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 information disclosure statement (IDS), dated 12/16/2022 and 05/29/2024, 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.
Specification
The disclosure is objected to because of the following informalities: 37 CFR 1.821(d) states that where the description recites a sequence the sequence identifier must be included. In specification, in examples 3 and 4 cite amino acids sequences, but it fails to provide SEQ ID. It appears that applicants also failed to provide a sequence listing.
Appropriate correction is required.
Claim objections
Claim 7 is objected to because of the following informalities: recited poly-A-substituted glycine is not art recognized name. If applicants intended to state poly-N-substituted glycine, the appropriate correction is required.
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 1-11 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.
Claim 1 recites “at least one composition” and claim defines wherein the composition includes items (a) to (e) in the claim language. It is not clear what are the other compositions Or how many compositions applicants intend to claim, and with what combinations of items (a) to (e). It is impossible to understand the metes and bounds of claimed composition. Accordingly, claim 1 and its dependents are rendered indefinite.
Claim 1 recites ‘composition includes’ in the claim language. It is not clear whether the listed items (a) to (e) are separate moieties or in the form of conjugate in the composition? Do applicants intend to claim ‘conjugate’ instead of ‘composition’? or composition includes the conjugate?
Claim 7 defines the composition with poly-A-substituted glycine and it does not meet all limitations of composition, as defined in the independent claim. For example, it does not have proline etc. So, it is not clear whether the definition or metes and bounds of the claimed composition.
Claims 8-11 define the composition with the recited compounds and these do not meet all limitations of composition, as defined in the independent claim. For example, these do not have binding moiety and second linking moiety etc. So, it is not clear whether the definition or metes and bounds of the claimed composition.
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 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 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 1 is drawn to a method for treating an individual for an infection caused by a pathogen, the method comprising: administering to an individual who has said infection or who is at risk of developing said infection, an amount of at least one composition, wherein the amount of the composition is effective to inhibit said infection, and wherein the composition includes(a) with the recited components (a) to (e).
Dependent claims further limit the composition or its components with the recited limitations.
Independent claim reads all possible infections with all possible pathogens in all possible populations by administering the recited broadly claimed composition with all possible modes of administrations, wherein the composition can be more than one composition or composition can be unlimited compositions. There are no structural limitations on the recited components in the composition. Item (a) can be any hydrophobic compound (peptide or non-peptide) and any helical structure. Linking moieties can be a compound or peptide or a conjugate and there are no structural limitations in the claims. The composition can be in any form and no limit on dosage amounts. So, it appears that there is no defined core structure or domain for the claimed generic composition or conjugate. The core structure or domain is responsible for the property of the compound or peptide, and in its absence of clear definition or description, it makes the invention unpredictable, and cannot be envisioned by a skilled person in the art.
Specification showed and described the structures of peptoids for the components (a), (b) and (c) in the Fig.1. Recited single sequence in examples 3 and 4 as a binding moiety. Second linker is not even described. It appears that properties of individual components in the composition are described, but not the properties of combination of all components in the composition. In other words, there is no shown data or description provided for the claimed composition for treating the claimed method. So, claimed method is purely speculative.
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 its absence, it makes the invention unpredictable, and cannot be envisioned by a skilled person in the art. In this case, there is a greater variability, as explained above, in all variables in the claimed subject matter.
So, the issue is, will claimed unlimited compositions treat all possible infections caused by all possible pathogens in all populations with all modes 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? Can a skilled person in the art extrapolate based on described properties of individual components in the composition, to broadly claimed subject matter, and reproduce applicants 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. In this case, there is species is shown and described for the claimed method.
(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. There is no shown data or description of claimed composition for the claimed method. Specification described the properties of individual components in the composition, viz., peptoids as shown in Fig.1, and recited sequence as binding moiety in examples 2 and 3. Preparation of conjugate of peptoid(s) and binding sequence is shown in example 4. Second linker is not even described.
So, there is no provided data or evidence for the claimed method. 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:
Figures 1-6 show molecular structures of peptoid mimics of Surfactant Protein C (SP-C) and these peptoids represent claimed (a), (b) and (c) in the composition.
No complete structure of composition or conjugate of the recited component (a) to (e) in the composition is shown. Binding sites for the linkers are also not shown and not described.
(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:
Properties of individual components in the composition are known in the art. However, the properties of individual components in the conjugate form through the linkers are not known. Binding moiety can be a compound or peptide or in conjugate form. There is no known single binding moiety which binds to all pathogens in the art. There is also unpredictability in the linkers in making the conjugates. For example, 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). Verdine et al (Methods in Enzymology, 2012, vol.503, 3-33) also showed or described possible unpredictability in staples in the peptide conjugates [see sections 3-5 and 13-14]. So, at least in light of unpredictability in linkers, the conjugate from the components (a)-(e) may result in functional or non-functional towards claimed method.
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 conjugates would be effective in treating all possible infections. 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 single 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.”
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.
Claim Rejections - 35 USC § 103
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Barron (US2013/0109627 A1) in view of Yan (Science, 27 March 2020, 367, 1444-1448; see applicants filed IDS dated 12/16/2022).
For claims 1-3:
Barron teaches a method of treating a mammalian pulmonary disorders by administering SP-C peptoid mimic compounds [see claims 1, 21 and 27; see Figure 1].
Barron further suggest that additives can be included in a synthetic formulation, not only to improve surface activity, but also to prevent surfactant inhibition, regulate surfactant homeostasis, control inflammatory response and treat bacterial and viral infections (e.g., antibiotic and/or antiviral agents) [see 0070].
In the above teachings, the SP-C peptoids read applicants (a)-(c).
Differences between Barron and instant claim are as follows:
(i) Barron silent on pathogen, which causes pulmonary disorder or disease.
(ii) Barron is silent on applicants (d) binding moiety and (e) a second linking moiety.
With regard to (i) of above, root causes of pulmonary diseases are well known in the art. For example, pneumonia, it can be viral or bacterial infection etc.
With regard to (ii) of above, applicants specification defined binding moiety, which is represented by sequence of ACE2 alpha1 helix sequence, which is also known in the art. For example, Yan teaches recognition of SARS-CoV-2 by full length human ACE2 [see title and abstract].
Established case law states that is it known to use A, and known to use B for the same purpose, then it is obvious to use both A and B, In re Susi, 169 USPQ 423, 426; In re Kerkhoven, 205 USPQ 1069. Thus, combining them flows logically from their having been individually taught in the prior art.
In this case, peptoid is known to treat lung related diseases, and ACE2 alpha1 helix sequence also treats lung related disease. Therefore, one would be motivated to make a conjugate to see any combinational effects, which may be superior properties than their corresponding individual components.
For claims 2-3:
Barron silent on second linking moiety or conjugate. However, a skilled person in the art would determine suitable binding sites on the individual components with second linking moiety through a routine experimentation.
For claims 4-6:
Barron teaches Mimic di-pCLeu3 [see Fig. 1], which comprises C-18 alkyl chain.
For claims 7:
The recited compound is nothing but backbone of peptoid. Barron teaches peptoids [see Fig.1], and these have peptoid backbone.
For claims 8-11:
Barron teaches identical peptoids [see Fig.1].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and their utilities in treating infections, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
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