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 .
Claim Status
Claims 1-18 are pending and being examined on the merits.
Information Disclosure Statement
The listing of references in the specification (e.g., at [0009]) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The title of the invention is not in English. A new title is required that is clearly indicative of the invention to which the claims are directed and is in English.
Claim Objections
Claims 8, 9, 11 and 12 are objected to because the “and/or” between species names should not be italicized.
Claim 14 is objected to because the phrase “the concentrating” should instead read --concentration of--.
Appropriate correction is required.
All other claims depend directly or indirectly from objected to claims and are, therefore, also objected to for the reasons set forth above.
Claim Rejections - 35 USC § 112(b)
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 6-12 and 18 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.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
In the instant case, the claims do not set forth any steps for using the extract and/or composition in the claims. This rejection could be overcome by rephrasing, for example, Claim 11 as:
“An aqueous extract for prevention and/or treatment of diseases associated with infection by C. acnes and/or S. aureus obtained from a plant of the genus Aster,”
or with similar phrasing commensurate in scope with the instant disclosure.
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 1-3, 6-16, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-3, 6-16, and 18 are directed to a natural product (i.e., a law of nature/a natural phenomenon). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception – i.e., as drafted, the claims read upon a product of nature (i.e., a law of nature/a natural phenomenon) for the following reasons:
Claims 1-3, 6-16, and 18 are drawn to a composition (for the intended use as an antibiotic or anti-inflammatory medicine, in some embodiments topically applied) formed entirely from natural ingredients (as disclosed in [0011]-[0014]; [0030]-[0031]; [0034]; [0037]-0043]; [0060]; [0066]; and [0067]-[0070] of the instant specification) including an aqueous (water) extract of Aster, specifically Aster aplinus or Aster tataricus leaves, and in some embodiments, further including glycerol (obtainable from soy beans, palm, or tallow), alcohol, water, and at least one pharmaceutically or cosmetically acceptable excipient (e.g., sugar). The claimed composition is not markedly different from their naturally-occurring counterparts because there is no indication that the composition has any characteristics or properties that are different from the naturally-occurring counterparts (including the natural compounds found therein). The cited claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements.
Furthermore, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials. While Claim 14 requires a minimum concentration of components in the active ingredient or composition, there is no indication that the amounts claimed result in a markedly different characteristic for the composition as compared to components found in nature.
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterparts (see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Col. V. Kalo Inoclulant Col. – 333 U.S. 127 (1948)) because, again, there is no evidence of a marked difference brought about by combining the instantly claimed herbal extracts. Please also note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)).
Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
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, 2, 6-13, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noh (KR 20210078189 A, machine translation, 8 pages).
The instant claims are as of record, drawn to an aqueous extract of Aster tataricus or Aster alpinus aerial parts.
Noh, however, anticipates the claims by teaching a composition comprising an extract of Aster tataricus leaves (aerial parts) as an active ingredient wherein the extract is obtained by drying and grinding the leaves into a powder, mixing and immersing in hot water (aqueous extract; aqueous maceration; absence of organic solvents; water), filtering, and removing the precipitate by secondary filtration (concentrating; Noh, Example 1, pg. 5; as required for instant Claims 1-5, and 11-13). The composition additionally comprises glycerin (glycerol), alcohols, and other pharmaceutically acceptable additives (excipients; Noh, pg. 4; as required for instant Claims 13 and 15). Noh additionally teaches that Aster tataricus is prescribed in oriental medicine (medication) for hemoptysis, asthma, pulmonary tuberculosis, cough, chronic bronchitis, and diuresis (Noh, pg. 2; as required for instant Claim 6) and the composition of Noh with Aster tataricus as the active ingredient was shown to inhibit lung inflammation (e.g., anti-inflammatory; Noh, pg. 5-6; as required for instant Claim 7).
With respect to the rejections above, please note that the intended use of the claimed composition for use in the prevention or treatment of diseases associated with infection by C. acnes or S. aureus does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
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 1-13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Noh (KR 20210078189 A, machine translation, 8 pages) in view of Handa et al. (Extraction Technologies for Medicinal and Aromatic Plants, 2008, pg. 21-54).
The instant claims are as of record, drawn to an aqueous extract of Aster tataricus or Aster alpinus aerial parts.
Noh teaches a composition comprising an extract of Aster tataricus leaves (aerial parts) as an active ingredient wherein the extract is obtained by drying and grinding the leaves into a powder, mixing and immersing in hot water (aqueous extract; aqueous maceration; absence of organic solvents; water), filtering, and removing the precipitate by secondary filtration (concentrating; Noh, Example 1, pg. 5; as required for instant Claims 1-5, and 11-13). The composition additionally comprises glycerin (glycerol), alcohols, and other pharmaceutically acceptable additives (excipients; Noh, pg. 4; as required for instant Claims 13 and 15). Noh additionally teaches that Aster tataricus is prescribed in oriental medicine (medication) for hemoptysis, asthma, pulmonary tuberculosis, cough, chronic bronchitis, and diuresis (Noh, pg. 2; as required for instant Claim 6) and the composition of Noh with Aster tataricus as the active ingredient was shown to inhibit lung inflammation (e.g., anti-inflammatory; Noh, pg. 5-6; as required for instant Claim 7).
Noh does not teach wherein the aqueous maceration is at room temperature.
Handa et al., however, teach that maceration at room temperature with agitation is a general method for extraction of medicinal plants (Handa et al., 1.2.1.1., pg. 22; as required for instant Claims 3-5).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to prepare the extract of Noh at room temperature as taught by Handa et al. because exposure to temperatures above ambient temperature can damage products during extraction (Handa et al., 1.2.1.11.1, pg. 27 & 1.2.1.12., pg. 28-29). A skilled artisan in the field of natural product extraction would therefore be motivated to use a lower temperature than that of Noh and could do so with a reasonable expectation of success.
Claims 1, 2, and 6-18 are rejected under 35 U.S.C. 103 as being unpatentable over Noh (KR 20210078189 A, machine translation, 8 pages) as applied to Claims 1, 2, 6-13, 15, and 18 above, and further in view of Zhang (CN 110859888 A, machine translation, 3 pages).
The instant claims and teachings of Noh are as of record.
Noh does not teach the extract concentration or topical application with specific dosage forms.
Zhang, however, teaches a composition comprising 10-30 parts by weight of an extract of Radix Asteris (Aster tataricus), wherein the composition is an external lotion (topical) that is anti-inflammatory and prevents and treats acne (Zhang, pg. 2; as required for instant Claims 8-10, 16, and 17).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the composition of Noh as a lotion as taught by Zhang. A skilled artisan would know from Noh that Aster tataricus leaf extract is an active ingredient which can reduce inflammation and would therefore be motivated to provide said extract in a composition such as a lotion for prevention or treating acne as taught by Zhang. A skilled artisan would also know from Zhang that providing such an extract for topical use is not toxic, has few side effects, good safety performance, low adverse reaction, and prevents relapse (Zhang, pg. 2), and could therefore provide the aster leaf extract of Noh in a topically applied composition as taught by Zhang with a reasonable expectation of success.
Additionally, if not expressly taught by the prior art, based upon the overall beneficial teaching provided by this reference with respect to use of Aster tataricus extracts in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable extract concentrations (instant Claim 14) for such a composition), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
With respect to the 35 U.S.C. 103 rejections above, please note that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Conclusion
No claims are currently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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