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 .
Acknowledgement is made to Applicant’s response filed 12/22/2025.
Claims 29-34 and 36-48 are pending.
Claims 37, 38, 45, 47, and 48 are withdrawn.
Claim 35 is newly cancelled.
Claims 29-34, 36, 39-44, and 46 are currently under consideration to the extent that they read upon Applicant’s elected species.
Claim Interpretation
It is noted that with regard to the amendments to claim 29, the instant claims now require that the patient be scored according to the HAM-D or HAM-A test prior to treatment. As such, a patient who would have a HAM-D or HAM-A score within the instantly claimed range, but was not tested with one of said tests, would not be within the scope of the instant claims. As such, a prior art reference, though it may anticipate the active steps for administering the identical composition to an identical patient, would not deem to anticipate the instant claims unless it teaches that the patient had been tested, diagnosed, and given a score using the HAM-D or HAM-A test.
Withdrawn Rejections
The rejection of claim(s) 29-34, 39, 42-44, and 46 under 35 U.S.C. 102(a)(1) as being anticipated by Venskutonis (J. Food Bioact., 2018) is withdrawn in view of Applicant’s amendments to claim 29, particularly Venskutonis, while teaching the composition has a positive impact on depression, does not expressly indicate the test utilized to determine the improvement.
The rejection of claim(s) 29-36, 39-44, and 46 under 35 U.S.C. 103 as being unpatentable over European Medicines Agency (2016) and Venskutonis (J. Food Bioact., 2018) is withdrawn in view of Applicant’s amendments to claim 29 and Applicant’s cancellation of claim 35, notably European Medicine Agency, while teaching the composition relieves symptoms of mild anxiety, does not expressly indicate the test utilized to determine the improvement.
New Grounds of Rejection – Necessitated by Amendment
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.
Claim(s) 29-34, 39, 42-44, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Venskutonis (J. Food Bioact., 2018) and Zimmerman (Journal of Affective Disorders, 2013).
Venskutonis teaches that 50% ethanol extracts of C. pinnatifida are more effective against the formation of alpha-glucosidase (see entire document, for instance, page 77, right column, first paragraph). Venskutonis further teaches that the levels of typical markers of depression in animal models were improved by the extract of C. pinnatifida (see entire document, for instance, page 79, right column, last paragraph). It is further noted that Venskutonis teaches that freeze-drying was reported as better than hot air drying for hawthorn (C. pinnatifida) in terms of alpha-glucosidase inhibitory potential (see entire document, for instance, page 81, right column, third paragraph from the bottom).
Venskutonis, while teaching that the composition is useful for improving depression in animals, does not directly teach that the Hamilton Depression Rating Scale is used (HAM-D).
Zimmerman teaches that mild depression has a HAM-D score of 8-16 and moderate depression is scored from 17-23 (see entire document for instance, Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to utilize the composition and method of Venskutonis for a patient who has a HAM-D score of 8-18. One would have been motivated to do so since Venskutonis teaches that depression was improved by utilizing the composition and method of Venskutonis. There would be a reasonable expectation of success since Venskutonis teaches the composition is useful for improving depression, wherein Zimmerman teaches a mechanism for determining which patients have depression to be treated. It further would have been obvious to retest the patient with the HAM-D scale to determine improvement.
It is noted that the method is directed to a method of treating or alleviating and not to a method of making, wherein if the same product is utilized for the method of treating, the method by which the composition is made does not change the scope of the claim. It is also noted that in a 50% ethanol extract, the other 50% would be the inert carrier water.
Claim(s) 29-34, 36, 39-44, and 46 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over European Medicines Agency (2016), Venskutonis (J. Food Bioact., 2018), and Hamilton (1959).
European Medicines Agency (EMA) teaches that traditional medicinal understanding of hawthorn includes its use relieve symptoms that include temporary nervous cardiac complaints that include perceived extra heart beats due to mild anxiety, and the composition can be used as a dry extract that is a 45%-70% ethanol extract (see entire document, for instance, page 62, section 6). EMA exemplifies the use of a 60% ethanol extract for use in cardiac erethism wherein the composition is a tablet containing 100mg of the extract, and the patient is given 1-2 tablets 3 times a day (i.e. 300-600mg/day (see entire document, for instance, page 7, Tablet 1, No. 8).
EMA, while teaching a range of 45-70% ethanol extract, does not exemplify the instantly elected 50% extract. Further, while teaching amounts that are similar and overlap with the instantly claimed amounts for the composition, does not anticipate the instantly claimed amounts.
Venskutonis teaches that 50% ethanol extracts of C. pinnatifida are more effective against the formation of alpha-glucosidase (see entire document, for instance, page 77, right column, first paragraph). Venskutonis further teaches that the levels of typical markers of depression in animal models were improved by the extract of C. pinnatifida (see entire document, for instance, page 79, right column, last paragraph). It is further noted that Venskutonis teaches that freeze-drying was reported as better than hot air drying for hawthorn (C. pinnatifida) in terms of alpha-glucosidase inhibitory potential (see entire document, for instance, page 81, right column, third paragraph from the bottom).
Hamilton teaches that 17 or less on the HAM-A scale indicates mild severity, and 18-24 is mild to moderate severity for anxiety (see entire document, for instance, page 1, right column, first paragraph).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize a 50% ethanol extract for the hawthorn of EMA. One would have been motivated to do so since Venskutonis teaches that 50% ethanol extracts of C. pinnatifida are more effective against the formation of alpha-glucosidase, wherein EMA teaches that ethanol extracts in a range of 45%-70% are useful. It further would be been obvious to optimize the amount of the composition in the Tablet of EMA. One would have been motivated to do so in order to optimize the benefits of the composition as articulated in EMA and Venskutonis. It is additionally noted that the instantly claimed ranges are modified by the term “about”, wherein the instant Specification does not provide any guidance as to the scope of said modifier.
It further would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to utilize the composition and method of EMA for a patient who has a HAM-A score of 17-30. One would have been motivated to do so since EMA teaches that mild anxiety was improved by utilizing the composition and method of EMA. There would be a reasonable expectation of success since EMA teaches the composition is useful for improving mild anxiety, wherein Hamilton teaches a mechanism for determining which patients have anxiety to be treated. It further would have been obvious to retest the patient with the HAM-A scale to determine improvement.
It is noted that the method is directed to a method of treating or alleviating and not to a method of making, wherein if the same product is utilized for the method of treating, the method by which the composition is made does not change the scope of the claim. It is also noted that in a 50% ethanol extract, the other 50% would be the inert carrier water.
Response to Arguments
It is noted that the previous grounds of rejection have been withdrawn in view of Applicant’s amendments and in favor of the rejections set forth above.
Applicant argues in the remarks filed 06/23/2026 that the prior art does not teach the instantly claimed required test of the HAM-A or HAM-D scoring. Applicant’s argument is not found persuasive against the new ground of rejection set forth above since the prior art teaches the HAM-A and HAM-D tests as being useful metrics for determining anxiety and depression.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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