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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 02/02/2026. Claim 1 is amended. Claim 5 is cancelled. Claims 7-11 are new. Claims 1-4 and 6-11 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/02/2026, with respect to the rejection(s) of claim(s) 1-4 and 6 under 35 U.S.C. 102(a)(1) as being anticipated by Nevyas-Wallace, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Nevyas-Wallace fails to disclose the projections and recesses present when the protective assembly is in its fully expanded configuration (Remarks, pg. 4).
In response to applicant’s first argument, Nevyas-Wallace discloses an expanded configuration in which band 52 is utilized to provide maximum displacement of leaves 20 and 30 (para. [0055]; fig. 16). It is understood band 52 limits the amount of movement and opening of the membrane via leaves 20 and 30, such that the maximum amount the leaves are allowed to expand is considered a fully expanded configuration of the membrane. Therefore, the claimed limitation is met, because fig. 16 depicts a fully expanded configuration in which movement of the leaves 20 and 30 relative to each other is limited by the band.
Applicant further argues Nevyas-Wallace fails to disclose a convergent peripheral portion and a flexible connector extending from the membrane (Remarks, pgs. 4-5).
In response to applicant’s second argument, it is respectfully submitted the new limitations are met as discussed below. Nevyas-Wallace discloses a converging peripheral portion of the membrane due to pivoting of leaves 20 and 30 such that the membrane converges towards the pivot (see fig. 16). Leaves 20 and 30 also include a flexible band 52 which extends from the membrane due to attachment to leaves 20 and 30.
Applicant further argues the amendments address and obviate the double patenting rejection (Remarks, pg. 5).
In response to applicant’s third argument, it is respectfully submitted the newly added claim limitations are still taught by Nevyas-Wallace as discussed below, such that the rejection is maintained.
Claim Objections
Claim 7 is objected to because of the following informalities: In claim 7, line 6, the phrase “that an two adjacently” should read “that any two adjacently”. Appropriate correction is required.
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) 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nevyas-Wallace (US 2010/0312253 A1) (previously of record).
Regarding claim 1, Nevyas-Wallace discloses (see abstract; paras. [0032]-[0036]; figs. 11-16) a protective assembly (fig. 16) for use during laparoscopic surgery (note this limitation recites intended use and does not result in a structural difference between the claimed invention and the device of Nevyas-Wallace, see MPEP 2111.02(II)), the assembly comprising:
a thin membrane (60, para. [0032]) formed from non-toxic material (polyethylene considered to be non-toxic since membrane 60 is inserted within the eye, para. [0032]), the membrane being sufficiently thin and maneuverable to be passed through a cannula of a trocar (sufficiently thin and flexible, considered to be capable of being passed through a cannula as the cannula of a trocar is not positively recited, para. [0032]) wherein the membrane comprises variable thickness (depicted in fig. 16, considered to be consistent with the instant spec. which describes overall thickness as including depth and height of the projections/recesses, such that depth and height is considered to contribute to thickness of the membrane, para. [0153] of published application) with opposed major membrane surfaces (includes front-facing and back-facing surfaces of 60, annotated fig. 16) being separated by a thickness of the membrane (thickness of 60 considered to separate surfaces), each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess (pleats formed by folding, considered to have rows when folded, para. [0033]; annotated fig. 16) configured to provide heat insulation to a tissue when the protective assembly is in a fully expanded configuration (considered to be capable of providing heat insulation to tissue when the instrument is in the fully expanded configuration, as this limitation is recited functionally and only recites intended use; further, pleats 62 would provide a level of insulation to tissue when fully expanded, see fig. 16 depicting band 52 constricting leaves 20 and 30 such that the device is considered to be fully expanded when maximum displacement of the device is reached due to band 52 limiting movement, para. [0035]; fig. 16), wherein the thickness of a portion of the membrane in between the any two adjacently located projections separated by a recess is substantially less than the average height of the projections and/or average depth of the recesses (depicted in fig. 16, average height and depth considered to be the height and depth of projections/recesses when membrane is folded, thickness of 60 is less than height/depth of projections and recesses) and wherein the membrane forming the projections comprises solid sheet material (formed by a thin sheet, depicted in fig. 16).
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Annotated Figure 16 of Nevyas-Wallace
Regarding claim 2, Nevyas-Wallace discloses the assembly of claim 1. Nevyas-Wallace further discloses wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough (fig. 16) and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces (aligned with projection on opposite surface when folded, fig. 16).
Regarding claim 3, Nevyas-Wallace discloses the assembly of claim 2. Nevyas-Wallace further discloses wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses (see annotated fig. 16 depicting an extending direction of the projections across from a direction of the rows of projections and recesses; note the claim language does not recite the specific direction of the rows of projections and recesses, such that any direction forming the rows of projections and recesses meets the claimed limitation).
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Annotated Figure 16 of Nevyas-Wallace
Regarding claim 4, Nevyas-Wallace discloses the assembly of claim 1. Nevyas-Wallace further discloses wherein average height of the projections is substantially equal to average depth of the recesses (accordion-style pleats considered to form projections/recesses of similar height/depth, depicted in fig. 16).
Regarding claim 6, Nevyas-Wallace discloses the assembly of claim 1. Nevyas-Wallace further discloses wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration (fig. 16).
Regarding claim 7, Nevyas-Wallace discloses (see abstract; paras. [0032]-[0036]; figs. 11-16) a protective assembly (fig. 16) for use during laparoscopic surgery (note this limitation recites intended use and does not result in a structural difference between the claimed invention and the device of Nevyas-Wallace, see MPEP 2111.02(II)), the assembly comprising: a thin membrane (60, para. [0032]) formed from non-toxic material (polyethylene considered to be non-toxic since membrane 60 is inserted within the eye, para. [0032]), the membrane being sufficiently thin and maneuverable to be passed through a cannula of a trocar (sufficiently thin and flexible, considered to be capable of being passed through a cannula as the cannula of a trocar is not positively recited, para. [0032]) wherein the membrane comprises variable thickness (depicted in fig. 16, considered to be consistent with the instant spec. which describes overall thickness as including depth and height of the projections/recesses, such that depth and height is considered to contribute to thickness of the membrane, para. [0153] of published application) with opposed major membrane surfaces (includes front-facing and back-facing surfaces of 60, annotated fig. 16) being separated by a thickness of the membrane (thickness of 60 considered to separate surfaces), each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess (pleats formed by folding, considered to have rows when folded, para. [0033]; annotated fig. 16) configured to provide heat insulation to a tissue when the protective assembly is in use (considered to be capable of providing heat insulation to tissue in use, as this limitation is recited functionally and only recites intended use, and further, pleats 62 would provide a level of insulation to tissue by extending inward when membrane 60 is folded, fig. 16), wherein the thickness of a portion of the membrane in between the any two adjacently located projections separated by a recess is substantially less than the average height of the projections and/or average depth of the recesses (depicted in fig. 16, average height and depth considered to be the height and depth of projections/recesses when membrane is folded, thickness of 60 is less than height/depth of projections and recesses) and wherein the membrane forming the projections comprises solid sheet material (formed by a thin sheet, depicted in fig. 16), and wherein the membrane further comprises a convergent peripheral portion (periphery of membrane attached to leaves 20 and 30, fig. 16) that converges in a direction towards a flexible connector (converges towards band 52, para. [0035]), wherein the flexible connector extends from the membrane (via leaves 20 and 30) to facilitate rolling or folding of the membrane when pulled into the cannula of the trocar during use (facilitates folding of membrane, considered to be capable of facilitating folding into an additional structure, as the cannula is not positively recited, see above, figs. 13-14).
Regarding claim 8, Nevyas-Wallace discloses the assembly of claim 7. Nevyas-Wallace further discloses wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough (fig. 16) and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces (aligned with projection on opposite surface when folded, fig. 16).
Regarding claim 9, Nevyas-Wallace discloses the assembly of claim 8. Nevyas-Wallace further discloses wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses (see annotated fig. 16 depicting an extending direction of the projections across from a direction of the rows of projections and recesses; note the claim language does not recite the specific direction of the rows of projections and recesses, such that any direction forming the rows of projections and recesses meets the claimed limitation).
Regarding claim 10, Nevyas-Wallace discloses the assembly of claim 7. Nevyas-Wallace further discloses wherein average height of the projections is substantially equal to average depth of the recesses (accordion-style pleats considered to form projections/recesses of similar height/depth, depicted in fig. 16).
Regarding claim 11, Nevyas-Wallace discloses the assembly of claim 7. Nevyas-Wallace further discloses wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration (fig. 16).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 and 6-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,857,220 B2 to Gerges in view of Nevyas-Wallace.
Regarding claim 1, Gerges claims the assembly of claim 1 (claim 15), but fails to claim wherein the membrane comprises variable thickness, each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess configured to provide heat insulation to a tissue when the protective assembly is in a fully expanded configuration, wherein the membrane forming the projections comprises solid sheet material.
Nevyas-Wallace teaches, in the same field of endeavor, a protective assembly comprising a membrane comprising variable thickness (depicted in fig. 16, considered to be consistent with the instant spec. which describes overall thickness as including depth and height of the projections/recesses, such that depth and height is considered to contribute to thickness of the membrane, para. [0153] of published application), each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess (pleats formed by folding, considered to have rows when folded, para. [0033]; annotated fig. 16) configured to provide heat insulation to a tissue when the protective assembly is in a fully expanded configuration (considered to be capable of providing heat insulation to tissue when the instrument is in the fully expanded configuration, as this limitation is recited functionally and only recites intended use; further, pleats 62 would provide a level of insulation to tissue when fully expanded, see fig. 16 depicting band 52 constricting leaves 20 and 30 such that the device is considered to be fully expanded when maximum displacement of the device is reached due to band 52 limiting movement, para. [0035]; fig. 16), wherein the membrane forming the projections comprises solid sheet material (formed by a thin sheet, depicted in fig. 16), for the purpose of providing a shielding area that is sterilizable and limits the likelihood of damage to tissue and facilitates collapsing of the instrument (paras. [0024] and [0032]-[0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the membrane comprising variable thickness, the rows configured to provide heat insulation to a tissue when the protective assembly is in a fully expanded configuration, and the membrane forming the projections comprising a solid sheet material, in order to provide a shielding area that is sterilizable, limits the likelihood of damage to tissue and facilitates collapsing of the instrument, based on the suggestions and teachings of Nevyas-Wallace (paras. [0024] and [0032]-[0033]).
Regarding claim 2, Gerges (as modified) claims the assembly of claim 2 (claim 15), but fails to claim wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces.
Nevyas-Wallace teaches wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough (fig. 16) and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces (aligned with projection on opposite surface when folded, fig. 16), for the purpose of forming accordion-style pleats that facilitate collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim each of the recesses shaped to form a trough and aligned with a projection, in order to form accordion-style pleats that facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 3, Gerges (as modified) claims the assembly of claim 2 (claim 15), but fails to claim wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses.
Nevyas-Wallace teaches wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses (see annotated fig. 16 depicting an extending direction of the projections across from a direction of the rows of projections and recesses; note the claim language does not recite the specific direction of the rows of projections and recesses, such that any direction forming the rows of projections and recesses meets the claimed limitation), for the purpose of further facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses, in order to further facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 4, Gerges (as modified) claims the assembly of claim 4 (claim 15), but fails to claim wherein average height of the projections is substantially equal to average depth of the recesses.
Nevyas-Wallace teaches wherein average height of the projections is substantially equal to average depth of the recesses (accordion-style pleats considered to form projections/recesses of similar height/depth, depicted in fig. 16), for the purpose of facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the average height of the projections is substantially equal to average depth of the recesses, in order to facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 6, Gerges (as modified) claims the protective assembly of claim 6 (claim 15), but fails to claim wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration.
Nevyas-Wallace teaches wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration (fig. 16), for the purpose of facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the average height of the projections is substantially equal to average depth of the recesses, in order to facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 7, Gerges claims the assembly of claim 1 (claim 15), but fails to claim wherein the membrane comprises variable thickness, each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess configured to provide heat insulation to a tissue when the protective assembly is in use, wherein the membrane forming the projections comprises solid sheet material.
Nevyas-Wallace teaches, in the same field of endeavor, a protective assembly comprising a membrane comprising variable thickness (depicted in fig. 16, considered to be consistent with the instant spec. which describes overall thickness as including depth and height of the projections/recesses, such that depth and height is considered to contribute to thickness of the membrane, para. [0153] of published application), each of the major membrane surfaces comprising rows of projections and recesses such that any two adjacently located projections are separated by a recess (pleats formed by folding, considered to have rows when folded, para. [0033]; annotated fig. 16) configured to provide heat insulation to a tissue when the protective assembly is in use (considered to be capable of providing heat insulation to tissue in use, as this limitation is recited functionally and only recites intended use, and further, pleats 62 would provide a level of insulation to tissue by extending inward when membrane 60 is folded, fig. 16), wherein the membrane forming the projections comprises solid sheet material (formed by a thin sheet, depicted in fig. 16), for the purpose of providing a shielding area that is sterilizable and limits the likelihood of damage to tissue and facilitates collapsing of the instrument (paras. [0024] and [0032]-[0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the membrane comprising variable thickness, the rows configured to provide heat insulation to a tissue when the protective assembly is in use, and the membrane forming the projections comprising a solid sheet material, in order to provide a shielding area that is sterilizable, limits the likelihood of damage to tissue and facilitates collapsing of the instrument, based on the suggestions and teachings of Nevyas-Wallace (paras. [0024] and [0032]-[0033]).
Regarding claim 8, Gerges (as modified) claims the assembly of claim 2 (claim 15), but fails to claim wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces.
Nevyas-Wallace teaches wherein each of the recesses on one of the major membrane surfaces is shaped to form a trough (fig. 16) and aligned with a projection of the rows of projections and recesses on the other of the major membrane surfaces (aligned with projection on opposite surface when folded, fig. 16), for the purpose of forming accordion-style pleats that facilitate collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim each of the recesses shaped to form a trough and aligned with a projection, in order to form accordion-style pleats that facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 9, Gerges (as modified) claims the assembly of claim 2 (claim 15), but fails to claim wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses.
Nevyas-Wallace teaches wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses (see annotated fig. 16 depicting an extending direction of the projections across from a direction of the rows of projections and recesses; note the claim language does not recite the specific direction of the rows of projections and recesses, such that any direction forming the rows of projections and recesses meets the claimed limitation), for the purpose of further facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein each of the projections on the major membrane surfaces of the membrane extend in a transverse direction relative to a direction of the rows of projections and recesses, in order to further facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 10, Gerges (as modified) claims the assembly of claim 4 (claim 15), but fails to claim wherein average height of the projections is substantially equal to average depth of the recesses.
Nevyas-Wallace teaches wherein average height of the projections is substantially equal to average depth of the recesses (accordion-style pleats considered to form projections/recesses of similar height/depth, depicted in fig. 16), for the purpose of facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the average height of the projections is substantially equal to average depth of the recesses, in order to facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Regarding claim 11, Gerges (as modified) claims the protective assembly of claim 6 (claim 15), but fails to claim wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration.
Nevyas-Wallace teaches wherein the portion of the membrane in between the any two adjacently located projections separated by the recess facilitates folding or rolling of the membrane in a folded configuration (fig. 16), for the purpose of facilitating collapsing of the instrument (para. [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the average height of the projections is substantially equal to average depth of the recesses, in order to facilitate collapsing of the instrument, based on the teachings of Nevyas-Wallace (para. [0033]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2007/0213734 A1 to Bleich, disclosing a barrier device (see fig. 17).
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/BRIGID K BYRD/Examiner, Art Unit 3771