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 3/5/2024 wherein claims 1-8 and 10-15 were amended. In addition, the Examiner acknowledges the abstract replacement filed 3/5/2024.
Note(s): Claims 1-15 are pending.
Priority and Priority Document
This application is a 371 of PCT/CZ2022/050087 filed 9/9/2022 which claims benefit to EPO EP21196175.0 filed 9/10/2021.
The Examiner acknowledges receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Note(s): The earliest effective filing date is 9/10/2021because the pending invention is fully supported in EPO EP21196175.0.
Claim Interpretation
Independent claim 1 is directed to compounds of Formula (I):
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120
209
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wherein the variable are as defined therein.
Claims 6 is directed to a method of preparing the compounds of Formula (I) as set forth therein.
Claim 7 is directed to a coordination compound comprising Formula (I) as set forth therein.
Claim 8 is directed to a method of preparing the coordination compounds of claim 7 as set forth therein.
Claim 9 is directed to a coordination compound as set forth therein.
Claim 10 is directed to a coordination compound dimer as set forth therein.
Claim 11 is directed to a conjugation comprising the coordination compound of claim 7.
Claim 12 is directed to a method of drug tracing as set forth therein.
Information Disclosure Statement
The information disclosure statement filed 3/5/2024 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 12 and 13 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 drugs and drug tracing that are applicable to the pending invention. 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 1-15 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 1-15: Independent claim 1 is ambiguous for the following reasons. (1) In line 5, did Applicant intend to write ‘nitrogen and N-oxide’? The manner in which the Markush grouping is written in claim 5 (‘nitrogen; N-oxide’’) is confusing as it is unclear whether or not additional components were inadvertently omitted. According to MPEP 803.02, proper Markush terminology requires a ‘closed’ listing of substances. (2) In line 7, ‘may be’ allows for other options to be present. Did Applicant intend to replace ‘may be’ with ‘is optionally’?. (3) In lines 8, 10, 19, and 29, did Applicant intend to write ‘is optionally’ instead of ‘can optionally be’? The use of ‘can’ is not a positive recitation, but only requires the ability to so perform that function. (4) Applicant’s attention is respectfully directed to MPEP 803.02.II and 803.02.III which are directed to proper Markush grouping and terminology, respectfully. The use of ‘and/or’ in a Markush grouping is not proper. See claim 1, lines 9, 10, and 30. (5) In lines 6,11, 12, 18, 22, and 29 did Applicant intend to insert ‘and’ before the last ingredient appearing in the Markush group? See MPEP 803.02.III regarding proper Markush terminology.
Since claims 2-15 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claim 2: The claim is ambiguous for the following reasons. In lines 4 and 5, did Applicant intend to write ‘is optionally’ instead of ‘can optionally be’? The use of ‘can’ is not a positive recitation, but only requires the ability to so perform that function.
Claim 3: The claim is ambiguous because (1) of the phrase ‘R4 and R5 are as defined above’ (see line 4). Specifically, R4 and R5 are not defined in claim 3. Is Applicant referring to claim 1? (2) In addition, the claim is ambiguous because of the phrase ‘preferably R4 and R5 are H’. 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, claim 3 recites the broad recitation of R4 and R5, and the claim also recites preferred embodiments for R4 and R5 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 4: The claim is ambiguous because of the phrases that identify preferable values for L (see line 12). 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, claim 4 recites the broad recitation of the variable L in lines 8-10, and the claim also recites preferred embodiments for L in line 12 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 5: The claim is ambiguous because the phrase ‘selected from the group comprising’ is not proper Markush terminology. Proper Markush terminology requires a ‘closed’ grouping of ingredients. The term ‘comprising’ is ‘open’ language and allows for unnamed ingredients to be present in the grouping. Applicant’s attention is directed to MPEP 803.02.III which addresses proper Markush terminology.
In addition, claim 5 is ambiguous because of the phrase ‘and the remaining substituents are present in the following combinations’ because claim 5 depends from claim 1 which discloses variables other than those that are found in claim 5 (e.g., the variable n). Thus, it is respectfully suggested that for clarity, one specifically references R1, A, R2, R3, R4 and R5. For example, the phrase may be replaced with ‘and R1, A, R2, R3, R4 and R5 are as follows:’.
Also, the claim is ambiguous because there is no period at the end of the sentence. Thus, it is unclear if one intended to incorporate additional text.
Claim 6: In line 16, did Applicant intend to replace ‘may be’ with ‘is’. Also, in lines 17-18, did Applicant intend to write ‘is optionally’ instead of ‘can optionally be’? The use of ‘may’ and ‘can’ are not positive recitations, but only requires the ability to so perform those function. In addition, it is unclear whether or not Applicant intended to insert ‘and’ after the semicolon in line 37 to indicate that step ‘vi)’ is the last step appearing in the claim. In other words, it is unclear whether or not Applicant intended to incorporate additional method steps.
Claim 7: The phrase ‘A coordination compound....claim 1’ is awkward and difficult to determine the metes and bounds of the claim. Did Applicant intend to write, ‘A coordination compound comprising the compound of general formula (I) and a metal cation selected from the group consisting of...’?
Claim 7: The claim is ambiguous because of the phrases that identify preferable values for the metal cation (see lines 4-6). 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, claim 7 recites the broad recitation of metal cations in lines 2-4, and the claim also recites preferred embodiments for the metal cations in lines 4-6 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 8: The claim is ambiguous because of the phrase that identifies preferable conditions for the method of preparation (see lines 9-11). 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, claim 8 recites the broad recitation of the method steps in lines 8-9 and the halogen (line 31), and the claim also recites preferred embodiments in lines 9-10 and a preferred halogen, chlorine, 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 8: The claim recites the limitation "the reducing agent" in line 25. There is insufficient antecedent basis for this limitation in the claim.
Claim 8: The claim contains hash (-) marks at the beginning of lines 14, 16, 18, 20, 22, 24, 27, 29, 31, 33, 36, 39, 41, 43, and 45. According to MPEP 608.01(a), where a claim sets forth a plurality of elements/steps, each element/step of the claim should be separated by a line of indentation. There may be plural indentations to further segregate sub combinations or related steps (see 37 CFR 1.75 and MPEP 608.01(i)-(p)).
In addition, the claim is ambiguous because
Claim 9: The claim recites the limitation "the following coordination compound" in line 3. There is insufficient antecedent basis for this limitation in the claim. In addition, the claims are ambiguous because of the phrase ‘another coordination compound’ because it is unclear if Applicant is stating that any substance containing a carboxyl group or an -SH group are coordination compounds or if Applicant is intending the phrase to reference distinct groups of compounds.
Claim 9: 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 (coordination compound), the claim limitation is not directed to the product, but rather to actions involving the product (the forming of an amide bond with R1, R4, R5, or A) or the formation of a disulfide bond between R1 or R5 or the formation of a triazole bridge between R1 and R5 which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product or when the active steps (formation of the various bonds). Thus, the metes and bounds of the claim cannot be ascertained.
Claim 10: The claim is ambiguous because it is difficult to read the structure as some of the bonds, atoms, and superscripts are unreadable. In addition, the claim is ambiguous because of the phrase that identify preferable values for the cations (see lines 6-8). 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, claim 10 recites the broad recitation of the cations in lines 4-6, and the claim also recites preferred embodiments for cations in lines 6-8 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 11: The claim is ambiguous because of the phrase that identify preferable values for R1, R4, and R5 (see lines 4-7) and antibodies (see lines 13-14). 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, claim 4 recites the broad recitation of the variables R1, R4, and R5 in lines 8-10 and antibodies (line 13), and the claim also recites preferred embodiments for R1, R4, and R5 in lines 4-7 and monoclonal antibodies (lines 13-14) 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.
In addition, the claim is ambiguous because it contains improper Markush terminology. The phrase ‘selected from the group comprising’ (see lines 4, 12 and 13)is open language and allows for unnamed elements to be present. Applicant is respectfully requested to review MPEP 803.02.III for proper Markush terminology and make the appropriate corrections to the claim.
Claim 11: 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 (conjugate), the claim limitation is not directed to the product, but rather to actions involving the product (the forming of an amide bond between -COOH group in R1, R4, or R5 and the peptide/protein, lines 8-10) which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a product or when the active steps (formation of the various bonds). Thus, the metes and bounds of the claim cannot be ascertained.
Claim 12: The claim is ambiguous because it is unclear what ‘drug’ (line 1) Applicant is referencing that is being traced. In addition, the terms ‘peptide based drug’ and ‘protein based drug’ (line 4) are being claimed. It is unclear what are the metes and bounds of how Applicant is interpreting the term ‘drug’. According to Merriam-Webster Dictionary, the term ‘drug’ is defined as (1) a substance used as a medication or in the preparation of medication; (2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; (3) a substance other than food intended to affect the structure or function of the body; and (4) a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device. Thus, it is unclear what specific substance Applicant is intended to be traceable using the method of claim 12.
Claim 12: The claim is ambiguous because of the phrase that identifies preferable values for the strong acid (line 5) and analysis (line 8). 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, claim 10 recites the broad recitation of the acids and type of analysis (see lines 5 and 7, respectively), and the claim also recites preferred embodiments for cations in lines 5 and 8, respectively 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.
Claims 13 and 14: The claim are ambiguous because they do not incorporate any additional limitations directed to the components present in the coordination compound, but, instead focus on the intended use of the compound (e.g., for development of testing new drugs, for drug marking and tracing in vitro, and for medical diagnosis such as MRI contrast agents.
Claim 15: The claim is ambiguous because of the phrase ‘selected from the group comprising...and/or R1, R4, and/or R5 contains a radioactive halogen as radiodiagnostic and/or radiopharmaceutic agents’ as it contains improper Markush terminology and is difficult to interpret. Did Applicant intend to write, ‘The coordination compound according to claim 7 wherein M is selected from the group consisting of 44Sc...177Lu, and wherein R1, R4, and R5 are contain a radioactive halogen’.
Comments/Notes
For clarity of the claimed invention, the following suggestion(s) is/are respectfully made: (1) in claim 4, line 3, replace ‘such that’ with ‘wherein’; (2) in claim 8, line 2, delete ‘the following steps’; (3) in claim 4, line 19, replace ‘resulting’ with ‘wherein’ and ‘being’ with ‘are’; and (4) in claim 12, line 12, delete ‘the following steps’.
Due to the fact that extensive modifications were necessary for the claims, it was determined that the office action should be a written communication.
It should be noted that no prior art is cited against the pending invention. However, one 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 the compounds as set forth in independent claim 1.
Conclusion
Claims 1-15 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
July 20, 2026
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