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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
Filed information disclosure statements (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group I, corresponding to claims 6,7,11-14,17,18,23,24,27,28,33-37,39-41 and 43, without traverse, in the reply filed on 01/01/2025 is acknowledged.
The examiner also acknowledges applicants response to election of species and providing a single species for the claimed variables. It appears that applicants elected species are free of art. Following an extensive search and examination, the originally elected species has been deemed free of the prior art. Per MPEP § 803.02, “If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended”. Accordingly, the search has been extended to the full scope of claimed method. The broadest genus has been rejected under 35 USC 112(a) as explained below.
Claim 38 and newly added claim 42 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim objections
Claims 1, 6, 17, 27, 37, 40 and 41 are objected to because of the following informalities: the numbers within the parenthesis in the claim language should be removed and make it as a separate limitation. Typically, the text within the parenthesis implies “also known as”. That is not the case in this context. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: Claim recites [Ala220] at N-terminus of recited SEQ ID NO:9. If applicants intend to claim ‘Ala’ at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Claim 17 is objected to because of the following informalities: Claim recites [Ala220] at N-terminus of recited SEQ ID NO:6. If applicants intend to claim ‘Ala’ at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Claim 27 is objected to because of the following informalities: Claim recites [Ala220] at N-terminus of recited SEQ ID NO:8. If applicants intend to claim ‘Ala’ at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Claim 37 is objected to because of the following informalities: Claim recites [Ala220] at N-terminus of recited SEQ ID NO:7. If applicants intend to claim ‘Ala’ at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Claim 40 is objected to because of the following informalities: peptide claims [X220] at N-terminus of recited sequences. If applicants intend to claim ‘X’ at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Claim 41 is objected to because of the following informalities: Claim recites [Val220] or [Ser220] or [Ala220] or [Gly220] at N-terminus of claimed sequences. If applicants intend to claim these amino acids at position 220 of Renalase A chain, then delete it and make it as a separate limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Written Description
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, 7, 11-14, 18, 23-24, 27-28, 33-36, 39, 40-41 and 43 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 for the claimed method. 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is based on the requirement(s), i.e., the guidelines provided by the MPEP 2163.04. These are listed below:
(A) identify the claim(s) limitations at issue, and
(B) establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. The MPEP 2163 further provided or expanded the guidelines for the written description requirements.
(A) IDENTIFY THE CLAIM LIMITATIONS AT ISSUE:
Claims are drawn to a peptide, represented by the following formula:
R-X220-Ile221-Arg222-Ph e223-Va1234-Ser225-Ile226-Asp227-Asn228-Lys229-R';
wherein the superscripts represent positions within the Renalase A chain (1- 342);
wherein R is selected from the group consisting of Ac-Ala-Gly-Thr-, Ac-Gly-Thr-, Ac-Thr-, Ac- , Ac-Z, H-, H-Z, B-Z- and B;
X at position 220 in Renalase A chain (1-342) is represented by the
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, wherein R1, R2 and Y are selected from the recited large sub-genus of chemical groups;
wherein R’ is selected from the group consisting of -NH2, Z'-NH2, -B, and Z'-B;
wherein Z is selected from one or more amino acid residues at positions 205-219 in Renalase A chain;
wherein Z’ is selected from one or more amino acid residues at positions 230-257 in Renalase A chain; and B is recited PEGs.
The term “comprising” is an open language and does not exclude other components in the peptide.
At least based on variables R1, R2 and Y, claimed peptide can generate several hundreds of divergent species, since these variables ranges from simple H atom to complex alkyl or cycloalkyl groups, further these are substituted by hydroxyl or methyl or both.
Claimed peptide is associated with Renalase A chain, and therefore, it should retain or show better properties or unexpected properties than that of Renalase A chain or it can be an inactive form, in light of divergent chemical groups for R1, R2 and Y. Whatever the associated property with the claimed peptide, which should be retained in all species, which fall under the generic claimed peptide, so that a skilled person can envision the claimed subject matter.
To support the above broadly claimed peptide, applicants described claimed subject matter with “Ala” for the claimed generic X220 in the peptide. No description or evidences are provided with any other species.
So, the issue is in the scope of the broadly claimed subject matter for the claimed peptide. Specification failed to describe the nexus between shown data and broadly claimed subject matter. In other words, the structure/function relationship for the claimed generic variables and claimed peptide is not described.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a divergency in the genus or broadly claimed subject matter, and if it expects unpredictability for the claimed method, then specification must describe the genus with divergent species, so that a skilled person in the art can understands claimed invention and can reproduce applicants claimed peptide and its properties. In this case, at least protein chemistry is probably one of the most unpredictable areas of biotechnology and consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted. So, in the absence of description with divergent species makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure. See MPEP 2163 II(A)(3)(a)(ii).
The number of species that describe the genus must be adequate to describe the entire genus. However, if there is substantial variability, a large number of species must be described.
The question is with several hundreds of possible divergent species in all possible combinations for the claimed peptide, (i) did applicants provide enough description for making all possible peptides with all possible combinations etc? (ii) will the these be capable of retain its property? Based (i) and/or (ii), will a skilled person in the art understand the claimed invention?
(B) ESTABLISH A PRIMA FACIE CASE BY PROVIDING REASONS WHY A PERSON SKILLED IN THE ART AT THE TIME THE APPLICATION WAS FILED WOULD NOT HAVE RECOGNIZED THAT THE INVENTOR WAS IN POSSESSION OF THE INVENTION AS CLAIMED IN VIEW OF THE DISCLOSURE OF THE APPLICATION AS FILED:
The further analysis for adequate written description considers, see MPEP 2163, the following:
(A) Determine whether the application describes an actual reduction to practice of the claimed invention:
Not provided. Shown description is limited to “Ala” for the claimed generic X220 in the peptide and amino acids from 205 to 240-NH2 sequence from the Renalase A chain. No description or evidences are provided with any other species.
So, the provided data is very limited.
Accordingly, applicants failed to describe actual reduction to practice of the claimed invention.
(B) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole:
Fig.1 describes sequence of Renalase chain A.
Fig.2 is limited to peptide 10, which is Ala for X220 in the peptide and amino acids from 205 to 240-NH2 sequence from the Renalase A chain.
Fig.3 describes activity of renalase agonists against cisplatin lethality, but specification fails to describe the peptides 1-10 and their structural features.
Fig.4 describes peptide 81, which does not fall in the scope of claimed peptide.
Fig.5-7 are limited to peptide 10, which is Ala for X220 in the peptide and amino acids from 205 to 240-NH2 sequence from the Renalase A chain.
Fig.8 describes peptide 81, which does not fall in the scope of claimed peptide.
Fig.9-14 limited to peptide 10, which is Ala for X220 in the peptide and amino acids from 205 to 240-NH2 sequence from the Renalase A chain.
So, as evidenced from the above description of drawings, it is clear that the claimed invention is not complete by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole.
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics, such as structure/function correlations, as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention:
At least, in the broadly claimed peptides, which can have all possible combination of several amino acids and divergent alkyl or cycloalkyl groups, and these are expected to drastically effect the properties of peptide sequence and its conformation, and so, a skilled person in the art cannot envision applicants claimed subject matter, since protein chemistry is probably one of the most unpredictable areas of biotechnology. Consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted.
For example, Bowie et al (Science, 1990, 247:1306-1310) teach that an amino acid sequence encodes a message that determines the shape and function of a protein and that it is the ability of these proteins to fold into unique three-dimensional structures that allows them to function and carry out the instructions of the genome and further teaches that the problem of predicting protein structure from sequence data and in turn utilizing predicted structural determinations to ascertain functional aspects of the protein is extremely complex (column 1, page 1306). Bowie et al further teach that while it is known that many amino acid substitutions are possible in any given protein, the position within the protein's sequence where such amino acid substitutions can be made with a reasonable expectation of maintaining function are limited. Certain positions in the sequence are critical to the three dimensional structure/function relationship and these regions can tolerate only conservative substitutions or no substitutions at all (column 2, page 1306). The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al (J. Cell Biol. 111:2129-2138, 1990) who teach that replacement of a single lysine reside at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al (Mol. Cell. Biol., 8:1247-1252, 1988) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
In view of above evidences, applicants have claimed wide range of variables in the claimed peptide and all possible combinations, and a skilled person in the art can expect unpredictability in the broadly claimed genus. There are no physical/chemical/structural features that applicants have tied to this property in a relevant teaching manner, making it impossible for an individual of ordinary skill in the art to determine which of the very large genus of claimed peptides would be effective. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.
Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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