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 Restriction/Election of Species
Applicant's election with traverse of Group I, corresponding to claims 1-7, in the reply filed on February 6, 2026, is acknowledged. The traversal is on the ground(s) that it would not be unduly burdensome to examiner each of the claims. This is not found persuasive because the burden on the Examiner is not the main standard for a determination of whether a restriction is proper under a § 371 application. The standard is whether the claimed feature is a special technical feature. As noted in the Requirement for Restriction of October 7, 2025, this is not the case in view of the known teachings of pregabalin and phospholipid taught by the prior art. Rejoinder may be considered at a later time should claims be found allowable and the remaining claims be in condition for allowance.
Applicant indicates that claims 1-7 are readable on the elected species.
The requirement is still deemed proper and is therefore made FINAL.
Claim of Foreign Priority
Applicant’s claim of foreign priority and copy of certified foreign priority documents are acknowledged.
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 Claims 11, 12, 18, 19, 21, 22, 24, and 35 are preliminarily withdrawn.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.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See Specification at least pages 53-54, bridging par.
Specification
The use of the terms Kollicream DO, Lipoid P 75, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections (Minor Informalities)
Claims 1-7 lack article. The claims should start with “A topical.” Bullet points or hyphens should not be used to start steps in the claim 5.
Claims 4 and 7 refer to ‘a high sheer mixing equipment.” This is not an article. A mixer, e.g., is an article.
Claim 7 recites: “which composition is can comprise further excipient”…. It appears Applicant intends to recite composition can comprise...
Similarly, claim 7 recites fatty alcohols “as” octyldodecanol and the term “as” precedes a number of component listings. The term “as” appears to mean either is or such as. The phrase “such as” is not proper as it provides an example. However, “is” would define a component properly. Clarification is requested.
In claim 7, a comma is required between the recitation of “vegetable oil coconut oil” at the bottom of page 5 of the claims.
Claim Rejections - 35 USC § 112
Claims 2, 4-7 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. In particular they refer to “preferably” which is not a requirement and claims are intended to include required limitations. As such, claims 4-7 are not clear. Correction is requested.
Claim 1 refers to the phospholipid and solvent, but does not previously refer to a solvent. Thus, solvent lacks antecedent basis.
Claims 2 and 5 refer to a high shear mixing equipment rather than a mixer. Further, claim 2 is missing the term “and” prior to the end of the Markush listing to complete the list.
Claim 3 refers to a process of claim 1. However, claim 1 is not a process. The “process” is further comprising a component which is also unclear.
Claim 4 refers to “to the thus given mixture.” It is not clear what this is referring to. The phrase “obtainable the process” is not clear. Further, the phrase “obtainable the process according” is not clear. Claim 1 from which is depends is not a process. The phrase “is added which were previously homogenized” is not clear. It is not clear what was previously homogenized.
Claim 5 refers to “and the thus obtained composition.” It is not clear what this is referring to. Claim 5 refers to a process of claim 1. However, claim 1 is not a process.
Claim 7 contains the trademark/trade names lipoid P75 and lipoid S75. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe specific formulations made by Lipoid Kosmetic AG and, accordingly, the identification/description is indefinite.
Claim 7 recites “is can further comprise.” The examiner interprets “can comprise” as optional. This is confusion and the listed components include some that are able to have 0% and others with a required percentage. Clarification is requested. The phrase “further comprises” would make clear that the following recitation is required. Claim 7 also refers to “such as” which is an example. The term “as” through appears to also mean such as.
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 compositions 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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313
450
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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 require components at the claimed concentrations in view of the cited prior art.
As such, no claim is allowed.
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.
Non-provisional:
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,551,458. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘458 patent are more specific and limited claims that include a product that is presently claimed. As such, it would be obvious to arrive at a claimed product in view of the product use in the methods taught by the ‘458 patent. The instant application was not filed as a direct response to a Restriction Requirement.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,161,613. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘613 patent are more specific and limited claims that include a product that is presently claimed. As such, it would be obvious to arrive at a claimed product in view of the product use in the methods taught by the ‘613 patent. The instant application was not filed as a direct response to a Restriction Requirement.
Provisional:
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 10, and 11 and of copending Application No. 18/273,575. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘575 patent include the same components and are almost identical to the instant claims.
The examiner notes that claims 1 and 6 will be continued to be evaluated for Statutory Double Patenting as they reflect only minor differences from instant claims 1 and 7.
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
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 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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