DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 May 2026 has been entered.
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 27 May 2026, in response to the Office Correspondence dated 27 January 2026, are acknowledged.
The listing of Claims filed 27 May 2026, have been examined. Claims 1-5 are pending. Claims 1 and 3 are amended, claim 6 is canceled, and no new claims have been added.
Response to Amendment
The applicant has amended independent claims 1 and 3 to require that the natural oil-based petrolatum composition possess a cone penetration value greater than 10 and a polydispersity index (PDI) from 1.3 to 2.0. The amendment has been entered. Claim 6 has been cancelled, and therefore all prior rejections to claim 6 are moot.
The applicant's amendment and Remarks have been fully considered but are not persuasive. The amendment does not place the claims in condition for allowance because the newly-recited PDI range remains obvious. The 35 USC §103 rejection of claims 1-5 over Kurth in view of Everaert is maintained. The nonstatutory obviousness-type double patenting rejection and provisional nonstatutory obviousness-type double patenting rejections are also maintained, as more specifically detailed below.
The applicant argues that the amendment clarifies that the recited weight percentages correspond to materials charged into the pre-esterification mixture and therefore resolves the prior indefiniteness issue. The applicant's argument is persuasive. Accordingly, the prior 35 USC §112(b) rejection based on ambiguity regarding the basis for the recited weight percentages is withdrawn. The amended claims now clearly state that the percentages are calculated based on "the total weight of the fatty acid dimer and the one or more components charged to form the pre-esterification mixture." A person of ordinary skill would understand the scope of the recited reactant ratios with reasonable certainty.
The amendments to claims 1 and 3, while addressing a prior concern, have introduced a new and critical ambiguity regarding the scope of the claimed composition. As such, a new ground of rejection under 35 USC §112(b) rejection for claims 1-5 is applied to the phrase "reaction product obtainable by esterifying", as detailed below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 contains a typographical error of "pre-esterification misture" which should read "pre-esterification mixture". Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which Applicant regards as his invention.
Claims 1-5 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, regards as the invention.
Claims 1 and 3 are rejected as indefinite for reciting, "a reaction product obtainable by esterifying a pre-esterification mixture...". The claims define the composition as "comprising a reaction product obtainable by esterifying a pre-esterification mixture," and the weight percentages of the components are expressly tied to "the total weight of the fatty acid dimer and the one or more components charged to form the pre-esterification mixture." While this language defines the reactant charge, it fails to define the final "natural oil-based petrolatum composition" itself with reasonable certainty.
During the esterification reaction, the reactants are consumed and new molecular species are created (e.g., various ester-linked oligomers and polymers as described in the specification). By-products, such as water, are also produced. The claims are ambiguous as to what structural components constitute the final "reaction product" and in what amounts. The claims do not inform one of ordinary skill in the art of the boundaries of the final composition, because measuring the properties of the final product (cone penetration, PDI) cannot determine whether it was made from a mixture having the now-unmeasurable charged weight ratios.
The claims do not recite structural characteristics sufficient to distinguish the resulting composition from other esterification products prepared from different reactant systems but exhibiting similar cone penetration and PDI values. Accordingly, it is unclear whether infringement would depend upon the composition itself, or the method by which it was produced. The metes and bounds of the claim therefore remain uncertain (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)).
Dependent claims 2, 4 and 5 are included in this rejection because they do not cure the defect noted above. To overcome this rejection, the applicant may consider defining the structural constituents of the final product, for example, by specifying the types and amounts of ester species, acylglyceride polymers, and unreacted materials present, or providing a more precise definition of the relationship between the starting materials and the final product (e.g., by specifying the product by its constituent chemical species and their respective ranges).
Alternatively, if the invention resides in a product that is uniquely defined by the process of its making, the applicant should consider clarifying that the claim is directed to a product defined by specified reactant-derived structural features, wherein the process imparts structural characteristics to the product that are necessary for patentability and distinguish it from other products.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AlIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-5 are rejected under 35 U.S.C. § 103 as being obvious over Kurth et al. (WO2019140375A1; published 18 July 2019, hereinafter “Kurth”), in view of Everaert et al. (US20250032378A1; published 30 January 2025, hereinafter “Everaert”).
Regarding instant claims 1, 3, and 5, Kurth teaches a composition in pre-esterification mixtures (claim 19) comprising 15-30 wt.% fatty acid dimer (T18), 50-65 wt.% fatty acids (TRV 1655, TRC 110, TRV 1895) plus 20-30 wt.% glycerol (combined 80-85 wt.%) (Example 2, Table 2, ¶[0108]). Kurth teaches that the compositions are useful as “flexible waxes” and “beeswax alternatives” for use in personal care products (¶[0009], claim 18), wherein, body wash, face wash, shampoo, conditioner, combing cream, skin moisturizer, skin lotion, lip moisturizer, or cosmetics are obvious enumerated personal care products within the broader category personal care products (¶[0009]) disclosed by Kurth (see Everaert ¶[0003]). A person of ordinary skill in the art would understand that if a composition is disclosed for general “personal care” use, it can be formulated in any specific personal care product, such as those of instant claim 5 (see KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Given the monoacylglyceride, diacylglyceride and triacylglyceride polymer fractions and molecular weight ranges (claims 20 and 4) would result in an approximate polydispersity index of 1.25 (bias towards low molecular weight monoacylglyceride/diacylglyceride and low polymer fraction) to >2.4 (bias towards high molecular weight and high polymer fraction), with middle mixture model settings resulting in an approximate polydispersity index of 1.4-1.5.
Kurth does not explicitly disclose specific cone penetration values, however based on invention disclosure of a soy oil/monoglyceride flexible structured wax (claim 1 and 12) with disclosed molecular weight ranges (claim 20), a drop point ranging from about 50-60°C (claim 13) and low stiffness (claims 15 and 16), the cone penetration value at 25° C would be expected to be approximately 15-80 dmm (1/10 mm units; approximately 15-35 with a firmer high 900-3000 Da molecular weight acylglyceride polymer content and 35-80 with a softer 75 wt.% low molecular weight monoacylglyceride/diacylglyceride).
Regarding instant claims 2 and 4, Kurth discloses, “In some aspects, the natural oil may be partially or fully hydrogenated.” (¶[0026] and ¶[0027]), wherein fully hydrogenated natural oils generally have iodine values ≤ 4, due to low levels of unsaturation. However, Kurth does not explicitly disclose iodine values for the invention. Kurth teaches embodiments of the invention as Formulation 607-1 containing 30% glycerin (0 iodine value), 18% fatty acid dimer T18 (UNIDYME 18 Dimer Acid (Kraton Corporation, Houston, TX) as per Table 1, ¶[0106]; approximately 0 iodine value), 10% coconut oil (approximately 10 iodine value when unhydrogenated and <3 when hydrogenated), and 42% hydrogenated soy (fully hydrogenated soy, (Cargill, Incoporated, Wayzata, MN) as per Table 1, ¶[0106]; approximately 1-2 iodine value), thus the iodine value for this formulation using unhydrogenated coconut oil would be approximately 1.84 on the high end.
Thus, Kurth does not explicitly target petrolatum-like properties. The primary difference between Kurth and the instant claimed invention is the intentional formulation and selection of reactants/ratios to achieve the specific rheological properties (cone penetration >10, PDI >1.3) that characterize a petrolatum mimic, as opposed to a beeswax mimic.
Everaert explicitly teaches the goal of creating natural oil-based petrolatum substitutes. Everaert discloses that such substitutes are characterized by specific, measurable properties, including cone penetration values at 25° C of > 20 dmm (1/10 mm units) (claim 19) and polydispersity index between 1.3 and 2.0 (¶[0052]). Everaert also teaches that such compositions are made from similar reactants, including hydrogenated oils and fatty acids, and have iodine values <5 (¶[0065]).
Thus, Kurth expressly discloses esterification products of fatty acid dimers, polyols (like glycerol), and natural/hydrogenated oils for use in personal care products. This establishes that compositions made from these reactants are suitable for the same field of use of personal care as the instant claims. Kurth’s stated goal of mimicking beeswax does not foreclose its formulations from being usable for other semi-solid applications. Whereas, Everaert directly addresses the problem the Applicant purports to solve of creating a natural oil-based substitute for petrolatum. Everaert teaches that a successful petrolatum mimic is defined by key properties, specifically a soft consistency (high cone penetration) and a broad molecular weight distribution (high PDI). Everaert provides the target property ranges that define this alternative application.
It would have been prima facie obvious to one of ordinary skill in the art (i.e., a formulator or chemist with a degree in chemistry, chemical engineering, or a related field and experience in developing lipid-based or oleochemical compositions for personal care applications, with knowledge of reaction chemistry, rheology, and standard analytical methods for characterizing waxes and semi-solids), prior to the instant effective filing date, to adjust Kurth’s formulations to achieve the property profile of a petrolatum substitute, a known and desirable goal in the art taught by Everaert. Given that Kurth teaches compositions made from the same classes of reactants (fatty acid dimers, C2-C6 polyols, natural/hydrogenated oils, fatty acids, acyl glycerols) for personal care, the modification involves routine experimentation in balancing reactant ratios, degrees of polymerization, and hydrogenation levels, all within the skill of the ordinary artisan.
Kurth’s own examples show variability in components (e.g., use of fully hydrogenated oils, different dimer acid percentages), demonstrating the flexibility of the system and discloses molecular weight ranges and component mixtures that would be expected to yield PDI values overlapping the claimed range (>1.3). Similarly, adjusting Kurth’s formulations toward softer consistency (e.g., by increasing mono/diglyceride content or using softer oils) to achieve a cone penetration >10 is a routine formulation goal for personal care ointments, taught by Everaert, based on the particular end-use product application to provide suitable structural integrity, texture, and compatibility with additional formulation ingredients such as surfactants. The low iodine value (<5) is an obvious selection for oxidation stability, achieved by using fully hydrogenated components as Kurth explicitly suggests (¶[0026]-[0027]).
The combination of Kurth’s composition and Everaert’s property guidance for a petrolatum substitute renders the claimed invention obvious. A person of ordinary skill, seeking a natural petrolatum alternative, would consult references like Everaert to identify the necessary properties and would look to known esterification systems like Kurth’s as a starting point for achieving them through routine adjustment.
Claim Rejections – Nonstatutory 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).
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, 18, and 19 of U.S. Patent No. 11,795,327 B2 (hereinafter “’327”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Patent ’327 claims a flexible wax composition comprising monoacylglycerides, diacylglycerides, acylglyceride polymers, dimerized fatty acid residues, glycerol-derived polymeric species, wherein the acylglyceride polymers contain one or more dimerized fatty acid residues and a plurality of glycerol moieties (claims 1, 18, and 19). Patent ’327 claim 18 further recites preparing the composition by mixing fatty acid and/or oil, a fatty acid dimer, and glycerin, followed by esterification and transesterification to obtain the final composition. The instant claimed composition likewise comprises a reaction product obtained by esterifying a pre-esterification mixture comprising a fatty acid dimer, C2-C6 polyols including glycerol, natural oils and/or hydrogenated natural oils, and fatty acids and acylglycerols. Thus, the core compositional framework of the instant claims and the patented claims is substantially identical.
The only material distinctions are that instant claims 1 and 3 recite cone penetration >10, PDI from 1.3-2.0, characterization as a "natural oil-based petrolatum composition." These limitations do not patentably distinguish the claims. The patented composition inherently comprises a distribution of mono-, di-, and polymeric acylglycerides spanning molecular-weight ranges of approximately 200-3000 Da (claims 7-11), which necessarily produces a broad molecular-weight distribution corresponding to a PDI greater than 1.0 and overlapping the claimed range.
Likewise, the patented composition is expressly described as a low-stiffness flexible wax having creep stiffness less than 30 MPa and drop points of 50-60°C (claims 13 and 15), which would have rendered selection of a cone penetration value greater than 10 an obvious optimization of a known rheological property (see In re Aller, 220 F.2d 454 (CCPA 1955); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)). Claim 17 further teaches use of the patented composition in personal care products. Accordingly, claims 1-5 are not patentably distinct from claims 1, 17, 18, and 19 of the '327 patent.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of co-pending U.S. Patent Application Publication No. 18/260,101 (hereinafter “’101”; published as US 2024/0009109 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’101 claim 1 recites a natural oil-based petrolatum composition, esterification product of a pre-esterification mixture, fatty acid dimer, glycerol, hydrogenated natural oil, and acid value less than 10. Co-pending application ’101 claim 7 recites the identical composition incorporated into personal care products. The instant claims differ primarily by broader component genus recitations, cone penetration >10, PDI 1.3-2.0, and iodine value <5. These distinctions do not render the claims patentably distinct.
Co-pending application ’101 and instant claims are directed to the same composition class, prepared from the same reactants, for the same intended purpose. Optimization of rheological properties such as cone penetration, iodine value, and molecular-weight distribution would have been routine for a skilled artisan formulating natural oil-based petrolatum compositions (see In re Longi, 759 F.2d 887 (Fed. Cir. 1985)). The claimed personal-care embodiments of claims 3-5 are expressly recited in co-pending application ’101 claims 7-12. Accordingly, instant claims 1-5 are not patentably distinct from claims 1-12 of co-pending application ’101.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending U.S. Patent Application Publication No. 18/260,109 (hereinafter “’109”; published as US 2024/0082140 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’109 claim 1 recites a natural oil-based petrolatum composition, fatty acid dimer, glycerin, hydrogenated natural oil, and esterification product. Co-pending application ’109 claims 9-11 further recite iodine value less than 10, PDI greater than 1.3, and cone penetration from 20-100 dmm. Co-pending application ’109 claim 12 recites a personal care product containing the composition. Co-pending application ’109 claim 15 recites body wash, face wash, shampoo, conditioner, combing cream, skin moisturizer, skin lotion, lip moisturizer, and cosmetic.
The instant claims differ only in broadening reactant categories beyond glycerin and hydrogenated oils, reciting PDI of 1.3-2.0 rather than >1.3, and reciting cone penetration >10 rather than 20-100. These are overlapping and obvious variants of the same claimed invention. The presently claimed composition constitutes, at most, an obvious species/genus variation of the composition already claimed in co-pending application ’109 (see In re Berg, 140 F.3d 1428 (Fed. Cir. 1998). Accordingly, claims 1-5 are not patentably distinct from claims 1-16 of co-pending application ’109.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of co-pending U.S. Patent Application Publication No. 18/260,093 (hereinafter “’093”; published as US 2024/0099958 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’093 claim 1 recites natural oil-based petrolatum composition, esterification product, fatty acid dimer, C8-C22 fatty acid, and hydrogenated natural oil. Co-pending application ’093 claims 6 and 7 further recite cone penetration greater than 20, cone penetration between 20 and 250. Co-pending application ’093 claim 9 recites a personal care product. Co-pending application ’093 claim 15 recites the identical personal-care product categories recited in instant claim 5.
The instant claims differ only in the inclusion of additional permissible reactants, PDI limitation, and narrower iodine value limitation. Such differences represent routine optimization of formulation parameters and do not create patentable distinction over the previously claimed petrolatum compositions (see In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993). Accordingly, claims 1-5 are not patentably distinct from claims 1-15 of co-pending application ’093.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of co-pending U.S. Patent Application Publication No. 18/850,418 (hereinafter “’418”; published as US 2025/0215350 A1), in view of Kurth et al. (WO2019140375A1; published 18 July 2019, hereinafter “Kurth”), and in further view of Everaert et al. (US20250032378A1; published 30 January 2025, hereinafter “Everaert”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’418 claim 1 recites a wax formulation comprising a natural oil-based petrolatum composition, wherein the natural oil-based petrolatum composition comprises about 0.1 wt% to about 40 wt% fatty acid dimer; about 99.9 wt% to about 60 wt% of one or more components selected from C2-C6 polyols, natural oils, hydrogenated natural oils, fatty acids, and acyl glycerols; cone penetration value greater than 10; and polydispersity index greater than 1.3. The instant claim 1 recites the identical natural oil-based petrolatum composition and identical reactant ranges about 0.1 wt% to about 40 wt% fatty acid dimer; about 99.9 wt% to about 60 wt% of one or more components selected from C2-C6 polyols, natural oils, hydrogenated natural oils, fatty acids, and acyl glycerols; cone penetration value greater than 10; and PDI from 1.3 to 2.0. Thus, the natural oil-based petrolatum composition recited in instant claim 1 is the same composition required by reference claim 1 as a component of the wax formulation. The only distinction is that the reference claims additionally recite incorporation of the petrolatum composition into a wax formulation.
A composition claim is not patentably distinct from a claim directed to a composition containing that same composition where the claimed composition is expressly required as a constituent of the broader formulation (see In re Schneller, 397 F.2d 350 (CCPA 1968)). Furthermore, Kurth teaches esterification products of fatty acid dimers, glycerol, oils, and acylglycerides possessing broad molecular-weight distributions and rheological properties suitable for wax-like materials (as detailed above). Everaert teaches cone penetration values greater than 20, iodine values less than 10, and petrolatum analog compositions useful in personal care products (as detailed above). Accordingly, one of ordinary skill in the art would have recognized the petrolatum composition recited in instant claim 1 as an obvious sub-combination of the wax formulation claimed in co-pending application ’418.
Instant claim 2 recites iodine value less than 5. Co-pending application ’418 claims 2 and 3 recite iodine values less than 5 and 0.5-5.0 respectively. Thus, instant claim 2 is fully encompassed by the reference claims. Instant claims 3-5 merely recite incorporation of the same petrolatum composition into personal care products. Such uses would have been obvious because Everaert expressly teaches personal care compositions employing petrolatum analog materials having overlapping rheological properties.
Accordingly, claims 1-5 are not patentably distinct from claims 1-14 of co-pending application ’418. The instant claims are obvious variants and patentably indistinct species within the same inventive concept of natural oil-based petrolatum substitutes, supported by Kurth and Everaert as evidence that the instant claimed compositional distinctions would have been obvious design and routine experimental optimization choices rather than patentably distinct inventions.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of co-pending U.S. Patent Application Publication No. 18/850,428 (hereinafter “’428”; published as US 2025/0223513 A1), in view of Kurth et al. (WO2019140375A1; published 18 July 2019, hereinafter “Kurth”), and in further view of Everaert et al. (US20250032378A1; published 30 January 2025, hereinafter “Everaert”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’428 claim 1 recites a wax formulation comprising a natural oil-based petrolatum composition containing a triglyceride component, hydroxyl-containing fatty acid chains, C8-C22 fatty-acid esterified chains, and a drop melting point of 35-70°C. The triglyceride component of the reference composition constitutes a natural oil-derived esterification product generated from fatty acid-containing glycerides and hydrogenated oils.
Kurth teaches that fatty acid dimers, glycerol, natural oils, hydrogenated oils, and acylglycerides may be esterified and transesterified to produce oligomeric and polymeric glyceride structures having wax-like and petrolatum-like rheological properties (as detailed above). Everaert teaches that such petrolatum analog compositions may exhibit cone penetration values greater than 20, iodine values less than 10, and be suitable substitutes for petrolatum in personal care applications (as detailed above).
Accordingly, the triglyceride-based petrolatum composition of co-pending application ’428 claim 1 and the fatty-acid-dimer-derived petrolatum composition of instant claim 1 represent obvious variants within the same disclosed genus of natural oil-based petrolatum substitutes. The distinction between selecting fatty acid dimers as one reactant of the instant claims, and selecting hydroxyl-containing triglycerides esterified with C8-C22 fatty acids of co-pending application ’428, would have constituted a routine design choice among known natural oil esterification pathways yielding the same intended petrolatum substitute functionality (see In re Kuhle, 526 F.2d 553 (CCPA 1975)).
Co-pending application ’428 claim 11 recites iodine values less than about 3.0, rendering instant claim 2's iodine value less than 5.0 an obvious variant. The wax formulations, candle compositions, and methods recited throughout the reference application establish that the same petrolatum analog material is being claimed in different statutory classes.
Accordingly, claims 1-5 are not patentably distinct from claims 1-21 of co-pending application ’428. The instant claims are obvious variants and patentably indistinct species within the same inventive concept of natural oil-based petrolatum substitutes, supported by Kurth and Everaert as evidence that the instant claimed compositional distinctions would have been obvious design and routine experimental optimization choices rather than patentably distinct inventions.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Patent Application Publication No. 18/710,762 (hereinafter “’762”; published as US 2025/0032378 A1), in view of Kurth et al. (WO2019140375A1; published 18 July 2019, hereinafter “Kurth”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’762 claim 1 recites a personal care composition comprising a triglyceride component comprising a mixture of triglycerides, ester-containing fatty acids, C8-C22 fatty acid esters, and drop melting point between 30°C and 70°C. Co-pending application ’762 claims 16-18 further recite esterification products comprising hydrogenated castor oil, C8-C22 fatty acids, and hydrogenated soybean oil. Co-pending application ’762 claim 19 recites cone penetration greater than 20. Co-pending application ’762 claim 20 recites iodine value less than 10.
The instant claims differ principally in reciting a fatty acid dimer as a reactant and expressly reciting a PDI range. Kurth teaches that fatty acid dimers, glycerol, oils, hydrogenated oils, and acylglycerides form a common class of esterification-derived acylglyceride structures exhibiting broad molecular-weight distributions and petrolatum-like rheological behavior (as described above). Accordingly, substitution of Kurth's fatty acid dimer esterification products for the triglyceride esterification products of the reference application would have been obvious because both are directed to natural oil-derived petrolatum substitute compositions intended for personal care use.
Co-pending application ’762 claim 15 recites exactly the same personal-care product categories recited in instant claim 5. Co-pending application ’762 claims 19 and 20 further disclose cone penetration and iodine value limitations overlapping those of instant claims 1 and 2. Accordingly, claims 1-5 are not patentably distinct from claims 1-20 of co-pending application ’762. The instant claims are obvious variants and patentably indistinct species within the same inventive concept of natural oil-based petrolatum substitutes, supported by Kurth and Everaert as evidence that the instant claimed compositional distinctions would have been obvious design and routine experimental optimization choices rather than patentably distinct inventions.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of co-pending U.S. Patent Application Publication No. 18/710,746 (hereinafter “’746”; published as US 2025/0049697 A1), in view of Kurth et al. (WO2019140375A1; published 18 July 2019, hereinafter “Kurth”), and in further view of Everaert et al. (US20250032378A1; published 30 January 2025, hereinafter “Everaert”). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Co-pending application ’746 claims 1, 12, and 21 recite compositions comprising triglyceride components, ester-containing fatty acids, C8-C22 fatty acid esters, monoglycerides and diglycerides, drop melting points between 30°C and 70°C, acid values between 0.5 and 20, and hydroxyl values between 10 and 90. Co-pending application ’746 claim 21 further recites a composition combining all of the above features. The instant claims recite a natural oil-based petrolatum composition produced through esterification of fatty acid dimers, polyols, oils, hydrogenated oils, fatty acids, and acylglycerides.
Kurth teaches that esterification and transesterification of fatty acid dimers with glycerol and natural oils produce oligomeric glyceride structures having overlapping molecular architectures and rheological characteristics with triglyceride-based petrolatum analogs (as detailed above). Everaert teaches cone penetration values greater than 20, iodine values less than 10, and personal-care suitability for such materials (as detailed above).
Therefore, the differences between triglyceride-derived petrolatum analogs of co-pending application ’746 and fatty-acid-dimer-derived petrolatum analogs of the instant claims, represent obvious variations within the same family of natural oil-based petrolatum substitutes designed to achieve substantially identical rheological and functional properties. The PDI limitation of instant claim 1 constitutes optimization of a known result-effective variable because Kurth teaches compositions containing monoacylglycerides, diacylglycerides, oligomeric esters, and polymeric acylglycerides exhibiting broad molecular-weight distributions (see In re Aller, 220 F.2d 454 (CCPA 1955).
Accordingly, claims 1-5 are not patentably distinct from claims 1-21 of co-pending application ’746. The instant claims are obvious variants and patentably indistinct species within the same inventive concept of natural oil-based petrolatum substitutes, supported by Kurth and Everaert as evidence that the instant claimed compositional distinctions would have been obvious design and routine experimental optimization choices rather than patentably distinct inventions.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 27 May 2026, have been fully considered, but are not persuasive for the reasons outline below.
The applicant argues that Kurth does not disclose a measured PDI within the presently claimed range of 1.3-2.0 and that the prior rejection relied upon extrapolated estimates rather than explicit disclosure. This argument is not persuasive. A reference need not expressly disclose a claimed property if the property would inherently result from the disclosed composition or would have been recognized as an obvious result of routine optimization (see MPEP § 2112; In re Best, 562 F.2d 1252, 1255 (CCPA 1977)).
Kurth's disclosure of flexible wax compositions and broad molecular weight ranges make it a logical starting point. Kurth teaches esterification products prepared from fatty acid dimers, glycerol and other polyols, fatty acids, natural oils, hydrogenated oils, in substantially the same compositional classes recited in the instant claims. Kurth further discloses distributions of monoacylglycerides, diacylglycerides, triacylglycerides, oligomeric esters, and polymeric species having a range of molecular weights. The presence of such molecularly diverse reaction products unavoidably produces a molecular weight distribution characterized by a PDI greater than 1.0.
The prior Office Correspondence explained that Kurth's disclosed molecular-weight ranges and polymer fractions reasonably encompass distributions yielding PDIs overlapping the presently claimed range of 1.3-2.0. Hence, the prior art teaches overlapping compositions, wherein the physical properties of that composition are inseparable, and thus also reasonably teaches overlapping PDI ranges. The applicant has not provided experimental evidence demonstrating that Kurth compositions falling within the disclosed ranges would necessarily possess PDIs outside the claimed range.
In addition, Everaert teaches that a petrolatum substitute should have a PDI of 1.3-2.0. The combination does not require Kurth to have already disclosed the exact PDI, it requires that one of ordinary skill would have been motivated to adjust Kurth's compositions to achieve the PDI taught by Everaert, and that they would have had a reasonable expectation of success in doing so. The flexibility of Kurth's system, as evidenced by its variable components and molecular weight ranges, supports the conclusion that such optimization would have been routine .
The applicant also argues that Kurth fails to disclose compositions simultaneously possessing cone penetration >10 and PDI from 1.3-2.0. This argument is likewise unpersuasive. The rejection relies on the combined teachings of Kurth and Everaert, not Kurth alone. Kurth supplies the composition framework fatty acid dimer, polyol, natural oil/hydrogenated oil, and esterification reaction products suitable for personal care applications. Everaert teaches that natural oil-based petrolatum substitutes desirably possess cone penetration values greater than 20 dmm, PDI values from 1.3 to 2.0, and low iodine values. Everaert therefore identifies a comparable property profile recited as desirable in the instant invention for petrolatum-mimetic compositions.
A person of ordinary skill in the art seeking to adapt Kurth's esterified structured lipid compositions for use as petrolatum substitutes would have been motivated to select known and desirable formulation properties for petrolatum substitutes that achieve the property profile expressly taught by Everaert. A person of ordinary skill is a person of ordinary creativity, not an automaton (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)). The cone penetration, PDI, and iodine value are result-effective variables that depend on known formulation parameters, as the applicant's own specification demonstrates. The applicant has not submitted any comparative data or other objective evidence showing that the claimed PDI range of 1.3 to 2.0, in combination with the claimed cone penetration, produces unexpected or superior results relative to the prior art. The modification merely involves routine optimization of known formulation variables within a known composition system to achieve a known target property profile, which is obvious (see In re Aller, 220 F.2d 454, 456 (CCPA 1955); MPEP § 2144.05).
The applicant argues that Kurth is directed to beeswax mimics and that modifying Kurth's compositions would destroy their intended purpose. This argument is not persuasive. While Kurth’s primary focus is a flexible, low-stiffness wax as a beeswax alternative, its teachings are not so narrow as to preclude modification for other semi-solid personal care applications. Kurth explicitly teaches compositions comprising esterification products of fatty acid dimers, polyols (e.g., glycerol), fatty acids, and hydrogenated oils (claims 1, 19; Example 2). Kurth’s disclosure of "low stiffness" (claims 15, 16) and a drop point of 50-60°C (claim 13) for its compositions establishes a rheological profile that is not a rigid wax, which overlaps conceptually with the softer regime of petrolatum. Such properties are consistent with a material that could be used in a petrolatum-like application.
The applicant is effectively arguing that because Kurth lists "beeswax alternative" as one possible use, its compositions are therefore unsuitable for any other use. This is not a valid argument against obviousness. A reference need not disclose the identical use for its teachings to be applicable (see In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980), wherein when the prior art teaches several compositions useful for the same purpose, it is prima facie obvious to combine two or more of those compositions for use for the very same purpose). The fact that Kurth's compositions are useful for a related purpose (personal care semi-solids) makes them a reasonable starting point for a person seeking a petrolatum alternative.
Everaert provides the crucial missing link and explicit motivation. Everaert teaches the desirability of creating a natural oil-based petrolatum substitute, defining the target product by, among others, a cone penetration at 25°C of >20 dmm (claim 19) and a PDI between 1.3 and 2.0 (¶[0052]). Everaert thus identifies a known, desirable goal in the art, a bio-based petrolatum substitute with specific, defining physical properties. Thus, a person of ordinary skill in the art seeking to create a natural petrolatum substitute, would have found motivation in Everaert’s explicit property guidance to modify related esterification systems. Kurth provides such a foundational system. A person of ordinary skill in the art would recognize that Kurth’s components (i.e., fatty acid dimers, polyols, hydrogenated oils) are the same classes of reactants used to construct semi-solid ester networks.
The modification to shift Kurth’s product profile from a firmer wax toward a softer, high-viscosity semi-solid (petrolatum mimic) would involve routine, predictable formulation adjustments, such as altering the ratio of mono-/di-acylglycerides to higher molecular weight polymer fractions to tune the PDI into the 1.3-2.0 range, as the PDI is a direct result of these distributions taught by Kurth (claim 20); and adjusting the degree of hydrogenation and cross-linking density (via dimer acid content) to achieve a softer consistency, reflected in a cone penetration value >10. This is not destroying Kurth’s purpose; it is applying its versatile esterification platform to a different, recognized application target (petrolatum vs. beeswax) as taught by Everaert.
The applicant contends that the rejection uses Everaert as a hindsight template. This argument is not persuasive. Everaert expressly teaches the desirability of petrolatum-like softness, defined cone penetration values, defined PDI values, and natural-oil-based petrolatum substitutes. The motivation to combine arises from the prior art itself rather than applicant's disclosure. The combination is a classic application of a known composition (i.e., Kurth’s flexible wax) to a known, desirable purpose (i.e., Everaert’s petrolatum substitute) through the routine optimization of result-effective variables (i.e., cone penetration, PDI).
Kurth’s purpose is broad encompassing flexible personal care waxes, and the modification merely tailors one broad flexible product into a softer version for a different, yet still personal care, application. References may properly be combined when one reference supplies the composition and another supplies the motivation or desired property (see MPEP § 2143). Everaert expressly provides both the motivation and the desired performance criteria.
In this case, the problem is clear, to create a natural oil-based petrolatum substitute. Everaert explicitly identifies the solution by compositions with a PDI of 1.3-2.0, cone penetration >20 dmm, and iodine value <5. Kurth provides the chemical starting point of esterification products of fatty acid dimers, polyols, and natural oils. One of ordinary skill, seeking to solve the problem identified by Everaert, would look to known esterification systems like Kurth's and adjust the reaction parameters (e.g., ratio of reactants, degree of hydrogenation, etc.) to achieve the properties taught by Everaert. This is precisely the type of routine optimization that is considered obvious absent a showing of unexpected results (see In re Aller, 220 F.2d 454, 456 (CCPA 1955). Thus, the rejection does not use the applicant's invention as a "hindsight template." It is based on the known problem of creating a natural petrolatum substitute (Everaert) and a known chemical system for creating wax-like personal care compositions (Kurth). The combination of these two references provides a clear path to the claimed invention.
The applicant asserts that amendment to a PDI range of 1.3-2.0 materially distinguishes the claims from Kurth. The argument is not persuasive because the applicant has not demonstrated criticality of the claimed range. When a claimed range overlaps or lies inside a prior-art range, the burden shifts to applicant to demonstrate criticality or unexpected results associated with the claimed range (see MPEP § 2144.05). No comparative evidence has been submitted showing that compositions having a PDI of 1.3-2.0 unexpectedly differ from compositions slightly above or below the claimed range. Accordingly, the claimed range is treated as an obvious optimization of a result-effective variable.
The newly-amended limitation reciting "a polydispersity index from 1.3 to 2.0" does not patentably distinguish over Everaert. Everaert expressly teaches PDI values within the identical range for natural oil-based petrolatum substitutes. Therefore, the amendment merely incorporates a property already taught by the secondary reference relied upon in the rejection. The amendment does not alter the rationale for combining Kurth and Everaert and does not overcome the previously-established prima facie case.
Everaert explicitly teaches a natural oil-based petrolatum substitute composition characterized by a cone penetration at 25°C of >20 dmm (claim 19), a polydispersity index between 1.3 and 2.0 (¶[0052]), and iodine values less than 5 (¶[0065]), made from hydrogenated oils and fatty acids. Everaert thus teaches a composition meeting all of the newly claimed property limitations and being identical in intended purpose.
To the extent that Everaert does not explicitly disclose the use of a fatty acid dimer as a reactant in its esterification mixture, Kurth teaches this. Kurth teaches the preparation of flexible wax esters via reaction of a mixture including a fatty acid dimer (e.g., T18 dimer acid), a polyol (e.g., glycerol), and fatty acids/natural oils (Kurth, Example 2, ¶[0108]). The use of dimer acids is a known approach to introduce branching and increase molecular weight distribution in polyester systems.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to incorporate the fatty acid dimer of Kurth into the composition of Everaert to modify the molecular architecture and broaden the molecular weight distribution of Everaert’s petrolatum substitute, with a reasonable expectation of successfully maintaining the required PDI in the 1.3-2.0 range and the cone penetration >10. This combination is nothing more than using a known reactant (a fatty acid dimer) from an overlapping esterification art (Kurth) to achieve a predicted effect (molecular weight distribution control) in a known base composition (Everaert), motivated by the fact that both are in the same field of bio-based semi-solid personal care ingredients. The skilled artisan would understand dimer acid as one of a finite number of well-known, commercially available diacids for making ester oligomers.
The applicant's arguments regarding patentable distinction are not persuasive. The newly-added PDI range does not establish patentable distinction because substantially identical PDI limitations are already disclosed in the co-pending family members and related applications identified in the rejection. The claimed invention remains directed to the same genus of fatty-acid-dimer/polyoI/natural-oil petrolatum analog compositions. The differences are minor variations in concentration ranges and a designation of specific product forms (e.g., shampoo, lip moisturizer) which are encompassed by the generic personal care product category.
The newly-recited PDI range represents only an optimization of a property already disclosed in the related applications. No comparative data demonstrating unexpected results attributable to these narrowed differences has been presented. Accordingly, the nonstatutory obviousness-type double patenting rejection over U.S. Patent No. 11,795,327 and the nonstatutory obviousness-type double patenting rejection over the identified co-pending applications are maintained. The applicant is reminded of the ability to file a Terminal Disclaimer to overcome the nonstatutory double patenting rejections.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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