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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/11/2025 has been entered.
Claim Objections
Claim(s) 1-11 is /are objected to because of the following informalities:
Claim 1, line 1 recites “spine alignment system,” instead of “A spine alignment system,” in order to be grammatically correct.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 8, 11 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites the limitation “wherein the second slot extends at least 200 degrees in circumference” which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the specification discloses that the “cap 132 may also be configured to form the slot 142 with an arc length angle of θ, where θ may be greater than 180 degrees. The slot 142 having an arc length angle of greater that 180 degrees enables the slot to receive the alignment rod 140 with a snap-fit engagement” (see para. [0058]); the specification fails to reasonably convey that the arc length angle be at least 200 degrees in circumference, omitting the range of 180 to 199 degrees, therefore adds a more specific range of greater than 200 degrees after a broader original disclosure. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)
Claim 11 recites the limitation “wherein the opposed inward ridges of the second slot comprise arcuate lips sized to elastically deform during rod insertion and then exert a lateral force on the alignment rod” which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. While the specification discloses that the “small flexibility of the cap material allows the slot 142 to deform enough to allow the alignment rod to be received therein, then retain the alignment rod 140 within the slot 140” (see para. [0058]), the specification fails to reasonably convey that the cap elastically deforms.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites the limitation “the substantially planar interior surface with the cap’s through-hole is located on an opposite side of the through-hole from the second slot of the cap”, which fails to further limit claim 1 from which it depends, since claim 1 has been amended to already include this limitation.
Claim 7 recites the limitation “where the cap’s through-hole includes a substantially planar interior surface is located on an opposite side of the through-hole from the second slot of the cap”, which fails to further limit claim 1 from which it depends, since claim 1 has been amended to already include this limitation..
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 32 and 39 is/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 recites the limitation "the second slot" in line 3. There is insufficient antecedent basis for this limitation in the claim. It appears that the claim should instead recite “a second slot” in order to provide sufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation “further comprising: a cap having a through-hole configured to receive the extension shaft” and “wherein the cap includes a second slot”, which renders the claim indefinite since these limitations are already included in claim 37, from which it depends. It appears that claim 39 should be amended to either remove these limitations or to refer back to the previously introduced limitation by reciting “the cap”, “the through-hole”, “the second slot”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 23-24, 26-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pisharodi (U.S. Pub. No. 2011/0245877 A1, hereinafter “Pisharodi”)
Pisharodi discloses, regarding claim 23, a method of assembling a spine alignment system (see Fig. 2F), comprising: securing a pedicle screw (12C1), having a head (22C1), to a bony pedicle of a vertebra (see Fig. 2F, see para. [0035]); securing an extension shaft (41C1) to the pedicle screw (12C1); engaging a cap (24C1) about the extension shaft such that the cap can translate axially over a length of the extension shaft (see Fig. 2F), the cap having a second slot (52) having a longitudinal axis that is substantially perpendicular to a longitudinal axis of the extension shaft when the cap is engaged with the extension shaft (see Figs. 1 and 2F); capturing an alignment rod (42) with the second slot of the cap (see Fig. 2F); incrementally translating the cap and alignment rod axially down the extension shaft (see para. [0042]); incrementally translating the alignment rod through a substantially cylindrical passage formed by a first slot (47) in the screw head and the second slot (52) in the cap (see Figs. 1 and 2F, see also para. [0042]); and, securing the alignment rod to the pedicle screw such that the alignment rod cannot be moved laterally with respect to the pedicle screw (see para. [0038]).
Regarding claim 24, further comprising: aligning a plurality of vertebra along the alignment rod as the alignment rod is incrementally translated down the extension shaft (see Fig. 2F, see para. [0042]).
Regarding claim 26, wherein the head of the pedicle screw includes an exterior thread (41) that threadedly engages a nut (88), wherein the nut secures the cap to the head of the pedicle screw (see Fig. 1, see para. [0036]).
Regarding claim 27, wherein the pedicle screw is poly-axial (see Fig. 1, see para. [0035]).
Regarding claim 28, wherein the alignment rod is substantially linear (see Fig. 2E).
Regarding claim 29, wherein the alignment rod is curved along a longitudinal axis (see Fig. 2F).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisharodi (U.S. Pub. No. 2011/0245877 A1, hereinafter “Pisharodi”) in view of Janowski (U.S. Pub. No. 2012/0209332 A1, hereinafter “Janowski”).
Pisharodi discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 25, wherein the extension shaft is generally cylindrical in shape and includes at least one substantially flat exterior surface parallel with the longitudinal axis of the extension shaft.
Janwoski a method of assembling a spine alignment system (see Figs. 4-5B), wherein the method includes capturing an alignment rod (1216, see Fig. 26) with the slot of the cap (see para. [0072]) and incrementally translating the cap and alignment rod axially down the extension shaft (via threads, see paras. [0043] and [0072]) in order to apply a force to the alignment rod to urge the rod to translate along the extension and guide the alignment rod toward the pedicle screw (see paras. [0043] and [0072]). In addition, Janowski discloses the extension shaft (706, see Figs. 15-16) including at least one substantially flat exterior surface (720) parallel with the longitudinal axis of the extension shaft (see Fig. 15), wherein the cap (714) includes a planar surface (718) in order to ensure that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat (710) as it travels along the extension (see para. [0065]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the extension shaft in Pisharodi to include at least one substantially flat exterior surface parallel with the longitudinal axis of the extension shaft and the cap to include a planar surface in view of Janowski in order to ensure that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat as it travels along the extension.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisharodi in view of Janowski, as applied to claim 23 above, and in further view of Boachie-Adjei et al. (U.S. Pub. No. 2012/0083853 A1, hereinafter “Boachie-Adjei”).
Pisharodi in view of Janowski disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 30, wherein the pedicle screw is mono-axial.
Boachie-Adjei discloses a spinal system (10, see Fig. 1), with mono-axial screws (see para. [0007]) in order to provide less range of motion for use in procedures that require the range of motion to be restricted (see para. [0007]).
It would have been obvious to one having ordinary skill in the art at the time the invention as made to modify the pedicle screw in Pissharodi in view of Janowski to be mono-axial in view of Boachie-Adjei in order to provide less range of motion for use in procedures that require the range of motion to be restricted.
Claim(s) 37, 39-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lange (U.S. Pub. No. 2002/0169450 A1, hereinafter “Lange”) in view of Janowski (U.S. Pub. No. 2012/0209332 A1, hereinafter “Janowski”).
Lange discloses, regarding claim 37, a spine alignment system (see Figs. 1-4), comprising: a pedicle screw (2) having a longitudinal axis (D), the pedicle screw having a screw head (14), an extension shaft (4) secured to the pedicle screw (see Fig. 4), such that a longitudinal axis (D) of the extension shaft is substantially coaxial with the longitudinal axis of the pedicle screw (see Fig. 4), wherein the extension shaft is detachable from the pedicle screw (see para. [0023] “break-away”); a cap (6) having a through-hole (7), and a second slot (e.g. slot formed between 8 and 9 that receives 1) extending more than 180 degrees around an alignment rod (1) in a snap-fit configuration (see Figs. 2 and 4, see para. [0024]), the second slot including inward ridges (8 and 9) configured to retain the alignment rod in a snap-fit configuration (see Fig. 4, see para. [0024]); and an alignment rod (1) configured to engage with the extension shaft such that the alignment rod is configured to translate axially along the extension shaft (see Fig. 4, see paras. [0025]-[0026]).
Regarding claim 39, wherein the through-hole (7) of the cap (6) is configured to receive the extension shaft (see Fig. 4), the through-hole having a longitudinal axis (D), wherein the second slot (e.g. slot between 8 and 9 that receives 1) of the cap has a longitudinal axis that is substantially perpendicular to the longitudinal axis of the through-hole (see Figs. 1 and 4) and wherein the screw head and the slot of the cap, together, form a substantially cylindrical passage configured to receive the alignment rod (1, see Fig. 5).
Regarding claim 40, further comprising: a nut (10) configured to receive the extension shaft and facilitate movement of the cap along the extension shaft (see fig. 4, see paras. [0025] and [0026]).
Regarding claim 41, wherein the alignment rod is received by the substantially cylindrical passage formed by the pedicle screw head and the cap, such that the alignment rod is laterally fixed within the substantially cylindrical passage (see Fig. 4, see para. [0024]).
Regarding claim 42, wherein the extension shaft is configured to receive a power driving instrument, to facilitate the powered driving of the extension shaft and the pedicle screw (see Fig. 4, note the nut 10 is threadably received on extension 4 and would be capable of being driven onto extension 4 via a powered driver).
Lange fails to disclose, regarding claim 37, wherein the through-hole of the cap with a mating substantially planar interior surface; wherein the screw head includes a first slot having a longitudinal axis that is substantially perpendicular to the longitudinal axis of the pedicle screw; regarding claim 38, wherein the extension shaft is generally cylindrical in shape and includes at least one substantially flat exterior surface parallel with the longitudinal axis of the extension shaft.
Janowski discloses an extension shaft (706, see Figs. 15-16), screw head (710), and a cap (714) for a spinal rod assembly (see Figs. 15-16), wherein the screw head includes a slot (e.g. seat for 702 in arm 710, see fig. 15, see para. [0065]), wherein the extension shaft includes at least one substantially planar exterior surface (720, see Fig. 15) and wherein the cap includes a substantially planar surface (718) within the through-hole (see para. [0035]) located on an opposite side from the slot (see Fig. 16, note that the flat side is located on a side of the opening facing away from the slot e.g. on an opposite side) in order to ensure that rod has a proper seat and that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat as it travels along the extension (see para. [0065]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the screw head in Lange to include a slot and to modify extension shaft and the cap in Lange to include at least one flat surface in view of Janowski in order to ensure that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat as it travels along the extension.
Claim(s) 31-36 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pisharodi (U.S. Pub. No. 2011/0245877 A1, hereinafter “Pisharodi”) in view of Janowski (U.S. Pub. No. 2012/0209332 A1, hereinafter “Janowski”) and in view of Yim et al. (U.S. Pub. No. 2015/0105831 A1, hereinafter “Yim”).
Pisharodi discloses, regarding claim 31, a method of assembling a spine alignment system (see Fig. 2F), comprising: securing a pedicle screw (12C1), having a head (22C1), to a bony pedicle of a vertebra (see Fig. 2F, see para. [0035]); securing an extension shaft (41C1) to a pedicle screw (12C1); placing a cap (24C1) over the extension shaft (see Fig. 2F); securing the cap and the extension shaft to the pedicle screw by applying torque for coupling (via 88, see paras. [0037] and [0042]), engaging an alignment rod (42) with the extension shaft such that the alignment rod can translate over a length of the extension shaft (see Fig. 2F), incrementally translating the alignment rod axially down the extension shaft (see para. [0042]); and, securing the alignment rod to the pedicle screw such that the alignment rod cannot be moved laterally with respect to the pedicle screw (see para. [0038]).
Regarding claim 32, further comprising: engaging the cap (24C1) about the extension shaft such that the cap can translate axially over a length of the extension shaft (see Fig. 2F), the cap having a second slot (52) having a longitudinal axis that is substantially perpendicular to a longitudinal axis of the extension shaft when the cap is engaged with the extension shaft (see Figs. 1 and 2F); and capturing the alignment rod with the second slot of the cap (see Fig. 2F, see para. [0038]).
Regarding claim 33, further comprising: incrementally translating the cap and the alignment rod axially down the extension shaft (see Fig. 2F, see para. [0042]).
Regarding claim 34, further comprising: aligning a plurality of vertebra along the alignment rod as the alignment rod is incrementally translated down the extension shaft (see Fig. 2F, see para. [0042]).
Regarding claim 36, wherein the head of the pedicle screw includes an exterior thread (41) that threadedly engages a nut (88), wherein the nut secures the cap to the head of the pedicle screw (see Fig. 1).
Pisharodi fails to disclose, regarding claim 31, wherein securing the cap and the extension shaft to the pedicle screw is done by operating a powered driving instrument to apply torque for coupling, wherein the extension shaft comprises a substantially flat surface and the cap comprises a corresponding flat interior surface to maintain orientation of a slot in the cap relative to a slot in the screw head; regarding claim 35, wherein the extension shaft is generally cylindrical in shape and includes at least one substantially flat exterior surface parallel with the longitudinal axis of the extension shaft; and regarding claim 43, wherein securing of the pedicle screw and extension shaft is performed by operating a powered driving instrument to apply a controlled torque during coupling.
Janwoski discloses a method of assembling a spine alignment system (see Figs. 4-5B), wherein the method includes capturing an alignment rod (1216, see Fig. 26) with the slot of the cap (see para. [0072]) and incrementally translating the cap and alignment rod axially down the extension shaft (via threads, see paras. [0043] and [0072]) in order to apply a force to the alignment rod to urge the rod to translate along the extension and guide the alignment rod toward the pedicle screw (see paras. [0043] and [0072]). In addition, Janowski discloses the extension shaft (706, see Figs. 15-16) including at least one substantially flat exterior surface (720) parallel with the longitudinal axis of the extension shaft (see Fig. 15), wherein the cap (714) includes a planar surface (718) in order to ensure that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat (710) as it travels along the extension (see para. [0065]).
Yim discloses an anti-torque tool (10, see Fig. 3) for tightening a locking cap or nut (148, see Fig. 2A, see also ABSTRACT), wherein the instrument is designed to accommodate a power driver (see Fig. 3, see para. [0048]) in order to enable the surgeon to not have to generate the torque by hand (see paras. [0042] and [0048]), require less physical effort by the surgeon, reducing surgeon fatigue, eliminating additional injury to the patient (see para. [0008]), and enabling single handed driving (see para. [0009]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the extension shaft in Pisharodi to include at least one substantially flat exterior surface parallel with the longitudinal axis of the extension shaft and the cap to include a planar surface in view of Janowski in order to ensure that the slot of the cap is maintained in a predetermined orientation relative to the slot of the seat as it travels along the extension. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the locking nut in Pisharodi to be tightened by a power driver / anti-torque tool in view of Yim in order to in order to enable the surgeon to not have to generate the torque by hand in order to enable the surgeon to not have to generate the torque by hand, require less physical effort by the surgeon, reduce fatigue, eliminate additional injury to the patient and enable single handed tightening of the locking nut.
Allowable Subject Matter
Claim(s) 1-5, 9-10, 12-23 is/are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest:
A spine alignment system comprising a pedicle screw, an extension shaft coaxial with the longitudinal axis of the pedicle screw, and a cap, the cap including a through-hole configured to receive the extension slot and a second slot having a longitudinal axis substantially perpendicular to the longitudinal axis; and as per claim 1, wherein the through-hole of the cap includes a substantially planar interior surface located on a side of the through-hole opposite the second slot.
A spine alignment system comprising a pedicle screw, an extension shaft, a cap and a nut, the cap includes a through-hole and a slot having a longitudinal axis that is substantially perpendicular to the longitudinal axis of the through-hole; and as per claim 12, wherein the extension shaft is substantially coaxial with the longitudinal axis of the pedicle screw and the slot in the cap being configured to receive and guide an alignment rod along a longitudinal axis while preventing lateral displacement of the rod.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive.
The Applicant asserts that the amended claims preserve the integrated combination the specification teaches: a cap with a greater than 180 degree snap-fit slot and inward ridges, planar keyed mating surfaces (cap/extension) that maintain rotational orientation, and an aligned cap/screw-head slot forming a substantially cylindrical passage that bone guides translation of the rod and prevents lateral escape during incremental reduction; optionally with powered coupling in the method. The Applicant asserts that Lange and Janowski refences do not teach or suggest this integrated mechanism. The Applicant further asserts that Pisharodi’s incremental method does not disclose the specific cylindrical passage formed by the co-aligned first and second slots under orientation control. And the Applicant asserts that Yim discloses powered tightening tools but not the claimed integration with the guided-translation architecture.
The Office respectfully disagrees. In response to Applicant's piecemeal analysis of the references, one cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.
Lange and Pisharodi disclose a cap with a greater than 180 degree snap-fit slot and inward ridges (see Fig. 4 and para. [0024] of Lange and para. [0038] of Pisharodi).
Janowski discloses planar keyed mating surfaces (cap/extension) that maintain rotational orientation (see Figs. 15-16, see para. [0065]).
Lange in view of Janowski disclose an aligned cap/screw-head slot forming a substantially cylindrical passage that bone guides translation of the rod and prevents lateral escape during incremental reduction (see Figs. 2 and 4 and paras. [0024]-[0026] of Lange; and Figs. 15-16 and para. [0065] of Janowski).
Pisharodi an aligned cap/screw-head slot forming a substantially cylindrical passage that bone guides translation of the rod and prevents lateral escape during incremental reduction (see annotated Fig. 2F below, see also paras. [0038] and [0040]).
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Yim discloses powered tightening tools that would be capable of being used with guided-translation architecture, and further the test for obviousness is not whether the features of one reference may be bodily incorporated into the other to produce the claimed subject matter but simply what the combination of references makes obvious to one of ordinary skill in the pertinent art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773