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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/14/2025, 5/1/2025, 10/24/2025, 2/2/2026, and 8/25/2026 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
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 4 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.
The term “about equal” in claim 4 is a relative term which renders the claim indefinite. The term “about equal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the parameters of “about equal” would be to satisfy the claim limitations. In the context of claim 4, two diameters can either be equal or not equal, and it is unclear how close to equal the two diameters must be to satisfy the requirement of being “about equal” as claimed.
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)(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.
Claims 1, 8, 9, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wolfertz et al. (U.S. 2016/0095744), herein Wolfertz. Regarding claim 1, Wolfertz discloses a sheath assembly for insertion of a percutaneous pump (“for insertion of a percutaneous pump” is intended use that fails to further define over the prior art), the sheath assembly comprising: a tubular sheath body 10 dimensioned for insertion into a blood vessel through a vessel aperture (see dimensions given in Table between paragraphs [0140] and [0141]) and comprising: a wall 20 having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen 12 substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of a portion of the percutaneous pump and the first lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure below); and a second lumen 13 disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion of the wall to the distal end portion of the wall, wherein the second lumen is dimensioned for passage of a guidewire and the second lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure below).
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Regarding claim 8, Wolfertz discloses that the outer surface of the wall includes markings for determining a depth of insertion (“the catheter may be provided with radiographic markers, which facilitate positioning of the catheter under radiographic control”, paragraph [0022]).
Regarding claim 9, Wolfertz discloses that the distal end portion of the wall is tapered and includes a tapered surface extending to a distal end face, the distal end face being substantially orthogonal to the longitudinal axis of the wall (see Figure 14 which indulges catheter tip 18 shown).
Regarding claim 15, Wolfertz discloses that the tubular sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67mm) or less (see dimensions given in Table between paragraphs [0140] and [0141]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6, 8-12, 15, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Loesener et al. (U.S. 2016/0008573) in view of Wolfertz et al. (U.S. 2016/0095744). Regarding claim 1, Loesener discloses a sheath assembly for insertion of a percutaneous pump (“for insertion of a percutaneous pump” is intended use that fails to further define over the prior art), the sheath assembly comprising: a tubular sheath body 212/311/400/510/610/710/812/1012 dimensioned for insertion into a blood vessel through a vessel aperture and comprising: a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface (outer walls shown in Figures 13-37), and an inner surface defining a first lumen 201/316/401/514A/614A/ 814A/1014A substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of a portion of the percutaneous pump and the first lumen comprises a proximal section and a distal section; and a second lumen 202/318/402/514B/614B/814B/1014B disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion of the wall to the distal end portion of the wall, wherein the second lumen is dimensioned for passage of a guidewire and the second lumen comprises a proximal section and a distal section (see Figures 13-37). However, Loesener fails to disclose a restriction between the proximal section and the distal section in each of the first and second lumen. Wolfertz teaches a sheath assembly the includes a tubular sheath body 10 dimensioned for insertion into a blood vessel through a vessel aperture (see dimensions given in Table between paragraphs [0140] and [0141]) and comprising: a wall 20 having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen 12 substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of a portion of the percutaneous pump and the first lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure above); and a second lumen 13 disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion of the wall to the distal end portion of the wall, wherein the second lumen is dimensioned for passage of a guidewire and the second lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure above). Wolfertz teaches that the restriction 32 is utilized “[i]n order to improve the advancability of the catheter or catheter tube 10“ (see paragraph [0111]). 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 invention of Loesener to include a restriction in each of the first and second lumen, as taught by Wolfertz, in order to improve the advancability of the catheter.
Regarding claim 2, Loesener discloses a stylet 524/651/824A/924C/924D/1018 positioned to substantially occlude the second lumen, wherein the stylet has a proximal end releasably secured to the sheath assembly (see Figures 19-30).
Regarding claim 3, Loesener discloses that the proximal section of the second lumen has a proximal section diameter and the distal section of the second lumen has distal section diameter, and wherein the proximal section diameter is greater than the distal section diameter (this is the result of the combination of Loesener in view of Wolfertz, where the restriction decreases the diameters of the lumen).
Regarding claim 4, Loesener discloses that the distal section diameter is about equal to an outer diameter of the stylet (for example, Figure 30 shows stylet 1018 as filling approximately all of the space within the lumen 1014B and, thus, it is respectfully submitted that the distal section diameter of the lumen is “about equal” to an outer diameter of the stylet).
Regarding claim 6, Loesener discloses a hub coupled to proximal end portion of the tubular sheath body, wherein the hub comprises: a first port 28A in fluid communication with the first lumen, and a second port 28B in fluid communication with the second lumen, wherein the second port is configured to secure the proximal end of the stylet (see Figure 1 and paragraph [0068]).
Regarding claim 8, it is respectfully submitted that the cutouts shown in Figures 13-21B of Loesener can be considered “markings for determining a depth of insertion” as a user can observe these cutouts during insertion to determine the relative depth of insertion.
Regarding claim 9, Loesener discloses that the distal end portion of the wall is tapered and includes a tapered surface extending to a distal end face, the distal end face being substantially orthogonal to the longitudinal axis of the wall (see Figures 13-21B).
Regarding claim 10, Loesener discloses that the second lumen has an outlet extending through the tapered surface of the distal end portion of the wall (see Figures 13-21B).
Regarding claim 11, Loesener discloses a stabilizing structure rotatably coupled to the tubular sheath body (see paragraph [0103]).
Regarding claim 12, Loesener discloses that the stabilizing structure is rotatable about the longitudinal axis (see paragraph [0103]).
Regarding claim 15, Loesener discloses that the tubular sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67mm) or less (see paragraph [0015]).
Regarding claim 25, Loesener discloses a length of the stylet is substantially equal to a length of the second lumen (see paragraph [0016]).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Loesener (U.S. 2016/0008573) in view of Wolfertz (U.S. 2016/0095744) as applied to claims 1-4, 6, 8-12, 15, and 25 above, and further in view of Cully et al. (U.S. 2012/0065579). Loesener in view of Wolfertz provides the invention substantially as claimed, but fails to disclose that the second lumen is coated with an antithrombogenic agent. Cully is in the field of indwelling medical devices (abstract) and teaches wherein the second lumen is coated with an antithrombogenic agent (surfaces of lumens 206 and 208 comprise a heparin coating, para. 0038, fig. 2A). 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 invention of Loesener in view of Wolfertz with the teaching of Cully for the purpose of preventing clotting of the patient’s blood in or near the device.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Loesener (U.S. 2016/0008573) in view of Wolfertz (U.S. 2016/0095744) as applied to claims 1-4, 6, 8-12, 15, and 25 above, and further in view of McGuckin (U.S. 2002/0107506). Loesener in view of Wolfertz provides the invention substantially as claimed, but fails to disclose that the outer surface of the wall includes at least one of a hydrophilic coating and a coating to reduce tissue adhesion. McGuckin teaches a sheath assembly that includes an outer surface of the wall including at least one of a hydrophilic coating and a coating to reduce tissue adhesion (see paragraph [0188]). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the sheath of Loesener in view of Wolfertz to include an outer surface including at least one of a hydrophilic coating and a coating to reduce tissue adhesion, as taught by McGuckin, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Loesener (U.S. 2016/0008573) in view of Wolfertz (U.S. 2016/0095744) as applied to claim1-4, 6, 8-12, 15, and 25 above, and further in view of Smith et al. (U.S. 2014/0121448). Loesener in view of Wolfertz provides the invention substantially as claimed, but fails to disclose that the stabilizing structure includes a feature configured for suturing to a patient or the stabilizing structure includes a pair of suture wings, each wing having a plurality of ribs for securing sutures. Smith is in the field of a cannula for a patient (abstract) and teaches wherein the stabilizing structure includes a feature configured for suturing to a patient (cannula comprises a suture wing for securing the elongated body to the patient, para. 0009; cannula 10 comprises a suture wing 30, para. 0023; fig. 5 shows a pair of suture wings on device 30). 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 invention of Loesener in view of Wolfertz with the teaching of Smit for the purpose of safely securing the device to a patient’s skin or tissues.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 1, 3-5, (1 and 6), 8-16, and 2, respectively, of U.S. Patent No. 10,737,008 in view of Wolfertz et al. (U.S. 2016/0095744). The patent discloses the invention substantially as claimed, as shown in the table below where differences in language is indicated by bolding, but fails to disclose a restriction between the proximal section and the distal section in each of the first and second lumen. Wolfertz teaches a sheath assembly the includes a tubular sheath body 10 dimensioned for insertion into a blood vessel through a vessel aperture (see dimensions given in Table between paragraphs [0140] and [0141]) and comprising: a wall 20 having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen 12 substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of a portion of the percutaneous pump and the first lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure above); and a second lumen 13 disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion of the wall to the distal end portion of the wall, wherein the second lumen is dimensioned for passage of a guidewire and the second lumen comprises a proximal section, a distal section, and a restriction 32 between the proximal section and the distal section (see annotated figure above). Wolfertz teaches that the restriction 32 is utilized “[i]n order to improve the advancability of the catheter or catheter tube 10“ (see paragraph [0111]). 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 invention of the ‘008 patent to include a restriction in each of the first and second lumen, as taught by Wolfertz, in order to improve the advancability of the catheter.
Current Application
U.S. Patent No. 10,737,008
1. A sheath assembly for insertion of a percutaneous pump, the sheath assembly comprising:
a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture and comprising:
a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of a portion of the percutaneous pump and the first lumen comprises a proximal section, a distal section, and a restriction between the proximal section and the distal section; and
a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion of the wall to the distal end portion of the wall, wherein the second lumen is dimensioned for passage of a guidewire and the second lumen comprises a proximal section, a distal section, and a restriction between the proximal section and the distal section.
1. An assembly for insertion of a percutaneous intravascular blood pump and a guidewire, the assembly comprising:
a guidewire having proximal and distal ends;
a stylet having proximal and distal ends;
a tubular sheath body dimensioned for insertion into a blood vessel through a vessel aperture, and for receiving and delivering an intravascular blood pump, the sheath body including:
a wall having a proximal end portion, a distal end portion, a longitudinal axis, an outer surface, and an inner surface defining a first lumen substantially parallel to the longitudinal axis, wherein the first lumen is dimensioned to allow passage of at least a portion of the intravascular blood pump; and
a second lumen disposed within the wall between the inner surface and the outer surface and extending from the proximal end portion to the distal end portion; and a hub coupled to the tubular sheath body and having a port in fluid communication with the second lumen, wherein the second lumen is sized to receive, individually, (1) the distal end of the guidewire and (2) the distal end of the stylet, and wherein when the stylet is positioned within the second lumen, the distal end of the stylet substantially occludes the second lumen and the stylet forms a liquid tight seal across the port.
2. The sheath assembly of claim 1, further comprising a stylet positioned to substantially occlude the second lumen, wherein the stylet has a proximal end releasably secured to the sheath assembly.
1. An assembly… comprising: …
a stylet having proximal and distal ends; … the distal end of the stylet substantially occludes the second lumen.
3. The sheath assembly of claim 2, wherein the proximal section of the second lumen has a proximal section diameter and the distal section of the second lumen has a distal section diameter, and wherein the proximal section diameter is greater than the distal section diameter.
3. The assembly of claim 1, wherein the second lumen has a proximal section having a proximal section diameter and a distal section having a distal section diameter, and wherein the proximal section diameter is greater than the distal section diameter.
4. The sheath assembly of claim 3, wherein the distal section diameter is about equal to an outer diameter of the stylet.
4. The assembly of claim 3, wherein the distal section diameter is about equal to an outer diameter of the stylet.
5. The sheath assembly of claim 1, wherein the second lumen is coated with an antithrombogenic agent.
5. The assembly of claim 1, wherein the second lumen is coated with an antithrombogenic agent.
6. The sheath assembly of claim 2, further comprising a hub coupled to a proximal end portion of the tubular sheath body, wherein the hub comprises: a first port in fluid communication with the first lumen, and a second port in fluid communication with the second lumen, wherein the second port is configured to secure the proximal end of the stylet.
1. An assembly… comprising:
a hub coupled to the tubular sheath body…
6. The assembly of claim 1, wherein the hub is coupled to the proximal end portion of the sheath body, the port is a second port on the hub, and wherein the hub further comprises: a first port in fluid communication with the first lumen, and wherein the second port is configured to secure the proximal end of the stylet.
7. The sheath assembly of claim 1, wherein the outer surface of the wall includes at least one of a hydrophilic coating and a coating to reduce tissue adhesion.
8. The assembly of claim 1, wherein the outer surface of the wall includes at least one of a hydrophilic coating and a coating to reduce tissue adhesion.
8. The sheath assembly of claim 1, wherein the outer surface of the wall includes markings for determining a depth of insertion.
9. The assembly of claim 1, wherein the outer surface of the wall includes markings for determining a depth of insertion.
9. The sheath assembly of claim 1, wherein the distal end portion of the wall is tapered and includes a tapered surface extending to a distal end face, the distal end face being substantially orthogonal to the longitudinal axis of the wall.
10. The assembly of claim 1, wherein the distal end portion of the sheath body is tapered and includes a tapered surface extending to a distal end face, the distal end face being substantially orthogonal to the longitudinal axis of the sheath body.
10. The sheath assembly of claim 9, wherein the second lumen has an outlet extending through the tapered surface of the distal end portion of the wall.
11. The assembly of claim 10, wherein the second lumen has an outlet extending through the tapered surface of the distal end portion of the sheath body.
11. The sheath assembly of claim 1, further comprising a stabilizing structure rotatably coupled to the tubular sheath body.
12. The assembly of claim 1, further comprising a stabilizing structure rotatably coupled to the tubular sheath body.
12. The sheath assembly of claim 11, wherein the stabilizing structure is rotatable about the longitudinal axis.
13. The assembly of claim 12, wherein the stabilizing structure is rotatable about the longitudinal axis.
13. The sheath assembly of claim 12, wherein the stabilizing structure includes a feature configured for suturing to a patient.
14. The assembly of claim 13, wherein the stabilizing structure includes a feature configured for suturing to a patient.
14. The sheath assembly of claim 13, wherein the stabilizing structure includes a pair of suture wings, each wing having a plurality of ribs for securing sutures.
15. The assembly of claim 14, wherein the stabilizing structure includes a pair of suture wings, each wing having a plurality of ribs for securing sutures.
15. The sheath assembly of claim 1, wherein the tubular sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67mm) or less.
16. The assembly of claim 1, wherein the sheath body is dimensioned to be introduced through a percutaneous access site of about 20 Fr (6.67 mm) or less.
25. The sheath assembly of claim 2, wherein a length of the stylet is substantially equal to a length of the second lumen.
2. The assembly of claim 1, the stylet and the second lumen each having a length, and wherein the length of the stylet is substantially equal to the length of the second lumen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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