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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 13 November 2025 and 22 May 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
The amendments and arguments filed 29 January 2026 are acknowledged and have been fully considered. Claims 1, 10, 13-15, 18, 21-24, and 31-37 are currently pending. Claim 1 is amended; claims 2-9, 11-12, 16-17, 19-20, and 25-30 are cancelled; claims 1, 10, 13-15, 18, and 33-36 are withdrawn; no claims are new.
Claims 21-24, 31-32, and 37 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 21-24, 31-32, and 37 are MAINTAINED rejected under 35 U.S.C. 103 as being unpatentable over Grother et al. (US 2023/0364013, effectively filed 8 October 2020) in view of Brooks (Contract Pharma, 2019) and Qu et al. (US 2019/0210946).
Claim 21 is drawn to a rapidly infusing buccal composition, comprising:
gelatin, in an amount of 10 to 35 wt.%, based on a total weight of the rapidly infusing composition on a dry basis;
a sugar alcohol, in an amount of 5 to 35 wt.%, based on a total weight of the rapidly infusing composition on a dry basis; and
cannabidiol (CBD) in an amount of 20 to 70 wt.%, based on a total weight of the rapidly infusing composition on a dry basis;
wherein the rapidly infusing composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt% (more specifically 99 to 99.9 wt% (Claim 31)), and wherein the rapidly infusing composition is lyophilized and has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37°C ± 2°C.
Grother et al. teach freeze dried oral dispersible or disintegrating dosage forms of epinephrine (Par. [0095]). Grother et al. further teach in Fig. 8 Batch 3 a composition comprising 10g gelatin, 8g mannitol, and 8g epinephrine. Grother et al. further teach this batch being processed into final dosage form by freeze-drying (Par. [0160]). After the removal of water by freeze drying, Fig. 8 Batch 3 of Grother et al. comprises:
27.4% by weight gelatin;
20.5% by weight mannitol; and
20.5% by weight epinephrine.
Grother et al. further teach the tablets of batch 3 having a disintegration time of less than 2 seconds (Par. [0164]), overlapping with the instantly claimed range.
As such, Grother et al. teach a rapidly infusing buccal composition, comprising: gelatin in an amount of 10 to 35 wt% based on a total weight of the rapidly infusing composition on a dry basis; a sugar alcohol (mannitol) in an amount of 5 to 35 wt% based on a total weight of the rapidly infusing composition on a dry basis; and an active ingredient in an amount of 20 to 70 wt% based on a total weight of the rapidly infusing composition on a dry basis, wherein the rapidly infusing composition is lyophilized and has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37°C ± 2°C.
The composition of Grother et al. differs from the instantly claimed composition in the following ways:
the composition of Grother et al. does not comprise a solid form of CBD having a purity between 99 and 99.9 wt%.
Yet, as to 1: Brooks teaches a composition to deliver pharmaceutical grade CBD for treatment of multiple sclerosis spasticity based on the Zydis® orally disintegrating tablet of Catalent (Pg. 1), i.e., the disintegrating delivery system taught by Grother et al.
Grother et al. teach the active agent being present in the composition in its crystalline form to improve stability (Par. [0097]).
Qu et al. teach the purification of CBD for pharmaceutical use (Par. [0002]). Qu et al. further teach high purity CBD crystals (Par. [0040]) having a CBD content of 99.25% (Par. [0044]), overlapping with the instantly claimed range.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art to have modified the composition of Grother et al. to comprise the high purity CBD crystals of Qu et al. as an active ingredient. It would have been obvious to substitute one crystalline active ingredient for another, to yield the predictable result of a stable disintegrating delivery system suitable for treating multiple sclerosis spasticity, with a reasonable expectation of success.
Based on all of the foregoing, claims 21 and 31 are rejected as prima facie obvious.
Claim 22 is drawn to the composition of claim 21 further comprising at least one selected from the group of a sweetener, a flavorant, and a colorant.
Claim 23 is drawn to composition of claim 22, wherein the composition comprises a flavorant comprising citrus flavor.
Claim 24 is drawn to the composition of claim 22, wherein the composition comprises a colorant comprising FD&C Yellow #5.
Grother et al. further teach the composition further comprising a flavoring agent such as lemon flavor and a coloring agent including FD&C Dyes (Par. [0103]).
As such, claims 22-24 are rejected as prima facie obvious.
Claim 32 is drawn to the composition of claim 21, wherein the gelatin is present in an amount of 16 to 24 wt% based on a total weight of the composition on a dry basis.
Grother et al. further teach the composition comprising 10-40 wt% a matrix former (Claim 1), wherein gelatin is the matrix former (Claim 7), overlapping with the instantly claimed range.
As such, claim 32 is rejected as prima facie obvious.
Claim 37 is drawn to the composition of claim 21, wherein the composition comprises less than 0.5 wt% of surfactants and lubricants, based on the total weight of the composition on a dry basis.
As the composition of Grother et al. taught in Fig. 8 Batch 3 consists of gelatin, mannitol, epinephrine, sucralose, and citric acid, Grother et al. teach a composition absent of surfactants and lubricants.
As such, claim 37 is rejected as prima facie obvious.
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.
Claims 21-24, 31-32, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 of U.S. Patent No. 11,672,761. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 16-19, 22, 24, and 31 of Patent No. ‘761 recites a rapidly infusing buccal composition, comprising: bovine gelatin, in an amount of 10 to 35 wt. %, based on a total weight of the rapidly infusing buccal composition on a dry basis; a sugar alcohol, in an amount of 5 to 35 wt. %, based on a total weight of the rapidly infusing buccal composition on a dry basis; a therapeutically effective amount of cannabidiol (CBD), in an amount of 20 to 70 wt. %, based on a total weight of the rapidly infusing buccal composition on a dry basis; wherein the rapidly infusing buccal composition is formulated with a solid form of the CBD having a purity between 95 and 99.9 wt. %, and wherein the rapidly infusing buccal composition is lyophilized and has a rapid disintegration time in a buccal cavity as demonstrated by a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37° C.±2° C, overlapping with instant claim 21.
Claim 17 of Patent No. ‘761 recites the composition of claim 16, further comprising at least one selected from the group consisting of a sweetener, a flavorant, and a colorant, overlapping with instant claim 22 .
Claim 18 of Patent No. ‘761 recites the composition of claim 17, wherein the flavorant comprises lemon-lime flavor, overlapping with instant claim 23.
Claim 19 of Patent No. ‘761 recites the composition of claim 17, wherein the colorant comprises FD&C Yellow #5, overlapping with instant claim 24.
Claim 22 of Patent No. ‘761 recites the composition of claim 16, wherein the CBD has a purity between 99 and 99.9 wt%, overlapping with instant claim 31.
Claim 24 of Patent No. ‘761 recites the composition of claim 16, wherein the bovine gelatin is present in an amount of 20 to 24 wt%, overlapping with instant claim 32.
Claim 31 of Patent No. ‘761 recites the composition of claim 16, wherein the composition comprises less than 0.5 wt% of surfactants and lubricants, overlapping with instant claim 37.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8, 10-12, and 16-18 of copending Application No. 18/252,668 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘668 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin, a sugar alcohol, and CBD. Claim 4 of Application No. ‘668 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 5 of Application No. ‘668 recites the composition comprising 10 to 35 wt% gelatin. Claim 8 of Application No. ‘668 recites the composition comprising 5 to 35 wt% sugar alcohol. Claim 10 of Application No. ‘668 recites the composition comprising 20 to 70 wt% CBD. Claims 11-12 of Application No. ‘668 recite the composition comprising a solid form of CBD having a purity between 95 and 99.9 wt%.
Claims 1, 4-5, 8, and 10-12 of Application No. ‘668 render instant claims 21, 31-32, and 37 obvious.
Claims 16-18 of Application No. ‘668 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 7, 9, and 15-17 of copending Application No. 18/252,693 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘693 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin, a sugar alcohol, and a solid form of CBD having a purity between 95 and 99.9 wt%, wherein the rapidly infusing composition has a disintegration time of approximately 1 to 30 seconds in deionized water maintained at 37°C. Claim 4 of Application No. ‘693 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 5 of Application No. ‘693 recites the composition comprising 10 to 35 wt% gelatin. Claim 7 of Application No. ‘693 recites the composition comprising 5 to 35 wt% sugar alcohol. Claim 9 of Application No. ‘693 recites the composition comprising 20 to 70 wt% CBD.
Claims 1, 4-5, 7, and 9 of Application No. ‘693 render instant claims 21, 31-32, and 37 obvious.
Claims 15-17 of Application No. ‘693 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 8, 10-12, and 16-18 of copending Application No. 18/252,694 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘694 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin, a sugar alcohol, and CBD. Claim 4 of Application No. ‘694 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 5 of Application No. ‘694 recites the composition comprising 10 to 35 wt% gelatin. Claim 8 of Application No. ‘694 recites the composition comprising 5 to 35 wt% sugar alcohol. Claim 10 of Application No. ‘694 recites the composition comprising 20 to 70 wt% CBD. Claims 11-12 of Application No. ‘694 recite the composition comprising a solid form of CBD having a purity between 95 and 99.9 wt%.
Claims 1, 4-5, 8, and 10-12 of Application No. ‘694 render instant claims 21, 31-32, and 37 obvious.
Claims 16-18 of Application No. ‘694 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7, 9-11, and 15-17 of copending Application No. 18/252,741 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘741 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin, a sugar alcohol, and a solid form of CBD having a purity between 95 and 99.9 wt%. Claim 4 of Application No. ‘741 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 5 of Application No. ‘741 recites the composition comprising 10 to 35 wt% gelatin. Claim 7 of Application No. ‘741 recites the composition comprising 5 to 35 wt% sugar alcohol. Claim 9 of Application No. ‘741 recites the composition comprising 20 to 70 wt% CBD.
Claims 1, 4-5, 7, and 9 of Application No. ‘741 render instant claims 21, 31-32, and 37 obvious.
Claims 15-17 of Application No. ‘741 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 7, 9, 11, and 13-15 of copending Application No. 18/317,964 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘964 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin, a sugar alcohol, and a solid form of CBD. Claim 4 of Application No. ‘964 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 5 of Application No. ‘964 recites the composition comprising 10 to 35 wt% gelatin. Claim 7 of Application No. ‘964 recites the composition comprising 5 to 35 wt% sugar alcohol. Claim 9 of Application No. ‘964 recites the composition comprising 20 to 70 wt% CBD. Claim 11 of Application No. ‘964 recites the composition comprising CBD having a purity between 95 and 99.9 wt%.
Claims 1, 4-5, 7, 9, and 11 of Application No. ‘964 render instant claims 21, 31-32, and 37 obvious.
Claims 13-15 of Application No. ‘964 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-24, 31-32, and 37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 11, and 13-15 of copending Application No. 18/317,977 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of Application No. ‘977 recites a method of administering to a subject a lyophilized rapidly infusing composition comprising gelatin in an amount of 10 to 35 wt%, mannitol in an amount of 5 to 35 wt%, and a solid form of CBD in an amount of 20 to 70 wt%. Claim 4 of Application No. ‘977 recites the method of claim 1, wherein the composition disintegrates in 1 to 5 seconds in deionized water maintained at 37°C. Claim 11 of Application No. ‘977 recites the composition comprising CBD having a purity between 95 and 99.9 wt%.
Claims 1, 4, and 11 of Application No. ‘977 render instant claims 21, 31-32, and 37 obvious.
Claims 13-15 of Application No. ‘977 recite the composition comprising a lemon-lime flavor and FD&C Yellow #5, rendering instant claims 22-24 obvious.
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 filed 29 January 2026 have been fully considered but they are not persuasive.
Applicant argues on pg. 8 of the remarks that one of ordinary skill in the art would not have a reasonable expectation of success for substituting insoluble CBD in the place of soluble epinephrine while maintaining the disintegration time of 1 to 5 seconds.
Applicant further argues on pg. 9 of the remarks that substituting water insoluble CBD in the composition of Grother et al. would render Grother et al. inoperable for its intended purpose of a “freeze-dried tablet with robust matrix structure and a disintegration time of ≤10 seconds that is desirable to ensure dissolution of the API in saliva, such to allow sublingual absorption” stating that insoluble drugs administered by disintegrating tablets are not absorbed through the oral mucosa.
This argument is not persuasive. Grother et al. do not teach an insoluble active ingredient or the affect that an insoluble active ingredient would have on disintegration or absorption. However, Brooks teaches that Catalent and Ethicann Pharmaceuticals are working together to produce a CBD formulation based on Catalent’s Zydis disintegrating tablets, indicating to one of ordinary skill in the art that the use of the disintegrating system of Grother et al. for the delivery of CBD is a commercially viable strategy, providing a reasonable expectation for success. Further, rapidly disintegrating compositions with insoluble active ingredients are well known in the art.
For example, it is evidenced by Otsuka (JP 2012/121850) that the insoluble active ingredient aripiprazole is suitable for delivery by rapidly disintegrating oral tablets (Abstract). Otsuka further teaches in pars. [0025-27] and Table 1 a lyophilized composition comprising 36-41 wt% gelatin, 24-27 wt% mannitol, 27-36 wt% aripiprazole, citric acid, and aspartame that disintegrates in 0-4 seconds.
As further evidenced by Bruun et al. (WO 2020/211915 cited on Applicant’s IDS filed 13 November 2025), fast disintegrating cannabinoid tablets were known in the prior art (Abstract). Bruun et al. further teach the transmucosal permeation and buccal absorption of CBD (Pg. 13 line 24 – pg. 14 line 4).
Based on the state of the prior art as evidenced by Otsuka and Bruun et al., one of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success for substituting CBD in the composition of Grother et al. to obtain a composition that disintegrates in less than 10 seconds and enables buccal or sublingual absorption.
Applicant argues on pgs. 10-11 of the remarks that the instantly claimed invention provides the unexpected result of a composition comprising 20 to 70 wt% of the insoluble active ingredient CBD that has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37°C.
This argument is not persuasive. It is well settled that a showing of unexpected results is generally sufficient to overcome a prima facie case of obviousness. In re Albrecht, 514 F.2d 1389 (CCPA 1975). However, as recognized by the court in In re Schulze, 346 F.2d 600 (CCPA 1965), mere arguments are not sufficient to demonstrate unexpected results. Rather, unexpected results must be established by factual evidence by comparing the claimed invention with that of the closest prior art. In re Burckel, 592 F.2d 1175 (CCPA 1979). As discussed by the court in In re De Blauwe, 736 F.2d 699 (Fed. Cir. 1994), “the absence of tests comparing [Applicant’s claimed invention] with those of the closest prior art… constitute mere argument”. In the instant case, Applicant has appropriately compared the claimed invention with that of the closest prior art (i.e., Grother et al) and provided factual evidence which Applicant asserts establishes unexpected results of the claimed invention. In particular, Applicant asserts the claimed invention: provides a greater than expected result.
A greater than expected result is evidence of nonobviousness. However, as discussed by the Court in In re Merck & Co., 800 F.2d 1091 (Fed. Cir. 1986), any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. As recognized by the court in Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991), the differences must be greater than those which would have been expected from the prior art to an unobvious extent.
In the instant case, the closest prior art of Grother et al. teaches rapidly infusing compositions comprising gelatin in an amount of 10 to 35 wt% based on a total weight of the rapidly infusing composition on a dry basis; a sugar alcohol (mannitol) in an amount of 5 to 35 wt% based on a total weight of the rapidly infusing composition on a dry basis; and an active ingredient in an amount of 20 to 70 wt% based on a total weight of the rapidly infusing composition on a dry basis, wherein the rapidly infusing composition is lyophilized and has a disintegration time of approximately 1 to 5 seconds in deionized water maintained at 37°C ± 2°C, overlapping with the ingredients of the instantly claimed composition as well as the disintegration time, as discussed in the rejection of claims under 35 U.S.C. 103 above.
While Grother et al. do not teach the affect that an insoluble active ingredient, it is evidenced by Otsuka (JP 2012/121850) that the insoluble active ingredient aripiprazole is suitable for delivery by rapidly disintegrating oral tablets (Abstract). Otsuka further teaches in pars. [0025-27] and Table 1 a lyophilized composition comprising 36-41 wt% gelatin, 24-27 wt% mannitol, 27-36 wt% aripiprazole, citric acid, and aspartame that disintegrates in 0-4 seconds.
As Grother et al. teach a composition with the instantly claimed gelatin content, sugar alcohol content, and amount of active ingredient that disintegrates within the instantly claimed time limit and Otsuka discloses a similar composition with an insoluble active ingredient that also disintegrates in under 5 seconds, the alleged unexpected result is expected in view of the prior art, and the argument of unexpected results is insufficient to overcome the prima facie case of obviousness.
Applicant argues on pg. 11 of the remarks that an e-Terminal Disclaimer has been filed to overcome the nonstatutory double patenting rejection.
This argument is not persuasive as no such terminal disclaimer has been filed in the instant application.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/ Examiner, Art Unit 1611
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