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 Office Action is responsive to the Response to Election/Restriction and Amendment filed 06/15/2026, wherein claim 1 was amended and claim 15 was cancelled.
Claims 1-14 and 16-32 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of the IRAK inhibitor compound,
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, and the patient population of a patient having or expected to develop acute respiratory distress syndrome (ARDS), in the reply filed on 06/15/2026, is acknowledged.
In the course of the search, the IRAK inhibitor compound was broadened to include the species
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.
Claims 10, 16-27 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.
Claims 1-9, 11-14, and 28-31 are examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
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 1-9, 11-14, and 28-31 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.
-In claim 1, the phrase “a patient. . .expected to develop acute respiratory distress syndrome (ARDS),” renders the claim indefinite because it is not clear what baseline or parameters are applied to determine which patients are those “expected to develop ARDS,” in comparison to those patients who are not expected to develop ARDS. Neither the specification nor the prior art further, definitively, defines this patient population.
In view of compact prosecution, for the purpose of applying prior art, this phase is interpreted as any disease or condition that can cause ARDS in any part of its patient population. For example, the instant specification teaches that patients with COVID-19 can develop ARDS. As such, the instant claim is interpreted such that a patient with COVID-19 is “a patient. . .expected to develop ARDS.”
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
-Claim 13 depends from claim 12, however, claim 12 does not recite “H” as a Markush member of “R.” As such the recitation of “H” in the Markush group of “R” in claim 13, fails to further limit the subject matter of claim 12.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 1-9, 11-14, and 28-31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2021/026451 to Taylor (published 02/11/2021, IDS of 03/08/2024).
Regarding claim 1, Taylor teaches pyrazole compounds for use as IRAK inhibitors for the treatment of cytokine release syndrome (abstract). As evidenced by the instant specification, a consequence of a cytokine storm is acute lung injury, which can progress into ARDS (pg. 1)
Regarding claims 2-9, 11-14, Taylor specifically teaches:
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, instant VII-1 and VI-176 (pg. 211, claim 12) and
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, the elected species and instant VII-18 (pg. 189) as the IRAK inhibitors.
Regarding claims 28-31, Taylor teaches oral, injectable, and nasal administration by inhalation or insufflation as modes of administration (pg. 123).
Claims 1 and 28-31 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2021/0188809 to Chan (published 06/2021, PTO-892).
Chan teaches a method of treating an inflammatory disease such as ARDS by administering an IRAK-4 inhibitor (claims 25-28).
Regarding claims 28-31, Chan teaches oral, intravenous, and inhalation as modes of administration ([0187]-[0188]).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 11-14, and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/172560 to Kelley (published 2016, IDS of 07/25/2025) in view of Pan (Selective inhibition of interleukin-1 receptor associated kinase 1 ameliorates lipopolysaccharide-induced sepsis in mice, published 2020, PTO-892).
Kelley teaches pyrazole compounds for use as IRAK inhibitors (abstract), such as
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(pg. 4; pg. 223, claim 36; pg. 224, claim 40).
Kelley specifically teaches:
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, instant VII-1 and VI-176 (pg. 50; pg. 247, claim 64).
Kelley teaches its compounds as useful for the treatment of bacterial infection, viral infection, respiratory diseases, and more (pg. 478, claim 68), such as pneumonia and sepsis (pg. 249, claim 70), which are diseases wherein ARDS can be expected to occur in a patient.
While Kelley teaches a method of treating diseases for which an IRAK inhibitor is indicated, such as sepsis, it differs from that of instant claim 1 in that it does not explicitly teach a method of treating sepsis, a disease in which a patient is expected to develop ARDS, by administering its compounds.
Pan teaches that IRAK inhibitors, especially IRAK1 and 4, are useful in the treatment of sepsis (abstract; pgs. 1-2, Introduction).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select sepsis as the disease/condition treated by the methods of Kelley, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Kelley teaches a method of treating diseases by administering IRAK inhibitors,
-Kelley teaches sepsis as a disease treated by its methods, and
-Pan teaches treating sepsis with IRAK inhibitors.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at an effective method of treating sepsis.
Regarding claims 2-9, and 14 the instant specification teaches its compounds as inhibiting IRAK1 and 4 (pg. 25), wherein
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of Kelley is instant VII-1 and VI-176.
Regarding claims 11-13,
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differs from that of instant claims 11-13 in that it does not teach an aliphatic, carboxyl ester, or alkyl phosphate at the instant R position.
Kelley teaches:
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(pg. 226, claims 43-46).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to substitute the H in
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with aliphatic, alkyl, carboxyl ester, or alkyl phosphate, to arrive at instant claims 11-13. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Kelley teaches that its R10 position can be hydrogen, aliphatic, alkyl, carboxyl ester, or alkyl phosphate,
-Kelley exemplifies similar compounds with these substituent groups for use as IRAK inhibitors, such as compound II-173 on pg. 204; II-164 on pg. 201; II-163 on pg. 200; II-107, II-105, II-103 on pg. 186; II-98 on pg. 184; II-97 on pg. 183; II-85 on pg. 179; II-84 on pg. 178; II-83 on pg. 177; II81, II-82 on pg. 176; II-80 on pg. 175; II-77, II-78 on pg. 174 and more on pgs. 171, 165, 164, 160, 158, 157, 156.
As such, an ordinary skilled artisan would have been motivated to make such a substitution to predictably arrive at a structurally and functionally similar compound.
Regarding claims 28-31, Kelley teaches oral, nasal, inhalation, insufflation, and injection as modes of administration (pg. 85, “B.”). Specifically regarding claim 30, inhalation is pulmonary administration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 14 and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,384,775 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘775 claims compounds of instant Formulas IV and VI, and species such as
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(I-1 of ‘775).
‘775 teaches its compounds for the treatment of ARDS (Col. 42, lines 45-55), and for administration orally, via injections, nasally, by inhalation or insufflation (Col. 46, lines 40-45).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Claims 1-6, 9, 11-14, and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,370,787 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘787 claims compounds of
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(claims 1-20).
‘787 claims a method of treating a disease or condition, such as a lung injury, respiratory diseases, bacterial infection, or viral infection, for which an IRAK inhibitor is indicated comprising administering a compounds of instant formula VII-18. As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
‘787 teaches its compounds for the treatment of cytokine release syndrome (Col. 61, lines 1-15), a condition which is expected to develop ARDS, and for administration orally, via injections, nasally, by inhalation or insufflation (Col. 64, lines 39-45).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Claims 1-6, 9, 11-14, and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 7 of U.S. Patent No. 12,441,723 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘723 claims a salt of a compound of instant VII-18 (claim 1)
‘723 claims a method of treating a disease or condition, such as a lung injury, respiratory diseases, bacterial infection, or viral infection, for which an IRAK inhibitor is indicated comprising administering a salt of a compound of instant formula VII-18 (Claim 3). As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
Regarding claims 28-31, while ‘723 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘723 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
Claims 1-3 and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,941,140 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘140 claims a method for inhibiting IRAK in a subject comprising administering to a subject a compound of instant formula IV(claim 1).
‘140 claims lung injury, respiratory diseases, bacterial infection, or viral infection, as diseases to be treated (Claim 20). As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
Regarding claims 28-31, while ‘140 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘140 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
Claims 1-2 and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15, 18-20 of U.S. Patent No. 10,774,076 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘076 claims a method for treating a disease or condition for which an IRAK4 modulator or inhibitor is indicated comprising administering a compound (claim 1).
‘076 claims sepsis as the disease (claim 20), wherein sepsis is a disease that can be expected to develop ARDS.
Regarding claims 28-31, while ‘076 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘076 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
Claims 1-6 and 28-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of copending Application No. 18/963,039 (claim set dated 07/09/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘039 claims compounds of instant formula VI (claims 13-17).
‘039 claims a method for treating a disease or condition for which an IRAK inhibitor is indicated, wherein the disease or condition is lung injury, respiratory disease, bacterial infection, and viral infection (claims 25-27, 29, 33). As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
Regarding claims 28-31, while ‘039 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘039 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 28-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18-21 of copending Application No. 18/204,304 (claim set dated 03/20/2026, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘304 claims a method for treating a disease or condition for which an IRAK inhibitor is indicated, wherein the disease or condition is lung injury, respiratory disease, bacterial infection, and viral infection (claims 1, 18-21). As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
Regarding claims 28-31, while ‘304 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘304 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 9, 11-14 and 28-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-16, 31-41 of copending Application No. 19/262,001 (claim set dated 09/23/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘001 claims a method for treating a disease or condition for which an IRAK inhibitor is indicated, wherein the disease or condition is lung injury, respiratory disease, bacterial infection, and viral infection, by administering a compound of instant formula VI (claims 15-16, 31-41). As evidenced by pg. 1 of the instant specification lung injury can progress into ARDS.
Regarding claims 28-31, while ‘001 does not claim modes of administration, an ordinary skilled artisan would have been motivated to administer the compound of ‘001 orally, or using an inhaler or nebulizer, to predictably arrive at a customary method of administering its compounds to a subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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