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 .
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 19 November 2025, in response to the Office Correspondence dated 19 August 2025, are acknowledged.
The listing of Claims filed 19 November 2025, have been examined. Claims 1-6 are pending. Claims 1-4 and 6 are amended and are supported by the originally-filed disclosure. No new claims have been added.
Information Disclosure Statement
The Information Disclosure Statement (IDS), filed 05 January 2026, is acknowledged and has been considered.
Response to Amendment
The amendments to claims 1-4 and 6 have been entered.
The Applicant' s arguments with respect to the Specification objection under 37 CFR § 1.75(d)(1) to the terminology “natural oil-based petrolatum” have been fully considered and are persuasive, thus the objection has been withdrawn.
The Examiner acknowledges that the Applicant has amended claims 1-4 and 6 to correct antecedent basis issues and typographical errors (e.g., “acyl glycerols”). These amendments overcome the prior informal objections, and the objections under this section are withdrawn.
The rejection of claims 1-6 under 35 U.S.C. § 112(b) based on an unclear wt.% basis is withdrawn. The Applicant has amended independent claims 1 and 3 to specify that the recited weight percentages are based on the total weight of the fatty acid dimer and the one or more additional components. However, the Applicant's amendment necessitated a new ground of rejection. Claims 1-6 are now rejected as being indefinite under 35 U.S.C. § 112(b), as outlined below.
The Applicant' s arguments regarding the rejection of claims 1-6 under 35 U.S.C. § 112(b) to the use of “natural oil-based petrolatum” in reference to the claimed composition have been fully considered and are persuasive, thus the objection has been withdrawn.
The rejection of claims 1-6 under 35 U.S.C. § 103 over Kurth (WO2019140375A1) in view of the Everaert (US20250032378A1) is maintained and the rejection of claims 1-6 for nonstatutory double patenting over U.S. Patent No. 11,795,327 B2 and the provisionally applied rejections over the co-pending U.S. Patent Application Publication Nos. 2024/0009109 A1, 2024/0082140 A1, 2025/0215350 A1, 2025/0223513 A1, 2025/0032378 A1, 2025/0049697 A1 and 2024/0099958 A1 are maintained. The Applicant’s arguments have been considered but are not persuasive, as detailed below in the Response to Arguments.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 19 August 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
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 1-6 are rejected under 35 U.S.C. § 103 as being obvious over Kurth et al. (WO2019140375A1; published 18 July 2019), hereinafter referred to as Kurth, in view of Everaert et al. (US20250032378A1; published 30 January 2025), hereinafter referred to as Everaert.
Regarding instant claims 1, 3, 5 and 6, 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 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,795,327 B2 (’327) and are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over co-pending U.S. Patent Application Publication No. 2024/0009109 A1 (’109), 2024/0082140 A1 (’140), 2025/0215350 A1 (’350), 2025/0223513 A1 (’513), 2025/0032378 A1 (’378), 2025/0049697 A1 (’697) and 2024/0099958 A1 (’958). 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:
The claims in the above-identified patent and patent applications recite compositions and methods of making acylglyceride-based petrolatum analogs containing fatty acid dimers, polyols, natural oils, and/or hydrogenated oils, optionally with limitations on cone penetration, iodine value, or polydispersity index, and their use in personal care formulations. The only differences between the instant claims and the claims of the listed patents/applications are minor variations in (i) the recited concentration ranges, (ii) selection of specific C₂–C₆ polyols, and/or (iii) recitation of specific personal care product forms. These differences do not patentably distinguish the subject matter because, the prior claims already encompass the same composition elements and overlapping ranges of components, which would have suggested to one of ordinary skill in the art to arrive at the presently claimed ranges and compositions through routine optimization. Additionally, the recited product forms (body wash, face wash, shampoo, conditioner, combing cream, skin moisturizer, skin lotion, lip moisturizer, cosmetics) are well-known subcategories of “personal care products” and would have been obvious embodiments in view of the prior claims (see KSR Int’l Co. v. Teleflex, 550 U.S. 398 (2007)). Evidence of unexpected results attributable to the differences in claimed ranges or product form have not been provided.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 19 August 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
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 1-6 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 recite a component at a specified wt. %. While Applicant’s amendment specifying that the weight percentages are “based on the total weight of the fatty acid dimer and the one or more components” addresses one indefiniteness issue, a critical ambiguity remains.
The claims recite that the composition comprises “an esterification product of a pre-esterification mixture.” The claimed weight percentages (0.1-40 wt% fatty acid dimer, 60-99.9 wt% of the one or more components) are defined only by reference to the reactants and their proportions in a pre-esterification mixture. However, the claims are directed to the final esterification product/composition (e.g., The claims define the composition by the properties such as cone penetration >10, PDI >1.3 of the final natural oil-based petrolatum composition). The claims fail to specify the relationship between the starting mixture and the final product. The esterification reaction will consume reactants, produce byproducts (e.g., water), and generate new molecular species (e.g., esters, oligomers).
Therefore, the recited weight percentages of starting materials do not define a definite compositional scope for the claimed final product, with reasonable certainty. One of ordinary skill in the art cannot determine what is actually contained in the natural oil-based petrolatum composition from the claims as written (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014) and MPEP 2173.02). The claims thus fail to inform the public of the invention’s boundaries with reasonable certainty. Dependent claims 2 and 4-6 are included in this rejection because they do not cure the defect noted above.
To overcome this rejection, the Applicant may amend the claims to define the composition by the structural characteristics of the final product (e.g., types and amounts of ester species present) or by clearly stating that the composition consists of the esterification product of the specified pre-esterification mixture, wherein the weight percentages define the reactants.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 19 November 2025, have been fully considered.
The Applicant argues that the terminology “natural oil-based petrolatum composition” is not misleading because the specification defines the term as a petrolatum mimetic and that Applicant is acting as its own lexicographer. The Examiner acknowledges that applicants may define terms and has withdrawn the objection. However, the Applicant is advised that the use of the term “petrolatum” within the name of the composition, which has a well-established meaning in the art as a hydrocarbon mixture derived from petroleum, even when modified by “natural oil-based,” remains misleading because it suggests compositional identity with petrolatum rather than merely functional similarity (i.e., “mimetic” or “substitute” properties). The instant disclosure explicitly acknowledges that the claimed compositions contain no hydrocarbons and are not petroleum-derived (see, e.g., ¶[0005], ¶[0007], ¶[0011], ¶[0013]) and is an alternative to petrolatum, not petrolatum itself. The use of terminology such as, “natural oil-based petrolatum alternative” or “bio-based petrolatum alternative”, throughout the specification, claims, title, and abstract would clearly reflect this distinction and avoid misleading nomenclature. Yet, the formal rejection of claims 1-6 under 35 U.S.C. § 112(b) and objection to the specification regarding the terminology “natural oil-based petrolatum” under 37 CFR § 1.75(d)(1) are withdrawn, as the Applicant is permitted to act as its own lexicographer by defining the term as a petrolatum mimetic in the Specification.
The Applicant argues that Kurth is directed to beeswax mimics, while the instant claims are directed to petrolatum mimics, and that modifying Kurth to exhibit petrolatum-like softness, polydispersity, and cone penetration would destroy Kurth’s intended purpose. These arguments are not persuasive for the following reasons:
1) Kurth is not limited to beeswax substitutes. Although Kurth discusses beeswax mimetics in certain embodiments, Kurth broadly discloses flexible structured wax compositionsfor personal care applications, formed by esterification of fatty acid dimers, polyols, fatty acids, and hydrogenated oils. Kurth does not require a specific hardness, melting point, or end-use limited to beeswax replacement. Kurth’s claims and examples encompass semi-solid, flexible, low-stiffness materials, which overlap with petrolatum-like rheological behavior.
2) Property optimization does not destroy Kurth’s purpose. The Applicant’s argument improperly characterizes Kurth as requiring high hardness and narrow molecular weight distribution. Kurth expressly discloses formulations with low stiffness, drop points as low as 50–60°C, and broad polymer fractions, which would reasonably yield cone penetration values and PDIs overlapping the claimed ranges. Adjusting component ratios to achieve different tactile or rheological properties is a matter of routine formulation optimization, not a function-destroying modification.
3) Everaert provides explicit motivation and guidance. Everaert expressly teaches natural oil-based petrolatum alternatives with cone penetration values >20 dmm, PDIs between 1.3 and 2.0, and iodine values <5. Everaert therefore provides both a motivation, as achieving petrolatum-like properties for personal care use, and a reasonable expectation of success for modifying Kurth’s compositions to fall within the claimed property ranges. A person of ordinary skill in the art would reasonably look to Everaert for guidance when tailoring esterified oil-based compositions for petrolatum-like performance, particularly where Kurth already discloses overlapping chemical components and personal care uses.
4) Claimed properties are result-effective variables. The cone penetration, polydispersity index, and iodine value are result-effective variables that depend on known formulation parameters such as degree of hydrogenation, fatty acid selection, and polymer fraction distribution. As such, selecting values within the claimed ranges would have been obvious absent a showing of unexpected results. The Applicant has not provided comparative data demonstrating that the claimed ranges produce unexpected or superior results relative to Kurth.
Accordingly, the combination of Kurth and Everaert renders claims 1-6 prima facie obvious, and the § 103 rejection is maintained.
The rejection of claims 1-6 for nonstatutory double patenting over U.S. Patent No. 11,795,327 B2 and the provisionally applied rejections over the identified co-pending applications are maintained. The Applicant’s arguments do not traverse the merits of the rejection. The claims remain patentably indistinct from the reference claims, as they recite substantially the same compositions (fatty acid dimers, polyols, natural oils/hydrogenated oils) with overlapping ranges and similar property limitations, directed to the same personal care uses. While the Applicant indicates that a terminal disclaimer may be premature, the rejection remains proper at this stage. The provisional nature of the rejection with respect to co-pending applications is noted.
Conclusion
No claims are allowed.
The Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (87 CFR 1.17(a)) 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 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