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 .
Examiner’s Note
Claims 32 – 51 recites the terms “proximal” and “distal” throughout the claims. However, the relative terms “proximal” and “distal” are given no point of reference. Each rejection applied below defines a proximal-distal axis by the Examiner.
Claim Objections
Claims 35, 40, 42 and 43 are objected to because of the following informalities:
Claim 35, “the second trajectory extends into” should read “the second trajectory is configured to extend into” or the like to prevent the cited parts of the human body (“vertebral level”) as part of the claimed invention.
Claim 40, “which at least of the closure mechanism” should read “which at least part of the closure mechanism:”.
Claim 40, “a first trajectory into a first vertebral level” should read “a first trajectory configured to extend into a first vertebral level” or the like to prevent the cited parts of the human body (“vertebral level”) as part of the claimed invention. The same is true for the second trajectory extending into a second vertebral level.
Claim 42 “the proximal distal axis” should read “a proximal-distal axis”.
Claim 43, “the second trajectory extends” should read “the second trajectory is configured to extend” or the like for reasons listed above.
Appropriate correction is required.
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:
“unilateral locking interface” in claims 39, 48
“closure mechanism” in claim 40
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.
Regarding the unilateral locking interface, paragraph [00162] discloses one or more grooves. Therefore, for purposes of examination the structure determined sufficient to perform the function of enabling a surgical instrument is one or more grooves or functional equivalents thereof.
Regarding the closure mechanism, paragraph [0010] discloses a threaded post. Therefore, for purposes of examination, the structure determined sufficient to perform the function of retaining the rod is a threaded post or functional equivalent 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 32 – 39 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 32 discloses the limitation “wherein the distal portion has a distal surface substantially parallel to a proximal surface”. It is unclear to what component the “proximal surface” belongs. For example, is the proximal surface part of the proximal portion or distal portion? For purposes of examination, the proximal surface is assumed to be part of the distal surface.
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) 32 - 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bailey (US 2001/0034521 A1).
Regarding clam 32, Bailey discloses a bone anchor coupling (Abstract, Fig. 1b), comprising:
a body (ref. 14, Fig. 1a) that includes a proximal portion, a distal portion, and a spanning portion that connects the proximal and distal portions (see remarked Fig. 1b below), the proximal portion defining an opening configured to receive at least a portion of an implant therethrough along a first trajectory into a first vertebral level (see remarked Fig. 1b below and Fig. 3a which best shows the opening ref. 42), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a sidewall of the implant (see remarked Fig. 1b below), the distal portion extending outward from a distal end of the spanning portion (Fig. 1B);
wherein the distal portion has a distal surface substantially parallel to a proximal surface (as best understood, the proximal/distal surfaces or top/bottom surfaces are shown to be substantially parallel) and defines a bone anchor opening configured to receive an auxiliary bone anchor therethrough along a second trajectory into a vertebral level adjacent to the first vertebral level (see remarked Fig. 1b below); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion (Fig. 1b).
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Regarding claim 33, Bailey discloses the bone anchor coupling of claim 32, wherein the distal surface of the distal portion is angled relative to a proximal-distal axis of the spanning portion and faces one of a direction to the left or a direction to the right of the proximal-distal axis when viewed from a perspective that visualizes the lateral surface of the spanning portion (the distal surface of the distal portion is angled relative to a proximal-distal/top-bottom axis, wherein the angle may be any angle, in addition the left-right angulation may be achieved by any portion of the distal portion, such as the curved semi-circular surfaces of the distal surface).
Regarding claim 34, Bailey discloses the bone anchor coupling of claim 33, wherein the second trajectory is substantially perpendicular to the distal surface of the distal portion such that the second trajectory extends into a vertebral level to one of the right or the left of the first vertebral level when viewed from a perspective that visualizes the lateral surface of the spanning portion (the trajectories of the implants are able to angulate due the ball and socket type of the connection, thus the trajectories are fully capable of functioning and extending in such a manner).
Regarding claim 35, Bailey discloses the bone anchor coupling of claim 32, wherein the second trajectory extends into a vertebral level in one of the caudal or cephalad directions relative to the first vertebral level (this is considered a functional limitation in which the body and anchors/implants may be implanted in any a number of orientations such as in a caudal/cephalad direction).
Regarding claim 36, Bailey discloses the bone anchor coupling of claim 32, wherein the second trajectory extends at an angle one of outward away from a proximal-distal axis of the spanning portion or inward towards the proximal-distal axis of the spanning portion (the ball and socket type joint allows for a plurality or polyaxial angulation).
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) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al. (US 2001/0034521 A1) in view of Lai et al. (US 12,144,530 B2).
Regarding claim 37, Bailey discloses the bone anchor coupling of claim 32, except wherein the bone anchor opening has a partially threaded interior surface configured to engage a threaded proximal head of an auxiliary bone anchor such that the auxiliary bone anchor is capable of being locked at any angle amongst a plurality of selectable angles relative to a central axis of the bone anchor opening.
Lai teaches an orthopedic implant (Abstract) comprising a hole (ref. 14) with a partially threaded interior surface (Figs. 3 – 4, ref. 17, 78) and a threaded proximal head of an anchor (Fig. 6) such that a bone anchor (ref. 16) may be a non-locking or variable angle bone anchor while still achieving a strong wedging engagement. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bone anchor opening of Bailey to be partially threaded on the interior surface, as taught by Lai, to better allow for non-locking or variable angle bone anchors to be used.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al. (US 2001/0034521 A1) in view of Ray (US 5,531,745).
Regarding claim 38, Bailey discloses the bone anchor coupling of claim 32, except wherein the bone anchor opening defined in the distal portion comprises a plurality of bone anchor openings.
Ray teaches an orthopedic coupling (Abstract) configured to couple to an implant (ref. 46) and a plurality of auxiliary bone anchors (ref. 188, Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of Bailey to comprise a plurality of openings, as taught by Ray, for the purpose of stronger anchoring into bone.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al. (US 2001/0034521 A1) in view of Gustine et al. (US 9,060,815 B1).
Regarding claim 39, Bailey discloses the bone anchor coupling of claim 32, except wherein the proximal portion includes a unilateral locking interface, wherein the unilateral locking interface is configured to enable a surgical instrument to hold onto one side of the wing.
Gustine teaches an analogous coupling (Abstract, Fig. 4) comprising a body (ref. 16, Fig. 5) with a unilateral locking interface (ref. 54, Fig. 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of Bailey to include the unilateral locking interface as taught by Gustine, for the purpose of better mating with an insertion tool.
Claim(s) 40 – 45, 50 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1).
Regarding claim 40, Hainard discloses a bone anchor assembly (Abstract), comprising:
a bone anchor (ref. 24);
an auxiliary bone anchor (ref. 16);
a receiver member (ref. 31) coupled to a proximal end of the bone anchor and defining a rod seat configured to receive a rod (Figs. 16);
a closure mechanism threadably mated to the receiver member (Fig. 16, ref. 26);
a wing (ref. 118, Fig. 16) that includes a proximal portion (ref. 152), a distal portion (ref. 154), and a spanning portion that connects the proximal and distal portions (see remarked Fig. 16 below), the proximal portion defining an opening through which at least of the closure mechanism or a proximal terminal end of the receiver member is disposed (Fig. 16), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a side wall of the receiver member (Fig. 16), the distal portion extending outward from a distal end of the spanning portion (Fig. 16); and
wherein the opening of the proximal portion defines a first trajectory into a first vertebral level (Fig. 18, ref. 164) and the distal portion of the wing defines a bone anchor opening through which the auxiliary bone anchor is disposed (Fig. 18), the bone anchor opening defining a second trajectory into a second vertebral level adjacent to the first vertebral level (ref. 184) (please note that the vertebral levels and the associated trajectories are considered to be intended use limitations in which the anchors are full capable of being implanted in a pluralities of different orientations and angles); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion.
Hainard is silent regarding a nut configured to threadably engage the closure mechanism to secure the proximal portion of the wing to the receiver member
Stein teaches a bone anchor assembly in the related field of endeavor comprising a receiver member (Fig. 3, ref. 12), a wing (Fig. 3, ref. 30), a closure mechanism threadably mated to the receiver (Fig. 3, ref. 54) and a nut configured to threadably engage the closure mechanism to secure a proximal portion of the wing to the receiver member (Fig. 3, ref. 58). Stein discloses that use of the nut in combination with the closure mechanism ensures that the wing is held to bone screws and prevents rotation of between the receiver and wing (paragraph [0033]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the closure mechanism of Hainard to include the closure mechanism and nut, as taught by Stein, for the purpose of better ensuring that the wing is held in pace relative the anchors and receiver
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Regarding claim 41, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein a distal surface of the distal portion is angled relative to a proximal-distal axis of the spanning portion within a plane that extends through the proximal distal axis of the spanning portion parallel to the lateral surface of the spanning portion (this is interpreted broadly, the proximal-distal axis is shown in remarked Fig. 16 above, any plane that extends through the axis at any angle could include a distal surface of the distal portion).
Regarding claim 42, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the second trajectory is substantially perpendicular to the distal surface of the distal portion such that the second trajectory extends at an angle relative to the proximal distal axis of the spanning portion.
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Regarding claim 43, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the second trajectory extends into a vertebral level in one of the caudal or cephalad directions relative to the first vertebral level (this is dependent upon the orientation of the assembly being inserted; thus, the assembly is fully capable of being positioned in such a way fulfill the claim limitation).
Regarding claim 44, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the second trajectory extends at an angle one of outward away from a proximal-distal axis of the spanning portion or inward towards the proximal-distal axis of the spanning portion (Fig. 18 shows an inwards direction along the proximal-distal axis).
Regarding claim 45, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein a proximal surface of the distal portion of the wing is substantially parallel to the distal surface of the distal portion (see remarked Fig. 18 below).
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Regarding claim 40 (in a second different interpretation), Hainard discloses a bone anchor assembly (Abstract), comprising:
a bone anchor (ref. 24);
an auxiliary bone anchor (ref. 16);
a receiver member (ref. 31) coupled to a proximal end of the bone anchor and defining a rod seat configured to receive a rod (Figs. 16);
a closure mechanism threadably mated to the receiver member (Fig. 16, ref. 26);
a wing (ref. 118, Fig. 18) that includes a proximal portion (ref. 152), a distal portion (ref. 154), and a spanning portion that connects the proximal and distal portions (see remarked Fig. 16 below), the proximal portion defining an opening through which at least of the closure mechanism or a proximal terminal end of the receiver member is disposed (Figs. 16, 18), the spanning portion extending longitudinally from the proximal portion to the distal portion with a lateral surface of the spanning portion configured to face a side wall of the receiver member (Figs. 16, 18), the distal portion extending outward from a distal end of the spanning portion (Figs. 16, 18); and
wherein the opening of the proximal portion defines a first trajectory into a first vertebral level (Fig. 18, ref. 164) and the distal portion of the wing defines a bone anchor opening through which the auxiliary bone anchor is disposed (Fig. 18), the bone anchor opening defining a second trajectory into a second vertebral level adjacent to the first vertebral level (ref. 184) (please note that the vertebral levels and the associated trajectories are considered to be intended use limitations in which the anchors are full capable of being implanted in a pluralities of different orientations and angles); and
wherein a proximal surface of the distal portion is distal to a distal surface of the proximal portion.
Hainard is silent regarding a nut configured to threadably engage the closure mechanism to secure the proximal portion of the wing to the receiver member
Stein teaches a bone anchor assembly in the related field of endeavor comprising a receiver member (Fig. 3, ref. 12), a wing (Fig. 3, ref. 30), a closure mechanism threadably mated to the receiver (Fig. 3, ref. 54) and a nut configured to threadably engage the closure mechanism to secure a proximal portion of the wing to the receiver member (Fig. 3, ref. 58). Stein discloses that use of the nut in combination with the closure mechanism ensures that the wing is held to bone screws and prevents rotation of between the receiver and wing (paragraph [0033]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the closure mechanism of Hainard to include the closure mechanism and nut, as taught by Stein, for the purpose of better ensuring that the wing is held in pace relative the anchors and receiver.
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Regarding claim 50, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein the first trajectory extends substantially parallel to a proximal-distal axis of the spanning portion (see remarked Fig. 18 above).
Regarding claim 51, Hainard in view of Stein discloses the bone anchor assembly of claim 40, wherein a distal-facing surface of the proximal portion opposes a proximal terminal end of the receiver member (Fig. 16).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1) and in view of Lai et al. (US 12,144,530 B2).
Regarding claim 46, Hainard in view of Stein discloses the bone anchor assembly of claim 40, except wherein the auxiliary bone anchor has a threaded proximal head and the bone anchor opening has a partially threaded interior surface configured to engage the threaded proximal head of the auxiliary bone anchor such that the auxiliary bone anchor is capable of being locked at any angle amongst a plurality of selectable angles relative to a central axis of the bone anchor opening.
Lai teaches an orthopedic implant (Abstract) comprising a hole (ref. 14) with a partially threaded interior surface (Figs. 3 – 4, ref. 17, 78) and a threaded proximal head of an anchor (Fig. 6) such that a bone anchor (ref. 16) may be a non-locking or variable angle bone anchor while still achieving a strong wedging engagement. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bone anchor opening of Hainard in view of Stein to be partially threaded on the interior surface, as taught by Lai, to better allow for non-locking or variable angle bone anchors to be used.
Claim(s) 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1) and in view of Ray (US 5,531,745).
Regarding claim 48, Hainard in view of Stein discloses the bone anchor assembly of claim 40, except wherein the bone anchor opening defined in the distal portion of the wing comprises a plurality of bone anchor openings.
Ray teaches an orthopedic coupling (Abstract) configured to couple to an implant (ref. 46) and a plurality of auxiliary bone anchors (ref. 188, Fig. 3). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of Hainard in view of Stein to comprise a plurality of openings, as taught by Ray, for the purpose of stronger anchoring into bone.
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hainard et al. (US 2013/0085534 A1) in view of Stein et al. (US 2017/0348026 A1) and in view of Gustine et al. (US 9,060,815 B1).
Regarding claim 49, Hainard in view of Stein discloses the bone anchor assembly of claim 40, except wherein the wing includes a unilateral locking interface, wherein the unilateral locking interface is configured to enable a surgical instrument to hold onto one side of the wing.
Gustine teaches an analogous coupling (Abstract, Fig. 4) comprising a body (ref. 16, Fig. 5) with a unilateral locking interface (ref. 54, Fig. 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of Bailey to include the unilateral locking interface as taught by Gustine, for the purpose of better mating with an insertion tool.
Allowable Subject Matter
Claim 47 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See related prior art directed towards methods of securing a bone anchor assembly to bone.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773