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 29-48 are pending.
Claims 37, 38, 45, 47, and 48 are withdrawn.
Claims 29-36, 39-44, and 46 are currently under consideration to the extent that they read upon Applicant’s elected species.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 29-34, 39, 42-44, and 46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Venskutonis (J. Food Bioact., 2018).
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).
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 further noted regarding claim 46 that the wherein clause appears to indicate that the treatment can be measured by the listed tests, wherein it is deemed that one performing the treating method with the composition of Venskutonis would be capable of performing said tests. It is also noted that in a 50% ethanol extract, the other 50% would be the inert carrier water.
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) 29-36, 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) and Venskutonis (J. Food Bioact., 2018).
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).
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 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 further noted regarding claim 46 that the wherein clause appears to indicate that the treatment can be measured by the listed tests, wherein it is deemed that one performing the treating method with the composition of Venskutonis would be capable of performing said tests. It is also noted that in a 50% ethanol extract, the other 50% would be the inert carrier water.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TREVOR LOVE/Primary Examiner, Art Unit 1611
Prosecution Insights