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 .
Status of Claims
This office action is responsive to the amendment filed 7 January 2026.
Claim 1 is amended.
Claims 1-14 are presently pending in this application.
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.
The following claim limitations are being interpreted under 35 U.S.C. 112(f):
“elastic means” in claim 9. The passage below from paragraph 0031 of the disclosure provides the supporting structure:
“With regard to Figs. 2 and 3, the proximal unit 122 of the case 120 encloses
elastic means under the form of a cylindrical spring 140 enclosing a locking clip 150 and a defecting member 160. The cylindrical spring 140 is adapted to be in pushing engagement on the proximal face of the stop portions 133 of the needle shield 130 and on an opposite surface of the proximal unit 122 of the case 120.”
“safety locking means” in claim 12. The passage below from paragraph 0041 of the disclosure provides the supporting structure:
“In the safety position shown in Fig. 14, the needle shield 130 can be blocked or fixed with regard to the case 120 by engagement of the pegs 135 located on the rigid arms 132 of the needle shield 130, with corresponding recesses or abutments located on the inside surface of the case 120 (not represented), thus acting as safety locking means.”
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sall (US Patent Publication No. 20170165428 A1) in view of Emmott et al. (US Patent Publication No. 20090227956 A1), hereinafter Emmott.
Regarding claim 1, Sall discloses an injection device (Sall: Fig. 1, device 10) for injecting a substance into a body (para. 0035), comprising: a barrel (Fig. 2, medicament container 20) adapted to receive the substance and provided with a stopper (Fig. 2, stopper 22) in sliding engagement inside the barrel (Fig. 2, stopper 22 moveable in longitudinal direction inside medicament container 20; para. 0035) and with an injection needle (Fig. 2, medicament delivery member 23); a plunger rod (Fig. 3, plunger rod 52) configured to push the stopper (plunger rod 52 acts on stopper 22; para. 0055) and moveable (para. 0051) in order to inject the substance when a pushing force is applied to the plunger rod (plunger rod 52 moves stopper 22 to expel medicament; para. 0055), a locking clip (Fig. 3, comprising actuator 42 and lock sleeve 58) fixed relative to the barrel (Fig. 6a and 7a, medicament container 20 and actuator 42 are fixed in relation to one another, as they do not move when the plunger rod 52 is extended) and provided with at least two jaws (Fig. 3, arms 46) adapted for engaging the plunger rod (arms 46 engaged with cutouts 54 of plunger rod 52; para. 0049) in a primary position of the plunger rod (Fig. 3, plunger rod 52), so as to prevent an injection movement of the plunger rod (Fig. 3, plunger rod 52) with regard to the barrel (Fig. 2, plunger rod 52 is held in position relative to actuator 42 by arms 46 and, thus, prevent injection movement; para. 0049), and a needle shield (Fig. 5A, delivery member cover 26) comprising a triggering portion (Fig. 2, end surfaces 32; para. 0037-0038), said needle shield (Fig. 5A, delivery member cover 26) being configured in sliding engagement with respect to the injection needle (Fig. 2, medicament delivery member 23), so as to define an initial position in which the needle shield (Fig. 5A, delivery member cover 26) covers the injection needle (Fig. 2, medicament delivery member 23; para. 0054) and a retracted position in which the needle shield (Fig. 5A, delivery member cover 26) does not cover at least a portion of the injection needle (Fig. 2, medicament delivery member 23); wherein the triggering portion (Fig. 2, arms 30 and end surfaces 32; para. 0037-0038) flexes the at least two jaws (Fig. 3, movement of cover 26 causes arms 30 to contact locking sleeve 58, flexing the arms 46 radially outwards; para. 0054) when the needle shield (Fig. 5A, delivery member cover 26) moves from the initial position to the retracted position, so as to disengage the locking clip (Fig. 3, actuator 42) from the plunger rod (Fig. 3, plunger rod 52) and to allow the injection movement of the plunger rod (Fig. 3, plunger rod 52; para. 0054).
Sall does not expressly disclose that the jaws are rotated.
Emmott teaches jaws (Emmott: Fig. 10, cantilever arms 9) that are rotated (Fig. 13, cantilever arms 9 are rotated in direction of arrow B; para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall such that the jaws are rotated as taught by Emmott in order to allow for a resultant force to be produced, allowing for the locking clip to return to a position (Emmott: para. 0057).
Regarding claim 2, Sall in view of Emmott discloses the injection device above, wherein the plunger rod (Fig. 3, plunger rod 52) comprises an intermediate stop (Fig. 3, cut-outs 54) and the two jaws (Fig. 3, arms 46) of the locking clip (Fig. 3, actuator 42) are arranged to engage said intermediate stop (Fig. 3, cut-outs 54) in the primary position of the plunger rod (Fig. 3, plunger rod 52; para. 0042 and 0049).
Regarding claim 14, Sall in view of Emmott discloses the injection device above, wherein the needle shield (Fig. 5A, delivery member cover 26) further comprises at least one longitudinal arm (Fig. 2, arms 30) extending along the barrel (Fig. 2, medicament container 20) and comprising an extremity provided with the triggering portion (Fig. 2, end surfaces 32; para. 0037-0038).
Claims 3-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sall in view of Emmott, in further view of Barrelle (US Patent Publication No. 20030212380 A1).
Regarding claim 3, Sall in view of Emmott discloses the injection device above, wherein the needle shield (Fig. 5A, delivery member cover 26) is further moveable to a safety position in which the needle shield (Fig. 5A, delivery member cover 26) covers permanently the injection needle (Sall: Fig. 2, medicament delivery member 23).
Sall does not expressly disclose that the injection device further comprises an operating stop configured to prevent the needle shield to move to the safety position, a flexible support supporting the operating stop and fixed with regard to the barrel, a deflecting member configured to contact the operating stop and/or the flexible support and to receive the pushing force from the plunger rod when the plunger rod is moved to a threshold position; wherein the deflecting member is further configured to move under said pushing force so as to deflect the flexible support and to release the operating stop.
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Barrelle teaches an injection device (Barrelle: Fig. 5, comprised of shield system 20 and syringe 120) comprising an operating stop (Fig. 2 and 12, radial portion 60) configured to prevent the needle shield (Fig. 2 and 12, needle shield 24) to move to the safety position (radial portion 60 releasably retain needle cover 24; para. 0045), a flexible support (Fig. 2 and 12, fingers 56) supporting the operating stop (Fig. 2 and 12, radial portion 60) and fixed with regard to the barrel (Fig. 2 and 5, fingers 56 are fixed to shield system 20, which is fixed to syringe 120), a deflecting member (Fig. 12, annular body portion 68 comprising camming surfaces 84) configured to contact the flexible support (camming surfaces 84 are driven against camming surfaces 62 of fingers 56; para. 0051) and to receive the pushing force from the plunger rod (Fig. 18A-18C and 19A as shown, abutment surface A transmits pushing force of plunger rod 132 to annular body portion 68; para. 0051) when the plunger rod (Fig. 8 and 9, plunger rod 132) is moved to a threshold position (Fig. 9, plunger rod 132 is in threshold position; para. 0051); wherein the deflecting member (Fig. 12, annular body portion 68 comprising camming surfaces 84) is further configured to move under said pushing force so as to deflect the flexible support (Fig. 19C, fingers 56 are deflected by contact of camming surfaces 84 with camming surfaces 62; para. 0051) and to release the operating stop (Fig. 19C, radial portion 60 is released when fingers 56 are deflected; para. 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott such that the injection device further comprises an operating stop configured to prevent the needle shield to move to the safety position, a flexible support supporting the operating stop and fixed with regard to the barrel, a deflecting member configured to contact the operating stop and/or the flexible support and to receive the pushing force from the plunger rod when the plunger rod is moved to a threshold position; wherein the deflecting member is further configured to move under said pushing force so as to deflect the flexible support and to release the operating stop as taught by Barrelle in order to allow the needle shield to move distally relative to the syringe (Barrelle: para. 0052).
Regarding claim 4, Sall in view of Emmott and Barrelle discloses the device above.
Sall in view of Emmott does not expressly disclose the deflecting member comprises: an abutment surface configured to receive the pushing force of the plunger rod when the plunger rod is in the threshold position and a sloped portion configured to slide on the flexible support and/or the operating stop so as to deflect the flexible support when the deflecting member moves under the pushing force of the plunger rod.
Barrelle teaches a deflecting member (Barrelle: Fig. 12 and 16B, annular body portion 68) comprising: an abutment surface (Fig. 18A-18C and 19A as shown, abutment surface A) configured to receive a pushing force of a plunger rod (Fig. 18A-18C and 19A as shown, abutment surface A transmits pushing force of plunger rod 132 to annular body portion 68; para. 0051) when the plunger rod (Fig. 8 and 9, plunger rod 132) is in a threshold position (Fig. 9, plunger rod 132 is in threshold position; para. 0051) and a sloped portion (Fig. 12, camming surfaces 84) configured to slide on a flexible support (Fig. 2 and 12, camming surfaces 84 slide along camming surfaces 62 of fingers 56; para. 0051) so as to deflect the flexible support (Fig. 2 and 12, fingers 56 and deflected; para. 0051) when a deflecting member (Fig. 12 and 16B, annular body portion 68) moves under the pushing force of the plunger rod (Fig. 8 and 9, plunger rod 132).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the deflecting member of Sall in view of Emmott to comprise an abutment surface configured to receive the pushing force of the plunger rod when the plunger rod is in the threshold position and a sloped portion configured to slide on the flexible support so as to deflect the flexible support when the deflecting member moves under the pushing force of the plunger rod as taught by Barrelle in order to allow the needle shield to move distally relative to the syringe (Barrelle: para. 0052).
Regarding claim 5, Sall in view of Emmott and Barrelle discloses the injection device above
Sall in view of Emmott does not expressly disclose the plunger rod comprises a pushing surface adapted to transmit the pushing force to the abutment surface of the deflecting member.
Barrelle teaches a plunger rod (Barrelle: Fig. 8 and 9, plunger rod 132) comprises a pushing surface (Fig. 18A-18C, radial finger flange 126) adapted to transmit the pushing force to the abutment surface (Fig. 18A-18C as shown, flange 126 contacts and pushes against abutment surface A) of the deflecting member (Fig. 12 and 16B, annular body portion 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plunger rod of Sall in view of Emmott to comprise a pushing surface adapted to transmit the pushing force to the abutment surface of the deflecting member as taught by Barrelle in order to allow the needle shield to move distally relative to the syringe (Barrelle: para. 0052).
Regarding claim 6, Sall in view of Emmott and Barrelle discloses the injection device above, wherein the injection device further comprises a case (Sall: Fig. 2, comprised of proximal housing part 12 and distal housing part 14) accommodating the locking clip (Sall: Fig. 2, housing parts 12 and 14 accommodate actuator 42 of drive mechanism 40), the barrel (Sall: Fig. 2, housing parts 12 and 14 accommodate medicament container 20), and the needle shield (Sall: Fig. 2, housing parts 12 and 14 accommodate tubular part 28 of cover 26).
Sall in view of Emmott does not expressly disclose the case further accommodating the deflecting member, and wherein the operating stop and the flexible support are fixed to or are part of the case.
Barrelle teaches a case (Barrelle: Fig. 19A, body 22) accommodating a deflecting member (Fig. 19A, body 22 accommodates annular body portion 68), and wherein an operating stop (Fig. 2, 12, and 19A, operating stop 60) and a flexible support (Fig. 2, 12, and 19A, fingers 56) are fixed to or are part of the case (Fig. 19A, operating stop 60 contacts ledges 42 and fixes fingers 56 in place; para. 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott such that the case further accommodates the deflecting member, and wherein the operating stop and the flexible support are fixed to or are part of the case as taught by Barrelle in order to limit axial movement of the tubular shield (Barrelle: para. 0048).
Regarding claim 7, Sall in view of Emmott and Barrelle discloses the injection device above, wherein the case (Sall: Fig. 2, comprised of proximal housing part 12 and distal housing part 14) comprises: a distal unit (Fig. 2, proximal housing part 12) accommodating the needle shield (housing part 12 accommodates tubular part 28 of cover 26) and the barrel (Fig. 2, housing part 12 accommodates medicament container 20) and a proximal unit (Fig. 2, housing part 14) accommodating the locking clip (Fig. 2, housing part 14 accommodates actuator 42 of drive mechanism 40).
Sall in view of Emmott does not expressly disclose the proximal unit accommodates the deflecting member.
Barrelle teaches a proximal unit (Barrelle: Fig. 19A, proximal portion of body 22) accommodating a deflecting member (Fig. 19A, proximal portion of body 22 accommodates annular body portion 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date to i modify the device of Sall in view of Emmott such that the proximal unit accommodates the deflecting member as taught by Barrelle in order to receive the plunger rod (Barrelle: para. 0048).
Regarding claim 8, Sall in view of Emmott and Barrelle discloses the injection device above, wherein the distal unit (Sall: Fig. 2, proximal housing part 12) of the case (Fig. 2, comprised of proximal housing part 12 and distal housing part 14) comprises a longitudinal window (Fig. 1, window 18 is arranged longitudinally on housing part 14) giving a visual access to the barrel (medicament container 20 is visible through window 18; para. 0035).
Regarding claim 9, Sall in view of Emmott and Barrelle discloses the injection device above, wherein the injection device further comprises elastic means (Sall: Fig. 2 and 5A-8A, cover spring 34) arranged in pushing engagement with the needle shield (Fig. 5A-8A, cover spring 34 arranged on cover 26; para. 0038) so as to move the needle shield (Fig. 5A-8A, cover 26) from the retracted position to the initial position and/or to the safety position (para. 0058).
Regarding claim 11, Sall in view of Emmott and Barrelle discloses the device above.
Sall in view of Emmott does not expressly disclose the deflecting member comprises a longitudinal tab adapted to pop up from the case when the deflecting member moves under the pushing force of the plunger rod.
Barrelle teaches a deflecting member (Barrelle: Fig. 12 and 16B, annular body portion 68) comprises a longitudinal tab (Fig. 11, 12, and 18A-18C, legs 70) adapted to pop up from a case (Fig. 19A, proximal portion of body 22 accommodates annular body portion 68) when the deflecting member (Fig. 12 and 16B, annular body portion 68) moves under the pushing force of a plunger rod (Fig. 18A-18C, when plunger rod 132 is driven down, legs 70 flex outwards from the body 22; para. 0050).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott such that the deflecting member comprises a longitudinal tab adapted to pop up from the case when the deflecting member moves under the pushing force of the plunger rod as taught by Barrelle in order to release the interlock between the body and deflecting member (Barrelle: para. 0050).
Regarding claim 12, Sall in view of Barrelle disclose the device above.
Sall in view of Emmott does not expressly disclose the device further comprising safety locking means adapted to lock the needle shield to the case when the needle shield in the safety position.
Barrelle teaches a safety locking means (Barrelle: Fig. 20, radial rib 54 of the needle shield 24 engages with detents 48 of the body 22; para. 0053) adapted to lock the needle shield (Fig. 12 and 20, needle shield 24) to the case (Fig. 12 and 20, body 22) when the needle shield (Fig. 12 and 20, needle shield 24) in the safety position (para. 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott to comprise a safety locking means adapted to lock the needle shield to the case when the needle shield in the safety position as taught by Barrelle in order to prevent retraction of the needle shield in the extended position (Barrelle: para. 0053).
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sall in view of Emmott and Barrelle, in further view of Stefansen (US Patent Publication No. 20160106920 A1).
Regarding claim 10, Sall in view of Emmott and Barrelle discloses the injection device above.
Sall in view of Barrelle does not expressly disclose the elastic means being accommodated in the proximal unit of the case.
Stefansen teaches an elastic means (Stefansen: Fig. 1, compression spring 680) accommodated in the proximal unit (Fig. 1, compression spring 680 is accommodated in the top housing 120) of the case (Fig. 1, comprised of housing 110 and 120).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott and Barrelle such that the elastic means is accommodated in the proximal unit of the case as taught by Stefansen in order to provide a distally directed force (Stefansen: para. 0060).
Regarding claim 13, Sall in view of Emmott and Barrelle discloses the injection device above.
Sall in view of Emmott does not expressly disclose the safety locking means comprise at least one recess provided on the other of the case and the needle shield, the recess being adapted to accommodate and hold the peg in the safety position of the needle shield.
Barrelle teaches a safety locking means (Barrelle: Fig. 20, radial rib 54 of the needle shield 24 engages with detents 48 of the body 22; para. 0053) comprise at least one recess (Fig. 20, detents 48) provided on a case (Fig. 12 and 20, body 22) and at least one radial rib (Fig. 12 and 20, radial rib 54) provided on a needle shield (Fig. 12 and 20, needle shield 24), the recess (Fig. 20, detents 48) adapted to accommodate and hold the radial rib (Fig. 12 and 20, radial rib 54) in the safety position (para. 0053) of the needle shield (Fig. 20, radial rib 54 of the needle shield 24 engages with detents 48 of the body 22; para. 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Sall in view of Emmott such that the safety locking means comprise at least one recess provided on the other of the case and the needle shield, the recess being adapted to accommodate and hold the peg in the safety position of the needle shield as taught by Barrelle in order to prevent retraction of the needle shield in the extended position (Barrelle: para. 0053).
Sall in view of Emmott and Barrelle does not expressly disclose at least one peg provided on one of the case and the needle shield.
Stefansen teaches a peg (Stefansen: Fig. 1, radially protruding surface 153) provided on a needle shield (Fig. 1, needle shield 150).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the radial rib of Sall in view of Emmott and Barrelle to be a peg provided on the needle shield as taught by Stefansen in order to keep the needle shield in the distal position (Stefansen: para. 0067). Furthermore, it would have been an obvious matter of design choice to make the peg or radial rib of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 7 January 2026, with respect to the rejections of claims 1-14 under 35 USC 102(a)(2) and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Sall in view of Emmott cited above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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