DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Response to Restriction Requirement filed 7/21/2026.
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 .
Status of the Claims
Claims 10-16 have been amended. No claims were cancelled or newly added. Accordingly, claims 1-16 remain pending in the application.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to the composition in the reply filed on 7/21/2026 is acknowledged.
Applicant remarks are acknowledged that amended claims 10 and 16 depend on an elected claim, however, due to the claim amendments Group II now includes claims 10-14 and is drawn to a method of making and Group III (claim 16) is drawn to a method of using. The Restriction Requirement dated 6/9/2026 is still applicable to the claims as amended for the reasons of record.
Claims 10-14 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
Accordingly, claims 1-9 and 15 are currently under examination.
Information Disclosure Statement
The IDS dated 2/20/2025 has been considered. A signed copy is enclosed herewith.
Claim Objections
Claims 1-3 and 6 are objected to because of the following informalities: said claims recite the terms “Quercetin” and/or “Poloxamer”. Said terms should be in lowercase form. Appropriate correction is required.
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 1-9 and 15 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 1-3 include periods in the middle of the claim (i.e., a., b., c., d.). MPEP 608.01(m) states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations”. The claims are indefinite because it is unclear whether the language following the periods further limits the claimed invention.
Dependent claims 4-9 and 15 do not remedy the indefinite issue and as such said dependent claims suffer from the same deficiency.
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.
Claims 1-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ding et al. (CN 106137981 A, Nov. 23, 2016, machine translation, hereafter as “Ding”) in view of Bhargava et al. (IN 202011046762 A, Nov. 6, 2020; hereafter as “Bhargava”) and Birbara (WO 2011/049629 A2, Apr. 28, 2011, hereafter as “Birbara”).
The instant claims are drawn to a pharmaceutical composition of quercetin nanosuspension comprising: quercetin dihydrate, about 0.1% w/w to 10% w/w of poloxamer, about 0.1% w/w to 10% w/w of polyvinyl pyrrolidone, and about 0.1% w/w to 10% w/w of polyethylene glycol.
Regarding instant claims 1-3, Ding teaches a nanosuspension composition comprising dabigatran etexilate (a poorly water-soluble active agent) and one or more stabilizing agents including sodium dodecyl sulfate, poloxamer, polyvinylpyrrolidone K30, lecithin, polyethylene glycol, Tween 80 and one kind of or the combination of more than two, the dosage thereof is 0.1 - 2% % (w/v) (abstract; page 3, 2nd para.; page 5, 1st para.).
Ding is silent to an embodiment combining a poloxamer, polyvinyl pyrrolidone and polyethylene glycol, however Ding teaches each of the aforementioned in a finite group of suitable stabilizing agents as well as “combinations”. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the particular stabilizing agents, a poloxamer, polyvinyl pyrrolidone and polyethylene glycol with a reasonable expectation of success because Ding teaches each stabilizing agent in a finite group (and combinations thereof) as suitable stabilizing agents for the purpose of stabilizing a nanosuspension formulation.
Ding is silent to quercetin dihydrate.
Bhargava teaches quercetin nanosuspension formulations comprising quercetin and surfactants, sodium lauryl sulfate and polyvinyl pyrrolidone for the purpose of improving aqueous solubility of quercetin ([0021]-[0022]; Table 1).
Birbara teaches compositions comprising flavonoids including nanosuspension formulations (abstract; page 21, last para.). Birbara teaches the particular flavonoid, quercetin (page 4, last para.). Birbara teaches that quercetin forms a dihydrate and is a poorly water-soluble active agent (paragraph bridging pages 8-9; page 76, last para.). Birbara also teaches the inclusion of poloxamers, polyethylene glycol and polyvinyl pyrrolidone (page 31, 1st para.; page 34, 3rd para.; page 46).
The references are all drawn to nanosuspension formulations, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute quercetin dihydrate for dabigatran etexilate in Ding, as suggested by Bhargava/Birbara, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that quercetin dihydrate and dabigatran etexilate are both known as poorly water-soluble active agents, nanosuspensions, in general, and quercetin nanosuspensions, in particular, are known to improve water solubility, and substituting one poorly water-soluble active agent for another in a known nanosuspension formulation for the purpose of improving the solubility of the active agent is prima facie obvious. MPEP 2144.06(II). One of ordinary skill would have reasonably expected a nanosuspension comprising quercetin dihydrate with improved solubility.
Regarding instant claim 4, The references teach the elements discussed above. Birbara further teaches that the microparticulate flavonoid (e.g., quercetin) has an average (particle) size of 200-500 nanometers, or advantageously an average size of 250 nanometers (page 9, 1st para.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to include a particle size below 400 nanometers, as suggested by Birbara, with a reasonable expectation of success because Birbara teaches an overlapping particle size of 200-500 nm (MPEP 2144.05(I)) and, preferably, 250 nm is a suitable particle size for quercetin in a nanosuspension formulation.
Regarding instant claim 5, Ding further does not teach nor require cellulosic polymers.
Regarding instant claim 6, The references teach the elements discussed above. Bhargava further teaches a composition comprising 125 mg of quercetin (4th para.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to include quercetin in an amount of 125 mg, as suggested by Bhargava, with a reasonable expectation of success because Bhargava teaches quercetin in an amount of 125 mg is a suitable amount of quercetin in a nanosuspension formulation.
Regarding instant claim 7, Ding further teaches the particular poloxamer, poloxamer F68 which is also known as P-188 (Example 3).
Regarding instant claim 8, Ding, as discussed above, teaches the particular polyvinylpyrrolidone, polyvinylpyrrolidone K30 (PVP K30) (page 5, 1st para.).
Regarding instant claim 9, Ding further teaches the particular polyethylene glycol, polyethylene glycol 400 (PEG 400) (Example 5).
Regarding instant claim 15, Ding further teaches the inclusion of freeze-dried supporting agents including glucose, sucrose and lactose (cryoprotectants) (page 5, 2nd para.).
Thus, the combined teachings of Ding, Bhargava and Birbara render the instant claims prima facie obvious.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 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, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASEY S HAGOPIAN/Examiner, Art Unit 1617
