DETAILED ACTION
This action is in response to applicant's amendments filed 09/03/25.
The examiner acknowledges the amendments to the claims.
Claims 11-20 are pending in this application.
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 .
Response to Arguments
Applicant's arguments filed 09/03/2025 have been fully considered but they are not persuasive.
Applicant generally argues that Lehtinen’s device would be incapable of receiving and guiding a flexible medical functional section that is insertable into the lumen and movable along the lumen, as recited in claim 11. However, the claim does not define or specify the degree of flexibility of the medical functional section. A skilled artisan would understand that the cannula tube of Lehtinen would be capable of receiving and guiding a medical functional section having a degree of flexibility that would still be rigid enough to pass through the cannula tube while being flexible enough to track through a patient’s body, for instance (such as a guidewire or Seldinger wire as recited in claims 16-17).
Applicant also generally argues that one of ordinary skill in the art would not combine Lehtinen with Dacanay because of their opposite functions. Dacanay is not relied upon for the distal blocking direction for the flexible medical functional section or for avoiding unwanted migration of a guidewire into the body. Lehtinen already teaches blocking proximal direction movement, as discussed below. Instead, Dacanay is relied upon for positioning the blocking device within a cannula tube, the blocking device being assigned to the lumen of the cannula tube and integrated in the cannula tube, as recited in claim 11. The examiner maintains that one of ordinary skill in the art would look to Dacanay to modify Lehtinen since both references teach cannulas with blocking devices that prevent movement in an undesired direction, irrespective of which direction. Dacanay is also relied upon to teach a guidewire or Seldinger wire, which are known in the art as being introduced through cannulas.
Therefore, the examiner maintains that it would have been obvious to one of ordinary skill before the effective filing date to modify the blocking device/elements of Lehtinen such that the blocking device is assigned to the lumen of the cannula tube and is integrated in the cannula tube, as taught by Dacanay, since doing so would be substitution of one known blocking device/element (blocking device integrated within the cannula tube lumen as in Dacanay) for another (blocking device located within cannula hub as in Lehtinen), which would yield predictable results, namely to allow desired distal movement of a flexible medical functional section relative to the cannula tube, and to block undesired proximal movement of the flexible medical functional section relative to the cannula tube. See MPEP 2143.
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:
“blocking device” and “blocking element” in claim 11
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 § 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.
Claims 11-13 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lehtinen et al., hereinafter “Lehtinen” (U.S. Pub. No. 2015/0297213) in view of Dacanay (U.S. Pub. No. 2020/0360669).
Regarding claim 11, Lehtinen discloses a cannula assembly (Figures 14-16) comprising:
a cannula tube (needle 408 with lumen 405) that is elongated and has a proximal inlet opening (that exits into bore 407), a distal outlet opening (opening through which stylet 409 exits in Figure 16), a lumen extending continuously between the inlet opening and the outlet opening (Id.), and a cannula tip that is sharpened (tip of needle 408; para [0098]) and that delimits the outlet opening; and
a blocking device with at least one blocking element 416a, 416b (para [0095]),
the cannula tube being configured to receive and guide a flexible medical functional section that is insertable into the lumen and movable along the lumen (it is noted that “configured to receive and guide a flexible medical functional section that is insertable into the lumen and movable along the lumen” constitutes functional claim language, wherein “a flexible medical functional section” is not positively recited and indicating that the claimed device need only be capable of being used in such a manner; the Office submits that the cannula tube is capable of receiving a flexible medical functional section through lumen 405 as claimed),
the at least one blocking element being configured to interact with the flexible medical functional section (para [0095]; tabs 416a, 416b are capable of interacting with or engaging a flexible medical functional section), and, depending on a movement direction of the flexible medical functional section is automatically transferred between a blocking position, in which the at least one blocking element blocks a proximally directed withdrawal movement of the flexible medical functional section by acting on the flexible medical functional section (tabs 416a, 416b are capable of blocking a flexible medical functional section, just as it blocks stylet 409 in Figure 16A, from moving back to a first, proximal position as shown in Figure 14A), and a release position in which the at least one blocking element releases a distally directed advancing movement (tabs 416a, 416b automatically move or are deflected radially outward to release a flexible medical functional section to move in a second, distal direction, just as it allows stylet 409 to move in a distal direction),
the blocking device being integrated with the cannula tube (the blocking device 416a, 416b is combined with the cannula tube 408 via needle hub 404 to form the cannula assembly).
However, Lehtinen does not disclose the blocking device being assigned to the lumen, or the blocking device being integrated in the cannula tube.
In the same field of art, namely cannula assemblies, Dacanay teaches a cannula tube 105 including a similar blocking device with blocking elements (tab(s) 312 in Figures 5A-5B; para [0041]) that is assigned to a lumen 40 of the tube and integrated in the cannula tube (attached to the inner wall of the cannula tube), wherein the blocking device is configured to move between a blocking position, wherein a flexible medical functional section (guidewire 70) is blocked from moving in a first direction 315 (para [0046]; tabs 312 provide a lateral or compressive force to the guidewire 70 to prevent undesired movement in direction 315), to a release position, wherein the flexible medical functional section is released to move in a second direction 317 (tabs 312 may bend radially outwardly as indicated by curved arrow in Figure 5B to allow movement of the guidewire 70 in direction 317; para [0041]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the blocking device/elements of Lehtinen such that the blocking device is assigned to the lumen of the cannula tube and is integrated in the cannula tube, as taught by Dacanay, since doing so would be substitution of one known blocking device/element (blocking device integrated within the cannula tube lumen as in Dacanay) for another (blocking device located within cannula hub as in Lehtinen), which would yield predictable results, namely to allow desired distal movement of a flexible medical functional section relative to the cannula tube, and to block undesired proximal movement of the flexible medical functional section relative to the cannula tube. See MPEP 2143.
Regarding claim 12, Lehtinen as modified teaches the at least one blocking element is a blocking pawl which is spring-elastically movable and/or pivotally movable between the release position and the blocking position (tabs 416a, 416b in Lehtinen are blocking pawls that are pivotally movable, between the release position when deflected radially outward and the blocking position when movable radially inward) and has a blocking edge (free end of tabs 416a, 416b) which is oriented in a distal direction (towards sharpened tip of needle 408 in Figures 14A, 16A) and, during the distally directed advancing movement, interacts slidably with an outer surface of the flexible medical functional section and, during the proximally directed withdrawal movement, is caused by frictional force to be positioned against the outer surface and blocks the proximally directed withdrawal movement with a force fit and/or form fit (para [0095]; tabs 416a, 416b are capable of engaging and allowing a flexible medical functional section to slide distally, just as stylet 409 is moved distally, and also preventing proximal movement by the tabs 416a, 416b by frictionally locking a flexible medical functional section in place). Furthermore, Dacanay teaches that the at least one blocking element (tabs 312; Figures 5A-5B) are spring-elastically movable, since the tabs 312 can move from providing a force fit (compressive force) in a blocking position, to flexing and translating radially outward in a release position (para [0041]), and then move back to a blocking position depending on the direction of movement of the flexible medical functional section (guidewire 70).
Regarding claim 13, Lehtinen as modified teaches the blocking pawl is configured as a bending spring (Dacanay teaches tabs 312 are considered as bending springs that may move from a blocking position providing a compressive force to guidewire 70 to a release position by bending radially outward to release guidewire, and then move back to a blocking, compressive position), wherein the bending spring is secured at one end relative to the lumen 40 (ends of tabs 312 attached to wall of cannula tube 105; Figures 5A-5B of Dacanay) and at the other end has the blocking edge (free edge of tabs 312).
Regarding claims 15-17, Lehtinen as modified teaches the claimed invention, as discussed above, except for further comprising the flexible medical functional section, wherein the flexible medical functional section is a medical guide wire, wherein the medical guide wire is a Seldinger wire. In Lehtinen, the medical instrument within cannula tube 408 is a stylet 409.
Dacanay further teaches a flexible medical functional section (guidewire 70; Figures 5A-5B; para [0041]) that interacts with blocking device (tab(s) 312) of the cannula tube 105. Dacanay teaches in para [0024] that guidewires are typically used to facilitate insertion into the body by using a common Seldinger technique.
It would have been obvious to one of ordinary skill before the effective filing date to modify Lehtinen as modified with flexible medical functional section, or a guidewire or Seldinger wire, as taught by Dacanay, in order to facilitate insertion into the body while preventing undesirable movement of the wire relative to the cannula tube.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lehtinen (U.S. Pub. No. 2015/0297213) in view of Dacanay (U.S. Pub. No. 2020/0360669), as applied to claim 12 above, and further in view of Greive (U.S. Patent No. 6,059,484).
Regarding claim 14, Lehtinen as modified teaches the claimed invention, as discussed above, except for the blocking pawl is formed by a tube wall portion, that is released as a tongue, of a tube wall of the cannula tube.
In Figures 2, 6-7, Greive teaches a tube 9 with a blocking pawl (tongue 6) formed by a tube wall portion that is released as a tongue (col. 8, lines 36-37), of a tube wall of the tube, wherein the blocking pawl blocks a flexible medical functional section or guidewire 15 (col. 9, lines 34-39).
It would have been obvious to one of ordinary skill before the effective filing date to modify Lehtinen as modified with the blocking pawl formed as a tongue as claimed, as taught by Greive, since doing so would be substitution of one known blocking pawl for another, which would yield predictable results, namely to allow desired distal movement of a flexible medical functional section relative to the cannula tube, and to block undesired proximal movement of the flexible medical functional section relative to the cannula tube. See MPEP 2143.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lehtinen (U.S. Pub. No. 2015/0297213) in view of Dacanay (U.S. Pub. No. 2020/0360669), as applied to claim 11 above, and further in view of Cahill et al., hereinafter “Cahill” (U.S. Pub. No. 2014/0236208).
Regarding claim 18, Lehtinen as modified teaches the claimed invention, as discussed above, except for the at least one blocking element comprises at least one blocking roller located at the cannula tube, each at least one blocking roller being positioned to rotatably contact the flexible medical functional section and freely rotate to allow the flexible medical functional section to move distally relative to the cannula tube, and not rotate to prevent the flexible medical functional section from moving proximally relative to the cannula tube.
Cahill teaches at least one blocking element (one-way rollers 365-1, 365-2; Figure 25; [0247]) comprising at least one blocking roller located at a tube 363, each
at least one blocking roller being positioned to rotatably contact a medical functional section 303 (Id. and Figure 23) and freely rotate to allow the medical functional section to move distally relative to the tube (the blocking rollers allow proximal movement of the tube 363 relative to the medical functional section 303, which would also include allowing the medical functional section 303 to move distally relative to the tube 363; Id.), and not rotate to prevent the medical functional section from moving proximally relative to the tube (the blocking rollers restrain distal movement of the tube 363 relative to the medical functional section 303, which would also include preventing the medical functional section 303 from moving proximally relative to the tube 363; Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify the at least one blocking element to be at least one blocking roller as claimed, as taught by Cahill, since doing so would be substitution of one known blocking element for another, which would yield predictable results, namely to allow desired distal movement of a flexible medical functional section relative to the cannula tube, and to block undesired proximal movement of the flexible medical functional section relative to the cannula tube. See MPEP 2143.
Allowable Subject Matter
Claims 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious a cannula assembly including, inter alia, a cannula tube, a blocking device with at least one blocking element being assigned to a lumen of the cannula tube, the blocking device being integrated in the cannula tube and configured to block a proximally directed withdrawal movement of a flexible medical functional section, wherein the at least one blocking element comprises at least one blocking roller located at the cannula tube and being positioned to rotatably contact the flexible medical functional section and prevent the flexible medical functional section from moving proximally relative to the cannula tube, wherein each at least one blocking roller is mounted in a respective guide slot extending along the cannula tube to move towards a distal outlet opening during distal movement of the flexible medical functional section relative to the cannula tube and to move towards a proximal inlet opening during proximal movement of the flexible medical functional section relative to the cannula tube.
Taylor et al. (U.S. Pub. No. 2004/0167559) teaches at least one blocking roller 38, 41 mounted in a respective guide slot 85, 87 (Figures 3, 9, [0109]). However, the at least one blocking roller is not integrated in the cannula tube or assigned to the cannula tube lumen, nor is mounted along the cannula tube 16. Instead, the blocking roller is mounted in proximal housing 25 outside of the cannula tube, and is silent with regards to being configured to block a proximally directed withdrawal movement of a flexible medical functional section.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771