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 .
Specification
The disclosure is objected to because of the following informalities:
On pages 5 and 8, it is unclear whether “[Chem. 1]”, “[Chem. 2]”, and “General Formula (1)” represent the same compound.
On pages 5 and 8, there are “…”after a chemical structure and before the names of General Formulas such as “(1)”, “(2-1)”, “(2-2)”, “(3-1)”, and “(3-2).” It is unclear what these three dots represent.
The mixed use of the terms “General Formula” and “Formula” throughout the specification creates ambiguity as to whether Applicant intends to attribute different technical meanings or limitations to these terms. To overcome this objection, Applicant required to amend the specification to consistently use either “General Formula” or “Formula” throughout.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
The mixed use of the terms “General Formula” and “Formula” within the claim creates ambiguity as to whether Applicant intends to attribute different technical meanings or limitations to these terms. To overcome this objection, Applicant required to amend the claim to consistently use either “General Formula” or “Formula.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112 Indefiniteness
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 1-12 are 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 1, the claim recites “General Formula (1)” and “[Chem. 1].” It is unclear whether “General Formula (1)” and “[Chem. 1]” represent the same compound. Additionally, the use of three dots (“…”) after a chemical structure and before the names of General Formulas such as “(1)”, “(2-1)”, “(2-2)”, “(3-1)”, and “(3-2)” renders the claim indefinite because it is unclear what these three dots represent.
Furthermore, the use of parentheses for introductory text such as “(in General Formula (1),……)”, “(in Formula (2-2),……)”, “(in Formula (3-1),……), and “(in Formula (3-2),……)” renders the claim indefinite because it is unclear why this text is in parentheses. If these parenthetical expressions represent preferences or examples, it may lead to confusion over the intended scope of the claim.
The dependent claims 2-6 and 8-11, and the independent claims 7 and 12 comprising the compound according to claims 1 and 2 fall therewith.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US 2009 0264397; cited on PTO-892) in view of Buschken et al. (US 5416215, 1995; cited on PTO-892).
Regarding claims 1, 3, 4, 8, and 9, Yu discloses a compound comprising the structure of fluorinated dendron such as
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when n is 1 (¶ 340), which reads on the X of general formula (2-2) when m is 2 and the Y of general formula (3-1) of instant claims. Regarding claims 6, 7, 11, and 12, Yu discloses that this moiety with fluorine atoms in spherically symmetric positions (symmetric branching) can greatly elevate the sensitivity for magnetic resonance detection of the 19F signal (¶ 143). Yu discloses that because there is no magnetic resonance imaging (MRI)-detectable endogenous 19F signal, this fluorocarbon moiety can serve as an excellent probe (contrast agent) for in vivo MRI of biochemical processes associated with normal physiological and pathophysiological states (¶ 143). Accordingly, Yu discloses the same intended use of the compound as recited in instant claims 6 and 11. Yu discloses that such a moiety can be attached to an chemical construct (¶ 143). Yu discloses that the fluorocarbon moiety can be attached to DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetate) or peptide for various applications (¶ 221).
Regarding claims 1, 2, 5, and 10, Yu does not disclose the structure of nitroxide radical-containing group
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attached to the fluorocarbon moiety (X-Y moiety of instant claims).
Buschken discloses the structure of 2,2,6,6-tetramethylpiperidine-N-oxyl (TEMP-N-oxyl, TEMPO) and its 4-position substituted derivatives of formula 1,
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where X can be Cl, Br, H, or OH (claim 1), which reads on the structure of the nitroxide radical-containing group of instant claims when R1, R2, R3, and R4 are methyl groups. Buschken discloses that these compounds can be important stabilizers for polymeric materials, and can be useful as redox catalysts, light stabilizers, or ESR (electron spin resonance) spin probes (column 2, lines 14-20).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to couple the fluorocarbon moiety of Yu with the stable TEMPO moiety of Buschken in order to develop an effective 19F MRI contrast agent. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Buschken teaches that the TEMPO moiety can be used as a stable compound, and Yu discloses that the fluorocarbon moiety can be attached to various compounds. Further, a person of ordinary skill in the art would have been motivated to couple the fluorine-rich scaffold with stable nitroxide radical in order to enable faster imaging and boosted sensitivity as a metal-free, safe MRI contrast agent. Accordingly, combining the teachings of Yu and Buschken constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders instant claims obvious.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, and 7 of copending Application No. 18/280,627 (US 2024 0173439; cited on PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-5 and 8-10, claim 1 of the ‘627 recites a fluorine-containing compound
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wherein R1, R2, R3, and R4 can be C1 alkyl groups; X can be
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, L4 can be - CH2-CH2-O-CH2-C(CH2-)3; and q can be 3.
Regarding claims 6, 7, 11, and 12, claims 6 and 7 of the ‘627 recites that the fluorine-containing compound can be used in a contrast medium for MRI diagnosis using fluorine as a detection nucleus, and that a contrast medium for MRI diagnosis using fluorine as a detection nucleus can comprise the fluorine-containing compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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