DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 1/07/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 27-28 and 30-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of a single method in the reply filed on 1/07/2026 is also acknowledged.
Applicant indicates that the elected method reads on claims 2, 4, 6, 10-13, 16-17, 19 and 21-23. However, the elected method does not appear to read on claim 6 (drawn to the treatment of major depressive disorder), claim 16 (which depends from cancelled claim 7 and is drawn to administration of an herb that is not Uncaria Rhynchophylla), or claim 21 (which is drawn to the method of claim 13 “wherein said VAS are general anxiety or mood”, none of which is contained in claim 13).
As such, the elected method is determined to read upon claims 2, 4, 10-13, 17, 19 and 22-23. Claims 5, 16, 18 and 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
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.
Claims 4, 10-13, 17, 19 and 22-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 4, 10-12, 17, 19 and 22-23 all depend from claim 1, which has been cancelled. As such, each of the claims lacks antecedent basis.
Claim 13 depends from claim 7, which has been cancelled. As such, claim 13 also lacks antecedent basis.
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.
Claims 2, 4, 10-13, 17, 19 and 22-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Xian et al (FASEB J 33:10393-10408, published 6/24/2019) in view of Yang et al (Front Psychiatry 9:696 (10 pages), published 12/14/2018).
Claim 2 is drawn to a method of treating or preventing stress (more specifically, chronic stress (claim 4)), said method comprising conjointly administering to a subject in need thereof:
(a) an Uncaria Rhynchophylla (UR) herb – wherein, as defined by the Specification, “the term ‘Uncaria Rhynchophylla (UR) herb’... refers to a natural plant material (also termed cat’s claw herb). Any effective part of the herb in accordance with the present invention can be used (for example, crude, purified or partially purified extracts in a form of e.g., a powder) including seeds, leaves, stems, flowers, roots bark, or any other plant parts which are useful for the purposes described” (Page 8); and
(b) at least one antidepressant or anxiolytic drug (more specifically, an SSRI (claim 12), even more specifically, escitalopram (claim 13)).
Xian et al teach that “[i]sorhynchophylline (IRN)... isolated from Uncaria rhynchophylla, elicited distinct antidepressant-like activity... in chronic unpredictable mild stress (CUMS)-induced depressive-like behaviors in mice” (Abstract), further noting that “CUMS is widely used in laboratory animals to mimic unpredictable life stressors that may contribute to the development of major depressive disorders in humans” (Page 10404, Column 1). In particular, Xian et al teach that when “mice were subjected to CUMS for 6 wk and administered with IRN (20 or 40 mg/kg) daily by oral gavage for 3 wk... IRN treatment could significantly reverse the behavioral and biochemical changes induced by CUMS” (Abstract).
As such, Xian et al teach a method of treating chronic stress (and depression-like behaviors associated with chronic stress), comprising administering isorhynchophylline (i.e., an Uncaria Rhynchophylla (UR) herb) to a subject in need thereof.
However, Xian et al do not teach conjointly administering escitalopram as claimed.
Yet, as taught by Yang et al, administration of escitalopram (10 mg/kg/day) by gavage to rats subjected to chronic unpredictable mild stress (CUMS) (Page 2, Column 2, Experiment Design and Pharmacological Treatments), resulted in “OFT scores and the percentage of sugar consumption [that was] significantly increased compared to those in the CUMS-induced rats” and “[t]here was no significant difference in OFT scores or percentage of sugar consumption between the Control... and CUMS-ESC groups” (Page 4, Column 2).
Accordingly, in further view of Yang et al, it would have been prima facie obvious to conjointly administer escitalopram along with Uncaria Rhynchophylla (UR) herb as taught by Xian et al for the treatment of chronic stress. As stated in MPEP 2144.06, “[i]t 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 (CCPA 1980).
As such, claims 2, 4 and 12-13 are rejected as prima facie obvious.
Claim 10 is drawn to the method of claim 2, wherein the UR is administered in an amount of 450 mg per day, 500 mg per day, 1000 mg per day, 2000 mg per day, or more.
As discussed above, Xian et al teach that when “mice were... administered with IRN (20 or 40 mg/kg) daily” (Abstract).
As stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of active ingredient for administration is clearly a result-effective variable as disclosed by Xian et al, who demonstrate that the differing daily doses of IRN (20 or 40 mg/kg) provided different results (see, e.g., Figure 3, Figure 4, Figure 5, etc.). Indeed, as indicated by the court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015), every ordinary artisan in medicine performs “merely routine optimization of drug dosage to maximize therapeutic effect.” Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal amount of IRN (UR) to administer in order to best achieve the desired results.
As such, claim 10 is also rejected as prima facie obvious.
Claim 11 is drawn to the method of claim 2, wherein the UR is administered once a day, twice a day, three times a day, or more.
As discussed above, Xian et al teach that when “mice were... administered with IRN (20 or 40 mg/kg) daily” (Abstract).
As such, claim 11 is also rejected as prima facie obvious.
Claim 17 is drawn to the method of claim 2, wherein said conjoint administration comprises administering the UR and the at least one antidepressant or anxiolytic drug in a single composition or in separate compositions.
At the outset, it is necessarily the case that any administration of two or more agents conjointly will entail administration “in a single composition or in separate compositions” – as this embraces the entirety of possibilities when administering two or more agents.
Nevertheless, as stated in MPEP 2144.06, “[i]t 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 (CCPA 1980).
Accordingly, it would have been obvious to administer the UR and escitalopram in a single composition.
As such, claim 17 is also rejected as prima facie obvious.
Claims 19 and 23 are drawn to the method of claim 2, wherein said conjoint administration reduces the time require for reduction of stress symptoms (claim 19) and/or does not cause weight gain, reduced sexual function, and/or reduced memory function (claim 23).
As noted by the court in Hoffer v. Microsoft Corp. (405 F.3d 1326 (Fed. Cir. 2005)), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ' l Ass ' n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003)).
In the instant case, the reduction in time required for reduction of stress symptoms (as recited by claim 19) as well as the lack of weight gain, lack of reduced sexual function, and/or lack of reduced memory function (as recited by claim 23) merely express the results of the prima facie obvious process taught by Xian et al in view of Yang et al.
As such, claims 19 and 23 are also rejected as prima facie obvious.
Claim 22 is drawn to the method of claim 2, wherein said conjoint treatment is for 1 day, 2 days... 3 weeks, 4 weeks... 6 weeks, or more.
As discussed above, Xian et al teach that when “mice were... administered with IRN (20 or 40 mg/kg) daily by oral gavage for 3 wk...” (Abstract).
And Yang et al teach “[t]he treatment lasted for 21 days” (Page 2, Column 2, Experimental Design and Pharmacological Treatments; see also Figure 1).
Accordingly, it would have been obvious to carry out the conjoint treatment for 3 weeks.
As such, claim 22 is also rejected as prima facie obvious.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611