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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/03/2026 has been entered.
The Amendment filed 05/26/2026, amended claim 12, cancelled claims 19-20, and amended claims 25.
Claims 12-17 and 25 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s deletion of claims 19-20 is sufficient to overcome these objections.
35 U.S.C. § 112(b)
Applicant’s deletion of claim 19 is sufficient to overcome this rejection.
35 U.S.C. § 112(d)
Applicant’s deletion of claim 20 is sufficient to overcome this rejection.
35 U.S.C. § 112(a)
Applicant’s amendment to independent claim 12 that adds the structure of the AKR1A1 inhibitor, in combination with the Declaration showing species of the compounds with an AKR1A1 inhibition IC50 ≤100nm, is sufficient to overcome this rejection.
The Declaration under 37 CFR 1.132 filed 05/26/2026, in combination with the amendment to independent claim 12, is sufficient to overcome the rejection of claims 12-17 and 19-20 based upon 35 USC 112(a), Written Description.
35 U.S.C. § 103
Applicant’s amendment to independent claim 12 that adds the imirestat analogue structure is sufficient to overcome this rejection as there is not sufficient motivation to particularly select an AKRA1A inhibitor of the structure of instant claim 12 that has an IC50 ≤ 100nm or to particularly select treating subjects having or at risk of elevated serum cholesterol levels as the disease/condition that requires raising SNO levels.
REJECTIONS-Maintained, Modified, & New
Applicant’s amendment to independent claim 12 has resulted in the below new and modified rejections.
Claim Objections
(New) Claim 12 is objected to because of the following informalities:
In claim 12, line 12, the term “or” between the terms “atoms” and “heterocyclyl,” should be deleted.
Appropriate correction is required.
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.
(New) Claim 25 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.
Claim 25 is indefinite because it depends from a deleted base claim. If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. MPEP 608.01(n).
In view of compact prosecution, and for the purpose of applying prior art, claim 25 is interpreted as depending from claim 12.
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.
(New) Claim 25 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.
Note: See the interpretation of claim 25 in the above 35 USC 112(b) rejection.
Claim 25 is interpreted as depending from claim 12, which recites the following generic compound:
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. As such, the recitation of compound
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, in claim 25, is outside the scope of
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, thereby failing to further limit this compound.
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.
(New) Claims 12-13, 16-17 and 25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 83/03543 to York (published 1983, PTO-892).
York teaches a method for treating diabetic complications in mammals by administering an effective amount of
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and
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, compounds of instant claim 25 (pgs. 50-53, claims 1, 7-8), wherein diabetic patients are at risk of elevated serum cholesterol levels (see instant claim 13 and [00103] of the instant specification).
York exemplifies 4mg/kg and 8mg/kg doses (pgs. 34-35).
While York does not teach “an amount effective to reduce serum cholesterol and PCSK9 levels in the subject,” York exemplifies administration of 4mg/kg and 8 mg/kg doses, and the instant specification teaches 1pg/kg to 10 g/kg doses as effective amounts ([00235]), thereby meeting this limitation.
Since
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and
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, are instantly claimed AKR1A1 inhibitors of the instant claims, i.e., claim 25, they would necessarily have an AKR1A1 IC50 ≤ 100nm.
Regarding the imirestat analogue in claim 12,
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, meets these limitations when instant R2-R4 and R6-R7 are H, and R5 is F.
Regarding claim 13, since York teaches treating patients with diabetes, it is patients with either type I or type II diabetes.
While York does not explicitly teach the functional limitations of claims 16-17, it is reasonable to assume that the method of York would have the same properties since it administers the same AKR1A1 inhibitors of instant claim 25 to the same patient population (diabetic patients, wherein the instant specification defines diabetes as a “cholesterol related disorder ([00103]), in the same dosage amounts (York teaches 4mg/kg and 8/mg/kg, and the instant specification teaches 1pg/kg-10g/kg [0235]), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those 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).
Regarding claim 25, York teaches
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and
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.
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.
(New) Claims 12-17 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over WO 83/03543 to York (published 1983, PTO-892) in view of Armstrong (ADA Releases Standards of Medical Care for Patients with Diabetes, American Family Physician, published 2006, PTO-892)
York is applied to claims 12-13, 16-17 and 25 as discussed above.
York differs from that of instant claims 14-15 in that it does not teach the LDL cholesterol level of its diabetic subjects.
Armstrong teaches that adult patients with diabetes should be tested for lipid disorder annually. Armstrong teaches that in patients with overt cardiovascular disease, the primary goal is a LDL cholesterol level of less than 100mg/dL and that for patients older than 40 years, statin therapy is recommended to achieve an LDL reduction of 30 to 40% (pgs. 5-6; pgs. 6-7, Table 3).
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 subjects with LDL cholesterol levels of at least about 70mg/dL, to arrive at instant claim 14. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-York teaches its subjects as diabetic, and
-Armstrong teaches diabetic patients as having a goal of LDL cholesterol less than 100mg/dL due to risk of cardiovascular disease.
As such, an ordinary skilled artisan would reasonably expect a diabetic patient to have an LDL-C of at least about 70 mg/dL.
While the combination of York and Armstrong does not teach the functional limitations of claim 15, it is reasonable to assume that the method of York would have the same properties since it administers the same AKR1A1 inhibitors of instant claim 25 to the same patient population (diabetic patients, wherein the instant specification defines diabetes as a “cholesterol related disorder ([00103]), a patient population known to be as risk of cardiovascular disease as taught by Armstrong, in the same dosage amounts (York teaches 4mg/kg and 8/mg/kg, and the instant specification teaches 1pg/kg-10g/kg [0235]), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach the properties of claim 15, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those 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).
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.
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, 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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