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 1-6 and 8-15 are pending.
Claims 8-10 and 14-15 are withdrawn.
Claims 1, 2 and 6 are amended
Claim 7 is cancelled.
Claim Rejections - 35 USC § 112
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.
Claims 1-5 and 11-13 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.
Claim 1 lists multiple definitions of the variables used. For example for variable Y, Y is originally defined as
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(instant claim 1, line 9), then changed to
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(instant claim 1, line 20), then again changed to
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(instant claim 1, line 27). This makes the claim confusing as to what Y is actually limited to being. This type of indefiniteness regarding multiple definitions and/or repeating of definitions of a variable is also present for other variables, such as X, Q1, Q2, and Hal.
Furthermore, some variables are used in multiple times in different locations, for example, variable Y is used as a variable in formula (I)
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(instant claim 1) and then again used in
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(instant claim 1) and
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(instant claim 1). It is unclear if all “Y”s are to be the same variable with the same definition or if they all require different definitions. This is also an issue for variable X.
The dependent claims fall therewith.
For compact prosecution purposes, each of the variables is assumed to be the broadest definition given, such as
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.
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 1-6 and 11-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10398791B2 in view of POMPER (WO 2019/157037).
The patent recites the following PSMA compound:
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(claim 1).
The patent does not teach adding Astatine-211 (211At) to the compound.
POMPER teaches PSMA targeted radiotherapy compounds for prostate cancer radiotherapy (abstract). 211At is used for radiopharmaceutical therapy due to its 7.2 hour half-life and 100% alpha emission per decay (Page 7, paragraph 2), which allows for effective alpha radiotherapy (Page 47, paragraph 2). The 211At is added to an aromatic ring on the PSMA compound, such as for example
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, wherein X is 211At (claim 8).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate adding 211At to the compound. The person of ordinary skill in the art would have been motivated to make those modifications, because allows for effective alpha radiotherapy, and reasonably would have expected success because the references are in the same field of endeavor, such as PSMA targeted radiotherapy compounds for prostate cancer radiotherapy.
The compound claimed in the US patent with 211At added to aromatic ring would result in the following structure:
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, which reads on instant claim 1’s formula.
Claims 1-6 and 11-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of U.S. Patent No. 10471160B2 in view of POMPER (WO 2019/157037).
The patent recites the following compound:
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(claim 28), wherein the linker is:
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(claim 28).
The patent does not teach adding Astatine-211 (211At) to the compound.
POMPER teaches PSMA targeted radiotherapy compounds for prostate cancer radiotherapy (abstract). 211At is used for radiopharmaceutical therapy due to its 7.2 hour half-life and 100% alpha emission per decay (Page 7, paragraph 2), which allows for effective alpha radiotherapy (Page 47, paragraph 2). The 211At is added to an aromatic ring on the PSMA compound, such as for example
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, wherein X is 211At (claim 8).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate adding 211At to the compound. The person of ordinary skill in the art would have been motivated to make those modifications, because allows for effective alpha radiotherapy, and reasonably would have expected success because the references are in the same field of endeavor, such as PSMA targeted radiotherapy compounds for prostate cancer radiotherapy.
The compound claimed in the US patent with 211At added to aromatic ring would result in the following structure:
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, which reads on instant claim 1’s formula.
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.
Claims 1-5 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over BENESOVA (Preclinical Evaluation of a Tailor-Made DOTA-Conjugated PSMA Inhibitor with Optimized Linker Moiety for Imaging and Endoradiotherapy of Prostate Cancer. J Nucl Med. 2015.) in view of POMPER (WO 2019/157037).
Regarding claims 1-2, BENESOVA teaches PSMA targeted radiotherapy compounds for prostate cancer radiotherapy (abstract), such as PSMA-617 which has the structure of
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(figure 1), which reads on the formulas in claims 1 and 2, with the exception of having a halogen on the aromatic rings (variable Y in claims 1 and 2).
Regarding claim 3, BENESOVA teaches the PSMA targeting ligand is DOTA (figure 1).
Regarding claim 4, BENESOVA teaches the DOTA compound comprises a metal such as 177Lu (table 1).
Regarding claim 12, BENESOVA teaches the compound is for use in treating prostate cancer (abstract).
BENESOVA does NOT teach adding Astatine-211 (211At) to the compound.
POMPER teaches PSMA targeted radiotherapy compounds for prostate cancer radiotherapy (abstract). 211At is used for radiopharmaceutical therapy due to its 7.2 hour half-life and 100% alpha emission per decay (Page 7, paragraph 2), which allows for effective alpha radiotherapy (Page 47, paragraph 2). The 211At is added to an aromatic ring on the PSMA compound, such as for example
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, wherein X is 211At (claim 8).
Regarding claim 5 and 11, POMPER teaches that 211At is added to the PSMA compound (Page 7, paragraph 2).
Regarding claim 13, POMPER teaches that the radioactive halogen could also be 125I (claim 9).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate adding 211At to the compound. The person of ordinary skill in the art would have been motivated to make those modifications, because allows for effective alpha radiotherapy, and reasonably would have expected success because the references are in the same field of endeavor, such as PSMA targeted radiotherapy compounds for prostate cancer radiotherapy.
Allowable Subject Matter
Claim 6 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant argues, that formula Ie is no longer comprised by the scope of the present invention.
Examiner does not find the argument persuasive because as discussed above, Y is interpreted as the broadest definition provided in instant claim 1, which is
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. As described above, the double patents read on the formula of claim 1, when interpreted with this definition.
Applicant argues, that the claims require the following linker structure, which is not taught by the references:
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. Specifically, the art teaches using a naphtyl structure:
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, not a phenyl structure
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.
Examiner does not find the argument persuasive because as discussed above, Y is interpreted as the broadest definition provided in instant claim 1, which is
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, which includes the naphtyl structure. As described above, the art reads on the formula of claim 1, when interpreted with this definition.
Applicant argues, that changing the linker structure from a naphtyl to a phenyl would be considered unpredictable in the art and would have a structural impact on the compound.
Examiner does not find the argument persuasive because as discussed above, Y is interpreted as the broadest definition provided in instant claim 1, which is
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, which includes the naphtyl structure. As described above, the art reads on the formula of claim 1, when interpreted with this definition. Therefor the motivation to change the naphtyl to a phenyl is not required.
Applicant argues, the compounds of the presently amended claims provide improved radiolabeling efficiency over the compound disclosed in Pomper. Additionally the two step labeling procedure used results in a high radiochemical conversion and radiochemical yield.
In order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the exemplified examples, PSAt-2, PSAt-3 and PSAt-4, are not commensurate in scope with the breadth of the claims. The claims encompass a vast amount of species, including the species taught by the art that reads on the claimed compound of formula I.
Furthermore, the claim set is towards a composition, not a method of making.
For a complete discussion of unexpected results, Applicants are referred to MPEP 716.02 et seq.
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 SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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 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.
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/S.L.M./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights