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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Response to Amendment
The Amendment filed 10/13/2025 has been entered. Applicant’s amendments are in response to in the Final Office Action mailed 07/14/2025. Applicant’s claims under examination are generally unchanged compared to the previously examined claims 1-10, thus, the thrust of the previous rejection is maintained, and new claim 26 (further limiting the compound amount to “at least 5%” by weight”) has been entered to draw a new ground of rejection. Further clarification of portions of the references is provided, in response to Applicant’s arguments.
The Examiner further acknowledges the following:
Claims 1-10 and 18-26 are pending.
Claims 18-25 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-10 and 26 are presented for examination and rejected as set forth below.
New 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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Pongsamart (International Journal of Pharmaceutics, 2016), as evidenced by Lefevre (US 2022/0409546 A1) and Bajaj (Journal of Applied Pharmaceutical Science, 2012).
Applicant’s claims are directed to an encapsulated composition comprising a poorly water-soluble compound, an oil, and an octenylsuccinic anhydride (GSA) modified starch, wherein the weight ratio of starch to oil within the composition is 1:1 or less, and wherein the poorly water-soluble compound comprises at least 3% by weight of the encapsulated composition. Dependent claim 26 has been added that further narrows the weight range of claim to being at least 5% by weight of the encapsulated composition (i.e., 5-100 wt%). Note the Examiner shifts from fenofibrate to FF throughout, for no particular reason.
Pongsamart teaches a dry emulsion and dry suspension composition comprising octenyl succinic anhydride starch as an emulsifying agent, an oil, and fenofibrate (FF) (abstract). Pongsamart is interested in emulsified formulations to increase oral bioavailability of poorly water-soluble drugs through improvement of dissolution behavior (pg 353, conclusion).
Regarding claim 1-4: Pongsamart teaches a dry emulsion (DE) composition comprising fenofibrate (described as poorly water soluble on pg 348, paragraph 1), octenyl succinic anhydride (OSA) starch, and oil (pg 348, Table 1). The fenofibrate is shown in embodiment DE-B to be 2.6 wt% (pg 349, 2.7 Compression of tablets), which is close enough to 3 wt% (a 15% difference). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (see MPEP 2144.05 (I)). See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (indicating that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close). Specifically, the concentration of component compositions claimed by the appellees in Titanium Metals differed from the values disclosed by the prior art by as much as 17% of the claimed values, and in the absence of evidence tending to establish different results were achieved by such a miniscule difference in concentrations, were upheld to be obvious permutations of the art disclosed. Id.
Furthermore, Pongsamart teaches dissolving fenofibrate into Miglyol (oil) near the saturation point at 7.5 wt% (pg 350, col 1) which is similar to results demonstrated in the instant Specification in Table 1 (pg 8-9). Note Pongsamart does compare oil solubilities and teaches that oils with higher solubility of fenofibrate lead to formulations containing higher fenofibrate (pg 350, col 1-2). Also, Pongsamart teaches the content of fenofibrate in the DEs are comparable to fenofibrate amount added to the formulation (pg 350, col 2). Pongsamart teaches: “it was found that the content of FF in DEs analyzed by HPLC method was comparable to FF amount added to the formulation” (paragraph 6, pg 350), which directly instructs a PHOSITA that if you want to make a final formulation with more FF, then a PHOSITA would add more FF dissolved in oil during the process of making.
The composition of formulation I demonstrates a starch to oil weight ratio in is 1:2.5 (pg 348, Table 1), in which fenofibrate could be added to advance it to the final composition (pg 348, 2.3 Preparation of dry emulsion and dry suspension). Dry emulsions (DE) are taught to be encapsulated (pg 347, paragraph 2). Since Pongsamart teaches a dry emulsion, it would be prima facie obvious to encapsulate it. Finally, Pongsamart teaches supersaturation of fenofibrate (pg 348, ‘2.3 preparation of dry emulsion and suspension; pg 350 paragraph 1) demonstrate a desirability to achieve higher concentrations of fenofibrate compositions.
Regarding claims 5-6: Pongsamart teaches the oil to be castor oil, peanut oil, olive oil, or soybean oil (pg 348, 2.1 Materials).
Regarding claim 7: Pongsamart teaches the octenyl succinic anhydride starch to be Cleargum CO 03 (pg 348, 2.1 Materials), which is a waxy maize starch, as evidenced by Lefevre ([0066], Table 1).
Regarding claim 8: Pongsamart teaches that fenofibrate is amorphous in the spray-dried powders (pg 351, paragraph 3).
Regarding claim 9: Pongsamart teaches a median particle size of d(v,0.5) to range from 13.3-19.2 um for the dried emulsions and dried suspensions (pg 351, Table 3), although the mean (average) particle size is not taught. However, Pongsamart teaches that the small and spherical particles (or the size and shape of the particle) will help improve the dispersion and dissolution in the water after reconstitution (pg 350, 3.2 Preparation of dry emulsion and dry suspension). Thus, mean particle size is a result effective parameter that a person of ordinary skill in the art would routinely optimize in order preserve dispersion and dissolution properties during reconstitution by maintaining a small particle. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation). Furthermore, The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claim 10: Pongsamart teaches that fenofibrate in embodiment DE-B was stable at 40 °C for 2 months (pg 353, 3.7 stability study). As evidenced by Bajaj (pg 131, accelerated stability testing), the higher temperature accelerated stability testing conditions provide more stress to the drug product to accelerate degradation compared to lower temperature conditions. Thus, the stability of the composition at the claimed conditions (25°C for 1 month) is expected based on the accelerated stability data of Pongsamart.
Thus, the instant composition claimed appears to be little more than the selection of art-known elements according to their known utility taught from within a single prior art reference, teaching the desirability of selecting such components, and obvious thereby, that the instant invention is obvious.
Claims 1-10 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Pongsamart (International Journal of Pharmaceutics, 2016), as evidenced by Lefevre (US 2022/0409546 A1) and Bajaj (Journal of Applied Pharmaceutical Science, 2012), as applied to claims 1-10 above, and in further view of Gue (J. Drug Del. Sci. Tech., 2014) and Ahmed (European Journal of Pharmaceutical Sciences, 2007).
As discussed above, Pongsamart teaches the claim composition comprising poorly water-soluble compound (fenofibrate), an oil and OSA-modified starch. Pongsamart teaches a correlation in the content of fenofibrate in DEs is comparable to fenofibrate amount added to the formulation (pg 350, col 2). However, Pongsamart does not explicitly teach the compound to be more than 5 wt% in the composition (instant claims 1 and 26).
Gue teaches fenofibrate spray-dried microparticles with interest in accelerating drug dissolution and increasing apparent drug solubility by then affording supersaturated solutions that are sufficiently stable for drug delivery (pg 185, paragraph 2). Gue teaches drug loadings of 10 wt% and 30 wt%, as suitable concentrations of fenofibrate for drug delivery via supersaturation mechanisms (abstract).
Ahmed teaches lyophilized dry emulsions (LDE), as a technology to enhance dissolution and bioavailability (abstract), among other techniques, including spray-dried emulsions (pg 59, paragraph 2) based on Miglyol oil. Ahmed teaches griseofulvin (GF) 47 wt% LDE tablet compositions of (Table 1 - 125 mg/268 mg), in which GF is a poorly-soluble active ingredient (pg 58, paragraph 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pongsamart’s invention to produce a higher loading of drug (e.g., up to 30 wt% fenofibrate) in the final composition because Gue demonstrated loadings of 10 and 30 wt% fenofibrate spray-dried pharmaceutical compositions with the goal of improving drug dissolution of poorly soluble compounds, Ahmed achieved 47 wt% GF loading in dry emulsion formulations, and Pongsamart has demonstrated an interest in improving dissolution of poorly soluble drugs for effective drug delivery. Additionally, it is seen as desirable to increase the amount of delivered dose of a drug to the desired site of action for therapeutic effect, especially for poorly soluble drugs that have poor bioavailability, as taught by Gue (pg 185, abstract, paragraphs 1 and 2) and Ahmed (pg 58, introduction). One way to accomplish this is to formulate a higher concentration into the administered dose, as demonstrated by the >10 wt% concentrations formulated by Gue and Ahmed. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).
Response to Arguments
Applicants arguments, see pg 5-8, filed 10/13/2025, with respect to the 103 rejection of claims 1-10 under rejection have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set and new added claims.
On page 5, Applicant argues against the language used in the Office Action “in which fenofibrate could be added to advance it to the final composition.” The Examiner points to teachings of Pongsamart as rebuttal: Pongsamart teaches “it was found that the content of FF in DEs analyzed by HPLC method was comparable to FF amount added to the formulation” (paragraph 6, pg 350), which directly instructs a PHOSITA that if you want to make a final formulation with more FF, then add more FF dissolved in oil during the process. There is no evidence in the Prior Art suggesting that incorporation of higher amounts of fenofibrate would provide non-functional formulations within the teachings of Pongsamart. Pongsamart teaches the desirability maximum delivery of drug to the site of action (i.e., bioavailability) (pg 347, ‘introduction’) and increasing the dosage strength is one way to accomplish this. Thus, incorporation of higher amounts of FF is obvious (to increase therapeutic dose) and leads to the expected result of a higher loaded FF formulation, as taught by Pongsamart. Furthermore, Gue teaches drug loadings of 10 wt% and 30 wt%, as suitable concentrations of fenofibrate for drug delivery via supersaturation mechanisms (abstract), where Gue is interested in improving drug release rates of fenofibrate formulations (pg 185, paragraph 3).
On page 5-6, Applicant argues that the limitations of weight ratio of starch to oil and at least 3 wt% compound are not considered together. Note that Pongsamart teaches both elements (2.6 wt% fenofibrate, which is close enough to 3 wt%) and the starch to oil ratio in the same disclosure. In an obviousness rejection, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Because Pongsamart progressed formulations B, C, D, and H to make dry emulsions does not invalidate Formulations A-P (Table 1). There is no statement in Pongsamart stating Formulation I is unstable and unsatisfactory. The fact of the matter is that Formulations A-P are all taught as potential candidates for dry emulsion formation. Furthermore, even when an embodiment is considered inferior: Art is art for all that it teaches, not just specific or preferred embodiments. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Thus, just because Pongsamart did not select Formulation I to further advance to an example formulation in the publication, based on their own particular criteria, does not mean Formulation I would not be used by a PHOSITA using different criteria and seeking different results.
On page 6, Applicant makes an argument that Formulation I (as relied on by the Examiner) is not a desirable modification of Pongsamart because it forms an unstable emulsion (i.e., Pongsamart describes stable emulsions as showing “no phase separation at least 2 h after the preparation”). For non-preferred embodiments note that: Art is art for all that it teaches, not just specific or preferred embodiments. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” Furthermore, the listing of formulations B, C, D, and H in Table 2 as stable emulsions does not mean the remaining formulations A-P in Table 1 are unstable (e.g., from a PHOSITA POV, formulations A, E-G, and I-L are very similar to formulations B-D and H in terms of ingredient amounts and would be expected to have similar stabilty properties). Thus, just because formulations A, E-G, and I-L were was not advanced to drug-loaded examples does not mean they represent unstable formulations. Pongsamart makes no direct statement related to the instability of Formulation I.
Furthermore, even if the alternate formulations of Table 1 were considered inferior: A known or obvious invention does not become patentable simply because it has been described as somewhat inferior to some alternative for the same use. In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994). Indeed, “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine. Medichem, SA v. Rolabo, SL, 437 F.3d 1157, 1165 (Fed. Cir. 2006). Additionally, stability is a relative measurable property, and varying degrees of stability can be still useful for drug delivery formulations.
On page 6, Applicant concludes by saying Pongsamart actually teaches that the claimed composition is not achievable due to the lack of emulsion stability when the starch to oil ratio is 1:1 or less because there is a lack of emulsion stability. These statements are not linked with appropriate evidentiary citations within Pongsamart and appear per se. Furthermore, Pongsamart does not directly criticize the emulsion formulations A-P of Table 1. In order to teach away from a proposed modification, the art must “criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The art does not criticize, discredit, or otherwise discourage the modification proposed by the Examiner. Thus, formulations A-P (pg 348, Table 1) could be used as vehicles to further add fenofibrate because they are not directly criticized by Pongsamart.
As far as a reasonable expectation of success of adding increasing amounts of fenofibrate to formulations A-P (pg 348, Table 1): “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Thus, it would be obvious to increase the amount of fenofibrate to increase the dose delivered to the body.
On page 6-7, Applicant argues against Gue and Ahmed, suggesting Gue does not instruct how to modify Pongsamart to achieve increased drug loadings, and similarly with Ahmed, and that both do not instruct how to increase the fenofibrate loading. Note that in an obviousness analysis, the secondary references are not required to bodily incorporate into the other reference: Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. At 420, 82 USPQ2d 1397. Furthermore, the Examiner has not asserted that Gue and Ahmed teach this; these references have been relied on to address the motivation to increase the amount of poorly soluble drug (e.g., fenofibrate) loaded into oral drug delivery formulations.
Furthermore, both references are analogous to the instant invention. Gue teaches fenofibrate spray-dried microparticles with interest in accelerating drug dissolution and increasing apparent drug solubility. Ahmed teaches lyophilized dry emulsions (LDE), as a technology to enhance dissolution and bioavailability (abstract), among other techniques, including spray-dried emulsions (pg 59, paragraph 2) based on Miglyol oil. Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). Both of these drug delivery technologies are from the same field of endeavor and reasonably pertinent to the particular problem.
While Applicant disputes the very specific formulation differences of Gue and Ahmed with the instant invention, the Examiner only employs Gue and Ahmed to demonstrate the obviousness of incorporation larger amounts of fenofibrate/poorly-soluble drugs through novel formulations. The secondary references need not have all elements of the instant invention: All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). As to Gue not using an emulsion, the main relevance of Gue is that of a high concentration spray-dried microparticle drug formulation. As to Ahmed using gelatin and not starch, the main relevance of Ahmed is that of lyophilized dry emulsions (LDE), as a technology to enhance dissolution and bioavailability (abstract) for high concentrations of poorly-soluble active ingredients (pg 58, paragraph 1).
With respect to the teachings of Gue and Ahmed, the main teaching is that up to 30 wt% fenofibrate is desirable in novel drug formulations intended to improve bioavailability for poorly soluble drugs. Thus, it provides a teaching that higher amounts of fenofibrate should be formulated into Pongsamart’s composition. Whether such an addition leads to a successful formulation, note that “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).” Thus, the increase of fenofibrate up to 30 wt% in Pongsamart’s compositions is obvious. No evidence has been provided to demonstrate no reasonable expectation of success by increasing the fenofibrate active ingredient loading of Pongsamart’s teachings per the teachings of Ahmed and Gue.
On page 7, Applicant reiterates that a prima facie case of obviousness was not achieved, when the Examiner argues otherwise. The 103 rejection provides a rationale demonstrating the obviousness of the claim invention. Furthermore, Applicant has not provided an argument of unexpected results compared to the closes prior art Pongsamart, as a demonstration of non-obviousness. Applicant’s Table 1 (pg 8-9 of the Specification) describes example formulations that appear indistinguishable from examples of Pongsamart’s emulsion formulations in Table 1 (pg 348).
In particular, compare the water/starch/oil ratios: 70:7.5:19.6 (Applicant “Formulation M” in Table 1, representing the highest loading of fenofibrate at 9.7 wt%) compared to 72:8:20 (Pongsamart “Formulation I” in Table 1). Pongsamart dissolves FF in oil at 2.9-7.5% w/w (paragraphs 3-4, pg 350), which is comparable to the 0-3.9% of Table 1 (pg 8-9 of the Specification). Thus, the teachings of Pongsamart heavily overlap with the instant embodiments. The only difference is that the instant Application adds a larger portion of FF in oil amount to achieve a higher drug loading in the final formulation, which is taught as obvious by the Prior Art and leads to the expected result of a FF drug formulation with a concentration of FF.
To further address this point, Pongsamart teaches: “it was found that the content of FF in DEs analyzed by HPLC method was comparable to FF amount added to the formulation” (paragraph 6, pg 350), which directly instructs a PHOSITA that if one wants to make a final formulation with more FF, then a PHOSITA would add more FF dissolved in oil during the process of making.
There is no evidence in the Prior Art suggesting that incorporation of higher amounts of fenofibrate would provide non-functional formulations within the teachings of Pongsamart. Pongsamart teaches the desirability maximum delivery of drug to the site of action (i.e., bioavailability) (pg 347, ‘introduction’) and increasing the dosage strength is one way to accomplish this. Furthermore, Gue teaches drug loadings of 10 wt% and 30 wt%, as suitable concentrations of fenofibrate for drug delivery via supersaturation mechanisms (abstract), where Gue is interested in improving drug release rates of fenofibrate formulations (pg 185, paragraph 3). Thus, incorporation of higher amounts of FF into spray-dried emulsion formulations is obvious, as taught by Pongsamart and Gue, and leads to the expected result of a higher-loaded FF spray-dried emulsion formulation, as taught by Pongsamart. Whether such an addition of more FF leads to a successful formulation, note that “Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).”
On page 8, Applicant discusses the claim amendments, which have been noted in the remarks and in the claim set.
Correspondence
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/R.P./Examiner, Art Unit 1614 1/12/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614