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 .
Claim Status
Claim 18 is new.
Claims 3, 4, 6, 7, 9 and 12 are cancelled.
Claims 1-2, 5, 8, 10, 11, 13-18 are pending. Applicant’s amendment has necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 11/05/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claim 11 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 12 was rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph. Applicant has amended the claims to overcome these rejections.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2, 5, 8, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wai et al. (WO2019186207) and Dulieu et al. (WO2008127669) and Battaglia, A. (US20140371210).
Applicant claims, for example:
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Claim interpretation: The instant specification teaches taking a tablet of naltrexone (first active) and adding it to a blister with a liquid/suspension of CCT formulation (second active), passed through a cryogenic freezing process to attach the tablet to the liquid/suspension of CCT to form a single unit dose. (Pages 27-28, Example 1).
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical formulation compositions, methods of making pharmaceutical dosage forms, pharmaceutical active ingredients and the conditions treated by said pharmaceutical active ingredients— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 2, 5 and 11, Wai et al. teach a combined preparation of naltrexone and vitamin D products in the form of a tablet where: “Numerous pharmaceutical forms and formulations for biologically active agents are known in the art, and any and all of these are contemplated by the present invention.” (Page 7, 2nd paragraph). A tablet is a single unit dosage form. The vitamin D or analogue thereof is administered at a daily dose in the range of about 400 IU to about 10000 IU per dosage form (Page 8, 2nd paragraph), which is about 400/40 = 10 mcg to about 10000/40 = 250 mcg and overlaps the claimed range of 80-200 mcg, or the composition may comprise from 0.01-25% by weight of the vitamin D product (Page 8, last paragraph). The naltrexone is employed in a therapeutically effective amount from about 0.01 to 50 mg (Page 10, 1st paragraph; claims 10-13), which overlaps the claimed range of 0.01 to 6 mg, with excipients (Page 10, 3rd and 4th paragraphs). See MPEP 2144.05(I): 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). Wai et al. teach employing vitamin D or an active metabolite (Page 6, 2nd paragraph).
Regarding claims 1 and 5, Battaglia teaches pharmaceutical compositions for the rapid transbuccal delivery of calcitriol (Claims 19 and 22), thereby bypassing first-pass liver metabolism and gastric/intestinal degradation [0002]. Battaglia also teaches sublingual dosage delivery forms are known to the artisan [0004].
Regarding claims 1 and 11, Dulieu et al. teach bilayer dosage forms designed to adhere to the oral mucosa (Abstract; Figure 1; claims 1-39) where the bilayer dosage form allows release of APIs with different rates such as fast and sustained release of the one or more APIs (Page 4, lines 9-12) and contain a mixture of coated and non-coated APIs where the non-coated API enters the blood stream by transmucosal absorption and the coated API enters the blood stream much later by systemic absorption (Page 4, lines 26-31; page 27, lines 15-24). The API can be in the form of grains, granules, pellets, beads powders, mini-tablets (Page 17, line 32 through page 18, line 2). The APIs are without limitation and include anti-cancers (Page 18, lines 3-7) and vitamin D (page 18, line 32) and 1, 25-dihydroxycholecalciferol (Page 19, lines 4-5), which is calcitriol. Dulieu et al. teach: “Sublingual, gingival and/or buccal medications are administered by placing them in the mouth, either under the tongue (sublingual), on gum tissue (gingival) or between the gum and the cheek (buccal).” (Page 3, lines 1-12), which can help avoid first pass metabolism (Page 13, lines 4-8). Dulieu et al. teach adding carotenes (Page 18, lines 5-6), which is a type of terpene. Dulieu et al. teach an embodiment where the lyophilized layer (a) is for immediate release while lozenge/tablet (b) is for extended release (Example 9). Dulieu et al. teach that the bilayer dosage form is prepared by providing a suspension suitable for preparing the lyophilized layer (a), providing layer (b) in the form of a tablet or lozenge suitable for preparing the lyophilized mucoadhesive layer (b), adding the suspension layer (a) on said layer (b), freezing the system and lyophilizing (Page 10, lines 4-14; page 32, lines 4-11), which attaches the lyophilized and frozen liquid solution/suspension/emulsion to the tablet/lozenge. Dulieu et al. teach an embodiment where the lyophilized layer (a) is for immediate release while lozenge/tablet (b) is for extended release (Example 9), hence (b) is for release and/or absorption after the other formulation (a) is released and/or absorbed.
The tablet/lozenge can be placed in a mould container such as a blister prior to adding the other component (Page 11, lines 25-32).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Wai et al. is that Wai et al. do not expressly teach calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1; wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet where the naltrexone is formulated for delayed release/absorption after the calcitriol is released/absorbed. This deficiency in Wai et al. is cured by the teachings of Dulieu et al. and Battaglia.
1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the tablet of Wai et al. with calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1 wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet where the naltrexone is formulated for delayed release/absorption after the calcitriol is released/absorbed, as suggested by Dulieu et al. and Battaglia, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rationale. Wai et al. suggest an active metabolite of vitamin D, and in this art, the ordinary artisan is aware that calcitriol is the active form of vitamin D and thus obvious over the disclosure of an active metabolite of vitamin D by Wai et al. It is then merely routine optimization to have a 1:1 to 10:1 ratio of the calcitriol to naltrexone in the single unit dosage form of Wai et al. Wai et al. suggest employing known pharmaceutical formulations and Dulieu et al. provides a bilayer tablet for sublingual administration that can contain more than 1 API including calcitriol where the bilayer dosage form is prepared by providing a suspension suitable for preparing the lyophilized layer (a), providing layer (b) in the form of a tablet or lozenge suitable for preparing the lyophilized mucoadhesive layer (b), adding the suspension layer (a) on said layer (b), freezing the system and lyophilizing, which attaches the lyophilized and frozen liquid solution/suspension/emulsion to the tablet/lozenge. Battaglia suggests calcitriol for transmucosal administration as well. Accordingly, it is obvious to formulate a single unit oral dose pharmaceutical tablet composition with calcitriol formulated in a composition for sublingual absorption and naltrexone formulated in a separate delayed release formulation for absorption in the GI tract from the esophagus onwards after the calcitriol is released/absorbed. Sublingual is just the position the bilayer tablet is placed in the oral cavity. In view of the combined references, the ordinary artisan would have a reasonable expectation of success.
The difference between the instant application and Wai et al. is that Wai et al. do not expressly teach adding a terpene. This deficiency in Wai et al. is cured by the teachings of Dulieu et al. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the tablet of Wai et al. with a terpene, as suggested by Dulieu et al. and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rationale. Dulieu et al. teach a terpene, carotenes, as discussed above and teach the API is without limitation. The ordinary artisan would add the terpene carotenes for the desirable properties provided by carotenes as suggested by Dulieu et al. to the single unit dosage form with a reasonable expectation of success in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 11/5/25 have been carefully considered but are not persuasive.
On page 2 of remarks, Applicant states that the “invention is based on the discovery that calcitriol, when administered at a constant level to the bloodstream of a patient, may be used to boost the above effects of naltrexone whilst it is being metabolized.” Applicant further states that: “a comparative ex vivo test was performed in order to assess the effects of the combination of calcitriol and naltrexone when used together with chemotherapeutic agents. The experiments show that the combination of naltrexone and calcitriol is more effective in boosting the effect of chemotherapeutic agents…” However, the art of Wai et al. already suggests separate, sequential or simultaneous administration of naltrexone and vitamin D active metabolite calcitriol (Claim 1; Page 5, 1st paragraph). And the presence of chemotherapeutic agents is absent in independent claim 1 and consequently data directed to chemotherapeutic agents is not of the same scope as the claimed subject matter. See also MPEP 2145 VI. ARGUING LIMITATIONS WHICH ARE NOT CLAIMED Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Bypassing the first-pass metabolism is well-known to the ordinary artisan in this art. (See Dulieu et al. teaching (Examiner added emphasis): “Sublingual, gingival and/or buccal medications are administered by placing them in the mouth, either under the tongue (sublingual), on gum tissue (gingival) or between the gum and the cheek (buccal). And (Page 3, lines 1-12), which can help avoid first pass metabolism (Page 13, lines 4-8). And Battaglia teaches pharmaceutical compositions for the rapid transbuccal delivery of calcitriol (Claims 19 and 22), thereby bypassing first-pass liver metabolism…). Respectfully, Applicant’s arguments are not persuasive.
On pages 3-6 of remarks, Applicant argues that Wai et al. do not the naltrexone in a first formulation and calcitriol in a second formulation. However, the rejection is not based on Wai et al. in a vacuum and the Examiner is relying upon Dulieu et al for the single unit dosage form construction and suggests that calcitriol be in the dosage form. It is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). In the present case, the Examiner has shown how Dulieu et al. construct the same single dosage form as Applicant. It is then merely a matter of placing naltrexone in the lozenge/tablet part and calcitriol in the lyophilized part that is then attached to the lozenge/tablet part to make the dosage form with no undue experimentation required. There is a motivation in the art to administer the active metabolite calcitriol and naltrexone together as taught by Wai et al., especially with calcitriol in the rapidly absorbed portion, as suggested by Battaglia, and Dulieu et al. provide the convenient single unit oral dosage form to do so. Battaglia is relied upon by the Examiner as characterized in the rejection and not as characterized by Applicant. The link is that Battaglia teaches pharmaceutical compositions for the rapid transbuccal delivery of calcitriol (Claims 19 and 22), thereby bypassing first-pass liver metabolism and gastric/intestinal degradation [0002], which provides the motivation to place the calcitriol in the rapid delivery aspect of the single unit dosage form of the combined references.
On pages 7-8 of remarks, Applicant argues that the base layer (b) of Dulieu et al. is formulated to adhere to the oral mucosa whereas the naltrexone tablet of the present invention is to be swallowed and formulated for absorption in the GI tract from the esophagus onwards. Respectfully, the Examiner has a different perspective. Dulieu et al. teach an upper layer (a) comprising a lyophilized dosage form and a base layer (b), such as a tablet or lozenge (claim 33), formulated to adhere to the oral mucosa and for delayed, sustained or extended release of active ingredients (Claim 1). Dulieu et al. teach layer (b) is a controlled release formulation, where the coated active ingredients are swallowed and passed through the GI system (Page 27, lines 15-24) and Dulieu et al. clearly contemplate controlled release of the API once the dosage form has been placed in the mouth of a patient with a “total release in the stomach at a desired and appointed time” and “in a predetermined place within the digestive tract” (Page 15, lines 11-22). Consequently, Dulieu et al. have embodiments with release of actives from the tablet/lozenge in layer (b) to the stomach/GI tract. Respectfully, the Examiner does not agree with Applicant’s interpretation of Dulieu et al. as the combined references render obvious the claimed dosage form where calcitriol is avoids first-pass metabolism by sublingual absorption and naltrexone is released for absorption in the stomach/GI tract. The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the Examiner has only applied knowledge present in the prior art where one skilled in the art with the references before in hand can make the single unit oral dosage form claimed without exercise of inventive faculty.
Respectfully, Applicant’s arguments have been carefully considered but are not persuasive.
Claims 11 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wai et al. (WO2019186207) and Dulieu et al. (WO2008127669) and Battaglia, A. (US20140371210), as applied to claims 1-2, 5, 8, 10 and 11 above, in further view of Maleki et al. (Food Chemistry 2019;299:11 pages) and Toledano (US20140275142) and Wendschuh et al. (US20160250270).
Applicant claims a single unit dose pharmaceutical composition according to claim 1 further comprising a cannabinoid or flavonoid or terpene.
The references of Wai et al., Dulieu et al. and Battaglia are discussed in detail above.
Maleki et al. teach that flavonoids are anti-inflammatory and include kaempferol, luteolin and catechin (Title; Abstract; Tables 1-2; page 3, 4. Anti-inflammatory effects of flavonoids: Mechanisms of action).
Toledano teaches the compositions for the treatment of pain comprising the combination of naltrexone (Claims 1-2) and calcitriol (Claim 6) for treating migraine (Claim 17) and cancer pain [0021]. Toledano adding one or more pharmacologically active agents such as anti-inflammatory drugs, muscle relaxants and tetrahydrocannabinol derivatives [0049] and NSAIDs [0025-0026].
Regarding claim 18, Wendschuh et al. teach compositions of cannabinoids with flavonoids and terpenes (Abstract; claim 1) where: the cannabinoids include, for example, cannabigerol, cannabidolic acid, cannabidiol, cannabivarin and tetrahydrocannabivarin (Claims 8-10; [0365-0368]) as well as cannabinoids within the context of this disclosure include compounds belonging to any of the following classes of molecules, their derivatives, salts, or analogs: Tetrahydrocannabinol (THC), Tetrahydrocannabivarin (THCV), Cannabichromene (CBC), Cannabichromanon (CBCN), Cannabidiol (CBD), Cannabielsoin (CBE), Cannabidivarin (CBDV), Cannbifuran (CBF), Cannabigerol (CBG), Cannabicyclol (CBL), Cannabinol (CBN), Cannabinodiol (CBND), Cannabitriol (CBT), Cannabivarin (CBV), and Isocanabinoids [0018]; the terpenes include, for example, limonene, myrcene, camphene, bisabolol, humulene and pinene (Claims 6-7, 15-20) as well as terpenoids in their forms ofhemiterpenoids, monoterpenoids, sesquiterpenoids, sesterterpenoid, sesquarterpenoids, tetraterpenoids, Triterpenoids, tetraterpenoids, Polyterpenoids, isoprenoids, and steroids [0022, 0364]; and the flavonoids include, for example, apigenin, catechin and quercetin (Claim 13-14) as well as flavonoids chosen from phenolic acids, stilbenoids, dihydroflavonols, anthocyanins, anthocyanidins, polyphenols, tannins, flavones, flavan-3-ols, Flavan-4-ol, Flavan-3,4-diol flavonols, phytochemicals, antioxidants, homoisoflavonoids, phenylpropanoids, Phloroglucinols coumarins, Naphthodianthrones, Steroid glycosides, bioflavonoids, isoflavonoids, and neoflavonoids [0370].
The difference between the instant application and Wai et al. as modified by Dulieu et al. and Battaglia, is that Wai et al. as modified by Dulieu et al. and Battaglia, do not expressly teach adding the cannabinoids, flavonoids or terpenes claimed. The deficiency in Wai et al. as modified by Dulieu et al. and Battaglia, is cured by the teachings of Toledano, Maleki et al. and Wendschuh et al. It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to formulate the tablet of Wai et al. as modified by Dulieu et al. and Battaglia with a cannabinoid or flavonoid, as suggested by Dulieu et al., Toldedano, Maleki et al. and Wendschuh et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rationale. Dulieu et al. teach that APIs include those for treatment of pain and migraine (Page 18, lines 13 and 15) as well as anti-inflammatories (Page 18, line 4). Toledano teach synergistic action from the combination of naltrexone and calcitriol [0027] and to add the cannabinoid tetrahydrocannabinol as well as anti-inflammatory drugs. The artisan in this art is well-aware through the teachings of Maleki et al. that flavonoids are anti-inflammatory compounds. The types of cannabinoid derivatives to employ in combination with flavonoids and terpenes is taught by Wendschuh et al. Consequently, it is obvious to add the cannabinoids, flavonoids and terpenes claimed to the single unit dose pharmaceutical composition of Wai et al. as modified by Dulieu et al. and Battaglia for at least an additive effect of the combined materials with a reasonable expectation of success.
Response to Arguments:
Applicant asserts that independent claim 1 is novel and non-obvious and therefore dependent claim 11 is also novel and non-obvious. Respectfully, the Examiner does not agree because at this time the combination of references renders obvious independent claim 1 and the Examiner has shown that the prior art teaches and suggests the subject matter of claims 11 and 18.
Claims 1 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wai et al. (WO2019186207) and Dulieu et al. (WO2008127669) and Battaglia, A. (US20140371210), as applied to claim 1 above, in further view of Dalgleish et al. (WO2014181131).
Applicant claims:
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The references of Wai et al., Dulieu et al. and Battaglia are discussed in detail above.
The ordinary artisan in this art for cancer treatment methods is a pharmaceutical/medical cancer research scientist aware of cancer treatment formulations, cancer treatment protocols and cancer treatment regimens.
Regarding claim 13, Dalgleish et al. teach the treatment of cancer with the combination of naltrexone and vitamin D3 (Claims 14, 17, 18, 34) where low dose naltrexone in combination with vitamin D3 had a marked clinical response against metastatic melanoma (Example 2). Dalgleish et al. also teach hepatocellular melanoma (Claim 18), which is a form of liver cancer, and liver cancer and kidney cancer (Page 11, lines 20 and 22).
The difference between the instant application and Wai et al. as modified by Dulieu et al. and Battaglia, is that Wai et al. as modified by Dulieu et al. and Battaglia, do not expressly teach treating cancer in a subject by administering the single unit oral dose pharmaceutical composition wherein the subject is undergoing or is selected to undergo treatment with an anti-cancer agent wherein the subject has liver cancer and/or kidney cancer and/or wherein the subject has a reduced ability to metabolize vitamin D wherein the single unit dose pharmaceutical composition is to be administered to the subject in a first treatment phase, and wherein after the first treatment phase, the subject is to be administered a therapeutically effective amount of an anti-cancer agent in a second treatment wherein the dosage regime is daily administration of a single unit dose. This deficiency in Wai et al. as modified by Dulieu et al. and Battaglia, is cured by the teachings of Dalgleish et al.
It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to administer the tablet of Wai et al. as modified by Dulieu et al. and Battaglia, to treat liver or kidney cancer or the subject has a reduced ability to metabolize vitamin D, as suggested by Dalgleish et al., and produce the instant invention. The ordinary artisan is motivated do so because the combination of naltrexone and vitamin D3 is already known for treating cancers, which reasonably extends to include kidney and liver cancer, as suggested by Dalgleish et al., and such a patient would have reduced ability to metabolize vitamin D into its active form calcitriol. Thus, directly administering the active form of vitamin D calcitriol to the cancer patient is an obvious variation of the prior art. The treatment regimen for the cancer patient is determined by the medical artisan and whether or not the patient is undergoing or is selected to undergo treatment with an anti-cancer agent is at the discretion of the ordinary artisan. Consequently, administration of a single unit dose daily in a first treatment phase followed by a second treatment with an anti-cancer agent is entirely within the purview of the medical artisan seeking to treat the patient with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant asserts that the combination of Wai et al. Dulieu et al. and Battaglia fail to teach and suggest the invention of claim 1 and the addition of Dalgleish et al. does not remedy the deficiencies. Respectfully, the Examiner does not agree because the combination of references renders obvious the single unit oral dose pharmaceutical composition arranged as claimed in independent claim 1. Furthermore, while Wai et al. teach that the composition is for use in the treatment of an autoimmune disease (Claims 16-17), the ordinary artisan also understands from the combined references that the combination of vitamin D3 and naltrexone is known for treating cancer as taught by Dalgleish et al. Moreover, the ordinary artisan understands that vitamin D3 is the inactive form made by the body from sunlight while calcitriol is the body’s active form of vitamin D made from conversion of vitamin D3 in the liver. Dalgleish et al. provide the guidance to employ the single unit oral dose pharmaceutical composition of the combined reference to treat the same patient populations as claimed. Consequently, it is obvious to administer the active from calcitriol for immediate action in combination with the naltrexone with a reasonable expectation of success in treating cancer in a subject. Especially when Wai et al. teach and suggest overlapping amounts of vitamin D active metabolite, which is calcitriol, and naltrexone with what is claimed by Applicant.
Conclusion
No claims are allowed.
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613