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 .
Application Status
Amended claim 34-37 and 39-48 are under examination.
Claim 49-52 are withdrawn from examination.
Claim 1-33 and 38 are cancelled.
Claim 34-37 and 39-48 are rejected. No claims are allowed.
Withdrawn Rejections
The objection over claim 40 as set forth in previous office action has been withdrawn in light of Applicant’s amendment.
The 35 USC § 103 rejection over claim 34-48 as being unpatentable over Crowley et al. (US 2012/0071567 A1) as evidenced by veganbaking.net (Ref. V), have been withdrawn in light of Applicant’s to recite new limitations in claim 34.
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.
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.
Claim(s) 34-37 and 39-48 are rejected under 35 U.S.C. 103 as being unpatentable over Ebenreth et al. (US 2021/0015753 A1, PCT/EP2018082156 filing date 11/22/2018) as evidenced by Coconut Milk (Ref. U, pg. 1-2) and veganbaking.net (Ref. V).
Regarding claim 34, 36, 37, 41 and 42, Ebenreth et al. (Ebenreth) discloses a freeze-dried multiparticulate solid dosage form, (freeze-dried nutraceutical composition) (‘753, Abstract, [0021]) comprising components including fruit puree (‘753, [0058]), micronutrients, vitamins, minerals, plant extract and fungal oil (‘753, [0034], [0035], [0042]). Ebenreth discloses the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) has a density of less than 0.8 g/cm3 (‘754, [0021], [0033]), which corresponds to less than 800 mg/cm3 and overlaps the cited range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Ebenreth does not disclose specific concentrations of each component, but giving the purpose of the dosage form to provide active ingredients to a consumer; it would have been obvious to one of ordinary skill in the art to vary each component to optimize a resulting effect.
Additionally, as Ebenreth uses like materials, a freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) (‘753, [0021]) in a like manner for oral administration; it would therefore be expected that the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) will have the same characteristics claimed, particularly a consumed product form which the melts in the mouth. Furthermore, with respect to the recitation of “…wherein the nutraceutical composition is freeze dried to obtain a ready to be consumed product form which melts in the mouth…”, is considered a functional limitations of the claimed product when it’s in the mouth; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
Regarding claim 35 and 48, Ebenreth does not explicitly disclose the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) with water concentration as recited in claim 35 and 48, however it would have been obvious to one of ordinary skill in the art to be motivated to reduce a water content including the cited concentrations in Ebenreth’s freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) to provide a desired shelf-stable consumable.
Regarding claim 39, Ebenreth discloses the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) comprising vitamins (‘753, [0090], Table 2), wherein the vitamins encompasses multivitamins.
Regarding claim 40, Ebenreth discloses the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) comprising opioids (‘753, [0030]), which is considered an herbal extract.
Regarding claim 46 and 47, Ebenreth discloses the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) comprising sugar (sweetener) (‘753, [0059], [0066]). Ebenreth does not disclose specific concentration of the sugar (sweetener) but giving the purpose of the dosage form to provide active ingredients to a consumer; it would have been obvious to one of ordinary skill in the art to vary each component to optimize a resulting effect.
Attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claim 43, 44 and 45, Ebenreth discloses the freeze-dried multiparticulate solid dosage form (freeze-dried nutraceutical composition) comprising coconut milk (‘753, [0090], Table 2) which contains coconut fat (oil) with saturated fatty acids as evidenced by Ref. U, Coconut Milk pg. 1-2) with a melting point of 25°C as evidenced by veganbaking.net (Ref. V, previously PTO-892 citation) which is in range with the cited range.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 34-37 and 39-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31-44 of copending Application No. 18/842,039 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims 34-37 and 39-48, recites similar freeze-dried composition and components with overlapping ranges as in claim 31-44 of copending Application No. 18/842,039.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to claim(s) 34-37 and 39-48 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The 35 USC § 103 rejection over claim 34-48 as being unpatentable over Crowley et al. (US 2012/0071567 A1) as evidenced by veganbaking.net (Ref. V), have been withdrawn in light of Applicant’s to recite new limitations in claim 34. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
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 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 HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ERIK KASHNIKOW can be reached at (571)270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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