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 Arguments
Regarding the previous claim objection, the amendment to claim 5 is acknowledged and the claim objection is withdrawn.
Applicant’s arguments, see pages 3-6, filed 06/26/2026, with respect to the rejection of claim 10 have been fully considered and are persuasive. The examiner agrees that Mark in view of Felder and Bettuchi fails to disclose or suggest “wherein in an engaged position the mounting piece is positioned distally relative to the first and second adapter casings…wherein the mounting piece defines a mounting piece channel that terminates in a closed distal end configured to receive a distal tip of the navigation element” as required in claim 10. Therefore, the 103 rejection over claims 10-13, 15, and 17-18 have been withdrawn. Claims 10, 15-18, and 20 are allowed. Claims 11, 12, and 14 are still rejected under 112(b) or 112(d), see below.
Applicant's arguments filed 06/26/2026 have been fully considered but they are not persuasive.
Claims 1, 3-7, and 9
Applicant argues that Mark in view of Felder fails to disclose or suggest the retaining member "is received at the reduced diameter section between the wider diameter sections to capture the locking member and restrict axial movement of the locking member relative to the receiving aperture" as required in amended claim 1. Applicant explains that Felder utilizes the locking member having the wider diameter sections in between the reduced diameter section to permit selective axial and rotational movement states of the drill sleeve relative to surrounding components, depending on thread engagement conditions. Applicant asserts that Felder fails to disclose any structure or function in which the reduced diameter region serves as a capture interface for a retaining element.
In response to applicant's argument that “Felder fails to disclose any structure or function in which the reduced diameter region serves as a capture interface for a retaining element”, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The examiner notes that the rejection of claim 1 is interpreted under a new interpretation of Mark in view of Felder that does not rely on simple substitution. Mark already discloses the retaining element as claimed. Mark further discloses that when the retaining member contacts the threaded portion of the locking member 110, the engagement prevents axial movement of the locking member (para. 0106 of Mark: “Retaining member 114 is positioned within channel 186 so as to extend above the threads of locking member 110 such as locking member 110 is being removed from receiving aperture 182, threads come into contact retaining member 114, thereby preventing complete removal of locking member 110 from handle portion 170”). Feldman teaches a known threaded configuration of a locking member and further teaches that when a protrusion is in contact with either threaded wider diameter sections, axial movement is prevented (para. 0046 of Felder: “As will be described in greater detail below, the blocking element 112 is movable relative to the housing 104 so that, in a first position, the protrusion 158 frictionally engages the drill sleeve 116 to prevent axial movement thereof and, in a second position, the protrusion 158 does not contact the drill sleeve 116. Specifically, in the first position, the protrusion 158 frictionally engages one of the first and second threaded portions 184, 188”). Therefore, one of ordinary skill in the art would understand that modifying the locking member of Mark with the threaded wider diameter sections/reduced diameter section configuration taught by Felder would result in the threaded wider diameter sections creating a boundary for the retaining member of Mark to be is received at the reduced diameter section and restrict axial movement of the locking member relative to the receiving aperture as claimed.
Applicant argues that modifying the locking member of Mark to include the two wider diameter sections would fundamentally alter the operating principle of Mark and is not simple substitution.
Applicant’s arguments with respect to the rejection relying on simple substitution has been considered but are moot because the new ground of rejection does not rely on the simple substitution rejection applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that “the proposed combination suffers from a fundamental functional incompatibility. In Mark, the retaining member must engage a threaded surface to prevent axial withdrawal of the locking member. In Felder, the reduced diameter section is specifically non-threaded and is not intended for such engagement. Positioning the retaining member within Felder's reduced diameter section would therefore defeat the very mechanism by which Mark achieves retention” (see page 3, first full paragraph of the remarks).
The examiner acknowledges applicant’s argument and directs applicant to the response to amended claim 1 above).
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:
“a positioning member” in claims 1 and 18. The limitation describing the positioning member in claims 1 and 18 (“wherein the positioning member extends from the distal end of the adapter body” in claim 1 and “extending distally from a distal end of the mounting piece”) fails to include sufficient structure to perform the recited function of "positioning". In the specification, the positioning member is described as comprising a body section and tip member that narrows from the body section to an adapter distal tip (para. 0051). Therefore, the positioning member is interpreted as member having a body section that narrows into a distal tip or any structural equivalents thereof that extends from the distal end of the adapter body.
“retaining member” in claims 1 and 10. The limitation describing the retaining member in claims 1 and 10 (“is configured to be positioned in the retaining channel and disposed adjacent to the reduced diameter section”) fails to include sufficient structure to perform the recited function of "retaining". In the specification, there is no specific structural language to describe the retaining member. Therefore, the retaining member is interpreted as a member that can be positioned in the retaining channel, disposed adjacent to the reduced diameter section or any structural equivalents thereof used to prevent the locking mechanism from being disengaged from the adapter (para. 0058).
“mounting piece” in claims 10 and 20. The limitation describing the mounting piece in claims 10 and 20 (“engaged with the first and second adapter casings”) fails to include sufficient structure to perform the recited function of "mounting". In the specification, the mounting piece is described as comprising a securing portion to secure to the first and second adapter casings (para. 0065). Therefore, the mounting piece is interpreted as a piece having a securing portion or any structural equivalents thereof that engages or secures to the first and second adapter casings.
“securing portion” in claim 13. The limitation describing the securing portion in claim 13 (engages with the engagement channel of the first adapter casing and the engagement channel of the second adapter casing”) fails to include sufficient structure to perform the recited function of "securing". In the specification, the securing portion is “defined by a flange member that is spaced from a proximal face such that an annular groove is formed between the flange member and the proximal face” (para. 0071). Therefore, the securing portion is interpreted as a flange member that is spaced from a proximal face such that an annular groove is formed between the flange member and the proximal face or any structural equivalents thereof that engages with the engagement channel of the first adapter casing and the engagement channel of the second adapter casing.
“one or more first cooperating members” and “one or more second cooperating members” in claim 14. The limitation describing the one or more first and second cooperating members in claim 14 (“configured to engage with the one or more first cooperating members of an inner surface of the first adapter casing to connect the first and second adapter casings together”) fails to include sufficient structure to perform the recited function of "cooperating". In the specification, the one or more first cooperating member is defined as “a detent” having a thickened end (para. 0064) and the one or more second cooperating member is defined as “an indentation” (para. 0067). Therefore, the one or more first and second cooperating members are interpreted the detent and indentation as described aboce or any structural equivalents thereof that engages each other to connect the first and second adapter casings together.
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
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 11 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "a distal end of the first adapter casing" in lines 2-3. It is unclear to the examiner if the limitation is meant to further define the distal end of the first adapter casing introduced in claim 10. For examination purposes, "a distal end of the first adapter casing" is interpreted as "the distal end of the first adapter casing".
Claim 11 recites the limitation "a distal end of the second adapter casing" in line 4. It is unclear to the examiner if the limitation is meant to further define the distal end of the second adapter casing introduced in claim 10. For examination purposes, "a distal end of the second adapter casing" is interpreted as "the distal end of the second adapter casing".
Claim 14 recites the limitation "an inner surface of the first adapter casing" in line 4. It is unclear to the examiner if the limitation is meant to further define the inner surface of the first adapter casing introduced in claim 10. For examination purposes, "an inner surface of the first adapter casing " is interpreted as "the inner surface of the first adapter casing ".
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites “wherein a portion of the mounting piece is disposed within a portion of an inner surface of the first adapter casing and a portion of an inner surface of the second adapter casing to secure the mounting piece to the first and second adapter casings”. This limitation fails to further limit the subject matter of claim 10 which already recites “wherein a portion of the mounting piece is disposed within a portion of an inner surface of the first adapter casing and a portion of an inner surface of the second adapter casing to secure the mounting piece to the first and second adapter casings”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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) 1, 3-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mark et al. (US 20140187922) [hereinafter Mark] in view of Felder (US 20140081281).
Regarding claim 1, Mark discloses an adapter 168, 170 for use with a surgical access assembly 100 (Figs. 2, 7, para. 0080, 0101), comprising:
an adapter body (interpreted as body of handle portion 170 and body portion 168) and a positioning member 172 (see annotated Fig. 8A below, Figs. 7A-8B, para. 0101);
wherein the adapter body is defined by a distal end and a proximal end 166 opposite the distal end (see annotated Fig. 8A below);
wherein the positioning member 172 extends from the distal end of the adapter body (see annotated Fig. 8A below, Figs. 7A-B, 8A, para. 0101-0102); and
wherein a channel 191, 198 configured for receiving a navigation element 112 extends through the adapter body, from the proximal end and toward the distal end (Figs. 7A, 8A, 9A, para. 0102, 0107, 0114),
the adapter body further comprising a locking mechanism which includes a receiving aperture 182 that receives a locking member 110 having a reduced diameter section (interpreted as section in between an enlarged portion and threaded portion the locking member 110), a retaining channel 186 (see Fig, 8A, para, 0106), and a retaining member 114 (not shown but described in para. 0081, 0106), wherein the retaining member 114 is configured to be positioned in the retaining channel 186 (Fig. 8A, para. 0106) and is received at the reduced diameter section to capture the locking member 110 and restrict axial movement of the locking member 110 relative to the receiving aperture 182 (para. 0106: “Retaining member 114 is positioned within channel 186 so as to extend above the threads of locking member 110 such as locking member 110 is being removed from receiving aperture 182, threads come into contact retaining member 114, thereby preventing complete removal of locking member 110 from handle portion 170”).
However, Mark fails to disclose the reduced diameter section in between wider diameter sections of the locking member, wherein each of the wider diameter sections are threaded sections and wherein the wider diameter sections are spaced apart from each other, and wherein the retaining member is configured to be received at the reduced diameter section between the wider diameter sections to capture the locking member.
Felder in the same field of endeavor of locking mechanisms teaches that it is known in the art to configure threads as a reduced diameter section 186 in between wider diameter sections 184, 188 of a locking member 116 (Figs. 15-17, para. 0048) and adjacent to an enlarged end 177 (Fig. 16, para. 0048: “The drill sleeve 116 extends from a proximal end 176 comprising a head 177 to a distal end 180 comprising a shaft 178 a longitudinal axis 182”), wherein each of the wider diameter sections 184, 188 are threaded sections (Figs. 15-17, para. 0048) and wherein the wider diameter sections 184, 188 are spaced apart from each other (Figs. 15-17, para. 0048) to prevent axial movement by way of engagement with a protrusion (para. 0046: “As will be described in greater detail below, the blocking element 112 is movable relative to the housing 104 so that, in a first position, the protrusion 158 frictionally engages the drill sleeve 116 to prevent axial movement thereof and, in a second position, the protrusion 158 does not contact the drill sleeve 116. Specifically, in the first position, the protrusion 158 frictionally engages one of the first and second threaded portions 184, 188”).
Thus, one skilled in the art would have readily recognized that providing the locking member of Mark with the reduced diameter section between two threaded sections, as taught by Felder, would provide for enhanced securement of the retaining member by further sectioning the reduced diameter section such that it is positioned between the threaded sections, thereby preventing axial translation when engaged with the retaining member of the locking member (see quote from para. 0046 of Felder above).
The combination of Mark in view of Felder would result in a product wherein the retaining member 114 of Mark (Fig. 9A, para. 0095) is configured to be received at the reduced diameter section between the wider diameter sections to capture the locking member (see quote from para. 0106 of Mark above).
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Annotated Fig. 8A of Mark
Regarding claim 3, modified Mark discloses wherein the channel 191, 198 terminates in a closed distal end that defines a seating portion 199 (Figs. 9A-B, para. 0114, 0141 of Mark discloses that first channel segment 191 extends into body portion 168 to second channel segment 198 which terminates in a closed distal end that defines a seating portion).
Regarding claim 4, modified Mark discloses wherein the adapter body further includes a window 194 providing visual access to the channel 191, 198, adjacent the seating portion 199 (Fig. 7A, para. 0110 of Mark).
Regarding claim 5, modified Mark discloses wherein the distal end tapers inwardly to define the seating portion (Figs. 9A-B, para. 0114, 0141 of Mark illustrates discloses the closed distal end of the channel tapers inwardly to define the seating portion).
Regarding claim 6, modified Mark discloses wherein the adapter body further includes a grip portion 178 disposed adjacent to the proximal end of the adapter body (Fig. 8A, para. 0105 of Mark).
Regarding claim 7, modified Mark discloses wherein the positioning member 172 includes a tip member 174 that tapers from a first diameter to a second diameter (Figs. 8A-B, para. 0101 of Mark).
Regarding claim 9, modified Mark discloses wherein the adapter body includes an engagement section that includes an annular angled surface encircling the proximal end of the positioning member (see annotated Fig. 8D of Mark below).
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Annotated Fig. 8D of Mark
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mark et al. (US 20140187922) [hereinafter Mark] in view of Felder (US 20140081281) as applied to claim 1 above, and further in view of Kahle et al. (US 20050065543) [hereinafter Kahle].
Regarding claim 8, Mark discloses all of the limitations set forth above in claim 1. However, Mark is silent on the material forming the adapter body and therefore fails to disclose wherein at least a portion of the adapter body is made of a transparent material.
Kahle in the same field of endeavor teaches an obturator 18 comprising an adaptor body 25, 21 (interpreted as handle 25 and shaft 21 of obturator), wherein at least a portion of the adapter body is made of a transparent material (para. 0061 discloses that the shaft 21 may be formed from a transparent polycarbonate material).
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 material of the body portion of the adapter in Mark to include the transparent material of Kahle since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
Allowable Subject Matter
Claims 10, 15-18, and 20 are allowed.
Claims 11, 12, and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) and 112(d), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Mark et al. (US 20140187922) does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of claims 13 and 16, which recites, inter alia “wherein in an engaged position the mounting piece is positioned distally relative to the first and second adapter casings…wherein the mounting piece defines a mounting piece channel that terminates in a closed distal end configured to receive a distal tip of the navigation element” as required in claim 10. Felder (US 20140081281) and Bettuchi et al. (US 20100094228) fail to cure the deficiencies of claim 10. See pages 3-6 of remarks filed 06/26/2026 for the reasons for allowance of claim 10.
Because none of the prior art documents teach the adapter as claimed, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the technical solutions of claim 10 according to the prior art documents or a combination thereof. Therefore, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771