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 .
Status of Claims
Claims 1-10, 19-22 and 24-26 are pending in the instant application. Claim 19 is amended and claims 11-18 and 23 are cancelled via the amendment filed January 15th, 2026.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/EP2021/077037 filed September 30th, 2021, which claims priority under 35 U.S.C. 119(a-d) to GB2015584.2, filed October 1st, 2020. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Withdrawn Rejections
Applicant’s arguments and amendments, filed January 15th, 2025, with respect to 35 U.S.C 102(a)(1) rejection of claims 19 and 21-22 over Shaw have been fully considered and are persuasive. The 35 U.S.C 102(a)(1) rejection of claims 19 and 21-22 over Shaw has been withdrawn.
Applicant has overcome this rejection by amending claim 19 to remove “or at risk of infection by influenza virus”.
Applicant’s arguments and amendments, filed January 15th, 2025, with respect to 35 U.S.C 102(a)(1) rejection of claims 19-20 and 22 over Friboulet have been fully considered and are persuasive. The 35 U.S.C 102(a)(1) rejection of claims 19-20 and 21 over Friboulet has been withdrawn.
Applicant has overcome this rejection by amending claim 19 to remove “or at risk of infection by influenza virus”.
Response to Remarks
Applicant’s arguments with respect to the 35 U.S.C. 102 rejections claim(s) 19-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s amendments have necessitated a new grounds rejection of claims 19-22, see below.
Applicant's arguments filed with respect to the 35 U.S.C. 103 rejections of claims 1, 3-4 and 8-9 over Tang in view of Xu and claim 2 in further view of Virginia Department of Health have been fully considered but they are not persuasive.
On p. 8 of the remarks, Applicant begins to traverse the 35 U.S.C. 103 rejection by arguing that Tang merely teaches how to treat inflammation. Applicant further argue that Tang only discloses that ALK inhibitors can reduce type I IFN inflammatory responses, not that ALK inhibitors possess the antiviral activity necessary to reduce the viral load of the patient. Applicant states that no anti-viral effect is taught in Tang.
In response, instant claim 1 is directed to a method of treating influenza. As taught by Tang, lung damage associated with influenza is considered to be inflammation to be treated with ceritinib (paragraph [0084]). As the instant claims are directed to a method of treating influenza and inflammation, specifically lung damage, appears to be a symptom of influenza, even though the teachings of Tang are directed to inflammation, this is still a symptom of influenza.
Further, Tang ultimately teaches the administration of ceritinib to patients with influenza. As such, although there is not explicit teachings of ceritinib as an anti-viral, the method as instantly claimed will naturally flow from the teachings of Tang as the same compound, ceritinib, is being administered to the same group of patients, those with influenza A, as instantly claimed. Apparently, Applicant has discovered a new property or advantage (“the treatment of influenza”) of the method made obvious by the prior art ("the administration of ceritinib to a patient suffering from influenza A subtype H1N1 or H3N2"). MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
On p. 9 of remarks, Applicant argues that Tang only discloses influenza A as one of many examples of suitable inflammatory disease in claim 10 and provides no date or evidence of its use in influenza.
However, as Tang teaches a list of diseases that includes inflammation, one of ordinary skill in the art would have been motivated by the general teachings of Tang to screen the compounds of the prior art in the particular utilities to determine which would provide optimum treatment outcome. Further, Tang features a dependent claim, with influenza being the sole disease to be treated (claim 16):
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On p. 9 of the remarks, Applicant argues that the claimed invention introduces, for the first time, that LTK inhibitors possess antiviral activity against influenza A virions, and then points to Figure 2 of the instant specification. Applicant argues that these surprising and unexpected results are in no way obvious from the citied reference nor would a skilled person have reasonable expectation that such results would occur.
Examiner acknowledges the data in the instant specification, but respectfully disagrees.
Figure 2 of the instant specification describes 0.001-10 μM of 6 LTK inhibitors administered to a canine kidney cell model of influenza A viruses.
Applicant refers to these alleged unexpected, surprising results; however, even if the results were considered unexpected, the results would not be commensurate in scope with the scope of the claims. The results provided do not occur over the entire claimed range (an unclaimed amount). In the instant Figure 2, 0.001-10 μM of the LTK inhibitors were used, however, the present claims do not require a specific dosage amount. Further, the Figures is based on cell models and animal models. It is unclear how results in a cell model or animal model would correlate with treatment in a human patient.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02 (d) and MPEP 716.02 (e).
An affidavit or deceleration under 37 CFR 1.132 must compare the claimed subject matter with the closes prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979).
Regardless, Applicant has not compared the unexpected results provided to the prior art to effectively rebut the prima facie case of obviousness previously set forth.
On p. 9-10 of the remarks, Applicant argues that Tang teaches away from the claimed subject matter. Applicant argues that a skilled person would not consult documents that reduced type I IFN and that this highlights the solution determined by the inventors of the present application was unexpected and therefore inventive.
In response, see arguments above regarding unexpected results.
In view of the above, the 103 rejection is maintained.
Restriction/Election
Search and examination has been limited as previously discussed in the Office action dated October 15th, 2025. Examination is limited to the extent that claims 1-4, 8-9 and 19-22 are readable on the elected Group I, drawn to a method of treating influenza and ceritinib. Since the elected species is not allowable, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration. Claims 5-7 and 24-26 are withdrawn as being not embraced by the elected embodiment. Claim 10 is also withdrawn as being embraced only by LTK inhibitor entrectinib and not ceritinib.
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, 3-4 and 8-9 stand rejected under 35 U.S.C. 103 as being unpatentable over Tang et al (US 2019/0167710 A1) in view of Xu et al (MMWR; June 21, 2019; Vol. 68; No. 24).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Tang teaches a method of reducing a type I interferon response in a patient having an inflammatory disease, comprising administering to the patient an amount of an ALK inhibitor or an inhibitor of ALK expression (claim 1). Tang teaches that the ALK inhibitor is LDK378 , crizotinib , alectinib , AP26113 , ASP3026 , or TSR 011 (claim 4). LDK378 is ceritinib, as evidenced by Li et al (Clin Lung Cancer. 2015 Mar;16(2):86-91). Further, Tang teaches that the inflammatory disease or condition is influenza A (claim 10). Tang teaches that the inflammation is associated with a viral disease and is lung inflammation associated with influenza (claim 16). Further, Tang teaches that patient is a human (paragraph [0041]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Tang does not teach a single embodiment where ceritinib is administered to a patient with influenza and wherein the influenza is caused by a Type A influenza virus of subtype H1N1, H3N2, H5Nx, H7N1 or H7N9, or a Type B influenza virus.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding claims 1, while the prior art does not explicitly teach an embodiment where ceritinib was administered to a patient with influenza caused by a Type A influenza virus of subtype H1N1, H3N2, H5Nx, H7N1 or H7N9, or a Type B influenza virus, Tang teaches ceritinib and its utility in treating influenza A. A person having ordinary skill in the art would have been motivated to screen the compounds of the prior art in the particular utility to determine which would provide optimum treatment outcome.
Further, Xu teaches that from September 30th, 2018-May 18th, 2019, 96% of specimens tested were positive for influenza A (page 544, right column, paragraph 2). Xu further teaches that 56.6% of these cases were H1N1 and 43.6% of them were H3N2 (page 544, right column, paragraph 2).
As Tang teaches the administration of ceritinib to patients with influenza A, one of ordinary skill in the art would recognize that the influenza A was of the subtype H1N1 or H3N2, as Tang teaches that the patient was a human and Xu teaches that of all influenza A cases, the subtype was 56.6% H1N1 and 43.6% H3N2.
Regarding claim 3, as seen above, the subtype of influenza is H1N1 or H3N2.
Regarding claim 4, the prior art is silent regarding “the LTK inhibitor inhibits assembly and/or secretion of the virus”. However: “the LTK inhibitor inhibits assembly and/or secretion of the virus” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (ceritinib) is being administered to the same subjects (subjects suffering from influenza A, subtype H1N1 or H3N2). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “the LTK inhibitor inhibits assembly and/or secretion of the virus”, by practicing the method made obvious by the prior art: "the administration of ceritinib to a patient suffering from influenza A subtype H1N1 or H3N2", one will also be “the LTK inhibitor inhibits assembly and/or secretion of the virus”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“the LTK inhibitor inhibits assembly and/or secretion of the virus”) of the method made obvious by the prior art ("the administration of ceritinib to a patient suffering from influenza A subtype H1N1 or H3N2").
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Regarding claim 8, Tang teaches that the composition may be administered intravenously (paragraph [0043]).
Regarding claim 9, Tang teaches that LDK378, ceritinib, is administered at an oral dose of 750 mg daily (paragraph [0112]).
Claim 1-4 and 8-19 stand rejected under 35 U.S.C. 103 as being unpatentable over Tang et al (US 2019/0167710 A1) in view of Xu et al (MMWR; June 21, 2019; Vol. 68; No. 24), as applied to claims 1, 3-4 and 8-9 above, which is incorporated here by reference, and in further view of Virginia Department of Health (https://www.vdh.virginia.gov/epidemiology/influenza-flu-in-virginia/novel-variant-and-pandemic-influenza/influenza-a-h7n9-virus-information-for-the-general-public/, Internet Archive Wayback Machine online date October 2nd, 2016).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Tang nor Xu explicitly teach that the influenza A subtype to be treated with ceritinib is H7N9. However, as seen in the rejection above, Tang teaches the administration of ceritinib to treat influenza A.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that the influenza A is of subtype H7N9.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
However, Virginia Department of Health teaches that the same influenza antiviral drugs that are used to treat season flu are used to treat H7N9 infection (page 1).
As the method of administering ceritinib to treat influenza A has been made obvious in the rejection above and Virginia Department of Health teaches that the treatment for H7N9 infection is the same as the methods used to treat seasonal flu, one of ordinary skill in the art would have been motivated to administer ceritinib to treat influenza A subtype H7N9.
Claim(s) 19-22 are newly rejected under 35 U.S.C. 103 as being unpatentable over Tang et al (US 2019/0167710 A1).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Tang teaches a method of reducing a type I interferon response in a patient having an inflammatory disease, comprising administering to the patient an amount of an ALK inhibitor or an inhibitor of ALK expression (claim 1). Tang teaches that the ALK inhibitor is LDK378 , crizotinib , alectinib , AP26113 , ASP3026 , or TSR 011 (claim 4). LDK378 is ceritinib, as evidenced by Li et al (Clin Lung Cancer. 2015 Mar;16(2):86-91). Further, Tang teaches that the inflammatory disease or condition is influenza A (claim 10). Tang teaches that the inflammation is associated with a viral disease and is lung inflammation associated with influenza (claim 16). Further, Tang teaches that patient is a human (paragraph [0041]).
Further, Tang teaches that the method of treating by including contacting a cell in vitro may be done , for example , by incubating the cell with the RNAi agent . Contacting a cell in vivo may be done , for example , by injecting the RNAi agent into or near the tissue where the cell is located , or by injecting the RNAi agent into another area , e.g., the bloodstream or the subcutaneous space , such that the agent will subsequently reach the tissue where the cell to be contacted is located (paragraph [0079).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Tang does not teach a single embodiment where ceritinib is administered to a cell infected with influenza A.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, regarding claim 19, as Tang teaches ceritinib and its utility in treating influenza A and also methods of treatment including contacting cells. A person having ordinary skill in the art would have been motivated to screen the compounds of the prior art in the particular utility to determine which would provide optimum treatment outcome.
Further, the prior art is silent regarding “the LTK inhibitor inhibits assembly and/or secretion of the virus”. However: “inhibits assembly and/or secretion of the virus” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compound (ceritinib) is being administered to the same subjects (cells infected with influenza virus). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “inhibits assembly and/or secretion of the virus”, by practicing the method made obvious by the prior art: "the administration of ceritinib to a cell infected with influenza", one will also be “the LTK inhibitor inhibits assembly and/or secretion of the virus”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“inhibits assembly and/or secretion of the virus”) of the method made obvious by the prior art ("the administration of ceritinib to a cell infected with influenza virus").
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Regarding claim 20, as seen above, Tang teaches both in vitro and ex vivo methods of treatment.
Regarding claim 21, Tang teaches that the patient is a human (paragraph [0041]).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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