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 .
DETAILED ACTION
Applicant’s election without traverse of claims 1-11 in the reply filed on 11/10/2025 is acknowledged. Further, the species election of a capsule is also acknowledged. As claims 7-8 are drawn to different forms of administration other than a capsule, they are withdrawn. Claims 1-6 and 9-11 are currently under examination and the subject of the present Office Action. Claims 7-8 and 12-21 are withdrawn from consideration without traverse.
As such, the restriction is made final.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 101176777 A (Bian, 2008; machine translation provided by PE2E via FIT).
In regards to claims 1-3, Bian teaches an application of a composition for treating a disease (see abstract; claim 10) comprising atractylis ovata in a 7-25 weight proportion (i.e., Rhizoma Atractylodis Macrocephalae), radix paeoniae alba in a 8-15 weight proportion (i.e., Radix Paeoniae Lactiflorae), cortex magnoliae officinalis in a 8-15 weight proportion, semen coicis in a 10-25 weight proportion (i.e., Semen coicis Lachryma-jobi), Chinese knotweed in a 9-22 weight proportion (i.e., Herba Polygoni Chinensis), myrobalan in a 5-16 weight proportion (i.e., Fructus Terminaliae Chebulae), and Corydalis tuber in a 7-14 weight proportion (i.e., Rhizoma Corydalis Yanhusuo) (see Bian, claims 1-3). These amounts overlap with the amounts listed in the instant claims. Further, as the teachings of Bian would yield an identical composition as instantly claimed, the properties, such as the increasing regulatory T cells, of the composition would be the same. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658. As the prior art teaches an identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
In regards to claim 6, the composition is taught to be in the form of a capsule (see Bian, claim 14).
In regards to claim 11, Bian teaches an example wherein the dosage given to the subject is 2.6g/kg (see Bian, page 4-5, embodiments 4-5).
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101176777 A (Bian, 2008; machine translation provided by PE2E via FIT) as evidenced by “Chaerunisaa” (2019) and Avicel® (2008).
The teachings of Bian have been described supra. Further in regards to claims 9-10, Bian teaches that the composition comprises cellulose, microcrystalline cellulose, sucrose, lactose, glucose, among other sugars (see Bian, page 2, paragraph 5-6). While the pH of these excipients is not taught directly, it is known in the art that microcrystalline cellulose is used in capsules in capsule filling processes (see Chaerunisaa, page 3, Table 1), and the pH of a solution of microcrystalline cellulose, specifically of Avicel PH 101 as taught in Chaerunissa (see Chaerunissa, page 9, 4.2 MCC as wet granulation filler; Table 1), is 5-7 (see Avicel®, page 4, Physical and Chemical Properties).
Bian does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Bian with a reasonable expectation of success to obtain the method of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over CN 101176777 A (Bian, 2008; machine translation provided by PE2E via FIT) as applied to claims 1-3, 6, and 9-11 above, and further in view of Gautam (2012) as evidenced by “Chaerunisaa” (2019) and Avicel® (2008)
The teachings of Bian as evidenced by “Chaerunisaa” (2019) and Avicel® (2008) have been described supra.
The teachings of Bian are silent on the composition being used to treat inflammatory bowel disease.
Gautam teaches a method of applying the extract of Terminalia chebula to ulcers that bear some resemblance to many histological characteristic of human ulcerative colitis (see Gautam, abstract; page 380, discussion, paragraph 1). Gautam further teaches that the extract of Terminalia chebula has promising healing effects in colitis and validates its traditional use in gastrointestinal inflammatory conditions (see Gautam, page 382, discussion, final paragraph).
In regards to claims 1-6 and 9-11, 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 combine the teachings of Bian with the teachings of Gautam to formulate the instant method as the composition of Bian uses the extract of Terminalia chebula (i.e., myrobalan) for similar uses (i.e., treating gastrointestinal conditions) as taught in Gautam. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As Gautam teaches that the extract can be used to treat ulcerative colitis, one with ordinary skill in the art would be motivated to combine the method/composition of Bian with the method of treating ulcerative colitis with Terminalia chebula extract of Gautam according to the known method of treating gastrointestinal conditions (see Bian, claim 10; Gautam, page 382, discussion, final paragraph) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Conclusion
No claims allowed.
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/A.A.A./Examiner, Art Unit 1611
/ISIS A GHALI/Primary Examiner, Art Unit 1611