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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on 04/06/2026. Claims 1, 2, 8-12, 18, 21-23, 25, 29, 31, 33, 47, 48 and 63 are pending. Claims 19 and 20 are canceled, Claim 63 is newly added.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 2, 8, 9, 13, and 18-23, 25, 29, 31, 33, 47 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Weikart et al. in view of Whitney et al.
Weikart et al. teaches a blood collection tube having a volume of 7.5 ml [0378] and a lumen 214 [0010].
Weikart et al. teaches that “the interior surface includes a tie coating or layer 289, a barrier coating or layer 288, and a pH protective coating or layer 286.
The tie coating or layer tie coating or layer 289 comprises or consists of SiOxCy or SiNxCy in which x is from about 0.5 to about 2.4 as measured by X-ray photoelectron spectroscopy (XPS), y is from about 0.6 to about 3 as measured by XPS. The tie coating or layer has an outer surface facing the wall surface and an interior surface (Abstract and [0011].
The barrier coating or layer can comprise SiOx, wherein x is from 1.5 to 2.9. [0012]
The pH protective coating or layer comprises or consists of SiOxCyHz, in which x is from about 0.5 to about 2.4 as measured by XPS, y is from about 0.6 to about 3 as measured by XPS, and z is from about 2 to about 9 as measured by at least one of RBS or HFS.
The arrangement of the tie coating or layer 289, a barrier coating or layer 288, and a pH protective coating or layer 286 is shown in Fig. 4.
In paragraph [0133] Weikart et al. teaches an alternative embodiment in which the pH protective layer can be applied over the barrier layer, which in view of Fig. 4 would read on the location of the pH protective layer recited in claim 1.
Weikart et al. teaches that “the pH protective coating or layer optionally can be from about 10 to about 1000 nm thick” [0044] and that “the barrier coating or layer 288 is from 2 to 1000 nm thick.” [0148]
Weikart et al. furthers teaches that the tube can contain EDTA which is one of applicant’s nucleic acid preservatives.
Wiekart et al. teaches that the tie coating or layer functions to improve adhesion of a barrier coating or layer [0131], the barrier coating or layer functions to present ingress of gases [0145], and that the protective coating or layer provides pH protection. Therefore, the tie coating or layer, the barrier coating or layer and protective coating or layer are all obvious to use in conjunction with a biological sample.
Wiekart et al. teaches EDTA, but does not teach a preservative composition comprising: (a) at least one volume excluding polymer;(b) at least one osmotic agent;(c) at least one enzyme inhibitor; and (d) optionally, a metabolic inhibitor.
Whitney et al. teaches storing biological samples “such as nucleic acid.” (Abstract).
Whitney et al. teaches PEG as a stabilizer [0149], NaCl as a buffer [0188], EDTA and citrate as buffers [0188], and sodium azide for protecting against pathogens.
It would have been obvious to one of ordinary skill in the art to modify Weikart et al. to includes PEG, EDTA, NaCl, citrate and sodium azide as taught by Whitney et al. for purposes of using Wiekart et al. for use with biological samples that include nucleic acid.
As to the newly added limitations to claim 1 which recite that the pH protective coating or layer as applied has a thickness of from 100 to 700 nm, and that the pH protective coating or layer has a thickness of from 50 to 500 nm two years after the tube is assembled, it is noted that applicant’s specification discloses that changes to the thickness of the pH protective coating or layer occur over the shelf life of the of the collection tube which is temperature dependent. In this regard applicant discloses shelf life in reference to “assuming storage at 20 to 25°C” at [0175], and Si dissolution rates at different temperatures.
Further, the claimed range thickness of the pH protective coating or layer of 100 to 700 nm is within the range taught by Weikart et al. which renders the initial thickness layer prima facie obvious as noted in MPEP 2144.05(I). In addition the composition of the pH protective coating or layer taught by Weikart et al. is the same as applicant’s claimed composition rendering it expected that the pH protective coating or layer initially provided at 100 to 700 nm would have a thickness of from 50 to 500 nm two years after the tube is assembled, absent evidence to the contrary.
Otherwise, it would have been obvious to one of ordinary skill in the art to provide the pH protective coating or layer anywhere within the thickness range taught by Weikart et al. , including a thickness of 100 to 700 nm, and store the assembled tube of Weikart et al. in view of Whitney et al. at a suitable storage temperature determined by routine engineering optimization experimentation to provide a desired thickness of the pH protective coating or layer suitable for use after a two year storage period, including a use thickness of 50 to 500 nm.
I.) Regarding applicant’s claim 1, as noted above, Weikart et al. in view of Whitney et al. teaches all the limitations of claim 1.
Therefore, Weikart et al. in view of Whitney et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that the pH protective coating or layer is characterized in that the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH from about 5 to about 9, is less than the rate of erosion of the barrier coating or layer, if directly contacted by the fluid composition.
Weikart et al. teaches that the pH protective coating or layer is made from SiOxCy or SiNxCy, and that the barrier coating or layer can be SiOx.
Inasmuch as Weikart et al. in view of Whitney et al. teaches that the pH coating or layer and the barrier coating or layer are made from the same compositions as applicant’s pH coating or layer and barrier coating or layer, Weikart et al. in view of Whitney et al. teaches all the limitations of claim 2.
Therefore, Weikart et al. in view of Whitney et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 8, as noted above Weikart et al. in view of Whitney et al, renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the tube contains about 1.4 ml of the one or more nucleic acid preservatives and is evacuated to about 25-26 mm Hg.
Weikart et al. in view of Whitney et al. teaches EDTA but does not teach the amount of EDTA to include.
Weikart et al. teaches evacuated sample collection tubes [0242], but does not teach pressure of the evacuation to use.
It would have been obvious to one of ordinary skill in the art to conduct routine engineering optimization experimentation to determine a suitable amount of biological sample to use and a suitable evacuation pressure to use to draw in a desired amount of sample, including 1.4 ml and an evacuation pressure of about 25-26 Hg.
Therefore, Weikart et al. in view of Whitney et al. renders claim 8 obvious.
IV.) Regarding applicant’s claim 9, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites a list of nucleic acid preservatives, including EDTA.
As noted above, Weikart et al. in view of Whitney et al. teaches EDTA.
Therefore, Weikart et al. in view of Whitney et al. renders claim 9 obvious.
V.) Regarding applicant’s claim 18, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 18 depends.
Claim 18 recites that recites that nucleic acid preservative is a composition comprising:
(a) the at least one volume excluding polymer is polyethylene glycol (PEG);
(b) the at least one osmotic agent is NaCl,
(c) the at least one enzyme inhibitor is EDTA or citrate,
wherein the nucleic acid preservative further comprises a metabolic inhibitor.
As noted above, Weikart et al. in view of Whitney et al. teaches PEG, NaCl, EDTA, citrate and sodium azide. Applicant discloses that sodium azide is a metabolic inhibitor.
Therefore, Weikart et al. in view of Whitney et al. renders claim 18 obvious.
VI.) Regarding applicant’s claim 21, as noted above Weikart et al. in view of Whitney et al. renders claim 2 obvious from which claim 21 depends.
Claim 21 recites that the pH protective coating or layer is characterized in that the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is less than 20% the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.
Weikart et al. teaches that the pH protective coating or layer is made from SiOxCy or SiNxCy, and that the barrier coating or layer can be SiOx.
Inasmuch as Weikart et al. in view of Whitney et al. includes a pH coating or layer and a barrier coating or layer are made from the same compositions as applicant’s pH coating or layer and barrier coating or layer, Weikart et al. in view of Whitney et al. teaches all the limitations of claim 21.
Therefore, Weikart et al. in view of Whitney et al. renders claim 21 obvious.
VII.) Regarding applicant’s claim 22, as noted above Weikart et al. in view of Whitney et al. renders claim 2 obvious from which claim 22 depends.
Claim 22 recites that the pH protective coating or layer is characterized in that the rate of erosion of the pH protective coating or layer, if directly contacted by a fluid composition having a pH of 8, is 5% tov20% the rate of erosion of the barrier coating or layer, if directly contacted by the same fluid composition under the same conditions.
Weikart et al. in view of Whitney et al, includes a pH protective coating or layer that is made from SiOxCy or SiNxCy, and that the barrier coating or layer can be SiOx as taught by Weikart et al.
Inasmuch as Weikart et al. in view of Whitney et al. includes a pH coating or layer and a barrier coating or layer are made from the same compositions as applicant’s pH coating or layer and barrier coating or layer, Weikart et al. in view Whitney et al. teaches all the limitations of claim 22.
Therefore, Weikart et al. in view of Whitney et al. renders claim 22 obvious.
VIII.) Regarding applicant’s claim 23, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 23 depends.
Claim 23 recites that an FTIR absorbance spectrum of the pH protective coating or layer has a ratio greater than 0.75 from:
• the maximum amplitude of the Si-O-Si symmetrical stretch peak between about 1000
and 1040 cm-1, and
• the maximum amplitude of the Si-O-Si asymmetric stretch peak between about 1060 and about 1100 cm-1.
In paragraphs [0050]-[0052] Weikart et al. teaches: In any embodiment of the invention, an FTIR absorbance spectrum of the pH protective coating or layer optionally can have a ratio greater than 0.75 between: the maximum amplitude of the Si-O-Si symmetrical stretch peak between about 1000 and 1040 cm-1, and the maximum amplitude of the Si-O-Si asymmetric stretch peak between about 1060 and about 1100 cm-1.
Therefore, Weikart et al. in view of Whitney et al. renders claim 23 obvious.
IX.) Regarding applicant’s claim 25, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 25 depends.
Claim 25 recites that the silicon dissolution rate of the tube is less than 170 ppb/day as measured in a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant.
Applicant discloses that “for the pH protective coating or layer 286 in any embodiment the silicon dissolution rate of the tube is less than 170 ppb/day as measured in a 50 mM potassium phosphate buffer diluted in water, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant.” [0152]
As noted above, Weikart et al. in view of Whitney et al. includes a pH protective coating or layer that is made from the same composition as applicant’s pH protective coating or layer, and therefore teaches the limitations of claim 25.
Further at [0180] Weikart et al. teaches that “Optionally, for the pH protective coating or layer 286 in any embodiment, the silicon dissolution rate by a 50 mM potassium phosphate buffer diluted in water for injection, adjusted to pH 8 with concentrated nitric acid, and containing 0.2 wt. % polysorbate-80 surfactant, (measured in the absence of the medicament, to avoid changing the dissolution reagent), at 40° C., is less than 170 ppb/day. (Polysorbate-80 is a common ingredient of pharmaceutical preparations, available for example as Tween®-80 from Uniqema Americas LLC, Wilmington Del.)”
Therefore, Weikart et al. in view of Whitney et al. renders claim 25 obvious.
X.) Regarding applicant’s claim 29, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 29 depends.
Claim 29 recites that the pH protective coating or layer is characterized by an O-Parameter of less than 0.4, as measured with attenuated total reflection (ATR), using the formula:
O-Parameter = Intensity at 1253 cm-1
Maximum intensity in the range 1000 to 1100 cm-1.
As noted above, Weikart et al. in view of Whitney et al. includes a pH protective coating or layer that is made from the same composition as applicant’s pH protective coating or layer, and therefore teaches all the limitations of claim 25.
Further at [0190] Weikart et al. teaches that “Optionally, the pH protective coating or layer 286 shows an O-Parameter measured with attenuated total reflection (ATR) of less than 0.4, measured as:
O-Parameter = Intensity at 1253 cm-1
Maximum intensity in the range 1000 to 1100 cm-1.
Therefore, Weikart et al. in view of Whitney et al. renders claim 29 obvious.
XI.) Regarding applicant’s claim 31, as noted above Weikart et al. in view of Whitney et a. renders claim 1 obvious from which claim 31 depends.
Claim 31 recites that the pH protective coating or layer is characterized by an N-Parameter of less than 0.7, as measured with attenuated total reflection (ATR) using the formula:
N-Parameter = Intensity at 840 cm-1
Intensity at 799 cm-1.
As noted above, Weikart et al. in view of Whitney et al. includes a pH protective coating or layer that is made from the same composition as applicant’s pH protective coating or layer, and therefore Weikart et al. in view of Whitney et al. teaches all the limitations of claim 31.
Further at [0193] Weikart et al. teaches that “Optionally, the pH protective coating or layer shows an N-Parameter measured with attenuated total reflection (ATR) of less than 0.7, measured as:
N-Parameter = Intensity at 840 cm-1
Intensity at 799 cm-1.
Therefore, Weikart et al. in view of Whitney et al. renders claim 31 obvious.
XII.) Regarding applicant’s claim 33, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 33 depends.
Claim 33 recites that x is from 0.5 to 1.5 and y is from 0.9 to 2 for the pH protective coating or layer.
Weikart et al. in view of Whitney et al. teaches that in the pH protective coating or layer x is from about 0.5 to about 2.4 as measured by XPS, y is from about 0.6 to about 3 as measured by XPS, but does not teach that x is between 0.5 and 1.5 and y is between 0.9 and 2 for the pH protective coating or layer.
It would have been obvious to one skilled in the art to conduct routine engineering optimization experimentation provide the pH protective layer with a range of x and y within Weikart et al.’s disclosed range, including providing x is between 0.5 and 1.5 and y is between 0.9 and 2.
Therefore, Weikart et al. in view of Whitney et al. renders claim 33 obvious.
XIII.) Regarding applicant’s claim 47, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 33 depends.
Claim 47 recites that the collection tube is characterized by a water vapor transmission rate (WVTR) in units of mg of moisture per day (mg/day) less than 0.01 mg/day, alternatively less than 0.008 mg/day, alternatively less than 0.005 mg/day, or alternatively less than 0.003 mg/day, as measured with the water vapor transmission rate (WVTR), using the formula:
PNG
media_image1.png
70
270
media_image1.png
Greyscale
where P, is the permeability of water vapor, l, is the thickness, p2, is the partial pressure of water vapor on one side of the film and p1; is on the other side, EA is the activation energy, R is the universal gas constant and T is the temperature.
As noted above, Weikart et al. in view of Whitney et al. teaches applicant’s lumen, tie coating or layer, barrier coating or layer and pH protective coating or layer recited in claim 1 from which claim 47 depends and therefore Weikart et al. in view of Whitney teaches all the limitations of claim 47.
Therefore, Weikart et al. in view of Whitney et al. renders claim 47 obvious.
XIV.) Regarding applicant’s claim 48, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 48 depends.
Claim 48 recites that the collection tube is characterized by an oxygen permeation rate of less than 0.00030 /day, alternatively less than 0.00020 /day, alternatively less than 0.00018 /day, or alternatively less than 0.00018 /day measured in a units of time -1 of the article, as measured with oxygen transmission rate (OTR) constant (Korg), using the formula:
PNG
media_image2.png
70
184
media_image2.png
Greyscale
where V is the BCT volume, Particle is the oxygen permeation rate constant of the BCT (with units moles time-1 pressure-1), T is the absolute temperature, and R is the Universal gas constant.
As noted above, Weikart et al. in view of Whitney et al. teaches applicant’s lumen, tie coating or layer, barrier coating or layer and pH protective coating or layer recited in claim 1 from which claim 48 depends and therefore Weikart et al. in view of Whitney et al. teaches all the limitations of claim 48.
Therefore, Weikart et al. in view of Whitney et al. renders claim 48 obvious.
XV.) Regarding applicant’s claim 63, as noted above Weikart et al. in view of Whitney et al. renders claim 18 obvious from which claim 63 depends.
Claim 63 recites that the metabolic inhibitor is sodium azide.
As noted above, Weikart et al. in view of Whitney et al. teaches sodium azide which applicant disclose as a metabolic inhibitor.
Therefore, Weikart et al. in view of Whitney et al. renders claim 63 obvious.
2. Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Weikart et al. in view of Whitney et al. as applied to claim 1 above, and further in view of Haj-Ahmad.
I.) Regarding applicant’s claim 10, as noted above Weikart et al. in view of Whitney et al. renders claim 1 obvious from which claim 10 depends.
Claim 10 recites that the one or more nucleic acid preservative preservatives is a composition comprising:
(a) a reducing agent;
(b) a first chaotropic substance;
(c) a second chaotropic substance;
(d) a third chaotropic substance;
(e) a first polyamine substance;
(f) a second polyamine substance; and
(g) a chelating agent.
Weikart et al. in view of Whitney et al. teaches vessels that are used nucleic acid testing, but does not teach the nucleic acid preservation composition of claim 10
Haj-Adman teaches compositions for preserving nucleic acids in blood samples prior to analysis. (Abstract and [0002].
At [0007]- [0023] Haj-Adman teaches glutathione, lithium salt (LiCl), guanidine hydrochloride, urea, spermidine, biuret and EDTA.
It would have been obvious to one of ordinary skill in the art to modify Weikart et al. in view of Whitney et al. to include the nucleic acid preservation composition components of Haj-Adman, including glutathione, lithium salt (LiCl), guanidine hydrochloride, urea, spermidine, biuret and EDTA for purpose of preserving blood samples to nucleic acid analysis.
Therefore, Weikart et al. in view of Whitney et al. and Haj-Adman renders claim 10 obvious.
II.) Regarding applicant’s claim 11, as noted above Weikart et al. in view of Whitney et al. and Haj-Adman renders claim 10 obvious from which claim 11 depends.
Claim 11 recites that reducing agent is glutathione, the first chaotropic substance is LiCl, the second chaotropic substance is guanidine hydrochloride, the third chaotropic substance is urea, the first polyamine substance is spermidine; the second polyamine substance is biuret, and the chelating agent is EDTA.
As noted above Haj-Adman teaches glutathione, lithium salt (LiCl), guanidine hydrochloride, urea, spermidine, biuret and EDTA.
Therefore, Weikart et al. in view of Whitney et al. and Haj-Adman renders claim 11 obvious.
III.) Regarding applicant’s claim 12, as noted above Weikart et al. in view of Whitney et al. Haj-Adman renders claim 11 obvious from which claim 12 depends.
Claim 12 recites that nucleic acid preservative is a composition comprising:
(a) glutathione in an amount from about 10 mM to about 200 mM;
(b) LiCl in an amount of from about 1 M to about 4 M;
(c) guanidine hydrochloride in an amount from about 0.1 M to about 0.9 M;
(d) urea in an amount from about 2 M to about 12 M;
(e) spermidine in an amount from about 10 µM to about 300 µM;
(f) biuret in an amount of from about 10 mM to about 100 mM; and
(g) EDTA in an amount of from about 1 mM to about 200 mM.
In paragraphs [0008]-[0023] Haj-Adman teaches that the components recited in claim 12 are used in the same amounts recited in claim 12.
Therefore, Weikart et al. in view of Whitney et al. and Haj-Adman renders claim 12 obvious.
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
Applicant argues that there must be some suggestion or motivation to combine the teachings of Wiekart et al. and Whitney et al.
Wiekart et al. teaches a blood collection tube and Whitney et al. teaches storing blood samples and PEG as a stabilizer [0149], NaCl as a buffer [0188], EDTA and citrate as buffers [0188], and sodium azide for protecting against pathogens.
It would have been obvious to modify Weikart et al. to include PEG, EDTA, NaCl, citrate and sodium azide as taught by Whitney et al. for purposes of using Wiekart et al. for use with biological samples that include nucleic acid.
Applicant argues that there must be an expectation of success.
Certainly providing Weikart et al. with the PEG, EDTA, NaCl, citrate and sodium azide as taught by Whitney et al. would held store blood samples.
Applicant argues that Weikart et al. and Whitney et al. must teach or suggest all the claim limitations – specifically pointing out the newly added limitations to claim 1 which recite that the pH protective coating or layer as applied has a thickness of from 100 to 700 nm, and that the pH protective coating or layer has a thickness of from 50 to 500 nm two years after the tube is assembled.
As pointed out above, applicant’s specification discloses that changes to the thickness of the pH protective coating or layer occur over the shelf life of the of the collection tube which is temperature dependent. In this regard applicant discloses shelf life in reference to “assuming storage at 20 to 25°C” at [0175], and Si dissolution rates at different temperatures.
Further, the claimed range thickness of the pH protective coating or layer of 100 to 700 nm is within the range taught by Weikart et al. which renders the initial thickness layer prima facie obvious as noted in MPEP 2144.05(I). In addition the composition of the pH protective coating or layer taught by Weikart et al. is the same as applicant’s claimed composition rendering it expected that the pH protective coating or layer initially provided at 100 to 700 nm would have a thickness of from 50 to 500 nm two years after the tube is assembled, absent evidence to the contrary.
Otherwise, it would have been obvious to one of ordinary skill in the art to provide the pH protective coating or layer anywhere within the thickness range taught by Weikart et al. , including a thickness of 100 to 700 nm, and store the assembled tube of Weikart et al. in view of Whitney et al. at a suitable storage temperature determined by routine engineering optimization experimentation to provide a desired thickness of the pH protective coating or layer suitable for use after a two year storage period, including a use thickness of 50 to 500 nm.
Applicant argues that Figs. 1-5 of Weikart et al do not show a blood collection tube.
In paragraph [0004] Weikart et al. teaches [0004] that the present disclosure also relates to improved methods for processing pharmaceutical packages or other vessels, for example multiple identical pharmaceutical packages or other vessels used for pharmaceutical preparation storage and delivery, venipuncture and other medical sample collection, which encompasses and otherwise renders obvious blood collection tubes.
Applicant argues that it is unexpected that the pH protective coating would have a thickness of from 50 to 500 nm after two years in contact with the nucleic acid preservative solution.
The prior art teaches a thickness range of the initial pH protective coating or layer and the claimed composition of the pH protective coating or layer, rendering it expected that after two years of storage at a suitable temperature (that is not claimed), the thickness of the pH protective coating or layer would be 50 to 500 nm, absent evidence to the contrary.
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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/MICHAEL STANLEY GZYBOWSKI/Examiner, Art Unit 1798