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 .
Status of the Claims
The amendments filed 7/07/2026 have been entered.
Response to Arguments
Applicant’s arguments, filed 7/07/2026, have been fully considered.
The rejection of claims under 35 U.S.C. 112(b) have been WITHDRAWN in view of Applicant’s amendments to the claims.
Claims 2, 4, 11-12, 17 and 22-23 are NEWLY rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohno et al (J Ethnopharmacology 216:89-96, 2018) based on Applicant’s amendments to the claims.
Claims 2, 4, 10-13, 17 and 22-23 are MAINTAINED rejected under 35 U.S.C. 103(a) as being unpatentable over Xian et al (FASEB J 33:10393-10408, published 6/24/2019; of record) in view of Yang et al (Front Psychiatry 9:696 (10 pages), published 12/14/2018; of record).
Applicant traverses the rejection of claims under 35 U.S.C. 103(a). As argued by Applicant, as amended “the present invention... concerns a method of enhancing the rate at which an antidepressant or anxiolytic drug affects the symptoms of anxiety, stress and/or depression in a subject by conjointly administering an Uncaria Rhynchophylla (UR) herb and an antidepressant or anxiolytic drug” (Applicant Arguments, Page 6).
Yet, as discussed in the basis of the rejection, the prior art teach or render obvious the same method of by conjointly administering an Uncaria Rhynchophylla (UR) herb and an antidepressant or anxiolytic drug to a subject in need of treatment for anxiety, stress and/or depression.
As such, the patient population (i.e., a subject in need of treatment for anxiety, stress and/or depression) and the active step (i.e., conjointly administering an Uncaria Rhynchophylla (UR) herb and an antidepressant or anxiolytic drug) taught by the prior art are identical to those recited by the instant claims. Accordingly, the preamble of the claims is not afforded patentable weight. 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)). Although the Hoffer court was discussing the weight of a whereby clause, the reasoning applies equally to the weight of a preamble. In the instant case, as discussed above, the preamble (i.e., enhancing the rate at which an antidepressant or anxiolytic drug affects the symptoms of anxiety, stress, and/or depression in a subject suffering therefrom) simply expresses the intended result of a process step positively recited (i.e., conjointly administering an Uncaria Rhynchophylla (UR) herb and an antidepressant or anxiolytic drug to said subject). As such, the instant preamble is not given patentable weight (see also Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814 F.2d 628 (Fed. Cir.), cert. Denied, 484 U.S. 827 (1987), noting that merely discovering and claiming a new benefit of an old process cannot render the process again patentable. As in Verdegaal Bros., Inc. v. Union Oil Co. of Calif., the burden of proof is limited to establishing that prior art discloses the same process. There is no additional burden of proving that the prior art recognized the agents of said process functioned in enhancing the rate at which an antidepressant or anxiolytic drug affects the symptoms of anxiety, stress, and/or depression in a subject suffering therefrom, as instantly claimed - that property was inherently possessed by the test compounds/agents in the disclosed process, and, thus the prior art process anticipates the claimed invention; and In re Woodruff, 16 USPQ2d 1934 (Fed. Cir. 1990), stating that “a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable”).
Applicant, however, further argues that “[a]s can be seen in the Examples, combination of Uncaria with, for example, SSRI caused these drugs to be effective about one week from the time they were taken” as opposed to “after three weeks of treatment” in “[m]ice treated with SSRI alone without Uncaria”, which Applicant argues is “not a mere additive effect” and is, indeed, “a very surprising effect” (Applicant Arguments, Page 7).
Turning to the data, Applicant demonstrates that:
(a) 1-week treatment with UR alone increased time in open arms from about 110 seconds (control) to about 150 seconds in a first experiment (Figure 1A), and from about 55 seconds (control) to about 75 seconds in a second experiment (Figure 1B). In each case, 1-week treatment increased time in open arms about 35%;
(b) 1-week treatment with SSRI alone increased time in open arms from about 110 seconds (control) to about 115 seconds (Figure 1A, escitalopram) a 5% increase, from about 55 seconds (control) to about 70 seconds (Figure 1B, fluoxetine) a 27% increase, and from about 55 seconds (control) to about 80 second (Figure 1B, sertraline), a 45% increase;
(c) 1-week treatment with UR in combination with SSRI increased time in open arms from about 110 seconds (control) to about 140 seconds (Figure 1A, escitalopram) a 27% increase, from about 55 seconds (control) to about 95 seconds (Figure 1B, fluoxetine) a 72% increase, and from about 55 seconds (control) to about 110 second (Figure 1B, sertraline), a 100% increase.
As such, there does not appear to be any unexpected effect in the combination of UR and escitalopram or fluoxetine. This is the also true when the administration was carried out for three weeks (Figure 2).
Regarding the combination of UR and sertraline, Applicant is reminded that “the objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support”. In re Clemens, 622 F.2d 1029 (CCPA 1980). In the instant case, the claims are not drafted commensurate in scope with the unexpected results to overcome the prima facie case of obviousness.
For all the foregoing reasons, Applicant’s arguments are not found persuasive. The rejection of claims is MAINTAINED.
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.
Claims 2, 4, 11-12, 17 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohno et al (J Ethnopharmacology 216:89-96, 2018).
As amended, claim 2 is drawn to a method enhancing the rate at which an antidepressant or anxiolytic drug or therapy affects the symptoms of anxiety, stress, and/or depression in a subject, 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)).
Ohno et al teach the treatment of mice subjected to “[t]he contextual conditional fear response procedure” (Page 90, Column 2) as follows:
on day 0, mice were placed in a box and exposed to “36 inescapable foot-shocks... at 1-10s intervals” (Page 90, Column 2);
on days 1-6, “Yokukansen (0.3 and 1 g/kg)... was administered orally (p.o.) once a day for 6 days” (Page 91, Columns 1-2) wherein, as further taught by Ohno et al, “Yokukansan is composed of seven kinds of dried medicinal herbs” including “3.0 g of Uncariae Uncis cum Ramulus (Uncaria rhynchophylla Miquel)” (Page 90, Column 1); and
on day 7, “[a] sub-effective dose of fluvoxamine (5 mg/kg, i.p.)” (Abstract) was administered and, 30 minutes later, mice were placed “in the same box without being exposed to foot-shocks” to measure “duration of freezing behavior” (Page 90, Column 2).
As such, Ohno et al teach a method comprising conjointly1 administering (a) an Uncaria Rhynchophylla (UR) herb and (b) an SSRI to a subject experiencing anxiety and acute stress in need of treatment thereof.
Significantly, the patient population (i.e., a subject experiencing anxiety and acute stress in need of treatment thereof) and the active step (i.e., conjoint administration (a) an Uncaria Rhynchophylla (UR) herb and (b) an SSRI) taught by the prior art are identical to those recited by the instant claims. As such, the preamble of instant claim 2 is not afforded patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150 (CCPA 1951).
Accordingly, claims 2, 4 and 12 are anticipated.
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, Ohno et al teach that “Yokukansen (0.3 and 1 g/kg)... was administered orally (p.o.) once a day for 6 days” (Page 91, Columns 1-2).
Accordingly, claim 11 is also anticipated.
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 separate compositions.
As discussed above, Ohno et al teach that “Yokukansen (0.3 and 1 g/kg)... was administered orally (p.o.) once a day for 6 days” (Page 91, Columns 1-2) and, subsequently, on day 7, “[a] sub-effective dose of fluvoxamine (5 mg/kg, i.p.)” (Abstract) was administered, which entails administration in separate compositions.
Accordingly, claim 17 is also anticipated.
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, Ohno et al teach that “Yokukansen (0.3 and 1 g/kg)... was administered orally (p.o.) once a day for 6 days” (Page 91, Columns 1-2) and, subsequently, on day 7, “[a] sub-effective dose of fluvoxamine (5 mg/kg, i.p.)” (Abstract) was administered, which entails administration in separate compositions.
And, as defined by the Specification, “the terms ‘conjoint’ or ‘conjointly’ refer to a combined administration... Specifically... to the combined administration of Uncaria Rhynchophylla (UR) herb with one or more antidepressant or anxiolytic drugs” which “encompasses.. sequential administration whereby UR may be administered either immediately prior to or immediately after the administration of the additional drug or therapy” (Page 12).
Since the UR “may be” – but need not be – administered immediately prior to or immediately after the one or more antidepressant or anxiolytic drug, the administration of UR one day prior to SSRI as taught by Ohno et al is determined to read on conjoint administration for 1 day.
Accordingly, claim 22 is also anticipated.
Claim 23 is drawn to the method of claim 2, wherein said conjoint does not cause weight gain, reduced sexual function, and/or reduced memory function.
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 lack of weight gain, lack of reduced sexual function, and/or lack of reduced memory function merely express the results of the process taught Ohno et al.
Accordingly, claim 23 is also anticipated.
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 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; of record) in view of Yang et al (Front Psychiatry 9:696 (10 pages), published 12/14/2018; of record).
As amended, claim 2 is drawn to a method enhancing the rate at which an antidepressant or anxiolytic drug or therapy affects the symptoms of anxiety, stress, and/or depression in a subject, 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).
Significantly, the patient population (i.e., a subject suffering from chronic stress in need of treatment thereof) and the active step (i.e., conjoint administration of Uncaria Rhynchophylla (UR) herb and escitalopram) taught by the prior art are identical to those recited by the instant claims. As such, the preamble of instant claim 2 is not afforded patentable weight. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150 (CCPA 1951).
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.
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.
Claim 23 is drawn to the method of claim 2, wherein said conjoint administration does not cause weight gain, reduced sexual function, and/or reduced memory function.
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 lack of weight gain, lack of reduced sexual function, and/or lack of reduced memory function merely express the results of the prima facie obvious process taught by Xian et al in view of Yang et al.
As such, claim 23 is also rejected as prima facie obvious.
Conclusion
The new ground(s) of rejection are presented in this Office action are necessitated by Applicant’s amendments to the claims. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
1 as defined by the Specification, “the terms ‘conjoint’ or ‘conjointly’ refer to a combined administration... Specifically... to the combined administration of Uncaria Rhynchophylla (UR) herb with one or more antidepressant or anxiolytic drugs” which “encompasses.. sequential administration whereby UR may be administered either immediately prior to or immediately after the administration of the additional drug or therapy” (Page 12). Since the UR “may be” – but need not be – administered immediately prior to or immediately after the one or more antidepressant or anxiolytic drug, the administration of UR one day prior to SSRI as taught by Ohno et al is determined to read on conjoint administration as instantly claimed.
Prosecution Insights