DETAILED ACTION
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 .
Status of Application
Applicant’s amendments of claim(s) 6 and 10-11 in the reply filed on 05/24/2024 is acknowledged.
Claims 1-11 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claims 4-8 recite “Radiopharmaceutical kit”. While the phrase normally indicates that a radioisotope is included, the examiner notes that the specification uses the term without requiring radioisotopes. For the purposes of examination, the examiner interprets “radiopharmaceutical kit” as not requiring a radioisotope. Therefore, any prior art which reads on the precursor compounds, whether or not a radioisotope is present, reads on the claim.
Claim 9 recites, “Use of the precursor of claim 1” for various imaging methods that require radioisotopes. The examiner notes that “precursor” is used throughout the specification to refer to the compound that can be complexed with a radioisotope but does not refer to the complexed compound. Further, the plain meaning of “precursor” means that it comes before the final compound. The final compound is the complexed compound. Therefore, the “precursor of claim 1” does not have a radioisotope in it. The examiner notes that every instance in the specification of PET imaging, SPECT imaging or endoradiotherapy has the precursor complexed to a radioisotope. Therefore, for the purposes of examination, the examiner interprets the “use of the precursor of claim 1” to mean using the precursor with anything else to allow for the imaging methods. Therefore, any prior art which uses the precursor for PET, SPECT, or endoradiotherapy reads on this claim.
Claims 9-11 recite a use of a compound or kit without stating any steps. However, the examiner notes that the specification shows images of a patient with contrast from the precursor and radioisotope (Fig 2). The patient is presumed to have been administered the compound and radiotracer. An additional use of the precursor would be to combine with a radioisotope. Without the claim nor the specification explicitly stating steps to be performed, the examiner interprets any prior art with a use of the compound or kit to read on this claim.
Claim Rejections - 35 USC § 112(a)
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 9 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for t, does not reasonably provide enablement for the precursor of claim 1 or radiopharmaceutical kit as stated. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is “reasonable” or is “undue.” Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. These factors include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427, F.2d 833, 839, 166 USPQ 18, 24 (1970). To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims discloses a use of the precursor of instant claim 1 or a kit with the precursor of instant claim 1 where X is a methyl for PET imaging, SPECT imaging, or endoradiotherapy. Therefore, the breadth of the instant claims allows for consideration any step that has the precursor or kit. As the steps may vary widely in the prior art, the scope of the instant claims enables different protocols with several parameters that differ among them.
The nature of the invention requires the precursor to be used for PET imaging, SPECT imaging, or endoradiotherapy. Based on the present state of the art, this could reasonably be expected to result in different solutions (e.g. radioisotope used) and method conditions (many of mixing).
The state of the art provides methods which includes several elements that are similar to the disclosed example.
Baryanyai, Z.; et al., WO 2020/099398 A1. for example, teaches chelating AAZTA conjugates with cyclic peptides and radioisotopes and their use as diagnostic and therapeutic agents (title; abstract). Baranyai teaches the chelator (pg 2, line 19-22, AAZTA structure), cyclic peptides (pg 3, lines 4-8, structure); radioisotopes (pg 4, lines 10-15), methods of imaging (pg 4, lines 18-20), and a kit comprising the compound (pg 9, lines 6-13). Biranyai teaches using the precursor with a radioisotope for PET imaging so somatostatin expressing tissue (pg 11, lines 7-10; pg 18, lines 7-28; claim 9). Biranyai teaches the use of radiopharmaceutical kits for PET imaging and SPECT imaging of somatostatin expressing tissue (pg 11, lines 7-10; pg 18, lines 7-28; claim 9). The art demonstrates that radioisotopes are essential for these imaging techniques.
The level of one of ordinary skill, based on the prior art, would have a Ph.D.
The level of predictability in the art is unclear as to how the precursor or a kit comprising the precursor could be used to perform PET imaging, SPECT imaging, or endoradiotherapy. In the narrowest embodiment of claim 9, only the precursor is required. And, in the narrowest embodiment of claim 11, only the precursor of claim 1 and a solvent selected from claim 6 is required. In such cases, it is unclear how the PET imaging, SPECT imaging or endoradiotherapy could be performed. It is impossible to know or predict based on the prior art and the guidance in the specification if the PET imaging, SPECT imaging, or endoradiotherapy based on the precursor was due to different conditions. And, the prior art does not fill this critical gap.
The amount of direction provided by the inventor shows that the precursor is used but the disclosure does not show how this is to be accomplished with the precursor by itself. The direction provided points only to the precursor used with radioisotopes. As there is no guidance as to how the PET imaging, SPECT imaging, or endoradiotherapy is to be performed with just the precursor, a huge number of experiments would be required to show how the parameters could be adjusted to provide such PET imaging, SPECT imaging, or endoradiotherapy.
The existence of working examples of the narrowest embodiment of the claims do not exist in the disclosure.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure is very large since the disclosure only provides examples of PET imaging, SPECT imaging, and endoradiotherapy when a radioisotope is used with the precursor.
Thus, having carefully considered all of these factors, including the scope of the claims, the limited example in the specification, the state of the prior art and the minimal guidance in the specification, it is concluded that it would require undue experimentation to practice the claimed invention.
Accordingly, the instant claims do not comply with the enablement requirement of §112(a), since to practice the claimed invention in its “full scope,” a person of ordinary skill in the art would have to engage in an unreasonable amount of experimentation, with no reasonable expectation of success.
Claims 9 and 11 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.
The instant specification teaches a precursor of a kit with the precursor with a solvent of claim 6 is used for PET imaging, SPECT imaging, or endoradiotherapy (e.g.).
However, the instant specification does not offer sufficient description of the common structural elements or identifying characteristics that constitute the narrowest embodiment of the precursor or kit. The instant specification does not indicate that the inventors have possession of the details of the structural elements that would comprise these distinguishing characteristics.
A person of ordinary skill in the art would appreciate that there are many different structural elements that would constitute the narrowest embodiment of the precursor or kit to facilitate the functions recited in the instant claims. However, the instant specification is silent as to which structural elements the inventor has determined to be sufficient to characterize narrowest embodiment of the precursor or kit. Therefore, the instant specification does not provide a disclosure of corresponding structure in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how the inventor intended what features constitute the narrowest embodiment of the precursor or kit to allow the function recited in the instant claims.
Claim Rejections - 35 USC § 112(b)
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 2-5 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.
Claim 2 recites the limitation "Radiotracer 68Ga-DAZTA5-PPA2 according to claim 1" in line 1. Given that the 68Ga is not referenced in claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "Radiotracer 177Lu-DAZTA5-PPA2 according to claim 1" in line 1. Given that the 177Lu is not referenced in claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "Radiopharmaceutical kit according to claim 1" in line 1. Given that the radiopharmaceutical kit is not referenced in claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "Radiopharmaceutical kit according to claim 1" in line 1. Given that the radiopharmaceutical kit is not referenced in claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "Radiopharmaceutical kit according to claim 1" in line 1. Given that the radiopharmaceutical kit is not referenced in claim 1, there is insufficient antecedent basis for this limitation in the claim.
Claims 9-11 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 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: any steps describing how to use the precursor of claim 1.
Claim is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: any steps describing how to use the radiotracer of claim 1.
Claim is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: any steps describing how to use the radiopharmaceutical kit of claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. See MPEP 2173.05(q).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baryanyai, Z.; et al. (Baranyai, Z.; Ghiani, S.; Maiocchi, A.; Hawala, I., WO 2020/099398 A1) and Nock, B. A.; et al. (Nock, B. A.; Kaloudi, A.; Nagel, J.; Sinnes, J-P.; Roesch, F.; Maina, T., Novel bifunctional DATA chelator for quick access to site-directed PET 68Ga-radiotracers: preclinical proof-of-principle with [Tyr3]octreotide, Dalton Trans., 2017, 46, 14584) and Talisman, T.; et al. (Talisman, T.; Biswas, S., US 2018/0153953 A1) and Mroz, P. A.; et al. (Mroz, P. A.; Perez-Tilve, D.; Liu, F.; Gelfanov, V.; DiMarchi, R. D.; Mayer, J. P., Pyridyl-alanine as a Hydrophilic, Aromatic Element in Peptide Structural Optimization, J. Med. Chem. 2016, 59, 8061-8067).
Baranyai, Z.; et al. (hereafter referred to as Baranyai) is drawn to chelating AAZTA conjugates with cyclic peptides and radioisotopes and their use as diagnostic and therapeutic agents (title; abstract). Baranyai teaches the chelator (pg 2, line 19-22, AAZTA structure), cyclic peptides (pg 3, lines 4-8, structure); radioisotopes (pg 4, lines 10-15), methods of imaging (pg 4, lines 18-20), and a kit comprising the compound (pg 9, lines 6-13).
As to claim 1, Baranyai teaches a precursor (pg 29, claim 1) for neuroendocrine theranostics (pg 30, claim 10) and explicitly teaches DAZTA5 where X on the DAZTA5 is CH2COOH (pg 29, claim 1, formula 1) and teaches a cyclic peptide (pg 29, claim 1, formula 1) for SSTR expressing in cancers and tumors (pg 3, lines 24-25).
Baranyai does not explicitly teach the precursor where X on DAZTA5 is CH3.
Baranyai does not teach the same peptide sequence for the cyclic peptide.
Nock, B. A.; et al. (hereafter referred to as Nock) is drawn to preclinical proof-of-principle with AAZTA conjugates with cyclic peptides (title; abstract). Nock teaches 68Ga chelated cyclic peptides (pg 14585, Fig. 1) for use as a radiopharamaceutical for PET/SPECT imaging (pg 14588, col 1, para 1, lines 9-15).
Regarding the precursor where X on DAZTA5 is CH3, Nock teaches X is CH3 (pg 14585, Fig. 1, Structure A) and that the DAZTA5 is conjugated to a cyclic peptide for somatostatin use as well (pg 14585, Fig. 1, Structure A; pg 14585, col 1, para 4, lines 1-8).
The prior art of Baranyai contained a precursor chelator which differed from the claimed precursor chelator by the substitution of some X component with the other X component. The substituted components and their functions were known in the art of Nock. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 143(I)(B).
Talisman, T.; et al. (hereafter referred to as Talisman) is drawn to cyclic peptides useful for treating pancreatic cancer (title; abstract). Talisman teaches exemplary cyclic peptides (pg 31, para [0248], Table 1) and teaches non-natural amino acid substituents (pg 17, para [[0123], line 1, 3; pg 30-31, Table 1, sequences 4-6).
Regarding the peptide sequence for the cyclic peptide, Talisman teaches a similar cyclic peptide (pg 31, Table 1, Structure) and teaches pyridylalanine in the position marked by “Z” (pg 30, Table 1, Sequences 4-6).
Talisman does not explicitly teach the same peptide sequence.
However, the prior art of Talisman contained a cyclic peptide which differed from the claimed cyclic peptide by the substitution of tyrosine and pyridylalanine. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Mroz, P. A.; et al. (hereafter referred to as Mroz) is drawn to substitutions of tyrosine with pyridyl-alanine to improve potency and solubility of peptides (title; abstract; pg 8061, col 2, para 2, lines 5-13) and the modification steps (pg 8062, Fig 1.) and motivation to replace tyrosine with pyridylalanine (pg 8061, col 2, para 2, lines 5-13).
Alternatively, Mroz teaches substitution of tyrosine with pyridylalanine (abstract; pg 8062, Fig 1) and teaches a motivation to switch tyrosine with pyridylalanine to improve potency and solubility (pg 8061, col 2, para 2, lines 5-13).
The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous device (method, or product). There were design incentives which would have prompted adaptation of the known device (increased potency and solubility). The differences between the claimed invention and the prior art were encompassed in known variations or in a principle known in the prior art. Therefore, a person of ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to a person of ordinary skill in the art. See MPEP 2143(I)(F).
As to claim 2, Baranyai teaches complexing the precursor with radioisotope 68Ga (pg 29, claim 3, line 3).
As to claim 3, Baranyai teaches complexing the precursor with radioisotope 177Lu (pg 29, claim 3, line 5).
As to claim 4, Biranyai teaches a kit (pg 9, lines 6-13).
As to claim 5, Biranyai teaches a kit (pg 9, lines 6-13).
As to claim 9, Biranyai teaches using the precursor with a radioisotope for PET imaging so somatostatin expressing tissue (pg 11, lines 7-10; pg 18, lines 7-28; claim 9).
As to claim 10, Biranyai teaches use of the radiotracer for PET imaging and SPECT imaging of somatostatin expressing tissue (pg 11, lines 7-10; pg 18, lines 7-28; claim 9).
As to claim 11, Biranyai teaches the use of radiopharmaceutical kits for PET imaging and SPECT imaging of somatostatin expressing tissue (pg 11, lines 7-10; pg 18, lines 7-28; claim 9).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baranyai, Nock, Talisman, and Mroz as applied to claims 1-5 and 9-11 above and as evidenced by Cesati, R. R.; et al. (Cesati, R. R.; Cheesman, E. H.; Lazewatsky, J.; Radeke, H. S.; Mongeau, E.; Zdankiewicz, D. D.; Devine, M., US 8,936,777 B2). The teachings of Baranyai, Nock, Talisman, and Mroz as applied in the rejections above are included by reference.
Cesati, R. R.; et al. (hereafter referred to as Cesati) is drawn to methods for preparing imaging agents comprising radioisotopes and targeting moieties (title; abstract). Cesati teaches imaging agents (claim 1) and radioisotope (claim 15), and pharmaceutically acceptable compositions and solutions for injection (col 72, lines 10-34; col 72, lines 45-58).
As to claim 6, Biranyai teaches pharmaceutically acceptable excipients (pg 9, lines 14-16; pg 9, lines 21-25) which includes water, Ringer’s solution, sodium chloride solutions as evidenced by Cesati (col 72, lines 52-54).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baranyai, Nock, Talisman, and Mroz as evidenced by Cesati as applied to claims 1-6 and 9-11 above, and further in view of Larsen, R. H.; et al. (Larsen, R. H.; Henriksen, G., US 2001/0008625 A1). The teachings of Baranyai, Nock, Talisman, Mroz, and Cesati as applied in the rejections above are included by reference.
As to claim 7, Biranyai teaches a vial containing the precursor (pg 9, line 8).
Biranyai does not explicitly teach two vials.
Larsen, R. H.; et al. (hereafter referred to as Larsen) is drawn to receptor binding conjugates and their radiopharmaceutical compositions and kits (title; abstract). Larsen teaches antibodies or fragments thereof for binding to receptors (claim 1), radioisotopes for chelating to the conjugate (claims 4 and 6), and kits for preparing (claim 23).
Regarding two vials, Larsen teaches a first vial containing a first conjugating moiety (claim 23, lines 1-3) a second vial containing a ligand (claim 23, lines 3-4-6).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, two vial system of Larsen, and that in combination, each vial merely performs the same function as it does separately. Therefore, a person having ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 8, Biranyai teaches pharmaceutically acceptable excipients (pg 9, lines 14-16; pg 9, lines 21-25) which includes water, Ringer’s solution, sodium chloride solutions as evidenced by Cesati (col 72, lines 52-54).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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, Sahana Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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