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 without traverse of Invention II (claims 92-102) in the reply filed on 10/02/2025 is acknowledged.
Claims 81-91 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention (Invention I), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/02/2025.
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 subject matter of:
claim 92: “the device comprises:(i) a hollow tube comprising a proximal end and a distal end, wherein the proximal end is in fluid communication with a source of an insulin or insulin analog formulation, wherein the distal end is configured to deliver the insulin or insulin analog formulation into a subcutaneous space of the subject; (ii) a glucose sensor located no more than a pre-determined distance away from the distal end, wherein the glucose sensor is a continuous amperometric or coulometric glucose sensor comprising an indicating electrode and a reference electrode; and(iii) an insulin infusion pump fluidically coupled to the proximal end of the insulin delivery cannula, wherein the insulin infusion pump is attached to the insulin delivery cannula either directly or via an intervening tube, wherein a lumen of the insulin delivery cannula is contiguous with a lumen of tubing that emerges from the insulin infusion pump, wherein electrical conductors for the indicating electrode and the reference electrode are disposed on a wall of the tubing or attached to a surface of the tubing”;
claim 94: “the pre-determined distance is about 7 mm”;
claim 95: “the glucose sensor comprises an electrode layer comprising the indicating electrode, wherein the electrode layer underlies a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand, and (2) an enzyme comprising glucose oxidase or glucose dehydrogenase”;
claim 96: “the glucose sensor further comprises an insulating layer and a metal layer, wherein the insulating layer is coupled to the metal layer, and wherein the metal layer is coupled to the electrode layer”;
claim 100: “the glucose sensor is disposed on an outer wall of the hollow tube”;
claim 101: “the electrical conductors for the indicating electrode and the reference electrode are disposed on the wall of the tubing”; and
claim 102: “a transimpedance amplifier (TIA) is operably connected to the glucose sensor”,
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 Objections
Claims 92 and 97-98 are objected to because of the following informalities:
Regarding Claim 92
Line 2 recites the language “delivery of the insulin”. For purposes of clarity, the claim language should be amended such that it reads –delivery of an insulin—
Lines 5-6 recite the language “a source of an insulin or insulin analog formation”. For purposes of clarity, the claim language should be amended such that it reads –a source of [[an]] the insulin or insulin analog formation—
Lines 13-14, 15, and 24-25 recite the limitation “the insulin delivery cannula”. For purposes of clarity, the claim language should be amended such that it reads –the hollow tube— Paragraph [0057] of the application states that “cannula” and “insulin delivery cannula” are equivalent terms that relate to “a hollow tube”.
Lines 20-21 recite the language “the source of the concentrated insulin or insulin analog formulation”. For purposes of clarity, the claim language should be amended such that it reads –the source of the
Lines 27-28 recite the language “a subcutaneous space of the subject”. For purposes of clarity, the claim language should be amended such that it reads –[[a]] the subcutaneous space of the subject—
Regarding Claim 97
Line 5 recites the language “a reference electrode”. For purposes of clarity, the claim language should be amended such that it reads –[[a]] the reference electrode—
Regarding Claim 98
Lines 6-7 recite the language “the concentrated insulin or insulin analog formulation”. For purposes of clarity, the claim language should be amended such that it reads –the
Appropriate correction is required.
Claim Interpretation
5. 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: “single insertion device” for “inserting the glucose sensor and the distal end of the hollow tube of the insulin delivery cannula into the subcutaneous space of the subject simultaneously” [at (d)] in claim 92.
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 § 112
8. 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 92-102 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 92
Claim limitation “single insertion device” for “inserting the glucose sensor and the distal end of the hollow tube of the insulin delivery cannula into the subcutaneous space of the subject simultaneously” [at (d)] invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of the claim limitation. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claims 93-102
Claims 93-102 are rejected insofar as they are dependent upon a rejected base claim.
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.
Claim(s) 92 and 100-101 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US 2010/0256593.
Regarding Claim 92
Yodfat discloses a method for managing blood glucose in a subject, comprising:
(a) obtaining a device (10) for delivery of the insulin or insulin analog formulation and measurement of subcutaneous glucose concentration (Yodfat, [0085], Figure 12a), wherein the device comprises:
(i) a hollow tube (330) comprising a proximal end and a distal end (Yodfat, [0022] and [0085], Figure 12a), wherein the proximal end is in fluid communication with a source of an insulin or insulin analog formulation (220), wherein the distal end is configured to deliver the insulin or insulin analog formulation into a subcutaneous space of the subject (Yodfat, [0034] and [0100]);
(ii) a glucose sensor (120, 121, 122) located no more than a pre-determined distance away from the distal end (Yodfat, Figures 12a and 131-13c) [the glucose sensor (120, 121, 122) of Yodfat is located on the on the outer surface of the hollow tube (330) [0101], and therefore under BRI (with the predetermined distance interpreted as the length of the hollow tube) the glucose sensor is located no more than a pre-determined distance away from the distal end as the glucose sensor must be located on the outer surface of the hollow tube (Yodfat, [0101], Figures 12a and 13a-13c)], wherein the glucose sensor (120, 121, 122) is a continuous amperometric or coulometric glucose sensor [under BRI the glucose sensor of Yodfat is an amperometric glucose sensor as it is a glucose sensor that utilizes the measurement of electric current] comprising an indicating electrode and a reference electrode (Yodfat, [0101], Figure 12a); and
(iii) an insulin infusion pump (1005) fluidically coupled to the proximal end of the insulin delivery cannula (330), wherein the insulin infusion pump (1005) is attached to the insulin delivery cannula (330) either directly or via an intervening tube (230, delivery tube) (Yodfat, Figure 12a),
wherein a lumen of the insulin delivery cannula (330) is contiguous with a lumen of tubing (230) that emerges from the insulin infusion pump (1005) (Yodfat, Figure 12a),
wherein electrical conductors (wires, 2100) for the indicating electrode and the reference electrode (Yodfat, [0101]-[0103], Figures 12a and 13a-13c) are disposed on a wall of the tubing or attached to a surface of the tubing (Yodfat, [0103], Figures 13a-13c) [The claim language “disposed on a wall of the tubing or attached to a surface of the tubing” is interpreted as “the hollow tube” (under BRI, see rejection under 35 U.S.C. 112(b) above)];
(b) connecting the proximal end of the hollow tube (230, 330) to the source of the concentrated insulin or insulin analog formulation (220) (Yodfat, Figure 12a) [the proximal end of the hollow tube (330) is connected to the source of the concentrated insulin or insulin analog formulation (220)];
(c) establishing an electrical connection with an electronic module (2200, processor-controller) located within a housing (200) that encloses the insulin infusion pump (1005) (Yodfat, [0101], Figure 12a); and
(d) inserting the glucose sensor (120, 121, 122) and the distal end of the hollow tube of the insulin delivery cannula (330) into the subcutaneous space of the subject simultaneously by a single insertion device (penetrating member, [0030]) (Yodfat, [0022] [0029]-[0030] [0037], Figure 12a). [While Yodfat does not explicitly disclose inserting the glucose sensor and the distal end of the hollow tube of the insulin delivery cannula into the subcutaneous space of the subject simultaneously by a single insertion device, Yodfat does disclose a tip (hollow tube) which is insertable into the body for both fluid delivery and for analyte monitoring (Yodfat, [0029]) using a single insertion device (penetrating member, [0030]), and one common insertion site along with the one tip for continuous insulin delivery and continuous glucose monitoring (Yodfat, [0037]). Therefore, it is inherent that the structure as taught by Yodfat is capable of performing the method as claimed.]
Yodfat further discloses in some embodiments (e) simultaneously (1) delivering the insulin or insulin analog formulation into a subcutaneous space of the subject using the insulin infusion pump, and (2) measuring the subcutaneous glucose concentration of the subject (Yodfat, [0022], Figure 12a). [Paragraph [0022] of Yodfat states “the tip functions as a probe for monitoring analyte levels within the body, for example, within the interstitial fluid (“ISF”) and at the same time as a cannula through which fluid is delivered to the body (hereinafter “tip”). Therefore, Yodfat simultaneously delivers insulin and measures the subcutaneous glucose concentration.]
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to simultaneously deliver insulin or insulin analog formulation into a subcutaneous space of the subject, and measure the subcutaneous glucose concentration of the subject as taught by Yodfat since it is a well-known configuration in the art for a system of continuous insulin delivery and continuous glucose monitoring (Yodfat, [0022] [0037] and [0100]-[0102], claim 52, Figure 12a).
Regarding Claim 100
Yodfat teaches the method of claim 92, wherein the glucose sensor (120, 121, 122) is disposed on an outer wall of the hollow tube (330) (Yodfat, [0102], Figure 12a).
Regarding Claim 101
Yodfat teaches the method of claim 92, wherein the electrical conductors (2100) for the indicating electrode and the reference electrode are disposed on the wall of the tubing (Yodfat, [0101]-[0103], Figures 12a and 13a-13c) [The claim language “disposed on a wall of the tubing” is interpreted as “the hollow tube” (under BRI, see rejection under 35 U.S.C. 112(b) above)].
Claim(s) 93-94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US 2010/0256593, in view of Voskanyan, US 2012/0046533.
Regarding Claim 93
Yodfat teaches the method of claim 92. However, Yodfat does not explicitly disclose that the insulin or insulin analog formulation comprises an excipient comprising a phenolic compound or cresol.
Voskanyan teaches that it is well known in the art for insulin to comprise an excipient comprising a phenolic compound or cresol in order to preserve the insulin (Voskanyan, [0008] [0017] [0020] and [0061]).
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to combine the insulin comprising an excipient comprising a phenolic compound or cresol as taught by Voskanyan with the system taught by Yodfat since this would provide the advantage of preserving the insulin.
Regarding Claim 94
Yodfat teaches the method of claim 92. However, Yodfat does not explicitly disclose that the pre-determined distance is about 7 mm.
Voskanyan teaches a pre-determined distance of about 7 mm (Voskanyan, [0064]).
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to combine the pre-determined distance of about 7 mm as taught by Voskanyan with that taught by Yodfat since this would provide the advantage of increased reliability and functionality, by reducing potential interference between the sensor and an infused drug (Voskanyan, [0064]).
Claim(s) 95-96 and 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US 2010/0256593, in view of Bommakanti et al., US 2012/0138484.
Regarding Claim 95
Yodfat teaches the method of claim 92, however, Yodfat does not teach that the glucose sensor comprises an electrode layer comprising the indicating electrode, wherein the electrode layer underlies a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand, and (2) an enzyme comprising glucose oxidase or glucose dehydrogenase.
Bommakani teaches a glucose sensor (101) (Bommakani, Figure 1) that comprises an electrode layer comprising the indicating electrode (Bommakanti, [0004]), wherein the electrode layer underlies a redox-catalytic layer (Bommakanti, [0019] and [0444]) comprising (1) a redox mediator comprising a metal compound (osmium, [0441]) covalently bound to a ligand (Bommakanti, [0441]), and (2) an enzyme comprising glucose oxidase or glucose dehydrogenase (Bommakanti, [0019] and [0442]).
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to modify the glucose sensor of Yodfat to include an electrode layer comprising the indicating electrode, wherein the electrode layer underlies a redox-catalytic layer comprising (1) a redox mediator comprising a metal compound covalently bound to a ligand, and (2) an enzyme comprising glucose oxidase or glucose dehydrogenase as taught by Bommakani since this would provide the advantage of preventing or reducing the diffusion loss of the electron transfer agent during the period of time that a sample is analyzed (Bommakani, [0439]).
Regarding Claim 96
Yodfat and Bommakanti teach the method of claim 95. Bommakanti further teaches that the glucose sensor further comprises an insulating layer (505) and a metal layer (501), wherein the insulating layer (505) is coupled to the metal layer (501), and wherein the metal layer (501) is coupled to the electrode layer (Bommakanti, [0427]-[0428], Figures 5A, 5B).
Regarding Claim 97
Yodfat and Bommakanti teach the method of claim 95. Bommakanti further teaches that the redox mediator and the enzyme allow electron transfer from subcutaneous glucose to the indicating electrode (Bommakanti, [0392] [0442] and [0444]) sufficient to cause a response of the glucose sensor to a subcutaneous glucose concentration of the subject at an applied bias potential of no more than about +300 millivolts (mV), +250 mV,+200 mV, +150 mV, +100 mV, or +50 mV relative to a reference electrode (Bommakanti, [0392] [0442] and [0444]).
Regarding Claim 98
Yodfat and Bommakanti teach the method of claim 97, wherein the applied bias potential of no more than about +250 mV, +200 mV, +150 mV, +100 mV, or +50 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of the excipient during continuous operation of at least one hour of the amperometric glucose sensor, thereby maintaining a sensitivity of the amperometric glucose sensor to the subcutaneous glucose concentration in presence of the concentrated insulin or insulin analog formulation (Bommakanti, [0392] [0442] and [0444]).
[The method as taught by Yodfat and Bommakanti in claim 97 is capable of performing the function of claim 98, as the subject matter of claim 98 is a functional limitation that the method of claim 97 would inherently perform.]
Regarding Claim 99
Yodfat and Bommakanti teach the method of claim 95. Bommakanti further teaches that the metal compound comprises a metal selected from the group consisting of: Osmium, Ruthenium, Palladium, Platinum, Rhodium, Iridium, Cobalt, Iron, and Copper (Osmium, Ruthenium) (Bommakanti, [0019]).
Claim(s) 102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al., US 2010/0256593, in view of Javey et al., US 2018/0263539.
Regarding Claim 102
Yodfat teaches the method of claim 92, however, Yodfat does not teach a transimpedance amplifier (TIA) is operably connected to the glucose sensor, wherein the TIA is configured to convert an electrical current generated by the glucose sensor to a voltage value.
Javey teaches a transimpedance amplifier (TIA) is operably connected to a glucose sensor (amperometric glucose sensor), wherein the TIA is configured to convert an electrical current generated by the glucose sensor to a voltage value (Javey, [0081]).
At the time the claimed invention was filed it would have been obvious to one of ordinary skill in the art to modify Yodfat to include a transimpedance amplifier (TIA) is operably connected to the glucose sensor, wherein the TIA is configured to convert an electrical current generated by the glucose sensor to a voltage value as taught by Javey, since this would provide the advantage of translating the electrical current output to volts in order to process the reading of the glucose sensor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L STANEK whose telephone number is (571)272-3565. The examiner can normally be reached Mon - Fri 8:30am-3:00pm.
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, MARK LAURENZI can be reached at 571-270-7878. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.L.S/Examiner, Art Unit 3746 12/19/2025
/MARK A LAURENZI/Supervisory Patent Examiner, Art Unit 3746 1/5/2026