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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 12/29/2025. Claims 1 and 10 are amended. Claims 3-4, 14-15, 18, 23 and 28 are cancelled. Claims 1-2, 5-6, 8-13, 16-17, 19-22 and 24-27 are currently pending.
The objection of claims 1 and 10 has been withdrawn due to applicant’s amendment.
The rejection of claims 1-2, 5-6, 8-13, 16-17, 19-22 and 24-27 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/29/2025, with respect to the rejection(s) of claim(s) 1-2, 5-6, 8-11, 13, 16-17, 19-22, 24-25 and 27 under 35 U.S.C. 102(a)(1) as being anticipated by Di Nardo; claim 12 under 35 U.S.C. 103 as being unpatentable over Di Nardo in view of Kahook; and claim 26 under 35 U.S.C. 103 as being unpatentable over Di Nardo in view of Abt, have been fully considered but are not persuasive.
1) Applicant argues, with respect to the interpretation with reference to fig. 2, the second tapered portion does not taper towards the cannula distal part, and instead tapers away; and further argues the hollow interior or opening 25 of instrument guide 23 is separate from cannula 10 of the pilot tube 1, therefore the portion does not taper towards the cannula distal part because the part is axially remote as provided in the pilot tube 1 (Remarks, pg. 10).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language does not recite which end the lesser diameter of the taper is at, only that the second tapered portion tapers from one structure to another. In other words, the claim language does not specify whether the larger diameter of the taper is at a proximal or distal end of the taper. Further, the claim language does not preclude the second tapered portion from being separate from the cannula distal part. The claim language only recites the second tapered portion tapering, and does not recite the second tapered portion needing to be in direct contact with the cannula distal part, for example. Therefore, the rejection is maintained.
2) Applicant further argues, with respect to the interpretation with reference to fig. 11, the second tapered tube portion does not taper as claimed, because the final section including plug 46 is inserted into cannula 10, such that the effective internal diameter at a further distal portion widens again, and the second tapered tube portion of Di Nardo does not provide significantly improved flow performance while maintaining a robust coupling of the capillary tube to the trocar module (Remarks, pgs. 10-11).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. As discussed above, the claim language does not preclude an effective internal diameter at a further distal portion widening again, and only recites a portion of the tube tapering from one structure to another. Further, an apparatus claim covers what a device is, not what it does (MPEP 2114(II)). Therefore, the instant application’s improved flow performance as discussed in the Remarks is not tied to any structure or claimed, and covers what a device does. Accordingly, the rejection is maintained.
3) Applicant further argues the cavity traversed by the capillary tube receives the infusion line 3, not a trocar cannula (Remarks, pg. 12).
In response to applicant’s third argument, it is respectfully submitted the arguments are narrower than the claim limitations. The claim language recites receiving at least a portion of the proximal part of the cannula functionally, such that under broadest reasonable interpretation, the cavity only needs to be capable of receiving the proximal part of the cannula, encompassing a direct and/or indirect connection of the structures. Further, fig. 7 depicts connector insert 4 residing within the space formed by pilot tube attachment 2, such that the claimed limitation is considered to be met.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “clamping elements” in claim 16.
Paras. [0043]-[0044] of the published application describe the “clamping elements” as fingers. “Clamping elements” uses the generic placeholder “element” coupled with the term “clamping”, which is functional in that the limitation alternatively recites an element for clamping, and the term “element” is not preceded by a structural modifier since the term “clamping” does not imply any structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 1-2, 5-6, 8-11, 13, 16-17, 19-22, 24-25 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Nardo (US 2008/0033462 A1) (all references previously of record).
Regarding claim 1, Di Nardo discloses (see abstract; paras. [0036]-[0078]; figs. 1-11) a trocar module (figs. 1-2) for ophthalmic surgery (para. [0001]), comprising:
- a tubular shaped cannula (device T, paras. [0036]-[0038]; figs. 1-2) having a distal part (10) for insertion through an eye's sclera (inserted into the eye, para. [0036]) and a proximal part (pilot tube attachment 2) for receiving a capillary tube (infusion line 3 including cannula 31, fig. 2) of a fluid connector in a coupled state with said fluid connector (para. [0062]; fig. 2), and
- a valve unit (plug as described in para. [0078]) arranged at the proximal part of the cannula for sealing said cannula in an uncoupled state (arranged within pilot tube attachment 2),
wherein the proximal part of the cannula has a first tapered tube portion, a second tapered tube portion and an intermediate tube portion located between the first tapered tube portion and the second tapered tube portion (annotated fig. 5),
wherein the first tapered tube portion is located at a proximal side of the intermediate tube portion (annotated fig. 5) and is tapered towards the intermediate tube portion for aligning with the capillary tube during coupling (annotated fig. 5),
wherein the intermediate tube portion has a constant cross section (annotated fig. 5) and encloses a distal end of the capillary tube in the coupled state (considered to enclose cannula 31, fig. 2), and
wherein the second tapered tube portion tapers from the intermediate tube portion towards the cannula distal part (annotated fig. 5).
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Annotated Figure 5 of Di Nardo
Regarding claim 2, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein the first tapered tube portion, the intermediate tube portion and the second tapered tube portion form a double tapered canal in the cannula (considered to be double tapered via first and second tapered portions, annotated fig. 5).
Regarding claim 5, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein a tapered end of the first tapered tube portion adjoins the proximal end of the intermediate tube portion (annotated fig. 5).
Regarding claim 6, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein the distal end of the intermediate tube portion adjoins a proximal end of the second tapered tube portion (annotated fig. 5).
Regarding claim 8, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein an inner diameter of the capillary tube is substantially the same or greater than an inner diameter of the cannula distal part (depicted as having a greater diameter in fig. 2).
Regarding claim 9, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein an inner diameter of the intermediate tube portion is substantially the same or greater than an outer diameter of the cannula distal part (depicted in figs. 1-2 and 7).
Regarding claim 10, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses further comprising a collar (flange 11, paras. [0038]-[0040]; fig. 2) arranged around the cannula and provided with a circumferential groove (13, para. [0040]) at its exterior side (fig. 2).
Regarding claim 11, Di Nardo discloses the trocar module according to claim 1. Di Nardo further discloses wherein the valve unit sealingly surrounds the cannula adjacent a proximal end of the tubular shaped cannula (considered to be at proximal end of 10, para. [0078]).
Regarding claim 1, Di Nardo discloses (see abstract; paras. [0036]-[0078]; figs. 1-11), under an alternative interpretation with respect to the cannula, a trocar module (figs. 1-2) for ophthalmic surgery (para. [0001]), comprising:
- a tubular shaped cannula (includes first section 1a and connector insert 4, para. [0065]; figs. 2 and 11) having a distal part (10) for insertion through an eye's sclera (inserted into the eye, para. [0036]) and a proximal part (connector insert 4) for receiving a capillary tube (infusion line 3, fig. 7) of a fluid connector in a coupled state with said fluid connector (fig. 7), and
- a valve unit (plug 46, para. [0072]) arranged at the proximal part of the cannula for sealing said cannula in an uncoupled state (seals outlet 16),
wherein the proximal part of the cannula has a first tapered tube portion, a second tapered tube portion and an intermediate tube portion located between the first tapered tube portion and the second tapered tube portion (annotated fig. 11),
wherein the first tapered tube portion is located at a proximal side of the intermediate tube portion (annotated fig. 11) and is tapered towards the intermediate tube portion for aligning with the capillary tube during coupling (annotated fig. 11),
wherein the intermediate tube portion has a constant cross section (annotated fig. 11) and encloses a distal end of the capillary tube in the coupled state (encloses infusion line 3 within pilot tube attachment 2 in fig. 7, further note infusion line 3 includes cannula 31 which is considered to be enclosed similarly to fig. 2, para. [0062]), and
wherein the second tapered tube portion tapers from the intermediate tube portion towards the cannula distal part (annotated fig. 11).
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Annotated Figure 11 of Di Nardo
Regarding claim 13, Di Nardo discloses a fluid connector (includes pilot tube attachment 2 and infusion line 3) for ophthalmic surgery (para. [0001]), comprising a capillary tube (3) and a connector body (pilot tube attachment 2) surrounding said capillary tube (fig. 7), the capillary tube having a proximal part for connection with a fluid input or output line (connects via infusion line), and a distal part (distal end of infusion line 3) for coupling with the trocar module according to claim 1 (fig. 7), wherein the connector body is provided with a cavity (space formed inward of tabs 20 and catch elements 21, fig. 8) traversed by the capillary tube distal part (fig. 7) for receiving at least a portion of the proximal part of the cannula, in the coupled state (fig. 7).
Regarding claim 16, Di Nardo discloses the fluid connector according to claim 13. Di Nardo further discloses wherein the connector body is provided with a multiple number of clamping elements (21, para. [0049]; fig. 9) extending inwardly into the cavity (via locking notches 26, para. [0051]) for clampingly engaging the trocar module, in the coupled state (fig. 7).
Regarding claim 17, Di Nardo discloses the fluid connector according to claim 13. Di Nardo further discloses wherein the clamping elements are mainly evenly distributed in a circular direction around the capillary tube (fig. 7).
Regarding claim 19, Di Nardo discloses a trocar system for ophthalmic surgery (figs. 1-2 and 7), comprising the trocar module according to claim 1 coupled with a fluid connector (includes pilot tube attachment 2 and infusion line 3) for ophthalmic surgery (para. [0001]) at a distal part of said fluid connector (fig. 7), said fluid connector comprising a capillary tube (3) and a connector body (pilot tube attachment 2) surrounding said capillary tube (fig. 7), the capillary tube having a proximal part for connection with a fluid input or output line (connects via infusion line), wherein the connector body is provided with a cavity (spaced formed inward of tabs 20 and catch elements 21, fig. 8) traversed by the capillary tube distal part (fig. 7) for receiving at least a portion of the proximal part of the cannula, in the coupled state (fig. 7), and wherein the intermediate tube portion of the trocar module encloses a distal end of the capillary tube in the coupled state (considered to enclose cannula 31 similarly to fig. 2, para. [0062]).
Regarding claim 20, Di Nardo discloses the trocar system according to claim 19. Di Nardo further discloses wherein the capillary tube of the fluid connector is engaged by the intermediate tube portion (considered to engaged similarly as depicted in fig. 2) and the valve unit of the trocar module (considered to be engaged to endpiece 46 since cannula 31 extends through opening 12).
Regarding claim 21, Di Nardo discloses the trocar system according to claim 19. Di Nardo further discloses wherein the distal end of the capillary tube abuts against the second tapered tube portion of the cannula (cannula 31 extends through opening 12, considered to contact and therefore abut second tapered tube portion when extending through opening 12, figs. 2 and 7, annotated fig. 11).
Regarding claim 22, Di Nardo discloses the trocar system according to claim 19. Di Nardo further discloses wherein the intermediate tube portion engages at least a portion of the distal part of the capillary tube (considered to engage cannula 31 when extending through opening 12).
Regarding claim 24, Di Nardo discloses a method for coupling the trocar module according to claim 1 with a fluid connector (includes pilot tube attachment 2 and infusion line 3) so as to form a trocar system (figs. 1-2 and 7) comprising the trocar module coupled with the fluid connector at a distal part of said fluid connector (fig. 7), said fluid connector comprising a capillary tube (3) and a connector body (pilot tube attachment 2) surrounding said capillary tube (fig. 7), the capillary tube having a proximal part for connection with a fluid input or output line (connects via infusion line), wherein the connector body is provided with a cavity (space formed inward of tabs 20 and catch elements 21, fig. 8) traversed by the capillary tube distal part for receiving at least a portion of the proximal part of the cannula, in the coupled state (fig. 7), and wherein the intermediate tube portion of the trocar module encloses a distal end of the capillary tube in the coupled state (considered to enclose cannula 31 similarly to fig. 2, para. [0062]), the method comprising the steps of:
- receiving the capillary tube of the fluid connector in the proximal part of the tubular shaped cannula of the trocar module (received through opening 12, para. [0062]), thereby receiving at least a portion of the proximal part of the cannula in the cavity of the connector body of the fluid connector (fig. 7), and
- advancing the capillary tube of the fluid connector into the cannula until the intermediate tube portion encloses a distal tip of the capillary tube (considered to enclose cannula 31, such that infusion line 3 is advanced an appropriate distance into opening 12 and therefore enclosed until infusion line 3 reaches opening 12, figs. 1-2, 7 and annotated fig. 11).
Regarding claim 25, Di Nardo discloses the method according to claim 24. Di Nardo further discloses further comprising the step of:
- advancing the capillary tube of the fluid connector into the cannula until the distal end of the capillary tube abuts against the second tapered tube portion of the cannula (cannula 31 extends through opening 12, considered to contact and therefore abut second tapered tube portion when extending through opening 12 and advanced until appropriate distance is reached, figs. 2 and 7, annotated fig. 11).
Regarding claim 27, Di Nardo discloses a method for decoupling a trocar system into the trocar module according to claim 1 (para. [0059]), the trocar system comprising the trocar module coupled with the fluid connector at a distal part of said fluid connector (fig. 7), said fluid connector comprising a capillary tube (3) and a connector body (pilot tube attachment 2) surrounding said capillary tube (fig. 7), the capillary tube having a proximal part for connection with a fluid input or output line (connects via infusion line), wherein the connector body is provided with a cavity (space formed inward of tabs 20 and catch elements 21, fig. 8) traversed by the capillary tube distal part (fig. 7) for receiving at least a portion of the proximal part of the cannula, in the coupled state (fig. 7), and wherein the intermediate tube portion of the trocar module encloses a distal end of the capillary tube in the coupled state (encloses infusion line 3 within pilot tube attachment 2 as depicted in fig. 7), the method comprising the step of retracting the capillary tube of the fluid connector from the cannula of the trocar module (considered to be retracted from pilot tube 1 when pilot tube attachment 2 is removed, para. [0059]).
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.
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.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Di Nardo in view of Kahook (US 2020/0138629 A1).
Regarding claim 12, Di Nardo discloses the trocar module according to claim 1.
However, Di Nardo fails to disclose wherein the distal part of the tubular shaped cannula has an exterior surface that is at least partly provided with laser fabricated texture structures.
Kahook teaches (para. [0065]), in the analogous art of the claimed invention, an intraocular device (para. [0055]; fig. 3) comprising an exterior surface that is at least partly provided with laser fabricated texture structures (microgrooves 143 which are formed by laser patterning, para. [0065]), for the purpose of facilitating retention of the device and minimizing migration of the device upon implantation (para. [0065]).
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 exterior surface of cannula 10 of Di Nardo to include laser fabricated microgrooves, in order to facilitate retention of the cannula and minimize migration during use, based on the suggestions and teachings of Kahook (para. [0065]).
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Di Nardo in view of Abt (US 2014/0025045 A1).
Regarding claim 26, Di Nardo discloses the method according to claim 24.
However, Di Nardo fails to disclose further comprising the step of determining the inner diameter of the distal part of the tubular shaped cannula by performing a fluid impedance measurement at a proximal side of the capillary tube.
Abt teaches (paras. [0049]-[0054]; fig. 10), in the same field of endeavor, a trocar module for ophthalmic surgery (abstract, para. [0001]) comprising a step of determining an inner diameter of a cannula by performing a fluid impedance measurement across the cannula (pressure differential data taken across the cannula for various diameters, paras. [0049]-[0052]), for the purpose of identifying flow data for passive flow through the cannulas, providing the user with data for determining the most effective sized cannula to use (paras. [0049]-[0054]).
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 method of Di Nardo to further include determining the inner diameter of the cannula by performing a fluid impedance measurement at the infusion line and therefore across the cannula, in order to identify flow data for passive flow of fluid through the cannula, providing the user with data to determine the most effectively sized cannula to use, based on the teachings of Abt (paras. [0049]-[0054]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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