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 .
Claim Objections Withdrawn
The objection to claims 1 and 10, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claim 10, the amendment cancels the claim. With respect to claim 1, inventor has amended the labels within the claim as suggested by the examiner.
Claim Objections, MAINTAINED
The objection to claim 9, outlined in the previous Office Action, is maintained because of the following informalities: the claim recites numbered (“…1)…2)…”) limitations. As noted in the previous Office Action, the examiner respectfully suggests, in keeping with ordinary English grammar, and to avoid any possible ambiguity, that the number labels be replaced with letter designations or italicized Roman numerals (as inventor has done in claim 1, for instance, in the latest amendment).
Inventor states in the remarks that accompany the amendment that the objection has been addressed. The examiner respectfully points out, however, that the claim has not, in fact, been amended to address the objection.
112 Rejections Withdrawn
The rejection of claims 1-9 under 35 USC 112(b) or 35 USC (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 3-5, the amendment cancels the claims. With respect to the remaining claims, the amendment rewrites the claims as proper method claims.
Claim Rejections - 35 USC § 112, NEW
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.
Claim 1 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “…the treatment of the disease is improving lung pathological conditions…”, and the claim also recites “…including [emphasis added] alveolar congestion, hemorrhage, [etc.]…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, the term improving (“…improving lung pathological conditions…”) is a relative term which also renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2 and 6-9 are also 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.
The claims all depend, or ultimately depend, from a claim which is indefinite yet do not clarify the indefiniteness. Dependent claims 2 and 6-9 are also, therefore, indefinite.
101 Rejections Withdrawn
The rejection of claims 1-9 under 35 USC 101, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 3-5, the amendment cancels the claims. With respect to the remaining claims, the amendment rewrites the claims as proper method claims.
102 Rejections Withdrawn
The rejection of claims 1 and 9 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment narrows the claimed subject matter such that it no longer reads on the cited art.
The rejection of claim 10 under 35 USC 102(a)(1), outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment cancels the claim.
103 Rejections Withdrawn
The rejection of claims 1-9 under 35 USC 103, outlined in the previous Office Action, is withdrawn in view of inventor’s extensive amendments and arguments and reformulated below. The amendment cancels claims 3-5.
Claim Rejections - 35 USC § 103, NEW
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1, 2 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,308,634 B2, prior art of record.
Inventor teaches a method for the treatment of (a) acute lung injury and (b) acute respiratory distress syndrome comprising administering the IRAK4 inhibitor of formula I, wherein (a) or (b) is caused by direct lung injury which is caused by diffuse lung infection, bacteria, virus, toxin or hypoxia, and mediated by a cytokine combination of eosinophils, neutrophils and lymphocytes, and the treatment improves lung pathological conditions including alveolar congestion, hemorrhage, neutrophil infiltration into airspaces or vascular wall, and alveolar wall thickening and hyaline membrane formation (claim 1). Dependent claim 2 (from claim 1) teaches that the direct lung injury is caused by bacteria. Dependent claim 6 (from claim 1) teaches that the disease is an LPS-induced disease. Dependent claim 7 (from claim 6) teaches that the drug is administered before LPS induction. Dependent claim 8 (from claim 7) teaches administration again after LPS induction. Dependent claim 9 (from claim 1) teaches that the compound is administered in the form of a drug which comprises a prophylactic and/or therapeutically effective amount of the compound of formula I and pharmaceutically acceptable carriers, diluents or excipients.
US 10,308,634 B2 teaches a method for the treatment of inter alia acute respiratory distress syndrome and acute lung injury by administering a pharmaceutical composition of an inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4) (abstract; column 3, line 46; column 1, line 30). The instant compound of formula I is one such exemplified IRAK4 inhibitor (column 59, Example 20). The pathogenesis of the pulmonary disorders, such as acute respiratory distress syndrome and acute lung injury, may be impacted by either infectious or non-infectious processes (column 3, line 50).
Inventor principally distinguishes over the cited prior art by describing the lung injury or acute respiratory distress syndrome in terms of the type or cause of injury, the mediating cytokines and inflammatory cells, and the desired results. However, the actual method steps of the prior art (i.e. administering a compound of formula I) and the reason for undertaking those steps (i.e. for treatment of inter alia acute respiratory distress syndrome or acute lung injury) are identical to those of the instant invention. Note that an obviousness rejection is proper when the prior art suggest a reason or provides motivation to make the claimed invention, even where the reason or motivation is based on a different motivation from that of applicant. It is not necessary in order to establish a prima facie case of obviousness that there be a suggestion or expectation from the prior art that the claimed invention will have the same or similar utility as the one newly discovered by applicant. (See MPEP 2144 (IV).) Furthermore, note that a chemical composition and its properties are inseparable. Products of identical chemical composition cannot have mutually exclusive properties. Thus, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (MPEP 2112.01 (II).)
Furthermore, it is well established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches to a person of ordinary skill in the art. (Note the discussion at MPEP 2141.02, VI.) The method of US 10,308,643 B2 is clearly intended to be a broadly applicable and generally useful approach to treatment, but it explicitly encompasses both the instant compound of formula I and the treatment of acute respiratory distress syndrome and acute lung injury - both infectious and non-infectious.
Finally, note that claim language that merely states a problem to be solved or a result obtained (“…the treatment of the disease is improving lung pathological conditions including, alveolar congestion, [etc.]…”), without setting forth well-defined boundaries of the claimed scope (i.e. by not specifying any way to achieve the desired results), is unclear. Typically no patentable distinction (no limit on the claim scope) is made by a recitation of an intended use or result unless some structural difference is imposed by the use or result on the structure or material recited in the claim, or some manipulative difference is imposed by the use or result on the action recited in the claim. Note the discussion at MPEP 2173.05(g).
Claims 6-8 are included in this rejection because administration before LPS-induction, or again after LPS-induction, would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention. Given the explicit teachings of US 10,308,634 B2 recognizing that infection may, or may not, accompany the pulmonary condition, one of ordinary skill (i.e. a highly skilled individual such as a clinical physician) would have been motivated, and with a reasonable expectation of success, to administer the compound of US 10,308,634 B2 (i.e. the instant compound), in the treatment protocol of US 10,308,634 B2, prior to LPS induction (i.e. prior to an LPS-induced inflammatory response) and certainly after LPS-induction (i.e. after a bacterial infection). One of ordinary skill would have been motivated to do so because the patient may well benefit from a modulated response (since, as has been well-known in the art for some time, the body’s inflammatory response itself can cause or exacerbate tissue injury).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP§ 706.07(a). 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 J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 9/12/2025