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 .
Claims 1-7 are pending and have been examined on merits.
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 1-7 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.
Claim 1 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim1, which is a method of treating acute respiratory distress syndrome (ARDS), acute liver injury (ALI), diabetes mellitus, or psoriasis is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the invention claims to treat multiple diseases, which are uncommon to each other. Invention also states to overcome treatment of multiple diseases which do not have similar symptoms by one intervention.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
Claims 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering Bletilla formosana extracts from the solvents and processes and plant parts disclosed and exemplified, and for the in vitro and (intraperitoneally- and intravenously-administered) murine examples, and for the respective exemplified mitigated effects thereof, does not reasonably provide enablement for the treating of the genus of humans or all mammals, for all extracts of B. formosana (and having the recited component compounds), as instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of treating a subject having acute respiratory distress syndrome (ARDS), acute liver injury (ALI), diabetes mellitus or psoriasis comprising administering to the subject an effective amount of an extract of Bletilla formosana, which, taken together with the specification, imply a breadth greater than supported by the disclosure.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art (including as cited in the instantly made of record below) is such that a singular effector for treating ARDS, ALI, diabetes, or psoriasis was not known and the providing B. formosana was known to the extent as taught in the prior art, including as instantly discussed herewith as taught by Kao et al and Lin et al (Kao et al. “Bletinib ameliorates neutrophilic inflammation and lung injury by inhibiting Src family kinase phosphorylation and activity,” Brit. J. Pharmacol,2021,178 (20),4069–4084; Lin et al. “Chemical Constituents of the Rhizomes of Bletilla formosana and Their Potential anti-inflammatory Activity,” J. Nat. Prod. (2016); 79: 1911-1921,15Aug.2016 (15.08.2016)).
Since the B. formosana extracts (including the solvents and plant part(s) suitable for treating the claimed diseases remained largely unsolved, means for providing treating of the diseases by the administration thereof is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. However the treating of the instantly claimed group of diseases administering of B. formosana remained beyond the purview of the skilled artisan. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided limited guidance (see esp. at Examples, tables, and figures, including the solvents and plant parts of B. formosana extracted thereby, the target cell/tissue/organism, and the effects measured resultant of the administering). However, the specification does not provide additional direction and guidance commensurate in scope with the claims.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Kao and Lin, and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention for the scope claimed.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kao et al. (“Bletinib ameliorates neutrophilic inflammation and lung injury by inhibiting Src family kinase phosphorylation and activity,” British Journal of Pharmacology,2021, 178 (20), 4069–4084; doi.org/10.1111/bph.15597) in view of Lin et al. (“Chemical Constituents of the Rhizomes of Bletilla formosana and Their Potential anti-inflammatory Activity,” J. Nat. Prod. (2016); 79: 1911-1921,15Aug.2016 (15.08.2016); doi: 10.1021/acs.jnatprod. 6600118).
The instant claims are drawn to a method of treating (claims 1-3+) a subject having acute respiratory distress syndrome (ARDS), acute liver injury (ALI), diabetes mellitus or psoriasis comprising administering to the subject an effective amount of an extract of Bletilla formosana, which comprises 3,3'-dihydroxy-5- methoxybibenzyl (Batatacin III), 9,10-dihydro-1-[(4-hydroxyphenyl)methyl]-4-methoxy-2,7- phenanthrenediol (Orchidble), 3',5-dimethoxy-3-hydroxybibenzyl (BF8-4-2), 3,5-dimethoxy-3'-hydroxybibenzyl (BF8-4-3) and 3-hydroxy-5-methoxybibenzyl (BF8-4-4).
The instant claim is distinguished over Kao ‘597, however, in that the reference does not recite in a singular preferred embodiment (does not anticipate under 35 USC 102) the extract of Bletilla formosana compounds in the composition. However, the reference does teach the therapeutic effects of treating the diseases listed in the instant claims. Kao ‘597 teaches, (Discussion all of section 4); “The plant B. formosana belongs to the Orchidaceae family and is widely distributed in Taiwan. Its tuber is extensively used in traditional Chinese medicine to treat pulmonary, gastrointestinal, and dermatological inflammatory diseases… a natural compound extracted from B. formosana, was found to significantly ameliorate neutrophilic inflammation by inhibiting SFK phosphorylation and activity and the related downstream signal transduction pathway… bletinib, a natural compound extracted from B. formosana, is a SFK inhibitor: Bletinib strongly inhibits superoxide anion production, ROS production, degranulation, NET formation, adhesion, transmigration, and CD11b/CD18 integrin expression in activated human neutrophils, all mediated by the inhibition of the phosphorylation and enzymic activity of SFKs. In addition, in our murine LPS-induced ALI model, bletinib exhibited therapeutic effects, suggesting the potential of bletinib as a novel therapeutic agent of choice for ARDS.”
The extracted compounds of Bletilla formosana were already known to be therapeutically effective prior to the effective filing date of instant claims. Lin et al. also teaches that the compounds extracted from Bletilla formosana were studied to analyze their anti-inflammatory effects against neutrophils of which many were found to be effective. It would have been obvious the use of Bletilla formosana for the treatment related to the diseases in the instant claim.
In claim 2, the instant claim states the extract is prepared by extracting Bletilla formosana bulbs…with water and ethyl acetate, which are aqueous, Kao ‘597 teaches, (Extraction and purification of bletinib 2.1) “B. formosana (10.0 kg) were extracted with ethanol”, however, the final eluted product with what the reference teaches (i.e. the structure of the administered extract, implied by the process of making steps) would not be different than the instant claims.
Instant claim 5, wherein the ARDS is transfusion-related lung injury, ventilator-induced lung injury, bacteria-induced lung injury, or virus-induced lung injury. Kao’ 597 (Introduction right column), teaches, “acute respiratory distress syndrome (ARDS), the clinical term for ALI, occurs most often in the course of sepsis and severe pneumonia,” the diseases as taught by the prior art and instant claims are broadly and reasonably interpreted as drawn to the side effects of the diseases, and accordingly, the instant invention and teachings of reference outcome would not be different (as instantly claimed, would have remained obvious in view of the cited references).
The instant claim 6 and 7 recites the method of claim 1 where in subject is mammal (claim 6), human (claim7), Lin ‘021 (1911 left column) teaches “the genus is used in folk and traditional medicine for the treatment of bleeding, colds, esophagitis, erosive gastritis, and burns. Bletilla species have been shown to exhibit shortening of the time for blood clotting, to afford mucosal protection, and to have antibactericidal, antifungal, antioxidant, antityrosinase, anti-inflammatory, and cytotoxic effects.”; the teachings would be obvious to one of ordinary skilled in the art to seek to treat humans. Additionally, the conditions of the cited references are recognized mammalian and human ailments and thus would also have been prima facie obvious to have provided in the treatment of humans or mammals affected thereby.
It would have been obvious to a person of ordinary skill in the art of the instant invention effective filing date to have provided a composition as instantly claimed because the cited reference teaches the components were known in the art as useful in a medicinal composition, and administering effective amount of the composition of Bletilla formosana to treat acute respiratory distress syndrome (ARDS), acute lung injury (ALI), diabetes mellitus or psoriasis. From the teachings of cited reference, it is apparent that one of ordinary skilled in the art would have had a reasonable expectation of success in producing the claimed invention.
Kao and Lin are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided by this reference with respect to providing therapeutic amounts of the composition in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable dosing and regimens (including amounts/proportions thereof including the amounts as within instant claim 4) and ranges in which to perform such a treating therewith), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, 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 effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alpa Amin whose telephone number is (571)272-0562. The examiner can normally be reached 7:30 - 5:00.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655