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 .
Claim Objections
The claims are objected to because of the following informalities:
Claim 1, line 7 recites “the length”. This should recite “a length”.
Claim 1, line 7-8 recite “the bending flexibility” and “the mechanical strength”. This should read “a bending flexibility” and “a mechanical strength”.
Claim 2 recites “the material, the cross-sectional shape or area, and/or the relative volume portion of the filament(s)”. This should read “a material, a cross-sectional shape or area, and/or the relative volume portion of the one or more filaments”.
Claim 3 recites “the filaments” in line 2. This should read “the one or more filaments”.
Claim 4 recites “the pitch of the helical winding of the filament(s)”. This should read “a pitch a helical winding of the one or more filaments”.
Claim 4 recites “the filament(s)” in line 4. This should read “the one or more filaments”.
Claim 5 recites “the pitch” twice. Both instances should read “a pitch”.
Claim 10 recites “the filaments”. This should read “the one or more filaments”.
Claim 11 recites “said internal projections”. This should read “said one or more internal projections.
Claim 15, line 6, “different to” should read “different from”.
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: “control mechanism” in claim 19.
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.
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.
Claim 3-7, 12, 15 and 16 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 3 recites “wherein the largest dimension of the or each filament”. It is unclear what the metes and bounds of this limitation are. For purposes of examination, it has been interpreted as “a largest dimension of the one or more filaments”.
Claim 4 recites “one ore more helically wound filaments”. It is unclear if these are the same filaments as those recited in claim 1 or additional filaments. For purposes of examination, they have been interpreted as the same.
Regarding claim 4, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5-7 are rejected due to their dependency on claim 4.
Claim 5 recites “a first helically wound filament portion” and “a second helically wound filament portion” but it is unclear if these portions are comprised of the helically wound filaments of claim 4 or if they are additional portions, or if they are even part of the ET tube at all. For purposes of examination, these portions are considered to be comprised of the helically wound filaments of claim 4.
Claim 6-7 are rejected due to its dependency on claim 5.
Regarding claim 12, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 15, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 16, “the main tube body” “the distal tip portion” and “the device” all lack antecedent basis.
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.
Claims 5-7 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 5 fails to further limit the subject matter of claim 4. Claim 5 introduces a first and second helically wound filament portion, however these portions do not limit claim 4 and it is not clear if they are part of the endotracheal tube at all. 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.
Claims 6-7 are rejected due to its dependency on claim 5.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Millet (US 6,146,814)
Regarding claim 1, Millet discloses: An endotracheal tube (10; col. 4, lines 37-41) having a body comprising a flexible hollow tube with a distal end (13) for insertion into a patient's trachea during intubation (col. 1, lines 13-16), and an opposite proximal end (opposite the insertion end), wherein: the endotracheal tube body comprises a polymeric material (claim 1) comprising a helically wound, meshed or braided reinforcement structure embedded therein (col. 2, lines 42-56), the helically wound, meshed or braided reinforcement structure being formed from one or more filaments (21, 22), and wherein one or more properties of the reinforcement structure vary along the length of the endotracheal tube such that the bending flexibility and/or the mechanical strength of the endotracheal tube varies along the length of the endotracheal tube (col. 2, lines 57-64).
Regarding claim 2, Millet further discloses wherein the material, the cross- sectional shape or area, and/or the relative volume proportion of the filament(s) forming the reinforcement structure vary along the length of the endotracheal tube (see figure 2).
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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) 1, 3-10 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimamura et al. (US 4,737,153) in view of Ukawa (JP 2020000451 A). The examiner relies on the translation of Ukawa below.
Regarding claim 1, Shimamura discloses: An endotracheal tube (12, figures 6-7; col. 4, line 58) having a body (4) comprising a flexible hollow tube with a distal end (end at 2) for insertion into a patient's trachea during intubation, and an opposite proximal end (opposite the insertion end), wherein: the endotracheal tube body comprises a polymeric material (col. 2, lines 57-61) comprising a helically wound, meshed or braided reinforcement structure embedded therein (col. 2, lines 66-68), the helically wound, meshed or braided reinforcement structure being formed from one or more filaments (col. 3, lines 31-43),
Shimamura does not explicitly disclose wherein one or more properties of the reinforcement structure vary along the length of the endotracheal tube such that the bending flexibility and/or the mechanical strength of the endotracheal tube varies along the length of the endotracheal tube.
However, Ukawa teaches it is known to have an endotracheal tube (abstract) wherein one or more properties of the reinforcement structure vary along the length of the endotracheal tube such that the bending flexibility and/or the mechanical strength of the endotracheal tube varies along the length of the endotracheal tube (figure 10; page 4, paragraph 5 beginning with 10 and 11; page 2 last paragraph describes different resistances to bending).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Shimamura such that one or more properties of the reinforcement structure vary along the length of the endotracheal tube such that the bending flexibility and/or the mechanical strength of the endotracheal tube varies along the length of the endotracheal tube as taught by Ukawa for the benefit of preventing kinking while also enabling the endotracheal tube to have specific properties in different areas along the tube.
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Regarding claim 3, Shimamura further discloses wherein the largest dimension of the or each filament in a direction perpendicular to the longitudinal extension of the filaments is in a range of from 0.1 to 1 mm (col. 4, lines 2-4).
Regarding claim 4, Shimamura further discloses wherein the reinforcement structure comprises one or more helically wound filaments, and wherein the pitch of the helical winding of the filament(s) is in a range of from 2 mm to 10 mm (col. 3, lines 10-11), optionally wherein the pitch of the helical winding of the filament(s) varies along the length of the endotracheal tube (figure 10 of Ukawa).
However, Shimamura does not explicitly disclose wherein the pitch of the helical winding of the filament(s) is in a range of from 0.75 mm to 5 mm.
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 pitch of Shimamura from between 2-10mm to 2-5mm as applicant appears to have placed no criticality on the claimed range (citation indicating the [0023] “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 5, Shimamura as modified further discloses wherein a first helically wound filament portion (52 of Ukawa) is arranged distally of a second helically wound filament portion (53 of Ukawa) along the length of the endotracheal tube, and the pitch of the first helically wound filament portion is greater than the pitch of the second helically wound filament portion (see figure 10 of Ukawa).
Regarding claim 6, Shimamura as modified further discloses wherein the first and second helically wound filament portions are provided as two distinct helically wound filaments sequentially arranged along the length of the endotracheal tube body (see figure 10 of Ukawa; Ukawa: page 4 paragraph 5 beginning with “10 and 11”).
Regarding claim 7, Shimamura as modified further discloses wherein one of the first and second helically wound filament portions has a substantially circular cross-sectional shape, and wherein the other of the first and second helically wound filament portions has a flattened cross-sectional shape (see figure 10 of Ukawa; Ukawa: page 4 paragraph 5 beginning with “10 and 11”).
Regarding claim 8, Shimamura as modified does not explicitly disclose wherein the helically wound, meshed or braided reinforcement structure extends along at least 80% of the length of the endotracheal tube.
However, Shimamura illustrates wherein the helically wound, meshed or braided reinforcement structure extends along at least 80% of the length of the endotracheal tube (figure 7). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the endotracheal tube within applicant’s claimed range as this is reasonably taught based on the drawings.
Regarding claim 9, Shimamura as modified further discloses wherein the helically wound, meshed or braided reinforcement structure extends along the ET tube body but does not extend within a distal tip portion of the tube (not located in 2 of Shimamura as per col. 4, lines 44-53).
Regarding claim 10, Shimamura as modified further discloses wherein the filaments comprise a metallic, polymeric, aramid, para-aramid or carbon-fibre material (col. 3, lines 31-43 of Shimamura).
Regarding claim 12, Shimamura discloses the endotracheal tube has excellent flexibility (col. 1, lines 7-14). While Shimamura does not explicitly state wherein the endotracheal tube is configured to bend at an applied torque of 1 Nm or less, optionally at an applied torque of 0.75 Nm or less to reach an articulation angle of 50°, the flexibility and pressure resistance is a property of the tube material/thickness (col. 1, lines 7-31) and the reinforcement material (col. 3, lines 31-43) and therefore is disclosed to be a result effective variable in that changing the tube material/thickness and the reinforcement material affects flexibility and thus the bending at different applied torques.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Shimamura wherein the endotracheal tube is configured to bend at an applied torque of 1 Nm or less as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 13, Shimamura discloses wherein the endotracheal tube has excellent pressure resistance (col. 1, lines 7-14). While Shimamura does not explicitly state wherein the endotracheal tube is configured to resist collapse at an applied pressures up to and including 300 cmH20, the ability to resist collapse is a property of the tube material/thickness (col. 1, lines 7-31) and the reinforcement material (col. 3, lines 31-43) and therefore is disclosed to be a result effective variable in that changing the tube material/thickness and the reinforcement material affects pressure resistance.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Shimamura wherein the endotracheal tube is configured to resist collapse at an applied pressures up to and including 300 cmH20 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Shimamura as modified further discloses wherein the endotracheal tube further comprises an inflatable cuff (13) provided at or near a distal end of the endotracheal tube (see figures 6-7).
Regarding claim 15, Shimamura as modified further discloses wherein the endotracheal tube body comprises a main body portion (4) and a distal tip portion, said portions being provided as separate components (col. 5, lines 26-32), optionally wherein the main body portion of the ET tube is made from a first material selected from a PVC (col. 3, lines 60-61, col. 2, lines 57-60), thermoplastic elastomer, or silicone material, and the distal tip portion is made from a second material selected from a PVC (col. 3, lines 60-61, col. 2, lines 57-60), thermoplastic elastomer, or silicone, that is different to the first type of material (col. 6, lines 37-40) (The examiner notes these limitations subsequent to the term “optionally” are optional and thus not required by the instant claim language).
Regarding claim 16, Shimamura as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above. Further, Shimamura discloses that the endotracheal tube is configured such that the main tube body (4) buckles at a lower applied axial load than the distal tip portion (2) of the device. (col. 6, lines 37-40)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimamura et al. (US 4,737,153) in view of Ukawa (JP 2020000451 A) in further view of Agdanowski (EP 0112668 A2).
Regarding claim 11, Shimamura as modified does not explicitly disclose wherein the endotracheal tube further comprises one or more internal projections, said internal projections projecting radially inwardly from an internal wall surface of a distal tip portion of the endotracheal tube.
However, Agdanowski teaches it is known for an endotracheal tube to comprise one or more internal projections (58), said internal projections projecting radially inwardly from an internal wall surface of a distal tip portion of the endotracheal tube (see figures 2-3).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shimamura to include one or more internal projections, said internal projections projecting radially inwardly from an internal wall surface of a distal tip portion of the endotracheal tube as taught by Agdanowski to center any catheter inserted for insufflation or suctioning (page 7, lines 15-21).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimamura et al. (US 4,737,153) in view of Ukawa (JP 2020000451 A) in further view of Kurtis (US 5,509,408)
Regarding claim 17, Shimamura as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above. Shimamura discloses the material of the endotracheal tube to be PVC (col. 2, lines 57-60) but does not explicitly disclose wherein the endotracheal tube comprises a material having a Shore A Hardness in a range of from 60 to 75.
Kurtis teaches an endotracheal tube (82) also made out of PVC and further discloses this material has a durometer in the range of 50 -90 according to Shore A Hardness (col. 8, lines 57-62).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Shimamura such that the PVC has a durometer in the range of 50 -90 according to Shore A Hardness as this is the typical range for that material (col. 8, lines 57-62).
As modified Shimamura does not explicitly disclose the Shore A Hardness in a range of from 60 to 75.
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 Shore A Hardness as taught by Kurtis from between 50-90 to 60-75 as applicant appears to have placed no criticality on the claimed range (page 16 paragraph 1 indicates the Shore A hardness “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shimamura et al. (US 4,737,153) in view of Ukawa (JP 2020000451 A) in further view of Poormand (GB 2,563,567). The examiner relies on the translation of Ukawa below. The examiner relies on the copy of Poormand provided by applicant in the rejection set forth below.
Regarding claim 18, Shimamura as modified by Ukawa discloses the endotracheal tube according to claim 1 (see claim 1 above). Shimamura as modified does not explicitly disclose the ET tube is in a system additionally comprising a stylet for guiding an endotracheal tube during intubation.
However, Poormand teaches it is known to have a system comprising a stylet with an endotracheal tube (page 9, lines 17-32).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Shimamura such that the ET tube is in a system additionally comprising a stylet for guiding an endotracheal tube during intubation for the benefit of ensuring the endotracheal tube is inserted in the correct position (Poormand: page 3, lines 20-22).
Regarding claim 19, Shimamura as modified by Poormand further discloses wherein the stylet (Poormand: figure 1a-1b) comprises a body having a pivotable tip (Poormand: 5) located at a distal end of the body (Poormand: see figure 2a), the pivotable tip moveable about a pivot point in two opposing directions from the longitudinal axis of the distal end of the stylet body (Poormand: figure 2a), and a control mechanism (Poormand: 7) for controlling the pivot angle of the pivotable tip (Poormand: page 14, lines 13-18) .
Regarding claim 20, Shimamura as modified by Poormand wherein each of the endotracheal tube (endotracheal tube has ET tube connector as set forth on page 9 lines 19-21 of Poormand) and the stylet comprise a connector (attaching portion of the stylet as set forth on page 9, lines 19-21 of Poormand) configured for respective engagement with one another to attach the stylet to the endotracheal tube (Poormand: lines 19-21).
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785