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 5/20/2022 wherein the specification was amended; claims 1-5 were cancelled; and claims 6-10 were added.
Note(s): Claims 6-10 are pending.
Priority & Priority Document
This application is a 371 of PCT/EP2020/083069 filed 11/23/2020 which claims benefit to Italy IT102019000022203 filed 11/26/2019.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy has been filed the pending application on 5/20/2022.
While a certified copy of the prior document was submitted, an English language translation is 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, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to prove the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 11/23/2020 as the pending invention is fully supported in the PCT application.
Claim Interpretation
Independent claim 6 is directed to a method of treating or diagnosing solid and systemic malignancies in individuals in need thereof, said method comprising: administering to said individuals a therapeutically effective amount of said UK 114 salmon protein; and treating or diagnosing said systemic malignancies in said individuals.
Claim 7 is directed to the method of claim 6 wherein said UK 114 salmon protein comprises a monomeric unit with SEQ ID NO:1 or SEQ ID NO:2.
SEQ ID NO: 1 (UK 114 RidA-A): GSHMSSIIRKIINTSKAPAAIGPYSQAVVVDRTMYVSGQLGMDPASGQLVE
GGVQAQTKQALVNMGEILKEAGCGYD SVVKTTVLLADMNDFAS VNDVYKTFF S
S SFPARAAYQVAALPRGGLVEIEAVAVLGPLTEVS
SEQ ID NO: 2 (UK 114 RidA-B):
GSHMAAVQKLFPYTPRAPIRQGIYSQAVVVDRTMYISGQLGLDVASGKLV
EGGVQAQARQALVNMGEILKAAGCGYDNVVKTTVLLADMNDFVNVNDVYKTF
F SKNFPARAAYQVVALPRGGLVEIEAVAVLGPISES
Claim 8 is directed to the method according to claim 6, wherein said UK 114 salmon protein is expressed by Escherichia coli.
Independent claim 9 is directed to a method of immunizing individuals treated for tumors, treating individuals for adjuvant therapy or vaccinating individuals at risk for occurrence or recurrence of malignant tumors, said method comprising: administering a therapeutically effective amount of said UK 114 salmon protein to said individuals; and immunizing, treating for adjuvant therapy or vaccinating said individuals.
Independent claim 10 is directed to a method of passive immunizing with monoclonal antibodies individuals suffering from or treated with tumors, for adjuvant therapy or individuals at risk or occurrence or recurrence of malignant tumors, said method comprising: pre-treating patients suffering from tumors with a therapeutically effective amount of said UK 114 salmon protein; obtaining monoclonal antibodies following said pre-treating steps; and passive immunizing with said monoclonal antibody said individuals suffering from or treated for tumors, treating said individuals for adjuvant therapy or treating said individuals at risk of occurrence or recurrence of said malignant tumors.
Applicant’s Election
Applicant’s election of Group I (pending claims 6-8) in the reply filed on 8/5/2025 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 is still deemed proper and is made FINAL.
The Examiner acknowledges receipt of Applicant’s election of the species of SEQ ID No: 1 and mammary cancer as the malignancy. Prior art was found to reject the elected invention. Thus, the full scope of the elected invention was not searched.
Withdrawn Claims
Claims 9 and 10 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 5/29/2022 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 6 and 8 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: (1) UK 114 salmon proteins other than that comprising SEQ ID Nos: 1 and 2 and ()2) solid and systemic malignancies other than tumors. 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.
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.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cusani (SciSpace, Dec. 13, 2017, “Novel recombinant protein uk 114 in stable polymer form for us in the treatment, diagnosis, and prevention of malignant solid and systemic tumors, 1 page) in view of Ceciliani et al (FEBS Letters, 1996, Vol. 393, pages 147-150) and Digiovanni et al (Scientific Reports, June 2020, Vol. 10, No. 101035, pages 1-14).
Independent claim 6 is directed to a method of treating or diagnosing solid and systemic malignancies in individuals in need thereof, said method comprising: administering to said individuals a therapeutically effective amount of said UK 114 salmon protein; and treating or diagnosing said systemic malignancies in said individuals.
In the document by Cusani dated December 13, 2017, it is stated that the UK 114 protein is useful in the treatment, diagnosis, and prevention of malignant solid and system tumors (see entire document). Thus, while Cusani disclose it is well known in the art that to treat, diagnose, and prevent malignant solid and systemic tumors using protein UK 114, the document, does not specifically state that the UK 114 protein is salmon protein, but UK 114 in general.
Ceciliani et al is directed to the primary structure of UK114. Specifically, UK 114 is a tumor antigen expressed by various malignant neoplasms. In addition, Ceciliani et al disclose that the presence of UK 114 in various adenocarcinoma type, human malignant neoplasms, is on the on the cell membrane. It was shown that anti-UK114 antibodies/proteins induce cytolysis in vitro and cause a marked delay of tumor growth in vivo (see entire document, especially, abstract; page 147, left and right columns, bridging paragraph). Thus, the information present in Ceciliani et al is consistent with that of Cusani.
Digiovanni et al is directed to reactive intermediate deaminase (Rid) protein that includes a superfamily among which is RidA. RidA is significant because it is conserved in all domains of life (see entire document, especially, abstract). In a broader study on eukaryotic RidA which had previously been characterized using the biochemical properties of goat UK 114. RidA was also identified in Salmo salar (Atlantic salmon). Thus, for salmon, RidA-1 and RidA-2 were identified (page 2, fourth and fifth complete paragraphs). RidA-1 and RidA-2, respectively, are similar to the sequences corresponding to Applicant’s SEQ ID Nos. 1 and 2.
In Figure 1 (page 3), it is disclose that various species all have RidA. The species include Homo sapiens (human), Capra hircus (goat), Gallus gallus (domestic chicken), Xenopus laevis (frog), Gadus mohrua (cod), Orizias latipes (Japanese rice fish), Salmo salar (Atlantic salmon), and Callorhincus milii (elephant shark).
Thus, based on the combined teachings of Cusani, Ceciliani et al, and Digiovanni et al, it would have been obvious to one of ordinary skill in the art before Applicant’s effective filing date to (1) treat or diagnose solid and systemic malignancies using UK 114 protein. (2) It would also have been obvious to one of ordinary skill in the art to use salmon protein because as indicated by Digiovanni et al to use UK 114 salmon protein because the document discloses that the RidA protein is conserved in all domains of life. Thus, it would have been obvious to interchange any of the listed species of Digiovanni et al’s Figure 1 (human, goat, chicken, frog, cod, Japanese rice fish, salmon, and elephant shark) all of which have the conserved RidA protein for one another since they are considered as RidA equivalents. Hence, selecting salmon protein and using it as the specific UK 114 protein in the treatment and diagnosis of malignant solid and systemic tumors is obvious since the RidA moieties of various species, including salmon, is conserved like in other species (human, goat, chicken, frog, cod, Japanese rice fish, and elephant shark). Hence, the limitations of independent claim 6 are met.
Claim 7 is directed to the method of claim 6 wherein said UK 114 salmon protein comprises a monomeric unit with SEQ ID NO:1 or SEQ ID NO:2.
SEQ ID NO: 1 (UK 114 RidA-A): GSHMSSIIRKIINTSKAPAAIGPYSQAVVVDRTMYVSGQLGMDPASGQLVE
GGVQAQTKQALVNMGEILKEAGCGYD SVVKTTVLLADMNDFAS VNDVYKTFF S
S SFPARAAYQVAALPRGGLVEIEAVAVLGPLTEVS
SEQ ID NO: 2 (UK 114 RidA-B):
GSHMAAVQKLFPYTPRAPIRQGIYSQAVVVDRTMYISGQLGLDVASGKLV
EGGVQAQARQALVNMGEILKAAGCGYDNVVKTTVLLADMNDFVNVNDVYKTF
F SKNFPARAAYQVVALPRGGLVEIEAVAVLGPISES
Digiovanni et al is directed to the primary structure, expression, and purification of RidA-1 and RidA-2. The salmon protein sequences of Digiovanni et al (RidA-1 and RidA-2) are similar to Applicant’s SEQ ID Nos. 1 and 2, but lack the amino acids GSH at the beginning of each sequence. However, it would have been obvious to one of ordinary skill in the art prior to Applicant’s effective filing date to incorporate GSH at the beginning of the sequences because on page 11 of Digiovanni et al (second paragraph), it is disclosed that the fusion proteins carried at the N-terminus, the sequence MGSSHHHHHHSSGLVPR/GSH, comprising a 6xHis-tag and the cleavage site for thrombin (/) inside the thrombin recognition site (underlined). Thus, based on Applicant’s sequences both RidA-1 and RidA-2 still have the GSH attached thereto which according to Digiovanni et al is an obvious modification to the N-terminus which is consistent with Applicant’s SEQ ID Nos. 1 and 2. Thus, the limitations of claim 7 are met.
Claim 8 is directed to the method according to claim 6, wherein said UK 114 salmon protein is expressed by Escherichia coli.
Digiovanni et al disclose the primary structure, expression, and purification of RidA-1 and RidA-2 which is present in UK 114 salmon protein. It is disclosed that in order to characterized the salmon RidA proteins, the CDS of Salmo salar (Atlantic salmon) RidA-1 and RidA-2 were cloned into pET-15b downstream to DNA region encoding a 6xHIs tag and a thrombin cleavage site. E. coli Rosetta (DE3) cells were transformed with the recombinant plasmids (see entire document, especially, abstract; page 4, Figure 2; page 4, first and second complete paragraphs; page 11, second complete paragraph). Thus, the limitation of claim 8 is met.
Conclusion
Claims 6-8 are rejected. Claims 9 and 10 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.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
November 5, 2025