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 05/24/2023, 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.
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification/prior art, while being enabling for treating SARS-CoV2 by administering compounds of 1-9 or its pharmaceutical composition, the specification does not reasonably provide enablement for preventing an individual having viral infection caused by all possible enveloped virus in an individual by administering all possible compounds covered by formula I. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404where the court set forth the eight factors to consider when assessing if a disclosurewould have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546(BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary.
(1, 5) The nature of the invention and the Breadth of the Claims:
Claims are drawn to a method for preventing or treating an infection by an enveloped virus in an individual comprising administering a compound of formula (I) or its pharmaceutical composition.
The bread of the claims are encompass the prevention of infection by an enveloped virus in an individual, which has potentially many different causes, each of which may or may not be addressed by the administration of the claimed sequences or compounds.
The meaning of “preventing” is completely eradicate the claimed diseases, both existing as well as from the future occurrence.
(2) The state of the prior art:
While the state of the art is relatively high with regard to delaying or the spread of viral infections and treating the progress of viral diseases. However, the state of the art with regard to prevention of such claimed viral diseases is underdeveloped. In particular, there do not appear to be any examples or teachings in the prior art wherein a compound or peptide similar to the claimed compounds was administered to a subject to provide prevent claimed viral diseases.
For example, there is no vaccine or drug to prevent AIDS disease, caused by enveloped virus. Similarly, there is no cure or prevention of disease caused by Ebola virus [see info in https://www.health.state.mn.us/diseases/ebola/basics.html].
It appears that more research is needed to gain a more in-depth knowledge of an infection by an enveloped virus in an individual, thus making it possible to identify new therapies that can contribute to its prevention.
So, the art provide guidance as to how to treat certain viral infections and reduce the spread or viral infections, but do not provide guidance as how to determine individuals who are susceptible to viral infections and how to prevent viral infections.
(3) The relative skill of those in the art:
The level of ordinary skill in the art of treating viral diseases is high, however, as an ordinary artisan in this art needs specialized knowledge for preventing claimed viral diseases with the recited compounds or peptides.
(4) The predictability of the art:
Despite the advanced training of practitioners in the art, it is still impossible, to predict from the structure of compounds(s) or peptide(s) and from its functionality that the peptide or the composition comprising the peptide(s) will be useful in preventing a condition e.g. applicants claimed viral diseases.
Absent a mechanistic link between the method steps and the observed effect, the pharmaceutical and medical treatment arts are highly unpredictable. Most progress is established through empirical and anecdotal evidence as to the efficacy of certain treatments. Once a mechanistic link has been established between the method and the mechanism of action become more predictable. However, many uncertainties can still exist even when the mechanism of action is known. For example, factors such as the bioavailability, pharmacokinetic profile, and potency of a compound can still be uncertain even if it can be expected to be active in disease models. The term "preventing" is interpreted as encompassing any improvement of the clinical outcome of a subject by administering the therapy prior to the occurrence of condition claimed. However, no working examples support administration of any composition prior to the occurrence of preventing viral diseases as claimed to improve the clinical outcome.
It cannot be predicted from the prior art or from the specification that how the occurrence of any condition as claimed can be completely prevented by administration of the agents as claimed. It cannot be predicted from the prior art or from the specification that claimed viral diseases can be completely prevented as prevention embraces the complete 100% inhibition. In addition, it cannot be predicted from any prior art or from any drug treatment that any condition can be completely prevented from occurring again. Treatment of a condition is possible but not prevention of a condition. In other words, there is no guarantee that claimed viral diseases will not occur ever again after administration of an effective amount of recited compounds or peptides.
(6, 7) The amount of guidance given and the presence of working examples:
It has been established that, “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).
There is no single example or evidence to the administration of the agents prior to the occurrence to prevent claimed viral diseases and the condition was completely prevented.
(8) The quantity of experimentation necessary:
Applicant fails to provide information sufficient to practice the claimed invention, absent undue experimentation. The burden of enabling the prevention of claimed viral diseases comprising administering the claimed compounds or peptides would be much greater than that of enabling the treatment of such condition. In the instant case, the specification does not provide guidance as to how one skilled in the art would accomplish the objective of preventing claimed viral diseases for example or how the subject could be kept from ever being susceptible to claimed viral diseases. Nor is there any guidance provided as to a specific protocol to be utilized in order to show the efficacy of the presently claimed agents for preventing claimed viral diseases. Genetech, 108 F.3d at 1366 states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and "patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable." Therefore, in conclusion, it is readily apparent from the aforementioned disclosure, in conjunction with a corresponding lack of scientific data and working embodiments regarding prevention of viral diseases as claimed of is not enabled because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Suggested language to overcome above rejection: delete term “preventing” from the claim language.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
I. Claims 1-4, are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Diamond (US 2007/0203073 A1).
For claims 1-4:
Diamond discloses a method of treating or preventing a viral infection in an individual in need of such treatment, comprising administering an effective amount of at least one compound that is an inhibitor of cathepsin L, wherein the viral infection comprises ebola or SARS, wherein the compound is selected from the group consisting of Leupeptin, Z-Val-Phe-CHO, Z-Val-Phe-FMK, Boc-Val-Phe-4-chlorobenzyl, Z-Val-Phe-NHO-enzyl, Z-Val-Phe-NHO-4-methoxybenzyl, and Z-Val-Phe-NHO-4-methylbenzyl. [see 0013, 0017, 0196 and claims 1-3].
In the compounds of Diamond, at least Leupeptin and Z-Val-Phe-CHO, read applicants compound of formula (I), when in applicants compound of formula (I), n=0, R2=H, R7 is carboxybenzyl (Z) or acetyl, R1 is Leucine functional group or R1 is Arg functional group, which reads R1, R3 and R5 do not all represent Leu functional group.
Accordingly, the claims are fully anticipated.
II. Claims 11, are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Diamond (US 2007/0203073 A1).
Diamond discloses a method of treating or preventing a viral infection in an individual in need of such treatment, comprising administering an effective amount of at least one compound that is an inhibitor of cathepsin L, wherein the viral infection comprises ebola or SARS, wherein the compound is selected from the group consisting of Leupeptin, Z-Val-Phe-CHO, Z-Val-Phe-FMK, Boc-Val-Phe-4-chlorobenzyl, Z-Val-Phe-NHO-enzyl, Z-Val-Phe-NHO-4-methoxybenzyl, and Z-Val-Phe-NHO-4-methylbenzyl. [see 0013, 0017, 0196 and claims 1-3].
In the compounds of Diamond, at least Leupeptin and Z-Val-Phe-CHO, read applicants compound of formula (I), when in applicants compound of formula (I), n=0, R2=H, R7 is carboxybenzyl (Z) or acetyl, R1 is Leucine functional group or R1 is Arg functional group, which reads R1, R3 and R5 do not all represent Leu functional group.
Diamond further discloses that their compounds are administered in the form of pharmaceutical composition [see 0303, 0305-0306].
Accordingly, the claims are fully anticipated.
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.
I. Claims 1-10 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (Cell Research, 2020, 30, 678-692; published on 15-Jun 2020; see applicants filed IDS dated 05/24/2023).
For claim 1:
Ma teaches inhibitor of SARS-CoV-2 viral replication, where the inhibitors are selected from the following compounds:
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[see Table 1].
The above compounds read applicants claimed formula (I).
However, Ma is silent on treating an individual, who is infected with enveloped virus. This can be cured with the following reasoning:
Ma established the fact that compounds, viz., MG-132 and Leupeptin inhibit SARS-CoV-2 replication, which is a first step in the development of drug for treating SARS-CoV-2 infection. Based on the data provided in the disclosure of Ma, a skilled person in the art would be motivated to extrapolate in vitro or in vivo data from the teachings of Ma, to animal models and then develop a method to treat SARS-CoV-2 associated diseases.
For claims 2-4:
Ma teaches inhibitor of SARS-CoV-2 viral replication, which belongs to Coronaviridae family.
For claims 5-6:
Ma is silent on age of individual in their disclosure. However, testing the tolerance of drug in different age groups or different populations or different diseased conditions is a routine practice in the art, since it can eliminate undesirable side effects and so, drug can be contraindicated with respect to specific populations.
For claim 7:
Ma is silent on second drug or compound in inhibiting SARS-CoV-2 replication. Established case law states that “If it is 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.
For claims 8-9:
Ma disclose the following compounds:
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[see Table 1].
In the above compounds read applicants compound of formula (I), when in applicants compound of formula (I), n=1, R2=H, R7 is acetyl or carboxybenzyl, R1 is Leucine functional group or R1 is Arg functional group, which reads R1, R3 and R5 do not all represent Leu functional group.
For claim 10:
Claim requires one of the limitation for the claimed method. The compounds of Ma differs in the sense that Ma silent on Norvaline [first limitation in the list]. However norvaline is positional isomer of valine. MPEP 2144.09 states “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)….are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, see In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
For claim 15:
Ma is silent on Betacoronavirus genus. However, it belongs to coronaviridae family. In light of their structural similarities, the teachings of Ma can be extrapolated to Betacoronavirus genus, absent evidence to the contrary.
For claim 16:
Ma is silent on other disease or condition of individual in their disclosure. However, testing the tolerance of drug in different age groups or different populations or different diseased conditions is a routine practice in the art, since it can eliminate undesirable side effects and so, drug can be contraindicated with respect to specific populations.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants compounds and their utility etc., 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 modify 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.
II. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (Cell Research, 2020, 30, 678-692; published on 15-Jun 2020; see applicants filed IDS dated 05/24/2023).
For claim 11:
Ma teaches inhibitor of SARS-CoV-2 viral replication, where the inhibitors are selected from the following compounds:
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[see Table 1].
The above compounds read applicants claimed formula (I).
Differences between Ma and instant claims are as follows:
(i) Ma is silent on treating an individual, who is infected with enveloped virus.
(ii) Ma is silent on pharmaceutical composition.
With regard to (i) of above, Ma established the fact that compounds, viz., MG-132 and Leupeptin inhibit SARS-CoV-2 replication, which is a first step in the development of drug for treating SARS-CoV-2 infection.
Based on the data provided in the disclosure of Ma, a skilled person in the art would be motivated to extrapolate in vitro or in vivo data from the teachings of Ma, to animal models and then develop a method to treat SARS-CoV-2 associated diseases.
With regard to (ii) of above, Ma teaches buffers in their enzymatic assays, and so compounds in buffer is interpreted as pharmaceutical composition.
For claim 12:
Ma is silent on second drug or compound in inhibiting SARS-CoV-2 replication. Established case law states that “If it is 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.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants compounds and their utility etc., 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 modify 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.
III. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (Cell Research, 2020, 30, 678-692; published on 15-Jun 2020; see applicants filed IDS dated 05/24/2023).
Ma teaches inhibitor of SARS-CoV-2 viral replication, where the inhibitors are selected from the following compounds:
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[see Table 1].
The above compounds read applicants claimed formula (I).
Differences between Ma and instant claims are as follows:
(i) Ma is silent on treating an individual, who is infected with enveloped virus.
(ii) Ma is silent on pharmaceutical composition.
(iii) Ma is silent on at least one other compound suitable for the prevention or treatment of an infection by an enveloped virus.
With regard to (i) of above, Ma established the fact that compounds, viz., MG-132 and Leupeptin inhibit SARS-CoV-2 replication, which is a first step in the development of drug for treating SARS-CoV-2 infection.
Based on the data provided in the disclosure of Ma, a skilled person in the art would be motivated to extrapolate in vitro or in vivo data from the teachings of Ma, to animal models and then develop a method to treat SARS-CoV-2 associated diseases.
With regard to (ii) of above, Ma teaches buffers in their enzymatic assays, and so compounds in buffer is interpreted as pharmaceutical composition.
With regard to (iii) of above, established case law states that “If it is 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.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants compounds and their utility etc., 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 modify 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.
IV. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (Cell Research, 2020, 30, 678-692; published on 15-Jun 2020; see applicants filed IDS dated 05/24/2023).
Ma teaches inhibitor of SARS-CoV-2 viral replication, where the inhibitors are selected from the following compounds:
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[see Table 1].
The above compounds read applicants claimed formula (I).
Differences between Ma and instant claims are as follows:
(i) Ma is silent on treating an individual, who is infected with enveloped virus.
(ii) Ma is silent on pharmaceutical composition.
(iii) Ma is silent on administering at least one other compound suitable for the prevention or treatment of an infection by an enveloped virus, simultaneously, separately or sequentially with compound of formula (I).
With regard to (i) of above, Ma established the fact that compounds, viz., MG-132 and Leupeptin inhibit SARS-CoV-2 replication, which is a first step in the development of drug for treating SARS-CoV-2 infection.
Based on the data provided in the disclosure of Ma, a skilled person in the art would be motivated to extrapolate in vitro or in vivo data from the teachings of Ma, to animal models and then develop a method to treat SARS-CoV-2 associated diseases.
With regard to (ii) of above, Ma teaches buffers in their enzymatic assays, and so compounds in buffer is interpreted as pharmaceutical composition.
With regard to (iii) of above, established case law states that “If it is 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. Since the functions of compounds are known, whether they can administer simultaneously, separately or sequentially, the effect is expected to be same, absent evidence to the contrary.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants compounds and their utility etc., 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 modify 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.
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