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
Election/Restrictions
The election of Group I in the remarks filed 02/06/2025 is acknowledged.
A follow-up species election requirement was made in a phone call made 02/26/2025 to Attorney John Mickelson. The species election requires one compound represented by the compound of Formula I of claim 14. Applicant elected the compound DCPIB found on p. 19 of the specification, shown below.
Elected Compound
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Status of Claims
Claims currently pending and under examination are claims 1, 13, 18, and 19.
Species under examination are the species represented by the compound of formula I (above).
Drawings
The drawings submitted 07/14/2025 have been accepted. The objection made to the drawings in the office action of 03/12/2025 has been withdrawn.
Claim Rejections - 35 USC § 112(a)
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.
112(a) Scope of Enablement
Claims 1, 13, 18, and 19 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 treatment, does not reasonably provide enablement for prevention. 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.
The following Wands Factors have been considered if not explicitly stated: (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.
Breadth of the claims
Claim 1 recites “A method for treating nonalcoholic fatty liver disease (NAFLD)in a patient in need of such therapy, comprising administering a therapeutically effective amount of a compound of formula I, or a pharmaceutically acceptable salt thereof to the human patient…”
Compound of formula I
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“Treatment” is defined on p. 23, starting line 10. “Treatment” as defined in the specification is “clinical intervention in an attempt to alter the natural course of the individual or cell being treated, and can be performed either for prophylaxis or during the course of clinical pathology. Desirable effect of treatment include one or more of preventing occurrence or recurrence of disease, alleviation of symptoms, diminishment of any direct or indirect pathological consequences of the disease, stabilized (i.e., not worsening) state of disease, decreasing the rate of disease progression, amelioration or palliation of the disease state, prolonging survival as compared to expected survival if not receiving treatment and remission or improved prognosis.” See p. 23, l. 10-22 for complete paragraph.
With the definition disclosed in the specification in mind, “treating” still embraces prophylaxis.
State of the prior art
The elected compound DCPIB and methods of administering DCPIB are known within the art. As discussed in Sah (cited below) p. 10, l. 5-9, DCPIB is known as a VSAC inhibitor. Its status as a SWELL1 modulator is also disclosed in Sah, p. 10, l. 8-9 and exemplified in the instant disclosure Fig. 2E. However, there is little or no discussion in the art that connects DCPIB directly to methods of preventing or treating NAFLD.
Regarding this enablement rejection, “prevention” within the context of NAFLD is not discussed within the instant specification. Prevention of a condition such as NAFLD would require testing prior to the onset of NAFLD that would indicate that a patient is predisposed to developing NAFLD. While the art discusses certain factors that would increase the likelihood of developing NAFLD, the current art is speculative in regards to whether a patient develops NAFLD or not.
Essentially, “preventing” assumes that a patient will develop NAFLD whereas the current state of the art can only make an educated guess as to whether a patient will develop NAFLD.
Working examples and level of predictability
The instant disclosure discusses SWELL1 modulation via SWELL1 knockout (KO) testing. The examples discussed in the instant disclosure (beginning p. 28) do not disclose any methods wherein DCPIB is administered. In fact, the instant specification on p. 37, l. 28 states “The current study provides an initial proof-of-concept for pharmacological induction of SWELL1 signaling using SWELL1 modulators (Smods) to treat metabolic syndrome at multiple homeostatic nodes, including adipose, liver, and pancreatic β-cell. Hence, Smod1 may represent a tool compound from which a novel drug class may be derived to treat both [type 2 diabetes], metabolic syndrome, and associated diseases such as NAFLD, the latter of which currently lacks therapeutic options, and thus represents a significant unmet need.”
The instant specification connects SWELL1 augmentation to treating NAFLD on p. 35, l. 31 – p. 36, l. 27. In this section, it is explicitly stated that administration of the Smod1 (DCPIB) lead to marked reduction in liver weights, hepatic steatosis, and liver triglycerides.
Level of Predictability
In order for one of ordinary skill in the art to practice prophylaxis, one of ordinary skill would require extensive testing to determine which patients would develop NAFLD and which would benefit from practice of the instant method.
It is recommended that applicant amend the claim to specifically exclude “prophylaxis”.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 13, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sah (WO2018027175, of the record) in view of Beaton (Can J. Gastroenterol. Vol. 26, NO. 6, 2012).
In regards to claims 1, 13, and 18-19 Sah teaches DCPIB as a SWELL1 inhibitor on p. 10, l. 5-13. Additionally, on p. 1, l. 33-35, Sah teaches “application of SWELL1 inhibitor DCPIB to cultured adipocytes induced a compensatory increase in SWELL1 protein expression.”
In regards to claim 18, Sah on p. 3, l. 27-29 contemplates SWELL1 associated proteins.
Sah on p. 2, l. 1-5 states “When administered to mice raised on a high-fat diet, DCPIB normalized glucose tolerance associated with obesity. These findings provide an in vivo proof of concept that DCPIB…can induce a compensatory increase in SWELL1 expression, which can positively modulate insulin sensitivity in the context of Type 2 diabetes.”
Sah teaches the administration of DCPIB to affect insulin resistance.
Sah does not teach NAFLD or methods to treat NAFLD. This is addressed by the combination of Beaton.
In regards to claim 1, Beaton on p. 353-354, sec. Insulin sensitizers teaches the administration of insulin sensitizer class thiazolidinediones (TZDs) as effective in treating NAFLD.
Beaton on p. 1, sec. Insulin sensitizers states “[Insulin resistance] is a hallmark of NAFLD; therefore, targeting this pathway has been a major focus on many studies of its therapy.”
Beaton teaches that insulin resistance has been targeted as a point for treating NAFLD and teaches that there is efficacy in increasing insulin sensitivity to treat NAFLD.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have taken the method of Sah and applied it to treating NAFLD with a reasonable assumption of success. One of ordinary skill in the art would have been motivated to make this change as Beaton teaches administration of insulin sensitizers can positively affect (treat) NAFLD.
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 1, 13, 18, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,059,403 in view of Beaton (cited above).
The reference claims are drawn to a method of treating type 2 diabetes comprising administering a compound identical to that claimed in instant claim 14. Reference claims 6 and 7 state “wherein the administering to the patient of the therapeutically effective amount of the SWELL1 modulator increases the patient’s insulin sensitivity” and “wherein the administering to the patient of the therapeutically effective amount of the SWELL1 modulator increases the patient’s insulin secretion” respectively.
Beaton, cited above, on p. 353-354, sec. Insulin sensitizers teaches the administration of insulin sensitizer class thiazolidinediones (TZDs) as effective in treating NAFLD.
As the reference claims are drawn to increasing insulin sensitivity, one of ordinary skill would find the instant claims obvious over the reference claims.
Response to Arguments
Applicant, in their response to both the 103 and double patenting rejection, argues that the instant claims are distinct from the art because the art does not teach TZDs as first line therapy.
Applicant in their remarks states “…after discussing certain limitations of TZDs for treating NAFLD, Beaton specifically teaches that ‘TZDs should be reserved for second-line treatment in the majority of patients.’ As such, Applicant respectfully submits that Beaton does not remedy the deficiencies of Sah…because Beaton does not direct the art worker to select TZDs as a first line of treatment.”
A similar argument is made in regards to the double patenting rejection.
In response to applicant's argument, it is noted that the first line treatment upon which applicant relies is not recited in the rejected claim(s). The claims and the specification do not make a distinction between first line therapy or second line therapy. As such, the 103 and double patenting rejections are maintained.
Conclusion
No claims 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.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624