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 .
Applicant’s arguments, filed 10/29/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-7, and 13-15, are pending and under examination.
Claim Objections
Claim 1 is objected to because of the following informalities: in ln 1, “orgal” should read “oral”. Appropriate correction is required.
Claims 2 and 6 are objected to because of the following informalities: in ln 2 of each claim, “comprise” should read “comprises”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 stands rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 depends from claim 1, and recites “wherein each unit solid formulation has a total weight of about 0.05 g or more,” however, claim 1 recites a total weight of “about 0.3 g or less.” Claim 13 includes amounts above the weight range recited by claim 1, therefore, claim 13 fails to further limit the instant claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. For purposes of examination, the claim will be interpreted as about 0.05 g to about 0.3 g.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-7, and 13-15, stand rejected under 35 U.S.C. 103 as being unpatentable over Crockett et al (US 20130189377 A1, cited on IDS dated 01/16/2025), in view of Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022, cited on IDS dated 01/16/2025), Belsey et al (Alim Pharm Ther, 2007, vol 25, issue 4, pp. 349-521), and Nam et al (KR 20190041233 A, cited on IDS dated 06/29/2023).
Crockett et al teach solid oral pharmaceutical compositions that can be used for colon cleansing, with embodiments comprising 20.24 g sodium sulfate, 3.48 g potassium sulfate, 17.1 g magnesium sulfate, and 34 g PEG 3500, where typically 40-120 tablets are required to administer this dosage (¶ 68, composition 5). For example at 120 tablets, the resulting unit solid formulation has a weight of about 0.62 g. The dosage forms may be less than 5 g, preferably more than 0.1 g, etc. (¶ 50). The optimal number of tablets required to deliver the required dose will depend upon the intended usage (¶ 63). The formulations may further include additives including excipients, sweeteners, flavoring agents., etc. (¶ 12). Excipients include binders, disintegrants, glidants, fillers, etc. (¶ 39).
Crockett et al do not specifically teach an embodiment with a unit solid formulation having a weight as instantly claimed, nor the inclusion of simethicone.
Ilhan et al teach multi-unit dosage forms, including mini tablets, where the dose is divided into subunits, were known to spread to the entire gastrointestinal tract resulting in a reduced risk of local irritation as a result of an equal drug release (pg 12 2nd col, table 1). Multi-unit dosage forms show a more reliable dissolution profile than single units, which means better bioavailability (pg 12 2nd col). Smaller tablets are advantageous for use in patients suffering from swallowing difficulty (abs, pg 12 1st col). Mini tablets were known to be used for colon treatments (pg 18 2nd col). Tables, capsules, and granules with an average weight less than 300 mg are disclosed (table 3).
Ilhan et al do not teach simethicone.
Belsey et al teach it was known that dividing colon cleansing formulations over multiple tablets demonstrated a reduced incidence of nausea, vomiting, etc., without sacrificing efficacy (pg 377 2nd col last ¶). Simethicone was known to be added to colon cleansing formulations, where a significant reduction in visible bubbles was reported with consequent improved visibility (pg 377 2nd col 3rd ¶).
Nam et al teach colonic purgative compositions comprising magnesium sulfate, potassium sulfate, sodium sulfate, and simethicone (¶¶ 15, 36). When simethicone was combined with magnesium sulfate, potassium sulfate, and simethicone, a synergistic effect was observed and the dosage could be reduced by 20% and exhibit an equivalent colon cleansing effect (¶ 40). Simethicone is recognized as a drug that suppresses the formation of intestinal gas bubbles, which improves the field of view of the endoscope during a colonoscopy (¶ 41).
Regarding claim 1, it would have been obvious to formulate the solid oral formulation of Crockett et al in smaller unit formulations, where Crockett et al teach the unit solid formulations may be less than 5 g, preferably more than 0.1 g, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Additional motivation for reducing tablet size and weight is provided by Ilhan et al, where it was known that multi-unit dosage forms, including small tablets with a weight of 300 mg or less, reduce local side effects, have improved dissolution profile, and are advantageous for use in patients suffering from swallowing difficulty. Further, additional motivation is also provided by Belsey et al, where it was known splitting colon cleansing formulations over multiple tablets demonstrate a reduced incidence of nausea, vomiting, etc., without sacrificing efficacy. As such, it would have been within the relative skills of the skilled artisan to split the dosage form over a larger number of tablets, thereby reducing the size and weight of each tablet for the above mentioned benefits.
Regarding claim 2, the embodiment of Crockett et al recited above comprises sulfate at 40.82 g, falling within the claimed range.
Regarding claims 3-5, the embodiment of Crockett et al recited above comprises sodium sulfate, potassium sulfate, magnesium sulfate, and polyethylene glycol.
Regarding claim 6, it would have been obvious to further include simethicone to the solid oral formulation of Crockett et al, where simethicone was known to have synergistic colon cleansing effects when combined with magnesium sulfate, potassium sulfate, and sodium sulfate, as taught by Nam et al above, and where simethicone was known to improve visibility of the colon as taught by Nam et al and Belsey et al above.
Regarding claim 7, where unit solid formulations having a total weight of 0.3 g or less are made obvious above, it would have been obvious for the skilled artisan to adjust the number of tablets in order to achieve desired unit formulation weights, as discussed above, by starting with the exemplified 120 tablets of Crockett et al, and adjusting up from there, where it is taught that the number of tablets can be optimized and unit solid formulations can be adjusted to unit solid formulations with a weight overlapping the claimed range. Further, it would have been obvious to split up the dosage into a larger number of tablets having less weight where it was known that smaller tablets (i.e., lower weight tablets) provide improved dissolution, are easier to swallow, and reduce side effects such as nausea, etc., as discussed above by Ilhan et al and Belsey et al.
Regarding claim 13, it would have been obvious to formulate the oral solid formulation of Crockett et al in smaller unit formulations, where Crockett et al teach the unit solid formulations may be less than 5 g, preferably more than 0.1 g, such as from about 0.05 g to about 0.5 g and from about 0.05 to about 0.3 g, overlapping the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Additional motivation for reducing tablet size and weight is provided by Ilhan et al and Belsey et al above, for the same reasons discussed above.
Regarding claim 14, it would have been obvious to further include excipients, sweeteners, etc., including binders, disintegrants, glidants, fillers, as taught by Crockett et al, which are evidenced by the instant specification as pharmaceutically acceptable additives (see pg 21 of the instant specification).
Regarding claim 15, the formulation made obvious above is in the form of tablets, as taught by Crockett et al.
Response to Arguments
First, Applicants assert Cockett et al disclose a broad tablet weight, where examples use a minimum weight of 0.62 g. Applicants assert Cockett et al do not specifically disclose a tablet weighing 0.3 g or less. Applicants assert without knowledge of the present disclosure, it would not be likely that consider a tablet weight that is approximately half of the minimal weight of 0.62 g disclosed in the examples.
Second, Applicants assert the claimed combination exhibits unexpectedly significant effects on gastrointestinal side effects, which are neither disclosed or recognized by Crockett et al. Applicants assert they have shown that tablets weighing at 0.6 g, which is close to those of the example of Crockett et al, did not improve side effects, whereas a tablet weighing 0.3 g or less showed significant improvement. Applicants point to the figure 1 of the declaration, as well as fig. 1 of the instant specification for support. Applicants assert if a reduction in tablet weight alone was sufficient to improve gastrointestinal side effects, such improvements would have been observed with tablets with lower weights, such as 600 mg; however, Applicants assert there is little difference from about 1500 mg to about 600 mg, but significant improvement with about 300 mg and about 150 mg tablets.
Third, Applicants assert that Ilhan et al refers to a mini tablet as a drug delivery system, wherein the drug undergoes adsorption, distribution, metabolism, and excretion (ADME) process. Applicants assert Crockett et al do not relate to drug absorption, rather, inducing defecation via osmotic action in the gastrointestinal tract Applicants assert the skilled artisan would not look to Ilhan et al for the same reasons.
Fourth, Applicants assert the mini tablet of Ilhan et al may be filled inside a capsulate or that a plurality of mini tablets may be compressed into a single tablet, thereby resulting in a dosage form that differs from Crockett et al and the claimed combination.
Fifth, Applicants assert that with solid bowel cleansing agents, the active ingredients are administered in significantly higher amounts than conventional drugs, leading to a significant increase in the tablets taken, which may exacerbate side effects. Applicants assert without knowledge of the present disclosure, the skilled artisan could not predict the effects of smaller tablets on bowel cleansing.
Sixth, Applicants assert Belsey et al discloses dividing a sodium phosphate solution from two administrations to three, not a tablet. Applicants assert Belsey et al only discloses that typical doses for solid bowel cleansing formulation is 28-40 tablets, and does not suggest anything to support dividing tablets into smaller units, much less the result of doing so.
Seventh, Applicants assert Nam et al do not cure the deficiencies of Crockett et al, Ilhan et al, and Belsey et al above. Applicants assert Nam et al teach tablet weights of 1380.38 mg and 1440.36 mg, and does not provide any motivation or suggestions to decrease tablet weights to those instantly claimed. Further, Applicants assert the figures show that the claimed tablet size unexpectedly reduced side effects compared to larger tables of about 1500 mg, which could not be predicted for the same reasons argued above.
First, respectfully, this argument is not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). While composition 5 of Crockett et al disclose tablet weights of about 0.62 g at 120 tablets, as discussed above, the teaching of the reference is not limited to the examples. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See MPEP 2123(I). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See MPEP 2123(II). Here, Crockett et al more broadly teaches the dosage forms may be less than 5 g, preferably more than 0.1 g, teaching that tablet weights as low as 0.1 g are suitable.
Second, respectfully, this argument is not persuasive. From the experimental design from which Applicants provide their results, the instant specification recites “each of tablets 1 to 3 was administered to three beagles together with water” and “tablets 1 to 3 were prepared and administered to three beagles.” It is unclear whether the experimental design involved administering tablet 1 to 3 beagles, tablet 2 to 3 beagles, and tablet 3 to 3 beagles (a total of 9 beagle dogs), or if tablet 1 was given to 1 beagle, tablet 2 was given to 1 beagle, and tablet 3 was given to 1 beagle (a total of 3 beagle dogs).
Additionally, from the results, it is not possible to determine whether the differences in the side effect score are due to the tablet weight or biological difference among the different beagle dogs themselves, where there are lack of controls. Therefore, it appears the experimental design is insufficient for valid statistical analysis and cannot serve as reliable objective evidence. With only three independent samples given to three independent beagle dogs, the influence of individual differences among the experimental animals cannot be adequately addressed. In such cases, even if difference in observed side effects are observed, the influence of biological differences among the beagle dogs or other factors cannot be ruled out, making it difficult to confirm the impact of the tablet weight differences. Additionally, regarding the side effect evaluation, it appears that Applicants relied solely on visual observation to assess the area and intensity of occurrence of hyperemia, hemorrhage, erosion, and edema, which can be highly subjective and cannot guarantee the objectivity of the data.
Purely arguendo, even if the results were sufficient, looking at the figures, while a reduction in the observed sore for side effects is observed for the about 300 mg and the about 150 mg tablet, compared to the about 600 mg tablet, this result appears to be expected based on the teachings of the prior art. As previously discussed, Crockett et al allows for tablet weights down to 0.1 g, and Ilhan et al teaches multi-unit dosage forms that can be used for colon cleansing, where dividing doses into smaller subunits were known to spread the dosage evenly throughout the gastrointestinal tract, thereby reducing the risk of local irritation. Accordingly, it appears that it would be expected that by splitting the dosage form of Crockett et al into smaller dosage forms, that a reduction in local irritation would occur for the same reasons, thereby reducing side effects. Applicants assert that if tablet weight alone were sufficient to improve gastrointestinal side effects, such improvements would have been observed at about 600 mg, however, from the figures, it appears that a reduction in side effects did occur for the about 600 mg tablets compared to the about 1500 mg tablets. Additionally, it is noted that while about 300 g had the lowest side effect score, side effects were still present, and the about 150 mg tablet had a side effect score falling between the about 600 mg and about 300 mg. Finally, even if unexpected results were shown, the results presented by Applicants are not commensurate in scope with the claims, where the figures appear to suggest the side effects get worse at tablet weight smaller than about 300 mg.
Third, respectfully, this argument is not persuasive. While Ilhan et al teach mini tablets that can be used for a variety of intended uses and drugs, Ilhan et al teach multi-unit dosage forms that can be used for colon cleansing, where dividing doses into smaller subunits were specifically known to spread the dosage evenly throughout the gastrointestinal tract, thereby reducing the risk of local irritation. Accordingly, when formulating the dosage form for colon cleansing as taught by Crockett et al, where dosage forms can be as small as 0.1 g, it appears that it would have been expected that smaller dosage forms would reduce gastrointestinal side effects. Further, it is respectfully not seen where the "ADME" process is disclosed by Ilhan et al. Nevertheless, Ilhan et al was not cited for the types of drugs used nor their mechanism of action, but rather splitting dosage forms into smaller tablets were known to reduce gastrointestinal side effect, as discussed above.
Fourth, respectfully, this argument is not persuasive. Applicants assert Ilhan et al teach mini tablets that are compressed into a single tablet, however, the reference also teaches multi-unit dosage forms that are not compressed into a single tablet, such as those shown in table 1. Even so, Ilhan et al was only cited for motivation to select from the smaller tablet sizes already disclosed by Crockett et al.
Fifth, respectfully, this argument is not persuasive. Applicants appear to be asserting speculative arguments of what "may" exacerbate side effects, without objective evidence to support these assertions. Nevertheless, even if more tablets need to be taken, such as the amounts taught by Crockett et al above, it appears that splitting the dosage form into smaller tablets would still reduce gastrointestinal side effects, by spreading the dosage more evenly throughout the colon.
Sixth, respectfully, this argument is not persuasive. While Belsey et al does appear to teach both solutions and 28-40 tablets as “doses”, immediately following in the same paragraph, the reference teaches that dividing the doses (i.e., the solutions or the tablets), reduced the incidence of nausea without sacrificing efficacy. While the reference may not explicitly recite that the tablets are smaller units, the skilled artisan would recognize that splitting the tablet dosages would result in smaller tablets.
Seventh, respectfully, this argument is not persuasive. Nam et al were simply cited for motivation to include simethicone, not for motivation for particle size reduction. Accordingly, where the tablet sizes as claimed are made obvious above, the claims stand rejected for the same reasons above and of record.
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 1-7, and 13-15, stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,510,884, hereinafter ‘884, in view of Crockett et al (US 20130189377 A1), Ilhan et al (Peertechz J Med Chem Res, 2017, 3.1, pp. 012-022), Belsey et al (Alim Pharm Ther, 2007, vol 25, issue 4, pp. 349-521), and Nam et al (KR 20190041233 A).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘884 disclose a bowel cleansing composition comprising polyethylene glycol (PEG) from 140-180 g and ascorbate ingredients (claim 1). The composition is in the form of a tablet, granule, powder, capsule or liquid (claim 1). The cleansing compositions further comprise sodium sulfate at a weight ratio of PEG to sodium sulfate of 7:1 to 12:1, with embodiments comprising 16-20 g of sodium sulfate (claims 3 and 22).
The claims of ‘884 do not disclose the unit solid formulation weight as instantly claimed, sulfate in an amount of about 25 g to about 60 g, embodiments comprising sodium sulfate, magnesium sulfate, and potassium sulfate, simethicone, nor wherein the solid formulation comprises the number of solid unit forms as instantly claimed.
It would have been obvious to modify the claims of ‘884 to include the formulation as unit solid forms in known weights suitable for colon cleansing formulations, such as those taught by Crockett et al above and for the same reasons. Additional motivation is provided by Ilhan et al and Belsey et al, for the same reasons discussed above.
It would have been obvious to adjust the amount of sodium sulfate of ‘884 to known amounts suitable for sulfates in colon cleansing formulations, such as 40.82 g as taught by Crockett et al above, falling within the claimed range.
Where ‘884 discloses the combination of PEG and sodium sulfate, it would have been obvious to modify the formulation of ‘884 by using known combinations of sulfates suitable for colon cleansing formulations used combination with PEG, such as sodium sulfate, magnesium sulfate and potassium sulfate, as taught by Crockett et al above.
It would have been obvious to further include simethicone, as taught by Nam et al and Belsey et al above and for the same reasons.
It would have been obvious to formulate the bowel cleansing composition in the form of multi-dose tablets, such as 120 tablet doses, which are taught by Crockett et al to be suitable for colon cleaning formulations. Further, it was known that multi-dose formulations of mini tablets were known to reduce the risk of local irritation, be easier to swallow, reduced incidence of nausea, vomiting, etc., without sacrificing efficacy, as taught by Ilhan et al and Belsey et al above.
Response to Arguments
Applicants assert the claimed unit solid dosage form weight of the present invention cannot be easily derived from the disclosed references without awareness of the present invention, and the present invention has a remarkable effect in minimizing side effects that cannot be expected from the cited references. Applicants assert that even considering the references discussed above, it would not have been obvious to modify the claims of the ‘884 patent.
Respectfully, this argument is not persuasive. For the reasons discussed above and of record, it appears that the cited references make obvious the instantly claimed oral solid formulation. Accordingly, it would have been obvious to modify the claims of the ‘884 with known unit solid formulation dosage weights, for the same reasons discussed above and of record.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612