DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 11/26/2025 wherein claims 1 and 14 have been amended.
Claims 1, 2, 7, 8 and 14 are presented for examination on the merits.
The following rejections are made.
Response to Applicants’ Arguments
Applicant’s arguments filed 11/26/2025 regarding the rejection of claims 1, 2, 7, 8 and 14 made by the Examiner under 35 USC 102(a)(1) over Park et al. (KR20160015634) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 8//27/2025.
In regards to the 102(a)(1) rejection, Applicant asserts the following:
A) Park does not describe a two-step extraction process using different solvents where a crude extract obtained from a first extraction is mixed with water and fractionated with a nonpolar solvent to obtain a nonpolar solvent extract. The instant invention has found that the two-step process (Example 2) yields improved therapeutic outcome when compared to single extraction process (Example 1)
In response to A, as observed in the previous Office Action, the improved results of Example 2 over Example 1-1 are noted but it is not clear that the improved therapeutic results are due to the two-step process. Moreover, Example 2 ultimately extracts the compounds with a nonpolar solvent (e.g. hexane, ethyl acetate) whereas Example 1 are polar extracts (e.g. ethanol/ethanolic solution). Due to the differences in the physical properties of extraction solvents, the outcome of Example 1-1 cannot be directly compared to Example 2. This is because the compounds in the nonpolar phase will necessarily be different (being nonpolar for example) from the compounds isolated in the polar phase. No evidence has been provided that the step-wise extraction which concludes with an hexane/ethyl acetate extraction step would result in any difference to an extraction process which utilizes a single extraction step with nonpolar solvent. If the two-step process is indeed the reason for the improved therapeutic outcome, then similar extraction solvents would need to be used to make an adequate comparison. Currently, the comparison between a polar extract and a nonpolar extract is not reasonable as the extracts are different by their physical nature. There is insufficient evidence that the two-step extraction process itself is the cause of improved therapeutic outcomes as no single nonpolar extraction composition is provided for comparison. Applicant’s arguments are not persuasive.
Maintained Rejections, of Record
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 7, 8 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (KR 20160015634; translation provided; of record).
Park discloses a composition comprising an extract of Veronicastrum sibiricum L Pennell (see page 1, 3 and page 9) (see instant claim 1). The Veronicastrum sibiricum L Pennell extract may be produced from the roots (see page 3) (see instant claim 2) and be made by extraction using water, a lower-alcohol such as methanol and ethanol (see page 4) (see instant claims 3 and 4) or a solvent such as hexane, chloroform and ethyl acetate (see page 4) (see instant claim 1). The resulting extract would be nonpolar as the extraction solvents contemplated, e.g. hexane, are nonpolar.
Regarding the means by which the extract is prepared, these are product-by-process limitations. See MPEP 2113 which states that ‘if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ The process steps of “…extracting Veronicastrum sibiricum L. Pennell with methanol to obtain a crude extract;(b) adding water to the crude extract in an amount of 0.0005 to 500 fold (v/w %) relative to the weight of the crude extract: and (c) sequentially performing fractionation of the resulting aqueous mixture first with n- hexane and then with ethyl acetate, to obtain the non-polar soluble extract” are not seen as differentiating the instantly claimed extract from that of the prior art because the prior art ultimately discloses extracting a nonpolar (hexane, chloroform, etc.) extract of Veronicastrum sibiricum L Pennell. The process steps of the instant claims are not seen as resulting in an end product materially different from that described by the prior art.
The composition would have the inherent ability to prevent/treat inflammation, an allergy and asthma as the claimed product and the product of the art are identical. Where the claimed and prior art products are of identical composition, said compositions must have the same properties, unless shown otherwise. See MPEP 2112.01.
Regarding instant claims 7 and 8, these are directed to diseases to be treated by the intended use of preventing or treating inflammation, an allergy and asthma. However, identification of diseases to be treated (e.g. dermatitis, asthma, etc.) do not limit the composition but rather provide a potential avenue/purpose for how the composition may be used. See MPEP 2111.02 which states that where a structurally complete invention in the claim body is set forth, language that states a purpose or intended use for the invention is not considered a claim limitation.
Regarding instant claim 14, the preamble of the claim states that the composition be a ‘food additive’. The phrase ‘food additive’ is an intended use and does not limit the structure of the composition itself. Instead, as discussed under paragraph 8, it provides a purpose for the invention without adding any structural limitation. See MPEP 2112.02.
New Rejections, Necessitated by Amendment
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.
Claims 1, 2, 7, 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (KR 20160015634; translation provided; of record) in view of Gao et al. (Chem. Pharm Bull, 51(1), 2004, 136-137) and Ma et al. (KR 101649475; translation provided).
In the event that the product-by-process does not inherently overlap with Park’s composition, the following obviousness rejection is made.
Park is relied upon for disclosure described in the rejection of claims 1, 2, 7, 8 and 14 under 35 U.S.C. 102(a)(1).
Park fails to teach the product as being made by a process of “…extracting Veronicastrum sibiricum L. Pennell with methanol to obtain a crude extract;(b) adding water to the crude extract in an amount of 0.0005 to 500 fold (v/w %) relative to the weight of the crude extract: and (c) sequentially performing fractionation of the resulting aqueous mixture first with n- hexane and then with ethyl acetate, to obtain the non-polar soluble extract.”
Gao teaches that Veronicastrum sibiricum (L.) Pennel is a medicinal plant that contains immunosuppressive diterpenes and anti-inflammatory compounds useful for treating rheumatism, dysentery and arthritis. Gao teaches that their Veronicastrum sibiricum (L.) Pennel extract is made by a process of treating the aerial parts of the plant (e.g. leaves, stems, etc.) with ethanol and then fractionating with various solvents, such as ethyl acetate and hexane (see page 137), so as to isolate various compound fractions.
Ma is directed to extracting actives from Reynoutria sachalinesis. Ma teaches that actives can be extracted from plants by a process of treating with methanol (or ethanol), diluting with water and then fractionating with various solvents such as hexane and ethyl acetate (see page 3).
As it was known that plant compounds exist in various solvent fractions (see Gao and Ma), applying such a technique to Veronicastrum sibiricum L Pennell extract as described by Ma would have been obvious as the use of known technique to improve similar products in the same way is supportive of obviousness. See MPEP 2143(I)(D). Regarding the water being added/removed to the crude extract during the product-by-process limitation, this is not considered critical to the outcome as the range yield 6-orders of magnitude.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611