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
This application claims the benefit of and priority US provisional application NO. 63/393,680, filed July 29, 2022, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/07/2023 was filed prior to the mailing of the instant first Office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. A copy of Form PTO/SB/08 is attached to the instant Office action.
Claim Rejections - 35 USC § 112
Claim20 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.
Claims 7-12 fails to point out or distinctly clarify the meets and bounds of the claims pertaining to the dosage intervals as expressed in the instant claims. Whereas, it is unclear as to whether the language of “daily from 1 to (n) days” is meant to be inclusive. The claims can include multiple interpretations where:
ponatinib is administered on each of the days 1 through (n) days or;
ponatinib is administered in any amount from 1 up to (n) days as encompassed by the instant claims.
Claim 20 contains the trademark/trade names Paxlovid and Veklury. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the source of nirmatrelvir and ritonavir (Paxlovid) and remdesivir (Veklury) (see paragraph 86 of the specification) and, accordingly, the identification/description is indefinite.
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.
(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.
Claim(s) 1-5 and 13-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kao WO 2022/232161 A1.
Regarding claims 1-2, Kao anticipates the treatment of coronavirus infection with a therapeutic amount of ponatinib (claim 1) and where the coronavirus infection is a SARS-CoV-2 infection (claim 2) where the coronavirus is a family of viruses that includes the SARS-CoV-2 specific virus (Background, p1 lines 14-16). Additionally, the administration of ponatinib to a subject needing treatment for the infection is acknowledged as multiple embodiments (Summary, p2, lines 12-19) to include as a singular treatment and/or in combination with multiple drugs combinations acknowledged within the reference.
Regarding claims 3-5, Kao anticipates the therapeutic effective amount to be administered of 30 mg and 15mg per day. The reference art acknowledges where ponatinib is administered daily (Discussion, p41, lines 22-23) and was administered “…in patients taking the standard oral dose of 15 mg…” (Discussion, p41, line 27).
Regarding claims 13-15 and the administration of ponatinib, Kao acknowledges (p6, lines 8-12) where the method of treatment and/or prevention of a viral infection includes the administration of a pharmaceutical compound by any suitable route to include orally (claim13), intravenously (claim 14) and intramuscularly (claim 15). Additionally, the embodiments for administration are further acknowledged prior to the onset of one or more manifestations of COVID-19 to be administered (as referenced in instant claims) as orally, intravenously, and intramuscularly (p19, lines 10-15).
Regarding claim 16 and where the administration to a subject a therapeutic amount of a second agent. As previously referenced, Kao acknowledges where the embodiments for the treatment of an infection included ponatinib as singular treatment and in combination with multiple second agents or combinations thereof (p2, lines 11-19). Additionally, it is further acknowledged where Kao claims that “The method of claim any one of claims 31-40, wherein the pharmaceutical composition is administered in combination with an additional therapeutic agent” (reference claim #40 p60).
Claim Rejections - 35 USC § 103
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.
Claim(s) 6-12 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kao WO 2022/232161 A1 as applied to claim 1 above.
The teachings of Kao are set forth above and teaches (p41, lines 20-27) where a method for the treatment of SARS-CoV-2 includes the combinations of montelukast, ponatinib, and rilpivirine daily and where the patients were administered the standard oral dose of 15 mg. Additionally, Kao teaches (p41, lines 29-31) that “There are no known adverse interactions among the three drugs, though the doses may require reduction due to common paths of elimination according to information on DrugBank.” Kao does not specifically teach or reference where a subject would be administered effective amounts of ponatinib from 1 mg to 10 mg daily.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing dated of the claimed invention, to arrive at the instantly claimed invention where the subject would be administered ponatinib from 1 mg to 10 mg daily (as in the instant claim 6).
Regarding claim 6, where Kao does not explicitly state where the therapeutic amount would include dosages from 1 mg to 10 mg daily, it would be reasonable to conclude that one skilled in the art would/could decrease the dosage because (as previously mentioned) reductions in administration may be required for reasons such as; (p41, lines 29-31) “…may require reduction due to common paths of elimination according to information on DrugBank.”, age, weight, and/or the needs or response of the subject. Therefore, per MPEP § 2144.05(I), where the claimed ranges or amounts do not overlap with prior art but are merely close.
The teachings of Kao are set forth above where as identified (instant claims 7-12) that ponatinib is administered daily at intervals ranging from 1-21 days. Kao mentions (p41, lines 22-29) where the ponatinib is administered daily in combination with two additional treatments as per the treatment regimen. Kao also teaches (p4, lines 16-20) where in some embodiments where the pharmaceutical compositions are effective when: (iii) to use in a subject with minimal toxicity, and or (iv) when administered to a subject to achieve a therapeutic effect. Kao also makes mention (p6, lines 4-7, and reference claim #37) where in some embodiments where the administration to a subject result in the amelioration of one or more manifestations of Covid-19. Finally, Kao teaches (p18-20, “III. Therapeutic Uses and Kits) where compositions (and combinations) are included as part of the method for the treatment of SARS-CoV-2 where identified embodiments may be administered before and or after first detection Kao does not specifically teach the range in days or the duration of treatments for ponatinib as in the instant claims.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing dated of the claimed invention, to arrive at the instantly claimed invention where the subject would be administered ponatinib from 1 mg to 10 mg daily (as in the instant claim 6).
Regarding claims 7-12, where Kao does not specifically identify the duration for the administration of ponatinib, it would be reasonable to conclude that one skilled in the art would administer ponatinib (and the combinations set forth) for the variable durations (as in the instant claims) because Kao suggests the durations to be determined by the needs and/or response by the subject to the treatment regimen. Furthermore, (as previously mentioned) the duration of the treatment to be determined based on multiple factors that include: the prescribed treatment regimen by the practitioner, standardized treatments kits containing a predetermined combination/dosage/duration/route of administration, and/or the continued presence of the coronavirus/SARS-CoV-2 virus. Therefore, per MPEP 2144.05 it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range for the administration of ponatinib (and or combinations thereof) to decrease the symptoms severity and/or viral presence.
The teachings of Kao are set forth above as identified (instant claims 17-18) and where the SARS-CoV-2 protein is a coronavirus spike protein. Kao identifies (Definitions, p12, line 31 and ending p13, line7) as utilized, the term “severe acute respiratory syndrome coronavirus” or “SARS-CoV” where the genomics organization is identified and includes a spike protein that is typical of coronaviruses and common among variants. It is further noted (p13, lines 14-16) where phylogenetically, SARS-CoV-2 was most closely related to SARS-CoV. However, Kao does not teach where the coronavirus spike protein is specific to SARS-CoV-2.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing dated of the claimed invention, to arrive at the instantly claimed invention where the secondary agent is an antibody against the SARS-CoV-2 (claim 17) and where the protein is a coronavirus spike protein (claim 18).
Regarding claims 17-18, as in the instant claims, it would have been obvious to one skilled in the art, that a second agent being administered would be and antibody against SARS-CoV-2 and where there is a coronavirus spike protein. As previously mentioned, the coronavirus is a family of viruses that includes the SARS-CoV-2 specific virus (Background, p1 lines 14-16). As in the reference art, Kao suggests that any treatments specific to SARS-CoV would also be effective to treat SARS-CoV-2 because the spike protein is a common characteristic of coronaviruses and SARS-CoV-2 shares 89% nucleotide similarity with SARS-CoV.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kao WO 2022/232161 A1 as applied to claim 1 above, and further in view of Hu et al, Characteristics of SARS-CoV-2 and Covid-19, Nat Rev Microbiol, 2021 Mar; 19(3):141-154.
The teachings of Kao are set forth above as identified (instant claims 17-18) and where the SARS-CoV-2 protein is a coronavirus spike protein. Kao identifies (Definitions, p12, line 31 and ending p13, line7) as utilized, the term “severe acute respiratory syndrome coronavirus” or “SARS-CoV” where the genomics organization is identified and includes a spike protein that is typical of coronaviruses and common among variants. It is further noted (p13, lines 14-16) where phylogenetically, SARS-CoV-2 was most closely related to SARS-CoV. However, Kao does not teach where the SARS-CoV-2 protein is an ACE2 Fusion protein.
Hu et al teaches that immunotherapy (Immunoglobulin therapy, p151) with SARS-CoV-2 specific monoclonal antibodies were effective in both in vivo and in vitro environments for the treatment of SARS-CoV-2 infections. Hu et al further discloses as pertaining to vaccines (Vaccines, p151) where multiple trials were being conducted on multiple vaccine platforms that targeted SARS-CoV-2 to include protein subunits, such as the SARS-CoV-2 S protein (Fig. 3a image and description, p144). Furthermore, Hu et al also discloses where the SARS-CoV-2 Ace2 binding to the 5 specific residues of Y455L, L486F, N493Q, D494S and T501N (Fig. 3c-d and description, p.144, Receptor Use and Pathogenesis, p146, ¶1). The author continues to describe additional actions (Therapeutics: Inhibition of virus entry, p. 149, col. 2, ¶1) where a therapeutic strategy “…is to block binding of the S protein to ACE2 through soluble recombinant hACE2, specific monoclonal antibodies or fusion inhibitors that target the SARS-CoV-2 S protein (see Fig 5 and description, p150).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to arrive at the instantly claimed invention where the SARS-CoV-2 protein is an ACE2 fusion protein for the following reasons:
Regarding claims 19 as in the instant claims, it would have been obvious to one skilled in the art, that the SARS-CoV-2 is an ACE2 fusion protein. As previously identified and well known within the art that the coronavirus is a family of viruses that demonstrates a common characteristic of spikes on the surface antigen and within it genomics. Additionally, it is known within the art that the ACE2 binding proteins are required to interact with the spike protein (SARS-CoV-2 S protein) to initiate viral replication and would be a target to inhibit or restrict binding as a treatment option. Therefore, one skilled in the art would have come to the reasonable conclusion that as part of the method for the treatment of coronavirus, specifically SARS-CoV-2, that one would utilize a mechanism of treatment that would include the recognition and limit the binding to the surface spike protein because the binding of ACE2 receptors is a critical mechanism of action needed for further viral replication and eventually system disruption. Further binding to the spike protein could lead to the downregulation of ACE2 receptors and disrupt other regulatory systems to increase inflammation and contribute to further organ/system damage. Finally, where the SARS-CoV-2 is found in both human and animal hosts, and SARS-CoV-2 uses the same ACE2 receptors as SARS-CoV, that the broad receptor usage implies usage in different animal populations and species of coronavirus infections.
Need to include a pdf copy for the file – I also can’t find anything with this WO number – double check for any typos in the doc number.
I can’t give a complete review, but I’ve done what I can below.
Summary of the Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
No claims are in condition for an allowance.
Conclusion
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/S.H.D./Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627