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 .
Status of the Claims
Claims 1-18 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/FR2022/052323, filed on 12/13/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 the applicant regards as his invention.
Claims 7, 9-10 and 13-16 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 “advantageously” renders claims 7 and 9-10 indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The term “advantageously” is used 60 times in the instant Specification, and in some instances in more refined context of “more advantageously” or “very advantageously”; however in none of those instances is the term “advantageously” defined as regards the context of the instant invention, let alone the intended distinction between levels of advantage, as regards “more advantageously” and “very advantageously”. The commonly accepted definition of “advantageously” is “in an advantageous manner”1, with “advantageous” defined as “giving and advantage” or “favorable”.2 A person of ordinary skill in the art would not understand whether claims 7 and 9-10 are meant to encompass only the most favorable embodiments disclosed therein, or all embodiments disclosed therein equally, and therefore would not understand the metes and bounds of the claims.
In claim 13, the claim limitation “configured for preparing the composition” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 13 further limits claim 1, regarding a composition comprising specific ingredients in specific concentration ranges, to a microalgal extract chosen from any of a Markush group of taxa, with the additional limitation that the microalgal extract is “configured for preparing the composition as claimed in claim 1”. The claim does not further specify what is the structure of the microalgal extract that satisfies the limitation of being “configured for preparing the composition” of claim 1. The instant Specification does not include the word “configured” anywhere, and does not disclose any requirement for a microalgal extract that is included in a composition according to claim 1. The instant Specification does provide an “Example 1”, wherein an extract is obtained of the microalga Tisochrysis lutea by extraction of fresh biomass in an ethanol/water mixture (95:5, v/v) and dilution of the alcoholic extract into coconut kernel oil (pages 13-14, bridging paragraph), and the extract thereby obtained is found to contain all the required ingredients of the composition of instant claim 1; however, neither the claim 13 nor the Specification requires that the present invention be prepared solely from a microalgal extract. Thus, the composition of claim 1 can be prepared in the absence of any microalgal extract, and the inclusion of a microalgal extract in the composition does not require that the microalgal extract contribute any of the required ingredients, much less all of the ingredients, nor even a mixture of all of the ingredients in respective proportions as described in claim 1. Thus, a person of ordinary skill in the art would not understand what microalgal extracts are “configured for preparing the composition as claimed in claim 1” and which microalgal extracts are not so configured. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 14 depends from and further limits claim 13, but does not resolve the indefiniteness of the claim limitation of a microalgal extract that is “configured for preparing the composition as claimed in claim 1”.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
In claim 15, the claim limitation of a composition according to claim 1 that is “configured to obtain a soothing effect on the skin and/or to maintain homeostasis” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 15 further limits claim 1, regarding a composition comprising specific ingredients in specific concentration ranges, to wherein the composition is “configured to obtain a soothing effect on the skin and/or to maintain homeostasis”. The claim does not further specify what is the structure of the composition that satisfies the limitation of being “configured to obtain a soothing effect on the skin and/or to maintain homeostasis”. The instant Specification does not include the word “configured” anywhere, and does not disclose any requirement for a composition that obtains a soothing effect and/or maintains homeostasis, beyond the composition already claimed in parent claim 1. The Specification states that “Applicant has discovered that a composition which comprises from 0.1 to 8.0 mg/g of at least one xanthophyll, from 1.0 to 45.0 mg/g of at least one omega-3 type fatty acid, from 0.02 to 0.8 mg/g of at least one sterol, from 0.05 to 1.5 µg/g of at least one phycoprostane and 700 to 990 mg/g of at least one plant oil have effects on the expression of certain proteins of interest in the neuro-immunocutaneous system, with the unexpected effect of soothing the skin, in particular sensitive skin. The composition also has effects on increasing the length of neuronal extensions, allowing homeostasis to be maintained.” No further structural requirement for a composition that includes the functional limitation of being configured to obtain a soothing effect on the skin and/or to maintain homeostasis” is provided; thus, it is unclear to a person of ordinary skill in the art whether claim 15 is further limiting to claim 1, and if claim 15 were further limiting, what additional structural requirement(s) exist for a composition to meet the claimed functional requirement being “configured to obtain a soothing effect on the skin and/or to maintain homeostasis”. The Specification does define the term “maintaining homeostasis” to an effect on the length of neurons in the skin, that being the maintenance and/or lengthening of said neurons (page 10, lines 31-36) and defines the term “providing a soothing effect” to mean reducing the gene and/or protein amount of the neuropeptide CGRP (Calcitonin Gene-Related Peptide), a known pain neuromediator (page 8, lines 22-25). The Specification includes “Example 2”, wherein cultured skin cells (keratinocytes) are exposed to “the composition according to the invention” and to an irritant (capsaicin or allyl isothiocyanate) or to vehicle-control (dimethyl sulfoxide) and after 30 minutes, the supernatant of each culture sample is recovered and analyzed by enzyme-linked immunosorbent assay (ELISA) for the concentration of CGRP (pages 14-18). The disclosure does not provide the precise composition used in Example 2; thus, it is unknown whether the same composition as prepared in “Example 1” from an extract of Tisochrysis lutea was used, or a different composition, and with what ingredients in what concentrations, and/or what structural requirement was observed beyond the limitations of claim 1 that would then meet the further limitation of claim 15 of being “configured to obtain a soothing effect on the skin and/or to maintain homeostasis”. The Specification does not provide any example in regard to the defined effect of “maintaining homeostasis” in terms of any effect on the length of skin cell neurons.
A review of the field of art finds that Applicant’s definition of “providing a soothing effect” is known in the art, as evidenced by Rizzi (Rizzi, et al.; Cosmetics, v8, article 66, pp1-80; 2021), who teaches that CGRP is one of about 25 neuromediators that have been found in skin, the release of said neuromediators being triggered by physical, chemical or even emotional stimuli (page 5). Rizzi teaches examples of “cosmeceutical” formulations that reduce the release of CGRP, as stimulated by, for example, exposure to capsaicin, similar to the instant Specification’s “Example 2”, including Pinus cembra wood extract (page 15), synthetic tetrapeptides in water/glycerol (“Skinasensyl LS 9749”, page 16; and “Skinasensyl LS 9852”, page 17), and a “Swiss Stone Pine Extract” (page 30). The Swiss Stone Pine Extract is cited to Wandrey (Wandrey, et al.; Personal Care Asia Pacific, “Flawless skin via Swiss stone pine extract”, pp27–30; 2016), who attributes the CGRP-reducing effect to the including of “pinosylvin”3, a stilbene derivative that does not fall under any of the categories of required ingredients of instant claim 1. Thus, a person of ordinary skill in the art would understand that the limitation of “providing a soothing effect” can be alternatively met by a composition that meets the limitations of instant claim 1, without any further structural limitation, or by any of various formulations that do not necessarily meet the limitations of claim 1, and thus it is not clear whether/how claim 15 further limits the structure of the composition of claim 1. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claim 16 depends from and further limits claim 15, but does not resolve the indefiniteness of the claim limitation of a composition that is “configured to obtain a soothing effect on the skin and/or to maintain homeostasis”.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-10 and 13-14 are anticipated by Pradelles.
Claims 1, 5-10 and 13-14 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pradelles (U.S. PG Pub 2020/0268816 A1).
Claim 1 is drawn to a composition comprising specific ingredients, each in a specific concentration range, as listed below:
at least one xanthophyll, from 0.1 to 8.0 mg/g;
at least one omega-3 type fatty acid, from 1.0 to 45.0 mg/g;
at least one sterol, from 0.02 to 0.8 mg/g;
at least one phycoprostane, from 0.05 to 1.5 mg/g;
at least one plant oil; from 700 to 990 mg/g.
Pradelles discloses a composition comprising specific ingredients, each in a specific concentration range, as listed below (Abstract):
at least one xanthophyll, at least 10 mg/g;
at least one omega-3 type fatty acid, from 50 mg/g;
at least one sterol, from 1 mg/g;
at least one phycoprostane, from 2 mg/g.
Pradelles further discloses “Example 4”, regarding a food supplement prepared from a Phaeodactylum tricornutum extract which comprises the following ingredients in mg/g concentrations (paragraphs [0229]-0233]):
Fucoxanthin, a xanthophyll, 20.0[Symbol font/0xB1]4.0;
Omega-3 type fatty acids (ALA, SDA, EPA, DHA), 66.6[Symbol font/0xB1]11.5;
Sterols, 3.0[Symbol font/0xB1]0.6;
Phycoprostane, 0.0025[Symbol font/0xB1]0.0005.
The food supplement disclosed by Pradelles is prepared by addition of coconut oil (a plant oil, according to the instant Specification, page 5, lines 25-32) to reach a proportion of 410[Symbol font/0xB1]20mg/g to the extract discussed above (paragraph [0234]), and that the supplement is incorporated into kibbles, by further dilution of the extract/coconut oil composition with more coconut oil, specifically an equal amount final mass (paragraph [0235]). This preparation of “supplement” (microalgal extract with coconut oil), further diluted with more coconut oil, ready for incorporation into a kibble, is composed as follows: each 1 gram of supplement includes up to 430 mg of coconut oil, and therefore approximately 570 milligrams of microalgal extract, and is further diluted with an equal mass of coconut oil, thus each 2 grams of pre-kibble composition contains 570 mg of the original extract, and so the ingredients listed above are reduced to 570/2000 or 28.5% of their original concentration, giving the following resulting content:
Fucoxanthin, a xanthophyll, 5.7[Symbol font/0xB1]1.1;
Omega-3 type fatty acids (ALA, SDA, EPA, DHA), 19.0[Symbol font/0xB1]3.3;
Sterols, 0.86[Symbol font/0xB1]0.2;
Phycoprostane, 0.00071[Symbol font/0xB1]0.0001.
The coconut oil in this pre-kibble preparation comprises 1.43 grams out of the 2 grams total, or 715mg/g. Thus, the pre-kibble preparation disclosed by Pradelles meets all the limitations of instant claim 1.
Thus, claim 1 is anticipated by the disclosure of Pradelles.
Claim 5 further limits claim 1 to wherein the plant oil is selected from a Markush group that includes medium-chain triglyceride oil, which the instant Specification defines as available as coconut oil. Claim 6 further limits claim 5 to wherein the medium-chain triglyceride oil is slected from a Markush group that includes coconut oil. Thus, claims 5 and 6 are met by the disclosure of Pradelles discussed above which uses coconut oil.
Claim 7 further limits claim 1 to wherein at least one of the omega-3 fatty acid(s) is chosen from stearidonic acid (SDA), eicosapentaenoic acid (EPA) docosahexaenoic acid (DHA) and/or any of the mixtures thereof, and is met by the disclosure of Pradelles discussed above, which comprises a mixture of SDA, EPA and DHA.
Claim 8 further limits claim 1 to wherein at least one of the xanthophyll(s) is fucoxanthin, and is met by the disclosure of Pradelles above.
Claim 9 further limits claim 1 to wherein the at least one sterol is chosen from phytosterols, which the instant Specification defines as including “natural sterols” (page 5, lines 1-7), and therefore must include the sterol(s) obtained by Pradelles by extraction of microalgae, a natural organism.
Claim 10 further limits claim 1 to wherein the phycoprostane(s) content is chosen from phycoprostanes, isoprostanes and neuroprostanes. The instant Specification defines that phycoprostanes are “naturally occurring, structurally prostaglandin-like lipids resulting from non-directly enzymatic oxidations of fatty acids naturally present in microalgal biomasses, combined in the present text under the term phycoprostanes” (page 5, lines 8-11). The Specification further discloses that the type of phycoprostane is defined by which fatty acid has undergone the oxidation, and that some phytoprostanes are derived from a-linolenic acid (ALA), while isoprostanes can be derived from EPA and neuroprostanes are mainly derived from DHA (page 5, lines 11-21). Since Pradelles’ pre-kibble composition includes phycoprostanes obtained from a microalgal extract that includes ALA, EPA and DHA, a person of ordinary skill in the art would at once envisage that the phycoprostanes found therein would include those that are derived from ALA, EPA and DHA, which would include phytoprostanes, isoprostanes and neuroprostanes.
Claim 13 further limits claim 1 to wherein the composition includes a microalgal extract from any of a Markush group of taxa that includes Phaeodactylaceae, and is met by the disclosure of Pradelles discussed above. Claim 14 further limits claim 13 to a smaller group of microalgal taxa that still includes Phaeodactylaceae, and is met by the disclosure of Pradelles discussed above.
Thus, claims 5-10 and 13-14 are anticipated by the disclosure of Pradelles.
Allowable Subject Matter
Claims 2 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 See, for example, Merriam-Webster dictionary: https://www.merriam-webster.com/dictionary/advantageously
2 See, for example, Merriam-Webster dictionary: https://www.merriam-webster.com/dictionary/advantageous
3 3,5-dihydroxystilbene
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