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 .
Election/Restrictions
Applicant' s arguments, filed 01/30/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 01/30/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 13, 15-16, 20, 23 and 60 have been amended.
Claims 1-3, 5-11, 13-16, 20-21, 23-24, 26-29, and 60 are the current claims hereby under examination.
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 14 and 24 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.
Regarding claim 14, the claim recites the limitation "the matrix material" in line 1. It is unclear which of the one or more water soluble matrix materials “the matrix material” refers to. Clarification is requested.
For the purposes of examination, “the matrix material” is interpreted as “the one or more water soluble matrix materials”.
Regarding claim 24, a similar recitation is found in line 1 of claim 24. Claim 24 is rendered indefinite for the same reasons as claim 14, and the phrase “the matrix material” is interpreted similarly.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 20-21, 23-24, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2005/0049549 by Wong et al. – previously cited, hereinafter “Wong”.
Regarding claims 20-21, Fig. 5 of Wong teaches a microneedle patch (microprojection array 60B) for use in diagnosis of cystic fibrosis in a patient comprising:
a support layer (thin sheet 61); and
an array of dissolvable microneedles extending from the support layer ([0118-01120]; The dissolvable microneedles comprise the biocompatible coating on the microprojections (62, 64, etc.). The coating takes on the shape of the projection and is configured to dissolve (i.e., needle)),
wherein the microneedle patch is configured for application to a patient’s skin ([0020, 0118]; microprojection patch is configured to be inserted into the skin) and the dissolvable microneedles comprise a cholinergic agonist, wherein the cholinergic agonist comprises pilocarpine ([0020, 0147]; The coating comprises an agent. The agent may comprise pilocarpine to enhance the production of sweat for cystic fibrosis testing),
wherein the cholinergic agent is dispersed in one or more water-soluble matrix materials which form the structures of the dissolvable microneedles, and wherein the cholinergic agent comprises pilocarpine ([0020, 0029-0034]; The coating formulation may comprise a buffer, a surfactant, a polymeric material, a hydrophilic polymer, a biocompatible carrier, and/or a stabilizing agent. The coating preferably has sufficient water solubility such that the he coating is easily and quickly dissolved. [0117-0120]; The coating may be on all sides of the projections, conforming to the shape of the projection. A depiction of this is shown in Fig. 2. This shows that the coating mimics the structure of the microneedles, thereby forming the structure of the dissolvable microneedles. [0147]; The agent contained in the coating can be pilocarpine for the production of sweat for cystic fibrosis testing.).
Regarding claims 23-24, Wong teaches the microneedle patch of claim 20, wherein the matrix materials comprises a poly(vinyl alcohol) (PVA), a disaccharide, or a combination thereof; and wherein the matrix material comprises PVA and sucrose ([0032-0034, 0099]; the coating may comprise at least one a hydrophilic polymer such as PVA, a biocompatible carrier, and a stabilizing agent such as a disaccharide or sucrose ([0034, 0099])).
Regarding claim 27, Wong teaches the microneedle patch of claim 20, wherein each of the microneedles has a base end (Fig. 5, the end close to the thin sheet 61) and an opposing tip end (Fig. 5, the end near the apex of the microprojection), and wherein the microneedle patch further comprises base pedestals between and connecting the support layer and each of the microneedles (The microprojection can be considered the base pedestal as is connects the coating and the support layer and is between the coating and the support layer.).
Claim Rejections - 35 USC § 103
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.
Claims 1, 3, 5-11, 13-16, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Australian Guidelines for the Performance for the Performance of the Sweat Test for the Diagnosis of Cystic Fibrosis (2006) by Coakley et al., hereinafter “Coakley” – previously cited, in view of Wong.
Regarding claims 1 and 16, Coakley teaches a method of diagnosis of cystic fibrosis in a patient (Introduction, sweat test for the diagnosis of cystic fibrosis (CF)), comprising: applying a patch (Sweat Stimulation and Collection; pads under the electrodes), to the skin of the patient; releasing the pilocarpine into the skin in an amount effective to induce secretion of sweat from the skin (Sweat Stimulation and Collection; Sweat for measurement is collected by pilocarpine iontophoresis); collecting a volume of the sweat secreted from the skin (Sweat Stimulation and Collection; Sweat can be collected with filter paper or gauze pads); and analyzing the collected sweat for an analyte indicative of cystic fibrosis, wherein the analyzing comprises measuring the chloride concentration in the collected sweat (Methods of Analysis and Reference Intervals, Interpretation and Reporting; The sweat is then analyzed for chloride to support the diagnosis of CF).
Coakley does not teach the patch being a microneedle patch which comprises dissolvable microneedles which comprise pilocarpine, to the skin of the patient effective to cause the microneedles to penetrate across the epidermis and into the dermis.
Fig. 5 of Wong teaches a microneedle patch (microprojection array 60B) for use in diagnosis of cystic fibrosis in a patient comprising an array of dissolvable microneedles ([0118-01120], The dissolvable microneedles comprise the biocompatible coating on the microprojections (62, 64, etc.). The coating takes on the shape of the projection and is configured to dissolve (i.e., needle)). The microneedle patch is configured for application to a patient’s skin ([0020, 0118], microprojection patch is configured to be inserted into the skin) and the dissolvable microneedles comprise pilocarpine ([0020, 0147], The coating comprises an agent. The agent may comprise pilocarpine to enhance the production of sweat for cystic fibrosis testing).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Coakley such that the applying step comprises applying a microneedle patch which comprises dissolvable microneedles which comprise pilocarpine, to the skin of the patient effective to cause the microneedles to penetrate across the epidermis and into the dermis. Applying the microneedle patch instead of using iontophoresis is another way to deliver pilocarpine to enhance the production of sweat for cystic fibrosis testing, as taught by Wong ([0147]). Therefore, this combination would merely comprise simple substitution of one known element to another to obtain predictable results. See MPEP 2143.I.B. Further, Wong teaches that the transport of agents through a body surface can be completed with electrotransport (including iontophoresis [0006]) or transdermally by delivering a biologically active agent using a microprojection array having a plurality of microprojections (i.e., microneedle. [0020]).
Regarding claim 3, Coakley in view of Wong teaches the method of claim 1, further comprising removing the microneedle patch from the skin after a period of time effective to release the pilocarpine from the microneedle patch into the patient’s skin. The method of Coakley comprises removing the electrodes and corresponding pads after the current has been maintained for no more than 5 minutes (effective to release the pilocarpine into the skin) such that the sweat collection can be performed over the area (Coakley, Sweat Stimulation and Collection). However, the substitution of the microneedle patch of Wong for the iontophoresis patch would require the patch to remain inserted into the skin for a period of time for the coating to dissolve (i.e., release the pilocarpine into the skin). Wong teaches that the coating has sufficient water solubility such that when the microprojections are disposed within the patient's tissue the coating is easily and quickly dissolved, thereby releasing the biologically active agent ([0020]). The time necessary to easily and quickly dissolve the coating is a period of time.
Regarding claim 5, Coakley in view of Wong teaches the method of claim 3, but does not teach wherein the period is between 1 second and 15 minutes. However, where the general conditions of a claim are disclosed in the prior art ([0020] of Wong teaches that the coating is easily and quickly dissolved, thereby defining the time period as “quick”), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed time period. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum time period of the method taught by Coakley in view of Wong.
Regarding claim 6, Coakley in view of Wong teaches the method of claim 1, further comprising removing the microneedle patch from the skin in a manner effective to separate the microneedles from a support layer of the microneedle patch, the separated microneedles remaining in the patient’s skin and dissolving to release the pilocarpine. The method of Coakley in view of Wong comprises removing the microneedle patch in order to collect the sweat from the area. The microneedles are comprised of the coating on the exterior of the microprojections, and they are quickly and easily dissolved in the patient’s tissue (Wong, [0020]). This comprises a separation of the microneedles (i.e., coating) from the microprojections and the support layer (the microprojections are connected to the support layer), and the separated microneedles remain in the patient’s skin and dissolved to release the pilocarpine.
Regarding claim 7, Coakley in view of Wong teaches the method of claim 1, but does not teach wherein at least 250 µg of pilocarpine is delivered per cm2 of skin. However, where the general conditions of a claim are disclosed in the prior art ([0075] of Wong discloses that the amount of active agent employed in the coatings of the invention will be that amount necessary to deliver a therapeutically effective amount of the active agent to achieve the desired therapeutic result.), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed pilocarpine delivered per cm2 of skin. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum pilocarpine delivered per cm2 of skin of the method taught by Coakley in view of Wong.
Regarding claim 8, Coakley in view of Wong teaches the method of claim 1, wherein the collecting of the sweat comprises applying an absorbent material to the skin (Coakley, Sweat Stimulation and Collection; Rinsed gauze pads or filter paper can be used to collect the sweat. Both items are absorbent materials.) or by positioning a collection tube at the skin surface to permit sweat to be drawn into a bore in the tube by capillary action.
Regarding claim 9, Coakley in view of Wong teaches the method of claim 1, wherein the volume of sweat collected is at least 15 µl (Coakley, Sweat Stimulation and Collection; A sweat test cannot be performed if <0.075 g of sweat is obtained using the Gibson Cooke method. 0.075g of sweat is approximately equal to 75 µl of sweat (assuming the density of water), which is at least 15 µl).
Regarding claim 10, Coakley in view of Wong teaches the method of claim 9, wherein the sweat collected per area of skin into which the pilocarpine is released is at least 2.6 µl per cm2 (Coakley, Sweat Stimulation and Collection; The minimum sweat secretion rate should not be less than 1g/m2/min over the collection period. This rate amounts to 100 µg/cm2/min. Coakley teaches that the collection time is no less than 20 minutes, therefore the minimum sweat secretion should be 2000 µg/cm2, which approximately equal to 2000 µl/cm2 (assuming the density of water)).
Regarding claim 11, Coakley in view of Wong teaches the method of claim 1, wherein the microneedle patch comprises a support layer from which an array of the microneedles extend (Wong; The microneedles extend from the thin sheet 61).
Regarding claims 13-14, Coakley in view of Wong teaches the method of claim 11, wherein the one or more water-soluble matrix materials comprise a poly(vinyl alcohol) (PVA), a disaccharide, or a combination thereof, and wherein the matrix material comprises PVA and sucrose (Wong; The coating may comprise at least one a hydrophilic polymer such as PVA ([0032]), a biocompatible carrier ([0033]), and a stabilizing agent such as a disaccharide or sucrose ([0034, 0099]). The matrix is soluble in water/interstitial fluid to release the agent (i.e. pilocarpine) (Wong, [0020])).
Regarding claim 15, Coakley in view of Wong teaches the method of claim 12, wherein the pilocarpine is in the form of pilocarpine nitrate (Coakley, Sweat Stimulation and Collection, par. 5, the electrolyte solution to be introduced is pilocarpine in the form of pilocarpine nitrate. Therefore, the solution (i.e., agent) to be introduced in the combination of Coakley and Wong can be pilocarpine nitrate) but does not teach wherein the microneedles comprise from 30% to 50% by weight pilocarpine nitrate. However, where the general conditions of a claim are disclosed in the prior art ([0075] of Wong discloses that the amount of active agent employed in the coatings of the invention will be that amount necessary to deliver a therapeutically effective amount of the active agent to achieve the desired therapeutic result.), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed pilocarpine weight percentage. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum pilocarpine weight percentage of the microneedles taught by Coakley in view of Wong.
Regarding claim 60, Coakley in view of Wong teaches the method of claim 1, wherein the microneedles comprise from 30% to 50% by weight pilocarpine (See the rejection of claim 15), wherein the volume of sweat collected is a least 15 µl (See the rejection of claim 9) and wherein the sweat collected per area of skin into which the pilocarpine is released is at least 2.6 µl per cm2 (See the rejection of claim 10).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Coakley in view of Wong, as applied to claim 1, in view of US Patent Publication 2016/0038068 by Chickering III et al. – previously cited, hereinafter “Chickering”.
Regarding claim 2, Coakley in view of Wong teaches the method of claim 1, but does not teach wherein the applying a microneedle patch comprises manually pressing the microneedle patch against the patient’s skin.
Fig. 10 of Chickering teaches a method of inserting an array of microneedles into the skin by manually pressing the patch against the skin.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Coakley in view of Wong such that applying a microneedle patch comprises manually pressing the microneedle patch against the patient’s skin, as taught by Fig. 10 of Chickering. It is noted that Wong teaches that the microneedle patch is configured to be inserted into the skin ([0020, 0118]; microprojection patch is configured to be inserted into the skin). Manually pressing the patch against the skin would comprise combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A. Also, such manual pressing would improve the chances for coupling between patch and the skin.
Claims 26 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wong, as applied to claims 20 and 27.
Regarding claim 26, Wong teaches the microneedle patch of claim 20, wherein the microneedles have a length less than 1000 µm ([0130]; “Preferably, the microprojections 62, 64, 72, 74 have a length less than approximately 1000 microns”. As the coating covers the microprojections, the coating has the same dimensions as the microprojections plus a thickness of less than 100 µm). Wong does not teach that the microneedles have a height of at least 500 µm. However, where the general conditions of a claim are disclosed in the prior art ([0130] of Wong discloses a preferable length of the microneedles and therefore the coating), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed microneedle range. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum microneedle height of the patch taught by Wong. Additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04 citing In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Regarding claim 28, Wong teaches the microneedle patch of claim 27, wherein the base pedestals have a height ([0130]; “Preferably, the microprojections 62, 64, 72, 74 have a length less than approximately 1000 microns, more preferably, less than approximately 500 microns.”) Wong does not teach that the base pedestals have a height between 200 µm and 800 µm. However, where the general conditions of a claim are disclosed in the prior art ([0130] of Wong discloses a preferable height of the microprojections (i.e., base pedestals)), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed base pedestal range. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum base pedestal height of the patch taught by Wong. Additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04 citing In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)).
Regarding claim 29, Wong teaches the microneedle patch of claim 20, but does not teach wherein the microneedles comprise from 30% to 50% by weight pilocarpine nitrate, wherein the microneedle patch is configured to deliver at least 250 ug of pilocarpine per cm2 of patient’s skin. However, where the general conditions of a claim are disclosed in the prior art ([0075] of Wong discloses that the amount of active agent employed in the coatings of the invention will be that amount necessary to deliver a therapeutically effective amount of the active agent to achieve the desired therapeutic result.), 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). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed pilocarpine weight percentage and pilocarpine delivered per cm2 of skin. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum pilocarpine weight percentage and pilocarpine delivered per cm2 of skin of the microneedles taught by Wong.
Response to Arguments
Applicant’s arguments, filed 01/30/2026 have been fully considered.
The amendments to claims 2 and 60 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claim 16.
Applicant’s arguments and assertions regarding the rejection of claim 20 under 35 U.S.C. 102 are acknowledged. The assertion regarding that the microneedles, as claimed, are formed of a water-soluble matrix comprising the active agent, and the microneedles of Wong are not formed of a water-soluble matrix comprising the active agent is not found persuasive. The rejection of claim 20 defines the coating of the microprojections of Wong as the microneedles, which are formed of the water-soluble matrix comprising the active agent. Applicant’s arguments that Wong teaches internally coated microneedles are not found persuasive. Applicant’s arguments are drawn to Fig. 3A, and microprojection 20. This embodiment is different than that of Fig. 5, wherein Wong recites in pars. [0118] and [0120] that both the inside face and outside face of microprojections 62 and 64 are coated with the coating. Fig. 2 is another embodiment showing the coating on all sides of a planar microprojection, similar to that of Fig. 5.
Applicant’s arguments and assertions regarding the rejection under 35 U.S.C. 103 are acknowledged. Applicant’s arguments that Coakley teaches standardizing existing, validated laboratory practices rather than introducing novel, experimental technologies is not found persuasive. Coakley teaches guidelines that govern the most reliable methods for collecting sweat with via iontophoresis. Coakley teaches important details that must be followed in order to obtain accurate results based on the NCCLS and UK guidelines, however, Coakley does not suggest that the only reliable ways of obtaining sweat are using iontophoresis. The substitution of delivering the pilocarpine with microneedles instead of via iontophoresis does not interfere with the goal of Coakley of providing additional guidelines for the analysis of sweat from a sweat test, as one of ordinary skill in the art would be capable of using another method of inducing sweating while adhering to the guidelines for the amount of sweat to be collected, the amount of time in which to collect sweat, and the methods for analyzing the sweat. Said another way, Coakley does not constitute teaching away from combination with Wong because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed. Further, a person of ordinary skill in the art is also a person of ordinary creativity, not an automaton and wwould be able to fit the teachings of multiple patents together like pieces of a puzzle (see MPEP 2141.03), and as such, one of ordinary skill would understand the purpose of Coakley use of lab procedure is to standardize the testing. Accordingly, one of ordinary skill in the art at the time of filing would recognize that you could substitute a step or method of the procedure as long as long as the procedure could be standardized to provide a reproducible procedure to provide testable results.
While Coakley teaches using the iontophoresis method to deliver pilocarpine to the skin, the principal mode of operation is considered to be delivering the pilocarpine to the skin and analyzing the sweat received. Wong teaches that “The agent contained in the coating could be one that enhances production of a desired material, such as pilocarpine to enhance the production of sweat for cystic fibrosis testing” in par. [0147]. This recitation teaches that the invention of Wong is suitable to be used for delivering pilocarpine to induce sweating for cystic fibrosis testing. While Wong does not teach experimental evidence into the efficacy of this application, the teaching does indicate that the use of the microneedles to induce sweating via the application of pilocarpine is a positively recited application of this invention. Therefore, it would have been obvious to one of ordinary skill in the art to have used the invention of Wong for the purpose of inducing sweating via the application of pilocarpine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791