Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 314a, 314b (see [0053] and Figure 8) and 528 (see [0056] and Figures 11-12).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 516 (see Figures 11-12).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the second lumen being surrounded by the first lumen (claim 37) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In [0001], “U.S. Patent Application No. 18/355,842, filed July 20, 2023,” should be replaced with “U.S. Patent Application No. 18/355,842, filed July 20, 2023, now U.S. Pat. No. 12,156,976,”.
In [0047], “lumen 14” should be replaced with “lumen 13”. See Figures 1, 1A, and 2.
In [0049], “polytetrafluoroethylene PEFE” should be replaced with “polytetrafluoroethylene (PTFE)”, “polyvinyl chlorideneoprene PVC” should be replaced with “polyvinyl chloride (PVC), neoprene”, and “silicone elastomer of fluoroelasatomers” should be replaced with “silicone elastomer or fluoroelastomers”.
In [0050], “a guidewire 122 (FIG. 6)” should be replaced with “a guidewire 225 (FIG. 6)”. See Figure 6 and [0052].
In [0053], “expandable slit 216” should be replaced with “expandable slit 218”. See Figures 6-7 and [0051].
In [0055], “district lumens” should be replaced with “distinct lumens”.
In [0057], “Hollow tube 636” and “hollow tube 636” should be replaced with “Hollow tube 634” and “hollow tube 634”. Also, “Ribbon 636” should be replaced with “Hollow tube 634”.
Appropriate correction is required.
Claim Objections
Claims 26-29, 32, and 35 are objected to because of the following informalities:
In claim 26, “are substantially D-shaped” should be replaced with “is substantially D-shaped”, because the subject is “at least one of the first lumen or the second lumen”.
In claim 27, “in a collapsed configuration” should be replaced with “in the collapsed configuration” for consistency with claim 21.
In claims 28 and 29, “introduction or removal of a medical fluid into a body of a human patient” should be replaced with “introduction of a medical fluid into, or removal of a medical fluid from, a body of a human patient.”
In claim 32, “comprising a third lumen” should be replaced with “wherein the catheter body further comprises a third lumen” to clarify that the third lumen is part of the catheter body.
In claim 35, “the catheter” should be replaced with “the catheter body” for consistency with claim 31.
Appropriate correction is required.
Claim Interpretation
In claims 21 and 31, the “first material” is the material that forms the inner surface of the recited lumens and has the lower melting temperature. The “second material” is the material with the higher melting temperature. This is the reverse of the terminology in the specification. There, the “first material 528” forms the catheter body 512, and the “second material 530,” which has the lower melting temperature, covers the inner walls of the body 512 that define the lumens 514a and 514b. See [0022]-[0025], [0056], and Figures 11-12. In this Office action, “first material” and “second material” are used as defined in the claims.
Claims 21 and 31 refer to an “inner surface” and an “outer surface” of a lumen. A lumen is a passage rather than a solid structure. The “inner surface” of a lumen is therefore interpreted as the surface of the catheter body that bounds the lumen. The “outer surface” of a lumen is interpreted as a surface of the part of the catheter body defining the lumen that faces away from the lumen. Examples are the outer surface of the catheter body, or a surface of a septum that faces an adjacent lumen. Accordingly, the requirement that the inner surface be made of the first material and the outer surface be made of the second material is interpreted to mean the following: the portion of the catheter body defining the lumen includes the first material at the lumen and the second material spaced from the lumen. The layer of material 530 on the inner walls of the catheter body 512 in Figures 11-12 is an example. See [0056].
Claims 21 and 31 are directed to an apparatus, but several of their limitations describe how the apparatus behaves during use or during a manufacturing process. Examples:
the third lumen (claim 21) or the second lumen (claim 31) is “configured to be in a collapsed configuration when” the other lumen(s) receive a fluid;
the first material “is configured to melt” when heated to a first temperature that “is insufficient to melt the second material”;
the collapsible lumen “is configured to set in the collapsed configuration when the first material is cooled from the first temperature”.
Apparatus claims cover what a device is, not what a device does or how it is manufactured. See MPEP 2114(II) and 2113(I). These limitations are therefore interpreted as requiring structure capable of performing the recited functions or the structure implied by the manufacturing process, as appropriate.
Additionally, the limitation that the first temperature is insufficient to melt the second material is met by any structure in which the first material has a lower melting temperature than the second material. That is because a temperature between the two melting temperatures would melt the first material without melting the second material.
The term “collapsed configuration” in claims 21 and 31 is interpreted as a configuration in which the lumen’s capacity to carry fluid is substantially reduced relative to its expanded configuration. The lumen need not be completely closed. Notably, claims 30 and 38 depend from claims 21 and 31 and only require the lumen to be substantially sealed in the collapsed configuration. A collapsed lumen therefore need not be completely, or even substantially, sealed. A mere reduction in cross-sectional area is not sufficient, however.
Claims 33 and 35 define the second lumen by the process used to make it: “created by removing the septum” and “exposing the catheter to a solvent.” These are product-by-process limitations. They are limited only by the structure implied by the process steps. See MPEP 2113(I). As discussed in the rejection of claim 33 under 35 U.S.C. 112(b) below, “removing the septum” is interpreted as removing material from within the septum. The structure implied by these limitations is a lumen extending through the septum. Nothing indicates that exposure to a solvent produces any additional or different structure.
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.
Claims 33-35 and 37 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 33 recites that the second lumen is created by removing the septum, which is interpreted as removing material from within the septum, as discussed in the rejection under 35 U.S.C. 112(b) below. Claim 31, from which claim 33 depends, requires the following of the second lumen:
it is configured to be in a collapsed configuration when the first lumen receives the fluid; and
it is configured to set in the collapsed configuration when the first material, which forms the inner surface of the first lumen, is cooled from the first temperature.
The original disclosure describes these features only in separate, alternative embodiments. Forming an expandable lumen by removing a removable material 330 from within the septum 316 is described for the embodiment of Figure 8. See [0053]-[0054]. Collapsing an expandable lumen by directing fluid through an adjacent lumen, and setting it in the collapsed configuration by melting and cooling a lower-melting material on the inner surface of the adjacent lumen, is described for the embodiment of Figures 11-12. See [0056].
The specification presents these as different ways of manufacturing a catheter having an expandable lumen. See [0053]. In the embodiment of Figure 8, removing the material 330 itself forms the slit 318. Nothing indicates that the resulting slit would then be collapsed and set as in the embodiment of Figures 11-12. The original disclosure does not describe a catheter having an expandable lumen that is both created by removing material from within a septum and set in a collapsed configuration by melting and cooling a material on the inner surface of an adjacent lumen. The general statement in [0058] that features may be combined is not sufficient to show possession of this particular combination of features from different embodiments.
Claims 34 and 35 are rejected based on their dependency from claim 33.
Claim 37 recites that “the second lumen is surrounded by the first lumen.” The original disclosure does not support this limitation. In every disclosed embodiment, the expandable lumen is in one of two places:
within a septum positioned between two other lumens (see [0048]-[0057] and Figures 3-13); or
between the inner wall of the catheter body and a resilient membrane (see [0006]-[0007], [0047], and Figures 1-2).
In the membrane embodiment, the expandable lumen 20 extends along the inner wall of the elongated body 12, and the body bounds the expandable lumen on one side. See [0006], [0047], and Figures 1A and 2. The original disclosure does not describe an expandable lumen surrounded by another lumen. Note that claims 21-40 were presented in a preliminary amendment filed after the filing date of the application and are not part of the original disclosure. See MPEP 608.04(b).
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 33-35 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 33 recites that “a septum separates the first lumen and the third lumen” and that “the second lumen is created by removing the septum.” It is unclear how the septum can both separate the first and third lumens and be removed. Further, claim 32 requires the second lumen to be positioned between the first lumen and the third lumen, i.e., in the location occupied by the septum. If the septum were removed, the first and third lumens would no longer be separated, and it is unclear how the second lumen could be positioned between them.
The specification does not describe removing the septum. Instead, it describes removing a removable material 330 positioned within the septum 316 to define the slit 318. See [0053]-[0054] and Figure 8. For purposes of examination, “the second lumen is created by removing the septum” in claim 33 is interpreted as “the second lumen is created by removing material from within the septum,” and “the removing the septum” in claim 35 is interpreted in the same way.
Claims 34 and 35 are rejected based on their dependency from claim 33.
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 22 is 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 21 requires the first and second lumens to be configured to receive a fluid. Claim 22 requires the first and second lumens to be configured to receive “a liquid, a gas, or combinations thereof.” Since a fluid is a liquid, a gas, or a combination thereof, claim 22 does not further limit claim 21.
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.
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 21-32, 36, and 38-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, 8, 10-15, 17, and 20 of U.S. Patent No. 12,156,976.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite the apparatus of the present claims, both as the article produced by the patent’s claimed method of manufacture and as the catheter used in the patent’s claimed method of use.
The terms “first material” and “second material” are used in the opposite sense in U.S. Patent No. 12,156,976 and in the claims under examination. In the patent, the “first material” forms the catheter body and has the higher melting temperature, and the “second material” is provided on an inner surface of the catheter body and has the lower melting temperature. The claims under examination reverse this. See the Claim Interpretation section above. In the discussion below, the materials of the patent are referred to by the terminology of the patent.
Regarding claim 21, claim 15 of the patent recites introducing a multi-lumen catheter into a body of a patient. The catheter comprises a catheter body including a first lumen, a second lumen, and a third lumen positioned between the first and second lumens. The third lumen is configured to expand in response to receiving a fluid or a guidewire. The catheter body is formed of a first material having a first melting temperature, and a second material is provided on an inner surface of the catheter body defining the first and second lumens, the second material having a melting temperature lower than the first material.
Claim 15 of the patent therefore recites the catheter body of claim 21, including a first lumen and a second lumen each having an inner surface made of the lower-melting material and an outer surface made of the higher-melting material, and a third lumen positioned between the first and second lumens.
Claim 21 additionally requires that the third lumen be configured to be in a collapsed configuration when the first and second lumens receive the fluid, that the lower-melting material be configured to melt when heated to a first temperature that is insufficient to melt the higher-melting material, and that the third lumen be configured to set in the collapsed configuration when the lower-melting material is cooled from the first temperature. These are functional limitations that require structure capable of performing the recited functions. See the Claim Interpretation section above and MPEP 2114(II). A catheter having the structure recited in claim 15 of the patent is capable of performing these functions. Claim 1 of the patent confirms this. It recites directing a fluid through the first and second lumens to move the third lumen to a collapsed configuration, melting the second material without melting the first material while the third lumen is in the collapsed configuration, and cooling the second material to set the second material with the third lumen in the collapsed configuration. The catheter body produced by the method of claim 1 of the patent is the apparatus of claim 21.
Regarding claim 31, the first lumen of claim 31 corresponds to the first lumen recited in claims 1 and 15 of the patent, and the second lumen of claim 31 corresponds to the third lumen recited in those claims. The third lumen recited in the patent is positioned between the first and second lumens and is therefore positioned adjacent the first lumen. Claims 4 and 5 of the patent further recite that the third lumen is configured to receive a guidewire in the expanded configuration and that a cross-sectional area of the third lumen is configured to increase when a guidewire is introduced into the third lumen.
Claim 31 requires the second lumen to be configured to be in a collapsed configuration when the first lumen receives the fluid, whereas claim 1 of the patent directs the fluid through both the first lumen and the second lumen. Claim 31 is broader in this respect, and the catheter body recited in claim 15 of the patent falls within its scope. To the extent that collapsing the lumen using fluid in one adjacent lumen rather than two is treated as a difference, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at that arrangement, because it amounts to the omission of one of two identically functioning elements, with a corresponding loss of the symmetry of the applied pressure.
Regarding claim 22, see claims 7 and 8 of the patent, which recite that the fluid is a liquid and that the fluid is heated air.
Regarding claim 23, see claim 4 of the patent.
Regarding claims 24 and 25, see claims 11 and 12 of the patent.
Regarding claims 26 and 36, the claims of the patent do not recite the cross-sectional shape of the lumens. Claim 14 of the patent recites that the third lumen extends through a septum of the catheter body, which requires the first and second lumens to be positioned on either side of that septum. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made those lumens substantially D-shaped, because a lumen bounded on one side by a planar septum and on the other by the wall of a catheter body having a circular outer profile takes that shape, and because doing so uses the available cross-sectional area of the catheter body efficiently.
Regarding claim 27, claim 1 of the patent requires the third lumen to be moved to a collapsed configuration and set in that configuration by a fluid directed through the first and second lumens. A lumen collapsed and set in this manner necessarily has a smaller cross-sectional area than the lumens that carry the fluid used to collapse it.
Regarding claim 28, see claim 13 of the patent.
Regarding claim 29, see claims 15 and 20 of the patent.
Regarding claims 30 and 38, see claim 10 of the patent.
Regarding claim 32, see claim 1 of the patent, which recites a catheter body including a first lumen, a second lumen, and a third lumen positioned between the first and second lumens. The second lumen of claim 32 corresponds to the third lumen of the patent, and the third lumen of claim 32 corresponds to the second lumen of the patent.
Regarding claim 39, see claim 5 of the patent.
Regarding claim 40, see claim 17 of the patent.
Allowable Subject Matter
Claims 21, 23-32, 36, and 38-40 would be allowable if the double patenting rejections set forth in this Office action were overcome. Claim 22 would be allowable if the double patenting rejection and the rejection under 35 U.S.C. 112 set forth in this Office action were overcome. Claims 33-35 and 37 would be allowable if the rejections under 35 U.S.C. 112 set forth in this Office action were overcome.
The following is a statement of reasons for the indication of allowable subject matter.
Claim 21 is directed to an apparatus comprising a catheter body. The catheter body includes a first lumen and a second lumen, each configured to receive a fluid and each having an inner surface made of a first material and an outer surface made of a second material, where the first material has a lower melting temperature than the second material. A third lumen is positioned between the first and second lumens and is configured to be in a collapsed configuration when the first and second lumens receive the fluid. When at least one of the inner surfaces is heated to a first temperature that is insufficient to melt the second material, the first material is configured to melt, and the third lumen is configured to set in the collapsed configuration when the first material is cooled from the first temperature.
It is known in the art to create multi-lumen catheters by extrusion. For example, see US 5,374,245 (“Mahurkar”), which was used in the prior art rejections made in App. No. 16/270,678. See the Office actions dated 1 November 2022 and 16 February 2023.
It is also known in the art to form a catheter from multiple materials having different properties. In some cases, a material with a melting point higher than that of the catheter body is used. For example, Mahurkar discloses a nylon reinforcing strip 120 and a silicone dual-lumen tube 116. See Figures 34 and 36 and lines 57-61 in column 9. Mahurkar also discloses a triple-lumen catheter 300 having a cylindrical body portion 304 containing a septum, two substantially D-shaped lumens 312 and 316, and a smaller third lumen 318 located between the lumens 312 and 316. See Figures 45-48 and lines 34-45 in column 13. The catheter 300 is formed with a silicone body and a nylon reinforcing member 310, and a narrow hollow cylinder 315 of that member lines the inside walls of the third lumen 318. The reinforcing member 310 may be co-extruded with the silicone body. See lines 32-38 and 50-53 in column 14. In other cases, a material with a lower melting point is used, as required by claim 21. For example, US 6,165,166 (“Samuelson”) discloses a three-layer coextruded tubing where the core layer has the lowest glass transition temperature. See lines 23-37 in column 4. In particular, the core layer 12 is made of a lubricious polymeric material to facilitate advancement over a guidewire or the advancement of a smaller catheter through a lumen 15 of the tubing 10. See lines 25-38 in column 6.
Even though it is known to incorporate a material with a lower melting temperature than that of the catheter body, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used such a material in the location recited in claim 21. Claim 21 requires three lumens, with the third lumen positioned between the first and second lumens and configured to be set in a collapsed configuration. In the prior art, a lumen with these characteristics would be used for a solid device, such as a guidewire, or for a fluid, while the other lumens would be used for fluids. Accordingly, if one of ordinary skill in the art wished to add a layer of material having a lower melting temperature than that of the catheter body, whether to facilitate advancement of a device through the catheter, to provide the lumen with different surface properties, or for another purpose, the layer would be added to the lumen corresponding to the claimed third lumen and not to the other lumens, as required by claim 21. Mahurkar illustrates this. The lining provided by the hollow cylinder 315 is on the third lumen 318 and not on the lumens 312 and 316. See Figure 48.
Mahurkar does not reach claim 21 for a second reason. The third lumen 318 of Mahurkar is lined by the hollow cylinder 315 of the nylon reinforcing member 310, which reinforces that lumen. Mahurkar does not disclose that the third lumen 318 is configured to be in a collapsed configuration when the lumens 312 and 316 receive a fluid.
Claim 31 is directed to an apparatus comprising a catheter body having a first lumen and a second lumen. The first lumen is configured to receive a fluid and has an inner surface made of a first material and an outer surface made of a second material, where the first material has a lower melting temperature than the second material. The second lumen is positioned adjacent the first lumen and is configured to be in a collapsed configuration when the first lumen receives the fluid. When the inner surface of the first lumen is heated to a first temperature that is insufficient to melt the second material, the first material is configured to melt, and the second lumen is configured to set in the collapsed configuration when the first material is cooled from the first temperature. When set in the collapsed configuration, the second lumen is configured to receive a guidewire and is configured to expand to receive the guidewire.
Unlike claim 21, claim 31 does not require a third lumen, and it does not require the collapsible lumen to be positioned between two lumens having the recited two-material construction.
With respect to the second lumen, the closest prior art is US 2005/0055012 (“Trerotola”). Trerotola discloses a catheter 34 having a center lumen 32 that accepts a guide wire 33 and two additional lumens 36 and 38. When the guide wire 33 is removed from the catheter 34, the lumen 32 collapses and the lumens 36 and 38 conform to fill the dead space. See [0027] and Figures 3(A) and 3(B). Trerotola therefore discloses a lumen that is positioned adjacent another lumen, that is collapsed when the guide wire is not present, and that expands to receive the guide wire.
Trerotola does not disclose the two-material construction required by claim 31. Trerotola does not describe the material of the catheter body, and it does not describe layers, melting temperatures, or any relationship between the melting temperatures of two materials.
As discussed above with respect to claim 21, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the inner surface of the first lumen with a material having a lower melting temperature than the material of the outer surface, where an adjacent lumen is the lumen that is collapsed and that expands to receive a guidewire. In Trerotola, the lumen that receives the guide wire 33 is the center lumen 32, which corresponds to the claimed second lumen rather than the claimed first lumen. Samuelson teaches providing the lubricious core layer 12, which has the lowest glass transition temperature, on the lumen through which a guidewire or a smaller catheter is advanced. See lines 25-38 in column 6. Applying that teaching to Trerotola would place the layer on the center lumen 32 and not on the lumens 36 and 38, which correspond to the claimed first lumen.
The lumens 36 and 38 of Trerotola also do not meet the requirements of the claimed second lumen. Although the lumens 36 and 38 decrease in cross-sectional area when the lumen 32 is expanded by the guide wire 33, the lumens 36 and 38 are not in a collapsed configuration. See Figure 3(A). See also the Claim Interpretation section above.
Claims 22-30 contain allowable subject matter based on their dependency from claim 21. Claims 32-40 contain allowable subject matter based on their dependency from claim 31.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John DeRusso whose telephone number is (571)270-1287. The examiner can normally be reached Monday-Friday, 9:00 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao (Sam) Zhao, can be reached at (571) 270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/John J. DeRusso/Primary Examiner, Art Unit 1744
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