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
The instant application was received 19 April 2024; it is a national stage application of PCT/CN2022/125749, filed 17 October 2022, and claims foreign priority to CN202111223046.6, filed 20 October 2021. Acknowledgment is made of Applicant’s claim for foreign priority and certified copies of the priority documents have been received.
Restriction/Election
Requirement for Restriction/Election was mailed 16 June 2026.
Applicant’s Response to Requirement for Restriction/Election was received 14 August 2026.
Applicant’s election without traverse of Group I (Claims 1-5) in the Response filed 14 August 2026 is acknowledged.
The claims in Group II (Claims 6-10) are withdrawn.
Status of the Claims
The listing of claims filed 14 August 2026 has been examined.
Claims 1-10 are pending.
Claims 6-10 are withdrawn.
Claims 1-5 are examined on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 19 April 2024 is acknowledged and has been considered.
Claim Interpretation
Examiner interprets the phrase, “…for preventing and/or treating a neurodegenerative disease…” in claim 1 as intended use of the claimed composition.
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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jo (KR20170076487A).
Regarding claims 1-5, Jo teaches compositions comprising caudatin (Original, p. 3; Translation, p. 1, Title), which is shown below.
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Note instantly recited Compound 1 (Claim 5) is caudatin. The compositions disclosed by Jo are intended as cosmetic compositions, pharmaceutical compositions, and/or health foods (Translation, p. 19, ¶ [0017]) and contain 0.00001-10weight% caudatin (Translation, p. 31, ¶ {[0032]). Jo indicates when the composition is a suspension, additional components may include water, propylene glycol, agar, and/or microcrystalline cellulose, which may all be used as carriers (Translation, p. 36, ¶ [0039]). As skilled artisan would recognize microcrystalline cellulose, for example, often serves as a filler in pharmaceutical compositions.
A compound meeting all the structural limitations required by claim 1 would be expected to exhibit the same uses as recited by claims 2-3. Claim 2 recites, “The pharmaceutical composition according to claim 1, wherein the neurodegenerative disease comprises one or more selected from the group consisting of dementia, Parkinson’s disease, and Huntington’s disease.” As mentioned above, the language “…for preventing and/or treating a neurodegenerative disease…” used in claim 1 is interpreted as a non-limiting intended use. However, an identical composition must inherently have the same functional activity, even if not expressly recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical composition, the properties/activities Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, a composition disclosed by Jo would inherently have the same properties as the instantly claimed compositions.
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.
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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ip (WO 2011/114220 A1) in view of Huang (Huang, Liejun et al. “Studies on cytotoxic pregnane sapogenins from Cynanchum wilfordii”, Fitoterapia, 13 November 2014; IDS dated 19 April 2024, Cite No. 2).
Huang teaches C21 steroidal saponins having a structure according to instantly recited formula I (p. 108, Fig. 1), such as Compound 11, which is shown below.
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Huang’s Compound 11, also called caudatin (CAS Registry Number: 38395-02-7), is structurally identical to instantly recited Compound 1 (Claim 5). Additionally, Huang’s Compound 9 is structurally identical to instantly recited Compound 2. Huang indicates the compounds disclosed in Fig. 1 are isolated from Cynanchum wilfordii, which is a plant found in China (p. 107, Cols. 1-2). Historically, C. wilfordii roots have been used in treating a wide range of diseases such as aging progression and neurasthenia (p. 107, Col. 1).
Huang does not explicitly teach a pharmaceutical composition.
Ip teaches compounds isolated from Adelostemma gracillimum, an herb found in China and Burma (p. 1, ¶ [0003]), as being neuro-protective NMDA receptor inhibitors (p. 8, ¶ [0027]) and amyloid-beta peptide inhibitors (p. 8, ¶ [0028]). Ip indicates over-active NMDA receptors have been implicated in neurodegenerative diseases including Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease (p. 2, ¶ [0008]). Additionally, amyloid-beta is a well-known hallmark of Alzheimer’s disease (p. 3, ¶ [0011]). Some compounds disclosed by Ip have a structure according to Formula (IVc), shown below, wherein R1 is a saccharide and R2 can be OH, C1-C6 alkoxy, or is combined with the hydrogen on the carbon to which each is attached to form =O (p. 38, ¶ [0129]).
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Furthermore, Ip states, “Pharmaceutical excipients useful in the present invention include… binders, fillers, disintegrants, lubricants, coatings, sweeteners, flavors and colors. One of skill in the art will recognize that other pharmaceutical excipients are useful in the present invention.” (p. 24, ¶ [103]).
Ip does not explicitly teach an exemplary compound which is instantly recited.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Huang would have found it prima facie obvious to prepare a pharmaceutical composition comprising a C21 steroidal saponin and a pharmaceutically-acceptable carrier based on the teachings of Ip because both Huang and Ip disclose compounds which are pregnane (i.e., C21 steroid) derivatives and Ip suggests including such compounds in pharmaceutical compositions alongside pharmaceutically acceptable carriers like fillers and disintegrants. Thus, a PHOSITA would have been motivated to prepare a pharmaceutical composition comprising a C21 steroidal saponin, as disclosed by Huang, in a pharmaceutical composition, as suggested by Ip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.B./Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
