taught by Wang et al. because the comparing would have been expected to enable a relative determination of the degree of demyelination enabling a diagnosis of the demyelination disorder. It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-10 of U.S. Patent No. 11,382,991 B2 so that I- in the above compound is a 125I or so that diamino stilbene further comprises a ring [18F]fluorine to arrive at
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and then administer that compound to a subject to detect in vivo the location, distribution and/or amount of that compound is bound to or labels myelin by PET in tissue as taught by Wang et al. because the modifying and administering would have been expected to enable in vivo PET detection of myelin related disorders in vivo and/or PET monitoring myelin changes. It would have been obvious to a person of ordinary skill in art before the effective filing date to modify claims 1-10 of U.S. Patent No. 11,382,991 B2 so that the corresponding R10 and R11 of above compounds are attached to form a naphthyl or quinolinyl and optionally so that the naphthyl derivative contains a 18F-fluoroalkyl (pentyl) amine as taught by Wang et al. because the attaching would have been expected to enable an equivalent homologue derivative capable of detecting (de/re)myelination and because the 18F-fluoroalkylation would have been expected to enable PET detection the (de/re)myelination. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-10 of U.S. Patent No. 11,382,991 B2 so that the obvious naphthyl/quinolinyl derivative contains an 18F acetyl group attached to the amine as taught by Wang et al. and Briard et al. because the obvious 18F acetyl group attached to the amine would have been expected to advantageously enable a single step high yield synthesis and a PET imaging method devoid of defluorination.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,765,763 B2, in view of Wang et al. (US 2014/0079635 A1; published 20 Mar. 2014; see attached 892), and Briard et al. (J. Med. Chem.; published 2009; see attached 892).
Claims 1-14 of U.S. Patent No. 10,765,763 B2 claim a method of detecting myelin in vivo in a subject’s tissue, the method comprising (i) administering to the subject a radioligand including a compound having the formula
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wherein R3 including a radiolabel selected from 18F, 123I, 125I. and 99mTc, and (ii) detecting the location, distribution and/or amount of the radioligand that is bound to and/or labels myelin to detect myelin in the tissue and (iii) comparing the detected distribution and/or amount of the radioligand to a control wherein a decreased distribution and/or amount of the radioligand compared to control is indicative of a decrease in myelination of the tissue and the presence of a myelination disorder wherein the radioligand is detected by PET wherein the radioligand is administered parenterally wherein the radioligand further comprises a chelating group or NIR group and wherein the neurodegenerative disease is MS.
Claims 1-14 of U.S. Patent No. 10,765,763 B2 do not claim a method wherein the molecular probe has one or more formulae and/ or compounds:
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Wang et al. teach as discussed above.
Briard et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-14 of U.S. Patent No. 10,765,763 B2 so that compound comprises a ring [18F]fluorine to arrive at
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and then administer that compound to a subject to detect in vivo the location, distribution and/or amount of that compound is bound to or labels myelin by PET in tissue as taught by claims 1-14 of U.S. Patent No. 10,765,763 B2 and Wang et al. because the modifying would have been expected to enable a 18F attached to sp2 hybridized carbon and the administering would have been expected to enable in vivo PET detection of myelin related disorders and/or PET monitoring myelin changes. It would have been obvious to a person of ordinary skill in art before the effective filing date to modify claims 1-14 of U.S. Patent No. 10,765,763 B2 so that the corresponding R10 and R11 of above compounds are attached to form a naphthyl or quinolinyl ring and optionally so that the naphthyl derivative contains a 18F-fluoroalkyl (pentyl) amine as taught by Wang et al. because the attaching would have been expected to enable an equivalent homologue derivative capable of detecting (de/re)myelination and because the 18F-fluoroalkylation would have been expected to enable PET detection the (de/re)myelination. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-14 of U.S. Patent No. 10,765,763 B2 so that the obvious naphthyl/quinolinyl derivative contains an 18F acetyl group attached to the amine as taught by Wang et al. and Briard et al. because the obvious [18F]fluoroacetamide would have been expected to advantageously enable a single step high yield synthesis and a PET imaging method devoid of defluorination.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,801,315 B2, in view of Wang et al. (US 2014/0079635 A1; published 20 Mar. 2014; see attached 892), and Briard et al. (J. Med. Chem.; published 2009; see attached 892).
Claims 1-17 of U.S. Patent No. 11,801,315 B2 claim a method of detecting myelin in vivo in a subject’s central nervous system tissue, the method comprising (i) administering optionally parenterally to the subject a radioligand including a compound having the formula
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wherein R1 includes a radiolabel selected from the group consisting of 18F, 123I, 125I, and 99mTc, and (ii) detecting the location, distribution and/or amount of the radioligand that is bound to and/or labels myelin to detect myelin in vivo, and (iii) comparing the detected distribution and/or amount of the radioligand that is bound to and/or labels a control wherein a decreased distribution and/or amount of the radioligand that is bound to and//or labels myelin compared to control is indicative of a decrease in myelination of the tissue and the presence of a myelination disorder such as AD wherein the radioligand is detected using PET and wherein the radioligand optionally further comprises a chelating group or a NIR group.
Claims 1-17 of U.S. Patent No. 11,801,315 B2 do not claim a method wherein the molecular probe has one or more formulae and/ or compounds:
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Wang et al. teach as discussed above.
Briard et al. teach as discussed above.
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify claims 1-17 of U.S. Patent No. 11,801,315 B2 so that the comprises a ring [18F]fluorine to arrive at
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and then administer that compound to a subject to detect in vivo the location, distribution and/or amount of that compound that is bound to or labels myelin by PET in tissue as taught by claims 1-17 of U.S. Patent No. 11,801,315 B2 and Wang et al. because the modifying would have been expected to enable an 18F attached to sp2 hybridized carbon and administering would have been expected to enable in vivo PET detection of myelin related disorders and/or PET monitoring myelin changes. It would have been obvious to a person of ordinary skill in art before the effective filing date to modify claims 1-17 of U.S. Patent No. 11,801,315 B2 so that the corresponding R10 and R11 of above compounds are attached to form a naphthyl or quinolinyl ring and optionally so that the naphthyl derivative contains a 18F-fluoroalkyl (pentyl) amine as taught by Wang et al. because the attaching would have been expected to enable an equivalent homologue derivative capable of detecting (de/re)myelination and because the 18F-fluoroalkylation would have been expected to enable PET detection the (de/re)myelination. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify claims 1-17 of U.S. Patent No. 11,801,315 B2 so that the obvious naphthyl/quinolinyl derivative contains an 18F acetyl group attached to the amine as taught by Wang et al. and Briard et al. because the obvious [18F]fluoroacetamide would have been expected to advantageously enable a single-step high-yield synthesis and a PET imaging method devoid of defluorination.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618