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 Amendments
Applicant’s amendments to the claims of July 13, 2026, in response to the Office Action of March 11, 2026, are acknowledged.
Response to Arguments
The Double Patenting Rejections are withdrawn in view of the filing and approval of a Terminal Disclaimer on July 13, 2026. A new provisional DP rejection is set forth below.
Applicant argues that Jablonski teaches a microemulsion wherein pregabalin is in aqueous solution, which conveys a solution, rather than a dispersion.
Applicant argues that claim 7 of the reference discloses no improvements above 0.9% pregabalin. Further, Jablonski does not teach topical administration, but rather administration as an eye drop. Applicant argues that drug release for a solution is different from a microemulsion.
Applicant argues that Kisak teaches absorption through the skin but not long lasting effect. Further, Kisak does not teach a reduced micelle concentration that has an effect over 5 to 8 hours.
Applicant argues that their reference example R-1 uses 2.5% weight pregabalin solution and this is an immediate release composition. Alternatively, the ME with 20% water, 30% oil, 50% surfactant mixtures comprising a 1:1 ratio of capryol 90 and soybean lecithin was stable and use the highest among of water in its internal phase capable of dissolving the required dose. Applicant argues that a high amount of lecithin is not acceptable and for an eyedrop, “the amount of the used lecithin is several milligrams.”
The examiner notes that claims 1-6 do not require any concentration of any component. Claims 1-6 do not require any amount of lecithin or pregabalin. As such, the examiner notes that the extended release transdermal composition does not appear to be included in the claims.
Applicant argues that only if these compositions were treated with high pressure homogenization resulting in a modified SAX curve did the reduction of pain having a long lasting effect.
Applicant argues that the unexpected result is the result of the use of a HPH homogenizer, which causes high shearing forces and pain alleviation for 5 hours. Compound “PGA2211119 had significant pain alleviation effect even after 8 hours (Figure 5).” This contrasts with PGA0470717, which has the same quantitative composition controlling for this.
The examiner notes that instant claims 1 includes a composition comprising pregabalin and phospholipid “obtainable by” a process. The examiner notes that this does not require an unexpectedly superior composition. This is an indication that a composition requiring at least pregabalin and phospholipid can be made through a process. Applicant’s argument is that an unexpectedly superior product can be made in this way too. While this may be true, the unexpectedly superior composition must be claimed in a manner that the claimed are commensurate in scope with such showing.
The examiner notes that claims 6 requires a composition to be homogenized, it does not include or require any concentration of components, including pregabalin or phospholipid. Further, any showing of unexpected results should include components and percentages claimed. For example, in the Specification each of the embodiments include a total of approximately 11 components each included at a specific concentration. The instant claim 1 requires a total of 2-3 components without any percentages claimed. Even further, aside from the concentrations of components that are “obtained” rather than obtainable by a process, the process appears to be undertaken sufficiently to bestow a specific particle size on the pregabalin requiring a specific micelle scattering contribution scaling factor.
The examiner notes that Jablonski teaches microemulsions were evaluated based on drug release, particle size, viscosity, and other physical parameters. See par. 138. The particle sizes used were less than 20 nm in numerous examples. Further, using microemulsions was shown to provide sustained release for pregabalin. See par. 146. While the drugs tested released 100% within 3-4 hours, the microemulsion formulations exhibited sustained release for up to 24 hours. See par. 37. The release was steady for up to 24 hours.
A main purpose of Jablonski is to provide ME that are capable of extended drug release. The drug would need to take the time to pass through multiple layers and stages for prolonged release- even for aqueous soluble drugs. See par.’s 65 and 66. Internal emulsifiers are contemplated to include lecithin, egg lecithin, phosphatidylcholine, phosphatidylethanolamine, and phosphatidylinositol, among others. See par. 67.
Even further, the ME includes globules that have a size of between 1 and 200 nm. See par. 81. The examiner also notes that therapeutic MES can be formulated for and administered through any suitable route, including topical, ocular, IV, SQ, intracranial, IM, and others. Jablonski explicitly states that transdermal and topical for different skin disorders are contemplated routes for the described MEs. See par. 95. Extended release formulations of pregabalin were provided in examples. See par. 132.
The composition described by Jablonski includes pregabalin within an internal emulsifier phase.
The instant claims are directed to a dispersion rather than a microemulsion as taught by the prior art. Applicant argues that the embodiments are shown by the Specification to provide for extended relief from pain.
The examiner notes that the prior art teaches formulations comprising a sustained and extended release pregabalin. While the claims are not method claims, the prior art does provide for administration of compositions taught therein by administration through any route of administration, including topical and transdermal routes. Even further, the prior art teaches particle sizes of less than 20 nm and a hydrogel comprising wherein pregabalin is dispersed within lecithin. These are micelles comprising pregabalin. A ME is a micellar dispersion wherein the pregabalin is dispersed therein.
As noted above, the instant claims do not require the use of HPH to yield a claimed product with claimed components at claimed percentages. Presently, the claimed include a composition with 0.9% pregabalin in a ME micellar dispersion formed to provide extended and sustained release when applied to the skin of a subject. This is taught. Applicant can claimed a product obtained by…and indicate the properties that are secondary to the process. However, to support a composition having specific properties, Applicant would need to described additional components and percentages as well as a particle size in the claimed to properly link those properties to all products produced within the breadth of a claim.
As evidenced by https://www.pion-inc.com/blog/how-high-pressure-homogenization-creates-stable-emulsions, Shechter, “How High Pressure Homogenization Creates Stable Emulsions,” December 28, 2025, Shechter teaches high and shear mechanical forces is commonly used for homogenization. Homogenization is a manner that is known to create a dispersion by helping particles form micelles. HPH are used to provide advantages including long-term stability. Further, homogenization reduces particles sizes more significantly than others.
As such, ME are a form of dispersion. Further homogenization techniques can form micelles that are stable and of small particle sizes. These features also appear to be described by the prior art even if the claims were directed to a product obtained by rather than merely obtainable by such process.
Claim Interpretation: Applicant can require a step of subjecting a claimed mixture to HPH to produce a product having specific properties, wherein the product comprises specific agents at specific concentrations. Presently, a step for mixing is only included in claims 4-6. However claims 4-6 do not require mixing. Rather, they depend from a claim describing a process wherein the composition is “obtainable by” such process. In other words, claims 4-6 indicate that HPH, e.g., is one way to obtain a compositions comprising pregabalin and phospholipid. The claims are directed to a composition comprising pregabalin and phospholipid not a specific embodiment obtained by that a method that use HPH, e.g. In an effort to expedite prosecution, the examiner attempts to address homogenization of the claimed mixture.
Applicant can claim properties produced by specific method steps should support exist in the instant Specification. Further, Applicant can explain how the claimed product provides an unexpected advantage as compared to the extended release formulations taught by the microemulsion/micellar dispersions taught by the prior art. Any unexpected result must be commensurate in scope with the breadth of the claims, unexpected overall, and unexpected as compared to the closest prior art. The examiner is willing to conduct an After Final interview if that would be helpful.
As such, a rejection is set forth below.
Status of Claims
Claims 1-7, 11, 12, 18, 19, 21, 22, 24, and 35 are pending. Claims 11, 12, 18, 19, 21, 22, 24, and 35 are preliminarily withdrawn. Claims 1-7 are examined.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski et al., (US2020/0383915), and in view of Kisak et al. (US2017/0290769) (of record).
Jablonski teaches microemulsions that include a water soluble drug selected from one of 4 preferred drugs, including pregabalin. See prior art claim 14. Further, the compositions includes an emulsifier including lecithin. See prior art claim 4. In one embodiment, the compositions can be in the form of a hydrogel comprising a mucoadhesive polymer selected from polyacrylic acid derivatives, including Carbopol® brand polymers. See par. 13. In one example soybean lecithin is used. See Figures 12-14. An aqueous layer is used. See par. 65, e.g. An external emulsifier can include propanol, ethanol or isopropanol, e.g. See prior art claim 8 and par. 74. The composition can further comprise tocopherol. See prior art claim 3, par.’s 8 and 71, e.g. An oil can includes MCTs, coconut oil, and any natural oil. See prior art claim 6. The microemulsion can include a dispersed oil phase, an aqueous phase encompassing the emulsifier. See par.’s 17-20. With respect to some of the claimed percentages, the examiner refers to Table 2, below, e.g.
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Moreover, Kisak teaches topical formulation comprising pregabalin, water, and a fatty alcohol. See Abstract. Kisak also provides examples in which 10% pregabalin and lecithin in the form of a gel, emulsion and microemulsion are contemplated. See par.’s 56 and 147. Other examples include 5% pregabalin. See par.’s 162-163, e.g. Kisak further discloses a composition comprising a solvent in a concentration of 10% to 40%. See par. 106. Further an emollient is contemplated in a concentration of 0.1-20 % emollient. See par. 135. A penetration enhancer can be used in a concentration of 0-20% penetration enhancer and 0-5% rheology modifier. Benzyl alcohol, ethanol, and isopropanol are contemplated as alcohol. See par. 121, 122. At least one preservative is used. These include benzalkonium chloride. See par. 143. Buffers are contemplated to arrive at any desired pH including about 6, e.g. See par. 146.
The examiner notes that the excipients are claimed are optional as described above, and further recited in claim 7: the emollient is claimed to include 0%, the penetration enhancer is claimed to include 0%, and the rheology modifier is claimed to include 0%.
The claims are product claims. The process by which they are prepared is also claimed. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on Applicant to show for the record that such process imparts different properties on the same components, e.g.
Even further, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, each of the claimed components are known result-effective variables that can be optimized through nothing more than routine experimentation.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Jablonski and Kisak to arrive at the claimed products. One would be motivated to do so because multiple prior art references teach the claimed components and categories of components at similar dosages for topical use. Further, the claimed components are each known result-effective variables that can be optimized through nothing more than routine experimentation. Further, the compositions are interpreted as uniform as they can be emulsions, hydrogels, and other forms known to appear uniform and homogeneous. As such there is a reasonable and predictable expectation of arriving at the claimed requires components at the claimed concentrations in view of the cited prior art.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jablonski et al., (US2020/0383915), and in view of Kisak et al. (US2017/0290769) (of record), and in view of Ibrahim et al., “Once Daily Pregabalin Eye Drops for Management of Glaucoma,” ACS Nano 2019, 13, 13728-13744.
Claims 4-6 have been amended to require a step for mixing to form a homogeneous form as one basis to arrive at a claimed product. Presently, a step for mixing is only included in claims 4-6. However claims 4-6 do not require mixing. Rather, they depend from a claim describing a process wherein the composition is “obtainable by” such process. In other words, claims 4-6 indicate that HPH, e.g., is one way to obtain a compositions comprising pregabalin and phospholipid. The claims are directed to a composition comprising pregabalin and phospholipid not a specific embodiment obtained by that a method that use HPH, e.g.
Jablonski teaches microemulsions that include a water soluble drug selected from one of 4 preferred drugs, including pregabalin. See prior art claim 14. Further, the compositions includes an emulsifier including lecithin. See prior art claim 4. In one embodiment, the compositions can be in the form of a hydrogel comprising a mucoadhesive polymer selected from polyacrylic acid derivatives, including Carbopol® brand polymers. See par. 13. In one example soybean lecithin is used. See Figures 12-14. An aqueous layer is used. See par. 65, e.g. An external emulsifier can include propanol, ethanol or isopropanol, e.g. See prior art claim 8 and par. 74. The composition can further comprise tocopherol. See prior art claim 3, par.’s 8 and 71, e.g. An oil can includes MCTs, coconut oil, and any natural oil. See prior art claim 6. The microemulsion can include a dispersed oil phase, an aqueous phase encompassing the emulsifier. See par.’s 17-20. With respect to some of the claimed percentages, the examiner refers to Table 2, below, e.g.
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Moreover, Kisak teaches topical formulation comprising pregabalin, water, and a fatty alcohol. See Abstract. Kisak also provides examples in which 10% pregabalin and lecithin in the form of a gel, emulsion and microemulsion are contemplated. See par.’s 56 and 147. Other examples include 5% pregabalin. See par.’s 162-163, e.g. Kisak further discloses a composition comprising a solvent in a concentration of 10% to 40%. See par. 106. Further an emollient is contemplated in a concentration of 0.1-20 % emollient. See par. 135. A penetration enhancer can be used in a concentration of 0-20% penetration enhancer and 0-5% rheology modifier. Benzyl alcohol, ethanol, and isopropanol are contemplated as alcohol. See par. 121, 122. At least one preservative is used. These include benzalkonium chloride. See par. 143. Buffers are contemplated to arrive at any desired pH including about 6, e.g. See par. 146.
The examiner notes that the excipients are claimed are optional as described above, and further recited in claim 7: the emollient is claimed to include 0%, the penetration enhancer is claimed to include 0%, and the rheology modifier is claimed to include 0%.
The claims are product claims. The process by which they are prepared is also claimed. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden is on Applicant to show for the record that such process imparts different properties on the same components, e.g.
Even further, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, each of the claimed components are known result-effective variables that can be optimized through nothing more than routine experimentation.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Jablonski and Kisak to arrive at the claimed products. One would be motivated to do so because multiple prior art references teach the claimed components and categories of components at similar dosages for topical use. Further, the claimed components are each known result-effective variables that can be optimized through nothing more than routine experimentation. Further, the compositions are interpreted as uniform as they can be emulsions, hydrogels, and other forms known to appear uniform and homogeneous. As such there is a reasonable and predictable expectation of arriving at the claimed requires components at the claimed concentrations in view of the cited prior art.
Ibrahim teaches forming pregabalin in the form of microemulsions wherein the drug can be provided in a continuous release form for up to 24 hours. This is a result of the miniscule droplet size of less than 20 nm in a microemulsion form. It is stable for one month. See Abstract. A small polydispersity index (PDI) value indicates that the ME emulsion formulations that were prepared were homogeneous with a narrow droplet size. See p13731, 3rd full par. Pregabalin release was shown to be fastest in water then in polymers and slowest in microemulsion form. See p13733, 3rd full par. Even further, Ibrahim is co-authored by Jablonski and provide a Table 1 composition that is substantially similar to Table 2 shown above.
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Thus, in view of Ibrahim, the formation of a microemulsion in a homogeneous is a product of the small particle size and the uniformity. The small droplet size of less than 20 nm is consistent with the described by Jablonski.
As such, it would appear that for Applicant to show unexpected results as compared to the closest prior art, such comparison would need to compare the claimed composition to a microemulsion composition with a low polydispersity index and a miniscule (i.e., less than 20 nm) particle size which are known to bestow advantages include sustained release and stability. As such, it would be prima facie obvious to a person of ordinary skill in the art prior to the filing of the instant application to combine the teachings of Jablonski and Kisak with those of Ibrahim to arrive at a claimed ME micellar dispersion comprising an extended release form of pregabalin that is stable. One would be motivated to do so because this is taught by the prior art and unexpected results have not been established.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 11, 12, 18, 19, 21, 22, 24, and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, and 26 of copending Application No. 18/273,694. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘694 patent are directed to products that comprise pregabalin and phospholipid in the form of a micelle with a claimed small angle X-ray scattering measurement. This would appear to be a distinction in size and the micelles taught by the prior art are at least less than 20 nm and include smaller sizes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
As such, no claim is allowed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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