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 in response to applicant’s reply filed on April 23, 2026.
Status of Claims
Amendment of claim 17 is acknowledged.
Claims 1-9 and 17-24 are currently pending and are the subject of this office action.
Claims 1-9 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 4, 2025.
Claims 17-24 are presently under examination.
The following species, elected by Applicant in the response dated September 4, 2025: MLN4924, as the NLPR1 inflammasome inhibitor, is under examination.
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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.
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.
Claim(s) 17-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hao et. al. (Am. J. Physiol. Lung Cell Mol. Physiol. (March 20, 2019) 316: L1070-L1080, cited by Applicant) as evidenced by Anthes et. al. (US 2005/0090527).
All references were cited in prior office action.
NOTE: since the specification does not disclose any example of “airway inflammation triggered by Enterovirus 3C protease-activated NLRP1”, for prior art purposes, any airway inflammation is going to be considered to be an “airway inflammation triggered by Enterovirus 3C protease-activated NLRP1”.
For claims 17-18, 22 and 24, Hao teaches a method of treating pulmonary inflammation (an airway inflammation as evidenced by Anthes, see [0011]) comprising the administration of a composition comprising the compound MLN4924, to a subject suffering from pulmonary inflammation (Male C57Bl/6 mice model of pulmonary inflammation). (See title; abstract; page L1071, left column, first sentence of second paragraph, Under Methods after animals and animal procedures; page L1077, left column, first and second sentences; and page L1078, right column, first sentence of second paragraph).
The prior art is silent regarding MLN4924 being an inhibitor of NLRP1 inflammasome activity. However, “inhibitor of NLRP1 inflammasome activity” is an inherent property of the compound MLN4924 as evidenced by the specification (see for example, page 2, first paragraph under Summary of the Invention, and page 3, lines 17-20).
MPEP 2112 I recites: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112 III recites: “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim, but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102/103 rejection. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102/103 rejection is appropriate for these types of claims as well as for composition claims.”
The prior art is also silent regarding pulmonary inflammation (I.e. an airway inflammation) being triggered by Enterovirus 3C protease-activated NLRP1, wherein the 3C protease is from a virus species selected from the group consisting of HEV-A, HEV-B, HEV-C, HEV-D, HRV-A, HRV-B and HRV-C (see claims 17-18).
However, it seems like “pulmonary inflammation” is the same regardless of what triggered the disease. The prior art does not make distinctions, when treating pulmonary inflammation, among the different origins or causes of the disease.
Apparently, Applicant discovered a new mechanism of action that causes or triggers pulmonary inflammation (Enterovirus 3C protease-activated NLRP1).
The office does not have the facilities and resources to provide the factual evidence needed to establish that the “pulmonary inflammation disease” disclosed by Han does not possess the same material, structural and functional characteristics of the “pulmonary inflammation” claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that “pulmonary inflammation” in the claimed method is different from the “pulmonary inflammation” taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
The statement in claim 19: “wherein said compound (MLN4924) inhibits N-glycine decron pathway ubiquitination and degradation of NLRP1 cleavage products”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating pulmonary inflammation comprising administering to a subject in need thereof a composition comprising the compound MLN4924".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “said compound (MLN4924) inhibits N-glycine decron pathway ubiquitination and degradation of NLRP1 cleavage products” appears to be the result of the process anticipated by the prior art: “a method of treating pulmonary inflammation comprising administering to a subject in need thereof a composition comprising the compound MLN4924", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 20, Hao teaches that the compound MLN4924 inhibits cullin (see page L1078, right column, middle of first paragraph).
For claim 21, Hao teaches that the compound MLN4924 is an inhibitor of NEDD8 (see page L10171, left column, first sentence of second paragraph).
The statement in claim 23: “wherein a subject administered said prophylaxis or treatment will have reduced IL-1 secretion, ASC oligomerization and/or lytic cell death in the airway compared to untreated subject”, does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating pulmonary inflammation comprising administering to a subject in need thereof a composition comprising the compound MLN4924".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein a subject administered said prophylaxis or treatment will have reduced IL-1 secretion, ASC oligomerization and/or lytic cell death in the airway compared to untreated subject” appears to be the result of the process anticipated by the prior art: “a method of treating pulmonary inflammation comprising administering to a subject in need thereof a composition comprising the compound MLN4924", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Examiner’s response:
First, the fact that Hao teaches a different mechanism of action (IL-17A-mediated) than Applicant (enterovirus-triggered) is irrelevant, because apparently both: Hao and the instant claims are treating the same disease: pulmonary inflammation (an airway inflammation). The fact that Applicant discovered a new mechanism of action of a treatment previously disclosed in the prior art is not justification for allowance.
Apparently, Applicant has discovered a new mechanism of action (enterovirus-triggered) of a known invention (administering MLN4924 to a subject suffering from airway inflammation). The explanation of an effect or mechanism of action obtained when using a compound, cannot confer novelty on a known process (administering MLN4924 to a subject suffering from airway inflammation) if the skilled artisan was already aware of the occurrence of the desired therapeutic effect. Though new properties of a compound or their mechanism of action are no doubt important contributions to scientific and pharmaceutical development, the assessment of patentability is based upon the therapeutic applications and effects of the compounds, not the mechanism or properties by which they exert such a therapeutic effect.
MPEP 2145 states: “Mere recognition of latent properties in the prior art does not render non-obvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991)”.
Second, Applicant states:
“The present claims pertain to the use of MLN4924 to treat enterovirus-triggered
inflammasome activation in human airway epithelial cells, which do not express IL-17A.”
The instant claims recite a “subject” without specifying that the subject is human.
Double Patenting (Maintained Rejection).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 17-24 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 1-2 of copending Application No.18/547,670 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications recite the treatment of airway inflammatory diseases comprising the administration of a composition comprising a compound like MLN4924. The specification teaches that airway inflammation is considered an inflammatory pathology triggered by ribosome stalling and/or ribosome collisions (see page 3, first paragraph and page 15, line 28 through page 16, line 2).
MPEP 804 II. B. 1 states:
“The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
April 29, 2026.
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