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 September 4, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group II (Claims 17-24) in the reply filed on September 4, 2025, is acknowledged.
Applicant further election of compound MLN4924 as the NLPR1 inflammasome inhibitor is also acknowledged.
Status of Claims
Claims 1-9 and 17-24 are currently pending and are the subject of this office action.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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.
Priority
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Claim Objections
Claims 17-24 are objected to because of the following informalities: Claims 17-24 depend on claim 1 which is non-elected (withdrawn). Appropriate correction is required.
For this examination, the limitation of claim 1 (inhibitor of NLPR1 inflammasome activity) is being incorporated into claims 17-24.
Claim Rejections - 35 USC § 112
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 17-24 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 17-24 recite: “airway inflammation and/or related complications”.
However, neither the prior art nor the instant specification discloses which diseases can be considered as “airway inflammation related complications”. The specification on page 28 lists a couple of diseases: asthma and COPD, but it is not clear if these diseases are considered as “airway inflammation related complications”.
Can for example: asthma, COPD and pulmonary inflammation be considered “airway inflammation related complications”?
The metes and bounds of the instant claims are not clearly defined.
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.
Claims 17-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of airway inflammation, does not reasonably provide enablement for the prevention (prophylaxis) of airway inflammation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 17-24 recite:
A method of prophylaxis (prophylaxis is synonym of prevention) or treatment of airway inflammation comprising the administration of a composition comprising an inhibitor of NLRP1 inflammasome activation.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
First, the term prevention is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of an airway inflammation do not yet suffer from airway inflammation, and if they were to be administer an inhibitor of NLRP1 inflammasome activation according to the instant claims, they will never ever suffer from airway inflammation. The general knowledge of the prior art clearly indicates that the art of preventing any diseases including airway inflammation, is highly unpredictable.
Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of airway inflammation with any drug.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure.
The instant claims recite a broad spectrum of diseases like airway inflammation diseases.
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification teaches some examples (see Examples 1-6) that correlate the administration of an inhibitor of NLRP1 inflammasome activation with the treatment of airway inflammation.
Thus, while the specification provides a procedure for treating airway inflammation, the specification appears to be silent on a nexus between:
treating airway inflammation and preventing airway inflammation
As such, if there is no correlation then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the prevention (100% success) of airway inflammation, is required for practice of the claimed invention.
6. The Quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 5), the skilled in the art will not accept that the administration of a composition a compound an inhibitor of NLRP1 inflammasome activation can prevent (100% success) airway inflammation as inferred by the claims and contemplated by the specification.
7. Conclusion
Accordingly, the inventions of claims 17-24 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
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 (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) 17-23 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).
For claims 17-18 and 22, Hao teaches a method of treating pulmonary inflammation (an airway inflammation as evidenced by Anthes, see [0011], or an airway inflammation related complication (see above 112(b)) 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; 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 states: “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.
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.
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 (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) 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), in view of Bastin et. al. (Organic Process Research and Development (2000) 4:427-435).
Hao teaches all the limitations of claim 24 (see 102(a)(1) above), except for the compound MLN4924 being in the form of a HCl salt.
However, Bastin teaches that making salts of known organic compounds and in particular HCl salts is routine practice in the pharmaceutical art (see title, abstract and Table 1), thus resulting in the practice of claim 24 with a reasonable expectation of success.
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 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 are 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.
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.
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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.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
September 19, 2025.