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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/13/2026 has been entered.
Note to Applicant
The examiner for this application has changed. Please address all future correspondence to Kyle Nottingham.
Status of Claims
Claims 1-2 and 4-8 are pending.
Priority
Instant application 17/766,410, filed 04/04/2022 claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received 09/10/2025 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 02/13/2026 has been entered. The supplemental response filed 05/13/2026 has also been entered.
Claims 1-2 and 4 were previously objected to over informalities relating to the claim status identifiers and markings. In view of the amendment filed 02/13/2026, the objections are overcome. Therefore, the previous objections are withdrawn.
Claim 4 was previously rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sharma (US 20210115043).
The declaration under 37 CFR 1.132 filed 05/13/2026 (“Declaration”) is sufficient to overcome the rejection of claim 4 based upon the Sharma reference applied under 35 U.S.C. 102(a)(2). The Declaration establishes that the process in Sharma does not produce an extract containing yohimbine hydrochloride in analytically detectable amounts of more than 0.1% of the extract. See the comparison table at page 10 of the Declaration:
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Therefore, in view of the foregoing, the rejection of claim 4 over Sharma is withdrawn.
Rejection 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.
Claim 4 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by SRIVASTAVA (WO 2010/113180, listed on the IDS).
The rejection as set forth in the previous office action is set forth below for convenience:
Claim 4 is a “product-by-process” claim which is drawn to “The extract obtained by the process as claimed in Claim 1 wherein the same contains yohimbine hydrochloride as a marker compound in analytically detectable amounts of more than 0.1% of the extract”.
See MPEP 2113: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." And “Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product”.
The reference discloses substances which are anticipatory of claim 4, at least as follows:
The methanol extract of Rauwolfia tetraphylla in example 2 at page 17 is produced by combining four successive methanol extractions of powdered leaves and evaporating to give a “crude MeOH extract” (page 17, line 12). This extract is asserted to be identical to the “concentrated extract” substance obtained in steps i-iv of the process of examined claim 1. Claim 4 can be interpreted as being drawn to this extract. The reference substance is produced by extracting the same Rauwolfia tetraphylla material using the same alcoholic solvent as the examined claims and therefore is presumed to be the same. The reference is silent as to the presence of more than 0.1% yohimbine hydrochloride, however given the same process conditions this substance is necessarily also present in the prior art extract.
Alternatively, the Alpha-yohimbine isolated as “K001” at page 26, line 18 (see also page 34, lines 5-7) is asserted to be identical to the substance obtained in step xv of the process of examined claim 1. Claim 4 can be interpreted as being drawn to this product, see the 112(b) rejection above. The reference is silent as to the presence of more than 0.1% yohimbine hydrochloride, however given the purification conditions this substance is presumed necessarily also present in the prior art isolated substance.
Applicant’s response:
Applicant’s traversal appears on page 2 of the response as follows:
“As to the rejection based on Srivastava, this rests on the Examiner's ‘presumptions’ set out in the action of March 14, 2025 that products obtained by the methods described in Srivasta will contain yohimbine hydrochloride in detectable amounts of more than 0.1%, even though Srivasta makes no mention of this. However, in support of this presumption the examiner points only to the fact that the product of Srivasta's Example 2 (i.e. that referred to at page 17 line 12 was obtained from Rauwolfia Tetraphylla Leaves by extraction with methanol and then dried and mixed with water. That is steps equivalent to steps (i) - iv) of those set out in claim 1 of the present application which are steps on the way to producing the product of claim 4. The Examiner gives no reason why the product resulting from carrying out the other steps of claim 1 would be the same as that of Example 2 of Srivasta. As shown by the analyses set out in and accompanying Ms. Soni's declaration, use of different steps in the extraction process can result in significant differences in the products obtained.
The Examiner's other candidate for anticipation is Srivasta' K001 resulting from fractions 98-129 of an HPLC separation of a chloroform extract apparently prepared by the method of Example 4. This requires immediate acidification of an initial extraction with methanol. Then basifying that extract, and extracting active material from it with chloroform. which is then subjected to HPLC. This again omits many of the steps set out in claim 1. There is therefore no basis for presuming that yohimbine would be present in the amount specified in claim 4 in the HPLC fractions noted by the Examiner.”
Examiner’s response:
The Examiner asserted that that the reference substance was necessarily identical to that produced in the final step of the claimed process: “the Alpha-yohimbine isolated as “K001” at page 26, line 18 (see also page 34, lines 5-7) is asserted to be identical to the substance obtained in step xv of the process of examined claim 1”.
The following argument was made in the ground of rejection: “The reference substance is produced by extracting the same Rauwolfia tetraphylla material using the same alcoholic solvent as the examined claims and therefore is presumed to be the same. The reference is silent as to the presence of more than 0.1% yohimbine hydrochloride, however given the same process conditions this substance is necessarily also present in the prior art extract”.
Applicant’s response acknowledges that Srivasta’s Example 2 extraction with methanol is equivalent to steps (i) – (iv) of those set out in claim 1. As shown in Applicant’s Declaration, the methanol extraction process results in an extract having yohimbine hydrochloride in amounts of more than 0.1% extract (see Declaration; the table at Page 6, and the table at page 10; specifically Annexure-01 and Annexure-i). The evidence provided by applicant supplies a basis for presuming that Srivastava’s process supplies an extract having yohimbine hydrochloride in analytically detectable amounts of more than 0.1% of the extract.
Therefore, the rejection is maintained.
New Rejections
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.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Tewari (US 20190330203 A1; published 31 October 2019).
Claim 4 is a “product-by-process” claim which is drawn to “The extract obtained by step (xv) of the process as claimed in Claim 1 wherein the same contains yohimbine hydrochloride as a marker compound in analytically detectable amounts of more than 0.1% of the extract”.
See MPEP 2113: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." And “Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product”.
Tewari describes a process for the extraction of Rauwolfia canescens leaves in the example on page 6 in para. [0063]-[0071]. The alpha yohimbine produced by Tewari’s process is described as having 90-93% purity. The reference substance is produced by extracting the same Rauwolfia material. The reference is silent as to the presence of more than 0.1% yohimbine hydrochloride.
However, Applicant’s own specification describes the Tewari process as a “Prior Art Process” (Specification, page 6, section titled “Prior Art vs Present Invention”). Patent No. 10,730,869 B2 is the patent that issued from the Tewari publication. Applicant’s own specification also provides a comparison in FIGS. 8A-8B described as “HPLC fingerprint of extract obtained by prior art process vs new process” (Specification, page 12). The HPLC fingerprint comparison in FIGS 8A and 8B are therefore being interpreted as showing a comparison between the extract obtained by the “Prior Art” (Tewari) process and the extracted obtained by the claimed method.
Should it be found that the “Prior Art Process” in FIG. 8 is not Tewari’s process, the description of this extract as obtained by a “prior art process” is still considered an admission constituting prior art. See MPEP 2129, stating: “A statement by an applicant in the specification or made during prosecution identifying the work of another as "prior art" is an admission which can be relied upon for both anticipation and obviousness determinations, regardless of whether the admitted prior art would otherwise qualify as prior art under the statutory categories of 35 U.S.C. 102.”
FIG. 8A shows the extract obtained by the “Prior Art” process. In FIG. 8A, the HPLC trace comprises alpha-yohimbine (rauwolscine) HCl and yohimbine HCl. The alpha-yohimbine HCL is present in an amount of 0.143%, which anticipates claim 4 (requiring “more than 0.1%”).
Accordingly, claim 4 is anticipated by Tewari.
Conclusion
Claim 4 is rejected. Claims 1-2 and 5-8 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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