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 .
Receipt is acknowledged of IDS filed on 07/31/2024.
Claims 1-4, 6-12, 18-28 are pending.
Claims 7-9, 18-20 22, and 24-28 are withdrawn.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-4, 6, 10-12, drawn to a compound having the formula I, Ia or Ib.
Group II, claim(s) 7-9, drawn to a compound having the formula II, IIa or IIb.
Group III, claim(s) 18, drawn to a method for radionuclide therapy.
Group IV, claim(s) 19-20, drawn to a method for therapeutic planning.
Group V, claim(s) 22, drawn to a method for diagnostic imaging.
Group VI, claim(s) 24, drawn to a method for in vitro detection.
Group VII, claim(s) 25, drawn to a method for diagnostic imaging or monitoring.
Group VIII, claim(s) 26, drawn to a method for therapeutic planning of a treatment.
Group IX, claim(s) 27-28, drawn to a method for theragnostic application.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IX lack unity of invention because even though the inventions of these groups require the technical feature of the highlighted section of the following formula
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, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of SCHIBLI (US 9,295,739 B2). SCHIBLI teaches the following general formula:
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(column 97, claim 29). A preferred embodiment is
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(column 71). The difference between the preferred embodiment and instant claim 1 is the ring saturating the N=C bonds in the ring ad adding a methyl (left circle in photo below) and adding an additional carbon to the chain (right circle in photo below).
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. However, the general formula shown above teaches that for the ring: X3 and X4 can be N, R3 can be a C1 alkyl (methyl), k can be 1, and r has a value between 1 and 7 and for the chain: S1 can be a branched C4 alkyl.
While the preferred embodiment differs from Applicants claim, it would be obvious to have the substitutions discussed since the general formula teaches that the variables can embody those differences, which would read on instant 1, where the chelator is DOTA, n is 4 and m is 4.
During a telephone conversation with Csaba Henter on 08/03/2026 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-4, 6, 10-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 7-9, 18-20, 22 and 24-28 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 2 and 4 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 2, it is unclear why the terms “and derivatives thereof, such as p-SCN-DOTA, maleimido-DOTA, DOTA-NHS- -2 - MERCK-5201 ester” and “and derivatives such as p-SCN-NOTA” is in parenthesis. Thus, it is unclear if this is a limitation in the claim or just a preferred embodiment.
While withdrawn, but for applicant’s convenience, it is noted that this situation is present in claim 8 as well.
Regarding claim 2, the “derivatives” does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus of derivatives of sterol encompassed by the claim, since there is no description of the structural relationship of these derivatives provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining a derivative.
While withdrawn, but for applicant’s convenience, it is noted that this situation is present in claim 8 as well.
Regarding claim 2, the terms “DTPA”, “DOTA”, “DFO”, “DFO*”, “DO3A”, “HP-DO3A”, “AAZTA”, “EDTA”, “TETA”, “EHPG”, “HBED”, “NOTA”, “DOTAGA”, “DOTMA”, “TETMA”, “PDTA”, “TTHA”, “LICAM”, and “MECAM”, are not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 2, at the very least, should define “DTPA”, “DOTA”, “DFO”, “DFO*”, “DO3A”, “HP-DO3A”, “AAZTA”, “EDTA”, “TETA”, “EHPG”, “HBED”, “NOTA”, “DOTAGA”, “DOTMA”, “TETMA”, “PDTA”, “TTHA”, “LICAM”, and “MECAM” by their formal name; once “DTPA”, “DOTA”, “DFO”, “DFO*”, “DO3A”, “HP-DO3A”, “AAZTA”, “EDTA”, “TETA”, “EHPG”, “HBED”, “NOTA”, “DOTAGA”, “DOTMA”, “TETMA”, “PDTA”, “TTHA”, “LICAM”, and “MECAM” is defined, the term “DTPA”, “DOTA”, “DFO”, “DFO*”, “DO3A”, “HP-DO3A”, “AAZTA”, “EDTA”, “TETA”, “EHPG”, “HBED”, “NOTA”, “DOTAGA”, “DOTMA”, “TETMA”, “PDTA”, “TTHA”, “LICAM”, and “MECAM” may be subsequently recited.
While withdrawn, but for applicant’s convenience, it is noted that this situation is present in claim 8 as well.
Regarding claim 2, it is rejected under 112b due to the combined use of “selected from the group consisting of” and the use of “or” combining the recited Markush group. See MPEP 2173.05(h) which states Markush format as "a material selected from the group consisting of A, B, and C". This rejection can be obviated by changing “or” to “and” to connect the Markush elements recited.
While withdrawn, but for applicant’s convenience, it is noted that this situation is present in claim 8 as well.
Regarding claim 4, the term "preferably" in claim 4 is a relative term which renders the claim indefinite. The term "preferably" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As drafted, "preferably" within claim 4 renders the metes and bounds of claim 4 undefined (hence rendering claim 4 indefinite) since the artisan has no idea what standard constitutes "preferably".
Furthermore, the limitation "preferably" can also be construed as rendering claim 4 indefinite since the artisan does not know whether the limitations following "preferably" are required limitations of the claim or are merely exemplary embodiments.
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 1-4, 6, 10-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29 of U.S. Patent No. US 9,295,739 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent teaches the following general formula:
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(column 97, claim 29). The general formula shown above teaches that for the ring: X3 and X4 can be N, R3 can be a C1 alkyl (methyl), k can be 1, and r has a value between 1 and 7 and for the chain: S1 can be a branched C4 alkyl, R1 can be NH2, X1 and X2 can be N, R2 can O, X5 can be N, m2 can be 0, Y1 can be O, L1 can be a covalent bond and A1 is H, m1 can be 2, L3 can be an alkyl, M is a radiometal chelator, L2 can be CO, D2 is an acidic group, S2 can be a branched alkyl, Y2 can be O, Y2’ can be N, and D1 can be a halogen (column 97, claim 29), which reads on Applicant’s instant claim 1.
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 1-4, 6, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over SCHIBLI (US 9,295,739 B2).
Regarding claims 1, 2, 4, 6 and 10, SCHIBLI teaches the following general formula:
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(column 97, claim 29). A preferred embodiment is
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(column 71). The difference between the preferred embodiment and instant claim 1 is the ring saturating the N=C bonds in the ring ad adding a methyl (left circle in photo below) and adding an additional carbon to the chain (right circle in photo below).
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. However, the general formula shown above teaches that for the ring: X3 and X4 can be N, R3 can be a C1 alkyl (methyl), k can be 1, and r has a value between 1 and 7 and for the chain: S1 can be a branched C4 alkyl.
While the preferred embodiment differs from Applicants claim, it would be obvious to have the substitutions discussed since the general formula teaches that the variables can embody those differences, which would read on instant 1, where the chelator is DOTA, n is 4 and m is 4, which is the preferred embodiment shown in instant claim 10:
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(instant claim 10).
Regarding claim 3 and 11, the chelator can coordinate a radiometal such as 51Cr (column 17, paragraph 4).
Regarding claim 12, a pharmaceutically acceptable carrier can be added to the composition (column 5, paragraph 3).
Conclusion
No claims are allowable.
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
/JAKE M VU/ Primary Examiner, Art Unit 1618
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