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 .
Response to Amendment
The Amendment filed 07/27/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 01/27/2026. Applicant’s claims are unchanged from the previous claim set, even in light of the Examiner’s Interview (see Summary filed 06/01/2026), whereby the discussion of the Interview encompassed unexpected results, in relation to the current instant claim scope. An Examiner’s Amendment was considered to expedite prosecution; however, the required changes of scope to instant claims 1 (and/or 18) were considered too large, and inappropriate for the Examiner’s Amendment process (i.e., the Examiner regarded writing feedback and allowing for proper time for consideration of the feedback and the resulting scope-changing amendments, as appropriate). The obviousness rejection is maintained because there were no amendments made.
The following objections/rejections are withdrawn: none.
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Claims 18-25 are withdrawn from consideration as directed to non-elected inventions.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.
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 between fenofibrate and FF, for no particular reason.
Note, Applicant defines “1:1 or less” in the Specification (pg 4): “The weight ratio of starch to oil within the composition is 1:1 or less. Preferably, the weight ratio of the starch to oil is less than 1:1, about 1:1.5, 1:2, 1:2.5, 1:3, 1:3.5, or 1:4. In other embodiments, the weight ratio of starch to oil ranges from about 1:1 to about 1:4, from about 1:1.5 to about 1:3.5, from about 1:2 to about 1:3, or about 1:2.5.”
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
Applicant’s arguments, see pg 5-7, filed 07/27/2026, with respect to the 103 rejection of claims 1-10 and 26 under rejection have been fully considered but they are not persuasive. The 103 rejection remains basically unchanged from the previous rejection, because no amendments were made.
On page 5-7, Applicant argues against the obviousness rejection above, which is addressed below.
From a perspective of obviousness (and in response to Applicant’s arguments against the 103 rejection of the previous Action on pg 5-7), the Examiner notes that the Applicant relies too heavily on the interpretation of Pongsamart alone (i.e., including specific interpretation of Pongsamart’s embodiments). In response (and to repeat previous rebuttals to Applicant’s arguments), the Applicant must consider the following guidance:
Attacking Pongsamart alone (pg 5-7): One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. It appears that the entirety of the argument fails to address the contributions of Gue and Ahmed, except for clerical discussion on pg 5. Gue and Ahmed provided rationale for increasing active ingredient amount (e.g., poorly-soluble actives such as fenofibrate) in pharmaceutical compositions.
Bodily Incorporation (pg 5-7): In additional consideration of the combined Prior Art, 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. Thus, simply put, the combined Art as a whole recognizes the combination of all of Pongsamart’s disclosed formulations (Table 1, pg 348), with 3 wt% or more of fenofibrate found in Gue and Ahmed. Whether or not Pongsamart actually formulated all emulsions with an active agent is irrelevant. Furthermore, Applicant has provided no objective evidence that the formulations of Table 1 could not be combined with any active agent.
Analogous Art (pg 5-7): Regarding Pongsamart, Gue, and Ahmed, 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). All references of the previous 103 are from the same field of endeavor and/or are reasonably pertinent to the instant claim set that is directed to the instant compositions that comprise poorly soluble active agents, oil, and OSA modified starch in low and high concentration active amounts.
Attacking the stability of Pongsamart’s formulations (pg 6): Applicant does not actually claim a stability limitation in claim 1: Limitations are being argued that are not claimed: Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571-72, 7 USPQ2d 1057, 1064-1065 (Fed. Cir.), cert. denied, 488 U.S. 892 (1988) (Various limitations on which appellant relied were not stated in the claims; the specification did not provide evidence indicating these limitations must be read into the claims to give meaning to the disputed terms.); In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims). Thus, the encapsulated composition of instant claim 1 is not required to be an emulsion and/or exhibit any kind of stability, thereby not providing differentiation from Pongsamart alone (i.e., unstable formulations and/or non-emulsions are encompassed by the current instant claim scope).
Attacking Pongsamart’s embodiments (pg 6): Note that specific embodiments do not define the teachings: “Applicants erroneously point to specific embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. 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).” When Applicant states “there would be no reason for Pongsamart to not investigate all stable formulations”, Applicant is making a statement that assumes Pongsamart’s judgement and personality. Although Pongsamart does not publish data on the proposed embodiments, that does not mean they were not considered at Pongsamart’s laboratory.
Impermissible Hindsight (pg 7): As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, “[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971). The Examiner has pointed to nothing other than what the art available at the time the instant application was filed to teach or suggest each and every limitation of the invention claimed, and relied on nothing other than the art to rationalize their combination in the manner you put forth. Simply put, adapting formulations of Pongsamart to incorporate higher concentrations of active ingredient (as framed by instant claim 1) is made obvious to PHOSITA by the combined Prior Art, as discussed above.
From a perspective of unexpected results (see pg 7, the term “surprisingly”), Applicant argues a surprising effect that is not taught by the combined Prior Art. The unexpected effect is achieved by setting the starch to oil ratio to 1:1 or less (in comparison to Pongsamart where there appears to be a limit of amount of solubilized compound to 2.6 wt% based on the starch to oil ratio Pongsamart chose to advance).
In view of an updated search, the Examiner agrees that there may be an unexpected effect present, that relies on a starch to oil ratio of 1:1 or less (i.e., meaning a ratio value of “less than 1” such as 0.74, which corresponds to 1:3.5 of instant claim 2), in comparison to the combined Prior Art (including Pongsamart and Heinze):
Pongsamart does not reasonably teach the claimed unexpected result of the instant claims: Pongsamart teaches embodiment DE-B to contain 2.6 wt% fenofibrate (pg 349, 2.7 compression of tablets), which is stable at 40 °C for 2 months (pg 353, 3.7 stability study). The 2.6 wt% represents the maximum concentration an active agent is demonstrated to be incorporated into a stable emulsion formulation, in which Pongsamart chose a starch to oil ratio of 1:35:1 (Formulation B, Table 1). Thus, Applicant’s incorporation of poorly water-soluble compounds in amounts greater than 3 wt% (i.e., including a direct comparison to Pongsamart through the demonstration of fenofibrate at 9.7 wt% (pg 8-9, Table 1; Formulation M or N) that demonstrates 3 month stability (pg 18, Table 5; Formulation M or N), provides a reasonable demonstration of the improved solubilization of active agent within formulations compared to Pongsamart (i.e., additionally the instant Application uses formulations similar to Pongsamart’s blank formulation embodiments that Pongsamart did not advance to final products, thereby Pongsamart did not provide an exact embodiment, close enough in nature to Applicant’s claim scope that specifies an instant starch to oil ratio of 1:1 or less, in which a comparison of embodiments would be made).
Heinze does not reasonably teach the claimed unexpected result of the instant claims: Heinze (WO 2019/014121 A1) teaches fairly generic ranges for poorly soluble active formulations (pg 24, paragraph 1) including 10 to about 50% active agent (pg 22, paragraph 3) in for example generic oil/water and water/oil emulsions (pg 25, paragraph 2). For further specification, the Examiner identifies two embodiments that differ from the instant ratio of 1:1 or less (e.g., a ratio of 1:3.5, as in instant claim 2): Heinze teaches many formulation types, including improved colloidal stabilizing and/or protection properties at interphases, like oil/water, water/oil, during the formation of emulsions, dispersion, and /or precipitates in colloidal, amorphous or fine crystalline form, etc. (pg 21, first and last paragraph, pg 25, paragraph 2).
Example 2 (pg 46): An emulsion containing “59.75 % by weight water, 0.2 % by weight citric acid and 0.05 % by weight sodium benzoate, were added to a flask and mixed with a propeller stirrer until all ingredients were dissolved. Then 24 % by weight starch were added. To this solution 16.0 % by weight Delios V Oil (MCT Oil purchased from BASF) were added and the solution was further stirred for 3 min at 20°C” (i.e., the starch to oil ratio is 1.5:1).
Example 3 (pg 49): An emulsion “consisting of 60 % by weight demineralized water, 31.86 % by weight OSA Starch 1, 0.14 % by weight ascorbic acid, 5.03% by weight Delios MCT Oil (BASF), 2.67 % by weight of a 30% natural beta-carotene dispersion and 0.3 % by weight alpha-tocopherol was prepared as described in Example 2” (i.e., the starch to oil ratio is 6.33:1; and furthermore, where only 0.8 wt% total active beta carotene is incorporated).
However, regarding the commensurate scope of the instant claims to the unexpected result: both independent claims 1 (and/or 18) refer to compositions and a weight ratio of starch to oil of 1:1 or less, such that the independent claims do not limit the composition type such that it is commensurate with the claim scope (e.g., homogenous dry emulsion, homogeneous emulsion, stable emulsion, etc.). In the case of Pongsamart (and/or Heinze), in further consideration of the combined Prior Art, it is still obvious to make unstable emulsion and/or non-emulsion compositions that comprise the limitations of instant claim 1. Thus, instant claim 1 is not commensurate in scope with the proposed unexpected result. Furthermore, dependent claim 10 does not cure the deficiency because claim 10 appears to refer to the stability of the active agent and not the stability of the overall formulation. Thus, an adjustment of the instant claim scope to properly reflect the unexpected result is required. Furthermore, any change made to the claim scope would require additional consideration and/or search.
On pg 7-8, Applicant concludes. An Examiner’s Amendment was considered to expedite prosecution; however, the required changes of scope were considered too large, and inappropriate for the Examiner’s Amendment process (i.e., the Examiner regarded writing feedback and allowing for proper time for consideration of the feedback and the resulting scope-changing amendments, as appropriate).
Thus, the claims remain under rejection, until a scope-changing limitation is incorporated into claims 1 (and/or 18) (i.e., requiring further consideration), that demonstrates the proposed unexpected effect as commensurate with the instant claim scope.
Correspondence
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 extension fee 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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/R.P./Examiner, Art Unit 1614 8/24/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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