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 4/3/2024 wherein the specification was amended.
Note(s): Claims 1-26 are pending.
Priority
This application is a 371 of PCT/US21/46181 filed 8/16/2021 and PCT/US21/46181 claims benefit to provisional application 63/066,072 filed 8/14/2020.
Note(s): The earliest effective filing date is 8/14/2020 as the pending invention is fully supported in the provisional application.
Claim Interpretation
Independent claim 1 is directed to compounds of formula
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wherein R, R2, R3, R4, R5, R6, R7, R8, and R9 are defined therein. It should be noted that the definitions of R, R1, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11, and R12 include alkyl groups. According to Applicant’s definition of
‘alkyl’ on page 7, paragraph [0036], of the specification, the term includes both substituted and unsubstituted groups.
Claim 8 is directed to determining the presence and/or location of a solid tumor as set forth therein.
Claim 15 is directed to a method of imaging a solid tumor as set forth therein.
Claim 21 is directed to a method of determining margins of a soldi tumor as set forth therein.
Claim 26 is directed to a kit comprising
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.
Information Disclosure Statement
The information disclosure statements filed 2/13/2023; 8/20/2024; 9/23/2024; and 9/25/2025 were considered.
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 1-4 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 1-4: The claims recite the limitation "the following structure" in line 1. There is insufficient antecedent basis for this limitation in the claim.
102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tung et al (US 20170072072).
Independent claim 1 is directed to compounds of formula
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wherein R, R2, R3, R4, R5, R6, R7, R8, and R9 are defined therein.
Tung et al disclose various compounds encompassed by pending claim 1. In particular, the following structures are disclosed:
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(Figure 5A; page 8, left column first structure; page 17, claim 20) wherein R and R1 = methyl; R8 and R9 = hydrogen; Z = oxygen; Y = CR11R12 wherein R11 and R12 = hydrogen; R2 and R3 = substituted alkyl groups;
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(Figure 6 and page 7, paragraph [0078]; page 17, claim 20) wherein R and R1 = one is methyl and the other a substituted alkyl groups; R8 and R9 = hydrogen; Z = oxygen; Y = CR11R12 wherein R11 and R12 = hydrogen; R2 and R3 = methyl; and
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(page 8, left column, second structure; page 17, claim 20) wherein R and R1 = one is methyl and the other a substituted alkyl groups; R8 and R9 = hydrogen; Z = oxygen; Y = CR11R12 wherein R11 and R12 = hydrogen; R2 and R3 = substituted alkyl group.
Thus, the limitations of independent claim are met.
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 2-25 are rejected under 35 U.S.C. 103 as being unpatentable over Tung et al (US 20170072072).
Independent claim 1 is directed to compounds of formula
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wherein R, R2, R3, R4, R5, R6, R7, R8, and R9 are defined therein. Claims 2-4 are directed to structures having various alkyl groups and/or hydrogen substituents present at positions R, R2, R3, R4, R5, R6, R7, R8, and/or R9.
As set forth in detail supra (see 102 rejection of independent claim 1 above), Tung et al discloses compounds encompassed by the formula in pending claim 1. While the document specifically discloses substituted alkyl groups at various locations on the structure, it would have been obvious to one of ordinary skill in the art before the effective date of the pending invention to include unsubstituted alkyl groups as well for the following reasons. Specifically, on pages 2-3, paragraph [0027] of Tung et al, it is disclosed that the alkyl group may be substituted or unsubstituted. The listed substitutions (substituted alkyl groups) are those disclosed in the 102 rejection supra. Thus, the skilled artisan would be motivated to used substituted as well as unsubstituted alkyl groups.
In addition, the skilled artisan would expect structures having Formula IV,
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, to have both substituted and non-substituted alkyl groups present in the structure. The locations wherein non-substituted alkyl groups may be present are consistent with Applicant’s R, R2, R3, R4, R5, R6, R7, R8, R9, R10, R11, and R12. Thus, the limitations of claims 1-4 are met.
Claim 5 is directed to a compound of claim 1 in combination with a pharmaceutically acceptable carrier.
Tung et al disclose that one may generate pharmaceutical formulations comprising one or mor pharmaceutically acceptable carriers and optionally one or more other therapeutic ingredients (page 8, paragraph [0081]). Thus, the limitation of claim 5 is met.
Claim 6 is directed to the concentration of the compound being 0.5 µM to 10 µM.
Tung et al disclose CypH-1 (see (Figure 2A; page 7, paragraph [0078]) which is listed in independent claim 1 and in a proviso of thereof. While the structure is present in the proviso, it is withing the structure requirements of that of pending independent claim 1 and exemplified in Tung et al. In Tung et al, it is disclosed that the compound is present in and amount of 0.5 µM. Thus, the limitation of claim 6 is rendered obvious.
Claim 7 is directed to a composition that is sprayable or an oral rinse.
Tung et al disclose that the compound/composition may be administered orally or as spray topically ( page 8, paragraph [0082]; page 10, paragraph [0089]; pages 10-11, paragraph [0093]). Thus, the limitation of claim 7 is met.
Claim 8 is directed to a method of determining the presence and/or location of a solid tumor as set forth therein. Claim 9 is directed to generating a signal in less than 5 minutes. Claim 10 is directed to signal detection in less than 1 minute.
Tung et al disclose the compounds/compositions may be used to detect cancer/tumors (page 10, paragraph [0089], [0091], and [0092]). In addition, Tung et al disclose that the cells may be imaging immediately since there is no fluorescence in neutral pH, so after incubation, the cells could be imaging immediately without any washes (page 12, paragraph [0102]). Thus, the limitations of claims 8-10 are met.
Claim 11 is directed to applying the compound topically. Claim 12 is directed to the composition being a spray or oral rinse.
Tung et al disclose that the compound/composition may be administered orally or as spray topically ( page 8, paragraph [0082]; page 10, paragraph [0089]; pages 10-11, paragraph [0093]). Thus, the limitations of claims 11 and 12 are met.
Claim 13 is directed to various tumors selected from ovarian, skin, pancreatic, genitourinary, colon, bladder, brain, esophagus, cervical, oral, and combinations thereof.
Tung et al disclose that various cancers including bladder, brain, colorectal, cervical, genitourinary, ovarian, esophagus, and pancreatic may be evaluated using their compound/composition (page 10,paragraphs [0088], [0091], and [0092]). Thus, the limitations of claim 13 are met.
Claim 14 is directed to solid tumor results in the protonation of the compound.
Tung et al disclose that when the amines of the compound are protonated under acidic conditions, one is able to get results regarding the tumor (pages 11-12, paragraph [0099]). Thus, the limitation of claim 14 is met.
Claim 15 is directed to a method of imaging a solid tumor as set forth therein. Claim 16 is directed to generating a signal in less than 5 minutes. Claim 17 is directed to the signal being directed in less than a minute.
Tung et al disclose the compounds/compositions may be used to detect cancer/tumors (page 10, paragraph [0089], [0091], and [0092]). In addition, Tung et al disclose that the cells may be imaging immediately since there is no fluorescence in neutral pH, so after incubation, the cells could be imaging immediately without any washes (page 12, paragraph [0102]). Thus, the limitations of claims 15-17 are met.
Claim 18 is directed to administering the compound topically. Claim 19 is directed to the compound be used as a spray or an oral rinse.
Tung et al disclose that the compound/composition may be administered orally or as spray topically ( page 8, paragraph [0082]; page 10, paragraph [0089]; pages 10-11, paragraph [0093]). Thus, the limitations of claims 18 and 19 are met.
Claim 20 is directed to various tumors selected from ovarian, skin, pancreatic, genitourinary, colon, bladder, brain, esophagus, cervical, oral, and combinations thereof.
Tung et al disclose that various cancers including bladder, brain, colorectal, cervical, genitourinary, ovarian, esophagus, and pancreatic may be evaluated using their compound/composition (page 10,paragraphs [0088], [0091], and [0092]). Thus, the limitations of claim 20 are met.
Claim 21 is directed to a method of determining tumor margins of a solid tumor as set forth therein.
Tung et al disclose that their compound/composition may be used to detect cancer/tumor before a tumor resection procedure or during the procedure by a topical spray. Thus, it would be obvious to the skilled artisan that tumors may be detect prior to or during a procedure (page 10, paragraphs [0089] and [0091]). On pages 10-11 (paragraph [0093]), it is disclosed that during surgery tumors/cancers that are to be resected, the compound/composition may result in robust fluorescence signal of discrete neoplastic lesion with millimeter range resolution. The fluorescence signal is strikingly enhanced at peripheral regions according to Tung et al. Thus, the limitation of claim 21 is met.
Claim 22 is directed to the compound being used as a spray or an oral rinse.
Tung et al disclose that the compound/composition may be administered orally or as spray topically ( page 8, paragraph [0082]; page 10, paragraph [0089]; pages 10-11, paragraph [0093]). Thus, the limitations of claim 22 are met.
Claim 23 is directed to a signal being detected in less than 5 minutes. Claim 24 is directed to a signal being detected in less than 1 minute.
Tung et al disclose the compounds/compositions may be used to detect cancer/tumors (page 10, paragraph [0089], [0091], and [0092]). In addition, Tung et al disclose that the cells may be imaging immediately since there is no fluorescence in neutral pH, so after incubation, the cells could be imaging immediately without any washes (page 12, paragraph [0102]). Thus, the limitations of claims 23 and 24 are met.
Claim 25 is directed to solid tumors selected from ovarian, skin, pancreatic, genitourinary, colon, bladder, brain, esophagus, cervical, oral, and combinations thereof.
Tung et al disclose that various cancers including bladder, brain, colorectal, cervical, genitourinary, ovarian, esophagus, and pancreatic may be evaluated using their compound/composition (page 10,paragraphs [0088], [0091], and [0092]). Thus, the limitations of claim 25 are met.
For the reasons set forth above, Tung et al renders obvious the pending invention.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Tung et al (US 20170072072) in view of Mao et al (US Patent No. 8,709,830).
Claims 1-25 are rendered obvious as set forth in detail supra.
Claim 26 is directed to a kit comprising the compound of claim 1.
Mao et al is made of record to illustrate that it is well known in the art to generate kits containing substances that enable one to detail the presences of conditions such as cancer/tumors using a dye (see entire document, especially, abstract; column 1, lines 45-67). Thus, one of ordinary skill in the art would be motivated to generate a kit for diagnostic purposes because of the ever present need for such kits in hospitals, clinics, or other medical facilities. Thus, a skilled practitioner in the art would be motivated to place the compound and/or components such as a pharmaceutically acceptable carrier in various containers to be used at a desired time with the subject. Hence, the limitation of claim 26 is rendered obvious according to the prior art.
Comments/Notes
Applicant is respectfully requested to ‘on/in’ (claim 8, line 4); ‘administering/applying’ (claim 11, line 1, claim 18, line 1); and ‘administration/application’ (claim 11, line 2; claim 12, line 1; claim 14, line 1; claim 18, lines 2; claim 19, line 1), with ‘ on or in’, ‘administering or applying’, and ‘administration or application’, respectively, for clarity of the claimed invention.
Conclusion
Claims 1-26 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
January 9, 2026