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 3/17/2025 wherein claims 1-8, 17-19, 22, 25, 26, 29, and 30 were amended; claims 9-14, 20, 21, 23, and 24 were canceled; and claims 31-34 were added.
Note(s): Claims 1-8, 15-19, 22, and 25-34 are pending.
Priority and Priority Document
This application is a 371 of PCT/IT2020/050169 filed 7/2/2020. In addition, this application claims foreign priority to Italy IT102019000011013 filed 7/5/2019.
Note(s): The earliest effective filing date of the pending invention is 7/5/2019 as the invention is fully supported in IT102019000011013.
Once again, the Examiner acknowledges receipt of the priority document filed on 1/5/2022.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 3/17/2026 to the rejection of claims 1-3, 7, 17, and 22 made by the Examiner under 35 USC 102 and/or 112 have been fully considered and deemed persuasive-in-part for the reasons below.
112 Second Paragraph Rejections
I. All outstanding 112 second paragraph rejections, except the following are withdrawn because the claims were amended to overcome the rejections.
II. 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, 7, 17, 22, 31, and 34 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, 7, 17, 22, 31, and 34: Independent claim 1 is confusing because of the comma inserted after ‘desalanyl-1’ in line 6. It appears that one is listing recombinant human desalanyl-1 and serine-125 human interleukin as two different options as proteins. In the art, the phrase ‘human desalanyl-1 and serine-125 human interleukin’ is recognized as a single component. Thus, the presence of the comma in the claim is confusing. Since claims 2, 3, 7, 17, 22, 31, and 34 depend upon independent claim 1 for clarification, those claims are also vague and indefinite. Note(s): The phrase containing the comma also appears in claim 3.
APPLICANT’S ASSERTIONS:
In is duly noted that in the response, this particular issue was not address.
EXAMINER’S RESPONSE:
The rejection is maintained as the claim is confusing. Specifically, the presence of the comma between “recombinant human desalanyl-1” and “serine-125 human interleukin” does not establish that one is referencing a single combined species especially when it follows “selected from” which indicates that a listing of substances are present. In addition, the presence of “a fragment or a mutant thereof” indicates that Applicant intends portions of a structure as well as derivatives to be present. Hence, absent “and” inserted between “recombinant human desalanyl-1” and “serine-125 human interleukin” which is consistent with how the phrase appears in the prior art, it is unclear how the phrases should be interpreted.
Claim 17: The claim is ambiguous because the imaging agent is the species of claim 1. The imaging agent of being referenced in claim 17 does not contain any additional components as it is the same compound of claim 1 comprising the protein, chelator, and radioisotope.
APPLICANT’S ASSERTIONS:
In summary, it is asserted that claim 17 was amended to recite that the radiopharmaceutical composition is formulated for PET imaging.
EXAMINER’S RESPONSE:
The amending of claim 17 to indicated that the composition is formulated for PET imaging does not further limit the product components, but now results in a product claim contain an active step that requires formulating the composition such that it is used for PET imaging. The new rejection is set forth in detail below.
Claim Not Further Limiting
The 112 fourth paragraph rejection is WITHDRAWN in light of the updated new 112 second paragraph rejection over claim 17 below.
102 Rejection
The 102 rejection is WITHDRAWN because Applicant amended the claims to overcome the rejection.
NEW GROUNDS OF REJECTIONS
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, 7, 17, 22, 31, and 34 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 fragments and mutants of recombinant human desalanyl-1 and serine-125 human inerleukin-2 independently or in combination. 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
Claims 1-3, 7, 17, 22, 31, and 34 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, 7, 17, 22, 31, and 34: Independent claim 1 is ambiguous because it is unclear what fragments and mutants of recombinant human desalanyl-1 and serine-125 human intyerleukin-2 Applicant is referring to that are compatible with the pending invention. Previously presented, independent claim 1 required that the fragment and mutant have at least one cysteine residue present. In the amendment filed 3/17/2026 the claim was broaden to exclude the presence of at least one cysteine residue. Since claims 2, 3, 7, 17, 22, 31, and 34 depend upon independent claim 1 for clarification, those claims are also vague and indefinite.
Claim 17: 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 comprising the components (a protein, chelator, and radioisotope) set forth in independent claim 1 or when the compositions of claim 1 is actually formulated and used in PET imaging.
Note(s): Applicant may want to consider amending claim 17 as follows: “A method of PET imaging comprising...” if the desire is that the composition is used in PET imaging.
Applicant’s Election
Once again, Applicant’s election of Group I (pending claims 1-3, 7, 17, 22, 31, and 32) in the reply filed on 4/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Thus, the restriction was deemed proper and made FINAL.
Applicant elected the species wherein the human desalanyl-1 serine-125 human interleukin-2 as the protein of interest, tris-hydroxypyridinone (THP) as the chelator, and 68Ga as the radioisotope. Pending claims 1-3, 7, 17, 22, 31, and 32 read on the elected species. Initially, Applicant’s elected species was searched. No prior art was found to reject the species. Thus, the search was expanded fully encompass Group I. The claims were not rejoined as there are 112 rejections that are pending as detailed above.
Withdrawn Claims
Claims 4-6, 8, 15, 16, 18, 19, 25-30, 32, and 33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Specification
Once again, the disclosure is objected to because of the following informalities: the specification does not contain the heading ‘Brief Description of the Drawings’ on page 12 prior to the explanations of the drawings.
Appropriate correction is required.
Comments/Notes
For clarity of claim 22, the following wording is respectfully suggested: “A kit comprising:
a first vial comprising a precursor compound comprising the radiopharmaceutical compound of claim 1 and one or more excipients and/or adjuvants.”
In claim 34, line 1, please replace “Kit” with “kit”.
Once again, Applicant is respectfully reminded that it has been held that the recitation that an element is ‘capable of’ (or ‘able to’) performing a function is not a positive limitation, but only requires the ability to so perform that function. Thus, such terminology does not constitute a limitation in any patentable sense (In re Hutchison, 69 USPQ 138).
It should be noted that while no prior art is cited against independent claim 1, Applicant must address and overcome the 112 first and second paragraph rejections over the claims of Group I. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious a recombinant human desalanyl-1 and serine-125 human interleukin-1 protein in combination with a radioisotope and THP or NODAGA-mal chelator.
Conclusion
Claims 1-3, 7, 17, 22, 31, and 34 are rejected. Claims 4-6, 8, 15, 16, 18, 19, 25-30, 32, and 33 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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
May 22, 2026
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