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 Claims
A new claim set was filed on 2/25/26 with the following:
Amended claims
1
Newly canceled claims
19
Newly added claims
23
Previously canceled claims
2-3
Previously withdrawn claims
Claims under instant examination
1, 4-18, 20-23
Withdrawn Claim Rejections
All rejections pertaining to claim 19 are moot because the claim was cancelled in view of the amendments filed on 2/25/26.
Maintained, Modified and New Claim Rejections - 35 USC § 103
Applicant' s claim amendments have necessitated the following new and modified grounds of rejection.
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 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 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.
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, 4-17 and 20-22 remain rejected and claim 23 is newly rejected under 35 U.S.C. 103 as being unpatentable over Kawakami (US20160367536A1, published 22 December 2016; of record) in view of POLIMIX (Flexibility and elasticity of polyurethane, retrieved 7 January 2025; of record) and Michinaka et al. (WO2015087927A1, published 18 June 2018; of record).
The English language translation of WO2015087927A1 was attached previously. The passages cited below which indicate the teachings of the ‘927 publication is based on its English translation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kawakami is directed to a patch preparation of a layered structure comprising a patch layer (3) including an adhesive plaster containing a drug (8) (drug layer), a patch support (7) (drug support layer), and a cover layer (2) [0028], see Figure 1 below:
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Where layer (5) is the cover adhesive (adhesive layer), layer (4) is the cover support (adhesive support layer), layer (6) is a buffer layer that may be integrated with the patch support layer (7), to create the patch layer (3), and layer (9) is a release liner [0029 and 0034]. Kawakami discloses the area of the cover layer (2) is larger than the patch layer (3) (Adhesive layer and support layer are all outside the drug layer and drug support layer) [Fig. 1 and 0030], the release liner is larger as well, as depicted [Fig. 1]. Kawakami further discloses the patch backing (drug support layer) is stretchable (elastic) or non-stretchable [0066]. (limitations of claim 1). A PET film is preferable. When the support is a film of PET or the like, it is preferable that the thickness thereof be 4 to 75 um (i.e., 0.004-0.075 mm) [0066].
Regarding claims 4-5, Kawakami discloses the patch support (7) (drug support layer) is selected from a fabric, a non-woven fabric, films of fabric, firms of polyurethane,
polyester, polyvinyl acetate, polyvinylidene chloride, polyethylene, polyethylene terephthalate (PET), and aluminum foil, and a composite material, and PET film is preferable [0066].
Regarding claim 6, the instant specification (0030) states the drug support layer may be composed of two kinds of materials, such as PET and a non-woven fabric. The Examiner interprets this as being equivalent to integrated layers (6) and (7) [0034] of Kawakami. Kawakami discloses the fabric weight of the non-woven to be 50 to 150 g/m? [0067].
Regarding claim 8, Kawakami discloses cover support (4) (adhesive support layer) is selected from a fabric, a non-woven fabric, films of polyurethane, polyester, polyvinyl acetate, polyvinylidene chloride, polyethylene, PET, and aluminum, and a composite material thereof. Polyurethane is known to have elasticity as evidenced by POLIMIX. POLIMIX discloses “polyurethane is highly elastic” [line 11].
Regarding claim 9, Kawakami discloses no particular limitation on the drug that can be added and the Markush group of drugs listed includes fentanyl and tizanidine [0042]. The Examiner notes that all of the drugs listed in the Markush grouping must necessarily have a color. The Examiner further notes these two drugs are included in the instant specification paragraph 16 and should meet the colored requirement of this instant claim. It is noted that the BRI of a “colored drug” includes drugs with any color (e.g., white).
Regarding claim 10, Kawakami discloses the adhesive plaster (8) (drug layer) may include absorption promoters including fatty acid esters, an ester, higher alcohols, and surfactants [0051].
Regarding claim 11, Kawakami discloses cover adhesive (adhesive layer), layer (5) is not particularly limited as long as it is a biocompatible material capable of bonding the patch preparation to the skin. It is preferable that the base ingredient be a pressure-sensitive adhesive, and more preferably polyacrylate, polydimethylsiloxane, polyisobutylene, or a combination thereof [0074].
Regarding claim 12, Kawakami discloses the release liner (9) is silicon-coated [0075].
Regarding claim 13, Kawakami discloses the adhesive plaster containing a drug (8) (drug layer) and the patch support (7) (drug support layer) are the same size (i.e., 100%) as depicted in Figure 1.
Regarding claims 14-15, Kawakami discloses and example where the adhesive plaster containing a drug (8) (drug layer) and the patch support (7) (drug support layer) are 61 mm x 61mm and the cover adhesive (5) (adhesive layer) is 71 mm x 71 mm [0033]. When calculated the adhesive plaster containing a drug (8) (drug layer) and the patch support (7) (drug support layer) is 73.8% of the cover adhesive (5) (adhesive layer). Falling within the limitation of this instant claim.
Regarding claim 16, Kawakami discloses the cover layer (2) that extends 5 to 15 mm (0.5 to 1.5 cm) on all four sides of the patch preparation [0033].
Regarding claim 17, cover adhesive (5) (adhesive layer) and the cover support (4) (adhesive support layer) are the same size (i.e., 100%), as depicted in Figure 1.
Regarding claim 20, Kawakami teaches that the patch support is stretchable and is for example, films of polyurethane, which as evidenced by POLIMIX, is an elastomer ([0066]).
With regards to instant claim 22, Kawakami teaches that the laminate support 7 consists of a PET film as a patch support and as a shielding film and a non-woven fabric as a buffer material ([0090]).
With regards to instant claim 23, Kawakami teaches that drugs can be added and specifically drugs that are a transdermally absorbable drug ([0042]). Kawakami teaches wherein such transdermally absorbable drug is, for example, tizanidine hydrochloride ([0042]).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Kawakami does not disclose in a single embodiment where every limitation of claims 1 and 4-17 are taught.
Kawakami does not directly disclose wherein the cross-sectional area of the closed space is 0.8 mm2 or more, at least when cut along the longitudinal centerline and the transverse centerline on the plane surfaces of the drug layer and the drug support layer, and; wherein the cross-sectional area of the closed space is 0.8 mm2 or more on average, when cut in the longitudinal direction and the transverse direction including the longitudinal centerline and the transverse centerline on the plane surfaces of the drug layer and the drug support layer as limited by claim 1 of the instant application.
Kawakami does not specifically address if it is a closed space with the portion surrounded by the outer edges of the drug layer and the drug support layer and the inner sides of the release layer and he adhesive layer, as required by instant claim 1. Kawakami does not specifically teach wherein a portion of the release layer and a portion of the adhesive layer that are outside the outer edges of either the drug layer or the drug support layer are attached with each other, as required by instant claim 1. Kawakami does not specifically teach wherein the drug support layer is directly in contact with the adhesive layer, as required by instant claim 21. The Examiner notes that it is clear that the Figure above is an overly-simplified depiction of the layers in the patch of Kawakami as all of the layers are exactly the same width no matter the material used to make each individual layer; in the description of Kawakami, the layers have different widths (See [0084-0090]). Furthermore, they depict the patch as a rigid, completely flat structure, whereas the layers are thin films (e.g., 4 µm PET film) that would have flexibility. Furthermore, Kawakami teaches that the patch preparation is provided with a release liner 9 that is releasably attached to the adhesive plaster 8 and covers the adhesive plaster 8 and others ([0029]). Kawakami does not specific what other layers other than 8 the release line 9 covers. Additionally, Kawakami teaches that cover layer 2 that comprises cover adhesive 5 is larger than that of the patch layer 3 which comprises the drug; cover layer 2 and patch layer 3 are layered so that the cover adhesive 5 is left around the patch layer 3. Again, they do not specifically show or state that this is a closed space. With regards to the release liner, Kawakami teaches that is protects the adhesive plaster (part of layer 3) and prevents decomposition of the drug in the adhesive plaster until the patch preparation is applied to the skin ([0075]).
Kawakami does not teach wherein the average thickness of the drug support layer is 0.65 mm or more and 2 mm or less, as required by instant claim 1. However, this deficiency is cured by Michinaka et al.
Michinaka et al. is directed to a patch with a support layer, drug reservoir layer, cover layer, and an adhesive layer [pg. 2, lines 56-60]. Michinaka et al. discloses the support layer is films, foamed sheets, porous sheets, woven and nonwoven fabrics, among others [pg. 4, lines 170-172]. Where the support layer includes polyesters and the support layer made of such material includes nonwoven fabrics [pg. 4, lines 170-172] (limitation of claim 7). Michinaka et al. further discloses the thickness of the support layer is not particularly limited, it is usually preferably about 2 to 600 um (0.002 to 0.6mm) [pg. 5, lines 182-185] and can be sufficiently adhered to the cover material when the cover material is laminated while maintaining sufficient strength [pg. 5, lines 182-185]. It is noted that there is no teaching away from going above 0.6 mm.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding limitations of the closed space that is “0.8 mm2 or more” as required by instant claim 1, Kawakami discloses the adhesive, cover layer and release liner may extend 5 to 15 mm around all four sides of the patch layer, that is 61 mm x 61 mm, and the patch backing has a thickness of 4 to 75µm (0.004 to 0.075 mm). Therefore, the area as depicted in Figure 1 (see above, area labeled with an X) when calculated is 0.02 to 1.13 mm2, resulting in a range that meets the limitation of 0.8mm2 or more. It is noted that Applicants indicate that once the release layer and adhesive layers attach to each other, the “triangle” area would range from 0.01-0.565 mm2 (See Remarks: p. 5; dated 2/25/26). The Examiner notes that Kawakami does not disclose the thickness of the adhesive plaster containing a drug (8) (drug layer) and the buffer layer (6), however these additional values would only increase the cross-sectional area as calculated. Furthermore, the Examiner notes that neither the specification or the claims provide a notable advantage of this space and that is only an important feature of the invention. MPEP 2144.05 (III)(A) states: applicants can rebut a prima facie case of obviousness by showing the criticality of the range. The thickness of the layer containing the drug (i.e., layer 8) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal drug layer thickness in order to best achieve the desired results as such would provide advantageous release profile. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, one of ordinary skill in the art would understand that modifying the drug layer thickness would affect the release rate; that is, increasing the thickness would lengthen the diffusion path typically leading to slower drug release. The Examiner considers it prima facie obvious to increase the drug layer thickness, which in turn would affect the close space area, to achieve a desired release rate, absent unexpectedly superior properties of the claimed invention. Therefore, such is an optimizable variable.
Regarding claims 1 and 4-17, Kawakami teaches all of the components of said claims with overlapping ranges to prepare a layered drug containing patch where the structure of patch improves the bonding of the adhesive plaster containing a drug (8) (drug layer) to the skin, prevents movement, and is capable of stable drug release [0013]. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time of the invention, to prepare a patch with the layers and dimensions disclosed in the above rejection. One would have been motivated to do this to prepare a layered drug containing patch with improved bonding to the skin, that prevents movement of the patch on the skin, and is capable of stable drug release. See MPEP 2143(I)(G).
Based on the teachings of Kawakami, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the patch depicted in Figure 1 of Kawakami with a closed space between layers 4/5 and 9 to achieve the predictable result of obtaining a composition suitable for drug delivering upon application to the skin. One of ordinary skill in the art would have been motivated to do so because Kawakami suggest that cover layer 2 and patch layer 3 are layered so that the cover adhesive 5 is left around the patch layer 3 and one would be motivated to allow cover adhesive 5 to adhere to release layer 9 (i.e., provide a closed space) completely as such would advantageously decrease or eliminate drug decomposition as no air would be allowed to reach layer 8 which includes the drug.
Both Kawakami and Michinaka et al. teach layered drug containing patches with a drug support layer. Where Kawakami only discloses the thickness of the PET drug support layer at 4 to 75 um and Michinaka et al. discloses the drug support layer is usually preferably about 2 to 600 µm (0.002 to 0.6mm) [pg. 5, lines 182-185].
Based on these teachings, it would have been prima facie obvious to one skilled in the art, at the time of the invention, to substitute the drug support layer of Kawakami with the thicker non-woven polyester drug support layer that Michinaka et al. discloses to prepare a layered drug containing patch. One would have been motivated to do this to make a patch with a thicker support layer that can be sufficiently adhered to the cover material when the cover material is laminated while maintaining sufficient strength, as taught by Michinaka [pg- 5, lines 182-185]. See MPEP 2143(I)(G)). As indicated in MPEP §2144.05(I): a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys.”); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., “not substantially less than 13%,” “not substantially below 17%,” and “between about 13[%] and 20%”); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of “less than 6 pounds per cubic feet” and the prior art range of “between 6 lbs./ft3 and 25 lbs./ft3” were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.). It is noted in the instant case, Michinaka et al. discloses the drug support layer is usually preferably about 2 to 600 µm (0.002 to 0.6mm) which is close to the newly amended claim 1 limitation “0.65 mm or more and 2 mm or less”. It is further noted, that Michinaka et al. do not teach away from going above 0.6 mm and the instant specification does not show that its claimed range produces unexpected results or shows criticality. In fact, the instant specification ([0032]) states: “The thickness of the drug support layer is appropriately determined, and the average thickness is preferably 0.4 mm or more. The thickness of 0.4 mm or more is expected to bring about a sufficient space around the drug layer leading to an increase of drug retention, and also to increase the stress of the adhesive layer toward the skin leading to an improved adhesiveness. It is more preferable that an average thickness is 0.5 mm or more, and even more preferably 0.6 mm or more.” That is, the instant specification only sheds light on a thickness of 0.4 mm or more (not 0.65 mm or more as instantly recited) providing increase of drug retention and improved adhesiveness.
From the 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 would have been prima facie obvious to one of ordinary skill in the art at the time of the invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 18 remains rejected under 35 U.S.C. 103 as being unpatentable over Kawakami (US20160367536A1, published 22 December 2016; of record) in view of POLIMIX (Flexibility and elasticity of polyurethane, retrieved 7 January 2025; of record) and Michinaka et al. (WO2015087927A1, published 18 June 2018; of record) as applied to claims 1, 4-17 and 20-23 above, further in view of Hirokatsu et al. (JP 2020/105084; published: 7/9/20; of record).
The English language translation of JP 2020/105084 is provided herein. The passages cited below which indicate the teachings of the ‘084 publication is based on its English translation.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kawakami, Polimix and Michinaka et al. read on the limitations of instant claims 1, 4-17 and 20-22 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Kawakami does not teach wherein the drug support layer consists of a polyester resin, as required by instant claim 18. However, this deficiency is cured by Hirokatsu et al.
Hirokatsu et al. is directed to medicated patches. Hirokatsu et al. teach polyester resin are used because they have characteristics such as difficulty in adsorbing the drug of the patch.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Kawakami and Hirokatsu et al. are both directed to drug-containing patches. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was filed, to modify the material of the drug support layer of Kawakami with one consisting of polyester resin to achieve the predictable result of obtaining a composition suitable for drug containing patch. One of ordinary skill in the art would have been motivated to do so because Hirokatsu et al. teach that polyester resin is advantageously because it has difficulty adsorbing drug contained in the patch.
From the 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 would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants state, with regards to the cross-sectional area of the closed space (previous claim 19 limitation; now, in instant claim 1) that the area labeled X on the above figure is not a closed space; the space becomes a closed form when the release layer and adhesive layer are attached to each other and the closed space become a triangle (Remarks: p. 5). Applicants argue, in view of the above, the calculated range of 0.02-1.13 mm2 on p. 10 of Office Action should be corrected to 0.01-0.565 mm2, which falls outside of the claimed range of 0.8 mm2 or more, as amended in instant claim 1 (Remarks: p. 5).
This is not found persuasive. This argument was based on a new claim amendment to instant claim 1. The Examiner addresses how such is prima facie obvious (see p. 10-11).
Applicants argue, with regards to the thickness of the drug support layer, that one or ordinary skill in the art would have no reason to modify the thickness of a support layer to reach the claimed thickness of 0.65 mm or more, as Michinaka explicitly states that the thickness of the support layer is about 2 to 600 µm from the viewpoint of maintaining sufficient strength while being able to adhere sufficiently to cover the material (Remarks: p. 6).
This is not found persuasive. In response, and as indicated in the instant rejection, “One would have been motivated to do this to make a patch with a thicker support layer that can be sufficiently adhered to the cover material when the cover material is laminated while maintaining sufficient strength, as taught by Michinaka [pg- 5, lines 182-185]. See MPEP 2143(I)(G)). As indicated in MPEP §2144.05(I): a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” As shown in MPEP §2144.05(I), such is supported by a plethora of case law. Furthermore, and as indicated in the instant rejection, “Michinaka et al. do not teach away from going above 0.6 mm and the instant specification does not show that its claimed range produces unexpected results or shows criticality. In fact, the instant specification ([0032]) states: “The thickness of the drug support layer is appropriately determined, and the average thickness is preferably 0.4 mm or more. The thickness of 0.4 mm or more is expected to bring about a sufficient space around the drug layer leading to an increase of drug retention, and also to increase the stress of the adhesive layer toward the skin leading to an improved adhesiveness. It is more preferable that an average thickness is 0.5 mm or more, and even more preferably 0.6 mm or more.” That is, the instant specification only sheds light on a thickness of 0.4 mm or more (not 0.65 mm or more as instantly recited) providing increase of drug retention and improved adhesiveness.”. It is further noted that Michinaka et al. specifically state “the thickness of the support layer is not particularly limited”. Therefore, the Examiner maintains that the claimed thickness range is found prima facie obvious over the cited prior art.
"The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. These cases have consistently held that in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). See MPEP §2144.05 III. Applicants have not provided any evidence showing that the claimed ranges are critical.
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 GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617