DETAILED ACTION
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 .
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.
Current Status of 17/421,980
This Office Action is responsive to the amended claims and arguments received 8 October 2025.
Claims 10, 36-37, and 46-63 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 1-3, 10-12, 14-15, 17-18, 20, 23, 26, 29-30, 32-33, and 35-37 in the reply filed on 18 March 2025 is acknowledged.
Applicant has also elected the following species:
A species of formula (I) of claim 1, being the fourth compound of original claim 14, shown below:
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The elected group and species have been determined to read on claims 10 and 36-37.
Claims 46-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A search for Applicant’s elected species did not retrieve applicable prior art or double patent art. The search was expanded only as necessary to arrive at the references and rejections below. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2020/13317 (filed 13 January 2020), 62/791,252 (filed 11 January 2019), and 62/884,529 (filed 8 August 2019) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Response to Amendments
The objections to the drawings, present in the previous office action, are hereby partially withdrawn due to the replacement drawing sheets.
The objections to the specification, present in the previous office action, are hereby withdrawn due to Applicant’s arguments, but new objections are made herein.
The objections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s cancellation of the relevant claims.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments and Applicant’s cancellation of some claims.
The 35 U.S.C. 102(a)(1) rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are made herein, as necessitated by Applicant’s amendments.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are made herein, as necessitated by Applicant’s amendments.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application for the following reasons: Portions of Figures 2, 5, 7, 10-13, 15, 23, 26, 28-30, 32, 36-37, 41-44, 46, 51-52, 66-67, and 70 contain text that is too small and/or low resolution to be legible. Many of the figures now contain text that is large, but still illegible, most likely meaning that the images do not have sufficient resolution. Applicant may choose to remove text that is illegible if Applicant does not have access to sufficiently high-resolution images.
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The abstract contains, what appears to be, a typographical error. It contains the phrase “compound sand”, which is probably intended to read “compounds and”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 10 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
MIEVILLE (US 4,072,705, Date of Patent 7 February 1978).
MIEVILLE teaches compounds, and preparations thereof, useful as hypolipaemiants (abstract); in other words, they are useful for the treatment of hyperlipaemia (Col. 4, Ln. 9-15). Table 1 of MIEVILLE, in columns 23-24 therein, teaches compound A-6, which is shown below. MIEVILLE also teaches pharmaceutical compositions of the compounds therein for the treatment of hyperlipaemia, wherein the compositions contain a physiologically acceptable excipient (Col. 4, Ln. 9-15).
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Compound A-6 of MIEVILLE is identical to compound PP9, which is claimed within instant claim 10.
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.
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 10 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over:
MIEVILLE (US 4,072,705, Date of Patent 7 February 1978)
in view of:
DESAI (US 6,749,868, Date of Patent 15 June 2004).
Regarding claim 37: Teachings of MIEVILLE are described in the first 35 USC 102 rejection above. MIEVILLE does not teach albumin as being present in compositions with the molecules taught therein.
DESAI teaches method and compositions to deliver molecules with low water solubility using a protein as a stabilizing agent (abstract). DESAI teaches that the invention therein provides a drug delivery system, wherein the pharmacological agent is bound to a protein such as human serum albumin (Col. 6, Ln. 20-24). DESAI teaches a list of classes of drugs, and specific examples within those classes, that the authors determined would benefit from being part of the protein-stabilized compositions taught therein (Col. 15-18). DESAI teaches hypolipidemic agents (synonymous with hypolipaemic) within that list, and gives several specific examples that include clofibrate. Clofibrate is drawn below, and is similar in structure to the compound shown to be taught by MIEVILLE above.
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It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to combine the stabilizing effect of the albumin compositions taught by DESAI with the “hypolipaemic” drug of MIEVILLE, for the purpose of increasing the stability of drug of MIEVILLE in pharmaceutical compositions. One of ordinary skill in the art would have expected success in this combination, because DESAI specifically states that hypolipidemic agents may be incorporated into the compositions therein.
Conclusions
No claims are currently allowable.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 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, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625