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 .
Priority
Acknowledgement is made to Applicant’s claim to PCT/AU2022/050464 filed May 16, 2023, and to U.S. Provisional App. No. 63/192,132 filed May 24, 2021.
Status of Claims
This Office Action is responsive to the preliminary amendment filed on November 22, 2023. As directed by the amendment: claims 1-126 have been cancelled; and claims 127-167 have been added. Thus, claims 127-167 are presently pending in this application.
Claim Objections
Claims 128, 135, and 162 are objected to because of the following informalities:
Claim 128 recites “wherein flexible material is a textile.”, ln 1 should read --wherein the flexible material is a textile.--;
Claim 135 recites “positioned radial ly”, ln 1 should read --positioned radially--;
Claim 162 recites “not extend to below a mental protuberance”, ln 2 should read --not extend below a mental protuberance--.
Appropriate correction is required.
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) 127-147, 149-152, and 154-167 are rejected under 35 U.S.C. 103 as being unpatentable over Romagnoli et al. (U.S. Pub. No. 2019/0290878; hereinafter: “Romagnoli”) in view of Henry et al. (WO 2015/070289 A1; hereinafter: “Henry”).
Regarding Claim 127, Romagnoli discloses a patient interface comprising: a plenum chamber (chamber formed by 3175, 3200; Fig. 4-14, 17-21) pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure (¶¶ 0036, 0043-0045, 0218), the plenum chamber having a plenum chamber opening (3500; Fig. 20a), and the plenum chamber having a first connection portion (3110; Fig. 4-16) positioned proximal to the plenum chamber opening; a seal-forming structure (3175, 3200; Fig. 4-14, 17-21) constructed and arranged to seal with a region of the patient's face surrounding an entrance to the patient's airways (Fig. 6-9, 17, 18, 21, 22), said seal-forming structure having a hole (hole formed by 3175; Fig. 20a-21) therein such that a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares (¶¶ 0126-0131), the seal-forming structure being joined to the plenum chamber to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use (¶¶ 0139-0144, 0174-0178); a chassis (3300, 3305; Fig. 4-16) including an inlet port (3302; Fig. 10) sized and structured to receive a flow of air at the therapeutic pressure and direct the flow of air into the plenum chamber through the plenum chamber opening for breathing by a patient (¶¶ 0129, 0182-0184, 0187), a second connection portion (3310; Fig. 4-16) positioned on the chassis and configured to releasably connect to the first connection portion, and the first connection portion and the second connection portion, when connected, being more rigid than the flexible material (¶¶ 0136-0138; Claim 7); a sealing lip (¶ 0178) positioned radially around the plenum chamber opening to seal between the plenum chamber and the chassis (¶ 0178); a positioning and stabilizing structure (3400; Fig. 4-9, 17-18) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (¶¶ 0126, 0128, 0129), the positioning and stabilizing structure comprising a tie (¶¶ 0275, 0283); and a vent structure (3700; Fig. 11b) having a plurality of holes to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient throughout the patient's respiratory cycle (¶¶ 0129, 0185-0189), said vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use (¶¶ 0129, 0185-0189); and wherein the patient interface is configured to leave the patient's mouth uncovered (¶ 0193; Fig. 26-29), or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breath from ambient in the absence of a flow of pressurised air through the inlet port (¶¶ 0129, 0185-0189, 0284).
Romagnoli does not specifically disclose the patient interface a chassis constructed from a flexible material.
Henry teaches a patient interface comprising a plenum chamber (3200; Fig. 4, 7, 10, 11, 16, 18, 19) having a first connection portion (3244, 3245; Fig. 4-6, 8, 10, 11), a seal-forming structure (3100; Fig. 4, 5, 9); a chassis (3310; Fig. 10, 11,13) constructed from a flexible material (¶¶ 49, 50) and having a second connection portion (3312, 3313; Fig. 10, 11), a sealing lip (3250; Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541), a positioning and stabilizing structure (3300; Fig. 34), a vent structure (3400; Fig. 18, 19), the patient interface is configured to leave the patient's mouth uncovered (being a nasal mask, fig. 10) for the purpose of sealing plenum chamber to the chassis (¶¶ 49, 50, 498).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Romagnoli to include the chassis constructed from the flexible material as taught by Henry for the purpose of sealing plenum chamber to the chassis (See Henry: ¶¶ 49, 50, 498).
Regarding Claim 128, the modified device of Romagnoli discloses the patient interface wherein flexible material is a textile (See Henry: ¶¶ 52, 772, 780, 781, 794).
Regarding Claim 129, the modified device of Romagnoli discloses the patient interface wherein the first connection portion is one of a hook material and a loop material and the second connection portion is the other of the hook material and the loop material (See Romagnoli: ¶¶ 0139-0144, 0151, 0174-01780).
Regarding Claim 130, the modified device of Romagnoli discloses the patient interface wherein the first connection portion is positioned radially outward of the plenum chamber opening (See Romagnoli: ¶¶ 0140-0144, 0174-0178; Fig. 11b-19c).
Regarding Claim 131, the modified device of Romagnoli discloses the patient interface wherein the second connection portion is positioned radially inward of a peripheral edge of the chassis (See Romagnoli: ¶¶ 0140-0144, 0174-0178; Fig. 11b-19c).
Regarding Claim 132, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is fixed to the chassis (See Henry: Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541).
Regarding Claim 133, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is fixed to the plenum chamber (See Henry: Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541; Examiner notes: Henry discloses the sealing lip fixed to the plenum chamber when the chassis is attached to the plenum chamber.).
Regarding Claim 134, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is positioned radially outward of the first connection portion and the second connection portion (See Romagnoli: ¶ 0178).
Regarding Claim 135, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is positioned radially inward of the first connection portion and the second connection portion See Henry: Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541).
Regarding Claim 136, the modified device of Romagnoli discloses the patient interface, shown above.
The modified device of Romagnoli does not explicitly disclose wherein the first connection portion and the second connection portion are continuous around the plenum chamber and the chassis, respectively.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to comprise the first connection portion and the second connection portion as continuous around the plenum chamber and the chassis, respectively, in the modified device of Romagnoli because Applicant has not disclosed that the first connection portion and the second connection portion being continuous around the plenum chamber and the chassis, respectively, provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec. ¶ 0200). One of ordinary skill in the art, furthermore, would have expected the connectable/disconnectable first connection portion and second connection portion of the modified device of Romagnoli, and Applicant’s first connection portion and second connection portion continuously around the plenum chamber and the chassis, respectively, to perform equally well because both mechanisms perform the same function of allowing the plenum chamber and the chassis to be connected/disconnected.
Therefore, it would have been prima facie obvious to modify the modified device of Romagnoli to obtain the invention as specified in claim 136 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired connectable/disconnectable relationship between the plenum chamber and the chassis and thus fails to patentably distinguish over the prior art of the modified device of Romagnoli.
Regarding Claim 137, the modified device of Romagnoli discloses the patient interface wherein one of the first connection portion and the second connection portion comprise a plurality of discontinuous portions positioned around the plenum chamber and the chassis, respectively, and the other of the first connection portion and the second connection portion is continuous around the plenum chamber and the chassis, respectively (See Romagnoli: 3110, 3310; Fig. 4-16; ¶¶ 0139-0144, 0174-0178).
Regarding Claim 138, the modified device of Romagnoli discloses the patient interface wherein each of the first connection portion and the second connection portion comprise a plurality of discontinuous portions positioned around the plenum chamber and the chassis, respectively, and wherein the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned at corresponding positions around the plenum chamber and the chassis, respectively, to connect to one another (See Romagnoli: 3110, 3310; Fig. 4-16; ¶¶ 0139-0144, 0174-0178).
Regarding Claim 139, the modified device of Romagnoli discloses the patient interface, shown above.
The modified device of Romagnoli does not explicitly disclose wherein the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned asymmetrically around the plenum chamber and the chassis, respectively.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned asymmetrically around the plenum chamber and the chassis, respectively, in the modified device of Romagnoli because Applicant has not disclosed that the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned asymmetrically around the plenum chamber and the chassis, respectively, provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec. ¶ 0203). One of ordinary skill in the art, furthermore, would have expected the connectable/disconnectable first connection portion and second connection portion of the modified device of Romagnoli, and Applicant’s the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned asymmetrically around the plenum chamber and the chassis, respectively, to perform equally well because both mechanisms perform the same function of allowing the plenum chamber and the chassis to be connected/disconnected.
Therefore, it would have been prima facie obvious to modify the modified device of Romagnoli to obtain the invention as specified in claim 139 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired connectable/disconnectable relationship between the plenum chamber and the chassis and thus fails to patentably distinguish over the prior art of the modified device of Romagnoli.
Regarding Claim 140, the modified device of Romagnoli discloses the patient interface wherein the plurality of discontinuous portions of each of the first connection portion and the second connection portion are positioned symmetrically around the plenum chamber and the chassis, respectively (See Romagnoli: 3110, 3310; Fig. 4-16; ¶¶ 0139-0144, 0174-0178).
Regarding Claim 141, the modified device of Romagnoli discloses the patient interface wherein the sealing lip, in an undeformed state, has a dimension extending from the plenum chamber or the chassis in a direction that is orthogonal to a surface to which the sealing lip is attached (See Henry: 3250; Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541), and wherein the dimension is greater than a combined thickness of the first connection portion and the second connection portion (See Henry: 3250; Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541).
Regarding Claim 142, the modified device of Romagnoli discloses the patient interface wherein the chassis includes the vent structure (See Romagnoli: ¶ 0129; Fig. 10, 11b, 12, 15, 16).
Regarding Claim 143, the modified device of Romagnoli discloses the patient interface further comprising an elbow (See Romagnoli: 3600; Fig. 10, 11b, 12, 15-18) configured to rotatably connect to the chassis at the inlet port at a first end and to an air circuit (See Romagnoli: 4180; Fig. 1b, 1c, 23) at a second end to direct the flow of air into the plenum chamber (See Romagnoli: ¶¶ 0129, 0145, 0185-0189).
Regarding Claim 144, the modified device of Romagnoli discloses the patient interface wherein the elbow includes the vent structure (See Romagnoli: ¶¶ 0185-0189).
Regarding Claim 145, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is constructed from an elastomeric material (See Henry: ¶¶ 498, 522-530, 539, 541).
Regarding Claim 146, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is constructed from silicone (See Henry: ¶¶ 498, 522-530, 539, 541).
Regarding Claim 147, the modified device of Romagnoli discloses the patient interface wherein the plenum chamber and the seal-forming structure are formed in one piece from a homogeneous material (See Romagnoli: ¶¶ 0190-0192).
Regarding Claim 149, the modified device of Romagnoli discloses the patient interface wherein the plenum chamber and the seal-forming structure are formed in one piece from silicone (See Romagnoli: ¶¶ 0126, 0130, 0199).
Regarding Claim 150, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is integrally molded to the plenum chamber (See Henry: ¶¶ 498, 522-530, 539, 541).
Regarding Claim 151, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is integrally molded to the plenum chamber (See Henry: ¶¶ 498, 522-530, 539, 541).
The modified device of Romagnoli does not specifically disclose the patient interface wherein the sealing lip is integrally molded to the chassis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to rearrange the parts such that the sealing lip is integrally molded to the chassis, since it has been held that rearranging parts of a prior art structure involves only routing skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding Claim 152, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is radially continuous (See Henry: ¶¶ 498, 522-530, 539, 541).
Regarding Claim 154, the modified device of Romagnoli discloses the patient interface wherein the chassis comprises a pair of tie (See Henry: 3305; Fig. 30, 31) attachment structures and the positioning and stabilizing structure comprises a pair of ties (See Henry: 3301; Fig. 31), each of the ties being configured to attach to a corresponding one of the tie attachment structures to connect the positioning and stabilizing structure to the chassis (See Henry: ¶¶ 500, 545-550).
Regarding Claim 155, the modified device of Romagnoli discloses the patient interface wherein the first connection portion is joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178).
The modified device of Romagnoli does not explicitly disclose wherein the first connection portion is joined to the plenum chamber with adhesive.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the first connection portion joined to the plenum chamber with adhesive in the modified device of Romagnoli because Applicant has not disclosed that the first connection portion being joined to the plenum chamber with adhesive provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec. ¶ 0204). One of ordinary skill in the art, furthermore, would have expected the first connection portion being joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178) of the modified device of Romagnoli, and Applicant’s the first connection portion being joined to the plenum chamber by adhesive to perform equally well because both mechanisms perform the same function of attaching the first connection portion to the plenum chamber.
Therefore, it would have been prima facie obvious to modify the modified device of Romagnoli to obtain the invention as specified in claim 155 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired joining of the first connection portion to the plenum chamber and thus fails to patentably distinguish over the prior art of the modified device of Romagnoli.
Regarding Claim 156, the modified device of Romagnoli discloses the patient interface wherein the first connection portion is joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178).
The modified device of Romagnoli does not explicitly disclose wherein the plenum chamber is overmolded to the first connection portion.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the plenum chamber as overmolded to the first connection portion in the modified device of Romagnoli because Applicant has not disclosed that the plenum chamber being overmolded to the first connection portion provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec. ¶ 0204). One of ordinary skill in the art, furthermore, would have expected the first connection portion being joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178) of the modified device of Romagnoli, and Applicant’s the first connection portion being joined to the plenum chamber by overmolding to perform equally well because both mechanisms perform the same function of attaching the first connection portion to the plenum chamber.
Therefore, it would have been prima facie obvious to modify the modified device of Romagnoli to obtain the invention as specified in claim 156 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired joining of the first connection portion to the plenum chamber and thus fails to patentably distinguish over the prior art of the modified device of Romagnoli.
Regarding Claim 157, the modified device of Romagnoli discloses the patient interface wherein the first connection portion is joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178).
The modified device of Romagnoli does not explicitly disclose wherein the first connection portion is molded into the plenum chamber.
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to form the first connection portion molded into the plenum chamber in the modified device of Romagnoli because Applicant has not disclosed that the first connection portion being molded into the plenum chamber provides an advantage, is used for a particular purpose, or solves a stated problem (See Instant Spec. ¶ 0204). One of ordinary skill in the art, furthermore, would have expected the first connection portion being joined to the plenum chamber (See Romagnoli: ¶¶ 0139-0144, 0174-0178) of the modified device of Romagnoli, and Applicant’s the first connection portion being joined to the plenum chamber by molding to perform equally well because both mechanisms perform the same function of attaching the first connection portion to the plenum chamber.
Therefore, it would have been prima facie obvious to modify the modified device of Romagnoli to obtain the invention as specified in claim 157 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired joining of the first connection portion to the plenum chamber and thus fails to patentably distinguish over the prior art of the modified device of Romagnoli.
Regarding Claim 158, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is positioned such that an increase in pressure within the plenum chamber increases a sealing force of the sealing lip between the plenum chamber and the chassis (See Romagnoli: ¶ 0178).
Regarding Claim 159, the modified device of Romagnoli discloses the patient interface wherein the second connection portion is positioned on the chassis with a gap between a peripheral edge of the chassis and an outer peripheral edge of the second connection portion (See Romagnoli: Fig. 4-19).
Regarding Claim 160, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure is configured so as not to enter the patient's mouth in use (See Romagnoli: Fig. 4-14, 17-21).
Regarding Claim 161, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure is configured so that the seal-forming structure does not extend internally of the patient's airways in use (See Romagnoli: Fig. 4-14, 17-21).
Regarding Claim 162, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure is configured so as not extend to below a mental protuberance region of the patient in use (See Romagnoli: ¶¶ 0126-0131; Fig. 26-29).
Regarding Claim 163, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure and the plenum chamber are configured so as not to cover the patient's eyes in use (See Romagnoli: ¶ 0193; Fig. 26-29).
Regarding Claim 164, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure comprises a nasal hole (See Henry: 3130; Fig. 15; ¶ 443) configured to direct the flow of air into the patient's nares during use.
Regarding Claim 165, the modified device of Romagnoli discloses the patient interface wherein the seal-forming structure comprises an oral hole (See Romagnoli: hole formed by 3175; Fig. 20a-21configured to direct the flow of air into the patient's mouth during use.
Regarding Claim 166, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is cantilevered from the chassis or the plenum chamber (See Henry: Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541).
Regarding Claim 167, the modified device of Romagnoli discloses the patient interface wherein the sealing lip is fixed to the plenum chamber or the chassis at a first end and is free at a second end and the sealing lip is curved between the first end and the second end (See Henry: Fig. 14, 17, 25-29; ¶¶ 498, 522-530, 539, 541).
Claim(s) 148 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romagnoli in view of Henry as applied to claim 127 above, and further in view of Baigent et al. (U.S. Pub. No. 2017/0326320; hereinafter: “Baigent”).
Regarding Claim 148, the modified device of Romagnoli discloses the patient interface, shown above.
The modified device of Romagnoli does not specifically disclose the patient interface wherein the plenum chamber and the seal-forming structure are formed in one piece from a textile.
Baigent teaches a patient interface comprising a plenum chamber (interior space formed by 3100, 3101, 3102; Fig. 6A-6C) and a seal- forming structure (3100; Fig. 6A-6C) being formed in one piece from a textile (¶¶ 0304-0307) for the purpose of providing a comfortable flexible sealing material that filters undesirable particulate matter from the flow of gas before the gas reaches the patient's airways (¶ 0306).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Romagnoli to include the plenum chamber and the seal-forming structure formed in one piece from the textile as taught by Baigent for the purpose of providing a comfortable flexible sealing material that filters undesirable particulate matter from the flow of gas before the gas reaches the patient's airways (See Baigent: ¶ 0306).
Claim(s) 153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romagnoli as applied to claim 127 above, and further in view of Baluchagi et al (WO 2019/119058 A1; hereinafter: “Baluchagi”).
Regarding Claim 153, the modified device of Romagnoli discloses the patient interface, shown above.
The modified device of Romagnoli does not specifically disclose the patient interface further comprising two inlet ports positioned on the chassis, wherein the positioning and stabilizing structure comprises a pair of conduits, each configured to connect to a corresponding one of the inlet ports to direct the flow of air into the plenum chamber.
Baluchagi teaches a patient interface (3000; Fig. 7-32) comprising two inlet ports (3201; Fig. 19-24, 51) positioned on a chassis (3200; Fig. 7, 9-24, 51), wherein a positioning and stabilizing structure (3300, 3900, 3901, 3902; Fig. 32-36) comprises a pair of conduits (3900; Fig. 32-36), each configured to connect to a corresponding one of the inlet ports (by 3800; Fig. 32-36) to direct the flow of air into a plenum chamber (3001-interior formed by 3100; Fig. 8, 9, 11-24; ¶¶ 0401-0415) for the purpose of providing positioning and stabilizing structure that is more comfortable for a patient to lie upon while the patient is sleeping (¶ 0362).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the modified device of Romagnoli to include the two inlet ports positioned on the chassis, wherein the positioning and stabilizing structure comprises the pair of conduits, each configured to connect to the corresponding one of the inlet ports to direct the flow of air into the plenum chamber as taught by Baluchagi for the purpose of providing positioning and stabilizing structure that is more comfortable for a patient to lie upon while the patient is sleeping (See Baluchagi: ¶ 0362).
Conclusion
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785
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