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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 16, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-2, 6-13, 16, 20, 26-30 and 31, drawn to a method for treating cancer in a subject, and the following species:
Erlotinib as the elected agent that modulates epidermal growth factor receptor signaling;
Anifrolumab as the elected agent that modulates interferon signaling; and
Non-small cell lung cancer (NSCLC) as the elected cancer,
are maintained.
Claims 35-38 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2025.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner
discover a prior art by Pan et al. that renders obvious the claimed invention (see rejection set forth below), wherein the prior art teaches gefitinib as an EGFR inhibitor; However, it is noted that the prior art does not teach the elected species of EGFR inhibitor (erlotinib). In light of this discovery, the search is expanded to the subject matter of the EGFR inhibitor to include gefitinib in addition to the elected EGFR inhibitor species (erlotinib), such that it does not encompass the full scope of the claims.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on March 16, 2026, wherein claims 1, 6 and 31 are amended; claims 2-5, 7-12, 14-15, 17-26 and 32 are cancelled; and claims 13, 16, 27-30 and 34-38 are unchanged.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, 13, 16, 27-31 and 34-38 are pending.
Claims 35-38 remain withdrawn.
Claims 1, 6, 13, 16, 27-31 and 34 are under examination in accordance with the elected invention and species.
Priority
The instant application 17/800,208 filed on August 16, 2022 is a 371 of PCT/US21/18718 filed on February 19, 2021, which claims priority to, and the benefits of U.S. Provisional Application No. 62/978,777 filed on February 19, 2020, and U.S. Provisional Application No. 62/984,624 filed on March 3, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/24/2025 and 3/16/2026 were filed after the mailing date of the Final Office Action on December 16, 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Action Summary
Applicant’s amendment to the claims overcome each and every objection previously sets
forth in the Final Office Action mailed on December 16, 2025.
Claims 1, 6, 13, 16, 27, 31 and 34 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification are withdrawn in light of the claim amendments.
Specification
The disclosure is objected to because it contains an embedded hyperlink and relies on external data that are not described. The cropped and uncropped western blots are only partially described in the disclosure. The uncropped western blot images referenced as being in “Source Data”, which is not provided within the specification. All supporting data must be fully included or clearly represented in the application itself. Additionally, the use of embedded hyperlink and/or other form of browser-executable code to external resources is improper, as all referenced information must be contained or fully described in the application. For instance, paragraph [0016], [00261], [00274], [00280], [00285], [00292] of the specification contains an embedded hyperlink.
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.
Appropriate correction is required.
Drawings
The drawings are objected to because of the followings:
Fig. 1C: -8 and 8 appears to be the same color (black) shown below (see arrows):
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; and therefore, it is not clear which cells illustrated therein have prominent signaling changes.
Fig. 1L, 2Q, 4D, 4H, 7A, 7B, 7C, 7D, 7E, 7H, 7I, 7J, 7K, 7L, 8A, 8B, 8C, 8D, 8E, 8P, 8Q, 8R, 8S, 8T, 8U, 8BB, 8CC, 9D, 9L, 9M, 9N, 9O, 9P, 9Q, 10B, 10C, 10D, 10E, 10F, 10G, 10H, 10I, 10J, 11A-11H, 11K, 11M, 14B, 14D, 14F, 15K, 15P, 15U, 15Z, 15EE, 15JJ, 15OO, 17A and 17B: these figures appear to contain western blot results, but these results are indistinguishable because they are simply black solids boxes. For instance, the western blot in Figure. 1 IL is shown below:
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; and Figure. 7H contains black solids boxes shown below (see arrow):
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. The Examiner cannot tell if these western blots are supposed to contain a band, if so, the Examiner cannot tell the intensity of the bands.
Fig. 8O: the letters below HCC827, H3255 and PC9 are small and unreadable shown below (see shaded):
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Figure 9R: the circle (shCtrl and shCtrl +Erl) and diamond (shlRF3 and shlFR3+Erl) are clustered in the graph, it is not clear which line is corresponding to a circle or a diamond group shown below (see shadow):
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Fig. 10C: 2 and -4 appears to be the same color (black) shown below; and therefore, it is not clear which cells illustrated therein have prominent changes.
Fig 13I-J: these figures appear to be color photographs; and it is noted that majority of the drawings are just black boxes.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Interpretation
The claimed term “active treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include improvement of the disease, pathological condition, or disorder instantly claimed.
The claimed term “casual treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include removal of the cause of the associated disease, pathological condition, or disorder instantly claimed.
The claimed term “palliative treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include relief of symptoms of the disease, pathological condition, or disorder instantly claimed.
The claimed term “supportive treatment” in claims 1 and 31, when reasonably construed in light of the paragraph [0048] of the specification shown below:
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, to include supplementing another specific therapy.
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, 6, 13, 16, 27-31 and 34 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.
Instant claim 1 recites “[a] method for treating lung cancer in a subject diagnosed as having lung cancer, the method comprising administering to the subject an effective amount of: (a) an epidermal growth factor receptor (EGFR) inhibitor selected from erlotinib, afatinib, gefitinib, lapatinib, and osimertinib, or a pharmaceutically acceptable salt thereof; and (b) anifrolumab or a pharmaceutically acceptable salt thereof, wherein treating is one or more selected from active treatment, causal treatment, palliative treatment, and supportive treatment”; and Instant claim 31 recites “[a] method for treating NSCLC in a patient diagnosed as having NSCLC, said method comprising administering to said patient an effective amount of erlotinib and anifrolumab, wherein treating is one or more selected from active treatment, causal treatment, palliative treatment, and supportive treatment”. There is insufficient written basis for causal treatment and supportive treatment in the specification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
According to MPEP 2163 I, “[t]o 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 had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116… An applicant shows 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)”.
Additionally, according to MPEP II-A-3-a-ii, “[t]he written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”; “[a] ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).”; and “’[a] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
In the instant case, the claims encompass a broad genus of treating lung cancer or NSCLC in a patient diagnosed as having said cancer, in which treating is one or more selected from active treatment, casual treatment, palliative treatment and supportive treatment. In contrast, the specification fails to sufficiently describe any representative species of casual treatment and supportive treatment, such as actual reduction to practice. The only factor presents in the specification is the definition of “casual treatment” in paragraph [0048]:
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; and the definition of “supportive treatment” in paragraph [0048]:
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. In other words, the disclosure does not appear to have a sufficient amount of representative method species in the specification to support the method of removing the cause of lung cancer or NSCLC; and the method of supplementing the full genus of “another specific therapy” for lung cancer or NSCLC. It is noted that applicant only describes the administration of erlotinib and anifrolumab for suppressing the tumor growth in the animal model in paragraph [00394]. Applicant does not describe any method species drawn to administrating any effective amount of the claimed EGFR inhibitor (“erlotinib, afatinib, gefitinib, lapatinib, and osimertinib, or a pharmaceutically acceptable salt thereof”) and anifrolumab or a pharmaceutically acceptable salt thereof to a subject diagnosed as having lung cancer or NSCLC for removing any cause of said lung cancer or NSCLC; and for supplementing another specific therapy, aside from broad recitation that any effective amount of the claimed EGFR inhibitor and anifrolumab or a pharmaceutically acceptable salt thereof can be used as “casual treatment” and “supportive treatment”.
While applicant is in the possession of treating lung cancer or NSCLC to the extent “treating” is active treatment and/or palliative treatment, applicant does not provide any concrete examples that reflect the diversity of what they are claiming. Therefore, in view of the foregoing, it is not apparent that applicant was actually in possession of administering any effective amount of the claimed EGFR inhibitor and anifrolumab or a pharmaceutically acceptable slat thereof for treating lung cancer or NSCLC to the extent “treating” includes casual treatment and/or supportive treatment, based on the limited disclosure provided.
Claims 1, 6, 13, 16, 27-31 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating lung cancer or NSCLC to the extent that treating does not includes casual treatment and supportive treatment, does not reasonably provide enablement for treating the entire scope of lung cancer to the extent treating includes casual treatment and supportive treatment. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these.
Attention is directed to in re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would 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. All of the Wand’s factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
Instant claim 1 recites “[a] method for treating lung cancer in a subject diagnosed as having lung cancer, the method comprising administering to the subject an effective amount of: (a) an epidermal growth factor receptor (EGFR) inhibitor selected from erlotinib, afatinib, gefitinib, lapatinib, and osimertinib, or a pharmaceutically acceptable salt thereof; and (b) anifrolumab or a pharmaceutically acceptable salt thereof, wherein treating is one or more selected from active treatment, causal treatment, palliative treatment, and supportive treatment”; and instant claim 31 recites “[a] method for treating NSCLC in a patient diagnosed as having NSCLC, said method comprising administering to said patient an effective amount of erlotinib and anifrolumab, wherein treating is one or more selected from active treatment, causal treatment, palliative treatment, and supportive treatment”.
The claimed term “active treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include improvement of the disease, pathological condition, or disorder instantly claimed.
The claimed term “casual treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include removal of the cause of the associated disease, pathological condition, or disorder instantly claimed.
The claimed term “palliative treatment” in claims 1 and 31, when reasonably construed in light of paragraph [0048] of the specification shown below:
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, to include relief of symptoms of the disease, pathological condition, or disorder instantly claimed.
The claimed term “supportive treatment” in claims 1 and 31, when reasonably construed in light of the paragraph [0048] of the specification shown below:
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, and is taken to include supplementing another specific therapy for improving disease, pathological condition or disorder associated with lung cancer or NSCLC.
The breadth of the claims includes administering the claimed epidermal growth factor receptor inhibitor, including erlotinib, and anifrolumab or a pharmaceutically acceptable salt thereof for treating lung cancer, including NSCLC, in a subject diagnosed with said cancer, such that the term “treating” includes improving the lung cancer; relieving the symptom of the lung cancer; supplementing another therapy for the lung cancer; and removing the cause of the lung cancer.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
As discussed above, the claimed inventions are drawn to a method of treating lung cancer or NSCLC in any subject diagnosed as having said cancer, the method comprising administering to said subject any effective amount of the claimed epidermal growth factor receptor inhibitor and anifrolumab or pharmaceutically acceptable salt thereof, wherein the term “treating” includes improving the lung cancer or NSCLC; relieving the symptom of the lung cancer or NSCLC; supplementing another therapy for the lung cancer or NSCLC; and removing the cause of the lung cancer or NSCLC.
At the time the application was filed, according to Furie et al. (Arthritis Rheumatol., 2017. Vol. 69 (2): 376–386; cited in the IDS filed on February 16, 2023), one skilled in the art would have known anifrolumab is a fully human, IgG1κ monoclonal antibody that binds to type I IFN-[Symbol font/0x61]/[Symbol font/0x62]/[Symbol font/0x77] receptor and inhibits the type I IFN gene signature; and according to Wu et al. (Lung Cancer, 2011. Vol. 72 (2): 205–212), one skilled in the art would have also known tyrosine kinase (TK) inhibitors of epidermal growth factor receptor (EGFR), such as erlotinib and gefitinib, are known to be effective for treating non-small cell lung cancer.
According to Canale et al. (Clin Cancer Res, 2017. Vol. 23 (9): 2195–2202), one skilled in the art would have known that mutations of the tumor suppressor TP53 gene occur in about 30%-40% of NSCLC patients and are highly correlated with smoking habits; and p53 wt is needed for gefitinib-induced apoptosis in NSCLC cell lines and leads to increased sensitivity to tyrosine kinase inhibitors through the induction of FAS and caspase-dependent cell death (see e.g., p. 2195, right column, 2nd paragraph to p. 2196, left column, line 1). In other words, to the extent that the term “treating” is casual treatment, the cited reference demonstrates the relative skill of those in the art with respect to administering any effective amount of the EGFR inhibitor and anifrolumab or a pharmaceutically acceptable salt thereof for treating lung cancer (removing each and every cause of lung cancer), such as TP53 mutated NSCLC, is considered low because wild type TP53 is generally required for gefitinib-induced apoptosis in NSCLC.
According to Tanaka et al. (BMC Cancer, 2012. Vol. 12: 558), one skilled in the art would have known that besides mutation in the epidermal growth factor receptor (EGFR) gene, the fusion of the anaplastic lymphoma kinase (ALK) with the echinoderm microtubule-associated protein-like 4 (EML4) was identified in non-small cell lung cancer (see e.g., p. 1, left column to right column, “Background” section). One skilled in the art would have also known in the preclinical study, EML4-ALK positive NSCLC was not responsive to erlotinib therapy; and EGFRTKI therapy showed no effects to the all 10 patients with EML4-ALK fusion gene (see e.g., p.3, left column, line 16-19). In other words, to the extent that the term “treating” is casual treatment, the cited reference demonstrates the relative skill of those in the art with respect to administering any effective amount of the EGFR inhibitor and anifrolumab or a pharmaceutically acceptable salt thereof for treating lung cancer (removing each and every cause of lung cancer), such as EML4-ALK positive NSCLC, is considered low because EML4-ALK positive NSCLC was not responsive to EGFR inhibitor, such as erlotinib.
According to Hamilton et al. (Cancer Chemother Pharmacol, 2014. Vol. 73:613–621), one skilled in the art would have known the co-administration or pretreatment with rifampicin resulted in significant and clinically relevant decreases in erlotinib exposure; and therefore, the use of alternative concomitant treatments lacking CYP3A4 inducing activity for treating concurrent illness is strongly recommended when prescribed with erlotinib (see e.g., p. 620, left column, line 3-8). In the words, to the extent that the term “treating” is supportive treatment, the cited reference demonstrate the relative skill of those in the art for administering the EGFR inhibitor and anifrolumab or a pharmaceutically acceptable salt thereof for supporting the full scope of therapy would have been low, because the EGFR inhibitor has a known drug-drug interactions with CYP3A4 inducers that reduces the effectiveness for treating the associated disease.
While the claimed invention may play a role in treating lung cancer or NSCLC to the extent that treating does not includes casual treatment and supportive treatment, it is uncertain whether administering any effective amount of any epidermal growth factor receptor inhibitor and anifrolumab or pharmaceutically acceptable salt thereof can successfully treat lung cancer to the extent that the claimed term “treating” includes the full subgenus, including active treatment, casual treatment, palliative treatment, and supportive treatment .
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. In the present case, the instant specification discloses the combination of erlotinib (6.25 mg/kg/d by oral gavage) plus anifrolumab (2 mg/kg/d by i.p. injection) results in a significant suppression of tumor growth in mouse xenograft models harboring mutant EGFR in paragraph [00394] and Figure 17C; and said combination, in which erlotinib was used at a dose of 100 mg/kg/d and the dose of anifrolumab has not been disclosed, was also found to be highly effective in inhibiting the growth of an EGFRwt/KRas mutant PDX model HCC4087 (see e.g., Figure 17D; [00394]). It is noted that the specification does not test the therapeutic effect of the claimed combination (the claimed EGFR inhibitor with anifrolumab) in any other subject species diagnosed with other lung cancer or any other subject species diagnosed with NSCLC, such as those with EML4-ALK positive NSCLC. The specification also does not describe the administration of the claimed combination (the claimed EGFR inhibitor with anifrolumab) with another specific therapy directed toward to the improvement of the disease associated with lung cancer or NSLCL. Therefore, to the extent that the claimed term “treating” is causal treatment (removal of the cause of lung cancer or NSCLC) and/or supportive treatment (supplementing another specific therapy), the quantity of experimentation necessary to carry out the entire scope of claimed invention is high, because one of the relative skill in the art would not reasonably predict whether the administration of any effective amount of each and every EGFR inhibitor species instantly claimed and anifrolumab or pharmaceutically acceptable salt thereof can successfully remove each and every cause of lung cancer or NSCLC in any subject diagnosed with said cancer based on the limited disclosure provided. One of the relative skill in the art would not reasonably predict whether the administration of any effective amount of each and every EGFR inhibitor species instantly claimed and anifrolumab or pharmaceutically acceptable salt thereof can successfully supplement each and every therapy towards for improving lung cancer or NSLCL.
Accordingly, the method of treating the entire scope of lung cancer or non-small cell lung cancer, to the extent that the claimed term “treating” includes casual treatment and supportive treatment, is not enabled by the instant specification. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Response to Arguments
Applicant's arguments filed on March 16, 2026 with respect to the rejection of claims 1, 6, 13, 16, 27, 31 and 34 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, have been fully considered but they are not persuasive.
Applicant amends claims 1 and 31 from the recitation of “[a] method for treating lung cancer in a subject” to the recitation of “[a] method for treating lung cancer in a subject diagnosed as having lung cancer…. wherein treating is one or more selected from active treatment, casual treatment, palliative treatment, and supportive treatment”, such that the claimed term “treating” does not includes curing and preventing lung cancer.
In Summary, applicant argues the claim amendments overcome the rejection on the record.
In response, applicant’s argument is not found persuasive, because even though the claims have been amended, the claims still have issues for the reasons set forth below. Therefore, the new ground of rejection has been applied in light of the claim amendments for the reasons set forth herein.
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.
Claims 1, 6, 16, 27, 31 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Lung Cancer, 2011. Vol. 72 (2): 205–212), in view of Pan et al. (Contemp Oncol (Pozn), 2016. Vol. 20 (4): 320–326), and Furie et al. (Arthritis Rheumatol., 2017. Vol. 69 (2): 376–386; cited in the IDS filed on February 16, 2023).
Wu et al. teaches erlotinib and gefitinib are tyrosine kinase (TK) inhibitors of epidermal growth factor receptor (EGFR) that are effective in treating non-small cell lung cancer (NSCLC) (see e.g., abstract). Wu et al. further teaches patients received gefitinib (250 mg daily) or erlotinib (150 mg daily) orally for treatment of NSCLC stage IIIb or IV (see e.g., p. 206, left column, 1st paragraph under “2.2. Use of EGFR TK inhibitors and evaluation of effectiveness”; abstract); and in both patient groups with mutant EGFR or wild-type EGFR, the effectiveness of gefitinib and erlotinib, including drug response or overall survival, were not different (see e.g., abstract).
Wu et al. does not teach anifrolumab.
Furie et al. teaches cell signaling by all type I IFNs, including IFN[Symbol font/0x61], IFN[Symbol font/0x62], IFN[Symbol font/0x65], IFN[Symbol font/0x6B], and IFN[Symbol font/0x77], is mediated by the type I IFN-[Symbol font/0x61]/[Symbol font/0x62]/[Symbol font/0x77] receptor (IFNAR) (see e.g., p.377, left column, line 29-31); and anifrolumab is a fully human, IgG1κ monoclonal antibody that binds to IFNAR and prevents signaling by all type I IFNs (see e.g., p. 377, left column, line 45-47). Furie et al. further teaches anifrolumab exhibits a favorable safety profile and sustained inhibition of the type I IFN gene signature in a phase I study of patient with scleroderma (see e.g., p. 377, left column, line 47-50). Furie et al. further teaches patient with systemic lupus erythematosus recited intravenous infusions of anifrolumab 300 mg or anifrolumab 1,000 mg every 4 weeks with the final dose administered at week 48 (see e.g., p. 377, right column, last paragraph); and the degrees of IFN gene signature inhibition were similar with the low and high anifrolumab dosages (see e.g., p. 385, left column, last paragraph). Furie et al. further teaches anifrolumab treatment was well tolerated, and adverse events reported were similar across the 3 treatment groups (see e.g. p. 385, right column, line 14-16).
Pan et al. teaches there were antagonistic interactions between an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) gefitinib and IFN-[Symbol font/0x61] in the human non-small cell lung cancer (NSCLC) cell lines, including A549 (EGFRWT, K-rasMT), H1299 (EGFRWT, K-rasMT) and HCC827 (EGFRDel722-726, K-rasMT), pretreated with IFN-[Symbol font/0x61] before administering gefitinib and IFN-[Symbol font/0x61] (see e.g., p. 323, left column, 2nd paragraph; Fig. 2). Pan et al. further teaches the antiproliferation of gefitinib alone was reduced after IFN-α pretreatment in the three cell lines; and the inhibition to gefitinib was the most significant in the HCC827 cell line (see e.g., p. 323, right column, 2nd paragraph; Figure 3). Pan et al. further teaches EGFR signaling may be dependent on STAT3 activation, in other words, the inhibitory effect of gefitinib may depend on STAT3 activation; the phosphorylation of STAT3 was inhibited by IFN-α pretreatment; therefore, the EGFR pathway, being somewhat dependent on STAT3 activation, may not have been activated, thereby reducing the gefitinib sensitivity of these cell lines (see e.g., p. 323, right column, 5th paragraph). Pan et al. further teaches finding the mechanisms of EGFR-TKI resistance is the current focus, IFN-α inactivates gefitinib in NSCLC, it may provide a new idea to explore and enrich the mechanisms of EGFR-TKI (see e.g., p. 326, left column, 1st paragraph).
In short, Wu et al. teaches administering 250 mg of gefitinib for treating non-small cell lung cancer in a patient with said cancer. The difference between the method of Wu et al. and the claimed invention is that the prior art does not teach the administration of anifrolumab. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by combining the method of Wu et al. (administering 250 mg of gefitinib) with the method of Furie et al. (administering 300 mg or 1,000 mg of anifrolumab) for treating non-small cell lung cancer in a subject diagnosed with said cancer. One would have been motivated to do so, because Pan et al. teaches IFN-α reduces the gefitinib sensitivity in non-small cell lung cancer, and further teaches that inhibitory effect of EGFR-TKI may depend on STAT3 activation, and the phosphorylation of STAT3 was inhibited by IFN-α pretreatment; and Furie et al. teaches the administration of both 300 mg and 1,000 mg of anifrolumab can successfully inhibits the type I IFN gene signature, including IFN-α, in similar degrees while maintaining a safety profile that is generally well-tolerated. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering 300 mg or 1,000 mg of anifrolumab can successfully inhibits the type I IFN gene signature, including IFN- α, and increase the sensitivity of gefitinib (250 mg) for treating non-small cell lung cancer by preventing the inhibition of STAT3 activation; and that renders obvious the limitation of “active treatment” because by treating non-small cell lung cancer, said cancer would necessarily be improved.
Regarding “erlotinib” in claims 6, 31, and 34, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Wu et al., Furie et al. and Pan et al. set forth above by substituting one art recognized equivalent EGFR inhibitor for non-small cell lung cancer. One would have been motivated to do so, because Wu et al. teaches gefitinib (250 mg) and erlotinib (150 mg) are both effective for treating non-small cell lung cancer in patients with mutant EGFR or wild-type EGFR. One would have been motivated to do so, because one would have reasonably expected that erlotinib would have exerted the same or substantially similar EGFR inhibiting effect as gefitinib; and therefore, by substituting gefitinib with erlotinib in the method of Wu et al., Furie et al. and Pan et al. set forth above, it would successfully treat non-small cell lung cancer.
Regarding “wherein the EGFR inhibitor and anifrolumab are not administered concurrently” in claim 16, the instant situation is amenable to the type of analysis set forth in Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) and also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), where the court found that the selection of any order of performing process steps is prima facia obvious in the absence of new or unexpected results. As such, applying the same logic to the instant process claims, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the order of administering gefitinib and anifrolumab in the method of Wu et al., Furie et al. and Pan et al. set forth above. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have expected that by not concurrently administering gefitinib and anifrolumab to the patient would successfully treat non-small cell lung cancer.
Regarding “the lung cancer express EGFR wild type” in claim 28, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Wu et al., Furie et al. and Pan et al. set forth above for treating non-small cell lung cancer expresses EGFR wild-type. One would have been motivated to do so, because Wu et al. teaches gefitinib can treat non-small cell lung cancer patient with wild-type EGFR; and Pan et al. teaches antiproliferation of gefitinib alone was reduced after IFN-α pretreatment in the three non-small cell lung cancer cell lines, including A549 (EGFRWT, K-rasMT) and H1299 (EGFRWT, K-rasMT). One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering anifrolumab would have successfully increase the sensitivity of gefitinib for treating non-small cell lung cancer that express EGFR wild-type; and therefore, the method of Wu et al., Furie et al. and Pan et al. set forth above would reasonably be expected to treat non-small cell lung cancer that express EGFR wild-type.
Regarding “the lung cancer express EGFR mutant” in claim 29, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Wu et al., Furie et al. and Pan et al. set forth above for treating non-small cell lung cancer expresses mutant EGFR. One would have been motivated to do so, because Wu et al. teaches gefitinib can treat non-small cell lung cancer patient with mutant EGFR; and Pan et al. teaches antiproliferation of gefitinib alone was reduced after IFN-α pretreatment in the three non-small cell lung cancer cell lines, including HCC827 (EGFRDel722-726, K-rasMT). One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering anifrolumab would have successfully increase the sensitivity of gefitinib for treating non-small cell lung cancer expresses mutant EGFR; and therefore, the method of Wu et al., Furie et al. and Pan et al. set forth above would reasonably be expected to treat non-small cell lung cancer that express mutant EGFR.
Regarding “wherein the lung cancer is resistant to EGFR inhibition” in claim 30, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Wu et al., Furie et al. and Pan et al. set forth above for treating non-small cell lung cancer that is resistant to EGFR inhibition. One would have been motivated to do so, because Pan et al. teaches EGFR pathway is somewhat dependent on STAT3 activation; IFN-[Symbol font/0x61] inhibits STAT3 activation and reduces the sensitivity of NSCLC cell lines to EGFR inhibitor gefitinib; and said mechanisms provide a new idea to explore and enrich the mechanisms of EGFR-TKI, including EGFR-TKI resistance. One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that administering anifrolumab would have successfully increase the sensitivity of gefitinib by preventing the inhibition of STAT3 phosphorylation, which can contribute to the EGFR-TKI resistance; and therefore, the method of Wu et al., Furie et al. and Pan et al. set forth above would reasonably be expected to treat non-small cell lung cancer that is resistant to EGFR inhibition.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1, 6, 13, 16, 27, 31 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (Lung Cancer, 2011. Vol. 72 (2): 205–212), in view of Pan et al. (Contemp Oncol (Pozn), 2016. Vol. 20 (4): 320–326), and Furie et al. (Arthritis Rheumatol., 2017. Vol. 69 (2): 376–386) as applied to claims 1, 6, 16, 27, 31 and 34 above, and further in view of Bilgic (WO 2010/090613 A1).
The teachings of Wu et al., Furie et al. and Pan et al. are set forth above and applied as before.
Wu et al., Furie et al. and Pan et al. does not teach co-formulated in claim 13.
Bilgic et al. teaches the combination of the active ingredients in a single dosage form will simplify treatment and increase patient's compliance to treatment (see e.g., abstract; p. 6, line 15-19).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Wu et al., Furie et al. and Pan et al. set forth above by co-formulating anifrolumab with gefitinib or erlotinib to arrive at the claimed invention. One would have been motivated to do so, because Bilgic et al. teaches combined active ingredients in a single dosage form will simplify treatment and increase patient's compliance to treatment. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by co-formulating anifrolumab with gefitinib or erlotinib would have successfully increase patient's compliance and simplify the treatment.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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