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 .
DETAILED ACTION
Status of the Claims
Pursuant to the amendment dated 12/05/2025, claims 22, 26, and 27 have been cancelled. Claims 2 and 17 have been cancelled previously. Claims 1, 3-16, 18-21, 23-25, and 28-30 are pending. Claims 1 and 3-14 stand withdrawn without traverse.
Claims 15, 16, 18-21, 23-25, and 28-30 are under current examination.
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 15, 16, 18, 19, 21, 23-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Winicov (US 5,368,868; issue date: 11/29/1994; cited in the IDS filed 03/10/2022) in view of Nguyen-Kim et al. (US 2016/0074517; publication date: 03/17/2016; of record), and further in view of Ofosu-Asante et al. (US 6,387,856; issue date: 05/14/2002; of record), Gambogi et al. (US 2006/0183653; publication date 08/17/2006; of record), and Kleine et al. (US 2018/0177189; publication date: 06/28/2018; of record).
With regard to instant claim 15, Winicov discloses an aqueous stable detergent-iodine germicidal composition for application to animal or human skin (abstract). The composition contains poloxamer (i.e. an EO-PO copolymer) as the “detergent” component, which serves to solubilize the antimicrobial agent, iodine (abstract and col 4, lines 29-40). The composition may be a concentrate (abstract) and Winicov discloses a step of diluting the concentrates (col 1, lines 12-14). The composition can be used as a bovine (i.e. an animal in a dairy herd) teat dip (col 2, line 24) and detergent iodine teat dips were known to help prevent mastitis (col 1, line 34). As the ingredients are very similar to the claimed ingredients, particularly the presence of iodine and poloxamer, a film forming polymer, the examiner considers Winicov’s composition to possess the property of being a film-forming composition that forms an aqueous protective antimicrobial film upon application. The composition does not contain NPE and LAE and has a pH between 2-4 (Winicov: claim 10). Although Winicov does not describe an example method wherein the composition is applied to an animal in a dairy herd it would have been prima facie obvious to do so because one having ordinary skill in the art would have immediately recognize this as a suitable and intended use for Winicov’s composition. Winicov indicates that viscosity modifiers (i.e. rheology modifiers) are common additives for teat dip compositions (col 2, lines 35-42): “There are many viscosity modifiers compatible with detergent-iodine systems, such as carboxymethylcellulose derivatives, polyacrylate derivatives, alginates, xanthates and polysaccharides. These are typically used at levels below 1% by weight in a final use composition. These types of ingredients, properly selected, have an insignificant effect on the homogeneity of a given use composition.” Accordingly it would have been prima facie obvious to add a thickener (i.e. rheology modifier) to Winicov’s composition because this would have merely been combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)).
With regard to the percentage of iodine and the two EO-PO polymers required by the instant claims, Winicov discloses that, when in the form of a concentrate, the composition may have 1-5% wt available iodine and 2 – 4.5 parts poloxamer (abstract, col 4, lines 20-25). Accordingly, Winicov discloses an identical range of iodine and an overlapping range in amount of total EO-PO polymer, noting that the claims require two EO-PO polymers, each at 1- 5%wt. The total amount of EO-PO polymer required by the instant claims (i.e. the percentage 5900-6500 Da EO-PO polymer plus the percentage of the 1000-3600 Da EO-PO polymer) is 2 – 10% by weight. If Winicov’s poloxamer is present at 1 – 4.5x the iodine, Winicov teaches a range of 2 – 22.5%wt. poloxamer, which overlaps with the ranges in percentage of EO-PO polymers required by the instant claims. Winicov’s poloxamer copolymer is taught to require a molecular weight of greater than 2600 and an EO content of from about 30-75% by weight (col 3, lines 50-55) and may be a mixture of commercially available poloxamers to achieve an intermediate value poloxamer (col 6, lines 15-17). Accordingly, Winicov teaches that a mixture of two different EO-PO polymers present in a total amount of 2-22.5% wt. can effectively solubilize iodine, with good high and low temperature stability at a low ratio of poloxamer to iodine (col 1, lines 25-26).
Thus, Winicov renders obvious a method for reduction of contagious and environmental mastitis in a dairy herd comprising applying an aqueous protective antimicrobial film forming composition to an animal in a dairy herd to form an aqueous protective antimicrobial film, the aqueous protective antimicrobial film comprising a mixture of EO-PO copolymers having an intermediate molecular weight of greater than 2600 and an antimicrobially effective amount of iodine compound wherein the composition is stable at temperatures from about 4 - 50C and the total composition is completely free of NPE and LAE. Further, Winicov directs the artisan of ordinary skill to seek low ratio of poloxamer to iodine (col 1, line 25).
The composition used in the instant invention differs from Winicov’s composition in that Winicov does not specify the molecular weights or relative amounts of the poloxamers used in the mixture of poloxamers noted above to form the intermediate value poloxamer when combining poloxamers.
Nguyen-Kim discloses a mixture of poloxamer surfactants (poloxamer component A and B) used in a method of solubilizing poorly water soluble substances (abstract; claim 40) and discloses that synergistic mixtures of poloxamers were known prior to their disclosure for solubilizing pharmaceutically active ingredients (0013). Nguyen-Kim discloses further: “Although PO-rich surfactants on their own often have a solubilizing effect, in relatively large concentrations they lead to a considerable increase in the viscosity of the solution, meaning that they are unsuitable for aqueous formulations as regards processing. In relatively small concentrations, however, the solubilizing effect is often not pronounced enough in order to be of practical use.” And also discloses: “Mixtures with EO-richer poloxamers sometimes have a tendency towards gelation, which is likewise undesirable for administration in the form of aqueous formulations.” Data contained in tables I-V on page 3 show great enhancement of solubility of the active agent when a combination of poloxamers is used relative to the solubilizing effect of one poloxamer in isolation. Nguyen-Kim explain that the poloxamer components A and B have the following structural formulae (see e.g. claim 40):
Component A:
(EO)x1′-(PO)y1-(EO)x1″, where y1 is 40 to 70 and (x1′+x1″) is 30-60 and (x1′+x1″)/y1 is less than 1
Component B:
(EO)x2′-(PO)y2-(EO)x2″, where y2 is 15 to 55 and (x2′+x2″) is 2-50 and (x2′+x2″) /y2 is less than 1
As is evident from the above structures, component A generally has a larger molecular weight than component B, although there is overlap. Nguyen-Kim’s discussion focuses more on the amounts of PO vs. EO in the copolymer; however, from the structures above and known molecular weight of EO and PO monomers, Nguyen-Kim clearly contemplates a range in molecular weight for component A of approximately 3642-4702 Da and component B of approximately 1000-5392 Da. Thus, Nguyen-Kim explains that poorly water soluble compounds can be solubilized in aqueous solutions using a combination of two poloxamers wherein the first poloxamer (component A) has a range in molecular weight that falls within the scope of the range “about 5900 to about 6500” (emphasis added) for instant “second EO-PO copolymer component” and a range in molecular weight for the second poloxamer (component B) that is very close to the range required for instant “first EO-PO copolymer component”. See MPEP 2144.05. One having ordinary skill in the art would have recognized that such combinations can solubilize hydrophobic substances using lower amounts of total poloxamer than can a single poloxamer without forming a composition that is too viscous, and without gelling, as can be problematic for high EO poloxamers.
It would have been prima facie obvious to use a combination of poloxamers as disclosed by Nguyen-Kim to solubilize iodine in Winicov’s invention. Noting that the “detergent” (i.e. the poloxamer) in Winicov’s composition serves to solubilize molecular iodine in aqueous solution (col 4, lines 29-42), the skilled artisan would have been motivated to employ a combination of poloxamers as disclosed by Nguyen-Kim in order to further reduce the “detergent” content, which Winicov discloses to be desirable (col 1, line 25 and paragraph bridging col 2-3). The skilled artisan would have had reasonable expectation of success because Winicov indicates that mixtures of poloxamers are suitable and because Nguyen-Kim discloses that poloxamers were known in the art to synergistically enhance dissolution of poorly water soluble substances. With regard to the ratio of EO-PO copolymer components (i) and (ii) required by the instant claims, it would have been a matter of routine testing of multiple concentrations for one of ordinary skill to discover working ranges for synergy for a given set of poloxamers to solubilize iodine. Moreover, the claims employ the term “about” to characterize each end of the range. The term “about” is not defined by the instant specification in any limiting fashion; the specification states: “The term ‘about’ generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.” As there is no evidence on the record to indicate that a combination of EO-PO polymers having the ranges disclosed by Nguyen-Kim would exhibit a function or result that is qualitatively different than the values recited in the instant claims, the examiner does not consider the ranges to patentably define over the combination of cited prior art, which teaches optimizing EO-PO content of poloxamers to achieve maximal aqueous solubility of poorly water soluble substances.
With regard to the limitation of instant claim 1 requiring a weight ratio for the first EO-PO copolymer component, the second EO-PO copolymer component, and the iodine compound of 1:1:1, the examiner notes that this corresponds to a 2:1 weight ratio of total EO-PO copolymer to iodine compound and Winicov teaches a ratio of (2-4.5):1. Therefore Winicov teaches a ratio of total EO-PO copolymer to iodine that includes the ratio recited in the instant claims, noting that Winicov also directs the artisan of ordinary skill to lower amounts of poloxamer (e.g. col 1, line 25, which describes low ratio of surfactant to iodine as desirable). As explained above, one having ordinary skill would have been motivated to combine poloxamers to achieve even better solubility at lower percentages of poloxamer following the suggestion of Winicov to use a mixture of poloxamers and the guidance of Nguyen-Kim on how to optimize the relative contributions of greater than one poloxamer for maximal solubilizing effect. The examiner does not consider the range in ratio of first EO-PO copolymer component, the second EO-PO copolymer component, and the iodine compound to patentably define over the cited prior art because this appears to have been routine optimization of a predictable property as of the instant effective filing date. Nguyen-Kim discloses a method of increasing solubilizing power of poloxamer surfactants by combining surfactants having different EO and PO content. It would have been a matter of routine for one of ordinary skill to optimize the relative and absolute quantity of each poloxamer (i.e. each EO-PO copolymer component) following Nguyen-Kim’s instruction to achieve a desired degree of iodine solubility while minimizing quantity of surfactant. The examiner points out that Winicov also discloses that poloxamers can be mixed to achieve a desired EO-PO content to increase iodine solubility/stability. Thus, Nguyen-Kim simply provides a detailed explanation of how to accomplish this.
Neither Winicov nor Nguyen-Kim disclose adding sodium xylene sulfonate to the composition, as required by instant claim 15.
Ofosu-Asante, in the analogous art of iodine disinfecting solutions, discloses that conventional hydrotropes can be added to iodine disinfectant solutions to improve solubility (col 10, lines15-16) and discloses a composition containing sodium xylene sulfonate (example 1, col 14).
Gambogi, in the analogous art of disinfecting compositions, discloses that sodium xylene sulfonate is a conventional hydrotrope (0039).
It would have been prima facie obvious to add a conventional hydrotrope such as sodium xylene sulfonate to Winicov’s composition because this merely represents combining prior art elements according to known methods to yield predictable results (see MPEP 2143(I)(A)). Specifically, sodium xylene sulfonate was a conventional ingredient to add to iodine disinfectant solutions to act as a hydrotrope, i.e. a substance that improves aqueous solubility of poorly water soluble substances. Predictably, the iodine would have been solubilized in the composition.
With regard to the limitation of instant claim 15 requiring that the composition is stable at temperatures from about 4C to about 50C, Winicov’s composition is intended to be stable at high and low temperatures (abstract) as low as 2C and as high as 40C (col 2, lines 1-5). Although the range targeted by Winicov is not identical to the range recited in the instant claims, the examiner considers it to have been prima facie obvious to adjust the amounts and identity of the poloxamer stabilizing agents in order to achieve maximal stability of the iodine, which is taught by the combined disclosures of Winicov and Nguyen-Kim because this is an objective in Winicov and because Nguyen-Kim and Winicov together establish that poloxamer combinations could reasonably be expected to solubilize iodine.
The relevant disclosures of Winicov, Nguyen-Kim, Ofosu-Asante, and Gambogi are set forth above.
None of these references disclose a step of washing the composition off of the teat prior to milking followed by re-applying the composition after milking as required by instant claims 15 and 16.
Kleine, in the analogous art of antimicrobial teat film-forming dips (title) discloses a method whereby the film forming antimicrobial composition is removed from the teat using an aqueous wash and the teat is treated again with the film forming antimicrobial composition after the milking has been completed (0081).
It would have been prima facie obvious to wash the iodine-containing teat dip composition disclosed by Winicov off the teat prior to milking and then reapply after milking. The skilled artisan would have been motivated to remove the composition to avoid contamination of the milk with iodine or other ingredients of the film forming antimicrobial composition and would have been motivated to reapply the composition in order to provide continued protection to the teat. The skilled artisan would have had reasonable expectation of success because Winicov’s compositions are soluble in aqueous media and therefore should dissolve rapidly in an aqueous wash.
With regard to claim 18, as noted above the ranges disclosed by Nguyen-Kim overlap with the range in molecular weights of the first EO-PO copolymer components recited in the instant claims and are close to the ranges for the second EO-PO copolymer. The relative amounts of EO-PO present in two different EO-PO polymers was a known parameter to optimize in order to improve solubility of a poorly water soluble compound while minimizing total amount of EO-PO surfactant present. The examiner considers optimizing the EO-PO content to have been routine for the artisan of ordinary skill.
With regard to claim 19, Winicov discloses iodine and sodium iodide (col 4, line 21).
With regard to claim 21, Ofosu-Asante discloses an example having 4.75 % wt. sodium xylene sulfonate (example 1, col 13). This amount of hydrotrope falls within the scope of the range recited in the instant claims and also solubilizes iodine in Ofosu-Asante’s composition. This information would have given one of ordinary skill in the art a starting point to optimize the quantity of hydrotrope required to achieve the desired amount of iodine solubility in Winicov’s composition. See MPEP 2144.05.
With regard to claims 23 and 24, the example compositions disclosed by Winicov contain glycerin, which is an emollient according to the instant invention (col 6, line 8).
With regard to claim 25, the example compositions contain about 1% available iodine (col 6, line 6).
With regard to claims 28 and 29, Nguyen-Kim teaches optimizing the EO AND PO content to provide synergistic solubilization efficacy, therefore arriving at an optimal number would have been a matter of routine for one of ordinary skill.
With regard to claim 30, poloxamers are EO-PO-EO polymers by definition and as described by Nguyen-Kim (abstract).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Winicov (US 5,368,868; issue date: 11/29/1994; cited in the IDS filed 03/10/2022) in view of Nguyen-Kim et al. (US 2016/0074517; publication date: 03/17/2016; of record), Ofosu-Asante et al. (US 6,387,856; issue date: 05/14/2002; of record), Gambogi et al. (US 2006/0183653; publication date 08/17/2006; of record), and Kleine et al. (US 2018/0177189; publication date: 06/28/2018; of record) as applied to claims 15, 16, 18, 19, 21, 23-25, and 28-30 above, and further in view of Kessler (US 2001/0056127; publication date: 12/27/2001).
With regard to claim 20, as noted above, Winicov discloses that thickeners (i.e. rheology modifying agents) are routinely added to teat dip compositions and mentions xanthates and celluloses, but Winicov does not disclose the specific rheology modifiers listed in instant claim 20.
Kessler discloses that xanthan gum, alkoxycelluloses, and guar gum are all known as of the instant effective filing date to function as thickening agents (i.e. rheology modifiers; 0032) for topical iodine disinfecting solutions (abstract).
It would have been prima facie obvious to use guar gum as the thickening agent (i.e. rheology modifier) in Winicov’s composition because one having ordinary skill would have recognized it to fall within the genera disclosed by Winicov and suitable based upon Kessler’s disclosure noted above. See MPEP 2144.07.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive.
On page 9, Applicant argues:
Winicov teaches that stable aqueous detergent-iodine compositions are formed when the detergent to iodine ratio is about 2:1 to about 4.5:1. Winicov at col. 1,11. 11-19. Winicov describes in the background section that existing detergent-iodine formulations have high detergent to iodine ratios of about 5:1, 7.5:1, or 8:1. Id. at col. 2, 11. 47-57. The purpose of Winicov is to produce a stable formulation that has a lower detergent to iodine ratio. Id. at col. 3, 11. 39-46. The lower detergent to iodine ratio described in Winicov is about 2:1 to about 4.5:1. While this ratio is lower than the ratios Winicov describes in the background, the formulations of Winicov still include, at a minimum, double the amount of detergent relative to the amount of iodine in the formulations.
On page 10, Applicant argues that Winicov does not teach a 1:1 ratio between detergent and iodine and that Winicov teaches the relatively low poloxamer to iodine ration of 2:1 to 4.5:1 provides the desired stable results with poloxamers having molecular weights of 2500 to 4000 Da. Finally, on page 10, Applicant argues that Winicov does not teach the claimed ratio of 1:1:1.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a 1:1 ratio of poloxamer to iodine) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Respectfully, the instant claims require a 1:1:1 ratio of first EO-PO copolymer:second EO-PO copolymer: iodine. That is, 1 part poloxamer : 1 part poloxamer : 1 part iodine, for a ratio of total poloxamer to iodine of 2:1. The claims specify the ratio of the two different poloxamers to each other; however, Winicov teaches low quantities of poloxamer to be desirable, and teaches that greater than one poloxamer can be used to achieve optimal solubility. Although Winicov provides no further guidance as to optimizing the relative amounts of poloxamer, Nguyen teaches a method of maximizing solubilizing effect of poloxamer combinations. The examiner considers the claimed range in ratio of the two claimed EO-PO copolymers to have been reasonably achievable by optimizing art-recognized variables, with the direction from Winicov to minimize surfactant concentration. The range in ratio of poloxamer to iodine taught by Winicov embraces the claimed ratio, Winicov directs one of ordinary skill to seek low amounts of poloxamer and to use a combination of poloxamers, and Nguyen provides a method of combining poloxamers to achieve improved solubility. See MPEP 2133.05(II):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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, 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%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.")
On page 9, Applicant argues that Winicov does not disclose poloxamers of two molecular weight ranges as in claim 15, only poloxamers within the molecular weight range of 2600-4000 Da.
The examiner notes that in this case, Winicov teaches combining poloxamers to achieve a target EO to PO ratio, and otherwise was not relied upon to establish the obviousness of the particular amounts of the two poloxamers. Nguyen-Kim lays out a detailed method to optimize the solubilizing power of combinations of poloxamer surfactants. 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).
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.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617