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 Amendment
Applicant's amendment and argument filed 02/19/2026 in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 29 and 31-48 are pending of which claims 34-48 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 09/20/2025.
Claims 29 and 31-33 are being examined on the merits.
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 29 and 31-33 are rejected under 35 U.S.C. 101 because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claims state the nature-based products which come from a fractional extract of Melissa leaf comprising: caffeic acid, EDPA (Ethyl 2 -(3,4-dihydroxyphenyl) acetate), and RME (Rosmarinic acid methyl ester), caffeic acid, rosmarinic acid, and a pharmaceutically acceptable carrier, the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way. The claims also recite a pharmaceutically acceptable carrier and when so broadly claimed and when considered could be water which is also a judicial exception and is subject to the same evaluation just described. The applicant has not shown that the broadly claimed carrier has any distinction from a judicial exception which when considered and so broadly claimed can be water.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming components which are found naturally within the Melissa Officinalis plant and in particular amounts.
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)). The only other limitations to consider would be the carrier and how the formulation is being claimed which is as a food or pharmaceutical composition. Neither of these amount to significantly more than the recited judicial expectations themselves.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive. The applicant argues that the newly claimed limitations which require the extract to contain particular ranges of the components found within the extract cannot be found existing in nature and thus must be a man-made product. Merely modifying the amounts of the judicial exceptions in a composition does not overcome the rejection as discussed in the above rejection. The applicant argues that the extract exhibits a markedly different functional profile including angiogenic activity that arises from the specific ratios of the EDPA and RME as described in the submitted declaration. Those activities appear to stem from the caffeic acid (CA) and rosmarinic acid (RA), EDPA and RME which are judicial exceptions. Merely increasing or decreasing their amounts to increase or decrease their naturally occurring activities does not overcome the rejection. The applicant believes they have found a synergistic blend by combining the EDPA, RME and CA and RA for angiogenic activity. This argument was argued against the previously recited 102 rejection and will be responded to in the next response to the rejection below as they have not argued it in response to the 101 rejection. It would be suggested to amend the claims to some specific formulations not found in nature and reciting some specific activities which might be determined only through synergistic combinations etc. As currently determined, there is no synergy noted.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Kim Min Young et. al. (From IDS filed on 09/26/2022, KR2009-0020285A), hereinafter Young. This rejection is maintained with slight modifications to take into account the amendments filed on 02/19/2026.
Regarding claims 29 and 31, Young discloses a “Melissa leaf extract extracted with 50-100% alcohol and dried, the alcohol extract is suspended with water and fractionated with ethyl acetate and dried, and the ethyl acetate fraction is resuspended with water and dried” (see claim 1). Here Young discloses a fractional extract of Melissa leaf and it would be inherently expected that the fractionated extract would contain the same components as being claimed because the applicant recites “The fractional extract of melissa leaf may be an ethyl acetate fraction of the ethanol extract of melissa leaf. [00107] The method effectively extracts soluble substances and insoluble substances by using 50-100% (v/v) alcohol, and has the effect of extracting insoluble substances with low solubility in water but high solubility in ethyl acetate. [00108] The ethyl acetate fraction of the melissa leaf ethanol extract may comprise 0.1 to 5 weight % of caffeic acid, 0.05 to 6 weight % of EDPA, 0.01 to 2 weight % of RME, and 5 to 50 weight % of rosmarinic acid based on the total weight of the fraction” (see instant specifications at 00107-00108). Thus, the same extraction and fractionation method would result in identical compositions.
Regarding claims 32-33, Young describes the melissa leaf extract fraction may be a pharmaceutical composition or a food composition (see page 3, para. 6).
Young does not specifically teach that the composition comprise of EDPA and RME in the particular amounts as instantly claimed, however Young teaches extracts using the same solvents and fractioning techniques on the same plant parts which would exert the same activities claimed. Determining the particular active components or mechanisms of action does not necessarily create a patentably distinct product. It would have been obvious to persons having ordinary skill in the art before the effective filing date to create the instant invention given the prior art. In this case the applicant is merely determining the active components within the extract already known for the same activities, which can be done through known methods such as various chromatographic tests such as high-performance liquid chromatography. These actions are obvious given that the activity has already been shown.
The adjustment of particular conventional working conditions (i.e. determining the suitable amounts of the active ingredients) is deemed merely a matter of judicious selection and routine optimization, which is well within the purview of the skilled artisan.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive. The applicant argues that the since the art does not teach each limitation specifically that of the range of EDPA and RME that every limitation has not been met and therefore cannot be anticipated. The extracts appear to be identical in nature and would be expected to have the same active components. Young teaches “350L of 75% ethanol was added to 100 kg of dried melissa leaves and extracted twice at 83 ° C. for 4 hours. After filtration through a 10um filter and concentrated under reduced pressure up to 30L, two ethyl acetate was added to each 40L fraction and fractionated. The fractions were washed with purified water, separated, concentrated to 15 L under reduced pressure, and hot air dried at 45 ° C. to finally prepare 5 kg of ALS-L1023” (see last para. page 10). Indeed Young teaches first extraction of the plant material with the same solvent, 75% ethanol and teaches two extractions, then teaches filtering and fractioning with ethyl acetate and concentrating. These are the same steps discussed in the applicant’s arguments and as the applicant stated in their own words “The fractional extract of melissa leaf may be an ethyl acetate fraction of the ethanol extract of melissa leaf. [00107] The method effectively extracts soluble substances and insoluble substances by using 50-100% (v/v) alcohol, and has the effect of extracting insoluble substances with low solubility in water but high solubility in ethyl acetate. The ethyl acetate fraction of the melissa leaf ethanol extract may comprise 0.1 to 5 weight % of caffeic acid, 0.05 to 6 weight % of EDPA, 0.01 to 2 weight % of RME, and 5 to 50 weight % of rosmarinic acid based on the total weight of the fraction” (see instant specifications at 00107-00108). These are the same extracts and the same fractions. The applicant also recognizes that these same extracted and fractioned components comprise of the same benefits which is inhibiting angiogenesis. Determining those active components is well within the purview of any skilled artisan.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). In this case the applicant is merely determining the active components within the extract already known for the same activities, which can be done through known methods such as various chromatographic tests such as high-performance liquid chromatography. These actions are obvious given that the activity has already been shown.
The applicant argues that there is a synergy effect by combining the EDPA and RME with caffeic acid (CA) and rosmarinic acid (RA). This does not appear to be a proper test for synergy as the EDPA and RME have not been tested for the activity alone (see applicant’s affidavit table 4 and page 3). This may be where the strongest activity lies (with the EDPA and/or RME) and merely combining it with the caffeic acid and rosmarinic acid and showing an increase activity would be expected especially if since the activity appears to come from either the EDPA and/or RME. The test shows increasing the concentrations of R+C and R+C+E+R indeed increases activity. The declaration under 37 CFR 1.132 filed February 19, 2026 is insufficient to overcome the rejection of claims 29 and 31-33 based upon 35 U.S.C. 103 as set forth in the instant Office action because of the reasons recited above in the response to arguments section. The declaration is not sufficient to determine if there is indeed any noted synergy.
Conclusion
No claims are allowed.
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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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