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 Application
This Official Action is Final.
The claims remain unchanged.
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 9-10, 12, 13, 30 and 31 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.
Claims 9-10 are rejected for reciting the base composition comprises fatty acids of a type in an amount that is substantially identical to a fatty acid composition of a cell membrane of a human cell. However, there are various different types of cells in a human. It is not clear what type of cell membrane is being referenced and what would be the corresponding fatty acid composition.
Claims 12, 13, 30 and 31 are rejected as they depend on claim 10 and include all the limitations of clam 10.
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.
Claims 1 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over INNOBIO™, INNOBIO™ High Oleic Sunflower Oil Powder WDP, Product Data Sheet, November 14, 2013 (INNOBIO) in view of TW201434397 (SYED).
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INNOBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%. INNOBIO teaches that consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases (pg. 2, last paragraph).
INNOBIO does not teach adding additional oils.
SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). High oleic sunflower oils are the most stable and odorless liquid oil and can increase the shelf life of additives (lines 63-67). Additionally, coconut oil and macadamia nut oils can be added as they provide good oxidative stability, minimal taste, no negative impact on the finished label, and do not cause any significant nutritional value such as large amounts of saturated or trans-fat (lines 60-62, 80-81, 151-153). These additives include essential oils (lines 120-123).
It would have been obvious to one skilled in the art to add the oils of SYED to INNOBIO to improve the flavor of the composition.
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INNOBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%.
INNOBIO does not teach adding additional oils.
SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). High oleic sunflower oils are the most stable and an odorless liquid oil and can increase the shelf life of additives (lines 63-67). Additionally, coconut oil and macadamia nut oils can be added (lines 80-81, 151-153). It would have been obvious to one skilled in the art to vary the amount of coconut oil and macadamia oil based on the desired flavor.
Claims 2-4 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over INNOBIO™, INNOBIO™ High Oleic Sunflower Oil Powder WDP, Product Data Sheet, November 14, 2013 (INNOBIO) in view of TW201434397 (SYED) and Cao et al., Seeing the Unseen of the Combination of Two Natural Resins, Frankincense and Myrrh: Changes in Chemical Constituents and Pharmacological Activities, Molecules 2019 Sep 24 (17) 3076 (CAO).
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INNOBIO and SYED are cited for the reasons noted above. In particular, INNOBIO shows that high oleic sunflower oil contains more than 80% monounsaturated fats. Consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases (INNOBIO, pg. 2, last paragraph).
SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). High oleic sunflower oils are the most stable and odorless liquid oil and can increase the shelf life of additives (lines 63-67). Additionally, coconut oil and macadamia nut oils can be added (lines 80-81, 151-153).
The references are silent as to adding a mixture of essential oils that include frankincense and myrrh that are dispersed in the composition.
CAO teaches frankincense and myrrh have been used in traditional Chinese and Ayurvedic medicine, they are used mainly for the treatment of chronic diseases. The main chemical constituents of frankincense and myrrh are terpenoids and essential oils. Their common pharmacological effects are anti-inflammatory and anticancer. More interestingly, in traditional Chinese medicine, frankincense and myrrh have been combined as drug pairs in the same prescription for thousands of years, and their combination has a better therapeutic effect on diseases than a single drug (CAO, abstract).
Tables 2 and 4 teach that frankincense and myrrh can be in oil form –
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It would have been obvious to one skilled in the art to combine and disperse the frankincense and myrrh in an oil (i.e., as an essential oil) with INNOBIO and SYED as CAO teaches that the compositions provide general healing and anti-inflammatory properties. As to an effective amount of essential oil, it would have obvious to one skilled in the art to add a sufficient amount of essential oils so as to modulate the signaling cascade of the inflammatory response and to induce the anti-inflammatory properties of myrrh and frankincense.
Given the compositions of INNOBIO, SYED and CAO both provide general health and anti-inflammatory properties, “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). **
As to the transitional phrase “consists of”, it would have been obvious to provide a composition limited to high oleic sunflower oil/fat powder and the claimed oils and essential oils given the compositions provide general health and anti-inflammatory properties.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over INNBIO, SYED, CAO applied to claim 4 above, and further in view of United States Patent No. 6,146,638 (KAKIMOTO).
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INNOBIO, SYED, and CAO are cited for the reasons noted above.
The references above are silent as to adding fermented garlic clove.
KAKIMOTO teaches that fermented garlic (i.e., one bulb of garlic is made up of individual lobes that are also covered in papery skin. Each of these lobes is called a clove of garlic). The composition is free from any unpleasant odor and is useful as a prophylactic or therapeutic agent for diabetes, hepatic diseases, cancer, immunopathy, hyperlipemia, and the like. Thus, the composition can be widely used a health food (col. 5, lines 55-65). The composition can be a powder (col. 4, lines 1-5).
It would have been obvious to one skilled in the art to combine fermented garlic clove with the references above, as KAKIMOTO teaches that garlic provides general healing properties and can be used to treat a variety of disorders.
It would have obvious to one skilled in the art to add a sufficient amount fermented garlic clove so as to modulate the signaling cascade of the inflammatory response.
Claims 9, 27 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over INNBIO and SYED as applied to claim 1 above, and further in view of United States Patent Application Publication No. 2009/0208552 (FAUCHER).
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The references above are silent as to the fatty acid types.
FAUCHER teaches a process that that facilitates the local delivery of one or more therapeutic agents in mammals including humans (abstract) via the use of fatty acids. In [0156], it is noted that the fatty acid composition is designed to allow materials associated with the fatty acids to cross cell membranes.
Thus, it would have been obvious to have the amount and type of fatty acid correspond with cell membranes, as FAUCHER teaches this facilitates the release and delivery of therapeutics.
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As to providing 20-75% palmitic acid, 11 to 13% stearic acid, 8 to 31% oleic acid and 15 to 23% oleic acid, FAUCHER teaches the local delivery of one or more therapeutic agents (abstract). In [0156], it is noted that the fatty acid composition is designed to allow materials associated with the fatty acids to cross cell membranes. Thus, it would have been obvious to have the amount and type of fatty acid correspond with the membranes, as FAUCHER teaches this facilitates the release and delivery of therapeutics.
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As to claim 29, INNBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). The INNBIO article teaches that 80% of the oils can be mono-unsaturated.
INNOBIO does not teach adding phospholipids and non-esterified fatty acid fractions.
However, in [0152], FAUCHER teaches that esterification is optional (i.e., non-esterified fatty acid fractions are present). In [0120], it is taught that providing phospholipids help bio-absorption. It would have been obvious to phospholipid fractions and non-esterified fatty acid fractions in an amount that mimics that allows additives to cross a cell membrane, as FAUCHER teaches this facilitates the release and delivery
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over INNOBIO in view of SYED and United States Patent Application Publication No. 2008/0044504 (KOMAKI).
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As to claim 21, INNOBIO teaches a sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%. INNOBIO teaches that consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases.
INNOBIO does not teach adding additional oils.
SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). High oleic sunflower oils are the most stable and odorless liquid oil and can increase the shelf life of additives (lines 63-67). Additionally, coconut oil and macadamia nut oils can be added (lines 80-81). It would have been obvious to combine these additives with essential oils to improve flavor (lines 120-123).
SYED teaches that bioactives from plants such as pomegranates can be added (lines 129-130).
The references are silent as to lyophilization.
However, KOMAKI teaches that lyophilization of pomegranate products is desirable as it allows the product to be stored but still maintain the viability of active ingredients ([0036] and [0078]).
Thus, it would have been obvious to skilled in the art to use the process of lyophilization, as KOMAKI teaches that the process maintains the viability of active ingredients within pomegranate products.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over INNOBIO, SYED and KOMAKI as applied to claim 21 above, and further in view of Cao et al., Seeing the Unseen of the Combination of Two Natural Resins, Frankincense and Myrrh: Changes in Chemical Constituents and Pharmacological Activities, Molecules 2019 Sep 24 (17) 3076 (CAO).
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INNOBIO teaches a sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%. INNOBIO teaches that consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases.
INNOBIO does not teach adding additional oils.
SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). High oleic sunflower oils are the most stable and odorless liquid oil and can increase the shelf life of additives (lines 63-67). Additionally, coconut oil and macadamia nut oils can be added (lines 80-81). It would have been obvious to combine these additives with essential oils to improve flavor (lines 120-123).
The references above are silent as to dispersing essential oils in a composition.
CAO teaches frankincense and myrrh have been used in traditional Chinese and Ayurvedic medicine, they are used mainly for the treatment of chronic diseases. The main chemical constituents of frankincense and myrrh are terpenoids and essential oils. Their common pharmacological effects are anti-inflammatory and anticancer. More interestingly, in traditional Chinese medicine, frankincense and myrrh have been combined as drug pairs in the same prescription for thousands of years, and their combination has a better therapeutic effect on diseases than a single drug (CAO, abstract). Additionally, CAO shows that high oleic sunflower oil contains more than 80% monounsaturated fats. Consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases. High oleic sunflower oil contains more vitamin E than any other edible oil. It is well known that Vitamin E has healing properties (CAO, pg. 2, last paragraph, and Tables 2 and 4 as noted above).
It would have been obvious to one skilled in the art to combine the frankincense and myrrh and disperse them in oil form (i.e., as an essential oil) with INNOBIO and SYED as CAO teaches that the compositions provide general healing and anti-inflammatory properties.
As to the transitional phrase “consists of”, it would have been obvious to provide a composition limited to high oleic sunflower oil/fat powder and the claimed oils and essential oils given the compositions provide general health and anti-inflammatory properties.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over INNBIO in view of SEYD as applied to 1 above, and further in view of United States Patent Application Publication No. 2008/0044504 (KOMAKI).
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INNOBIO in view of SYED teaches a nutritional supplement as above with regard to claim 1.
The references above are silent as to lyophilization.
However, KOMAKI teaches that lyophilization of pomegranate products is desirable as it allows the product to be stored but still maintain the viability of active ingredients ([0036] and [0078]).
Thus, it would have been obvious to skilled in the art to use the process of lyophilization, as KOMAKI teaches that the process maintains the viability of active ingredients within pomegranate products.
Claims 14-18, 20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication No. 2019/0008907 (AL-WALI) in view of Javanmard, Potent health effects of pomegranate, Advanced Biomedical Research, 2014, pg. 1-8 (JAVANMARD) and United States Patent No. 6,800,292 (MURAD)
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AL-WALI teaches a composition including a mixture of honey pollen [0019]-[0020] , curcumin, propolis or any two of them is used to treat a variety of medical conditions. The composition can be administered topically, orally, by inhalation or parenterally. The composition is useful in treating inflammation. The base composition can be a powder [0044].
JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. It is demonstrated that certain components of pomegranate such as polyphenols have potential antioxidant, anti-inflammatory, and anticarcinogenic effects (abstract).
These polyphenols are found in the aril/seed (see pg. 1 heading Seed), peel (see pg. 2 juice and peel) and even fermented pomegranate juice (see pg. 2, right column, paragraph above Table 1). It would have been obvious to include all of three parts of the pomegranate as they contain polyphenols that prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. JAVANMARD does not provide specific amounts. However, I t would have been obvious to provide enough of the pomegranate ingredients to stimulate a cascade inflammatory response as JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities.
At page 6 of JAVANMARD, it is taught that the pomegranate can be delivered in powdered capsules (see Products and supplementation).
It would have been obvious to one skilled in the art to combine AL-WALI with the pomegranates of JAVANMARD as they are both associated with inhibiting inflammation.
The references above are silent as to adding orange and other fruits.
However, MURAD teaches that it is desirable to add extracts of apricots, apples, pears, peaches, pineapples, papayas, pomegranates, cherries, kiwis, tangerines, grapes, oranges, or mixtures thereof to anti-inflammatory compositions (col. 6, lines 10-21).
Thus, it would have been obvious to one skilled in the art to add orange extracts to an anti-inflammatory composition.
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At page 6, JAVANMARD teaches that leaves and flowers are also used (see Products and supplementation).
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AL-WALI teaches a composition including a mixture of honey pollen [0019]-[0020] , curcumin, propolis or CAPE or any two of them is used to treat a variety of medical conditions. The composition can be administered topically [0044].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication No. 2019/0008907 (ALI-WALI) in view of JAVANMARD and MURAD as applied to claim 18 above, and further in view of United States Patent Application Publication No. 2008/0044504 (KOMAKI).
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ALI-WALI and JAVANMARD are silent as to lyophilization.
However, KOMAKI teaches that lyophilization of pomegranate products is desirable as it allows the product to be stored but still maintain the viability of active ingredients ([0036] and [0078]).
Thus, it would have been obvious to skilled in the art to use the process of lyophilization to obtain the powder of JAVANMARD, as KOMAKI teaches that the process maintains the viability of active ingredients within pomegranate products.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication No. 2019/0008907 (ALI-WALI) and Javanmard, Potent health effects of pomegranate, Advanced Biomedical Research, 2014, pg. 1-8 (JAVANMARD) .
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AL-WALI teaches a composition including a mixture of honey pollen {0019]-[0020] , curcumin (i.e. form the turmeric plant), propolis or CAPE or any two of them is used to treat a variety of medical conditions. The composition can be administered topically, orally, by inhalation or parenterally. The composition is useful in treating inflammation. The base composition can be a powder [0044].
JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. It is demonstrated that certain components of pomegranate such as polyphenols have potential antioxidant, anti-inflammatory, and anticarcinogenic effects (abstract). It would have been obvious to combine products such as pomegranate extracts and curcumin together as both are taught as treating inflammation.
These polyphenols are found in the aril/seed (see pg. 1 heading Seed), peel (see pg. 2 juice and peel) and even fermented pomegranate juice (see pg. 2, right column, paragraph above Table 1). It would have been obvious to include all of three parts of the pomegranate as they contain polyphenols that prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. JAVANMARD does not provide specific amounts. However, I t would have been obvious to provide enough of the pomegranate ingredients to stimulate a cascade inflammatory response as JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities.
At page 6, JAVANMARD teaches that the pomegranate can be delivered in powdered capsules (see Products and supplementation).
It would have been obvious to one skilled in the art to combine AL-WALI with the pomegranates of JAVANMARD as they are both associated with inhibiting inflammation.
Response to Arguments
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
As explained above, the claimed invention is directed to a recipe for a nutritional supplement with known ingredients acting in an expected manner. While food items are patentable, the culinary creativity of chefs is not the type of creativity which meets the standards for patentability. See General Mills v. Pillsbury Co.,378 F.2d 666 (8th Cir.1967) (first commercially successful one step mix for angel food cakes is not patentable because of nonobviousness standard since alleged invention is only the exact proportion of an already known leavening agent). In this regard, courts have taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In re Levin, 178 F.2d 945, 948 (C.C.P.A.1949) (butter substitute not patentable).
Applicant’s arguments have been considered but not persuasive in light of the reasons that follow.
b. The Appellant argues that INNOVIO in view of SYED does NOT disclose and would NOT have
suggested adding "additional oils" to high oleic sunflower oil to arrive at "A FROZEN COMPOSITION, A LYOPHILIZED COMPOSITION, OR A POWDER COMPOSITION" comprising "a MIXTURE of high oleic sunflower oil AND an oil selected from a group consisting of coconut oil, macadamia nut oil, emu oil, and mixtures of two or more of the foregoing" as recited in claim 1. In particular, it is argued that the Examiner does not provide an adequate articulated reasoning based on adequate evidence within the prior art for a suggestion to add "additional oils" to high oleic sunflower oil to arrive at "a frozen composition, a lyophilized composition, or a powder composition" comprising a "mixture of high oleic sunflower oil and an oil selected from a group consisting of coconut oil, macadamia nut oil, emu oil, and mixtures of two or more of the foregoing".
However, INNOBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%. INNOBIO teaches that consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases (pg. 2, last paragraph).
SYED explicitly teaches at lines 55-57 that the composition comprises a base oil and an additive. Thus, it would have been obvious that the composition of SYED comprises a base oil such as “coconut oil” and “macadamia nut oils”, as listed in lines 78-81. Thus, mixtures are provided.
i. The appellant argues that the rejection lacks a rational underpinning for the combination. It is argued that SYED only teaches provide good oxidative stability, minimal taste, no negative impact on the finished label.
However, SYED outlines the criteria for a good oil and makes clear that additional oils can be added (lines 60-62, 80-81, 136-147, 151-153, ). These additives include oils and even other edible oil (see line 144). In this regard, any edible oil. SYED plainly teaches a mixture and one skilled in the art would have been motivated to select coconut and macadamia oil It would have been obvious to add. Moreover, SYED teaches the parameters needed - "provide good oxidative stability, minimal taste, no negative impact” that are needed to determine what would be considered an acceptable oil.
ii. The appellant argues that coconut and macadamia oils are not part of the inventive composition of SYED.
The Examiner does not disagree that SYED teaches high oleic sunflower oil for oxidative stability to increase the shelf life of additives, including food grade additives, and essential oils (e.g., see line 64). SYED teaches that the high oleic sunflower is used to support other ingredients. It is the Examiner’s position that one skilled in the art would have found obvious the addition of coconut and macadamia oils, especially as they are discussed as base oils and the additive can be any edible oil (see line 144).
iii. The appellant argues that INNOBIO and SYED would have not suggested adding coconut oil and macadamia nuts oils to high oleic sunflower oil. In particular, it is argued that there is no disclosure in SYED and INNOBIO that would have taught or suggested to one of ordinary skill in the art to add the alleged coconut and macadamia nut oils to the high oleic sunflower oil as alleged by the Examiner.
However, as noted above, SYED teaches that high oleic sunflower oil can be mixed with many ingredients, including other edible oils (lines 55-57 and line 144). The high oleic sunflower oil reduces flavor intensity and provides the properties discussed above. It is not clear why one skilled in the art would have omitted specifically recited oils.
iii. a. The appellant argues that SYED teaches that coconut and macadamia nuts are inferior.
However, SYED teaches that the high oleic sunflower oil can be used to improve flavor (lines 55-57) and improved oxidative stability to increase the shelf life of additives, including food grade additives, and essential oils" (lines 63-64). Thus, providing motivation to one skilled in the art to make such a combination.
iii. b. It is argued that the cited references teach away from that claimed.
However, sunflower oil is also hydrophobic. INNOBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57, 80-801, 144). This includes coconut oil and macadamia nut oils can be added (lines 80-81). It would have been obvious to deliver the combination in powdered form. Pg. 2 teaches that the microencapsulated lipid powder shows no lumping, caking, or sticking and can be widely used in powdered beverages, functional foods, premixes and hard capsules.
c. The alleged modification does not change the principle of operation of INNOBIO.
The Examiner maintains the position that it would have been common sense for one skilled in the art would to mix the oils first and then microencapsulate the mixture as taught by INNOBIO. Pg. 2 teaches that the microencapsulated lipid powder shows no lumping, caking, or sticking and can be widely used in powdered beverages, functional foods, premixes and hard capsules. It would have been obvious to provide the combination in powdered form so that it would be used in such products.
iv. The appellant argues that the Examiner erred in finding the “total fat”. In particular, it is argued that the total fat taught by INNOBIO does not include coconut oil and macadamia but oil.
However, INNOBIO teaches a high oleic sunflower oil/fat powder where the oil/fat in the powder in an amount of 70% w/w% (See INNOBIO™ Product Data Sheet). This reads on the claimed range of 30 to 100%. INNOBIO does not teach adding additional oils but SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of base oils and additives in compositions to improve the flavor of compositions (lines 55-57). Additionally, coconut oil and macadamia nut oils can be added (lines 55-57, 80-81, line 144). It would have been obvious to one skilled in the art to add the oils of SYED to INNOBIO to improve the flavor of the composition.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim 28
As to the amount of macadamia nut and coconut oil, the claimed invention is directed to a recipe for a nutritional supplement with known ingredients acting in an expected manner. It would have been obvious to vary the claimed amounts to improve taste.
Claims 2, 4, and 24
It is argued that one skilled in the art would have not have combined CAO, INNOBIO, or SYED as they are all in different forms.
However, the Examiner maintains the position that it would have been common sense for one skilled in the art would to mix the oils first and then microencapsulate the mixture as taught by INNOBIO. Pg. 2 teaches that the microencapsulated lipid powder shows no lumping, caking, or sticking and can be widely used in powdered beverages, functional foods, premixes and hard capsules. It would have been obvious to provide the combination in powdered form so that it would have been used in such products.
As to CAO, However, Tables 2 and 4 in CAO do reference essential oils as follows:
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Thus, CAO does reference oils and essential oils.
It would have been obvious to one skilled in the art to combine the frankincense and myrrh with INNBIO SYED, as CAO provides general healing and anti-inflammatory properties. As to any difference in forms, it is merely the manner in which the known combination is used to deliver the product.
As to the amount of essential oil, it would have obvious to one skilled in the art to add a sufficient amount of essential oils to SYED so as to modulate the signaling cascade of the inflammatory response and to induce the anti-inflammatory properties of myrrh and frankincense.
The applicant argues that CAO does NOT disclose "adding a mixture of essential oils that include frankincense and myrrh" to "a frozen composition, a lyophilized composition, or a powder composition" as required by claims 2, 4 and 24 by virtue of their dependencies from claim 1 or to the asserted cold water dispersible powder composition of INNOBIO in view of SYED.
However, applicant fails to take the overall teachings of the references into consideration. As noted above, INNOBIO shows that high oleic sunflower oil contains more than 80% monounsaturated fats. Consuming high oleic sunflower oil helps decrease “bad” cholesterol/LDL in the body, therefore reduces the risk of heart diseases (INNOBIO, pg. 2, last paragraph). SYED teaches that a liquid carrier in the form of high oleic sunflower oil can (lines 68-82) be used as a carrier for a variety of additives in compositions to improve the flavor of compositions (lines 55-57). CAO teaches frankincense and myrrh have been used in traditional Chinese and Ayurvedic medicine, they are used mainly for the treatment of chronic diseases (CAO, abstract).
All the products relate to nutritional ingredients. “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). **
b. The applicant argues that the legal principle is INAPPLCAIBLE.
While the applicant argues that in contrast to Kerkhoven, to arrive at the claimed nutritional supplement, the Examiner must pick and choose among different components of INNOBIO, SYED and CAO and, then change the principle of operation of SYED of using "a liquid carrier in the form of high oleic sunflower oil". Thus, the factual situation at issue in Kerkhoven differs markedly from that of the present case.
However, the prior art teaches that these are ingredients that can be used in nutritional supplements. Thus, it would have been obvious to combine these ingredients.
The applicant argues that the purpose of “general health and anti-inflammatory properties are insufficient. In particular, it is argued that "dispers[ing] the frankincense and myrrh" natural resins of CAO] in an oil" as alleged by the Examiner at page 9 of the Office Action would have resulted in a liquid composition, not a cold water dispersible powder composition as in the asserted composition of INNOBIO in view of SYED and not in "a frozen composition, a lyophilized composition, or a powder composition".
However, INNOBIO does teach an oil material can be microencapsulated. The motivation lies in that the oil materials of SYED and CAO can be combined as noted above and microencapsulated per INNOBIO. The skilled artisan would not have been so limited as suggested by applicant and well aware of microencapsulation techniques for oils.
d.) It is also argued that one of ordinary skill in the art would also not have been motivated to select "essential oils that include frankincense and myrrh" out of "a wide variety of chemical constituents" of frankincense and myrrh resins CAO (pp. 20-21), which are which are "gelatinous" substances (CAO, p. 2), and, then, use in a completely different "cold water dispersible" powder composition of INNOBIO as alleged by the Examiner in the rejection.
However, Table 2 of CAO as noted above does teach oil extracts. It would have been obvious to use oil forms of frankincense and myrrh.
Claims 5 and 8
i), ii) and iii)
The appellant argues that KAKIMOTO does not remedy the deficiencies of INNOBIO,
SYED and CAO. In particular, it is argued that KAKIMOTO does not teach a garlic clove. Thus, the appellant concludes that a prima facie case of obviousness has not been established.
However, KAKIMOTO does teach the use of fermented garlic (i.e., one bulb of garlic is made up of individual lobes that are also covered in papery skin. Each of these lobes is called a clove of garlic). Moreover, KAKIMOTO teaches that various forms of garlic can be used including a powder (col. 4, lines 1-5).
It would have been obvious to one skilled in the art to combine fermented garlic clove with the references above, as KAKIMOTO teaches that garlic provides general healing properties and can be used to treat a variety of disorders.
Claim 6
The appellant argues that INNOBIO, SYED and CAO do not teach a signaling cascade, as
claimed.
However, KAKIMOTO teaches that fermented is useful as a prophylactic or therapeutic agent for diabetes, hepatic diseases, cancer, immunopathy, hyperlipemia, and the like. Thus, the composition can be widely used a health food (col. 5, lines 55-65).
It would have obvious to one skilled in the art to add a sufficient amount fermented garlic clove so as to modulate the signaling cascade of the inflammatory response given one would want to treat the pathologies outlined by KAKIMOTO .
Claims 9, 13, 28-29
i), ii) The appellant argues that there is no recognition of using fatty acids similar to a fatty composition of a human cell membrane.
However, FAUCHER does facilitate the local delivery of one or more therapeutic agents. (abstract). In [0156], it is noted that the fatty acid composition allows materials associated with the fatty acids to cross cell membranes. It would have been obvious to add fatty acids AND in an amount that mimics that allows additives to cross a cell membrane, as FAUCHER teaches this facilitates the release and delivery of therapeutics. Moreover, it is not clear why one skilled in the art would seek a fatty acid composition not consistent with human physiology.
Claims 14-18, 20, 26, and 32
The appellant argues that AL-WALI is limited to viscous honey and that it cannot be a powder. However, this disregards the other references which clearly teach converting materials to a powder.
In particular, JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. It is demonstrated that certain components of pomegranate such as polyphenols have potential antioxidant, anti-inflammatory, and anticarcinogenic effects (abstract).
At page 6, it is taught that the pomegranate can be delivered in powdered capsules )see Products and supplementation).
Claims 21-23
The appellant argues that no motivation is provided as to why one skill in the art would combine JAVANMARD, INNOBIO, SYED and CAO.
However, all of the references are discussed in detail as noted above. Moreover, all of the references are directed to nutritional supplements. Thus, one skilled in the art would have sought out their nutritional benefits. Given the compositions of SYED and CAO both provide general health and anti-inflammatory properties, “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). **
Claim 25
Claim 25 is dependent from claim 1 now with the references cited above.
Claim 32
The appellant argues that AL-WAILI and JAVANMARD do not teach or suggest a mixture of two or more of the recited ingredients and that KOMAKI does not remedy these references.
However, AL-WALI teaches a composition including a mixture of honey pollen {0019]-[0020] , curcumin (i.e. form the turmeric plant), propolis or CAPE or any two of them is used to treat a variety of medical conditions. The composition can be administered topically, orally, by inhalation or parenterally. The composition is useful in treating inflammation. The base composition can be a powder [0044].
JAVANMARD teaches that pomegranates can help prevent or treat various disease risk factors including high blood pressure, high cholesterol, oxidative stress, hyperglycemia, and inflammatory activities. It is demonstrated that certain components of pomegranate such as polyphenols have potential antioxidant, anti-inflammatory, and anticarcinogenic effects (abstract). It would have been obvious to combine products such as pomegranate extracts and curcumin together as both are taught as treating inflammation.
As noted above, one skilled in the art to combine AL-WALI with the pomegranates of JAVANMARD as they are both associated with inhibiting inflammation.
JAVANMARD is silent as to lyophilization.
As noted by the appellant, KOMAKI does teach that lyophilization was a well-known process at the time the application was filed.
Claim 19
The appellant argues that AL-WAILI and JAVANMARD do not teach or suggest a mixture of two or more of the recited ingredients and that KOMAKI does not remedy these references. As noted by the appellant, KOMAKI does teach that lyophilization was a well-known process at the time the application was filed.
However, AL-WAILI and JAVANMARD are proper for the reasons noted above.
112(b)
As noted above, the indefiniteness rejection relating to the phrase "fatty acids of a type in an amount that is substantially identical to a fatty acid composition of a cell membrane of a human cell" is maintained (i.e., the others are withdrawn).
As to the indefiniteness rejection, Biochemistry. 2011 Aug 24;50(37):7858–7867. doi: 10.1021/bi2011527 (SANDERS) teaches that the fatty composition can vary (see abstract). However, the claims require that the fatty acid content be “substantially identical” to a fatty acid composition of a cell membrane of a human cell. It is not clear how one can obtain a “substantially identical” fatty acid profile when the fatty acid profile varies.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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/PHILIP A DUBOIS/Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791