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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/11/2025 has been entered.
Election/Restrictions
Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/13/2022.
Response to Arguments
All of Applicant’s arguments filed 6/18/2025 have been fully considered and are not persuasive.
Applicant argues that the process of the present invention (i.e. softening tissue and then coarsely grinding to produce a powder) is different from the process of CN’478 which teaches vacuum drying and vacuum embrittlement to produce a brittle crude powder.
This is not persuasive as applicant’s are arguing limitations not recited by the instant claims. The instant claims simply require the powder to be tissue softened which is made obvious below. While the claims recite a tissue softening process, Applicant are reminded that the claimed are product claims and the patentability of the claims rests on the final structure and the not method of achieving said structure absent factual evidence showing the claimed process to be result in a distinct structure.
Applicant argues that the softening process leads to a patentably distinct structure as defined by its unique particle distribution and the particles having only one peak.
This is not persuasive as it is unsupported by factual evidence. As discussed in the rejection below, the particle size distribution as amended is made obvious by CN’478. Regarding the one peak, no evidenced had been shown to support Applicant’s assertions. As previously noted, Applicant has not compared the claimed powder to the closest prior art powder (i.e. CN’478 which teaches tissue softened ginseng) which is a necessary requirement when trying to establish unexpected results.
An applicant bears the burden of proving unexpectedly good results. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196, (Fed. Cir. 1984).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “reduced” in claim 1 is a relative term which renders the claim indefinite. The term “reduced” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear from the claim what levels of pressure would be considered “reduced” as the claim fails to provide a standard to determine said reduction. Reduced from what?
Claims 2-3 do not cure the deficiencies of claim 1 and therefore are rejected for the same reasons discussed above.
Maintained/Modified 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 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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 6,071,521) and CN104546478.
Regarding claim 1: Kim discloses a pharmaceutical composition comprising an extract of Pulsatilla Radix and Clematidis Radix and at least one powdered ingredient of Ginseng Radix (selected from a finite number of options) (Abs). The pharmaceutical composition can be formulate as a powder (col. 3, lines 65-67) and can comprise additives such as surfactants, excipients, etc. (col. 3, lines 20-35).
While Kim fails to teach a cosmetic composition, “cosmetic” is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the composition of the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitations. As the prior art teaches a pharmaceutical composition in the form of a powder, the composition is expected to be capable of being used as a cosmetic and applied to skin absent evidence to the contrary.
Ginseng Radix is taught to be a marvelous medicine in Chinese medicine art. It has various purposes, such as controlling bleeding, agent for acute gastritis, and as an anticarcinogenic (Col.1 lines 65-67 to Col. 2 lines 1-5). Working examples 4-6 show the Pulsatilla Radix (or Clematidis Radix) and the Ginseng Radix to be used in a weight ratio of 2:1 when preparing the extract (Working examples and Kim – claim 2). Kim teaches the final composition to comprise 18-63% w/w of Pulsatilla Radix (Kim – claim 1), thus it’s reasonable to assume that the final composition also comprises Pulsatilla Radix and the powdered Ginseng Radix in a weight ratio of 2:1, as such the amounts of powdered Ginseng Radix are expected to fall within the claimed 2-90wt% given the broad range claimed. Furthermore, Kim teaches that each ingredient should be used in amounts effective to treat a tumor, as such it’s obvious to optimize the amounts of Ginseng Radix used in the composition to achieve the desired effect.
However, Kim does not teach the ginseng powder to have the claimed particle structure as recited by claim 1 and does not teach the limitations of instant claim 2.
CN’478 discloses a Chinese medicine superfine powder. CN’478 teaches that the powder is made by cleaning and cutting the Chinese materials, vacuum-drying the cut material; pulverizing the material after vacuum drying and then subjecting the material to vacuum embrittlement and then ultrafinely pulverizing the material to obtain a final product [0011-0016].
CN’478 teaches that the method adopts both vacuum drying and vacuum embrittlement, this increases the brittlement of the coarse powder, reduces the water content in the material, reduces the size of the crushed particles and shortens the time for ultrafine crushing [0017]. This ultrafine powder allows for the dissolution of active ingredients to be shorted and patients have a better effect when taking the medicine.
CN’478 teaches the vacuum drying to be performed at a pressure of 0.01-0.12 MPa [0025 and 0061], which reads on a reduced pressure vacuum, in view of the 112b rejection above. CN’478 teaches that in order to facilitate the pulverization of the vacuum dried Chinese herbal medicine, the material is vacuum dried to a moisture content of ≤6% [0023], The “formed by…” is a product by process step and the patentability of the claims rests on the final structure and the not method of achieving said structure. The instant specification teaches that tissue-softening of ginseng refers to removing water from ginseng and tissue softened ginseng maybe water-removed dried ginseng. The spec teaches “the tissue of the fresh ginseng or white ginseng is softened by removing water. (pg. 8)” Therefore, as the prior art teaches dried ginseng wherein the water has been removed using low vacuum pressure, the product of the prior art appears to be the same as the product of the instant claims (i.e. tissue softened ginseng).
An exemplified Chinese herbal material for use is panax notoginseng [0146-0152], also suitable for use is pearl ginseng [0033] and American ginseng [0035] . Table 14 teaches that the panax notoginseng powder obtained using the method of CN’478 has a D90 (µm) of 8.365, and a D50 (µm) of 3.521 which falls within the claimed range of 3-8 µm, reading on instant claims 2.
It is noted that CN’478 also teaches obtaining D90 of 8.867, 8.981, 9.105 (tables 2, 8, 11 and 17) and teaches that the amounts of water present after vacuum drying affects the size of the crush particle and shortens the time of ultrafine crushing.
CN’478 teaches a D50 that fall within the claimed range and while 8.365 doesn’t overlap with the claimed D90 10-16 µm, 8.365 is sufficiently close to 10 µm that one skilled in the art would have expected them to have the similar properties. Furthermore, CN’478 emphasizes the importance of removing water from the material prior to crushing and teaches that after vacuum drying the brittleness of the power increases and this affects the size of the crushed particles [0044] and teaches preference for a final moisture content below or equal to 6%, as such it would have been prima facie obvious to a person of skill in the art to optimize the final water content to control the properties of the particles and particle sizes to achieve an D90 such as those claimed.
While the art fails to teach the D90 and D50 to be obtained using a volume-based particle diameter distribution measured by laser diffractometry the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kim with those of CN’478. One of skill in the art would have been motivated to prepare the powdered Ginseng Radix of Kim using the method of extraction of CN’478 as this method is taught to result in an ultrafine powder with increased dissolution of active ingredients to be shorter and has a better effect on the patients. One of skill in the art would have a reasonable expectation of success as CN’478 teaches that the method can be used in a variety of Chinese herbal medicines, including various species of ginseng.
Regarding the claimed property of one peak, the prior art makes obvious preparing the ginseng powder by using a tissue softening process as claimed (i.e. reduced pressure) which is stated by the claim to result in the claimed one peak. As demonstrated by the instant specification (Test Ex. 2 and Table 1), the presence of the claimed characteristic peak is a result of using ginseng subjected to a tissue softening process, therefore, as the prior art teaches tissue softened ginseng as claimed, the ginseng claimed and the ginseng of the prior art are expected to have similar properties.
Claim(s) 1-2, and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 6,071,521) and CN104546478, as applied to claims 1-2 above, and further in view of CN1139556 and KR20080067031. Examiner has provided a translation of table 14 for clarity.
As discussed above, Kim and CN’478 make obvious the limitations of claims 1-2, however, CN’478 does not teach the particles to have the claimed specific surface area.
CN’556 teaches micro-ginseng powder having a specific surface area of 1.5 m2/g for use in formulating cosmetics, healthcare food, etc.
KR’031 teaches ultrafine ginseng powder for the preparation of soft capsules having an average particle diameter of 2-10µm and teaches the powder to have an increased specific surface area, so that solubility is greatly improved which improves the absorbency of the ginseng component and thus improves bioavailability.
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kim and CN’478 with those of CN’556 and KR’031. One of skill in the art would have been motivated to optimize the specific surface area of the ginseng powder, made obvious by Kim and CN’478, starting from 1.52 m2/g to achieve a desired solubility as CN’556 teaches that this is a suitable specific surface area for ginseng powder when used for pharmaceutical and cosmetic purposes and KR’031 teaches that the specific surface area affects the solubility of the ginseng powder which in turn affects its absorbency and bioavailability.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613