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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 1/11/2022. It is noted, however, that applicant has not filed a certified copy of the 202210027815.3 application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112 – 2nd paragraph
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 1-14 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.
Claims 1-14 are drawn to “an application of ginsenoside Rd in preparation for a drug…”. As such, it is unclear what is being claimed as the examiner is unclear if applicants are claiming a composition or a method. It is noted if applicants are claiming a method there should be some form of active step performed in the method claim. The examiner is interpreting the claims as composition claims since they have no active steps.
Claim 1 is indefinite wherein the claim is drawn to “An application of ginsenoside Rd in preparation of a drug for relieving or/and treating acute or chronic inflammations or health food/medicinal and edible food/functional food/dietary supplement.” It is unclear if applicants are claiming the composition to also be a “health food/medicinal and edible food/functional food/dietary supplement” and if so how it can be all of these.
Claim 2 provides the acute inflammation is various things “and the like”. It is unclear what is encompassed by “and the like”.
Claim 5 is indefinite wherein the claim provides “the ginsenoside Rd is cited separately”. It is unclear what this is intended to mean.
Claim 10 is indefinite wherein the claim is not seen to be a closed group as the claim states the drug further contains “one or more of a disintegrant, humectant, … etc.” A proper Markush group should be closed and not open ended with “etc”, as such, the metes and bounds of the claim cannot be determined since there is no ending.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation that the drug is an oral preparation, a topical preparation, or an injection, and the claim also recites the narrower preferable forms of each of these oral preparation, a topical preparation, or an injections, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation that the drug is an oral preparation, and the claim also recites the narrower preferable forms of these oral preparations, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Claim Rejections - 35 USC § 112 – 4th paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 provides the acute inflammations include various things, however, stating what is included therein is not limiting the acute inflammation to only these diseases as these diseases would have been necessarily present in the acute inflammation in the claim from which this depends. Thus, stating what is “included in” is not limiting but rather merely a definition of what is included therein. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 provides the chronic inflammations include various things, however, stating what is included therein is not limiting the chronic inflammation to only these diseases as these diseases would have been necessarily present in the chronic inflammation in the claim from which this depends. Thus, stating what is “included in” is not limiting but rather merely a definition of what is included therein. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 provides where the ginsenoside Rd can be obtained from, but it is not clear how the manner of obtaining the ginsenoside Rd would affect the compound itself which is then used in the composition. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) compositions comprising naturally occurring product ginsenoside Rd, which is seen to be a product of nature without more. This judicial exception is not integrated into a practical application because the products as they are claimed are seen to be the same as they would naturally occur in nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no difference in function, structure, or other properties and thus no markedly different characteristics than the products as found in nature.
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.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN101766640.
‘640 discloses compositions comprising Ginsenoside Rd and propylene glycol in various concentrations such as a solution formed by 5-25 mg/ml ginsenoside Rd in 60 vol% propylene glycol aqueous solution (see page 3). The intended use of the present compositions would have been met by the arts’ compositions since they could have been used for the very same purpose. The compositions are taught to be oral solutions (see page 3) and the ginsenoside Rd can be obtained from Panax notoginseng or synthesized by chemical synthesis (see page 5).
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 2021/0000853.
‘853 discloses compositions comprising various phenolic acids, flavonoids, tanshinones, saponins, and volatile oils. The saponins are taught to comprise ginsenoside Rd (see [0021] and [0025]). The compositions are taught to optionally be oral compositions including optionally tablets, capsules, oral solutions, etc. (see [0036]). Various binders and carriers are used (see [0035]) and various additional agents are included therein (see examples).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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