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 .
Preliminary claims filed March 21, 2023.
Claims 1, 6-7, 15-21, 34-41, 53-54 are pending. Claims 2-5, 8-14, 22-33, 42-52, 55-91 are canceled. Claims 1, 6-7, 15-21, 34-41, 53-54 are examined.
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.
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, 15-21, 34-41, 53-54 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.
Claims 18 and 37 recite ITGA1 variant nucleic acid molecule chosen from a list of variant by name which is not provided with a reference sequence to locate the changes which renders the claims ambiguous as to the claim limitations. One of skilled in the art would need the identification of the terms shown on page 7, line 10, of the specification. Claims 1, 15-17, 19-21 encompass claim 18 limitations. Claims 34, 35-36, 38-41, 53-54 encompass claim 37 limitations.
Claim 17 and 34 recite “dosage amount” that is the same as or less than a standard dosage amount to a subject which is confusing and ambiguous because the standard dosage amount is a relative amount to which another “dosage amount” which would be a relative amount is related to for specificity of the claim limitation. Claims 1, 15-16, 18-21 encompass claim 17 limitations. Claims 35-41, 53-54 encompass claim 34 limitations.
Claims 1, 6-7, 15-21, 34-41, 53-54 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass a method of treating a subject having fibrotic lung disease or at risk fo developing a fibrotic lung disease, having pulmonary fibrosis or at risk of developing pulmonary fibrosis, having interstitial lung disease or at risk of developing interstitial lung disease, having chronic obstructive pulmonary disease (COPD) or at risk of developing COPD, and/or having asthma or at risk of developing asthma by administering an ITGA1 inhibitor to the subject. Claims encompass treatment of the subject after diagnosing ITGA1 variant and the negative absence of the variant in subject are treated with ITGA1 inhibitor. However, one skilled in the art is not aware of treating treating the diseases with a negative diagnoses with ITGA1 variant in the biological sample. The amount of direction provided in the specification is limited to diagnosis of ITGA1 variant correlation with forced expiratory volume and forced vital capacity to measure airway obstruction. No example is provided for treatment of diseases claimed. No example is provided for treatment of subject at risk of diseases claimed. The state of the art is such that one skilled in the art teach treatment lung fibrosis with ITGA1 inhibitor (Pradines et al. (US 2019/0218299). One skilled in the art is not able to predict the etiology behind the types of diseases claimed based on the diagnostic of ITGA1 variant negative test in the sample alone. One skilled in the art is not able to predict the claimed disease where the negative ITGA1 variant in sample of the at risk subjects with no symptomscan be treated with ITGA1 inhibitor because the at risk patient has no symptoms to treat to determine the effect. The ITGA1 variant diagnostic does not provide teaching sufficient to enable the treatment of at risk disease or diseases whose etiology is caused by ITGA1 positive function alone. In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation.
Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the invention of claims without undue experimentation.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 6-7 is/are rejected under 35 U.S.C. 102A1 as being anticipated by Pradines et al. (US 2019/0218299).
Pradines teach the method of treatment of lung fibrosis (paragraph 15-20) by administering ITGA1 agent antisense oligonucleotides including shRNAs and siRNAs (Table 1; Paragraph 35, 38, 48, 58).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674