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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 5/20/2026 wherein claims 1-20 were canceled and claim 21 was amended. In addition, the Examiner acknowledges receipt of the acceptable terminal disclaimer filed over US Patent No2. 10,744,212 and 11,730,830.
Note(s): Claims 21-40 are pending.
Priority
This application is a CON of 16/994,127 filed 8/14/2020, now US Patent No. 11,730,830 and 16/994,127 is a CON of 15/069,198 filed 3/14/2016, now US Patent No. 10,744,212.
Note(s): The earliest effective filing date is 3/14/2016 as the pending invention is fully disclosed in Serial No. 15/069,198.
Claim Interpretation
Independent claim 21 is directed a composition comprising
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in combination with at least two solvents selected from PEG-300 , propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, and laurocapram wherein the variables are as set forth therein.
Independent claim 30 is directed to a method of imaging myelin basic protein as set forth therein.
Independent claim 36 is directed to a kit as set forth therein.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 5/20/2026 to the rejection of claims 21-40 made by the Examiner under 35 USC 103, 112, and/or double patenting have been fully considered and deemed persuasive-in-part for the reasons set below.
Double Patenting Rejections
The double patenting rejections are WITHDRAWN because Applicant submitted an acceptable terminal disclaimer.
Written Description Rejection
The outstanding 112 first paragraph (written description) rejection is WITHDRAWN after re-evaluation.
112 Second Paragraph Rejections
The 112 second paragraph rejections of claims 21, 30, and 36 are WITHDRAWN because Applicant amended the claims to overcome the rejection.
The 112 second paragraph rejection over claim 30 is WITHDRAWN after re-evaluation.
103 Rejection
Note(s): The 103 rejection is MAINTAINED-IN-PART as set forth below. The rejection is withdrawn as it relations to claim 30, 36, and claims that depend upon claims 30 or 36 because the cited prior art fails to disclose or render obvious polyvinyl pyrrolidone present in the mixture in an amount of at least 1%.
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 21-26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Tan Hehir et al (US 2010/0310457) in view of Yazdanfar et al (US 2010/0312122) and Siclovan et al (US 2010/0310456).
Independent claim 21 is directed a composition comprising
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in combination with at least two solvents selected from PEG-300 , propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, and laurocapram wherein the variables are as set forth therein.
Claim 22 is directed to various R3 (electron withdrawing groups) such as -CHO, -COR, -COOR, -COOH, -CONH2, -CONHR, -CONR2, -CF3, -CN, C=C(CN)2-SO3h, -NH3, -NR3+, -NO2, -SOR, -SO2R, -SO2NH2, -SO2NHR, or -SOR2NR2.
Claim 23 is directed to various R2 (electron donating groups) values such as -NR’R”, -NHR, -NH2, -NC(NH2)2, -OH, -OR, -SR, -NHCOR, -OCOR, -C6H5, or -CH=CR2.
Claim 24 is directed to R1 groups having 1-6 carbon atoms.
Claim 25 is directed to R1 groups having 1-4 carbon atoms.
Claim 26 is directed to R1 being methyl, ethyl, n-propyl, isopropyl, n-, s-, and t-butyl.
Claim 28 is directed to the compound
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.
Claim 29 is directed to the compound
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.
Tan Hehir et al disclose compounds that are used for imaging myelin basic protein and generating kits thereof (see entire document, especially, abstract). The compounds have the structure
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wherein R1 is an alkyl group; R2 is an electron donating group; and R3 is an electron withdrawing group (page 2, paragraph [0012]; page 8, Formula II). The compound may be in the presence of substances (e.g., solvents) such as propylene glycol and PEG-300, for example (page 3, paragraph [0030]). Electron donating groups in Tan Hehir et al may be selected from -NR’R”, -NHR, -NH2, -OH, -OR, -NHCOR, -OCOR, -R, -C6H5, and -CH=CR2. Electron withdrawing groups include -COH, -COR, -COOR, -COOH, -COCl, -CF3, -CN, C=C(CN)2, -SO3H, -NH3+, -NR3+, and -NO2 (page 3, paragraphs [0035] – [0036]).
In Table III (page 12), Formula Ia wherein R1 = CH3, R2 = NH2, and R3 = CN correspond to the species disclosed in pending claim 29.
Yazdanfar et al is made of record for its disclosure regarding compounds that are used for imaging myelin basic protein during open and minimally invasive surgery (see entire document, especially, abstract). The compounds used for imaging myelin basic protein have the formula
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wherein R1 is an alkyl group (e.g., alkyl having 1-6 carbon atoms), R2 is an electron donating group (e.g., -NH2, NHR, NR’R”, and OR), and R3 is an electron withdrawing group (e.g., -CN, -COOR, and -SO2R) (page 1, paragraphs [0009] – [0011]; page 5, paragraphs [0057] – [0058]).
Siclovan et al is directed to compositions used for imaging myelin basic protein and kits thereof (see entire document, especially, abstract). The compounds used in the compositions have the formula
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wherein R1 is an alkyl group (e.g., alkyl group having 1-6 carbon atoms, preferably, from 1-4 carbon atoms including methyl, ethyl, n-propyl, isopropyl, and n-, s-, and t-butyl), R2 = an electron donating group (e.g., primary, secondary, or tertiary amine or an alkoxy group), and R3 is an alkyl, substituted alkyl, amine, or substituted amine (page 2, paragraph [0013]; page 4, paragraphs [0039] – [0041])). The species of claim 28 is rendered obvious by Siclovan et al (page 8, line 4) which discloses the species
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wherein R1 = CH3, R2 = NH2, and R3 = SO2CH3.
Thus, based on the combined teachings of Tan Hehir et al, Yazdanfar et al, and Siclovan et al, the limitations of claims 21-26, 28, and 29 are met.
Since Tan Hehir et al, Yazdanfar et al, and Siclovan et al all are directed to compounds encompassed by Applicant’s formula
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that are useful for myelin-basic protein imaging or kits thereof, the references may be considered to be within the same field of endeavor. Thus, the reference teachings are combinable. Hence, for the reasons set forth above, the cited prior art renders obvious the pending invention.
APPLICANT’S ASSERTIONS
In summary, it is asserted that independent claim 21 requires at least two solvents selected from PEG-300, propylene glycol, polyvinyl pyrrolidone, polyvinyl alcohol, and Laurocapram. But, the cited references do not provide motivation to combine solvents in an aqueous pharmaceutical carrier. In addition, it is asserted that the pending specification demonstrates that the specific combination of solvents in the claimed aqueous pharmaceutical carrier provides improved nerve-to-tissue contrast that would not have been predicted from the prior art.
EXAMINER’S RESPONSE
All of Applicant’s arguments were considered, but deemed non-persuasive for reasons of record and those below. Specifically, the primary reference (Tan Hehir et al, US 2010/0310457) discloses on page 3, paragraph [0030], that the pharmaceutical carrier refers to a composition which allows the application of the agent material to the site of the application, surrounding tissues, or prepared tissue section to allow the agent to have an effective residence time for specific binding to the target or to provide a convenient manner of release. In addition, it is disclose that solubilization strategies may include the administering of co-solvents. The carrier listing includes propylene glycol and PEG-300. Thus, based on the teaching of the primary reference, it would have been obvious to one of ordinary skill in the art prior to Applicant’s invention to administer a carrier combination comprising propylene glycol and PEG-300. In regards to the presence of aqueous mixtures, throughout Tan Hehir et al during the synthesis of compounds an aqueous mixture is utilized (for example, see page 9, paragraphs [009], [0080], and [0084]; and page 11, paragraphs [0095], [0096], and [0097]).
For the reasons set forth herein, the rejection is still applicable to independent claim 21 and its respective dependent claims.
NEW GROUNDS OF REJECTIONS
112 Second Paragraph Rejections
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 35 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.
Claim 35: The claim is ambiguous because there is no period at the end of the sentence. As a result, it is unclear if one intended to incorporate addition text/structures into the claim.
Allowable Claims
Claims 30-34 and 36-40 are allowable over the prior art of record. In particular, the prior art neither anticipates nor renders obvious the species of independent claims 30 and 36. In particular, the prior art neither anticipates nor renders obvious a compound combination comprising 1-30% PG-300, 1-20% propylene glycol, 1-10% polyvinyl pyrrolidone, and 0-10% Laurocapram (specifically, the prior art does not disclose incorporating polyvinyl pyrrolidone into the mixture). The closest art is Tan Hehir et al (US 2010/0310457) which was previously cited over the claims.
Claim Objections
Claim 27 is 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.
Note(s): In particular, this claim is distinguished over the prior art of record because the prior art neither anticipates nor renders obvious a compound combination comprising 1-30% PG-300, 1-20% propylene glycol, 1-10% polyvinyl pyrrolidone, and 0-10% Laurocapram (specifically, the prior art does not disclose incorporating polyvinyl pyrrolidone into the mixture). The closest art is Tan Hehir et al (US 2010/0310457) which was previously cited over the claims.
Conclusion
Claims 21-26, 28, 29, and 35 are rejected. Claim 27 is objected. Claims 30-34 and 36-40 are allowable over the prior art of record.
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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
July 21, 2026
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