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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/16/2025 has been entered.
Claim Status
Applicants' response and amendments to the claims, filed 10/16/2025, are acknowledged and entered. No claims were cancelled or newly added.
Claims 3-4, 6-7, and 9-22 are pending and under examination.
Claim Rejections - 35 USC § 112(b)
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
CLAIMS 3-4, 6-7, and 9-22
Claims 3-4, 6-7, and 9-22 remain 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 3, 7, and 9 were previously amended to require a step of “…selecting an individual having normal or undamaged lung tissue”. This limitation is still present in claims 7 and 9. It remains unclear if “an individual having normal or undamaged lung tissue” is intended to exclude individuals having lung cancer. As an individual having lung cancer would not be considered to have “normal or undamaged lung tissue” such would appear to exclude individuals diagnosed with lung cancer from the claimed subject population. It is unclear from the language of the claims whether “normal or undamaged lung tissue” means lung tissue that is only not damaged from radiation or not damaged at all.
Claim 3 has been amended to require selecting an individual “…diagnosed with having a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung, wherein the radiation exposure will be sufficient to cause radiation-induced [damage?] to the lung tissue”. Applicant deleted “damage in the normal or undamaged” from the claim so that it now reads “…will be sufficient to cause radiation-induced to the lung tissue…”. It is unclear what the radiation induces to the lung tissue. Claim 7 still requires selecting an individual who “…will be exposed to a sufficient amount of a DNA damage-inducing factor, radiation, or a drug therapy for a cancer treatment to cause DNA damage in the normal lung tissue”. Claim 9 still requires selecting an individual who “…will be exposed to a sufficient amount of a DNA damage-inducing factor, radiation, or a drug therapy for a cancer treatment to cause lung tissue fibrosis”. It is totally unclear how a person of ordinary skill in art can select, a priori, individuals for treatment before it is determined whether or not the DNA damage-inducing factor, radiation, or a drug therapy for a cancer treatment they are or will be exposed to actually causes radiation-induced damage in the normal or undamaged lung tissue, DNA damage in the normal lung tissue, and/or lung tissue fibrosis. Put another way, the claims require selecting individuals for treatment with the claimed compound of Formula 1 before it is even determined whether or not their exposure to a DNA damage-inducing factor, radiation, or a drug therapy for a cancer treatment actually causes radiation-induced damage in the normal or undamaged lung tissue, DNA damage in the normal lung tissue, and/or lung tissue fibrosis. As not all patients exposed to, for example, radiation therapy for cancer treatment will inevitably develop radiation-induced damage in the normal or undamaged lung tissue and/or lung fibrosis, it is totally unclear how one can select individuals for treatment before they are exposed to a DNA damage-inducing factor, radiation, and/or a drug therapy for a cancer treatment. For example, MARKS ET AL. (Seminars in Radiation Oncology, 2003, vol.13, no.3, p.333-345) teach that radiation is frequently used to treat tumors in and around the thorax and in these patients radiation therapy induced lung injury occurs in ~5% to 20% of patients with lung cancer. Thus, in 80%-95% of lung cancer patients radiation therapy will NOT cause radiation-induced damage in the lungs. However, before being exposed to the radiation therapy one skilled in the art cannot know, a priori, which individuals exposed to the same dose of radiation therapy will actually develop radiation-induced lung damage.
Applicants are claiming a preventative therapy and are therefore attempting to define a subject population by what might happen when they are exposed to a DNA damage-inducing factor, radiation, and/or a drug therapy for a cancer treatment. However, as it is impossible to know, a priori, whether any given exposure to a DNA damage-inducing factor, radiation, and/or a drug therapy for a cancer treatment will actually cause damage to normal or undamaged lung tissue or lung fibrosis in any given subject, a person of ordinary skill simply cannot know what subjects are intended to be encompassed by the claims.
Accordingly, the metes and bounds of the subject population(s) of the claims remain entirely unclear.
Response to Arguments
Applicants did not acknowledge, let alone address, this ground of rejection in their response. Accordingly, the Examiner presumes Applicants do not traverse the rejection.
CLAIMS 3-4, 11, 19, and 22
Claims 3-4, 11, 19, and 22 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.
Claim 3 has been amended to recite “…selecting an individual diagnosed with having a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung, wherein the radiation exposure to the lung will be sufficient to cause radiation-induced to the lung tissue”. The only active method step recited in the claim is “…(b) administering to the individual before the radiation therapy a pharmaceutical composition…”. It is unclear whether the selected individual is actually required to also be administered radiation therapy as part of the claimed method. For example, one possible interpretation of the claim is that an individual is diagnosed with lung cancer and “needs” treatment with radiation. However, in lieu of such treatment with radiation the individual is instead administered a compound of Formula 1. There is nothing in the amended claim that recites or requires that radiation exposure to the lung actually occurs after the individual is administered a compound of Formula 1 because Applicants deleted the phrase “wherein the individual will be exposed to a [radiation]” from the claim.
Accordingly, it is unclear from the amended claim language whether radiation exposure to the lung of the selected individual is a required active method step of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 3-4, 6, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JANNE ET AL. (Lancet Oncol., 2014, vol. 15, p.1433-1441).
This is a new ground of rejection because Applicants have amended claim 3 such that it is no longer a clear requirement of the claimed method that the individual will actually be exposed to a radiation therapy because Applicants removed the limitation “wherein the individual will be exposed to a [radiation]”.
JANNE ET AL. teach selecting individuals diagnosed with advanced lung cancer and administering to the individuals dacomitinib orally once daily (30 mg or 45 mg). As the individuals were “treatment-naïve” and were not administered radiation therapy, the dacomitinib was administered “before the radiation therapy” as required by the claims. Individuals with “advanced lung cancer” would be understood by those skilled in the art to have a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung. Whether such individuals are actually treated with such radiation exposure to the lung is immaterial because the claims do not recite or require that radiation exposure to the lung actually occurs as part of the claimed method.
Claim(s) 7, 9, and 12-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WILLIAMS ET AL. (PLOS ONE, May 2014, vol. 9, Issue 5, e98557, p.1-11).
Williams et al. teach orally administering dacomitinib1 once daily for 5 consecutive days to SCID mice bearing FaDu cell tumors and on days 2 and 5 administering local ionizing radiation immediately following drug administration (p.3, left column, “Animal Experiments”). The dacomitinib was in a “pharmaceutical composition” comprising 1 mg/mL dacomitinib prepared in 100% DMSO (p.2, right column, “Compound Dilutions”).
Response to Arguments
Applicants have not amended any of claims 7, 9, or 12-18 and present the same arguments they previously presented in their reply filed 02/07/2025.
Accordingly, the Examiner’s response to these arguments as set forth in the Final Office Action mailed 04/17/2025 are herein incorporated by reference in their entirety. Note that claim 3 and claims dependent therefrom have been removed from this ground of rejection because claim 3 was amended to require “…selecting an individual diagnosed with having a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung, wherein the radiation exposure to the lung will be sufficient to cause radiation-induced to the lung tissue”. The mice in Williams et al. bore FaDu cell tumors and received local ionizing radiation, which are not construed have to have a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung.
Claim(s) 7, 9, and 12-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PRAWIRA ET AL. (Invest. New Drugs, 2016, vol. 34, p.575-583).
Prawira et al. teach administering 15 mg, 30 mg, or 45 mg dacomitinib orally or through a feeding tube on a continuous daily schedule from day 1 to day 49, cisplatin at 100 mg/m2 intravenously every 3 weeks, and a radiotherapy dose of 70 Gy in 35 daily fractions to human patients having locoregionally advanced squamous cell carcinoma of the head and neck (Title; Abstract; p.576, right column, “Treatment”; Table 1).
Response to Arguments
Applicants have not amended any of claims 7, 9, or 12-18 and present the same arguments they previously presented in their reply filed 02/07/2025.
Accordingly, the Examiner’s response to these arguments as set forth in the Final Office Action mailed 04/17/2025 are herein incorporated by reference in their entirety. Note that claim 3 and claims dependent therefrom have been removed from this ground of rejection because claim 3 was amended to require “…selecting an individual diagnosed with having a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung, wherein the radiation exposure to the lung will be sufficient to cause radiation-induced to the lung tissue”. The individuals in Prawira et al. were diagnosed with locoregionally advanced squamous cell carcinoma of the head and neck, which is not construed to be a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 3-4, 6-7, and 9-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over USP NO. 7,772,243 (Issued Aug. 10, 2010) and USP NO. 8,623,883 (Issued Jan. 7, 2014) in view of PRAWIRA ET AL. (Invest. New Drugs, 2016, vol. 34, p.575-583) and JANNE ET AL. (Lancet Oncol., 2014, vol. 15, p.1433-1441).
US ‘243 teaches the claimed compound of Formula 1 and a pharmaceutical composition comprising the compound or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier (Claims 8 and 9). It expressly teaches a 100 mg tablet formulation of the claimed compound of Formula 1:
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(col. 15, l.30-45).
Applicants are advised that the recited intended use of the claimed pharmaceutical composition, i.e., “for inhibiting DNA damage or for protecting or mitigating radiation against radiation-induced damage”, is not afforded patentable weight. Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). See MPEP 2111.02(II). Regarding claim 6, it teaches pharmaceutically acceptable salts include, inter alia, hydrochloride salts (col. 14, l.21-26). Regarding claims 3, 7, and 9-17, it teaches the compounds are used in methods for the treatment of abnormal cell growth in a mammal which comprises administering to said mammal an amount of a compound of formula 1, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, that is effective in treating abnormal cell growth in combination with an anti-tumor agent selected from the group consisting of mitotic inhibitors, alkylating agents, antimetabolites, intercalating agents, growth factor inhibitors, cell cycle inhibitors, enzymes, topoisomerase inhibitors, biological response modifiers, antibodies, cytotoxics, antihormones, and anti-androgens (col 5, l.22-32). Regarding claims 19-22, it teaches the compounds can be administered to humans and animals either orally, rectally, parenterally, intracisternally, intravaginally, intraperitoneally, intravesically, locally, or as a buccal or nasal spray (col. 12, l.30-34). Indeed, they teach preparation of a parenteral solution comprising the claimed compound [dacomitinib] (col.16, l.16-25).
US ‘883 teaches:
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(Claim 1). Regarding claim 6, it teaches pharmaceutically acceptable salts include, inter alia, hydrochloride salts (col. 14, l.11-16). Regarding claims 19-22, it teaches the compounds can be administered to humans and animals either orally, rectally, parenterally, intracisternally, intravaginally, intraperitoneally, intravesically, locally, or as a buccal or nasal spray (col. 12, l.20-24). Indeed, they teach preparation of a parenteral solution comprising the claimed compound [dacomitinib] (col.15, l.65 to col. 16, l.7).
PRAWIRA ET AL. teach administering 15 mg, 30 mg, or 45 mg dacomitinib orally or through a feeding tube on a continuous daily schedule from day 1 to day 49, cisplatin at 100 mg/m2 intravenously every 3 weeks, and a radiotherapy dose of 70 Gy in 35 daily fractions to human patients having locoregionally advanced squamous cell carcinoma of the head and neck (Title; Abstract; p.576, right column, “Treatment”; Table 1).
JANNE ET AL. teach selecting individuals diagnosed with advanced lung cancer and administering to the individuals dacomitinib orally once daily (30 mg or 45 mg) (Abstract). As the individuals were “treatment-naïve” and were not administered radiation therapy, the dacomitinib was administered “before the radiation therapy” as required by the claims. Individuals with “advanced lung cancer” would be understood by those skilled in the art to have a disease or condition needing as a treatment a therapy comprising radiation exposure to the lung.
It would have been obvious to a person of ordinary skill in the art to formulate the claimed compound of Formula 1 (dacomitinib) in a pharmaceutical composition and administer the composition alone or in combination with other anticancer drugs and/or radiation therapy to a subject having lung cancer. This is in fact exactly what the prior art teaches doing.
The Examiner recognizes that Applicants’ reason for doing what the cited prior art already teaches is different from the prior art reason. Whereas the prior art teaches formulating the claimed compound of Formula 1 (dacomitinib) in a pharmaceutical composition and administering the composition alone or in combination with other anticancer drugs and/or radiation therapy to a subject having cancer to treat the subject’s cancer, Applicants’ reason for doing so is to prevent or treat pulmonary fibrosis or for protecting or mitigating radiation against radiation-induced damage. However, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Furthermore, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). "The fact that appellant 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 (Bd. Pat. App. & Inter. 1985).
Here, the fact that administering dacomitinib prevents pulmonary fibrosis induced by radiation exposure or drug therapy for anticancer treatment and/or protects or mitigates radiation-induced damage would flow naturally from carrying out the methods taught in the cited prior art because the same compound (dacomitinib) is administered to the same subjects (subjects undergoing treatment with anticancer drugs and/or radiation therapy).
Response to Arguments
Applicants have not amended any of claims 7, 9, or 12-18 and present the same arguments they previously presented in their reply filed 02/07/2025.
Accordingly, the Examiner’s response to these arguments as set forth in the Final Office Action mailed 04/17/2025 are herein incorporated by reference in their entirety. The Examiner modified this ground of rejection by removing the Williams et al. reference and adding the Janne et al. reference to more directly address the obviousness of administering dacomitinib to individuals diagnosed with lung cancer. The basis and rationale for the rejection remain substantially unchanged.
Conclusion
Claims 3-4, 6-7, and 9-22 are rejected.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
400 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 Dacomitinib is the claimed compound of Formula 1. Specification at p.3 (“Dacomitinib ((2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl}-4-Cl pipendinyl)-2-butenamide)”)