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
The Amendments filed on 3/2/2026 has been received and entered.
Claims 1-16 and 19-23 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election without traverse of the species osteoporosis, osteoblasts in the reply filed on 6/12/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/2/2026, 6/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
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 1-16 and 19-23 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 1-3 recite calcium citrate and has in parenthesis coral skeleton plus lemon juice. It is unclear if the calcium citrate is limited to just coral skeleton. Clarification is requested as to the origin of calcium citrate used.
Claims 4-16 and 19-23 are dependent on Claim 1 and failing to cure the indefiniteness are also rejected.
Claims 15-16, and 19-23 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. This not a new rejection.
In Claims 15, 16, the term “natural” renders the claims vague and indefinite because one does not know what origin or process would make something "natural" as opposed to not being "natural". In Claim 15, what is “natural kingdom” and “naturally occurring portion”? In Claim 16, what is “natural intelligence” and “native natural intelligence”? For example, all of the listed ingredients in the composition used in claim 1 are some sort of extract meaning that some sort of extraction process was performed to make each extract (including the listed oils) and thus it is unclear how those processes would be "natural" versus not being "natural". Therefore, the term “natural" makes the claims unclear.
In Claim 23, the Organization for Economic Co-operation and Development test 301F analysis needs to be defined and listed in the claim. Elements in the claims must be claimed without reference to other sources. Please specify the test.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8, 15-16, 21, and 23 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 equisetum flowering tops, acacia, malpighia fruits, coral skeleton, egg shell, agave leaves, cetraria stems, agaricus, and calcium citrate, which are plants and minerals that are found in nature. 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 1-5, the homogenized form of 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 6 with carrier, the ingredient can be water, which is product of nature. 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, claims 8 and 21, the form of a powder does not make the fruit or vegetable have markedly different characteristic. Powder form is found in nature when the fruit or vegetables dries and become ground by gravity or animals.
In this case, Claims 15-16 and 23, the descriptions and characterization, are not an additional element that renders the claim markedly different from the natural product found in plants and minerals.
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 plants and vegetables 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 1-3 are amounts that can be found in plants and minerals. 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.
Response to Arguments
Applicant argues that the claims have been amended to reflect the changes to the last Office rejection of record.
In response to Applicant’s argument, Applicant has not amended all the claims to respond to the above rejection. Please go through the claims and amend as appropriate.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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