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 election with traverse of Species A in the reply filed on 1/27/2026 is acknowledged. The traversal is on the ground(s) that the embodiment shown in fig. 55G shows the needle hub having the claimed projection and the claimed filter and therefore these elements do not constitute different species. This argument is convincing and therefore the restriction requirement is withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the needle hub having a female luer connector having a tapered surface and a filter within the hub (claims 9-11, 16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19, 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 17, from which claims 19 and 20 depend, calls for a needle hub and a filter located within the needle hub such that the cavity within the hub comprises a cavity first portion proximal to the filter and a cavity second portion distal to the filter. This configuration appears to only be shown in figs. 55A and 55D. Claim 19 further calls for a projection. The projection in combination with the filter can be seen in fig. 55G, however, there is no disclosure of an embodiment including the filter, the projection, and the cavity first portion and the cavity second portion. Therefore, it is not clear that the inventors/applicants has possession of the invention as recited in claim 19. Claim 20 inherits the deficiencies of claim 19.
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 12 is 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 12 recites the limitation "the straight axis" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 13, 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 11,865,039 in view of Spurbeck et al (CA 2 788 463 A1).
Regarding claim 1 of the application, claim 1 of the patent recites, an injector device for drug delivery (claim 1, line 60) comprising: a needle hub comprising a proximal opening (claim 1, lines 61-62), an end wall (claim 1, line 66), and a female luer connector having a tapered surface (claim 1, lines 64-65), wherein the tapered surface is between the proximal opening and the end wall (claim 1, lines 65-66), and wherein the female luer connector is configured to be coupled with a male luer connector at a distal end of a drug reservoir (claim 1, lines 63-64); a fluid passageway extending axially through the needle hub (claim 1, lines 3-4); a projection extending in a proximal direction away from the end wall (claim 1, lines 5-6), wherein the projection comprises a projection proximal end and a projection distal end (claim 1, lines 7-8), wherein the projection proximal end is farther from the end wall than the projection distal end (claim 1, lines 8-9), wherein the projection comprises an axial length as measured along a straight axis that passes through a center of the projection (claim 1, lines 9-10), wherein the axial length of the projection is less than a length of the tapered surface (claim 1, lines 10-11), wherein the axial length is less than a width of the proximal opening (claim 1, lines 16-17), wherein the projection comprises a projection opening that is in fluid communication with and axially aligned with the fluid passageway extending axially through the needle hub (claim 1, lines 13-15); a space between a portion of the projection and a distal portion of the tapered surface (claim 1, lines 21-23); and a needle having a proximal portion, a distal portion, an exit port, and a lumen, wherein the lumen of the needle is in fluid communication with the fluid passageway (claim 1, lines 28-30).
Claim 1 of the application differs from claim 1 of the patent in calling for the projection proximal end to have a different width than the projection distal end. Spurbeck teaches a needle hub having a projection 130 wherein the projection has a tapered profile causing the projection proximal end to have a different width than the projection distal end (fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the projection of claim 1 of the patent to include a tapered profile as taught by Spurbeck to provide a mechanism to ease the connection of the hub with the syringe tip and providing a secure fluid tight connection therebetween.
Regarding claim 2, Spurbeck further teaches that projection comprises a projection first surface and a projection second surface, wherein the projection first surface is farther from the proximal opening than the projection second surface, and wherein the projection first surface is at an angle relative to the projection second surface. Regarding claim 3, Spurbeck further teaches that projection first surface comprises a sloped surface, and wherein the projection second surface faces the proximal opening. Regarding claim 4, Spurbeck further teaches that a first portion of the projection first surface is closer to the straight axis than a second portion of the projection first surface. See annotated fig. 1 below. These are a direct result of the tapered configuration and therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the modified patent claim 1 discussed above would include these features.
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Regarding claim 5 of the application, claim 1 of the patent discloses that the fluid passageway extends through the projection (claim 1, lines 12-13).
Regarding claim 6 of the application, claim 1 of the patent discloses that the projection comprises an open center, and wherein a portion of the fluid passageway comprises the open center (claim 1, lines 12-15).
Regarding claim 13 of the application, claim 1 of the patent recites an injector device for drug delivery (claim 1, line 60) comprising: a needle hub comprising a proximal opening (claim 1, line 61), an end wall (claim 1, line 66), and a female luer connector having a first tapered surface (claim 1, line 65), wherein the first tapered surface is between the proximal opening and the end wall (claim 1, lines 1-2), and wherein the female luer connector is configured to be coupled with a male luer connector at a distal end of a drug reservoir (claim 1, lines 62-63); a fluid passageway extending axially through the needle hub (claim 1, lines3-4); a projection (claim 1, line 5), wherein the projection comprises a projection proximal end, a projection distal end (claim 1, lines 7-8), wherein the projection is between the end wall and the proximal opening (claim 1, lines 5-6), wherein the projection proximal end is farther from the end wall than the projection distal end (claim 1, lines 8-9), wherein a portion of the fluid passageway comprises the open center (claim 1, lines 13-14),; and a needle having a proximal portion, a distal portion, an exit port, and a lumen, wherein the lumen of the needle is in fluid communication with the fluid passageway (claim 1, lines 24-26).
Claim 13 of the application differs from claim 1 of the patent in calling for the projection to have a second tapered surface, wherein a width of the projection proximal end is less than a width of the proximal opening, wherein the width of the projection proximal end is different than the width of the projection distal end, wherein the projection comprises a projection length as measured along an axis that extends through an open center of the projection, wherein the projection length is less than a length of the first tapered surface, wherein the second tapered surface is closer to the axis than the first tapered surface, and wherein the second tapered surface is shorter than the first tapered surface. Spurbeck teaches a syringe hub having a projection having a tapered profile, the tapered profile resulting in the limitations recited above. see fig. 1 annotated above. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the projection of claim 1 of the patent to include a tapered profile as taught by Spurbeck, thereby resulting in the claimed configuration, to provide a mechanism to ease the connection of the hub with the syringe tip and providing a secure fluid tight connection therebetween.
Regarding claim 14, the second tapered surface must either face a different direction than the first tapered surface of face the first tapered surface. Therefore, this feature is necessarily included in the combination described above with regard to claim 13.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Higaki et al (US 7,077,830) in view of Bock (US 6,319,236).
Regarding claim 1, Higaki discloses an injector device for drug delivery comprising: a needle hub 1 comprising a proximal opening (fig. 1: opening toward bottom of the page), an end wall, and a female connector having a tapered surface (fig. 1), wherein the tapered surface is between the proximal opening and the end wall (fig. 1), and wherein the female connector is configured to be coupled with a male connector at a distal end of a drug reservoir (col. 2, lines 50-51); a fluid passageway extending axially through the needle hub (fig. 1); a projection extending in a proximal direction away from the end wall (fig. 1), wherein the projection comprises a projection proximal end and a projection distal end, wherein the projection proximal end is farther from the end wall than the projection distal end (fig. 1: proximal end toward bottom of the page, distal end toward top of the page), wherein the projection proximal end has a different width than the projection distal end (fig. 1: projection is tapered), wherein the projection comprises an axial length as measured along a straight axis that passes through a center of the projection, wherein the axial length of the projection is less than a length of the tapered surface (fig. 1: projection is shorter than the tapered hub), wherein the projection comprises a projection opening that is in fluid communication with and axially aligned with the fluid passageway extending axially through the needle hub (fig. 1); a space between a portion of the projection and a distal portion of the tapered surface (fig. 1); and a needle 2 having a proximal portion, a distal portion, an exit port, and a lumen, wherein the lumen of the needle is in fluid communication with the fluid passageway (fig. 1).
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Claim 1 further calls for the axial length of the projection to be less than a width of the proximal opening of the hub. Higaki does not explicitly disclose this feature, however, in fig. 1 shown above the length of the projection is pictured as being less than the width of the proximal opening. Therefore, it would have been obvious to one of ordinary skill in the art that the relative dimensions of the projection and the opening could be arranged as claimed as this is the configuration shown in the figures.
Claim 1 calls for the needle hub to be a female luer configured to connect to a male luer of a syringe. Spurbeck does not explicitly disclose that the connectors are female and male luers. Bock teaches that conventional syringes have male and female luer tapers designed to create a secure and fluid tight connection between the syringe and the needle (col. 1, lines 13-15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle hub of Spurbeck to be a luer connectors as taught by Bock as luer connectors are standard within the art and provide easy and secure fittings between needles and syringes.
Regarding claim 2, Higaki discloses that projection comprises a projection first surface and a projection second surface, wherein the projection first surface is farther from the proximal opening than the projection second surface, and wherein the projection first surface is at an angle relative to the projection second surface (see fig 1. annotated below).
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Regarding claim 3, Higaki discloses that projection first surface comprises a sloped surface, and wherein the projection second surface faces the proximal opening (see fig. 1 annotated above).
Regarding claim 4, Higaki discloses that a first portion of the projection first surface is closer to the straight axis than a second portion of the projection first surface (fig. 1: first surface is tapered and therefore a portion is closer to the axis and a portion is further).
Regarding claim 5, Higaki discloses that the fluid passageway extends through the projection (fig. 1).
Regarding claim 6, Higaki discloses that the projection comprises an open center and wherein a portion of the fluid passageway comprises the open center (fig. 1).
Regarding claim 7, Higaki discloses that the female connector comprises a cavity, wherein the space comprises a portion of the cavity (fig. 1).
Regarding claim 8, the injector of Higaki is configured such that when the male luer is attached to the female connector, a gap is located between the male luer and the projection, based on the length of the chosen make connector.
Claim(s) 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spurbeck et al (CA 2 788 463 A1) in view of Bock (US 6,319,236).
Regarding claim 13, Spurbeck discloses an injector device for drug delivery (fig. 1) comprising: a needle hub 110 comprising a proximal opening 112, an end wall, and a female connector having a first tapered surface (fig. 1), wherein the first tapered surface is between the proximal opening and the end wall (fig. 1), and wherein the female connector is configured to be coupled with a male connector at a distal end of a drug reservoir 101 (fig. 1); a fluid passageway extending axially through the needle hub (fig. 1); a projection 130, wherein the projection comprises a projection proximal end, a projection distal end, and a second tapered surface (fig. 1: proximal end toward right side of the page, distal end toward left side of the page), wherein the projection is between the end wall and the proximal opening (fig. 1), wherein the projection proximal end is farther from the end wall than the projection distal end (fig. 1), wherein a width of the projection proximal end is less than a width of the proximal opening (fig. 1: tapered projection), wherein a width of the projection distal end is less than the width of the proximal opening, wherein the width of the projection proximal end is different than the width of the projection distal end (fig. 1), wherein the projection comprises a projection length as measured along an axis that extends through an open center of the projection, wherein the projection length is less than a length of the first tapered surface (fig. 1: length of projection 130 is less than length of female tapered 110), wherein the second tapered surface is closer to the axis than the first tapered surface (fig. 1: projection is axially within female taper), wherein a portion of the fluid passageway comprises the open center (fig. 1), wherein the second tapered surface is shorter than the first tapered surface (fig. 1); and a needle 119 having a proximal portion, a distal portion, an exit port, and a lumen, wherein the lumen of the needle is in fluid communication with the fluid passageway (fig. 1).
Claim 13 calls for the needle hub to be a female luer configured to connect to a male luer of a syringe. Spurbeck does not explicitly disclose that the connectors are female and male luers. Bock teaches that conventional syringes have male and female luer tapers designed to create a secure and fluid tight connection between the syringe and the needle (col. 1, lines 13-15). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle hub of Spurbeck to be a luer connectors as taught by Bock as luer connectors are standard within the art and provide easy and secure fittings between needles and syringes.
Regarding claim 14, Spurbeck discloses that second tapered surface 130 faces the first tapered surface (fig. 1).
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) 17, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaillancourt (US 4,127,131).
Regarding claim 17, Vaillancourt discloses an injector device for drug delivery comprising: a needle hub 15 comprising a proximal opening 21 (fig. 1), a cavity 20, an end wall (fig. 2: wall surrounding opening 22), and a first tapered surface (fig. 2: outer surface of hub), wherein the first tapered surface is between the proximal opening and the end wall (fig. 2), and wherein the needle hub is configured to be coupled with a male luer connector at a distal end of a drug reservoir (col. 4, lines 29-34); a fluid passageway extending axially through the needle hub (fig. 2); a filter 18, wherein the filter is between the end wall and the proximal opening such that the cavity comprises a cavity first portion proximal the filter and a cavity second portion distal the filter (fig. 2), wherein the cavity first portion is closer to the proximal opening than the cavity second portion (fig. 2), wherein a volume of the cavity first portion is greater than a volume of the cavity second portion (fig. 2), wherein a width of the cavity first portion is greater than a width the cavity second portion (fig. 2: caused by tapered profile of the hub), wherein a length of the cavity first portion is greater than a length of the cavity second portion (fig. 2), wherein the filter is wider than the cavity second portion (figs. 1, 2: filter overall width is wider than second cavity portion), wherein a width of the filter is less than a length of the first tapered surface (fig. 1), wherein the filter is closer to the end wall than to the proximal opening (fig. 2), wherein the filter comprises a filter first surface and a filter second surface opposite the filter first surface, wherein the filter first surface is closer to the proximal opening than the filter second surface (fig. 2), wherein the filter first surface faces the proximal opening, wherein the filter second surfaces faces away from the proximal opening (fig. 2); and a needle 16 having a proximal portion, a distal portion, an exit port, and a lumen, wherein the lumen is in fluid communication with the fluid passageway (fig. 1).
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Regarding claim 18, Vaillancourt discloses that the width of the filter is less than a width of the proximal opening (fig. 1). The limitation “wherein when the male luer connector is attached to the needle hub, a gap is between the male luer connector and the filter” is interpreted to be a functional limitation. The device of Vaillancourt is capable of being arranged as claimed when the male luer is of a sufficiently small length.
Allowable Subject Matter
Claims 9-12, 15, 16, 19, 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 9, the prior art fails to teach or fairly suggest the filter is between the end wall and the proximal opening, wherein the filter is closer to the end wall than to the proximal opening, and wherein the filter is between the projection and the proximal opening, in combination with the features of the invention, substantially as claimed.
Regarding claim 12, the prior art fails to teach or fairly suggest that the female luer connector comprises an inner diameter at a distal end of the tapered surface, wherein the axial length is less than the inner diameter, in combination with the features of the invention, substantially as claimed
Regarding claim 15, the prior art fails to teach or fairly suggest the projection length is less than the inner diameter of the female tapered portion, in combination with the features of the invention, substantially as claimed.
Regarding claim 16, the prior art fails to teach or fairly suggest the filter between the end wall and the proximal opening, wherein the filter is closer to the end wall than to the proximal opening, wherein the filter is between the projection and the proximal opening, in combination with the features of the invention, substantially as claimed.
Regarding claim 19, the prior art fails to teach or fairly suggest a projection, wherein the projection length is less than the width of the filter, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783