DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 1, 3-20 are pending. Applicant’s election with traverse of Group I (i.e. claims 1, 3-20 drawn to a lysate of dedifferentiated cells of the plant Helichrysum stoechas) in the reply filed on June 16, 2025 is acknowledged.
Applicant's election with traverse of Group I and the following species:
1. Gel: "linear or branched or crosslinked polymers of polyelectrolyte type" as a thickening and/or gelling agent; and "glycerol" as a solvent;
2. Water-in-oil emulsion: "Caprylic/capric triglyceride" as the oil; and "compositions of alkylpolyglycosides and of fatty alcohols, more particularly the composition of Cl4-C22 alcohols and C12-C20 alkylpolyglucosides" as the emulsifying surface-active agent; and
3. Oil-in-water emulsion: "PEG-100 Stearate and Glyceryl Stearate" as the surface-active agent of the oil-in-water type; and "Caprylic/capric triglyceride" as the oil, in the reply filed on June 16, 2025 is acknowledged.
With regard to the restriction requirement, Applicant has argued that the claims of the identified groups are related as a product and a process specifically adapted for the manufacture of said product which is expressly permitted by 37 CFR 1.475(b)(1). With regard to the species election, Applicant further argues that the Office Action merely lists the criteria applicable to requiring an election of species without explaining how those criteria are considered to apply to the claimed subject matter. However, Applicant’s arguments have not found to be persuasive for the reasons of record:
Groups I and II lack unity of invention between groups because the technical feature (i.e. a lysate of dedifferentiated cells of the plant Helichrysum stoechas) does not make a contribution over the prior art in view of Recio, et al, (1991). Anti-Inflammatory Activity of Helichrysum stoechas. Planta Medica- PLANTA MED. 57. 10.1055/s-2006-960317, which teaches topical and anti-inflammatory properties of Helichrysum stoechas (see Requirement for Restriction, dated 4/16/25 at page 4). Moreover, as previously of record, species (a)-(e) do not relate to a general inventive concept because each species is not considered to be of a similar nature and are structurally dissimilar such that the species are drawn to different forms (gel, o/w emulsion, w/o emulsion), of dissimilar chemical types (solvents, agents, waxes, oils), and would have different utility in the art (Requirement for Restriction, dated 4/16/25 at page 6). Accordingly, the species lack a special technical feature and lack unity of invention. The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on August 16, 2022 and April 2, 2025 have been considered by the Examiner; however, the IDS’s contain references that are in a foreign language. The relevant portions of 37 CFR § 1.98 (a) and (b) state:
(a) Any information disclosure statement filed under § 1.97 shall include the items
listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section...
(2) A legible copy of:
(i) Each foreign patent;
(ii) Each publication or that portion which caused it to be listed, other than U.S. patents and U.S. patent application publications unless required by the Office;
(iv) All other information or that portion which caused it to be listed.
(3)(i) A concise explanation of the relevance, as it is presently understood by the individual designated in § 1.56(c) most knowledgeable about the content of the information, of each patent, publication, or other information listed that is not in the English language. The concise explanation may be either separate from applicant’s specification or incorporated therein.
(ii) A copy of the translation if a written English-language translation of a non-English-language document, or portion thereof, is within the possession, custody, or control of, or is readily available to any individual designated in § 1.56(c).
(b)(4) Each foreign patent or published foreign patent application listed in an
information disclosure statement must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(5) Each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication.
Accordingly, the references have been considered to the extent presented in the English language; as presented and accompanied by reference document which is an English language equivalent or translation, to the extent cited in the instant Application’s disclosure, or as cited by the Examiner in a PTO-892. References which have been considered have been initialed (fully considered) or also annotated in the IDS (to indicate the extent considered). References which have not been considered have been lined through.
In the instant case, several Foreign Patent Documents and Other Documents lack an accompanied document and/or a reference document which is an English language equivalent or translation as indicated in the IDS, and therefore have not been considered and/or considered fully.
Please also note, Applicant is required to provide page numbers and/or a page sheet count in the citation.
Claim Rejections - 35 USC § 112
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 the applicant regards as his invention.
Claims 3-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “suitable” in claim(s) 3, 6, 10, 11, and 13 is a relative term which renders the claim(s) indefinite. The term “suitable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claim recites a lysate of dedifferentiated cells of the plant Helichrysum stoechas in a form suitable for topical administration (as disclosed in claim 1 of the instant application). Thus, the claim does recite a product of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, lysis of naturally occurring Helichrysum stoechas cells only breaks cells down into its component’s parts, including proteins and/or nucleic acids, which are also naturally occurring products. There is no evidence or reason to expect that any new compounds are formed. The lysate itself is a mixture of the naturally occurring proteins and/or nucleic acids found in the larger cell(s). Thus, while lysis alters the structure of the cell(s), the result of lysis is still a mixture of components which are naturally found i.e., the components are not inventive or “man-made.” Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, Applicant’s claim is directed to a lysate of dedifferentiated cells of the plant Helichrysum stoechas in a form suitable for topical administration with an intended use of eliminating or reducing inflammation of the skin and/or scalp. Applicant’s claim is directed to a lysate with an intended use of eliminating or reducing inflammation of the skin and/or scalp. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Moreover, Helichrysum stoechas and water is a form suitable for topical administration. The combination of Helichrysum stoechas and water is present in nature and therefore there is no additional element to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and/or the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
In addition, applicant’s intended use of treating inflammation of the skin and/or scalp is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 3-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paufique, J. (FR3040625A1) in view of Izuhara, et al. “Periostin in inflammation and allergy.” Cell Mol Life Sci. 2017 Dec;74(23):4293-4303. Doi: 10.1007/s00018-017-2648-0. Epub 2017 Sep 8.
The instant claim(s) is/are of record, drawn to the following: a lysate of dedifferentiated cells of the plant Helichrysum stoechas in a form suitable for topical administration for eliminating or reducing inflammation of the skin and/or of the scalp, in some embodiments, further comprising a gel (i.e. comprising “linear or branched or crosslinked polymers of polyelectrolyte type” as a thickening and/or gelling agent; and “glycerol” as a solvent); water-in-oil emulsion (i.e. comprising “caprylic/capric triglyceride” as the oil; and “compositions of alkylpolyglycosides and of fatty alcohols, more particularly the composition of Cl4-C22 alcohols and C12-C20 alkylpolyglucosides” as the emulsifying surface-active agent); or oil-in water emulsion (i.e. comprising “PEG-100 Stearate and Glyceryl Stearate” as the surface-active agent of the oil-in-water type; and “caprylic/capric triglyceride” as the oil) form(s)).
Paufique, J. teaches use of Helichrysum stoechas (comprising Helichrysum stoechas in its “natural state”) as a topical cosmetic composition to fight against skin aging (see Claim 1; Description page 2) (as required in claim(s) 1, 3-20, broadly teaching a lysate of dedifferentiated cells). Paufique, J. teaches that periostin, a matrix protein stimulated by the active ingredients found in Helichrysum stoechas, plays a role in the formation and maturation of collagen fibers and modulates cell activity to maintain the integrity of the skin tissue and protect it against mechanical aggression. Paufique, J. teaches composition(s) in the form of oil-in-water emulsions, water-in-oil emulsions, and aqueous gels (see Claim 15) (as required in claim(s) 1, 3-20, broadly teaching said composition form(s)). Paufique, J. further teaches:
The compositions according to the invention may contain as adjuvant at least one compound chosen from: oils, which may be chosen in particular from silicone oils, linear or cyclic, volatile or non-volatile; waxes, such as ozokerite, polyethylene wax, beeswax or carnauba wax, silicone elastomers, surfactants, preferably emulsifiers, whether they are nonionic, anionic or cationic or amphoteric, co-surfactants, such as linear fatty alcohols, thickeners and / or gelling agents, humectants, such as polyols such as glycerine, organic filters, inorganic filters, dyes, preservatives, fillers, tensors, sequestering agents, perfumes, and their mixtures, without this list being limiting.
(see Description, page 3; emphasis added) (as required in claim(s) 3-20,
broadly teaching gelling and/or thickening agents, emulsion oil, and surface-
active agent” of the o/w emulsion).
Paufique, J. is silent as to Helichrysum stoechas for treating inflammation of the
skin and/or scalp and/or reducing and/or eliminating stinging and/or tingling and/or itching and/or heating and/or red patches and/or skin discomfort and/or tightness of the skin caused by inflammation of human skin and/or the scalp (as required in claims 5, 9, 14-15).
However, Izhura, et al., teaches periostin is involved in inflammatory processes (e.g. atopic dermatitis). Izhura, et al., further teaches periostin’s role in inflammatory processes and allergy and high expression in chronic inflammatory diseases including atopic dermatitis (see Abstract) (as required in claims 5, 9, 14-15; broadly teaching reducing inflammation of the skin and/or scalp caused by inflammation of huma skin and/or scalp).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have modified the composition comprising Helichrysum stoechas for treating anti-aging as taught by Paufique, J. for treating inflammation of the skin and/or scalp. A person of ordinary skill in the art would have been motivated to use a composition comprising Helichrysum stoechas for treating inflammation of the skin and/or scalp, particularly where it was known in the art that periostin is involved in inflammatory processes (e.g. atopic dermatitis) such as periostin’s role in inflammatory processes and allergy and high expression in chronic inflammatory diseases including atopic dermatitis (see Abstract) (as required in claims 1, 3-20; broadly teaching reducing inflammation of the skin and/or scalp)).
A person of ordinary skill in the art would have had a reasonable expectation of success for using Helichrysum stoechas for treating inflammation of the skin and/or scalp in a composition comprising a gel, w/o emulsion or o/w emulsion form and agents thereof, as instantly claimed. Thus, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Paufique, J. and Izhura, et al., and to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the percent by weight of each ingredient in the claimed compositions) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within recited processes), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Relevant Art
The relevant and/or prior art made of record and not relied upon is
considered pertinent to applicant’s disclosure, including the following:
Mandeau, et al. (WO 2019106203A1), considered relevant for generally teaching Helichrysum gymnocephalum extract for its use in the treatment and/or prevention of inflammatory dermatoses. (see Abstract). For example, Mandeau, et al. teaches “the use of an extract of Helichrysum gymnocephalum for the manufacture of a dermo-cosmetic or dermatological composition intended for the treatment and/or the prevention of inflammatory dermatoses” (see page 2) wherein “said extract… is advantageously obtained from the aerial parts of the plant (eg stems and /or leaves) or from the whole plant, fresh or dried, whole, cut or crushed, subjected (s) at least one extraction with a… solvent” (see page 2). Mandeau, et al. teaches the Helichrysum gymnocephalum extract is “advantageously intended for topical application, in particular by application to the skin.” (see page 3). Mandeau, et al. further teaches the extract may comprise a solvent (e.g. glycerol) and/or alkylpolyglycoside. Mandeau, et al. is silent regarding a lysate of dedifferentiated cells (claim(s) 1, 3-20); gelling and/or thickening agents (e.g. comprising “linear or branched or crosslinked polymers of polyelectrolyte type”) (claim(s) 3-9, 16-20); “caprylic/capric triglyceride” as the emulsion oil (as required in claim(s) 10-15); and “PEG-100 stearate and glyceryl stearate” as the surface-active agent” of the o/w emulsion (as required in claim(s) 10, 13-15).
Chang, et al. “Generic development of topical dermatologic products:
formulation development, process development, and testing of topical dermatologic products.” AAPS J. 2013 Jan;15(1):41-52, considered relevant for generally teaching development of semi-solid topical generic products (Abstract). For example, Chang, et al. teaches formulation components for topical drug products including Emollient/Stiffening Agent/Ointment Bases (e.g. polyethylene glycol); Emulsifying agent/solubilizing agents; Thickening Gelling Agents; Preservatives; Permeation Enhancers; Chelating agents; Antioxidants; Acidifying/Alkalizing Buffering Agents; and Vehicle Solvents. (see Table II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vani G. Verkhovsky whose telephone number is (571)272-3777. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at (571) 272-0775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655
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