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 1-11, 22, 24-26 and 28, in the reply filed on 04/29/2026 is acknowledged.
The examiner also acknowledges applicants response to election of species, and providing a single species for the claimed variables. 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 elected group. The broadest genus has been rejected under 35 USC 112(a) as explained below.
Claims 16-19, 23, 29-32 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 1-11, 22, 24-26 and 28 are examined on merits in this office action.
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 1-11, 22, 24-26 and 28 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 product. 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:
Claim 1 is drawn to an antiviral agent comprising a multivalent peptide, wherein the multivalent peptide comprises three or more peptides, wherein the three or more peptides are each independently selected from the group consisting of P9R (SEQ ID NO:2) and P9R-like peptides, wherein the P9R-like peptides comprise 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO:2, and wherein the three or more peptides that comprise the multivalent peptide are connected via isopeptide bonds to form the multivalent peptide.
Dependent claims describe isopeptide bonding in the multivalent peptide and, also the properties of multivalent peptides and its composition.
Based on the claim language, first, the terms “comprising” and “comprises” are open language and so, antiviral-agent can have additional sequences or components in it. Second, ‘three or more peptides’ in multivalent peptide means three or unlimited number of peptides. Third, ‘70% or more’ in the sequence means remaining 30% or less can be any amino acids, which can generate hundreds of sequences with various combinations of amino acids. Fourth, ‘three or more peptides’ in the multivalent peptide connected via isopeptide bond. If it is three, then how the remaining are connected? and where is this isopeptide bond located in the peptide or what amino acids are involved in the formation of isopeptide bond? Or is isopeptide bond other than from the claimed sequence? Finally, antiviral agent means, the agent which acts on all possible viruses.
So, in light of divergency and uncertainty in the claimed subject matter, it appears that there is no defined structural features for the claimed antiviral agent and effect of its property on all possible viruses. The structural features are responsible for the property of the agent to treat all possible viruses, and in its absence of clear definition makes the claimed invention unpredictable, and cannot be envisioned by a skilled person in the art.
To support the above claimed subject matter, applicants specification described and showed multivalent 8P9R peptide, wherein eight P9R (SEQ ID NO:2) constitute multivalent peptide, wherein virus is limited to SARS-CoV-2. H1N1, Parainfluenza virus 3 and human rhinovirus. The bonding or structural features of 8P9R are not described or shown. Description of isopeptide bond is very generic. No data is shown with any other multivalent peptide and also P9R-like peptides. There is no description in the specification on ‘how the shown data’ can be extrapolated to other divergent species in the P9R-like peptides.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a variability in the broadly claimed subject matter, and if the variability expects unpredictability or uncertainties in the function/property for the claimed subject matter, then specification must describe/clarify the nexus between shown data and the broadly claimed subject matter, so that a skilled person in the art can understands the invention and can reproduce applicants claimed invention. In its absence, it makes the invention unpredictable, and cannot be envisioned by a skilled person in the art. In this case, structural features and limitations of claimed P9R-like peptide and virus are not described, and so, a skilled person in the art would not know whether claimed P9R-like peptides binds to all possible virus or not.
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, in this case lack of structural features of claimed polypeptide, 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 (MPEP 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The issue at question is in absence of limits/structural features of multivalent peptides, P9R-like peptides and viruses, will claimed all possible multivalent peptides and P9R-like peptides be capable of retaining its property? Do applicants provide enough description for all the variable in the peptide and their association towards its end property, so that a skilled person in the art understands 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:
Shown data is limited 8P9R multivalent peptide and its properties towards SARS-CoV-2. H1N1, Parainfluenza virus 3 and human rhinovirus. However, its structural features of 8P9R are not shown or described. No data is shown with any other multivalent peptide and no data is shown with P9R-like peptides. Description of isopeptide bond is very generic.
There is no description in the specification on ‘how the shown data’ can be extrapolated to other divergent species in the P9R-like peptides, to all possible multivalent peptides and to treat all possible viruses. So, the specification has not adequately shown sufficient description or examples for broadly claimed subject matter, to show possession of the invention as claimed. In other words, applicants have not described the structure required to meet the cited functional limitation, i.e., antiviral agent.
(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:
Figures 1-5 describe the properties of P9, P9R. PA1 and P9RS towards SARS-CoV-2, MERS-CoV, H1N1, H7N9, Rhinovirus and Parainfluenza. No description is provided for the claimed multivalent peptides and its limitations, also no description on P9R-like peptides.
Figures 6-8 described properties of branched P9R, i.e., 8P9R, towards recited viruses.
So, multivalent peptide is limited to 8P9R. However, structural features of 8P9R is not described in the drawings.
(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:
As explained above, claimed multivalent peptide is limited to 8P9R and viruses are limited to SARS-CoV-2. H1N1, Parainfluenza virus 3 and human rhinovirus.
No structural features of 8P9R are described.
No description for P9R-like peptides comprising at least 70% sequence identity to SEQ ID NO:2 is provided, and so, the remaining part can have any sequence or other components. If it is amino acid sequence, then it may influence the property of sequences and eventually antiviral agent as a whole, because divergent amino acids show divergent properties 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. 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, properties of broadly claimed multivalent peptides and P9R-like peptides are unpredictable in light of conjugation between monomers, linking groups and divergent sequence etc., and so, a skilled person in the art cannot envision applicants claimed subject matter. Also, there are no physical/chemical/structural features that applicants have tied to the recited property in a relevant teaching manner, which makes it impossible for an individual of ordinary skill in the art to determine which of the very large genus of multivalent peptides and P9R-like 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.
Nonstatutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-11, 22, 24-26 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of US copending application # 18/735,027.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Instant claims are drawn to an antiviral agent and its composition comprising a multivalent peptide, wherein the multivalent peptide comprises three or more peptides, wherein the three or more peptides are each independently selected from the group consisting of P9R (SEQ ID NO:2) and P9R-like peptides, wherein the P9R-like peptides comprise 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or more sequence identity to SEQ ID NO:2, and wherein the three or more peptides that comprise the multivalent peptide are connected via isopeptide bonds to form the multivalent peptide.
Claims of copending application are drawn to an antiviral agent and its composition comprising a multivalent peptide, wherein the multivalent peptide comprises four copies of one or a combination of peptides selected from the group consisting of P9R (SEQ ID NO:2) and P9R-like peptides derived from P9R, wherein the peptides branch from the multivalent peptide.
The subject matter claimed antiviral agent and its composition is fully disclosed and covered in the US copending patent application.
Both claiming common subject matter, which is antiviral agent comprising multivalent peptide comprising P9R (SEQ ID NO:2) and P9R like peptide.
Difference is that claims of copending application are broader in scope, since claims do not define P9R like peptide and type of bonding in multivalent peptide.
However, scope of claimed subject matter overlaps, that means both are in the same field of use, differences are minor or routine, co-pending application suggests the same or similar properties of peptides, and there is no evidence of criticality or unexpected results in the claimed subject matter.
Accordingly, claims are obvious over the claims of US copending application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
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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