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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 11/20/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 11/20/2025 of Group I, claims 1, 3-4 and 9-13 is acknowledged.
Applicant has elected with traverse in the Reply filed on 11/20/2025 the following species:
A. the biomarker gene is SHISA4 (claim 1)
a search of the literature has identified CEACAM6 and the biomarker gene has been expanded to include either SHISA4 or CEACAM6 (claims 1 and 13)
Applicant argues that Steele does not explicitly tech all the listed biomarkers.
The Examiner notes that the claim does not require the use of all the biomarkers, but only one or more of the biomarkers. In addition, Steele is used for the restriction, not the species election. The rational for the species election explained on page 10 of the Restriction/Species Election requirement mailed 9/26/2025.
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 1, 3-4 and 9-13 are pending.
Claims 1, 3-4 and 9-13 are under examination in this Office Action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4 and 9-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 3-4 and 9-13 depend directly or indirectly from claim 1.
The claims 1 and 3-4 limitations directed to an abstract idea are e) comparing the levels of expression of said one or more biomarkers obtained from first and second biological samples, optionally taking into account control values; wherein the method further comprises the step of g1) continuing the administration of the antifibrotic agent to the patient or g2) reducing the dose or dose frequency; if a beneficial response in the patient has been detected; wherein the method further comprises the step of g3) discontinuing the administration of the antifibrotic agent to the patient or g4) increasing the dose or dose frequency of the antifibrotic agent; if no beneficial response in the patient has been detected.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a) obtaining a first biological sample from the patient prior to the start of administering an antifibrotic agent; b) administering or having administered an antifibrotic agent to the patient; wherein the antifibrotic agent is selected from: (i) nintedanib, or its pharmaceutically acceptable salts, and (ii) pirfenidone, wherein each antifibrotic agent is administered to the patient either as a monotherapy, c) obtaining a second biological sample from the patient after administering the antifibrotic agent; d) measuring in said first and second sample the levels of expression of the genes CEACAM6. Steele et al. (12/27/2012) US Patent Application Publication 2012/0329666 A1 (hereinafter known as "Steele") teaches obtaining a biological sample from the patient; and d) measuring in said first and second sample the levels of expression of the genes CEACAM6 (see [0004] to [0084]). Vanchen et al. (2018) American Journal of Respiratory and Critical Care Medicine volume 197 pages 356 to 363 cited in the 11/20/2025 IDS (hereinafter known as "Vanchen") teaches b) administering or having administered an antifibrotic agent to the patient; wherein the antifibrotic agent is selected from: (i) nintedanib, or its pharmaceutically acceptable salts, and (ii) pirfenidone, wherein each antifibrotic agent is administered to the patient either as a monotherapy (see entire document especially Abstract, Figure 1 and pages 357 to 359).
Claim Rejections - 35 USC § 103(a)
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) 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.
5. Secondary considerations (objective evidence of nonobviousness): a) commercial success; b) long felt need; c) evidence of unexpected results; d) skepticism of experts; and e) copying.
Common Ownership of Claimed Invention Presumed
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 1, 3-4 and 9-13 are rejected under 35 U.S.C. 103(a) as being unpatentable over Steele et al. (12/27/2012) US Patent Application Publication 2012/0329666 A1 (hereinafter known as "Steele") in view of Vanchen et al. (2018) American Journal of Respiratory and Critical Care Medicine volume 197 pages 356 to 363 cited in the 11/20/2025 IDS (hereinafter known as "Vanchen").
With regards to claims 1, 10 and 12-13, Steele teaches:
a) as in claims 1, 10 and 12-13, a method comprising a) obtaining a first biological sample from the patient prior to the start of administering an antifibrotic agent; d) measuring in said first sample the levels of expression of the gene CEACAM6; and e) comparing the levels of expression of said one or more biomarkers obtained from the first biological sample to control values; wherein the PF-ILD is idiopathic pulmonary fibrosis (IPF); wherein the biological sample is a blood sample; wherein the one or more biomarker is CEACAM6 (see [0004] to [0084]).
Steele does not explicitly teach:
a) as in claims 1, 3-4, 9 and 11, a method for treating progressive fibrosing interstitial lung (PF-ILD) diseases in a patient in need of treatment, the method comprising b) administering or having administered an antifibrotic agent to the patient; wherein the antifibrotic agent is selected from: (i) nintedanib, or its pharmaceutically acceptable salts, and (ii) pirfenidone, wherein each antifibrotic agent is administered to the patient either as a monotherapy, or in combination with one another; wherein the method further comprises the step of g1) continuing the administration of the antifibrotic agent to the patient or g2) reducing the dose or dose frequency; if a beneficial response in the patient has been detected; wherein the method further comprises the step of g3) discontinuing the administration of the antifibrotic agent to the patient or g4) increasing the dose or dose frequency of the antifibrotic agent; if no beneficial response in the patient has been detected; wherein the antifibrotic agent is selected from nintedanib monoethanesulphonate, optionally in combination with pirfenidone; wherein at the start of administration of the antifibrotic agent, the patient shows a forced vital capacity of about 40% or more and/or a diffusing capacity of lung for carbon monoxide of about 40% or more.
With regards to claims 1, 3-4, 9 and 11, Vanchen teaches:
a) as in claims 1, 3-4, 9 and 11, a method for treating progressive fibrosing interstitial lung (PF-ILD) diseases in a patient in need of treatment, the method comprising b) administering or having administered an antifibrotic agent to the patient; wherein the antifibrotic agent is selected from: (i) nintedanib, or its pharmaceutically acceptable salts, and (ii) pirfenidone, wherein each antifibrotic agent is administered to the patient either as a monotherapy, or in combination with one another; wherein the method further comprises the step of g1) continuing the administration of the antifibrotic agent to the patient or g2) reducing the dose or dose frequency; if a beneficial response in the patient has been detected; wherein the method further comprises the step of g3) discontinuing the administration of the antifibrotic agent to the patient or g4) increasing the dose or dose frequency of the antifibrotic agent; if no beneficial response in the patient has been detected; wherein the antifibrotic agent is selected from nintedanib monoethanesulphonate, optionally in combination with pirfenidone; wherein at the start of administration of the antifibrotic agent, the patient shows a forced vital capacity of about 40% or more and/or a diffusing capacity of lung for carbon monoxide of about 40% or more (see entire document especially Abstract, Figure 1 and pages 357 to 359).
One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have had a reasonable expectation of success in arriving at the Applicant's invention as claimed with the above cited references before them. Steele teaches the advantages of using marker CEACAM6 for diagnosing diopathic pulmonary fibrosis (see [0004] to [0084]). Vanchen teaches the advantages of treating idiopathic pulmonary fibrosis with nintedanib (see entire document especially Abstract, Figure 1 and pages 357 to 359). One of ordinary skill in the art before the time of the effective filing date of the claimed invention would have recognized the advantages of combining Steele's method of diagnosis of idiopathic pulmonary fibrosis with Vanchen's method of treatment of idiopathic pulmonary fibrosis using nintedanib to treat patients with idiopathic pulmonary fibrosis. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the time of the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684