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
Status of Claims
Claims 10-15 are pending in the instant application. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
An action on the merits of claims 10-11 is contained herein.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 5/5/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 9/5/2025.
Status of Rejections
35 USC § 112 (a)
The rejection of claims 10-11 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 9/5/2025, with respect to the rejection set forth in the Non-Final Office Action mailed 5/5/2025, have been fully considered but are not found persuasive.
To reiterate the rejection of record, claims 10-11 are rejected under 35 U.S.C. 112, 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.
Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. Analysis of sections (A)-(F) is described below:
(A) Breadth of claims: The claims are drawn to the treatment of fibrotic diseases using the claimed compounds. Some examples of the latter as stated in Laure Rittié (ed.), Fibrosis: Methods and Protocols, Methods in Molecular Biology, vol. 1627,
DOI 10.1007/978-1-4939-7113-8_1, © Springer Science+Business Media LLC 2017 (see page 3) include but are not limited to the following:
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804
470
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370
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. Based on the above analysis, the claims are very broad.
(B) The nature of the invention: The nature of the invention is related to the modulation of biological pathways for treating disease states such as fibrotic disorders. Overall, the nature of the invention may be construed to one of ordinary skill as very complex.
(C) State of the Prior Art:
A number of papers have been published in literature describing the potential treatment of fibrotic disorders including pulmonary fibrosis via inhibition of protein kinases such as ROCK inhibitors. However despite extensive exploration, therapeutic interventions for treating fibrotic diseases has not been successful and it is speculated that one single drug would not be capable of treating these disorders generally due to the complexity in pathology (see page 15, section 6.4, Laure Rittié (ed.), Fibrosis: Methods and Protocols, Methods in Molecular Biology, vol. 1627, DOI 10.1007/978-1-4939-7113-8_1, © Springer Science+Business Media LLC 2017). Furthermore in reference to ROCK inhibitors such as the claimed compounds, there are no approved inhibitors for the treatment of pulmonary fibrosis via this pathway due to similar challenges (see abstract of J. Med. Chem. 2023, 66, 4342−4360).
(D) Skill of those in the art: The level of skill in the art is high and one would possess a Ph.D. in synthetic organic chemistry or chemical biology.
(F) Direction or Guidance: Little guidance or direction other than ROCK inhibitory in vitro and limited in vivo data of the claimed compounds is provided by Applicant in reference for treating the claimed fibrotic diseases. Based on the preponderance of evidence described in section (C) detailing the current state of ROCK inhibition and fibrotic diseases; one of ordinary skill would expect undue experimentation executing the full scope of the claimed method.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Applicants argue that the instant claims are enabled due to the claim amendments and data filed in the instant specification. The examiner respectfully disagrees. In particular, limiting the scope of substituents that may be present on the claimed chemical formulas in the instant claims does not address the enablement issue at hand. How does the latter address the examiner’s concerns and published literature surrounding the state of the art with respect to protein kinase inhibition using ROCK inhibitors?
Regarding the arguments surrounding the data disclosed in the disclosure; it was stated of record that little guidance or direction other than ROCK inhibitory in vitro and limited in vivo data of the claimed compounds is provided by Applicant in reference for treating the claimed fibrotic diseases. The discussion of the mechanisms of action of the claimed compounds does not address the published literature put forth by the examiner. To summarize, a number of papers have been published in literature describing the potential treatment of fibrotic disorders including pulmonary fibrosis via inhibition of protein kinases such as ROCK inhibitors. However despite extensive exploration, therapeutic interventions for treating fibrotic diseases has not been successful and it is speculated that one single drug would not be capable of treating these disorders generally due to the complexity in pathology (see page 15, section 6.4, Laure Rittié (ed.), Fibrosis: Methods and Protocols, Methods in Molecular Biology, vol. 1627, DOI 10.1007/978-1-4939-7113-8_1, © Springer Science+Business Media LLC 2017). Furthermore in reference to ROCK inhibitors such as the claimed compounds, there are no approved inhibitors for the treatment of pulmonary fibrosis via this pathway due to similar challenges (see abstract of J. Med. Chem. 2023, 66, 4342−4360).
Therefore, the published literature does not support Applicant’s claims that the compounds are capable of treating fibrotic disorders generally. The limited data present in the specification does not obviate the teachings in the prior art and appear to be speculative in terms of treatment. The published literature has not been addressed by Applicant and no supporting data in a declaration has been presented to contradict the state of the prior art. Thus, the arguments are found unpersuasive.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624