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
The filed information disclosure statement (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 II corresponding to claims 24, 27-30, 32, 35, 37-44 and 46-48 without traverse, in the reply filed on 10/13/2025 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 for the elected group has been rejected under 35 USC 112(a) as explained below.
Claims 1, 4-7, 9, 12 and 14-15 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The claims 24, 27-30, 32, 35, 37-44 and 46-48 are examined on merits in this office action.
Claim Rejections - 35 USC § 112
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 24, 27-30, 32, 35, 37-44 and 46-48 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 pre-AIA the applicant regards as the invention.
(i) Claims 24, 30 and 37 recite term “derivatives” in the claim language. First, applicants specification failed to provide definitive definition for the term “derivative”. Second, the term “derivative” rendered its scope unclear, since it is not known to the skilled reader which structure are intended to be encompassed by this term. Such as term includes compounds or peptoids from another compound or peptoid by a chemical reaction (including compounds which are structurally remote from the starting material), functional derivatives (such as compounds, wherein heteroatoms are exchanged by alternative atoms), compounds with numerous different types of side groups etc. However, there is no clear definition in the application to which extent the peptoid might be modified while still being regarded as derivatives. This has the effect that the person skilled in the art cannot decide clearly which peptoids are to be covered by said claim and which are not. Accordingly, claims 24, 30 and 27, and their dependents are rendered indefinite.
(ii) Claim 30 recite “derivatized with a functional group” in the claim language. Applicants specification have not defined what they mean by “derivatized” so the term is interpreted as it is used in the art. The definition of derived (Merriam Webster online dictionary) is “to obtain (a chemical substance) actually or theoretically from a parent substance.” This definition covers materials made from the recited peptoid, including multimers (from conjugation reactions) or smaller compounds, such as single amino acids (from hydrolysis reactions). If this is not how applicants intend the claim to be interpreted, they can amend the claim to more closely match their intended meaning.
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 24, 27-30, 32, 35, 37-44 and 46-48 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:
Independent claim 24 is drawn to a method of blocking virus entry into cells by associating the cells with claimed peptoids or their multimers or derivatives thereof.
Independent claim is broad with respect to all possible viruses, all possible cells, and all possible associating methods, with all possible derivatives of recited peptoids with all possible dosage amounts.
Dependent claims define or cite sub-genus for peptoids and their multimeric species thereof, in addition to other variables, such as linkers, cell types and viruses etc., in the broadly claimed peptoids.
Specification described binding of claimed peptoids to ACE2 receptor and its possible effects on SARC-CoV-2 virus entry into human cells, wherein human cells are selected from MCF7, HeLa, H1299, HEK293T and Caco-2. But the shown data is limited to dimeric forms of claimed peptoids to H1299 cell lines with SARS-CoV-2. Also, based on shown data, in order to practice claimed method, the cell types must express ACE1. However, no description is provided how the shown single species can be extrapolated to the claimed genus in the claimed method.
Applicants can claim as broadly as possible for the claimed invention. However, if there is a variability in the genus or broadly claimed subject matter, and if the variability expects unpredictability for the claimed subject matter, 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 invention. In this case, at least viruses and cell types are probably one of the most unpredictable areas of biotechnology and consequently, the effects of dissimilarities and function cannot be predicted. So, the absence of description with divergent species makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
The issue is, will recited peptoids and their all possible derivatives capable of block all possible viruses entry into all possible cells, with all possible mode of administrations? Do applicants provide enough description for all the variables in the broadly claimed subject matter and their association towards the end property, so that a skilled person in the art understands the claimed invention?
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. However, no such description is provided in the specification.
(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. The claimed genus of viruses and cells can read all possible viruses and possible cell lines. Specification simply described binding of claimed peptoids to ACE2 receptor and its possible effects on SARS-CoV-2 virus entry into human cells, wherein human cells are selected from MCF7, HeLa, H1299, HEK293T and Caco-2. But the actual shown data is limited to dimeric forms of claimed peptoids to H1299 cell lines with SARS-CoV-2, in Example 1.9. Also, based on shown data, in order to practice claimed method, the cell types must express ACE1. Linker is also limited to a single lysine based linker. The dosage range information and mode of administrations have not been provided, further, it is completely generic. No actual animal models data are shown.
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.1-2 describe, theoretically using block diagrams, blocking virus entry into cells. Fig.6 shows binding of monomeric peptoids to human ACE1 positive cells. Fig.8-9, shows interaction properties of monomeric and dimeric peptoids to ACE1. Fig.10 shows in vitro studies, wherein dimers, trimers and tetramers of peptoids prevent binding of spike protein to ACE2.
Fig.11 shows blocking of pseudo SARS-CoV2 entry into H1299 cells using dimers of peptoids. It appears that only in vivo data is shown in Fig.11.
Remaining shown figures are supportive data for the recited components in the claimed method.
(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:
The specification fails to describe a correlation between structure and function for the claimed divergent genus, in this case all possible cell types and all possible viruses etc. Different cell types and different viruses have different properties towards different drugs. There is no single or common receptor on all cell types for viruses. Each virus has varying pathological manifestations and require different treatment modes.
For example, Smith [Science, vol.304, 9 April 2004, 237-242] teaches that to infect a cell, a virus must first attach itself to the surface of a cell. The molecules to which viruses bind constitute a diverse collection of cellular proteins, carbohydrates, and lipids. They differ from one virus to the next, and they range from abundant and ubiquitous to rare and cell specific. Some of them merely serve as attachment factors that concentrate viruses on the cell's surface. Others are true receptors in that they not only bind viruses but are also responsible for guiding the bound viruses into endocytic pathways and for transmitting signals to the cytoplasm. Receptors can also serve as cues that induce conformational changes that lead to membrane fusion and penetration. The identity and distribution of attachment factors and receptors determines to a large extent which cell types, tissues, and organisms a virus can infect. [see section Receptors and Attachment Factors in page 237].
With regard to staples/linkers, the properties of conjugates are sensitive to the linker moiety [see section 6 in He et al, Molecules, 2019, 24, 1855, 1-34; see abstract and conclusion in Lu et al, International Journal of Molecular Sciences, 2016, 17, 561, 1-22].
The art also recognizes that the choice of a linker has great impacts on biological activity, expression yield, and pharmacokinetic properties of a fusion partner (see Chen et al. Adv. Drug Deliv. Rev. 65:1357-1369, 2013).
In view of above evidences, applicants have claimed unlimited range of cell types and viruses in blocking virus entry into cells and so, 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 individual components would be effective for the claimed method. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658