DETAILED ACTION
Status of Claims
Claims 1-21 are currently pending. Claims 1-5 and 12-19 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 6-11 and 20-21 are withdrawn from consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-5 and 12-19) in the response filed on November 11, 2025 (to the September 17, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 6-10 and 20) and Group III (claims 11 and 21) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant has elected the claims of Group I with traverse. The traverse is based on applicant’s argument:
The applicant TRAVERES the Examiner’s proposed division of the claims into the aforesaid groups, and assert that a concurrent search of the prior art could be made extending to the subject matter of all claims, without causing an undue burden on the Examiner. Hence, reconsideration of the requirement and its withdrawal is requested.
Should the Examiner choose to maintain the requirement, and only for ensuring that this paper is fully responsive to the Paper, the applicant provisionally elects the subject matter of the Group I claims (claims 1-5, 12-19) for further prosecution.
11/11/2025 Remarks, p. 2, par. 2-3. In response: the establishment of burden on the Office applies to US cases only. The instant application is a national stage entry of an international application under 35 U.S.C. § 371. As a result, lack of unity practice is observed for restriction purposes.
.
Accordingly, the November 11, 2025 Requirement for Restriction is made FINAL, and claims 1-5 and 12-19 are examined as follows.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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.
Claims 4 and 17-18 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 pre-AIA , that applicant regards as the invention.
X. Regarding claims 4, the use of “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase (i.e., “phenethyl alcohol”) are part of the claimed invention. It is noted that descriptions of examples and preferences are properly set forth in the specification rather than in a claim. See MPEP § 2173.05(c). Subsequent claim[s] 17-18 depend on claim 4 and are thus, indefinite as well.
Further clarification is required.
Claim Rejections – 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. § 103(a) 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 C.F.R. § 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 1-3, 5, 12-15 and 18-19 are rejected under 35 U.S.C. § 103 as being unpatentable over LAMBERT (WO 2019/193203 A1, Publ. Oct. 10, 2019, hereinafter, “Lambert”; of record), in view of JOKIC (Jokić, S., et al., Subcritical water extraction laboratory plant design and application, Ann. Croat. Acad. Eng., 21 (2018) pp. 247-258; accessed at https://hrcak.srce.hr/file/315428 on Nov. 28, 2025; hereinafter, “Jokić”).
Lambert is directed to:
Title: COSMETIC COMPOSITION
Abstract: A cosmetic composition is provided, which comprises a carrier and a Patchouli stem extract, in particular an extract from exhausted Patchouli stems. This composition provides anti- oxidant, anti-elastase, anti-hyaluronase, and anti-tyrosinase activities.
Lambert, title & abstract. In this regard, Lambert teaches a “Preparation of Patchouli Stem Extract,” wherein “25 g of powder were extracted at room temperature in 500 g of ethanol (70% in water) for 30 min under stirring”:
Example 1: Preparation of Patchouli Stem Extract
Dried hydrodistilled Patchouli stems were crushed to obtain a powder. 25 g of powder were extracted at room temperature in 500 g of ethanol (70% in water) for 30 min under stirring. The extract (around 420 g) was filtered over an Eaton KDS15 filter (123 cm2). The filtrate was concentrated by a factor of 5.2 by evaporation under vacuum to obtain about 80 g of concentrated product.
One batch of the concentrated product (Batch A) was used as such. This non decolorized product was black.
A second batch of the concentrated product (Batch B) was decolorized on charcoal filters (24 cm2). This decolorization process efficiently decreased colour. It decreased dry matter around 2 fold.
The two batches were finally filtered over an Eaton S60 filter (24 cm2) and sterile PES filtration unit (VWR) to store the final products without preservatives.
Lambert, p. 5, ln. 8-20.
Regarding independent claim 1 and the requirements:
1. ([…]) A method of preparing a cosmetic active ingredient, said method comprising the steps of:
a) providing exhausted patchouli aerial parts; and
b) performing a sub-critical water extraction on the exhausted patchouli aerial parts.
Lambert clearly teaches an “extract from exhausted Patchouli stems” (Lambert, abstract), which relates to the instant “cosmetic active ingredient” and the active step of claim 1 for “a) providing exhausted patchouli aerial parts” (see the instant published application, US 2024/0000700 A1, at par. [0006] describing “stems” as “aerial parts “[f]or the production of patchouli oil, patchouli stems and leaves—i.e. the aerial parts—are used”; see also, the instant published application; and also, at par. [0023], defining “exhausted patchouli aerial parts” as referring to “patchouli aerial parts that have previously been subjected to distillation, in particular to steam distillation,” and “[o]ptionally, the patchouli aerial parts may also have been dried and/or fermented”). However, Lambert teaches a “Preparation of Patchouli Stem Extract,” wherein “25 g of powder were extracted at room temperature in 500 g of ethanol (70% in water) for 30 min under stirring” (Lambert, p. 5, ln. 8-20), and therefore, DOES NOT TEACH the requirements of instant claim 1 for the active step, “b) performing a sub-critical water extraction on the exhausted patchouli aerial parts,” as well as the particular conditions recited in claims 2 and 12-15:
2. ([…]) The method of claim 1, wherein sub-critical water extraction is performed at a temperature of 100 to 175° C., and a pressure of 1 to 50 bar.
[…]
12. ([…]) The method of claim 2, wherein the sub-critical water extraction is performed at a temperature of 110 to 150° C.
13. ([…]) The method of claim 12, wherein the sub-critical water extraction is performed at a temperature of about 125° C.
14. ([…]) The method of claim 2, wherein the sub-critical water extraction is performed at a pressure of 10 to 30 bar.
15. ([…]) The method of claim 14, wherein the sub-critical water extraction is performed at a pressure of about 20 bar.
since the choice of a particular extraction method, and conditions thereof, is well within the purview of the ordinarily skilled artisan.
Jokić, for instance, is directed to:
Subcritical Water Extraction Laboratory Plant Design and Application
Abstract: The demand for different green extraction techniques, which provide shortened extraction time and reduced organic solvent consumption, constantly increase. Subcritical water is a green, cheap and non-toxic processing medium, which makes treatments inexpensive, ecofriendly, more selective and less time consuming. Furthermore, lower viscosity and higher values of diffusion coefficient and thermal conductivity at subcritical temperatures improve mass and heat transfer rates. All these properties make subcritical water a satisfactory replacement for organic solvents in extraction processes.
The subcritical water extraction (SWE) technology continuously increases its application in different fields. Thus, the aim of this work was to give an overview of two types of the SWE design: dynamic (continuous flow) and static (batch) systems. The design and development of one SWE static system used for laboratory procedures is given in detail. Some applications together with the optimal extraction parameters of this SWE technology are also shown.
Jokić, title & abstract. In this regard, Jokić discusses “Subcritical water extraction” with regard to water properties in “normal conditions,” “subcritical/near critical state” and “supercritical state” in which a changes of extraction temperature and pressure result in a change of water properties:
Subcritical water extraction
Subcritical water is water at temperatures above its normal boiling point (100°C) and below its critical point (374°C) at a pressure at which it remains in the liquid state. It represents a cheap, safe and non-toxic processing fluid (Ramos et al., 2002). At these conditions, water becomes less polar and therefore it is a suitable replacement for organic solvents. At a temperature above 374 °C and a pressure above 220 bar, water is considered to be in the supercritical state. Water properties in normal conditions, subcritical/near critical state and supercritical state are presented in Table 1 in which it can be seen that with a change of extraction temperature and pressure main water properties change.
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At ambient conditions water is considered an extremely polar solvent, and its polarity is characterized by a dielectric constant of around 80. In this state, water is suitable for the extraction of highly polar compounds. But, at a temperature between 100 and 374°C, and under a high and sufficient pressure to keep water in the liquid state, the polarity of water considerably decreases and it becomes suitable for the extraction of both, polar and non-polar compounds. This is caused by a dramatical drop of the dielectric constant with increasing temperature. At elevated temperatures in the subcritical state, surface tension, water viscosity and density, aside from polarity, are significantly lowered too. At elevated temperatures the surface tension of water decreases; this enables enhanced water wetting of the extracting material and the dissolution of targeted compounds in the solvent much faster. Decreased water viscosity enhances its penetration inside the extracting material and thus improves the diffusion rate. The improved diffusion rate enables accelerated extraction as well (Plaza, Turner, 2015).
(Jokić, p. 248, par. 1-2, cont. on p. 249, and Table 1), which relates to the requirement of instant claim 1 for the active step, “b) performing a sub-critical water extraction,” but for a particular extraction material. Further in this regard, Jokić lists subcritical water extraction operating conditions for numerous extraction resources with pressures ranging from 2 bar (Ginger) to 101 bar (Ginseng leaf), and temperatures ranges including 79.15-220.5 °C (Water savory), 100-140 ºC (Citrus peel), 110-200°C (Ginseng leaf), and 120-160°C (Timeric rhizomes):
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(Jokić, p. 250-252, Table 2), which overlap the conditions recited in claims 2 and 12-15. In this regard, it is noted that MPEP § 2144.05 (I), states, “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); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to obtain Lambert’s “extract from exhausted Patchouli stems” (Lambert, abstract) by “subcritical water extraction (SWE),” as taught by Jokić (Jokić, abstract & p. 248, par. 1-2, cont. on p. 249, and Table 1). One would have been motivated to do so with a reasonable expectation of success in order to obtain the advantage of a “green, cheap and non-toxic processing medium, which makes treatments inexpensive, ecofriendly, more selective and less time consuming” that is a “satisfactory replacement for organic solvents in extraction processes” (Jokić, abstract), namely Lambert’s extraction with “ethanol (70% in water)” (Lambert, p. 5, ln. 8-20). Further, in this respect, it is further noted, “[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); and also MPEP § 2144.05(II)(A). In the instant case, “Subcritical water extraction” involves changes in extraction temperature and pressure for affecting a change of water properties, wherein “the polarity of water considerably decreases and it becomes suitable for the extraction of both, polar and non-polar compounds” (Jokić, p. 248, par. 1-2, cont. on p. 249, and Table 1), which are clearly result-effective variables. Therefore, it would have been customary for an artisan of ordinary skill to select an appropriate temperature and pressure in optimizing subcritical water extraction for a particular extraction material overlapping Jokić’s listing for particular extraction resources with pressures ranging from 2 bar (Ginger) to 101 bar (Ginseng leaf), and temperatures ranges including 79.15-220.5 °C (Water savory), 100-140 ºC (Citrus peel), 110-200°C (Ginseng leaf), and 120-160°C (Timeric rhizomes).
Thus, the prior art renders claims 1-2 and 12-15 and obvious.
Regarding claims 3, 5 and 18-19 and the requirements:
3. ([…]) The method of claim 1, further comprising the step of:
c) solid-liquid separation.
[…]
5. ([…]) The method of claim 1, further comprising the step of:
e) sterilization.
[…]
18. ([…]) The method of claim 4, further comprising the step of:
e) sterilization.
19. ([…]) The method of claim 5, comprising the step of:
e) sterile filtration.
Lamber teaches that “The two batches were finally filtered over an Eaton S60 filter (24 cm2) and sterile PES filtration unit (VWR) to store the final products without preservatives” (Lambert, p. 5, ln. 8-20), which encompasses the active step requirements of:
claim 3 for “c) solid-liquid separation,”
claims 5 and 18 for “e) sterilization,” and
claim 19 for “e) sterile filtration.”
(see the instant published application, US 2024/0000700 A1, at par. [0038] describing: “Solid-liquid separation may be achieved by filtration or centrifugation, for instance”; see also, the instant published application; and also, at par. [0048] describing: “Alternatively or in addition, the extract may also be sterilized, e.g. by sterile filtration or heat treatment (pasteurization).”
Thus, the prior art renders claims 3, 5 and 18-19 and obvious.
Claims 4 and 16-17 are rejected under 35 U.S.C. § 103 as being unpatentable over LAMBERT (WO 2019/193203 A1, Publ. Oct. 10, 2019, hereinafter, “Lambert”; of record), in view of JOKIC (Jokić, S., et al., Subcritical water extraction laboratory plant design and application, Ann. Croat. Acad. Eng., 21 (2018) pp. 247-258; accessed at https://hrcak.srce.hr/file/315428 on Nov. 28, 2025; hereinafter, “Jokić”), as applied to claims 1-3, 5, 12-15 and 18-19, above, and further in view of SIRILUN (Sirilun, S. et al., Phenethyl alcohol is an effective non-traditional preservative agent for cosmetic preparations, Asian J. Pharm. Clin. Res., 10 (August 2017) pp. 129-133; hereinafter, “Sirilun”).
The teachings of Lambert and Jokić, as set forth above, are hereby incorporated. However, the references DO NOT EXPRESSLY TEACH the incorporation of a preservative, such as phenethyl alcohol, per the requirements of claims 4 and 16-17:
4. ([…]) The method of claim 1, further comprising the step of:
d) adding a preservative, preferably phenethyl alcohol.
[…]
16. ([…]) The method of claim 3, further comprising the step of:
d) adding a preservative.
17. ([…]) The method of claim 4, wherein the preservative is phenethyl alcohol.
which is well within the purview of the ordinarily skilled artisan.
Sirilun, for instance, is directed to:
PHENETHYL ALCOHOL IS AN EFFECTIVE NON-TRADITIONAL PRESERVATIVE AGENT FOR COSMETIC PREPARATIONS
ABSTRACT
Objective: Preservatives are used in the cosmetic products to protect the potential growth of microbes, therefore, to prolong the shelf life of products, and to protect the consumer from infections. However, several preservatives can cause various health problems, and the safety profiles of those preservatives are still unclear. Many natural substances are used in the cosmetic products to substitute the traditional preservatives. The present study deals with the evaluation of conservative nature of phenethyl alcohol (PEA) in three cosmetic formulations (emulsion, cleansing, and conditioner).
Methods: Three different concentrations of PEA (0.3%, 1%, and 2.5%) were used in cosmetic formulations. The physical appearance of the formulas was assessed manually, and the antimicrobial nature of PEA and PEA-containing cosmetic formulations was evaluated by agar well plate assay.
Results: The use of PEA has not affected the physical appearance and quality of the formulations, except the high concentration of PEA in the cleansing solution, which reduced the foam formation. The minimal required concentration of PEA in emulsions and cleansings was 1.0% and 2.5% in the conditioners. All cosmetic preparations were subjected to antibacterial and antifungal evaluation. The alkaline pH (>8) affected the antimicrobial activity of PEA in a cosmetic product.
Conclusion: The results suggested that PEA is a potent non-traditional preservative for the cosmetic formulations, especially, in the emulsion, cleansing solutions, and conditioners.
(Sirilun, title & abstract), wherein “phenethyl alcohol (PEA)” is noted as “phenethyl alcohol’ of claims 4 and 17, and a “preservative” of claims 4 and 16-17.
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to obtain Lambert’s “extract from exhausted Patchouli stems” (Lambert, abstract) by SWE per Jokić (Jokić, abstract & p. 248, par. 1-2, cont. on p. 249, and Table 1), as discussed above, and to have further incorporated “phenethyl alcohol (PEA)” per (Sirilun, abstract). One would have been motivated to do so in order to obtain the advantage of suitable “[p]reservatives [that] are used in the cosmetic products to protect the potential growth of microbes, therefore, to prolong the shelf life of products, and to protect the consumer from infections.” Sirilun, abstract.
Thus, the prior art renders claims 4 and 16-17 and obvious.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 5, 12-15 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting over claim 6 of copending Application No. 16/980,061 (‘061 Application), in view of the disclosure of JOKIC (Jokić, S., et al., Subcritical water extraction laboratory plant design and application, Ann. Croat. Acad. Eng., 21 (2018) pp. 247-258; accessed at https://hrcak.srce.hr/file/315428 on Nov. 28, 2025; hereinafter, “Jokić”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims a drawn to a method of prepanng an active cosmetic ingredient by extracting exhausted Patchouli stems using water. However, to the extent that the ‘061 DOES NOT RECITE the requirements of instant claim 1 for the active step, “b) performing a sub-critical water extraction on the exhausted patchouli aerial parts,” as well as the particular conditions recited in claims 2 and 12-15, the use of sub-critical water extraction would be obvious per Jokić, as discussed above, in order to obtain the advantage of a “green, cheap and non-toxic processing medium, which makes treatments inexpensive, ecofriendly, more selective and less time consuming” that is a “satisfactory replacement for organic solvents in extraction processes” (Jokić, abstract).
Thus, the ‘061 Application per Jokić render claims 1-3, 5, 12-15 and 18-19 obvious.
Claims 4 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting over claim 6 of copending Application No. 16/980,061 (‘061 Application), in view of the disclosure of JOKIC (Jokić, S., et al., Subcritical water extraction laboratory plant design and application, Ann. Croat. Acad. Eng., 21 (2018) pp. 247-258; accessed at https://hrcak.srce.hr/file/315428 on Nov. 28, 2025; hereinafter, “Jokić”), as applied to claims 1-3, 5, 12-15 and 18-19, above, and further in view of the disclosure of SIRILUN (Sirilun, S. et al., Phenethyl alcohol is an effective non-traditional preservative agent for cosmetic preparations, Asian J. Pharm. Clin. Res., 10 (August 2017) pp. 129-133; hereinafter, “Sirilun”). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
The recitations of the ‘061 Application and Jokić, as discussed above, are hereby incorporation. To the extent that the references DO NO RECITE the incorporation of a preservative, such as phenethyl alcohol, per the requirements of claims 4 and 16-17, the incorporation thereof would be obvious per Sirilun, in order to obtain the advantage of suitable “[p]reservatives [that] are used in the cosmetic products to protect the potential growth of microbes, therefore, to prolong the shelf life of products, and to protect the consumer from infections” (Sirilun, abstract).
Thus, the ‘061 Application per Jokić and Sirilun render claims 4 and 16-17 obvious.
Conclusion
Claims 1-5 and 12-19 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
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//DOMINIC LAZARO/ Primary Examiner, Art Unit 1611