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
Claim Objections
Claims 4, 5, 9, 11, 12, 14 and 16 are objected due to the following informalities:
In claim 5, lines 1-2, “wherein the trenches are formed downwards from the tips of the microneedle” should be removed since this is already recited claim 1.
In claim 9, line 3, “through holes” should be corrected to “through-holes” for grammatical correctness.
In claim 11, line 2, In claim 9, line 3, “through holes” should be corrected to “through-holes” for grammatical correctness.
In claim 12, lines 2-3, “intersecting each other by any angle” should be corrected to “intersecting each other at any angle” for grammatical correctness.
In claim 14, lines 3 and 4, “In claim 9, line 3, “through holes” should be corrected to “through-holes” for both occurrences for grammatical correctness.
In claim 16, lines 1-2, In claim 9, line 3, “through holes” should be corrected to “through-holes” for grammatical correctness.
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.
Claim(s) 10-11, 13 and 15-19 is/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.
Claim 10, lines 1-2 recites “adjacent medicine storage reservoirs”. Claim 10 depends on claim 9 however claim 9 does not recite “adjacent medicine storage reservoirs”. It is unclear if the Applicant intended for the “adjacent medicine storage reservoirs” of claim 10 to refer to the “medicine storage reservoirs” of claim 9, or introduce new medicine storage reservoirs in addition to the reservoirs in claim 9. For the sake of Examination, it is being interpreted that the “adjacent medicine storage reservoirs” of claim 10 is intended to refer to the “medicine storage reservoirs” of claim 9. Therefore, Applicant is suggested to amend claim 10 to recite “adjacent one of the medicine storage reservoirs” to overcome rejection.
Claim 11, lines 2-3 recites “the back side of the substrate”. Claim 11 depends on claim 1, however claim 1 does not recite “the back side of the substrate”. It is unclear if the Applicant intended for claim 11 to recite “a back side of the substrate” and maintain dependency on claim 1 or depend on claim 9 and maintain the language “the back side”. Applicant is suggested to amend claim 11 to overcome rejection.
Claim 13, line 5 recites “the microneedle cluster” and it is therefore unclear if claim 13 refers to just one of “the plurality of microneedle clusters” as written, or intended to recite “each microneedle cluster” and refer to all of the microneedle clusters.
Claim 15, line 2 recites “adjacent medicine storage reservoirs”. Claim 15 depends on claim 14 and therefore suffers from the same issue as claim 10. For the sake of Examination, it is being interpreted that the “adjacent medicine storage reservoirs” of claim 15 is intended to refer to the “medicine storage reservoirs” of claim 14. Therefore, Applicant is suggested to amend claim 15 to recite “adjacent one of the medicine storage reservoirs” to overcome rejection.
Claim 16, lines 2-3 recite “the back side of the substrate”. Claim 16 depends on claim 13 and therefore suffers from the same issue as claim 11. It is unclear if the Applicant intended for claim 16 to recite “a back side of the substrate” and maintain dependency on claim 13 or depend on claim 14 and maintain the language “the back side”. Applicant is suggested to amend claim 16 to overcome rejection.
Claim 17, lines 2-3 recites “two microneedles” but fails to specify if these microneedles of claim 17 are the same as “the at least two microneedles” of claim 13 or if claim 17 is intended to introduce new microneedles in addition to the microneedles in claim 13. For the sake of Examination, claim 17 is being interpreted as limiting the number of “the at least two microneedles” of claim 13. Additionally, MPEP 2111.03 sets forth that “composed of” means either “consists of” or “consists essentially of”. Applicant is therefore suggested to amend claim 17 to recite “wherein the at least two microneedles consist of two microneedles” since “consist” reads better than “composed” in these amendments.
Claim 18, lines 2-3 recites “two microneedles” but fails to specify if these microneedles of claim 18 are the same as “the at least two microneedles” of claim 13 or if claim 18 is intended to introduce new microneedles in addition to the microneedles in claim 13. For the sake of Examination, claim 18 is being interpreted as limiting the number of “the at least two microneedles” of claim 13. Additionally, MPEP 2111.03 sets forth that “composed of” means either “consists of” or “consists essentially of”. Applicant is therefore suggested to amend claim 17 to recite “wherein each of the microneedle clusters is composed the at least two microneedles consist of more than two microneedles […]” since “consist” reads better than “composed” in these amendments.
Claim 19, lines 2-3 recites “four microneedles” but fails to specify if these microneedles of claim 19 are the same as “the at least two microneedles” of claim 13 or if claim 19 is intended to introduce new microneedles in addition to the microneedles in claim 13. For the sake of Examination, claim 17 is being interpreted as limiting the number of “the at least two microneedles” of claim 13. Additionally, MPEP 2111.03 sets forth that “composed of” means either “consists of” or “consists essentially of”. “wherein each of the microneedle clusters is composed the at least two microneedles consist of four microneedles […] since “consist” reads better than “composed” in these amendments.
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.
Claim(s) 1-3, 5, 7, 12-13, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kawaguchi et al. (JP 2005246595 A).
Regarding claim 1, Kawaguchi discloses a microneedle array chip (microneedle array 100 in Fig. 1a), comprising a substrate (base 101 in Fig. 1a) and a plurality of microneedles (plurality of needles 10 in Fig. 1a) arranged on a front side of the substrate (needles 10 are positioned upward from the surface of base 101 [0019]; it is interpreted the upward surface is the front side) in an array (needles 10 are arranged at regular intervals [0019]), wherein trenches are formed (notches 11a and 11b in Fig. 1d divides needle into four sections and forms small gap B between them [0020]) downwards from tips of the microneedles (gap B is seen to run from tip of needle 10 down to the bottom end of needle 10 in Fig. 1c), and each of the trenches has a width not less than 10 nm (dimension of gap B in Fig. 1c is 10μm [0020]; it is interpreted that 10μm is not less than 10 nm), and a depth not less than 50 nm (dimension of height H in Fig. 1c is 150μm [0020]; it is interpreted that 150μm is not less than 50nm).
Regarding claim 2, Kawaguchi disclosed all limitations of claim 1. Kawaguchi further discloses wherein the microneedles each comprise an upper portion (see upper portion in annotated Fig. 1c below) and a lower portion (see lower portion in annotated Fig. 1c below, wherein the upper portion is formed with tip portions (upper portion is defined by tip of needle 10 in Fig. 1c, and the trench is formed between the tip portions (gap B is formed between the tips of the four sections in Fig. 1c).
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Annotated Fig. 1c of Kawaguchi
Regarding claim 3, Kawaguchi disclosed all limitations of claim 2. Kawaguchi further discloses wherein the tip portions are triangular tip portions (since notches 11a and 11b split needle 10 into four triangular pyramid sections [0020]; it is interpreted the tip of each section is also triangular).
Regarding claim 5, Kawaguchi disclosed all limitations of claim 1. Kawaguchi further discloses wherein the trenches are formed downwards from the tips of the microneedle (gap B is seen to run from tip of needle 10 down to the bottom end of needle 10 in Fig. 1c), and the depths of the trenches are equal to heights of the microneedles (height of microneedle is equal to height of gap since gap extends down to the bottom end of needle 10 in Fig. 1c).
Regarding claim 7, Kawaguchi disclosed all limitations of claim 1. Kawaguchi further discloses wherein the trenches are rectangular trenches (gap B is interpreted to be in rectangular shape in Fig. 1c).
Regarding claim 12, Kawaguchi disclosed all limitations of claim 1. Kawaguchi further discloses wherein the trenches are each a straight trench or formed by two straight trenches intersecting each other by any angle (gap B is seen to extend straight down from tip to bottom end of needle 10 in Fig. 1c).
Regarding claim 13, Kawaguchi discloses a microneedle array chip(microneedle array 100 in Fig. 1a), comprising a substrate (base 101 in Fig. 1a), wherein a front side of the substrate is provided (needles 10 are positioned upward from the surface of base 101 [0019]; it is interpreted the upward surface is the front side) with a plurality of microneedle clusters (plurality of needles 10 in Fig. 1a) arranged in an array (needles 10 are arranged at regular intervals [0019]), each of the microneedle clusters is composed of at least two microneedles (notches 11a and 11b split needle 10 into four triangular pyramid sections [0020]; each of the needles 10 is interpreted as a “microneedle cluster”, and each of the four triangular pyramid sections is interpreted as a “microneedle”, therefore resulting in each microneedle cluster (10) comprising four microneedles (triangular pyramid sections)), a gap between the microneedles in each microneedle cluster (notches 11a and 11b in Fig. 1d divides needle into four sections and forms small gap B between them [0020]) is not less than 10 nm and not greater than 300μm (dimension of gap B in Fig. 1c is 10μm [0020]; it is interpreted that 10μm is between 10 nm and 300μm), and the gap between the microneedles in the microneedle cluster is less than an interval (needles 10 are arranged at regular intervals W [0019]) between the microneedle clusters on the microneedle array chip (dimension of interval W is 300μm [0019]; it is interpreted that the dimension of gap B which is 10μm is less than interval W which is 300μm).
Regarding claim 18, Kawaguchi disclosed all limitations of claim 13. Kawaguchi further discloses wherein each of the microneedle clusters is composed of more than two microneedles (notches 11a and 11b split needle 10 into four triangular pyramid sections [0020]), and the microneedles are circumferentially arranged (the triangular sections are arranged in circumferential array in Fig. 1d).
Regarding claim 19, Kawaguchi disclosed all limitations of claim 13. Kawaguchi further discloses wherein each of the microneedle clusters is composed of four microneedles (notches 11a and 11b split needle 10 into four triangular pyramid sections [0020]), and the four microneedles are arranged in a circumferential array or are centrosymmetrically arranged (the triangular sections are arranged in circumferential array in Fig. 1d).
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.
Claim(s) 4 is/are rejected under 35 U.S.C 103 as being unpatentable over the embodiment in Fig. 1a of Kawaguchi et al (JP 2005246595 A), and further in view of the embodiment in Fig. 2a of Kawaguchi.
Regarding claim 4, Kawaguchi in the embodiment of Fig. 1a disclosed all limitations of claim 1. However, Kawaguchi disclosed in the embodiment of Fig. 1a wherein the trenches are formed extending downwards from the tips of the microneedles (gap B is seen to run from tip of needle 10 down to the bottom end of needle 10 in Fig. 1c), but failed to explicitly disclose the depths of the trenches are less than heights of the microneedles.
However, Kawaguchi teaches in the embodiment of Fig. 2a, a portion of needle 20 is divided by notches 21a and 21b with gap B between the two notches. Vertical height of gap B is designated by H’ which is less than height of the needle 20 designated by H [0022]. One of ordinary skill in the art recognizes that needle 10 and needle 20 performs same function since fluid is capable of passing through both needles regardless of the length of notches 21a and 21b [0022].
Therefore, it would have been to one of ordinary skill in the art, prior to effective filing date of the invention to modify the trench of the embodiment of Kawaguchi in Fig. 1a to have depth less than the height of the microneedle since it has been held 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." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.II.A. In the instant case, the trench of Fig. 1a of Kawaguchi would not operate differently if the depth is less than the height of the microneedle. Further, Applicant places no criticality on depth of trench being less than the height of microneedle in claim 4.
Claim(s) 6 is/are rejected under 35 U.S.C 103 as being unpatentable over Kawaguchi et al. (JP 2005246595 A), and further in view of Ueno et al. (JP 2007260889 A).
Regarding claim 6, Kawaguchi disclosed all limitations of claim 1. However, Kawaguchi failed to explicitly disclose wherein the trenches are V-shaped trenches.
However, Ueno teaches V-shaped groove 1502 at the tip of the needle body 15 [0033; see also Fig. 7(3)]. One of ordinary skill in the art teaches the needle 10 of Kawaguchi is to be configured to be shaped with V-shaped groove at the tip as taught by Ueno.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include wherein the trenches are V-shaped trenches as taught by Ueno since such a modification enables the microneedle of Kawaguchi to be suitable for holding medicinal substance [Ueno, 0033]
Claim(s) 8 is/are rejected under 35 U.S.C 103 as being unpatentable over the embodiment in Fig. 1a of Kawaguchi et al. (JP 2005246595 A), and further in view of the embodiment in Fig. 4a of Kawaguchi.
Regarding claim 8, Kawaguchi in the embodiment of Fig. 1a disclosed all limitations of claim 1. However, Kawaguchi in the embodiment of Fig. 1a failed to explicitly disclose wherein two side surfaces of each of the trenches are bevels.
However, Kawaguchi teaches in the embodiment of Fig. 4a microneedle 50 with bottom half in the shape of a square prism and upper half in the shape of square pyramid, which forms bevels (see annotated Fig. 4b below) on the sides surrounding the gap B ([0024]). One of ordinary skill in the art recognizes that needle 10 and needle 50 performs same function, since Kawaguchi specifies needle 50 as a mere modification of needle 10 [0024].
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Annotated Fig. 4b of Kawaguchi
Therefore, it would have been to one of ordinary skill in the art, prior to effective filing date of the invention to modify the microneedle of the embodiment of Kawaguchi in Fig. 1a to have bevel on the sides surrounding gap B since it has been held 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." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929). See MPEP 2144.05.II.A. In the instant case, the microneedle 10 of Fig. 1a of Kawaguchi would not operate differently if it is configured to have bevel. Further, Applicant places no criticality on the sides around the trench having bevels in claim 8.
Claim(s) 9, 10, 14 and 15 is/are rejected under 35 U.S.C 103 as being unpatentable over Kawaguchi et al. (JP 2005246595 A), and further in view of Gartstein (US 20040087992 A1) and Black et al. (US 20110306853 A1).
Regarding claim 9, Kawaguchi disclosed all limitations of claim 1. However Kawaguchi failed to explicitly disclose wherein a back side of the substrate is provided with medicine storage reservoirs, and the medicine storage reservoirs are in fluid communication with the trenches through through holes.
However, Gartstein teaches in Figs. 53-55 a through hole 806 positioned between the gap of two microneedles 824 and 844. One of ordinary skill in the teaches the device of Kawaguchi is to be configured to include a through hole between the trenches of the microneedles as taught by Gartstein.
Furthermore, Black teaches in Fig. 2a a fluid delivery system 10 with a polymeric support 12 with an array of microneedles 14 with through-holes (see Fig. 2a) coupled to support 12. Support 12 is also provided with a plurality of microchannels 16 between microneedles 14 and first and second reservoirs 18. Black further teaches the support 12, microchannels 16 and reservoir are all integrally formed, which is interpreted as microchannels 16 and reservoirs 18 formed in the backside of support 12 [0060]. One of ordinary skill in the art teaches the microneedle array chip of Kawaguchi is to be configured to be equipped with through-hole extended between base 10 and the end of microneedle 10 with through-hole of Gartstein configured to be in Kawaguchi, and to be equipped with reservoirs to be in fluid communication with the through holes as taught by Black.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include wherein a back side of the substrate is provided with medicine storage reservoirs, and the medicine storage reservoirs are in fluid communication with the trenches through through holes as taught by Gartstein and Black since such a modification enables the device of Kawaguchi to provide outgoing fluids to the microneedle directly from the reservoirs [Black, 0061].
Regarding claim 10, Kawaguchi as modified by Gartstein and Black disclosed all limitations of claim 9. However, Kawaguchi failed to explicitly disclose wherein adjacent medicine storage reservoirs are connected by a shallow groove.
However, Black teaches in Fig. 2a microchannels 16 between the first and second reservoirs 18.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi as modified by Gartstein and Black to include wherein adjacent medicine storage reservoirs are connected by a shallow groove as taught by Black since such a modification enables the device of Kawaguchi to provide capillary channels between the reservoirs [Black, 0061].
Regarding claim 14, Kawaguchi disclosed all limitations of claim 13. However, Kawaguchi failed to explicitly disclose wherein a back side of the substrate is provided with medicine storage reservoirs, bottom surfaces of the medicine storage reservoirs are in fluid communication with the front side of the substrate through through holes, and the through holes are located in positions between the microneedles in the microneedle clusters.
However, Gartstein teaches in Figs. 53-55 a through hole 806 positioned between the gap of two microneedles 824 and 844. One of ordinary skill in the teaches the device of Kawaguchi is to be configured to include a through hole between the microneedles as taught by Gartstein.
However, Black teaches in Fig. 2a a fluid delivery system 10 with a polymeric support 12 with an array of microneedles 14 with through-holes (see Fig. 2a) coupled to support 12. Support 12 is also provided with a plurality of microchannels 16 between microneedles 14 and first and second reservoirs 18. Black further teaches the support 12, microchannels 16 and reservoir are all integrally formed, which is interpreted as microchannels 16 and reservoirs 18 formed in the backside of support 12 [0060]. One of ordinary skill in the art teaches the microneedle array chip of Kawaguchi is to be configured to be equipped with through-hole extended between base 10 and the end of microneedle 10 with through-hole of Gartstein configured to be in Kawaguchi, and to be equipped with reservoirs to be in fluid communication with the through holes as taught by Black.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include wherein a back side of the substrate is provided with medicine storage reservoirs, bottom surfaces of the medicine storage reservoirs are in fluid communication with the front side of the substrate through through holes, and the through holes are located in positions between the microneedles in the microneedle clusters as taught by Gartstein and Black since such a modification enables the device of Kawaguchi to provide outgoing fluids to the microneedle directly from the reservoirs [Black, 0061].
Regarding claim 15, Kawaguchi as modified by Black disclosed all limitations of claim 14. However, Kawaguchi failed to explicitly disclose wherein adjacent medicine storage reservoirs are connected by a shallow groove.
However, Black teaches in Fig. 2a microchannels 16 between the first and second reservoirs 18.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi as modified by Gartstein and Black to include wherein adjacent medicine storage reservoirs are connected by a shallow groove as taught by Black since such a modification enables the device of Kawaguchi to provide capillary channels between the reservoirs [Black, 0061].
Claim(s) 11 and 16 is/are rejected under 35 U.S.C 103 as being unpatentable over Kawaguchi et al. (JP 2005246595 A), and further in view of Gartstein (US 20040087992 A1).
Regarding claim 11, Kawaguchi disclosed all limitations of claim 1. However, Kawaguchi failed to explicitly disclose further comprising through holes extending from bottom surfaces of the trenches to the back side of the substrate.
However, Gartstein teaches in Figs. 53-55 a through hole 806 positioned between the gap of two microneedles 824 and 844. One of ordinary skill in the teaches the device of Kawaguchi is to be configured to include a through hole between the trenches of the microneedles as taught by Gartstein.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include further comprising through holes extending from bottom surfaces of the trenches to the back side of the substrate as taught by Gartstein since such a modification enables the device of Kawaguchji to form a through-slot or opening that can be used to dispense a fluidic compound [Gartstein, 0229].
Regarding claim 16, Kawaguchi disclosed all limitations of claim 13. However, Kawaguchi failed to explicitly disclose further comprising through holes extending from the front side of the substrate to the back side of the substrate, and the through holes are located in positions between the microneedles in the microneedle clusters.
However, Gartstein teaches in Figs. 53-55 a through hole 806 positioned between the gap of two microneedles 824 and 844. One of ordinary skill in the teaches the device of Kawaguchi is to be configured to include a through hole between the microneedles as taught by Gartstein.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include further comprising through holes extending from the front side of the substrate to the back side of the substrate, and the through holes are located in positions between the microneedles in the microneedle clusters as taught by Gartstein since such a such a modification enables the device of Kawaguchji to form a through-slot or opening that can be used to dispense a fluidic compound [Gartstein, 0229].
Claim(s) 17 is/are rejected under 35 U.S.C 103 as being unpatentable over Kawaguchi et al. (JP 2005246595 A), and further in view of Atari (US 20200330739 A1).
Regarding claim 17, Kawaguchi disclosed all limitations of claim 13. However, Kawaguchi failed to explicitly disclose wherein each of the microneedle clusters is composed of two microneedles.
However, Atari teaches microneedle 60 in Fig. 5 to have two puncture portions 64 and 65 on outer surfaces 62 and 63 respectively [00936]. One of ordinary skill in the art interprets the outer surfaces 62 and 63 to be two individual microneedles since both 62 and 63 are capable piercing via puncture portions 64 and 65 respectively.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the invention to modify the microneedle array chip of Kawaguchi to include wherein each of the microneedle clusters is composed of two microneedles as taught by Atari since such a modification enables the device of Kawaguchi to be capable of holding a drug [Atari, 0093].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20090143749 A1 (Sugimura) – related to a microneedle device in triangular shape.
US 20100305516 A1 (Xu) – related to a microneedle array with needles in an array of clusters.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783