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 .
This office action is in regard to the application filed on November 10, 2021 and in response to Applicant’s Amendments and Arguments/Remarks filed on February 4, 2026.
Status of Application
The amendment filed February 4, 2026 has been entered. Claims 1, 2, 4-10, and 12-21 are currently pending in the application. Claims 1 and 9 have been amended; claims 3 and 11 have been canceled; claim 21 is new. Claims 1, 2, 4-10, and 12-21 are hereby examined on the merits.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1 recites adjusting the pH value “in advance before the ultrasonic treatment” in lines 6-7. It is redundant to recite both “in advance” and “before;” please select one or the other.
Claim 9 has two commas after the first iteration of “dispersion” in line 12.
Appropriate correction is required.
Claim Interpretation
Claim 9 recites the phrase “room temperature” without defining the term. The instant specification gives examples wherein room temperature is 25°C (Examples 1-2, pp. 5-6). However, “room temperature” as recited in claim 9 will be interpreted as a temperature range of 20-27 °C to account for variations of how people of ordinary skill in the art would consider a temperature to be “room temperature.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 15, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 13, 15, and 18 are rejected as being dependent on a canceled claim, claim 3. For the purposes of examination, the claims will each be interpreted as being dependent on claim 1.
It is noted however, if the dependency of each claim was amended to be dependent on claim 1, there would be further potential issues as claims 13, 15, and 18 would be exact duplicates of claims 4, 5, and 6, respectively.
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, 2, 4, 5, 7-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109511745, using US PG Pub 2021/0360940 as the English language equivalent; both cited on PTO-892 dated June 20, 2024) in view of Benetti et al. (“SPI microgels applied to Pickering stabilization of O/W emulsions by ultrasound and high-pressure homogenization: rheology and spray drying.” Food Research International, vol. 122, pp. 383-391, August 2019; cited on PTO-892 dated June 20, 2024) and Wang et al. (US PG Pub 2020/0170279; cited on PTO-892 dated June 20, 2024), herein after referred to as Wang, Benetti, and Wang ‘279, respectively.
Regarding claims 1 and 10, Wang discloses a preparation method of a Pickering emulsion (claim 1; [0040]; [0045]) comprising:
(1) preparing a peanut protein isolate dispersion by stirring a peanut protein isolate solution and hydrating the solution (i.e., peanut protein isolate and water as raw materials) [0041];
(2) adding a transglutaminase to the peanut protein dispersion and performing a crosslinking reaction to obtain a monolithic gel (i.e., subjecting the resultant to crosslinking reaction with transglutaminase to obtain a monolithic gel) [0042];
(3) adding water to the monolithic gel, shearing and homogenizing the monolithic gel to obtain a coarse dispersion of microgel particles (i.e., a crude microgel particle dispersion), then subjecting the gel to an ultrasonic treatment to obtain a microgel particle dispersion ([0043], claim 1 step(a)), wherein the ultrasonic treatment is performed at 210 W for 15 minutes [0043].
The ultrasonic treatment taught by Wang lies within the claimed ranges of 100-500 W and 10-40 minutes.
Wang does not teach spray drying the microgel particle dispersion to obtain the Pickering dry powder and thereby also does not teach explicitly a preparation method of a Pickering particle dry powder.
Benetti, in the same field of invention, teaches production of soy protein isolate microgels which are spray dried after shearing and homogenizing steps (2.2.1., 2.2.3., 2.2.5.). Benetti teaches that these microgels are emulsified with oil to create Pickering emulsions then the emulsions are dried by means of spray drying in order to obtain a powder (i.e., a Pickering particle dry powder) (2.2.3., para. 5 under Introduction). Benetti offers the motivation that drying the emulsion protects oil droplets entrapped into dry matrices against oxidation and degradation, increases the shelf life, and allows for easy transportation and storage (para. 5 under Introduction). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method steps of Wang by incorporating the spray drying step of Benetti. One would have been motivated to make this modification for the benefit of mitigating oxidation and degradation, increasing shelf life, and allowing for easy transportation and storage of a Pickering emulsion.
Wang also does not teach that maltodextrin is added to the crude microgel particle dispersion in step 3.
However, Benetti teaches that maltodextrin can be added to emulsions prior to spray drying. Benetti offers the motivation that maltodextrin is an agent widely used in spray-drying processes in order to easily spray dry an emulsion (para. 5 under Introduction). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have added the maltodextrin of Benetti to the method of Wang and Benetti. One would have been motivated to make this modification for the benefit of feasibly completing the spray drying process.
Wang and Benetti are silent as to that the pH value of the peanut protein isolate dispersion is adjusted to 6.3 to 8.1 before the ultrasonic treatment of the peanut protein isolate dispersion.
Wang ‘279, in the same field of invention, teaches a peanut protein isolate dispersion wherein the pH is adjusted to 6.3 prior to the addition of transglutaminase for a crosslinking reaction [0043], as well as that the peanut protein isolate dispersion is adjusted to a pH within a range of 6.3 to 7.9 [0022]. This pH and pH range lies within the claimed range of 6.3 to 8.1.
Wang ‘279 offers the motivation that the pH range of 6.3 to 7.9 is beneficial to achievement of the crosslinking reaction in the presence of transglutaminase [0022]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated the pH adjustment step at the taught range into the method of modified Wang. One would have been motivated to make this modification for the benefit of ensuring the completion of the crosslinking reaction with transglutaminase.
Wang ‘279 does not teach an ultrasonic treatment step and thus does not explicitly teach that the pH of the dispersion is adjusted prior to ultrasonic treatment. However, where Wang teaches that the crosslinking reaction occurs prior to the ultrasonic treatment (as set forth above) and where Wang ‘279 teaches that the pH adjustment is performed prior to the crosslinking reaction (Wang ‘279: [0043]), incorporating the pH adjustment step of Wang ‘279 into the method of Wang prior to the crosslinking reaction step would necessarily adjust the pH prior to the ultrasonic treatment step.
Furthermore, subjecting a dispersion to ultrasonic treatment does not affect the pH of the dispersion and as such, the pH of the dispersion will remain the same before and after ultrasonic treatment.
Wang, Benetti, and Wang ‘279 do not explicitly teach the exact order of the claimed process steps. Namely, the ultrasonic treatment taught by Wang occurs after the shearing and homogenizing step, while the claimed method performs the ultrasonic treatment directly after the step of obtaining the peanut protein isolate dispersion; the maltodextrin taught by Benetti is added prior to the spray drying step (para. 5 under Introduction), while the claimed method adds the maltodextrin prior to the homogenization step. In the instant claim, the homogenization step occurs prior to the spray drying step. However, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946). See MPEP 2144.04.IV.C. Therefore, the method steps of Wang, Benetti, and Wang ‘279 read on the method steps of the instant claim.
Regarding claim 2, Wang teaches that in the first step, the peanut protein isolate dispersion has a mass concentration of 17% [0041], which lies within the claimed mass concentration range of 5 to 30%.
Regarding claims 4, 12, and 13, Wang teaches that in the crosslinking reaction step, the additional amount of transglutaminase is 12 to 40 U/g peanut protein isolate (i.e., U/g of transglutaminase based on the mass of the peanut protein isolate added to the cross-linking reaction) (claim 3). This range lies within the claimed range of 10 to 50 U/g.
Regarding claims 5 and 14-16, Wang teaches that in the shearing and homogenizing step, the shearing is performed at a speed of 10,000 rpm for 30-120 seconds (claim 9 step (c)). This rpm lies within the claimed range of 6,000-12,000 rpm and the time range is identical to the claimed time range of 30-120 seconds.
Regarding claim 7, Wang ‘279 further teaches a microgel particle dispersion added to edible oil wherein the mass particle concentration is 0.1-2% at an oil phase mass fraction of 10-90% ([0013], [0026]). Taking the mass particle concentration of only the microgel particle dispersion (i.e., calculating the mass particle concentration without the oil phase at the taught ranges) gives a low mass concentration of 0.11% (mass particle concentration of 0.1% at an oil phase mass fraction of 10%) and a high mass concentration of 20% (mass particle concentration of 2% at an oil phase mass fraction of 90%). This range encompasses the claimed mass concentration range of 3 to 15%. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Wang ‘279 offers the motivation that concentrations at these levels are beneficial to the stability of the final emulsions [0026]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the microgel particle dispersion of Wang to have the mass concentration of Wang ‘279, thereby arriving at the claimed invention with the reasonable expectation that the taught ranges ensures stability of the emulsions.
Regarding claim 8, Benetti further teaches that in the spray drying step, the inlet temperature of the spray drying is 150-170°C, the feed rate (i.e., injection amount) is 3 mL/min, and the atomization air rate (i.e., fan delivery) is 742 L/h (2.2.5. Emulsion spray drying; Table 2). The taught inlet temperature range lies inside the claimed range of 135-225 °C, while the taught feed rate and air rate lie outside of the respective claimed ranges of 4-50 mL/min and 25-35 m3/h.
However, 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, 456, 105 USPQ 233, 235 (CCPA 1955). Since both feed rate and air rate are known variables/parameters that affect spray drying processes and results thereof, these are both result-effective variables. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range through no more than routine optimization, as varying feed rate and air rate would achieve recognized results. See MPEP 2144.05.II. Thus, the parameters of spray drying taught by Benetti renders obvious the instant claim limitations.
Regarding claim 9, modified Wang teaches the preparation method as set forth above with regard to claim 1.
Wang further teaches:
in said (1), mixing by stirring a peanut protein isolate solution (i.e., peanut protein isolate and water) having a mass concentration of 17%, then refrigerating (i.e., temperature of 3-4 °C) the solution overnight (i.e., 8-10 hours) to hydrate the solution to obtain a peanut protein isolate dispersion [0041];
in said (2), adding transglutaminase to the dispersion and performing a crosslinking reaction at 42°C to obtain a monolithic gel [0042];
in said (3), shearing the monolithic gel at 10,000 rpm for 30 seconds to obtain a microgel particle coarse dispersion (i.e., a crude microgel particle dispersion) [0043] and homogenizing the dispersion at 1,100-1,200 bar for 1-2 minutes to obtain a microgel particle dispersion ([0043]; [0058]).
The homogenization time taught by Wang overlaps with the claimed range of 2-5 minutes, and where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I
Wang and Benetti do not explicitly teach hydrating the peanut protein isolate with water at 3-5 °C for 1-18 hours.
However, Wang ‘279 teaches preparing a peanut protein isolate solution (i.e., peanut protein isolate and water) and refrigerating the solution at 1-10 °C for 12-16 hours. The time lies within the claimed range of 1-18 hours and the temperature range encompasses the claimed range of 3-5 °C. Where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.I.
Wang ‘279 offers the motivation that refrigerating at this temperature and time will fully hydrate the protein so as to obtain a peanut protein isolate dispersion. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have performed the stirring step of Wang at the temperature and time of Wang ‘279, thereby arriving at the claimed invention. One would have been motivated to make this modification for the benefit of fully hydrating the solution to obtain a peanut protein isolate dispersion.
Modified Wang is silent as to stirring the peanut protein isolate solution at room temperature at 200 to 1,250 rpm for 0.5-4 hours. Wang does teach “fully” stirring the peanut protein isolate solution [0056]. Modified Wang is also silent as to that the crosslinking reaction is performed for 1-4 hours.
However, 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, 456, 105 USPQ 233, 235 (CCPA 1955). Regarding temperature, stirring speed, and stirring time, since these are all known variables/parameters that affect mixing processes and results thereof, these are all result-effective variables. Regarding reaction time, since reaction time is a known variable/parameter that affect reactions and results thereof, reaction time is a result-effective variable. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range through no more than routine optimization, as varying temperature, stirring speed, stirring time, and reaction time would achieve recognized results. See MPEP 2144.05.II. Thus, the stirring and crosslinking reaction steps taught by modified Wang renders obvious the instant claim limitations.
Claims 6 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109511745, using US PG Pub 2021/0360940 as the English language equivalent) in view of Benetti et al. (“SPI microgels applied to Pickering stabilization of O/W emulsions by ultrasound and high-pressure homogenization: rheology and spray drying.” Food Research International, vol. 122, pp. 383-391, August 2019) and Wang et al. (US PG Pub 2020/0170279; cited on PTO-892 dated June 20, 2024), as applied to claims 1, 2, 4, and 5 above, and further in view of Miller et al. (CA 2792396; cited on PTO-892 dated June 20, 2024), herein after referred to as Miller.
Modified Wang teaches the preparation method as set forth above with regard to claims 1, 2, 4, and 5.
Regarding claims 6 and 17-20, modified Wang teaches that maltodextrin (i.e., an agent) is added in step 3, as set forth above with regard to claims 1, 2, 4, and 5.
Since maltodextrin is an agent, and as established by the rejections of claims 1, 2, 4, and 5, modified Wang teaches that the homogenization is performed with an agent, wherein the agent is added into a crude dispersion of microgel particles obtained by said shearing, and then the resultant is homogenized, wherein the agent is maltodextrin.
Modified Wang is silent as to that the amount of the maltodextrin added in step 3 is 0.5-10% by mass based on the amount of the peanut protein isolate.
Miller, in the same field of invention, teaches spray drying Pickering emulsions with maltodextrin, wherein the amount of maltodextrin in the composition prior to spray drying is 8.5% by mass (Example 14: [00263]), which lies within the claimed range of 0.5-10% by mass.
Miller teaches suitable amounts of maltodextrin for spray drying protein compositions where modified Wang is silent, thereby offering a guideline as to suitable amounts of each. Therefore, where spray drying protein concentrations with maltodextrin is known, it would have been obvious to one of ordinary skill in the art, to have modified the method of modified Wang to have the amount of maltodextrin of Miller, thereby arriving at the claimed invention, with the reasonable expectation that the amount is suitable for use in the claimed method and composition.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109511745, using US PG Pub 2021/0360940 as the English language equivalent) in view of Benetti et al. (“SPI microgels applied to Pickering stabilization of O/W emulsions by ultrasound and high-pressure homogenization: rheology and spray drying.” Food Research International, vol. 122, pp. 383-391, August 2019) and Wang et al. (US PG Pub 2020/0170279; cited on PTO-892 dated June 20, 2024), as applied to claim 1 above, and further in view of Zhang et al. (“A Novel Solid Nanocrystals Self-Stabilized Pickering Emulsion Prepared by Spray-Drying with Hydroxypropyl-β-cyclodextrin as Carriers;” Molecules; March 2021; 26, 1809), herein after referred to as Zhang.
Modified Wang teaches the preparation method as set forth above with regard to claim 1.
Modified Wang is silent as to that the agent further comprises lactose and mannitol.
Zhang, in the same field of invention, teaches Pickering emulsions prepared by spray drying an emulsion with maltodextrin, mannitol, lactose, and other carrying agents (p. 3, 2.3.1. Preparation of Solid NSSPE). Zhang also teaches that spray drying is a common method for preparing dry emulsions and that lactose, maltodextrin, and mannitol are all commonly used solid carriers in these spray drying processes (p. 2, second paragraph). Therefore, where modified Wang teaches spray drying the emulsion with maltodextrin as set forth above with regard to claim 1, and as it was known in the art to produce Pickering emulsions, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have added the additional agents as claimed to the maltodextrin, by modifying the method of modified Wang, as Zhang teaches that all of maltodextrin, lactose, and mannitol are known to be carrying agents in emulsions to be spray-dried.
Response to Amendment
The declaration under 37 CFR 1.132 filed February 4, 2026 is insufficient to overcome the rejection of claims 1-20 based upon a specific reference applied under 35 U.S.C. 103 as set forth in the last Office action because: the facts presented are not germane to the rejection at issue.
Declarant provides results from experiments that adjust the pH of the dispersion prior to the ultrasonic treatment and performing the ultrasonic treatment for a range of times. Declarant provides measurements of emulsification and emulsification stability as a function of ultrasonic treatment time at a pH of 7 (after pH adjustment). Declarant states that the emulsification index and emulsification stability index reached maximum value at 20 minutes of the ultrasonic treatment (Declaration, paragraphs 4-7).
These facts presented are not germane to the rejection at issue because the emulsification properties presented are based on the time of the ultrasonic treatment, not the pH adjustment, while the rejection at issue that needs to be overcome is the order of process steps related to the pH adjustment. Declarant has only shown results for the adjusted pH and not for the non-adjusted pH; Declarant has not shown how the emulsification properties change with the ultrasonic treatment of the dispersion when the pH is at the level pre-adjustment. In other words, Declarant needs to show the emulsification properties at both the non-adjusted pH and the adjusted pH in order to have a sufficient showing of improvement of emulsification properties.
The ultrasonic treatment time is not the rejection at issue because the prior art already teaches these times within the instantly claimed ranges. The prior art does not explicitly teach the claimed order of steps, specifically regarding the pH adjustment, ultrasonic treatment, and crosslinking reaction. The facts presented are not germane to these issues.
The instant specification states that the adjustment of the pH prior to ultrasonic treatment is “conducive to providing a milder environment, which is convenient for transglutaminase to keep high activity in the subsequent cross-linking reaction” (p. 3 lines 6-10). Thus, it seems the pH adjustment step is advantageous for the cross-linking reaction step, which Declarant has not provided any evidence or results for. Thus, to help overcome the rejection, a showing of evidence for how the cross-linking reaction step changes with and without pH adjustment, as well as with and without ultrasonic treatment would be beneficial. Ultrasonic treatment does not change the pH of the dispersion, so additional evidence as to why adjusting the pH prior to the ultrasonic treatment is critical/provides unexpected results would also be beneficial.
Declarant provides results for the effect of ultrasound time on the particle size (Declaration, paragraphs 8-9).
These facts presented are not germane to the rejection at issue because nowhere do the instant claims require specific particle sizes and thus the rejection does not address particle size.
Therefore, the declaration is insufficient to overcome the rejections of the instant claims.
Response to Arguments
Applicant's arguments filed February 4, 2026 have been fully considered but they are not persuasive.
The prior art rejection has been amended in light of applicant’s amendments to the claims, however, the essential prior art rejection has been maintained by the examiner for the following reasons.
Applicant argues that the prior art does not teach or suggest the amended claim limitation of claim 1. Applicant argues that the adjustment of the pH prior to ultrasonic treatment provides unexpected and advantageous results, as shown by the submitted Declaration, and that the prior art does not teach or suggest these alleged advantageous results (Remarks, p. 5-6).
This argument is not persuasive. As set forth above in the response to the declaration, there is insufficient evidence to overcome the rejections. The results provided by Applicant are not a sufficient showing of unexpected results or criticality.
Moreover, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
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.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791