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 .
Benefit
The claim of benefit to US Provisional 63/636,904 (22 April 2025) is acknowledged.
Formal Matters
Claims 1-20 are pending and under examination.
Claim Interpretation
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.
Claim Rejections - 35 USC § 112(b)
Claim 10 is 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 10, line 2 recites “located about below”. This recitation is unclear and confusing. The word “about” is generally understood to be a range of 10% in either direction of an end point. The word below is generally understood to indicate directionality as being underneath something. It is unclear what a location “about below” is intended to mean.
For the purpose of compact prosecution, the phrase will be broadly interpreted as “located below”.
Claim Rejections - 35 USC § 102 or 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 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hatch et al., US 20030220658 (27 November 2003).
Regarding independent claim 1, Hatch teaches a surgical instrument (FIG 1, surgical instrument 100) comprising:
a shaft having a longitudinal axis (FIGs 1, 2, elongated shaft 140; ¶54), a distal end (FIG 1, distal portion 105; ¶54), and a proximal end (FIG 1, proximal portion 145; ¶54);
a first jaw (FIGs 1, 2, tissue platform 120; ¶53) and a second jaw (annotated FIG 1, articulating jaw 11o; ¶53) wherein the first jaw and the second jaw are located at the distal end of the shaft (FIGs 1, 2, “located at the distal end 105 are articulating jaw 110, tissue platform 120, and suture grasper 130”; ¶54), and wherein the first jaw (FIGs 1, 2, comprising tissue platform 120 and suture grasper 130; ¶54) includes at least one surface feature located on a surface of the first jaw (FIGs 1, 2, grasper guide 170; ¶61) that is opposite another surface of the first jaw (FIG 1, “surface 127 of tissue platform 120 that faces articulating jaw 119 includes serrations 123”; ¶73) facing the second jaw (FIGs 1, 2, articulating jaws 11o, comprising needle 115; ¶53) (see also, annotated FIG 1, below); and
a handle assembly (FIG 1, handle 190 includes articulating handle 191 and stationary handle 192; ¶55) configured to move at least one of the first jaw and the second jaw (¶53).
The specification defines “surface feature” as a feature that can be provided directly below the location of a needle pass to identify the exact location of the needle and/or suture pass (¶¶2, 11). A surface feature can identify the position of the instrument on bone when grasping soft tissue (¶¶2, 11). A surface feature can be adjusted to go proximal or distal of a needle pass, depending on the passing application (¶¶2, 11). A surface feature can be coated on the bottom of a lower jaw (¶11). A surface feature can be a bump, nub, protrusion, protuberance, projection, lump, or any similar structure that provides a feeler to identify different structures with relation to the instrument (¶11). A surface feature can also aid in feeling for anchor bone holes, anchors, and or sutures coming from the anchors in bone wherein the surgeon cannot visualize the surgical site (¶13). The surface features can act as a guide for passing of fixation devices such as anchors, and/or sutures, and/or any surgical devices through bone, and also for soft tissue reduction, when there is no visualization (¶13). At least one surface feature can be provided on one of the jaws of the instrument to identify the passing location of the needle pass and/or flexible strand (¶14). The at least one surface feature can be fixed, stationary, non-movable, immobile, and integral with the suture passer or can be non-fixed, moveable, and non-integral with the suture passer (¶14). The at least one surface feature can be located on a surface of the mounted stationary jaw facing away from the moveable jaw (¶19). The at least one surface feature is shown in FIG 1 as element 66.
The broadest reasonable interpretation of the “at least one surface feature” in light of the Specification, as applied to the phrase in claim 1 “wherein the first jaw includes at least one surface feature” with regard to the teachings of Hatch, is: a jaw comprising tissue platform 120, as indicated in annotated FIG 2, below, including at least one surface feature where the “at least one surface feature” broadly encompasses one or more of the following surface features expressly taught by Hatch: tissue platform 120, serrations 123, surface 127, suture grasper 130, suture capture device 132 in the form of an arm 133, U-shaped tip 134, and grasper guide 170, as shown in FIGs 1, 2 and textually discussed at ¶¶54, 60, 61, 73.
The designation of a jaw as an “upper” or “lower” jaw is a relative recitation. The jaw must merely be capable of being below the upper jaw. The device would still work if a surgeon rotates the device 180 degrees, thus making a first jaw the lower jaw. See annotated Hatch FIG 2 and Annotated Hatch FIG 2 rotated 180 degrees.
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Regarding claim 2, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the at least one surface feature is a bump, nub, protrusion, protuberance, projection or lump (FIGs 1, 2; grasper guide 170; ¶61).
Regarding claim 3, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the at least one surface feature extends away from the surface of the first jaw (FIGs 1, 2; grasper guide 170; ¶61).
Regarding claim 4, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the at least one surface feature is stationary and integral with the first jaw (FIGs 1, 2; grasper guide 170; ¶61).
Regarding claim 5, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the at least one surface feature is movable relative to the first jaw (FIG 4A, “arm 133 of suture capture device 132 of suture grasper 130 advances forward to hold the suture in the U-shaped tip 134 against the distal wall 121A of suture slot 121X; ¶61).
Regarding claim 6, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the another surface of the first jaw is a needle passing surface (FIGs 4A/B, passageway 122; ¶60) or a tissue grasping surface (FIG 1, tissue platform 120; ¶54).
Regarding claim 10, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the at least one surface feature (FIG 2, serrations 123; ¶73) is located about below a needle passage (FIGs 4A/B, passageway 122; ¶60) located within the first jaw.
The phrase “about below” is unclear and confusing, as set forth above. For the purpose of compact prosecution, the phrase will be broadly interpreted as “located below”.
Regarding claim 12, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the instrument is a tissue grasper (¶55).
Regarding claim 13, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the instrument is a suture passer (Title; FIG 1, suture passing surgical instrument 100; ¶20).
Regarding claim 14, Hatch teaches the surgical instrument of claim 1, as set forth above, wherein the first jaw and the second jaw are slotted (FIG 4B, suture slots 121X, 121Y; ¶60) to allow passage (passageway 122; ¶60) of at least one fixation device (FIG 10, anchor; ¶71).
Regarding claim 15, Hatch teaches the surgical instrument of claim 14, as set forth above, wherein the at least one fixation device is a suture anchor (FIG 10, anchor; ¶71).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 11 is rejected under 35 U.S.C. 103 as obvious over Hatch et al., US 20030220658 (27 November 2003).
Regarding claim 11, Hatch teaches the surgical instrument of claim 1, as set forth above.
In embodiment 100, Hatch teaches wherein the handle assembly (FIG 1, handles 190, ¶) includes a pair of handles (FIG 1, articulating handle 191, stationary handle 192).
Embodiment 100 of Hatch does not teach a locking mechanism as part of the handle assembly.
Embodiment 250 of Hatch teaches wherein the handle assembly (FIGs 15A, 15B, handle assembly 250; ¶77) includes a pair of handles (FIGs 15A, 15B; ¶77) and a locking mechanism (FIG 15B, locking mechanism 236; ¶77).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the multiple embodiments of Hatch given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Hatch provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Hatch teaches different embodiments of handle assemblies each solving known problems in the art, including a spring or ratchet-type lock used to hold the suture capture device in a retracted position and to retain the suture capture device in a suture holding position (¶77). One of ordinary skill in the art would be motivated to select among the various embodiments of Hatch to meet use-case needs. One of ordinary skill in the art would have a reasonable expectation of success in selecting from the finite embodiments taught by Hatch that are best suited for the particular end-use case, such as being able to retain the suture capture device in a suture holding position by locking the handle assembly (¶77).
Claims 7-9 are rejected under 35 U.S.C. 103 as obvious over Hatch et al., US 20030220658 (27 November 2003) in view of Pilling, US 5,522,839 (4 June 1996) and further in view of Schneider et al., US 20170027559 (2 February 2017).
Regarding claim 7, Hatch teaches the surgical instrument of claim 1, as set forth above.
Hatch does not expressly teach wherein the first jaw is a lower jaw and the at least one surface feature acts as a feeler to identify at least one structure in relation to the surgical instrument.
Pilling teaches forceps comprising a first jaw (FIG 1, jaw 8; col 2, line 48) and a second jaw (FIG 1, jaw 6; col 2, line 48) comprising at least one surface feature (FIG 2, bump 42; col 3, line 30) on lower jaw (8) and the at least one surface feature (bump 42) acts as a feeler to identify at least one structure (tissue elements 44 and 46; col 3, lines 39-43) in relation to the surgical instrument (outer portion of jaw 6 and 8; col 3, lines 39-43). Pilling teaches that bumps 40 and 42 prevent tissue elements 44 and 46 from continuing along the outer portion of the jaw 6 and 8 (col 3, lines 41-43).
Schneider teaches sensing gauges to identify tissue differences and give the end user feedback on these differences (¶¶7, 23; claims 1 and 6).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Hatch, Pilling, and Schneider given that the prior art included each element claimed, although not necessarily in a single reference. Hatch, Pilling, and Schneider teach in the same field of endeavor of surgical instruments comprising forceps devices.
Although, Hatch discloses the claimed surgical instrument comprising a shaft, a first jaw, a second jaw, at least one surface feature, method of passing at least one flexible strand through soft tissue with a surgical instrument (FIGs 7E-G, ¶¶66, 71) and passing the at least one flexible strand at the transition between the first tissue and the second tissue (FIGs 7H-O; ¶¶67-68), Hatch does not expressly disclose wherein the first jaw is a lower jaw and the at least one surface feature acts as a feeler to identify at least one structure in relation to the surgical instrument.
Pilling specifically addresses forceps comprising a first jaw (FIG 1, jaw 8; col 2, line 48) comprising at least one surface feature (FIG 2, bump 42; col 3, line 30) on the lower jaw (8) and the at least one surface feature (bump 42) acts as a feeler to identify at least one structure (tissue elements 44 and 46; col 3, lines 39-43) in relation to the surgical instrument (outer portion of jaw 6 and 8; col 3, lines 39-43).
Because Hatch’s suture passing device includes a shaft having a proximal and distal end, a pivot point/hinge, first and second jaws which are capable of being rotated, and a suture passing needle configured to hold a suture, a person of ordinary skill in the art, seeking to provide sensing information in the lower jaw (broadly interpreted as a structural surface feature of a lower jaw that transmits sensing information through the tool to the user) to identify at least one structure in relation to the surgical instrument, would reasonably consult Pilling’s bump solution. Pilling’s bump can be incorporated alongside jaw end effectors (same general location without affecting the needle passing/suture passing capability) using known assembly methods without redesigning Hatch’s core device.
Similarly, Schneider specifically addresses sensing gauges to identify tissue differences and give the end user feedback on these differences (¶¶7, 23; claims 1 and 6). Because Hatch’s suture passing device includes a shaft having a proximal and distal end, a pivot point/hinge, first and second jaws that clamp, and a suture passing needle configured to hold a suture, a person of ordinary skill in the art, seeking to provide sensing information in the form of a feeler (broadly interpreted as a structural surface feature that transmits sensing information through the tool to the user) to identify at least one structure in relation to the surgical instrument, such as tissue density feedback (¶32; claim 12) in Hatch’s architecture would reasonably consult Schneider’s sensor solution. Schneider’s sensors can be incorporated alongside Hatch’s handle assembly, shaft, and jaw end effectors (same general location and needle passing/suture passing capability) using known assembly methods without redesigning Hatch’s core device.
Because the references address the same engineering problem (needle passing/suture passing devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a sensor to the distal end of the end effector adjacent to the existing jaws), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Additionally, as discussed above in reference to claim 1, the designation of a jaw as an “upper” or “lower” jaw is a relative recitation. The jaw must merely be capable of being below the upper jaw. Accordingly, the device of Hatch would still work if a surgeon rotates the device 180 degrees, thus making a first jaw the lower jaw. So although Hatch does not expressly teach wherein the first jaw is a lower jaw, the jaws are capable of being rotated 180 degrees and still working. See annotated Hatch FIG 2 and Annotated Hatch FIG 2 rotated 180 degrees.
Regarding claim 8, Hatch modified by Pilling and Schneider teaches the surgical instrument of claim 7, as set forth above, for the reasons set forth above.
Hatch teaches wherein the at least one structure is cartilage rim (tendon/fibrous bundles; ¶68) or osseous footprint (FIGs 7D-O, bone; ¶102).
Regarding claim 9, Hatch modified by Pilling and Schneider teaches the surgical instrument of claim 7, as set forth above for the reasons set forth above.
Schneider teaches wherein the at least one surface feature (sensing gauges) allows a user to determine and locate a transition (¶¶7, 23; claims 1 and 6) between a first tissue with a first density (¶32; claims 6, 12) and a second tissue with a second density (¶32; claims 6, 12).
Schneider does not expressly teach that the first density is different from the second density.
However, Schneider teaches that the sensing features are capable of determining tissue density to identify differences in tissue that is clamped (claim 6). Accordingly, the sensing features of Schneider are capable of determining tissue density differences between a first tissue with a first density and a second tissue with a second density by measuring the individual tissues. These measurements of tissue density are results effective variables that can be optimized depending on the needs of the surgeon in any particular anatomical situation.
One of skill in the art would clearly recognize that measurements of different tissues can be optimized depending on the end effect desired for the use case. One of ordinary skill in the art would have had a reasonable expectation of success in determining differences between two or more tissue densities using the sensing features of Schneider without undue experimentation based on the ability of the sensing features to take multiple measurements and to identify differences as set forth in claim 6 of Schneider. As such, determining tissue density differences between a first tissue with a first density and a second tissue with a second density would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Claims 16-20 are rejected under 35 U.S.C. 103 as obvious over Hatch et al., US 20030220658 (27 November 2003) in view of Schneider et al., US 20170027559 (2 February 2017).
Regarding independent claim 16, Hatch teaches a method of passing at least one flexible strand through soft tissue (tendon/fibrous bundle; ¶68) with a surgical instrument (FIGs 7E-G, ¶¶66, 71) and passing the at least one flexible strand at the transition between the first tissue and the second tissue (FIGs 7H-O; ¶¶67-68).
Hatch does not teach identifying a transition between a first tissue and a second tissue.
Schneider teaches sensing gauges to identify tissue differences and give the end user feedback on these differences (¶¶7, 23; claims 1 and 6).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Hatch and Schneider, given that the prior art included each element claimed, although not necessarily in a single reference. Hatch and Schneider teach in the same field of endeavor comprising suture passing devices.
Although, Hatch discloses the claimed method of passing at least one flexible strand through soft tissue with a surgical instrument (FIGs 7E-G, ¶¶66, 71) and passing the at least one flexible strand at the transition between the first tissue and the second tissue (FIGs 7H-O; ¶¶67-68), Hatch does not disclose identifying a transition between a first tissue and a second tissue.
Schneider specifically addresses adding sensing gauges to suture passing devices to identify tissue differences and give the end user feedback on these differences (¶¶7, 23; claims 1 and 6). Because Hatch’s suture passing device includes a shaft having a proximal and distal end, a pivot point/hinge, first and second jaws that clamp, and a suture passing needle configured to hold a suture, a person of ordinary skill in the art, seeking to provide sensing information and tissue density feedback (¶32; claim 12) in Hatch’s architecture would reasonably consult Schneider’s sensor solution. Schneider’s sensors can be incorporated alongside Hatch’s handle assembly, shaft, and jaw end effectors (same general location and needle passing/suture passing capability) using known assembly methods without redesigning Hatch’s core device.
Because the references address the same engineering problem (needle passing/suture passing devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a sensor to the distal end of the end effector adjacent to the existing jaws), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 17, Hatch modified by Schneider teaches the method of claim 16, as set forth above, for the reasons set forth above.
Schneider teaches wherein the step of identifying the transition between the first tissue and the second tissue comprises moving the at least one surface feature (FIG 4, indicator 404; ¶27) relative to the first jaw and in a forward or backward motion (“the gauges detect tissue differences 503 as the end user articulates the jaws and grasps 502, touches, or is in close proximity to different areas of tissue”, ¶29).
Regarding claim 18, Hatch modified by Schneider teaches the method of claim 16, as set forth above, for the reasons set forth above.
Schneider teaches wherein the step of identifying the transition between the first tissue and the second tissue (FIG 4, indicator 404; ¶27) comprises feeling with the instrument a difference between the first tissue and the second tissue (“the gauges detect tissue differences 503 as the end user articulates the jaws and grasps 502, touches, or is in close proximity to different areas of tissue”, ¶29) and without visualizing the first tissue and the second tissue (FIG 4, “tactile feedback … (e.g. vibration)”; ¶27).
Regarding claim 19, Hatch modified by Schneider teaches the method of claim 18, as set forth above, for the reasons set forth above.
Hatch teaches wherein the first tissue is cartilage rim (tendon tissue/fibrous bundles, ¶68) and the second tissue is bone (FIGs 7D-O; ¶102).
Regarding claim 20, Hatch modified by Schneider teaches the method of claim 16, as set forth above, for the reasons set forth above.
Hatch teaches the method further comprising passing at least one fixation device (FIG 10, anchor; ¶71) through the soft tissue (tendons and fibrous bundles; ¶68) and at the transition between the first tissue (tendons and fibrous bundles; ¶68) and the second tissue (bone) (FIGs 7E-O; ¶¶66-68).
Conclusion
No claims are allowed.
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/CHERIE M POLAND/Examiner, Art Unit 3771