DETAILED ACTION
Claims 1 and 19-35 are pending. Of these, claim 1 is withdrawn as directed to a nonelected invention. Therefore, claims 19-35 are under consideration on the merits.
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/Restriction
Applicant’s election of Group III is acknowledged. Since Applicant did not point to any alleged deficiencies in the restriction requirement, the election has been treated as having been made without traverse. The restriction requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/23, 11/3/23, 1/28/25, 2/17/25, 4/7/25, and 4/11/25 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
37 CFR 1.121
The following is a quotation of 37 CFR 1.121(c):
(Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
The amendment submitted 4/24/26 is not in compliance with 37 CFR 1.121, since claim 32 was newly added but was not identified as such. Applicant is reminded to ensure that the claim identifiers are correct in the response to this Office Action.
Claim Objections
Claim 30 is objected to because of the following informalities: in line 3, “weigh” should be “weight.” Correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 and 24 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention.
While all of the factors have been considered, only those required for a prima facie case are set forth below.
Newly added claim 24 recites that the skin condition is dandruff. Applicant did not point to where support could be found for this limitation. The Office has reviewed the specification but could not locate any disclosure that the skin condition may be dandruff. Therefore, claim 24 prima facie comprises new matter.
Claim 21 recites that the first total fatty acid content comprises at least 80% C18:1, C18:2, and C18:3 free fatty acids, wherein C18:1 comprises from about 10-30%, the C18:2 comprises about 35% to 65%, and the C18:3 comprises from about 10% to about 40%. Applicant did not point to where support could be found for this claim. The Office has reviewed the specification but could not locate any support for “at least 80% C18:1, C18:2, and C18:3 free fatty acids.” Paragraph 160 as published provides ranges for C18:1, C18:2, and C18:3 free fatty acids individually that encompass the ranges recited by the claim, but does not recite that in combination they comprise at least 80%” of the first total fatty acid content. Paragraph 177 as published recites that the oil composition can comprise “at least 80%” free fatty acids, but this refers to the total amount of free fatty acids, and not the amount of C18:1, C18:2, and C18:3 free fatty acids specifically. Therefore, claim 21 prima facie comprises new matter.
Claims 19, 21-23, 25-26, 28-30, and 32-35 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while enabling for a method of treating or preventing a skin condition whose etiology involves a microbial infection, is not enabling for a method of treating or preventing other skin conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with the claims.
The factors for determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the full scope of the claimed invention without undue experimentation.
While all of the factors have been considered, only those deemed necessary for a prima facie case are set forth below.
Scope or breadth of the claims
The claims are broadly drawn to a method for treating or preventing a “skin condition” in a subject in need thereof. The claims encompass, for example, the treatment or prevention of skin cancer, sunburn, wrinkles, insect bites, age spots, and vitiligo, all of which the skilled artisan would recognize as “skin conditions.”
Degree of predictability/Teachings of the prior art
Nakatsuji et al. (Journal of Investigative Dermatology (2009), Volume 129) teaches that medium chain fatty acids such as lauric acid have strong bactericidal properties, exhibiting an inhibitory effect on the growth of skin bacteria such as P. acnes, S. Aureus, and S. epidermidis at a concentration 15 times lower than that of benzoyl peroxide, which is a frequently used acne treatment. Zheng et al. (FEBS Letters 879 (2005) 5157-5162) teaches that long chain unsaturated fatty acids such as oleic acid, linoleic acid, and linolenic acid have antibacterial activity including against Staphylococcus aureus. Therefore, the prior art indicates that it was known that fatty acids can inhibit bacterial strains that are known to cause skin infections. The prior art does not, however, teach or suggest that administration of compositions comprising fatty acids within the scope of the claims could treat or prevent any and all skin conditions, including those unrelated to bacterial infections. The skilled artisan could not have reasonably predicted based upon the prior art that the claimed method could treat or prevent, for example, skin conditions that are not characterized by a bacterial infection such as skin cancer, sunburn, wrinkles, mosquito bites, age spots, or vitiligo.
The evidence viewed as a whole, therefore, indicates a high degree of unpredictability in the technical field of administering fatty acid compositions to treat skin conditions not caused or exacerbated by a bacterial infection.
Amount of guidance/Presence of working examples
The specification discloses working examples showing the ability of inventive compositions to inhibit various bacterial strains (e.g., Examples 24-29, 34-41, 44-47), but there are no working examples demonstrating the ability of the claimed methods to treat or prevent any skin conditions not involving a bacterial infection.
Quantity of experimentation required to make and use the invention
One of ordinary skill in the art would have to conduct a myriad number of experiments in order to determine what skin conditions, if any, other than those involving an antimicrobial infection, could be treated or prevented using the claimed methods.
For the foregoing reasons, the preponderance of the evidence, viewed as a whole, demonstrates that one of ordinary skill in the art at the time of the invention could not have made and used the full scope of the invention as claimed without undue experimentation. Therefore, the claims are prima facie non-enabled.
Claim Rejections - 35 USC § 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 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 19 is rejected under 35 U.S.C. 103 as unpatentable over Hollander et al. (US Pat. Pub. 2015/0025145) in view of Nakatsuji et al. (Journal of Investigative Dermatology (2009), Volume 129).
As to claim 19, Hollander teaches that certain medium chain fatty acids having 6-12 carbon atoms such as lauric acid have beneficial antimicrobial properties, but that the triglycerides containing these fatty acids do not have antimicrobial activity themselves, but rather the fatty acids must be separated from their glycerol backbone and used in their free fatty acid form (paragraphs 2-4). Hollander discloses an antimicrobial composition comprising as the active ingredient free fatty acids obtained by splitting a lauric oil so as to recover a composition comprising 95 wt% or more free fatty acids (which reads on the “at least 80% free fatty acids” range recited by the claim, and which further implies that the triacylglycerol content is 5 wt% or less, which reads on the “less than 5%” range recited by the claims), and wherein the lauric acid may be obtained from a mixture of coconut oil and palm kernel oils (wherein said mixture is an “oil component” comprising a “first oil having a first fatty acid content” and a “second oil having a second fatty acid content” of claim 19 (see claims 15, 18, and 21 of Hollander).
As to claim 19, Hollander does not further expressly disclose a method for treating or preventing a skin condition in a subject in need thereof comprising applying the antimicrobial composition to the skin of a subject in need thereof as recited by claim 19.
Nakatsuji teaches that lauric acid has strong bactericidal properties, exhibiting an inhibitory effect on the growth of skin bacteria such as P. acnes, S. Aureus, and S. epidermidis at a concentration 15 times lower than that of benzoyl peroxide, which is a frequently used acne treatment (Abstract and 1st full paragraph of page 2484). Nakatsuji concludes that lauric acid is a suitable alternative treatment option to antibiotic therapy of acne vulgaris.
As to claim 19, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Hollander by administering the lauric acid antimicrobial composition taught therein to the skin of a subject to treat a skin condition involving a bacterial infection such as acne, because Nakatsuji teaches that lauric acid has strong inhibitory activity against skin bacteria such as P. acnes, making it an alternative treatment option for acne.
Claims 21-23 and 26-34 are rejected under 35 U.S.C. 103 as unpatentable over Hollander et al. (US Pat. Pub. 2015/0025145) in view of in view of Nakatsuji et al. (Journal of Investigative Dermatology (2009), Volume 129) as applied to claim 19 above, and further in view of Zheng et al. (FEBS Letters 879 (2005) 5157-5162)
The teachings of Hollander and Nakasuji are relied upon as discussed above, and Hollander further teaches that the antimicrobial composition additionally comprises C8 and C10 fatty acids as recited by claim 22 (paragraphs 24-29). Additionally, since Hollander teaches that the composition comprises 95 wt% or more free fatty acids as discussed above, this implies that the splitting of the glycerol backbone is not complete such that some monoacylglycerols may be present as recited by claims 28 and 32. Hollander and Nakasuji do not further expressly disclose, however, that the first total fatty acid content comprises the C8 and C10 fatty acids in the amount recited by claim 22, nor that the first total fatty acid content comprises C18:1, C18:2, and C18:3 free fatty acids in the amounts recited by claim 21, 28-29, and 33 nor the amounts of C16, C18:1, and C18:2 recited by claim 32, nor the relative amounts of the first and second amounts of the oil component is within the ranges of claims 23, 26, 30 and 34.
Zheng teaches that long chain unsaturated fatty acids such as oleic acid (a monounsaturated acid, i.e., C18:1), linoleic acid (a C18:2 fatty acid), and linolenic acid (a C18:3 fatty acid) have antibacterial activity including against Staphylococcus aureus, and further that long chain saturated fatty acids including palmitic acid and stearic acid also have antibacterial activity, but to a lesser degree (Abstract and first paragraph of section 1 and first full paragraph of page 5161). Zheng discloses that the antimicrobial activity of the fatty acids can vary according to the number of carbons in the fatty acid (see Table 1).
As to claims 21-22, 28-29 and 32-33, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Hollander and Nakasuji as combined supra by incorporating oleic acid (a C18:1 fatty acid), linoleic acid (a C18:2 fatty acid), and linolenic acid (a C18:3 fatty acid) into the antimicrobial composition comprising lauric acid as antimicrobial active taught by Hollander, because Zheng teaches that these fatty acids have antibacterial activity including against Staphylococcus aureus which is the same bacteria lauric acid has activity against as taught by Nakatsuji, such that the skilled artisan reasonably would have expected that they would impart additional anti-acne activity to the Hollander composition. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious). MPEP 2144.06 I. It further would have been prima facie obvious to conduct an optimization process to arrive at the relative amounts of these fatty acids as recited by the claims, because Zheng teaches that different fatty acids have different levels of antimicrobial activity and that unsaturated fatty acids exhibit greater inhibition of antimicrobial activity such that the skilled artisan would have been motivated to optimize the relative amounts of the fatty acids to determine the best proportions. The skilled artisan would have had a reasonable expectation of success in arriving at the claimed ranges because the optimization would have been for the same function of the fatty acids in the claimed method, i.e., to treat a skin condition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 23, 26, 30, and 34, it further would have been prima facie obvious to conduct an optimization process to arrive at the relative amounts of the first oil and the second oil as recited by these claims, because Zheng teaches that different fatty acids have different levels of antimicrobial activity such that the skilled artisan would have been motivated to optimize the relative amounts of the first and second oils (which come from a different source and therefore have different fatty acid contents) to determine the best proportions. The skilled artisan would have had a reasonable expectation of success in arriving at the claimed ranges because the optimization would have been for the same function of the fatty acids in the claimed method, i.e., to treat a skin condition. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 20 and 35 are rejected under 35 U.S.C. 103 as unpatentable over Hollander et al. (US Pat. Pub. 2015/0025145) in view of in view of Nakatsuji et al. (Journal of Investigative Dermatology (2009), Volume 129) and Zheng et al. (FEBS Letters 879 (2005) 5157-5162) as applied to claims 21-23 and 26-34 above, and further in view of Alexander et al. (British Journal of Dermatology (2020) 182, 1331-1342).
The teachings of Hollander, Nakasuji, and Zheng are relied upon as discussed above, but they do not further expressly disclose that the skin condition is atopic dermatitis as recited by claim 20 or that the composition is a cream (claim 35).
Alexander teaches that patients with atopic dermatitis have an increased risk of bacterial skin infection which can cause significant morbidity, and that the most common infection in these patients is by Stabphylococcus aureus (Summary on page 1331). Alexander further cites to another reference which discloses that atopic dermatitis may be treated by application of a cream comprising an active ingredient against atopic dermatitis (see footnote 114 on page 1341).
As to claims 20 and 35, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Hollander, Nakasuji, and Zheng as combined supra by administering the antimicrobial composition to a subject suffering from atopic dermatitis in the form of a cream, because Alexander teaches that patients with atopic dermatitis have an increased risk of bacterial skin infection which can cause significant morbidity and that an active for treatment of atopic dermatitis may be delivered to a patient by formulating it as a cream, and that the most common infection in these patients is by Staphylococcus aureus, and Nakasuji teaches that the lauric acid present in the Hollander composition has strong bactericidal properties against the growth of S. Aureus, such that the skilled artisan reasonably would have expected that it could treat a bacterial skin infection caused by S. Aureus on the skin of a patient with atopic dermatitis, helping to prevent significant morbidity from occurring in said patient when administered in the form of a cream.
Claims 24-25 are rejected under 35 U.S.C. 103 as unpatentable over Hollander et al. (US Pat. Pub. 2015/0025145) in view of in view of Nakatsuji et al. (Journal of Investigative Dermatology (2009), Volume 129) and Zheng et al. (FEBS Letters 879 (2005) 5157-5162) as applied to claims 21-23 and 26-34 above, and further in view of Mas-ud et al. (J. Pure Appl. Microbiol., 14(1), 147-156 (March 2020).
The teachings of Hollander, Nakasuji, and Zheng are relied upon as discussed above, but they do not further expressly disclose that the skin condition is dandruff (claim 24) or that the composition is in the form of a shampoo (claim 25).
Mas-ud discloses that multiple factors can contribute to dandruff including shampooing too often, that bacteria are involved in the formation of dandruff along with fungi, and that Staphylococcus aureus was the predominant strain found on the scalp of a subject suffering from dandruff and that this bacterial strain is a target for treatment to control dandruff (Abstract; page 148; 1st and 2nd paragraphs; paragraph bridging pages 153 and 154; Conclusion section on page 156).
As to claims 24-25, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Hollander, Nakasuji, and Zheng as combined supra by incorporating the lauric acid-containing composition into a shampoo and administering it to a subject for the treatment of dandruff, because Nakasuji teaches that lauric acid inhibits the grown of Stapylococcus aureus and Mas-ud teaches that Stapylococcus aureus is a bacterial species that is present in dandruff such that the skilled artisan reasonably would have expected that the lauric acid-containing composition of Hollander could be used to treat dandruff in a subject having Stapylococcus aureus on the scalp, and because Mas-ud teaches that frequent shampooing can exacerbate dandruff such that the skilled artisan would have been motivated to incorporate the lauric acid composition into a shampoo to provide for convenient administration of the composition to scalp containing dandruff as well as to counteract the dandruff-promoting effects that may be caused by too frequent shampooing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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