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 8/12/2026 wherein claims 1, 3, 4, 11, 12, 14, 15, and 22 were amended and claims 8-10 and 19-21 were canceled. In addition, the Examiner acknowledges the amendment filed 12/22/2023 wherein the specification and claims were amended.
Note(s): Claims 1-7, 11-18, and 22-28 are pending.
Priority
This application is a 371 of PCT/US2022/073093 filed 6/22/2022 and PCT/US2022/073093 claims benefit to PRO 63/213,850 filed 6/23/2021.
Note(s): The earliest effective filing date is 6/23/2021 because the provisional application fully supports the pending invention.
Claim Interpretation
Independent claim 1 is directed is directed to compounds having a formula,
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wherein the variables are as defined therein.
Independent claim 12 is directed a method of imaging collagen turnover as set forth therein.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1-7 and 11) filed 8/12/2026 is acknowledged. The restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the species encompassed by the formula
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wherein: the [Detectable Moiety] is 99mTc, [Moiety A] is (HisGlu)3, n is 1, [Linker] is GGG, and z is 9. While Applicant asserts that claims 1-7 and 11 read on the elected species, the Examiner is not in agreement with that statement. Claims 1, 3-5, and 7 read on the elected species.
Note(s):
(A) For claim 2, Applicant did not elect an ancillary ligand as a component of the elected species. Thus, claim 2 does not apply to the elected species.
(B) For claim 6, the [Linker] is a peptide (GGG) that is connected between [Moiety A] and [GPO] in the standard way, C-terminus bound to the N-terminus of [GPO]; thus, the condition of claim 7, not 6 is satisfied.
(C) Claim 11 does not fit the formula
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when n = 1 because Applicant did not elect an ancillary ligand for the elected species.
Initially, Applicant’s elected species was searched and no prior art was found which could be used to reject the claims. Thus, the search was extended to the species below. The search was not further extended because prior art was found which could be used to reject the claims.
Withdrawn Claims
Claims 2, 6, and 11-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement filed 4/3/2024 was considered.
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 1, 3-5, and 7 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. (1) The pending application does not sufficiently describe the invention as it relates to peptides comprising 1-20 amino acids having natural or unnatural amino acid residues other than SEQ ID Nos: 1-6. (2) In addition, the pending application does not sufficiently describe the invention as it relates to small cyclic organic molecules and small acrylic organic molecules that are linker moieties, [Linker]. 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 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 1, 3-5, and 7 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, 3-5, and 7: Independent claim 1 is ambiguous for the following reasons: (1) it is unclear what derivatives of the formula
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Applicant is referencing that are compatible with the pending invention. In particular, what portion of the parent formula is being modified such that one has an effective/compatible derivative. (2) In addition, it is unclear what organic compound and leaving atom or leaving group combination Applicant is referring to that are compatible with the pending invention. (3) It is unclear if the peptide (lines 10-11) comprising 1-20 natural or unnatural amino acid residues is the same peptide being referenced in lines 15-16. (4) The term “small” in line 17 is a relative term which renders the claim indefinite. The term “small” 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. (5) In line 13, did Applicant intend to replace ‘can be’ with ‘is optionally’? Applicant is reminded that it has been held that the recitation that an element is ‘can be’ present is not a positive limitation, but only requires the component may or may not be present. (6) The phrase ‘each instance of proline is independently optionally (2S,4S)-4-fluoroproline’ is confusing. Is Applicant saying that one has ‘proline or (2S,4S)-4-fluorproline’ present? (7) The phrase ‘one or more coordinate bonds, one or mor covalent bonds’ (see lines 24-26) is confusing. The phrases are confusing because you have the term ‘each --- independent represents’ or ‘each ___ independent represents’ in front of the bond descriptions. Since one has the term ‘each’ then the phrase should be ‘each --- independently represent a coordinating bond, a covalent bond, or a combination thereof’ (lines 24 -25) and ‘each ___ independently represents a covalent bond’ (line 26).
Since claims 3-5, and 7 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claims 1, 3-5, and 7: Independent claim 1 is ambiguous for the following reasons. According to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite under 35 USC 112(b), in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. In the pending claims, the invention is directed compounds of formula
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wherein
[Detectable Moiety] is 3H, 11C, 13C, 13N, 15O, 18F, 32P, 35S, 99mTc, 123I, 64Cu, 67Ga, 68Ga, 111In, Gd3+, Fe3+, Mn2+, and Mn3+;
each [Detectable Moiety’ is optionally coordinated to one or more ancillary ligands;
each [Moeity A] is a peptide comprisng 1-20 natural or unnatural amino acid residues;
a polyaminopolycarboxylator base chelator is present;
an organic compound comprisng a leaving atom or leaving group is present;
[Linker] is a peptide comprising 1-20 natural or unnatural amino acid residues, a smal cyclic organic molecule, a small acyclic organic molecule, polyethylene glycol, polypropylene glycol, and a hydrocarbon chain;
[GPO] is glycine-proline (or (2S,4S)-4-fluoroproline)-hydroxyproline;
n is an integer of 1-10; and
z is an integer of 2-20.
Thus, the claim encompasses compounds defined by multiple Markush groups and subgroups thereof. As a result, pending claim 1 encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. Hence, due to an inability to envision the compounds defined by the Markush groups, the claim is deemed to be vague and indefinite.
Claim 5: The phrase ‘optionally wherein the [Linker] is GGG’ (line 9) is confusing because GGG is listed as one of the values of the linker in line 9.
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 1, 3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bennink et al (Mol. Pharmaceutics, 2017, Vol. 14, pages 1906-1915) in view of Yu et al (US 2013/0164220).
Independent claim 1 is directed to compounds encompassed by the formula
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wherein the variables are as defined therein.
Claim 3 is direct to the compound of claim 1 wherein z may be 9.
Claim 5 is directed to the compound of claim 1 wherein the linker may be GGG.
Claim 7 is directed to the compound of claim 1 wherein the [Linker] is a peptide which C-terminus is covalently bound to the N-terminus of the [GPO]z.
Bennink et al is directed to collagen hybridizing peptides and their fluorophore conjugates. The peptides comprising the sequence Gly-Pro-Hyp wherein Hyp is hydroxyproline. The peptides are conjugated to fluorescent dyes (see entire document, especially, abstract). In particular, the claim discloses the carboxyfluorescein (CF) labeled peptide CF-GGG-(GPO)9, wherein CF is the detectable moiety, GGG is the linker, [Moiety A] may be 1-8 of the GPO groupings; and [GPO]z varies depending on how many GPO groups are a part of the peptide of [Moiety A]. While Bennink et al disclose a detectable moiety conjugated to a GGG-(GPO)9 linker-peptide, the document does not disclose a detectable moiety that is one of the radioisotopes or metals of independent claim 1, lines 5-6.
Yu et al is made of record for its teachings of collagen mimetic peptides that are used for imaging and therapeutic use. The peptides comprise a detectable label (see entire document, especially, abstract). In particular, Yu et al disclose a peptide synthesized with (GPO)9 conjugated to a fluorophore (5(6)-carboxyfluorescein, CF) through a flexible GGG linker (page 16, paragraph [0136]). Yu et al disclose that the detectable label may be 5(6)-carboxyfluorescein or isotopes such as 3H, 11C, 13C, 15N, 18F, 123I, 111In, 99mTc, 64Cu, and 68Ga (page 7, paragraph [0072]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending the invention to modify the invention of Bennink et al using the teachings of Yu et al for the following reasons. Both Bennink et al and Yu et al disclose a peptide synthesized with (GPO)9 conjugated to a fluorophore (5(6)-carboxyfluorescein, CF) through a flexible GGG linker. In addition, Yu et al disclose that the detectable label may be 5(6)-carboxyfluorescein or isotopes such as 3H, 11C, 13C, 15N, 18F, 123I, 111In, 99mTc, 64Cu, and 68Ga. Thus, the replacement of 3H, 11C, 13C, 15N, 18F, 123I, 111In, 99mTc, 64Cu, and 68Ga in place 5(6)-carboxyfluorescein would be an obvious modification as all the species are detectable moieties compatible with the peptide.
Since both Bennink et al and Yu et al are directed to overlapping sequences, the documents may be considered to be within the same field of endeavor. Thus, the reference teachings are combinable.
For the reasons set forth herein, the limitations of claims 1, 3, 5, and 7 are met.
Comments/Notes
For clarity of claim 3, it is respectfully suggested that Applicant replace ‘wherein at least one of the following applies’ with ‘selected from’.
Conclusion
Claims 1, 3-5, and 7 are rejected and claims 2, 6, and 11-28 are withdrawn.
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.
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 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
September 21, 2026
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