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 2/20/2024 wherein claims 1-20 were canceled and claims 21-40 were added.
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 therein.
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, carbopol, 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.
Information Disclosure Statement
The information disclosure statement filed 7/11/2023 was considered.
Double Patenting Rejections
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,744,212. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to species encompassed by Applicant’s formula
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wherein the variable definitions overlap. The claims also read on a method of imaging myelin based protein and kits thereof. The compositions of the patent as well as pending invention may be a combination of PEG-300, polyvinyl alcohol, propylene glycol, polyvinyl pyrrolidone, and laurocapram. The claims differ in that those of the patented invention identify specific amounts of the solvents whereas pending claim 21 is not limited to any particular percentage of solvent. Thus, the skilled artisan would recognize that the pending claims encompasses the patented invention.
Claims 21-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-15, and 24-30 of U.S. Patent No. 11,730,830. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to species encompassed by Applicant’s formula
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wherein the variable definitions overlap. The claims also read on a method of imaging myelin based protein and kits thereof. The compositions of the patent as well as pending invention may be a combination of PEG-300, polyvinyl alcohol, propylene glycol, polyvinyl pyrrolidone, and laurocapram. The claims differ in that those of the patented invention identify specific amounts of the solvents whereas pending claim 21 is not limited to any particular percentage of solvent. Thus, the skilled artisan would recognize that the pending claims encompasses the patented invention.
Written Description Rejection
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21, 24-27, 30-34, and 36-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The instant application does not sufficiently describe the invention as it relates to electron donating groups and electron withdrawing groups compatible with the structure
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other than those in claims 23 and 22, respectively. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
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.
Claims 21-40 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.
Claims 21, 30, and 36: It appears as if there is a typographical error in claim 21, line 9. Should ‘carbapol’ be ‘carbopol’? If so, Applicant is respectfully reminded that ‘carbopol’ is a trademark/trade name. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular solvent and, accordingly, the identification/description is indefinite.
Likewise, in claim 21, line 9 (see also claim 30, line 11; claim 36, line 7), the trademark/trade name, ‘Laurocapram’ is also listed. Thus, Applicant is requested to make the appropriate corrections to the claims.
Claim 30: The claim is ambiguous for the following reasons. (1) In lines 2 and 3, the term ‘applying’ is somewhat ambiguous. Did Applicant intend to use the term ‘administering’ which encompasses various modes of giving the drug to a subject whereas ‘applying’ seems to apply that the pharmaceutical agent is topically given to a subject. (2) Applicant makes reference to an ‘application field’ in line 3. It is unclear what area is actually being referenced. The phrase ‘to an application field at a surgical site’ may be replace with ‘at a surgical site’ for clarity. (3) Still, the claim is confusing because of the phrase ‘spectral excitation characteristics of the pharmaceutical agent’ (lines 4-5 and 13-14). Is Applicant referring to ‘wavelength’?
103 Rejection
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, 28-32, and 34-40 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, carbopol, 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.
Independent claim 30 is directed to a method of imaging myelin basic protein as set forth therein.
Claim 31 is directed to a solution comprising the pharmaceutical agent of claim 21.
Claim 32 is directed to a gel comprising the pharmaceutical agent of claim 21.
Claim 34 is directed to the pharmaceutical agent further comprising one or more surfactants, non-ionic surfactants, triglycerides, cyclodextrins, phospholipids, buffers, stabilizers, or preservatives.
Tan Hehir et al, Yazdanfar et al, and Siclovan et al all read upon imaging myelin basic protein using overlapping compounds and kits thereof as explained supra (Tan Hehir et al, abstract; page 4, paragraphs [0045], [0046], and [0050]); pages 13-15, claims 1-5, 7, 9, 12, 13, 27, 28, 31, and 32; Yazdanfar et al, abstract; page 2, paragraphs [0023] – [0026] and [0030]; page 5, paragraphs [0057]; Siclovan et al, abstract; page 4, paragraphs [0047] and [0051]). In addition, two of the documents disclose that that the form of the composition can vary as long as the substance does not depart from the spirit or essential characteristics thereof (Tan Hehir et al, page 13, paragraph [0114]; Siclovan et al, page 12, paragraph [0099]). Hence, it would have been obvious to one of ordinary skill in the art to have the various forms of the composition including gels and solutions.
Tan Hehir et al and Siclovan et al disclose that the pharmaceutical agent may further comprise stabilizers, buffers, preservatives, surfactants, and cyclodextrins (Tan Hehir et al, page 3, paragraph [0030]; Siclovan et al, page 2, paragraph [0023] and page 3, paragraph [0029]).
For the reasons set forth herein, the limitations of claims 30-32 and 34 are met.
Independent claim 36 is directed to a kit as set forth therein. Claim 37 is directed to a multi-chambered vessel. Claim 38 is directed to components of the multi-chambered vessel. Claim 39 is directed to additional components to the composition selected from a co-solvent, surfactant, buffer, stabilizer, preservative, or a combination thereof.
Tan Hehir et al, Yazdanfar et al, and Siclovan et al all read upon imaging myelin basic protein using overlapping compounds and kits thereof as explained supra (Tan Hehir et al, abstract; page 4, paragraphs [0045], [0046], and [0050]); pages 13-15, claims 1-5, 7, 9, 12, 13, 27, 28, 31, and 32; Yazdanfar et al, abstract; page 2, paragraphs [0023] – [0026] and [0030]; page 5, paragraphs [0057]; Siclovan et al, abstract; page 4, paragraphs [0047] and [0051]).
Yazdanfar et al disclose a system (see Figure 2) comprising two fluorescence device sources (1 and 2) in combination with a white light CCD source (3), a relay lens (4), and filters (5, 6, and 7). The invention also utilizes a dual mode system (see Figure 5) containing multiple components (chambers) necessary to obtain and evaluate collected data (page 3, paragraphs [0035]-[0037]; pages 3-4, paragraph [0045]; page 4, paragraphs [0046] –[0049]).
Tan Hehir et al and Siclovan et al disclose that the pharmaceutical agent may further comprise stabilizers, buffers, preservatives, surfactants, and cyclodextrins (Tan Hehir et al, page 3, paragraph [0030]; Siclovan et al, page 2, paragraph [0023] and page 3, paragraph [0029]).
For the reasons set forth herein, the limitations of claims 36-39 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.
Conclusion
Claims 21-40 are rejected.
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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
February 19, 2026