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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 8, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See [0035], line 19, page 12; [0060], line 5, page 21; [0069], line 8, page 25; [0075], line 21, page 29. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
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 9-13 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.
The claimed invention is directed to a peptide or peptide complex comprising SEQ ID NO: 3 and SEQ ID NO: 4 that specifically binds to the S1 spike protein of SARS CoV2 virus. The specification reduces to practice experiments to teach reduced binding between ACE2 and S1 proteins in the presence of SEQ ID NO: 3, SEQ ID NO: 4 (Fig 7A, Fig 7C, Fig 7D, Fig 8) using Ni-NTA column and protein interaction of SEQ ID NO 3 or SEQ ID NO: 4 with S1, using spotting on nitrocellulose membrane (Fig 5A, Fig 5B, Fig 6A, Fig 6B). The Applicant does not reduce to practice SARS CoV2 virus infection in vitro or in vivo, the binding of peptides to S1 protein of virus infected cells nor does the Applicant reduce to practice a method of treating SARS CoV2 infected cells or subject.
Claims 9 is 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. Claim 9 is directed to a method of treating a subject comprising administering the peptide of claim 1. The specification provides adequate written description for the peptide of claim 1 but does not provide adequate written description for the method of treatment. The instant specification discloses embodiments of “a method of treating“ as “effecting prophylaxis of SARS CoV2 infection in a subject” [0053] and as administering to the subject an effective amount of the mimic peptide of SEQ ID NO:3 or SEQ ID NO: 4 or the peptide complex comprising SEQ ID NO: 3 and SEQ ID NO: 4, thereby inhibiting or blocking interaction of SARS CoV2 spike protein with ACE2 receptor in the subject (see [0014] line 3). Thus, the scope of “treating” a viral infection encompasses prevention of disease to reduction of disease progression to alleviation of symptoms of disease. Therefore, “treating” as claimed, also encompasses 100% prevention of SARS CoV2 infection.
With the teachings of a method of treatment as disclosed by the specification, the Applicant fails to present specific guidance on how the treatment of SARS CoV2 infection in a subject can be achieved by administering the peptides SEQ ID NO: 3 or SEQ ID NO: 4. Applicant shows that the SEQ ID NO:3 and SEQ ID NO: 4 reduces interaction of ACE2 with the viral S1 spike protein in in vitro assays. Applicant does not teach reduced interaction of ACE2 with the viral S1 spike protein in SARS CoV2 infected cells in a subject. In the absence of an adequate written description and a reference to a potential method for practicing it, 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.
An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved. The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. "Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002). See MPEP §2163.03.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991)
Claims 10 is 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 is directed to a method of treatment of SARS CoV2 infection in a subject comprising treatment with the peptide complex of SEQ ID NO: 3 and SEQ ID NO: 4. The specification teaches reduced ACE2-S1 interaction in the presence of the peptide complex (Figure 8) but does not provide sufficient written description or a potential method of treating a subject with SARS CoV2 infection using the peptide complex as claimed. Therefore, the claim 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.
Claims 11 and 12 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. Applicant provides sufficient written description regarding conjugating peptides of SEQ ID NO: 3 and SEQ ID NO: 4 with gold nanoparticles ([0078], line 4) and the interaction of gold nanoparticle conjugated peptide of SEQ ID NO: 3 or SEQ ID NO: 4 with the S1 spike protein (Fig 5B and Fig 6B respectively) but does not provide sufficient written description in the disclosure, of treatment of a subject with nanoparticle conjugated peptides. A person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of treatment of SARS CoV2 infection with 10 nm to 20 nm nanoparticles conjugated with peptide of SEQ ID NO: 3 or SEQ ID NO: 4.
Claims 13 is 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. Claim 13 is directed to a method of treatment of SARS CoV2 infection in a subject, administered using a nasal spray. The instant specification does not provide a reference method of using the peptides as a nasal spray or nebulizer. Further, the embodiments do not teach a method for the treatment of a subject with SARS CoV2 infection, executed through a nasal spray or nebulizer. In the absence of a potential method of treatment using the peptides as nasal spray or nebulizer composition, 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.
Claim Rejections - 35 USC § 112
Claims 9-13 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As stated in § MPEP 2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’. These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5.The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation needed to make or use the invention based on the disclosure.
See in re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). The eight Wands factors are applied to claims 9-13 as follows:
The breadth of the claims and the nature of the invention
Claims 9-13 are directed to a method of treatment of a subject infected with SARS CoV2. The instant specification discloses embodiments of “a method of treating“ as “effecting prophylaxis of SARS CoV2 infection in a subject” and as administering to the subject an effective amount of the mimic peptide of SEQ ID NO:3 or SEQ ID NO: 4 or the peptide complex comprising SEQ ID NO: 3 and SEQ ID NO: 4, thereby inhibiting or blocking interaction of SARS CoV2 spike protein with ACE2 receptor in the subject (see [0014] line 3, [0053] line 1). As such, scope of “treating” a viral infection encompasses prevention of disease to reduction of disease progression to alleviation of symptoms of disease. Therefore, “treating” as claimed, also encompasses 100% prevention of SARS CoV2 infection. The specification provides no evidence that the mimic peptide can treat or prevent a SARS CoV2 infection in a subject.
Accordingly, claims 9-13 are unduly broad with respect to treating or preventing SARS CoV2 infection.
The State of the Prior Art
The prior art in the field of treating or preventing SARS CoV2 infection in a subject is non-existent for the 2019 coronavirus (SARS CoV2) that emerged as a global pandemic in 2019. No registered therapies for treating coronavirus infections using short peptides are available in the prior art . Although conjugation of peptides with 10 nm to 20 nm nanoparticles is well established in the prior art , it is noted that there is no prior art that teaches administering the mimic peptides (with or without nanoparticle conjugation), to the subject, in order to treat or prevent SARS CoV2 infection.
The Level of Skill in the Art
Practitioners in this art (medicinal chemists, clinicians, pharmacists, scientists) would presumably be highly skilled in the art for prevention of SARS CoV2 infection in a subject.
The Level of Predictability in the Art
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Prior art has investigated therapeutics acting on SARS CoV2 infection. Despite computational approaches to search potential peptide therapeutics, analogous screening of drugs, etc there are no therapeutics that have successfully passed the stages of in vitro screening towards treatment. This is because the art is unpredictable and there is no precedent for peptide treatment of SARS CoV2 infection. It is not obvious from the instant disclosure, of a specific method that can achieve prevention or treatment of a subject infected with the SARS CoV2 virus using the mimic peptide.
The Amount of Direction Provided by the Inventor and The Presence or Absence of Working Examples
The instant specification does not provide adequate guidance with regard to the actual treatment or prevention or the effective amount of the peptide that is required to treat or prevent the infection. Applicant’s limited disclosure is noted but is not sufficient to justify claiming treatment or prevention of SARS CoV2 infection in a subject broadly.
Absent a reasonable a priori expectation of success for using the mimic peptide in a method of treatment, one skilled in the art would have to extensively test the peptide on a representative number of SARS CoV2 infected subjects, determine dosing using different concentrations of peptide and ascertain a prevention or treatment standard. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. As discussed in “[t]he Level of Predictability in the Art” section supra, the specification teaches several working examples examining the interaction of peptide with the S1 protein and the reduced interaction of ACE2 with the S1 protein in the presence of peptides (See Fig 5-8). However as noted in the “Breadth of the Claims and Nature of Invention” section, treatment and prevention encompass 100% prevention. As such the examples used in the specification are not indicative of the desired result of 100% prevention of the SARS CoV2 infection.
It is further noted that Applicant provides no data, examples, figures, etc. demonstrating that the peptide is capable of preventing the SARS CoV2 infection. In the absence of such information, a person of ordinary skill in the art would reasonably require undue quantity of experimentation.
Conclusion of Enablement Analysis 35 USC § 112(a)
MPEP § 2164.01(a), 4th paragraph states that “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
After applying the Wands factors and analysis to claims 9-13, in view of the applicant’s entire disclosure, it is concluded that the practice of the invention as claimed in claims 9-13 would not be enabled by the written disclosure excluding that of a peptide composition SEQ ID NO: 3 and SEQ ID NO: 4 binding to the S1 protein of SARS CoV2. Therefore claims 9-13 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to treat or prevent SARS CoV2 infection in a subject.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han, Y (ACS Nano 2020, 14, 5143-5147; Published 14 April 2020).
Han, Y teaches peptide inhibitors designed from the ACE2 protein, that conformationally match the S protein and that is highly specific for SARS CoV2 blocking. The peptide sequences for the four inhibitors designed and tested by Han, Y is provided in Supplementary Table S1. Specifically, Han, Y teaches that inhibitor 1 is less stable, having the largest RMSD fluctuations (Fig S1), whereas inhibitors 2-4 provide conformational matching to the RBD of SARS CoV2 and a full cover of the RBD surface. Han, Y teaches that inhibitors 1-4 show varying interaction energies or binding to the receptor binding domain (RBD) of the ACE2 receptor (Fig 2f-g), but all inhibitors engage with the RBD site for SARS CoV2 blocking (Fig 2a-e). Each of the four inhibitors taught by Han, Y is a 100% sequence match to SEQ ID NO: 4 in the instant claims.
Claims 1, 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang, J. et al. (Nature Communications 2020, 11 (1): 4541; Published 11 September 2020).
Yang, J. et al. teaches the S1 subunit specifically binds to ACE2 receptors, using single molecule force-probing techniques such as atomic force microscopy (AFM). To mimic cell surface receptors, ACE2 is covalently immobilized onto gold surfaces and S1 interaction to the receptors is quantified by grafting the S1 subunit to the free end of a polyethylene glycol (PEG) linker-spacer attached to the AFM tip. Specificity is demonstrated by the significantly lower binding frequency associated with the spacer control, not functionalized with the S1 protein, compared to the PEG linker that contains the S1 protein (Fig 2C). Yang, J. et al. teaches, that in cells expressing ACE2-eGFP, the S1 subunit protein interacts with the ACE2 receptor with higher binding probability compared to cells not expressing the ACE2-eGFP (Fig 3). Notably, Yang, J. et al. teach four inhibitor peptides that mimic the regions of ACE2 and inhibit S1-ACE2 binding. The [22-44] peptide with sequence EEQAKTFLDKFNHEAEDLFYQSS (Supplementary Fig 9) reduces binding probability between the S1 subunit and ACE2 by ~76%. The [22-57] peptide, EEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNITEE reduces binding probability by ~74% (Fig 4). Notably, the peptides that mimic ACE2 binding regions, inhibit S1 and ACE2 interaction and are a 100% sequence match to SEQ ID NO: 4 of the instant specification (highlighted in bold).
Regarding claim 1, Yang, J. et al. (supplementary Fig 9) teaches peptides selected to mimic the regions of ACE2 that interacts with the S1 subunit. The peptides [22-44], [22-57] and [22-44-g 351-357] listed below, is a 100% sequence match (bold) to SEQ ID NO: 4.
[22-44] EEQAKTFLDKFNHEAEDLFYQSS
[22-57] EEQAKTFLDKFNHEAEDLFYQSSLASWNYNTNITEE
[22-44-g 351-357] EEQAKTFLDKFNHEAEDLFYQSS G LGKGDFR
Regarding claims 5 and 7, Yang, J. et al. (Methods section, ‘MD simulation between ACE2 peptides and S glycoprotein) teaches water with the peptide in the simulation system for MD simulation.
The disclosure of Yang, J. et al. satisfies the claim limitations as recited in instant claims 1, 5 and 7 Accordingly, the disclosure of Yang, J. et al. anticipates instant claims 1, 5 and 7.
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 (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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Han, Y (ACS Nano 2020, 14, 5143-5147; Published 14 April 2020) in view of Zong, J et al., (Biomater. Sci., 2017, 5, 872; Published 17 March 2017).
Claim 3 is drawn to the mimic peptide of SEQ ID NO: 3 or SEQ ID NO: 4 conjugated with about 10 nm to 20 nm nanoparticles.
Han, Y teaches the design of peptide inhibitors against the SARS CoV2 coronavirus that is extracted from critical amino acids of the virus binding domain of the ACE2 receptor. Molecular dynamics simulations demonstrate that Inhibitors 1-4, (Table S1) individually bind the receptor binding domain (RBD) on SARS Cov2 (Fig 2a-g) providing highly promising trails for SARS CoV2 blocking. The inhibitors taught by Han, Y, is a 100% query match to SEQ ID NO: 4 in the instant application. Han, Y also teaches that binding affinities of peptide inhibitors 1-4 could be further enhanced by multivalent binding to nanoparticles (See Abstract and Conclusion).
Han, Y does not explicitly teach peptide inhibitors conjugated to nanoparticles in the size ranging from 10 nm-20 nm.
Zong, J et al., teaches various therapeutic peptides conjugated with gold nanoparticles for improved molecular detection and targeted drug delivery and reports that the size of the gold nanoparticles conjugated to the peptides, affects cellular internalization. Larger gold nanoparticles (60 nm) are internalized to a lesser extent by HeLa cells compared to smaller (13 nm and 30 nm) nanoparticles. Zong, J et al., teaches that peptides conjugated with gold nanoparticles in the size range of 20-60 nm have the highest uptake in HeLa cells (See section 4.2). Zong, J et al., teaches that the Bombesin peptide which has a high affinity for gastrin releasing peptide (GRP) receptor sites, specifically targets these receptors overexpressed in prostate, breast and lung carcinomas. The higher the binding between the gold nanoparticle and the Bombesin peptide, the higher the cell binding affinity as shown by lower IC50 values (See section 4.3, Figure 15).
Han, Y explicitly teaches that binding affinities of peptide inhibitors 1-4 could be further enhanced by nanoparticle conjugation.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify SEQ ID NO: 4 taught by Han, Y with nanoparticles, as taught by Zong, J et al., to produce peptide inhibitors conjugated with nanoparticles in the 10 nm-20 nm size range as claimed in the instant application. One motivated to do so would have a reasonable expectation of success, as nanoparticle conjugation to peptides, demonstrates enhanced target binding and improved therapeutic delivery. Thus, one would have recognized that applying the teaching of Yan, H to the to the method of Zong, J et al., would have yielded predictable results and improved the ability of SEQ ID NO; 4 to inhibit SARS CoV2 infection (See MPEP §2143).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, J. et al. (Nature Communications 2020, 11 (1): 4541; Published 11 September 2020) Yang, J. et al., teaches ACE2 derived peptides [22-44], [22-57], [22-44-g 351-357] comprising water (about 20, 000 molecules) in MD simulations between ACE2-derived peptides and the SARS CoV2 spike protein complex (see page 8). Yang, J. et al., teaches therapeutic peptides to block SARS CoV2 infection.
Therefore, it is obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add water to the ACE2 derived peptides. This modification of the peptide takes a known technique of adding water to a product, and use the peptide-water composition in order to confirm interactions between ACE2 and S1 to yield predictable results.
One would have had a reasonable expectation of success because prior art elements are combined according to known methods to yield predictable results under KSR rationale (A). (See MPEP 2143 (I)(A)).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, J. et al. (Nature Communications 2020, 11 (1): 4541; Published 11 September 2020)
Claim 7 is directed to the mimic peptide of claim 5 wherein the pharmaceutically acceptable carrier includes at least one of, water…and/or polyalcohol.
Yang, J. et al., teaches ACE2 derived peptides [22-44], [22-57], [22-44-g 351-357] comprising water (about 20, 000 molecules) in MD simulations between ACE2-derived peptides and the SARS CoV2 spike protein complex (see page 8).
Therefore, it is obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add water to the ACE2 derived peptides. This modification of the peptide takes a known technique of adding water to a product, and use the peptide-water composition in order to confirm interactions between ACE2 and S1 to yield predictable results.
One would have had a reasonable expectation of success because prior art elements are combined according to known methods to yield predictable results under KSR rationale (A). (See MPEP 2143 (I)(A)).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yang, J. et al. (Nature Communications 2020, 11 (1): 4541; Published 11 September 2020) in view of Han, Y (ACS Nano 2020, 14, 5143-5147; Published 14 April 2020) in view Zhang, Q CN104274818A (Published 14 January 2015, Priority 04 July 2013).
Claim 8 is directed to the treatment composition, wherein the composition is a nasal spray or nebulizer.
Yang, J. et al., teaches water in the mimic peptide composition as discussed above. Yang, J. et al., does not teach the composition is a nasal spray or nebulizer.
Han, Y teaches peptide inhibitors as noted above. Han, Y also teaches that the proposed peptide inhibitors could be used as inhaled therapeutics for topical lung delivery, providing an efficient way to prevent virus activation in lungs and to combat COVID-19 (concluding paragraph).
Zhang, Q teaches pharmaceutical preparations for peptide nasal spray.
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the peptide as taught by Yang, J. et al., and combine the teaching of Han, Y for a nasal spray composition and apply a known technique as taught by Zhang, Q for an improved treatment composition as claimed. It would have been obvious to use a known technique of creating a nasal spray from peptide, for improvement, to yield predictable results
One would have had a reasonable expectation of success because the well-established function of the peptide inhibitor is combined according to known methods of creating a nasal spray from peptide, to yield predictable results and an improvement such as prevention of virus activation in the lungs under KSR rationale (D). (See MPEP 2143 (I)(D)).
Conclusion
Claims 2, 4 and 6 are objected to because of the dependency of the claims on a rejected claim (See MPEP § 706.01).
The following is a statement of reasons for the indication of allowable subject matter in claims 2, 4 and 6: Claims 2, 4 and 6 are directed to the peptide complex including the amino acid sequence of SEQ ID NO: 3 and SEQ ID NO: 4. Since SEQ ID NO: 3 is free of the prior art, Claims 2, 4 and 6 contain allowable subject matter.
Correspondence
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654