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 .
Claims 2, 4-5, 14-15, and 20-23 have been cancelled.
Election/Restrictions
Applicant’s election without traverse of the antibody species in claim 1 as amended on 7/28/2026 in the reply filed on 7/28/2026 is acknowledged.
Claims 3, 6-13, and 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/28/2026.
Claims 1 and 19 are under consideration.
Specification
The disclosure is objected to because of the following informalities:
The Brief Description of the Drawings does not reference the subparts in each of the figures.
Appropriate correction is required.
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 and 19 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 methods as discussed below, does not reasonably provide enablement for all methods encompassed by the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Paragraph [0035] of the specification defines “treatment” as referring to clinical intervention in an attempt to alter the natural course of the individual or cell being treated, and can be performed either for prophylaxis or during the course of clinical pathology. Desirable effects of treatment include preventing occurrence or recurrence of disease, alleviation of symptoms, diminishment of any direct or indirect pathological consequences of the disease, preventing or decreasing inflammation and/or tissue/organ damage, decreasing the rate of disease progression, amelioration or palliation of the disease state, and remission or improved prognosis. In some embodiments, antibodies of the present disclosure are used to delay development of a disease or disorder.
Paragraph [0037] of the specification defines an “effective amount” as referring to an amount effective, at dosages and for periods of time necessary, to achieve the desired therapeutic or prophylactic result.
Example 3 discloses that administration of HuL217 (ENO-1 mAb having the CDRs of SEQ ID NO: 1, 2, 3, 4, 5, and 6, see paragraph [0056]) in a bleomycin-induced pulmonary fibrosis model attenuates body weight loss and lung weight gain.
Claim 1 does not require any particular therapeutic effect and as such, all therapeutic effects encompassed by the claim must be enabled. Claim 1 is considered to include prevention, cure, and reversal of pulmonary fibrosis. There is no evidence of record nor reason to believe that administration of the claimed antibodies will prevent, cure, or reverse pulmonary fibrosis, particularly for idiopathic pulmonary fibrosis, pulmonary hypertension, non-specific interstitial pneumonia (NSIP), or usual interstitial pneumonia (UIP) as recited in claim 19. At least for example, a pathological consequence of pulmonary hypertension is right-sided heart enlargement and heart failure. There is no evidence of record nor reason to believe that administration of the claimed antibodies will diminish these pathological consequences. Many people with idiopathic pulmonary fibrosis have gastroesophageal reflux disease (GERD). There is no evidence of record nor reason to believe that administration of the claimed antibodies will diminish GERD.
The experimental results of Example 3 cannot be extrapolated to predict results for all therapeutic outcomes encompassed by the claims. The scope of the claims is not enabled.
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.
Claims 1 and 19 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 1 is directed to a method treating a pulmonary fibrotic disease by administering an “effective amount.” The claim does not require any particular therapeutic effect and as such, it is unclear what amount meets the limitations of the claims. The metes and bounds of the claim cannot be determined. It also appears that “of” should be inserted between “method” and “treating.”
Claim 19 recites “wherein the pulmonary fibrotic diseases is selected form the group consisting of… pulmonary hypertension.” This is confusing as pulmonary hypertension is not itself a pulmonary fibrotic disease. Pulmonary hypertension can occur in the absence of pulmonary fibrosis. Only pulmonary hypertension classified as Group 3 is defined as pulmonary hypertension associated with lung diseases such as interstitial lung disease. See at least abstract and Tables 1 and 3 of Simonneau et al. Applicant is cautioned against introducing new matter. It also appears that the preamble of claim 19 should recite “wherein the pulmonary fibrotic disease is selected from” to correct grammar and spelling errors.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al. (U.S. Patent Application Publication 2019/0322762).
Tsai et al. discloses an antibody that binds human ENO1 where the VL has the CDRs of SEQ ID NOS 6, 7, and 8 and the VH has the CDRs of SEQ ID NOS: 50, 4, and 5. See at least the claims. This antibody corresponds to the antibody of instant claim 1 where the X in instant SEQ ID NO: 7 is serine or alanine. Methods for treating an ENO1 protein-related disease or disorder such as an inflammatory disease or an immune disorder are disclosed. Administering therapeutically effective amounts are disclosed. See at least claims 1 and 9-10 and 12. A dosage of 10 mg/kg is disclosed. See at least paragraph [0195]. This dosage is disclosed as being an effective amount in the instant application. See paragraph [0037] of the instant specification.
Any subjects treated according to Tsai et al. would be “in need of” preventing pulmonary fibrotic diseases, including those in claim 19. Note that instant claim 1 does not require that the subject already has a pulmonary fibrotic disease and “treating” encompasses prevention as discussed above. Note that instant claim 19 does not require that the subject already has one of the recited pulmonary fibrotic diseases and “treating” encompasses prevention as discussed above. Absent evidence to the contrary, administration of the claimed antibody would inherently prevent a pulmonary fibrotic disease, including those recited in claim 19.
Claims 1 and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yuan et al. (U.S. Patent Application Publication 2024/0207433, published 27 June 2024, filed 10 May 2021) or Yuan et al. (WO 2021/228044 published 18 November 2021, filed 10 May 2021).
The applied references have a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Both Yuan et al. references are equivalent. U.S. Patent Application Publication 2024/0207433 will be referenced.
Yuan et al. discloses a conjugate containing an anti-ENO1 antibody having the CDRs of instant claim 1. See at least claim 7. SEQ ID NOS: 1, 2, 3, 4, 5, and 6 correspond to instant SEQ ID NOS: 1, 2, 3, 4, 5, and 6, respectively. Treatment of idiopathic pulmonary fibrosis is disclosed. See at least paragraphs [0020, 0040, 0101} and claims 1, 10, and 13.
Claims 1 and 19 do not exclude administering an immunoconjugate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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