DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Status of the Claims
The claims filed 02/16/2024 are under consideration.
Claims 1-7 are pending.
Claims 1 and 7 are independent
Claims 1-7 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
1. Claim 1 includes the limitation:
preparing a mixture containing
a predetermined amount of at least one type of plant-derived oil, or
a predetermined amount of fruit or part of a fruit infused with herbs;
a predetermined amount of extracts from shea tree;
predetermined amount of extracts from aloe vera,
a predetermined amount of wax;
a predetermined amount of chitosan;
at least an inorganic compound, and
predetermined amount of at least one type of organosilicon compound;
It is not entirely clear which of the listed ingredients is required by this limitation.
For example, the mixture may require a plant-derived oil, OR a plant-derived oil may be an alternative to fruit or part of a fruit infused with herbs.
The remaining ingredients, e.g., extracts from shea tree, extracts from aloe vera, wax, chitosan, and inorganic compound may only be required with the selection of “part of a fruit infused with herbs.”
Dependent claims do not clarify this issue.
Clarification is required.
2. Claim 1 includes the limitation of “until the oil changes color” but claim does not require an oil. Oil appears to be an optional ingredient since claim 1 recites preparing a mixture containing
a predetermined amount of at least one type of plant-derived oil, or
a predetermined amount of fruit or part of a fruit infused with herbs.
Although the oil appears optional in step a), line 2, the oil appears to be required in step c).
Dependent claims do not clarify this issue.
Clarification is required.
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Latefi, US 20170246262 A1 and Smith, Human Vaccines & Immunotherapeutics, 10, 3, 2013 and Pitt, GB2485483 A.
Applicable to claims 1, 6, 7, 10: Latefi teaches compositions for administration to the nasal mucosa (Latefi, e.g., 0002-0004 and claim 27), e.g., able to form a film on the mucosa which is resistant to clearance from the nasal cavity (Latefi, e.g., 0005 and 0052), which compositions are effective against infection from pathogens, e.g., microbes and viruses (Latefi, e.g., 0052).
Compositions comprise base ingredients including aloe vera, shea butter, emollient oils, e.g., castor oil, coconut oil, and occlusive substances, e.g., beeswax, dimethicone (Latefi, e.g., 0180 and table 4). Inorganic compounds such as sodium bicarbonate, zinc, copper, and/or silver may be included (Latefi, e.g., 0179, Table 3, and claim 15). Compositions may further comprise olive oil (Latefi, e.g., 0235 and 0260). Compositions may further comprise botanical extracts (Latefi, e.g., 0179, table 3, claims 6 and 19). Latefi teaches the composition comprising dimethicone (organosilicone compound) as an occlusive agent (Latefi, e.g., 0180).
Latefi does not expressly teach the composition comprising chitosan.
However, chitosan was known and used for intranasal compositions as evidenced by the teachings of Smith. Smith teaches chitosan as an immune enhancing intranasal adjuvant (Smith, e.g., Title) which offers a high degree of safety and offers mucoadhesive properties which are a critical component for nasal drug and vaccine delivery applications (Smith, e.g., pg. 798-802).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions for nasal administration taught by Latefi by incorporating chitosan with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to improve the mucoadhesive properties of the composition, thereby improving the composition’s resistance to clearance from the nasal cavity as desired by Latefi. The skilled artisan would have had a reasonable expectation of success because both references teach formulations for intranasal administration.
The combined teachings of Latefi and Smith teach a method for preparing the composition comprising mixing a carrier with base ingredients, e.g., emollient, occlusive, humectant, and essential oil (Latefi, e.g., 0054, 0055, 0161, 0179-0181, Tables 3-4, and 0212). The method further comprises packaging for use (Latefi, e.g., 0237). Formulations may be stored in unit-dose containers (Latefi, e.g., 0246). Compositions may be stored at, e.g., about 25°C, e.g., room temperature for a desired duration (Latefi, e.g., 0255).
The combined teachings of Latefi and Smith do not expressly teach the method comprising the steps of melting all ingredients together and allowing the mixture to simmer for a predetermined period of time until the oil has turned into a different color.
Pitt teaches methods for preparing skin care compositions containing botanical agents, wherein the extraction of plant actives may be done by gently simmering an oil mixture with the desired botanical mixture over a water bath for 3 hours (Pitt, entire document, e.g., pg. 19: extraction of active plant compounds, lines 18-24). This process is exemplified in Pitt in each of the examples, e.g., example 1, pp. 29-31. When viewed as a whole, Pitt teaches simmering for from 3 hours to 5 hours to “macerate” the oil thereby infusing the botanical extracts into the oil. The macerated oil may be mixed with ingredients similar to the “base composition” of Latefi, e.g., comprising melted cocoa butter, melted beeswax, melted shea butter, macerated oil, aloe vera, and further oils for further simmering time (Pitt, e.g., pg. 31: Mixing the balm ingredients).
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Latefi, Smith, and Pitt to arrive at a method as claimed with a reasonable expectation of success.
It would have been obvious before the effective filing date of the presently claimed invention to modify the method for production suggested by Latefi and Smith using techniques known from Pitt to prepare the intranasal composition comprising botanical extracts with a reasonable expectation of success. Since Latefi clearly teaches the intranasal composition comprising active plant extracts in compositions comprising oils, waxes and butters, the skilled artisan would have been motivated to practice the method of production using steps including melting ingredients and simmering the desired plants in oils as known from Pitt to infuse the melted oils, butters, and waxes with the desired plant extracts. The skilled artisan would have used a simmering technique known to save time, e.g., extraction is done in 3-5 hours rather than one month as explained in Pitt. The skilled artisan would have had a reasonable expectation of success because Pitt teaches techniques for preparing compositions for topical use comprising plant extracts.
Since the prior art teaches simmering for a period of time overlapping with the claimed range, the art teaches simmering for a period of time until the oil has turned into a different color, e.g., so that the oil is infused with the botanical extract resulting in a color change.
Applicable to claim 2: The claimed range (3-4 hours) is within the range suggested by Pitt (3-5 hours). 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). MPEP 2144.05.
Applicable to claim 3: Latefi teaches at least coconut oil and olive oil.
Applicable to claim 4: Latefi and Pitt teach olive oil which is part of the olive fruit.
Applicable to claim 6: Pitt teaches cayenne, or chamomile to reduce irritation, and flax seed oil, grapeseed oil as a moisturizer (Pitt, e.g., claim 2).
Accordingly, the subject matter of claims 1-4, and 6 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Latefi, US 20170246262 A1 and Smith, Human Vaccines & Immunotherapeutics, 10, 3, 2013 and Pitt, GB2485483 A as applied to claims 1-4, and 6 above, and further in view of Boman, Contact Dermatitis, 21, 1989.
The combined teachings of Latefi, Smith, and Pitt teach a composition according to claim 1, which may include a silicone (Latefi, e.g., 0239), such as an occlusive dimethicone (Latefi, e.g., 0180). The composition includes occlusive substances to achieve a barrier function (Latefi, e.g., 0005 and 0180). However, the combined teachings of Latefi, Smith, and Pitt do not expressly teach the composition comprising polysilane.
However, polysilane was known and used for barrier function when applied topically as seen from the teachings of Bowman. Bowman teaches barrier creams containing polysilane (Bowman, e.g., pg. 135, Table 1).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions taught by the combined teachings of Latefi, Smith, and Pitt by incorporating an effective amount of polysilane as known from Boman with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of a known technique to improve similar compositions in the same way. The skilled artisan would have been motivated to make this modification to for improved barrier properties desired by Latefi with a reasonable expectation of success.
Accordingly, the subject matter of claim 9 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
Claims 1-6 are rejected.
Claim 7 is allowable. The prior art of record does not teach or fairly suggest the combination of ingredients in the specific amounts recited in claim 7 without exercising improper hindsight.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615