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 .
This office action is in response to the reply filed 6/16/2026.
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Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.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 6/16/2026 have been fully considered.
112 Rejection
In view of the amendments to the claim, the 112 rejection over claim 1 is withdrawn.
103 Rejection
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 Applicants are arguing limitations not recited by the instant claims. The instant claims simply require the powder to be tissue softened under vacuum conditions 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. While the method used in the specification and the method of CN’478 are not identical, both remove water by vacuum drying and reduce particle size.
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).
Applicant remarks that the specification confirms the distinction and these differences are reflected in the structural characteristics in amended claim 1.
This is not persuasive as Applicant’s have not compared the instant invention with the closest prior art which teaches a vacuum drying (i.e. a tissue softening process), thus Applicants have not provided a proper side-by-side comparison as required by the MPEP which requires comparing the instant invention to the closest prior art or something even closer.
Applicant argues that the Office action provides no evidence that one of skill in the art would have expected similar properties between 8.365 and 10 microns.
This is not persuasive. As established by the MPEP 2144.05: "Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.)." Applicant has not provided any evidence to the contrary.
MPEP 2144.05 II: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.)"
New Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-3 and 12-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 and 12 recites “without a shoulder peak” and “without the shoulder peak” this is not supported in the originally filed disclosure. Applicant remarks that the support is found in figures 2-3, however fig 3 appear to show a shoulder peak (see arrow).
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As evidenced by Malley, Fig,. 2, the above is considered to have shoulder peak.
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As such, the amendments are not supported by the originally file disclosure.
Claims 2-3 and 13 are rejected in view of their dependency on claim 1, as they do not cure the deficiencies of claim 1.
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 and 12-13 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 formulated 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.
Regarding claim 13: As discussed above, CN’478 teaches a D50 that fall within the claimed rang, but also teaches a D50 of 14.476 and 23.819, which creates a range that overlaps with the claimed 4-8 and 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 D50 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 and instant claim 12, the prior art makes obvious preparing the ginseng powder by using a tissue softening process as claimed (i.e. reduced pressure and vacuum conditions) which is stated by the claim to result in 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, 3, and 12-13 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 and 12-13, 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.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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