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 6/24/2024 wherein the specification and claims 10, 15-19, and 22-24 were amended and 11-14 were canceled.
Note(s): Claims 1-10 and 15-24 are pending.
Priority and Priority Document
This application is a 371 of PCT/CN2022/141252 filed 12/23/2022 and claims benefit to
PCT/CN2021/141330 field 12/24/2021 and CHINA CN202211627117.3 filed 12/16/2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy has been filed with the pending application on 6/24/2024.
While certified copies of the prior documents were submitted, English language translations are not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, certified English language translations of the foreign applications should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to provide the certified translations may result in no benefit being accorded for the non-English documents.
Note(s): The earliest effective filing date is 12/23/2022 because the pending invention is fully disclosed in PCT/CN2022/141252.
Claim Interpretation
Independent claim 1 is directed to compounds of Formula II:
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Claim 18 is directed to a method of preparing a metal compound of Formula II as set forth therein.
Claim 19 is directed to a method of preparing compounds of Formula II as set forth therein.
Claim 20 is directed to compounds of Formula III:
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Claim 21 are directed to compounds as set forth therein.
Claim 23 is directed to a method of treating or radiodiagnosing a tumor as set forth therein.
Information Disclosure Statement
The information disclosure statements filed 3/24/2026 and 12/10/2024 were 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- 10, 15, 18, 20, and 22-24 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 pending application does not sufficiently describe the invention as it relates to metal chelating groups (for example, L2, claim 1, line 69) other than
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, and 8- to 20-memberd saturated monocyclic or bridged carbocyclic rings. 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 2-8, 10, 15-19, 21, and 23 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.
Claim 2: (1) The claim recites the limitation "the following conditions" in line 3. There is insufficient antecedent basis for this limitation in the claim. (2) The phrase ‘the metal ion does not bind to non-metal nuclide’ is ambiguous. Is Applicant attempting to say, ‘the metal complex does not bind non-metal nuclides’?
Claim 3: The claim recites the limitation "the following conditions" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 4: The claim recites the limitation "the following schemes” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 5: (1) The claim recites the limitation "the following conditions” in lines 3-4 and “the following metals” in line 49. There is insufficient antecedent basis for this limitation in the claim. (2) The phrase ‘the metal ion does not bind to non-metal nuclide’ is ambiguous. Is Applicant attempting to say, ‘the metal complex does not bind non-metal nuclides’? (3) The phrase ‘as a whole’ is ambiguous in line 54.
Claim 6: The phrase ‘the following conditions’ (lines 3-4); “the following general formula I” (line 5); and “the following metals” (line 24) are ambiguous. Regarding claim 6 (line 28) the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7: The phrase ‘the following conditions’ (lines 3-4 lacks antecedent basis.
Claim 8: The phrase ‘the following conditions’ (lines 3-4) and “the following groups (line 19) lack antecedent basis.
Claim 10: The phrase ‘the following conditions’ (line 4) lacks antecedent basis. In addition, did Applicant intend to write ‘is selected from’ instead of ‘satisfies any one...schemes’ since a Markush grouping follows the terminology?
Claim 10, lines 96-97: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation of L1 values in lines 91-95, and the claim also recites preferred values of L1 in lines 96-98 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10, line 101: The phrase ‘the following structure’ lacks antecedent basis.
Claim 15: The phrase ‘the “one or more”’ in line 6 lacks antecedent basis. In addition, the phrase is confusing. Applicant is respectfully requested to state the specific variables or values being referenced.
Claim 16: The phrase ‘the following structures’ (lines 4-5) and ‘the following compounds’ (lines 23, 35, 48, 57, and 66) lack antecedent basis.
Claim 16 (lines 23, 35, 48, 57, and 66): According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product, the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product or when the complex s formed by a compound complex with a metal.
Claim 17, line 4: The phrase ‘the following structures’ lacks antecedent basis.
Claim 18, line 4: The phrase ‘the following steps’ lacks antecedent basis.
Claim 19: The phrase ‘the following steps’ (line 2) lacks antecedent basis. In addition, the phrase "for example" (see lines 13, 17, 21-22, and 24) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21: The phrase ‘the following’ lacks antecedent basis. Did Applicant intend to write ‘A compound selected from the group consisting of...’ in line 1?
Claim 23: The claim is confusing because radiodiagnosis and treatment are two distinct methods. They require different method steps and have a differ mode of action. In addition, the claim does not disclose how one diagnoses the tumor in a subject . Still, the claim is ambiguous because lines 8-11 of the claim are directed to a preferred embodiment with a broad method. Thus, one has a broader range of he method followed by narrow limitations of the same methods steps.
Comments/Notes
It should be noted that no prior art is cited against the pending claims. However, Applicant must address and overcome the 112 rejections above. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious compounds and metal complexes and methods thereof as set forth in the pending invention.
Conclusion
Claims 1-10 and 15-24 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.
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 3, 2026
Prosecution Insights