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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7 October 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 7 October 2025 in response to the final rejection mailed 11 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 7 October 2025 replaces all prior versions and listings of the claims.
Claims 11 and 13-16 are pending. Claims 12 and 17-22 are canceled by Applicant’s amendment. Claim 11 is amended. Claims 11 and 13-16 are being examined on the merits.
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 11, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (J Physiol & Pathol Korean Med, 2018, 247-254) in view of Ströhle et al. (Dtsch Arztebl Int, 2018, 611-620).
The instant claims are as of record, drawn to a method for treating an anxiety disorder comprising administering to a subject having an anxiety disorder associated with adenosine A1 receptor activity deficiency a composition comprising at least one extract selected from the group consisting of Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas.
Oh et al., however, anticipate the claims by teaching administration of a composition of Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas combined in a 1:1:1.08 ratio, extracted with distilled water, and administered at dosages of 100 and 300 mg/kg (Oh et al., Plant material and preparation of CPAE, page 248; FST for chronic restraint-induced stress model, page 249; as required for instant Claims 11, 13, and 14), which appears to be identical to the presently claimed method since it is formulated and/or obtained from the same component materials because the specification describes that Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas were combined in a 1:1:1.08 weight ratio ([0076], page 19) and administered in 100 and 300 mg/kg doses ([0078], page 20).
Mice subjected to chronic restraint-induced stress (subject in need thereof) were administered the composition (Oh et al., Animals, page 249; as required for instant Claim 11). The composition acted as an agonist of the 5-HT6 receptor and improved stress-induced depression (Oh et al., Conclusions, page 253). Serotonin (5-HT) is associated with depression, anxiety, obsessive-compulsive disorder, and panic disorder, and 5-HT6 receptor agonists are also known to have anti-anxiety (treating an anxiety disorder associated with adenosine A1 receptor activity deficiency) effects (Oh et al., Introduction, page 247; Conclusions, page 253; as required for instant Claim 11). The composition could therefore be developed into food (food composition) and drug (pharmaceutical composition) products (Oh et al., Conclusions, page 253; as required for instant Claims 15 and 16).
Oh et al. do not specifically state that the anxiety disorder is separation anxiety, isolation anxiety, paranoia, panphobia, or anxiety neurosis.
Ströhle et al. teach that the various clinical manifestations of anxiety disorder include generalized anxiety disorder (anxiety neurosis) and separation anxiety (Ströhle et al., Table 1, page 3).
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 take the composition of Oh et al., which is known to act as a 5-HT6 receptor agonist, and apply it to the various anxiety disorders of Ströhle et al. because 5-HT6 receptor agonists are known to have anti-anxiety effects. Additionally, a skilled artisan would be motivated to try a composition known to generally have anti-anxiety effects against various anxiety disorders because treatment decisions are made based on various factors, not just which specific disorder the patient has, and because there is already overlap between various pharmacotherapies for treatment of anxiety disorders (Ströhle et al., Table 2, page 7). A skilled artisan could therefore apply the composition of Oh et al. to the various anxiety disorders of Ströhle et al. and the instant claims with a reasonable expectation of success.
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (J Physiol & Pathol Korean Med, 2018, 247-254) in view of Ströhle et al. (Dtsch Arztebl Int, 2018, 611-620) as applied to Claims 11-13, 15, and 16 above, and further in view of Zhang et al. (Chin Med, 2018, 26 pages).
The instant claims and teachings of Oh et al. and Ströhle et al. are as of record.
Oh et al. and Ströhle et al. do not teach wherein at least one solvent is selected from the group consisting of ethyl ether, ethyl acetate and butanol.
Zhang et al. teach a solvent system comprising solvent system comprising ethyl acetate, n-butanol, ethanol, and water is described (solvent fraction; Separation based on partition coefficient, page 14; as required for instant Claim 14).
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Oh et al. and Ströhle et al. with the extraction methods of Zhang et al. to arrive at the instantly claimed invention. Zhang et al. teach that the selection of solvent is crucial for solvent extraction and polarity values help determine which compounds will effectively be extracted (Zhang et al., Extraction, page 2; Table 1, page 14). A skilled artisan would therefore know to use different types of solvents in various combinations with a reasonable expectation of success.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing 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 (including compositions within the processes thereof), 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).
Response to Arguments
Applicant's arguments filed 7 October 2025 have been fully considered but they are not persuasive.
Applicant argues on page 7 of the reply filed on 27 May 2025 that Oh et al. fails to describe the feature of “adenosine A1 receptor activity deficiency,” however, as is indicated in the rejection above, the method requires the single step of administering the composition to a subject having one of the disorders listed in Claim 11. The cited reference discloses administration of a composition of Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas combined in a 1:1:1.08 ratio, extracted with distilled water, and administered at dosages of 100 and 300 mg/kg (Oh et al., Plant material and preparation of CPAE, page 248; FST for chronic restraint-induced stress model, page 249), which appears to be identical to the presently claimed method since it is formulated and/or obtained from the same component materials and is administered/administrable to a subject. Additionally, the specification describes that Cynanchum wilfordii, Phlomis umbrosa and Angelica gigas were combined in a 1:1:1.08 weight ratio ([0076], page 19) and administered in 100 and 300 mg/kg doses ([0078], page 20). Since the patient population is the same (e.g., requiring treatment for anxiety due to stress induced by chronic restraint), the single-step method of administration is the same, and the composition being administered is the same and also administered at the same dose, the prior art anticipates the instant claims.
Additionally, in response to applicant's argument regarding independent Claim 11, as well as dependent Claim 14, that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a specific adenosine A1 receptor-mediated mechanism) are not recited in the rejected claims. The claims as amended only require that the disorder to be treated be characterized by an association with adenosine A1 receptor activity, not that that the composition requires a specific mechanism of action. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In addition to this feature regarding an adenosine A1 receptor-mediated mechanism, merely recognizing the effects of a known method does not change how the process is performed, and the only difference is that applicants have recognized an inherent result (adenosine A1 receptor agonism) of an old process which was not known before.
Applicant goes on to argue that because the adenosine A1 receptor and 5-HT6 receptor represent different pathways, a skilled artisan would have no motivation to apply the composition of Oh et al. to treat an anxiety disorder associated with adenosine A1 receptor activity deficiency. According to the instant specification, however, anxiety disorders cover various and different mental disorders that are caused by a complex combination of genetics, changes in the brain, social and psychological aspects, and past experiences (Specification, page 2). Additionally, it is well known in the art that 5-HT6 receptors are associated with anxiety and that both agonists and antagonists of this receptor have anxiolytic effects (Wesolowska, Pharmacol Rep, 2010, 564-577; Oh et al., Introduction, page 247 & Conclusions, page 253). Nowhere in the prior art or instant disclosure is it taught or implied that only certain types of anxiety disorders are associated with a given receptor, therefore association with adenosine A1 receptor activity deficiency does not exclude association with 5-HT6 receptors. A skilled artisan would be more than able to reach the conclusion that one composition which acts upon 5-HT6 receptors associated with anxiety would be useful for treating various types of anxiety disorder.
Conclusion
No claims are allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655