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 .
Response to Arguments
Applicant's arguments, filed February 10, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The new claim 7 require each of the five ingredients to be present in an equal ratio in the homeopathic mixture. The specification discloses that each ingredient make up a fifth of the mixture (page 4, ¶ 2 of the specification as filed), meaning each ingredient has a proportion of 20%. Independent claim 4 recites the homeopathic mixture comprises the five ingredients, meaning the mixture may include additional, unnamed ingredients. Consequently, if other ingredients are added, the ratio of the five ingredients would drop below 20%, even if they remain equal to one another. Because the specification only supports a fixed 20% (“a fifth”), it does not provide adequate support for the broader “equal ratio” limitation in claim 7. Accordingly, claim 7 introduces new matter because the specification does not reasonably convey that the inventor possessed the invention as currently claimed at the time of filing.
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) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dolev et al. (Integrative Cancer Therapies, 2021) in view of Leuer et al. (US 2021 0213083 A1).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 31, 2025 and those set forth herein.
Regarding new claim 7, the ratio of each ingredient in the mixture is clearly result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the ratio of each ingredient in the mixture in order to best achieve the desired activity as the amount of each ingredient critically determines the activity of the mixture. “[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.” See MPEP § 2144.05.
Applicant argue that a person having ordinary skill in the art (PHOSITA) would have been discouraged from making such a combination because some literatures warn that adding additional ingredients creates an unpredictable and potentially inhibitory new action (teaching away).
This argument is unpersuasive. Dolev teaches that several ingredients can be combined and the homeopathic mixture containing several ingredients can be effective in relieving cancer treatment related fatigue symptom. Dolev teaches that combining multiple diluted substances from different sources allows them to work together to treat the symptom. It would have been obvious to a person of ordinary skill in the art to add or combine multiple ingredients to make a more effective homeopathic mixture as taught by Dolev.
Applicant argues that the claimed invention shows unexpected results and synergy. Applicant argues that the claimed five-ingredient formula represents a specific, non-obvious advancement that overcomes the technical prejudice in the art against complex mixtures.
These arguments are unpersuasive. Applicant does not disclose evidence supported by data. Applicant must demonstrate that the results are greater than what would have been expected by a PHOSITA. A simple description of the invention’s benefits is not enough. Applicant must present data showing what the expected result would have been and what the actual result was in order to argue that the claimed invention shows unexpected results. There is no evidence of record with comparative test data to establish unexpected results for the claimed composition. See MPEP § 716.02.
Applicant argue that component substitution is not obvious in homeopathic pharmacology. Applicant argue that there is no suggestion in Dolev as to which component could be removed.
These arguments are unpersuasive. Dolev discloses that administration of homeopathic mixture comprising cadmium sulphuratum, X-ray dilution, phosphoricum acidum, radium bromatum, and carcinosinum burnett to breast cancer female patients relieves cancer treatment related fatigue symptoms. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate additional ingredient such as carbo animalis into the homeopathic mixture of Dolev for the purpose of relieving cancer treatment related fatigue symptoms. The homeopathic mixture of instant claims comprises the five ingredients, meaning the mixture is open to other ingredients and the mixture can contain additional ingredient such as carcinosinum burnett of Dolev. Removal of carcinosinum burnett is not required to render the claimed composition obvious. The obviousness rejection over Dolev is not about substitution or removal of an ingredient (carcinosinum burnett), but about the incorporation of additional ingredient (carbo animalis). It would have been obvious to incorporate carbo animalis into the homeopathic mixture of Dolev as discussed in the Office Action mailed December 31, 2025.
Applicant argue that Leuer provides an exhaustive list (laundry list) and that there is a lack of motivation to combine.
These argument are unpersuasive. The fact that it would have been equally obvious to use other ingredients from Leuer does not make the use of carbo animalis any less obvious. As discussed in the Office Action mailed December 31, 2025, it would have been obvious to a person of ordinary skill in the art to incorporate carbo animalis into the homeopathic mixture of Dolev for the purpose of relieving cancer treatment related fatigue symptoms. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Leuer teaches carbo animalis can be used for cancer treatment related fatigue symptoms. A person of ordinary skill in the art would have been motivated to modify the homeopathic mixture of Dolev by including carbo animalis as taught by Leuer, to enhance relief of cancer treatment related fatigue symptoms. There is no evidence of record as to unexpected results arising from the claimed composition.
Applicant argue that Leuer is from a divergent field of art.
This argument is unpersuasive. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See MPEP § 2141.01(a). Leuer discloses a cannabinoid powder comprising carbo animalis can be used for treatment of chemotherapy chronic fatigue syndrome, which reads on cancer treatment related fatigue symptoms. Accordingly, Leuer is analogous art because Leuer is reasonably pertinent to the problem faced by the inventor.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Nissa M Westerberg/Primary Examiner, Art Unit 1618