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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 4/25/2023 has been considered except where lined through.
Specification
The specification is objected to because it contains numerous embedded hyperlinks and/or other form of browser executable codes (see for example, paragraphs 005, 006, 0023). 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 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 10, 22 and 24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 22, the claim recites that the “one or more additional therapeutic agents further includes ribavirin and interform-beta”. However, it is unclear whether the claim is attempting to further define the one or more additional therapeutic agents as recited in claim 17 or if these are in addition to the one or more additional therapeutic agents as recited in claim 17. For example, purposes the examiner will be interpreting this as the former, e.g. defining what the one ore more additional therapeutic agents are.
Regarding claim 24, the claim recites that the “one or more additional therapeutic agents further includes azithromycin”. However, it is unclear whether the claim is attempting to further define the one or more additional therapeutic agents as recited in claim 17 or if these are in addition to the one or more additional therapeutic agents as recited in claim 17. For examination purposes, the examiner will be interpreting this as the former, e.g. defining what the one ore more additional therapeutic agents are.
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arumugaswami et al. (US2023/0190736A1, 2023-06-22, priority to US63/008,231 filed on 2020-04-10).
Arumugaswami et al. teach a method of treating a viral infection in a subject in need thereof, comprising administering a kinase inhibitor including, but not limited to, an ATR inhibitor (column 031). Specifically, Arumagaswami et al. teach that the kindase inhibitors include, but are not limited to, a compound referred to as VE-822 which is also referred to as Berzosertib in the document (paragraph 0033 and Figure 5 for example for recitation of Berzosertib being VE-822). With regards to the virus, the publication teaches that the virus includes, but is not limited to, coronavirus, specifically COVID 19 (see claims 21 and 25). Regarding when the compound is administered, the publication teaches that the compound is administered after the subject tests positive or after the subject has been exposed to the virus, but not tested (paragraph 0042). Moreover, the publication teaches that the method further comprises administering an additional anti-viral agent such as remdesivir (paragraph 0043). With regards to the Berzosertib, the publication teaches that two compounds, Berzosertib and Vistusertib had antiviral activities at IC50 values of 25 nM, wherein many of the other compounds had IC50 values in the range of 250nM to 500nM (paragraph 0116). Interestingly, the publication specifically tested Berzosertib in Air-Liquid Interface (ALI) Cells and found that it is safe even at the highest tested concentration of 50 uM in human ALI lung cells (paragraph 0118).
While the publication provides a number of tyrosine kinase inhibitors including Berzosertib, the publication does not specifically select Berzosertib for the contemplated methods of treating coronavirus, specifically COVID-19. Nor does the publication contemplate the time of administration as contemplated in the claimed invention.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to specifically select Berzosertib for use in the method taught by Arumugaswami et al.. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
- Arumugaswami et al. teaches that Berzosertib had one of the lowest antiviral IC50’s of the 34 compounds tested, and
-Arumugaswami et al. teach that is safe even at the highest tested concentration of 50uM in human ALI lung cells.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to optimize the time when Berzosertib would be administered to the patient to achieve the desired therapeutic outcome. One of ordinary skill in the art would have been motivated to make such and optimization, with a reasonable expectation of success, because:
- Arumugaswami et al. contemplates various time points of when the compound could be administered to the patient. For example, the publication teaches that the compound is administered after the subject tests positive or after the subject has been exposed to the virus, but not tested.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) See MPEP 2144.05.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arumugaswami et al. (US2023/0190736A1, 2023-06-22, priority to US63/008,231 filed on 2020-04-10), as applied above to claims 1-20, in view of Siddhi et al. (Future Medicinal Chemistry 2020; 12(17): 1579-1601, IDS).
Arumugaswami et al. teach a method of treating a viral infection in a subject in need thereof, comprising administering a kinase inhibitor including, but not limited to, an ATR inhibitor (column 031). Specifically, Arumagaswami et al. teach that the kindase inhibitors include, but are not limited to, a compound referred to as VE-822 which is also referred to as Berzosertib in the document (paragraph 0033 and Figure 5 for example for recitation of Berzosertib being VE-822). With regards to the virus, the publication teaches that the virus includes, but is not limited to, coronavirus, specifically COVID 19 (see claims 21 and 25). Regarding when the compound is administered, the publication teaches that the compound is administered after the subject tests positive or after the subject has been exposed to the virus, but not tested (paragraph 0042). Moreover, the publication teaches that the method further comprises administering an additional anti-viral agent such as remdesivir (paragraph 0043). With regards to the Berzosertib, the publication teaches that two compounds, Berzosertib and Vistusertib had antiviral activities at IC50 values of 25 nM, wherein many of the other compounds had IC50 values in the range of 250nM to 500nM (paragraph 0116). Interestingly, the publication specifically tested Berzosertib in Air-Liquid Interface (ALI) Cells and found that it is safe even at the highest tested concentration of 50 uM in human ALI lung cells (paragraph 0118).
Arumugaswami et al. differs from the claimed invention in that it does not teach that the additional agent is one of those recited in claims 21-26.
Siddhi et al. review focuses on repurposed small molecules as therapeutic intervention for COVID-19 along with an understanding of the main targets both viral and host based (page 1580, 3rd full paragraph). For example, Siddhi et al. teach the following repurposed small molecules for treatment of COVID-19: chloroquine, hydroxychloroquine, remdesivir, ribavirin, lopinavir and ritonavir, azithromycin, and interferons such as interferon-1-beta (abstract; page 1582, paragraph 5; page 1585, paragraphs 1, 3; page 1588, paragraph 1; page 1589, paragraph 2; page 1591, paragraph 1; page 1595, paragraph 2, 5).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to combine Berzosertib as taught by Arumugaswami et al. with another therapeutic agent in view of the teachings of Siddhi et al.. One of ordinary skill in the art would have been motivated to make such a combination, with a reasonable expectation of success, because:
- "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arumugaswami et al. (US2023/0190736A1, 2023-06-22, priority to US63/008,231 filed on 2020-04-10), as applied above to claims 1-20, in view of Das et al. (Drugs of the Future 2019, 44(7):517-525).
Arumugaswami et al. teach a method of treating a viral infection in a subject in need thereof, comprising administering a kinase inhibitor including, but not limited to, an ATR inhibitor (column 031). Specifically, Arumagaswami et al. teach that the kindase inhibitors include, but are not limited to, a compound referred to as VE-822 which is also referred to as Berzosertib in the document (paragraph 0033 and Figure 5 for example for recitation of Berzosertib being VE-822). With regards to the amount of the compound, the publication teaches that selected dosage level will depend upon a variety of factors including the activity of the particular compound, the route of administration, time of administration, etc., wherein a physician or veterinarian having ordinary skill in the art can readily determine and prescribe the therapeutically effective amount of the compound (paragraphs 0079 and 0080). With regards to the virus, the publication teaches that the virus includes, but is not limited to, coronavirus, specifically COVID 19 (see claims 21 and 25). Regarding when the compound is administered, the publication teaches that the compound is administered after the subject tests positive or after the subject has been exposed to the virus, but not tested (paragraph 0042). Moreover, the publication teaches that the method further comprises administering an additional anti-viral agent such as remdesivir (paragraph 0043). With regards to the Berzosertib, the publication teaches that two compounds, Berzosertib and Vistusertib had antiviral activities at IC50 values of 25 nM, wherein many of the other compounds had IC50 values in the range of 250nM to 500nM (paragraph 0116). Interestingly, the publication specifically tested Berzosertib in Air-Liquid Interface (ALI) Cells and found that it is safe even at the highest tested concentration of 50 uM in human ALI lung cells (paragraph 0118).
The publication differs from the claimed invention in that it does not specifically teach the amount, number of days or oral administration.
Das et al. teach that Berzosertib was found to be a highly specific against ATR in pancreatic cancer cell line studies that demonstrated the agent to have a 100-fold greater specificity for ATR than ATM or SNA-PK (page 520, 1st column, Preclinical Pharmacology). Das et al. further teach that although berzosertib (oral doses of 30 or 60 mg/kg over 4 consecutive days per week) did not demonstrate significant activity in any model, the combination arm with cisplatin demonstrated significant enhancement of cisplatin activity (page 520, 1st column, Preclinical Pharmacology)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to orally administer and optimize the amount/number of days berzosertib is administered in the method taught by taught by Arumugaswami et al. in view of the teachings of Das et al.. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Arumugaswami et al. teaches that selected dosage level will depend upon a variety of factors including the activity of the particular compound, the route of administration, time of administration, etc., wherein a physician or veterinarian having ordinary skill in the art can readily determine and prescribe the therapeutically effective amount of the compound, and
-Das et al. teach oral administration of berzosertib and at least starting amounts of 30 or 60 mg/kg over 4 consecutive days per week.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) See MPEP 2144.05.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-4 and 6-30 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-4 and 6-30 of copending Application No. 18/009,207 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
Therefore, NO claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626