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 .
Status of the Application
The claims are identical to those filed 11/05/2021 in parent application 17/520,147 and addressed in the Non-Final Office Action filed 10/05/2022. This action is made FINAL (see Conclusion).
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-6
Currently rejected claims: 1-6
Allowed claims: None
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Morita et al. (U.S. 2011/0183056 A1).
Regarding claim 1, Morita et al. discloses a process for preparing a steviol glycoside composition comprising the steps of (i) providing Stevia rebaudiana leaves ([0030], [0046]), wherein the leaves comprise RebM ([0022]; Tables 4-6, “VIII”), (ii) providing a solvent comprising water ([0030], [0046]), (iii) contacting the leaves with the solvent to extract the steviol glycosides from the leaves ([0030], [0046]), and (iv) separating the leaves to obtain a Stevia extract solution ([0031], [0046]) comprising RebM (Tables 4-6, “VIII”).
Morita et al. does not explicitly disclose the RebM in the leaves or the extract solution as being at a relative concentration of greater than 1.4%.
However, Morita et al. suggests that selective cross breeding of Stevia varieties may be performed to alter the relative concentrations of steviol glycosides in the plants ([0004]). Such skill is considered to be within the ordinary skill in the art ([0007]). Since Morita et al. indicates RebM is a desirable steviol glycoside ([0029], [0039], [0044]), the production of a Stevia variety wherein the relative concentration of RebM is increased to 1.4% in the leaves is considered obvious to a skilled practitioner. A skilled practitioner would reasonably expect the relative concentrations of steviol glycosides in the extracts to be representative of the relative concentrations in the leaves as well, thus also rendering such a concentration of 1.4% in the extract obvious. Such a conclusion of obviousness is further supported by the teaching in Morita et al. that such a purified glycoside may be used as a sweetener ([0029], [0039], [0044]), thus suggesting the desirability for relatively high concentrations of such components in the leaves and extract.
As for claim 2, Morita et al. discloses further purification of the extract solution and drying to obtain an extract with a total steviol glycoside content of at least 6.9% by weight ([0031], [0046]).
As for claims 3 and 4, the disclosure of Morita et al. regarding providing Stevia rebaudiana leaves in general ([0030], [0046]) renders the use of any particular cultivar of Stevia rebaudiana obvious for extracting steviol glycoside compositions. The use of leaves as is (claim 3) or leaves from a cultivar (claim 4) of the three claimed cultivars (807086, 814011, and 817096) is thus considered obvious.
As for claim 5, the present specification describes “untreated aqueous extract(s)” as being an extract that has not been “subjected to techniques used to purify, isolate or further concentrate a certain steviol glycoside, or a group of steviol glycosides, from the extract” (P3, L15-L18), which is understood as requiring that the relative concentrations of steviol glycosides are not manipulated. In light of the obviousness of cross breeding of Stevia varieties in order to specifically select for those exhibiting a RebM relative concentration of 1.4% as discussed previously in relation to claim 1, the production of such an untreated extract would likewise be obvious to the extent that further manipulation of an extract obtained according to the method of Morita et al. from a cross-bred variety exhibiting RebM relative concentrations above the claimed threshold would be unnecessary to achieve such a relative concentration of RebM in an extract.
Claim 5 is additionally rejected according to the following alternative rationale. Claim 5 is a product-by-process claim. MPEP 2113 I states: “[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.” For a RebM concentration at its common relative concentration, such an extract would be indistinguishable from a conventionally-produced extract that comprised RebM. Morita et al. discloses a Stevia extract solution ([0031], [0046]) comprising RebM (Tables 4-6, “VIII”), which would be an untreated aqueous Stevia extract wherein the RebM is present at its common relative concentration.
As for claim 6, Morita et al. discloses a food comprising the Stevia extract ([0045]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,202,461. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are merely broader than the claims of the ‘461 patent.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,856,972. Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are merely broader than the claims of the ‘972 patent.
Conclusion
This is a continuation of applicant's earlier Application No. 17/520,147. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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