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 .
DETAILED ACTION
Claims 1-22 and 24 are pending. Claims 1-3, 6-12, 17, 21-22 and 24 are pending. Claims 4-5, 13-16, 18-20, and 24 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-22) and the species vitamin C, zinc, in the reply filed on Jan. 26, 2025 is acknowledged.
Claims 4-5, 13-16, 18-20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jan. 26, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/23/2023 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
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 8, 11, 12, and 17 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.
In Claim 8, the total polyphenol content includes “a content of ellagic acid and derivatives”. This phrase is indefinite because it is not clear what is exactly encompassed by “derivative” of ellagic acid. For the ingredient to still have polyphenol characteristics, a derivative cannot be simple molecules. Since applicant’s definition of “derivative” is opened ended, what is encompassed by “derivative” cannot be definitely determined. Numerous compounds could possibly be derived from ellagic acid including simple elements like carbon and hydrogen. It is not clear what compounds would still be considered “derivatives” in keeping with this limitation in the claims and what is taught in applicant’s specification.
In Claims 8, 11, 12, and 17, the terms “preferably”, “about” and “preferably about” are indefinite because a definition for “about” in the specification in not defined. What is the range of “about”? Furthermore, in Claim 8, last line, “preferably not less than 3% is not within the range specified by “between 1% w/w and 15% w/w”. The term “preferably” is indefinite because it is a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation. In the present instance, claims 8, 11, 12, and 17 recite the broad recitation, and the claims also recite narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Please amend.
Claim Rejections - 35 USC § 101
Claims 2-3, 6-12, 17, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 1-3 are directed to a composition comprising natural products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In this case, applicant’s claims pomegranate extract, vitamin C (lemon), vitamin B (eggs), and zinc (nuts), which are from fruits, eggs and nuts. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, in claims 1-3, the homogenized form the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition contains a mixture of products that are found in nature (the individual natural molecules) and thus must be evaluated as per the described analysis. As for Claim 21 at least one pharmaceutically acceptable excipients and/or vehicle can include gum arabic or starch, which are sourced from plants. Mixing together various natural molecules doesn’t change those molecules per se; they are simply mixed together and thus would have the same characteristics as the same molecules prior to being mixed together.
In this case, claim 7, the form of a dry extract does not make the ingredients have markedly different characteristic. Dried form is found in nature when the fruit is dried by the wind or sun.
In claims 6, 8, 11-12, 17, the amounts are claimed for the ingredients in specific weights or percentages. The homogenized form the ingredients mixed together would still be a product of nature because as long as there are nature-based molecules found in the composition, the composition amounts do not exhibit markedly different characteristics because they are used as supplements as food or beverages. Thus, its form of use in the amounts do not have markedly different characteristics.
Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application.
The homogenized composition of the different ingredients together are non-natural. However, a composition can be used in many different ways and thus not integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the amounts of Claims 8, 11, 12, 17 are amounts that can be formulated in a food or beverage as in Claim 22. The mixing of homogenized fruits and vegetable are well understood, routine, and conventional method of making a product for supplementing nutrition such as a fruit juice or powder (see Liu, 2013, J American Society for Nutrition Adv Nutr, 4: 3845-3925). Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
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)(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.
Claim(s) 1-3, 6-10, and 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Murad (US 20030224071 A1) as evidenced by Dreher (WO 2011038116 A2).
Murad teaches a composition comprising Vitamin C 800 mg, Vitamin B Natural 280 IU, Zinc Oxide 24 mg, Pomegranate Extract 5 mg (Example 3). The pharmaceutical compositions used in the methods of the present invention include the active ingredients described above, and may also contain pharmaceutically acceptable carriers, excipients and the like, and optionally, other therapeutic ingredients [0090]. The composition is administered orally (Claim 3). The compositions for use in the methods of the present invention may be prepared in various formulations, such as suspensions, solutions and elixirs; aerosols; or carriers such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like, in the case of oral solid preparations (such as powders, capsules, and tablets) [0093]. The fruit extract is obtained from pomegranate. The fruit extract is preferably present in an amount of about 0.01 to 80 weight percent and more preferably in about 0.1 to 20 weight percent of the pharmaceutical composition. A preferred oral daily dose range of the fruit extract, when included in the composition, should be from about 0.01 mg to 2,000 mg; more preferably about 400 mg to 1,600 mg; and most preferably about 800 mg to 1,200 mg [0064]. Vitamin B group would include all the forms of vitamin B groups in Claim 10. Pomegranate polyphenol would contain a total of polyphenol content of Claim 8 (Table 1, WO 2011038116 A2).
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.
Claim(s) 1-3, 6-12, 17, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Murad (US 20030224071 A1) as evidenced by Dreher (WO 2011038116 A2).
Murad teaches a composition comprising Vitamin C 800 mg, Vitamin B Natural 280 IU, Zinc Oxide 24 mg, Pomegranate Extract 5 mg (Example 3). The pharmaceutical compositions used in the methods of the present invention include the active ingredients described above, and may also contain pharmaceutically acceptable carriers, excipients and the like, and optionally, other therapeutic ingredients [0090]. The composition is administered orally (Claim 3). The compositions for use in the methods of the present invention may be prepared in various formulations, such as suspensions, solutions and elixirs; aerosols; or carriers such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, lubricants, binders, disintegrating agents, and the like, in the case of oral solid preparations (such as powders, capsules, and tablets) [0093]. The fruit extract is obtained from pomegranate. The fruit extract is preferably present in an amount of about 0.01 to 80 weight percent and more preferably in about 0.1 to 20 weight percent of the pharmaceutical composition. A preferred oral daily dose range of the fruit extract, when included in the composition, should be from about 0.01 mg to 2,000 mg; more preferably about 400 mg to 1,600 mg; and most preferably about 800 mg to 1,200 mg [0064]. Vitamin B group would include all the forms of vitamin B groups in Claim 10. Vitamin B group amounts ranges from about 0.5-15 weight percentage [0067]. Pomegranate polyphenol would contain a total of polyphenol content of Claim 8 (Table 1, WO 2011038116 A2).
However, Murad does not teach the amounts and percentages in Claims 11, 12, 17.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising the amounts and percentages in Claims 11, 12, 17 of the active agent combination for the following reasons. The reference does teach the composition for nutrition. Murad teaches a composition comprising Vitamin C 800 mg, Vitamin B Natural 280 IU, Zinc Oxide 24 mg, Pomegranate Extract 5 mg (Example 3). The fruit extract is obtained from pomegranate. The fruit extract is preferably present in an amount of about 0.01 to 80 weight percent and more preferably in about 0.1 to 20 weight percent of the pharmaceutical composition. A preferred oral daily dose range of the fruit extract, when included in the composition, should be from about 0.01 mg to 2,000 mg; more preferably about 400 mg to 1,600 mg; and most preferably about 800 mg to 1,200 mg [0064]. Vitamin B group would include all the forms of vitamin B groups in Claim 10. Vitamin B group amounts range from about 0.5-15 weight percentage [0067]. Pomegranate polyphenol would contain a total of polyphenol content of Claim 8 (Table 1, WO 2011038116 A2). Thus, it would have been obvious to make a concentrated composition containing pomegranate extract, vitamin C and vitamin B group for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655