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 .
Response to Amendments
Applicant amendments to claims 1, 4, 17-18, and 38-39 are acknowledged and the previous claim objections are withdrawn.
Applicant amendments to claims 13, 17, and 18 are acknowledged and the previous 112(b) rejections are withdrawn.
Applicant amendments to claims 1 and 4 to include the “in use” language are acknowledged and the previous 101 rejections are withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4, 9, 10, 13, 14, 16-18, 21-25, 36, and 38-40 rejected under 35 USC § 103 over Farnan and evidenced by Farnan ‘490 have been fully considered and are persuasive. The examiner agrees that modified Farnan fails to disclose or suggest “wherein the fixation mechanism operates to position and to secure or fix the opening at or adjacent the wall of the blood vessel at the point of insertion of the tip without the tip intruding into a lumen of the blood vessel” (claim 1) and “wherein the fixation mechanism positions and fixes the opening of the tip at the wall of the blood vessel at a point of insertion of the tip such that the tip does not project into a lumen of the blood vessel” (claim 4) as required in claims 1 and 4. Therefore, the rejection has been withdrawn. However, upon further consideration, a 112(a), new matter, rejection is made in light of the new language highlighted above in claims 1 and 4.
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:
“fixation mechanism”, “intravascular part”, and “extravascular part” in claims 1,4, 9-10, 13-14, 16-18, 25, and 38-39. The limitation describing the fixation mechanism member in claims 1 and 4 (“comprises an intravascular part that engages with an inner surface of the wall of the blood vessel through which the tip is inserted to inhibit or prevent withdrawal of the tip from the blood vessel and an extravascular part that engages with tissue of the patient outside of the blood vessel to inhibit or prevent over-insertion of the tip into the blood vessel” fails to include sufficient structure to perform the recited function of "fixation" other than comprising “parts”. The specification describes the fixation mechanism and thereby the intravascular and extravascular parts as framework (stent/mesh like structure) (para. 0026), a disc or flange members comprising a covered mesh structure (para. 0137), prongs or elongate barbs (para. 0141), cantilevered arm members (par. 0153), plurality of elongate arm members (para. 0157). Therefore, the fixation mechanism and thereby the intravascular and extravascular parts are interpreted as the following structures listed above or any structural equivalent thereof that comprises an intravascular part that engages with an inner surface of a wall of tissue that inhibits or prevents withdrawal of the tip from the tissue and an extravascular part that engages with an external surface of the tissue of the patient that inhibits or prevents over-insertion of the tip.
“activation member” in claim 16. The limitation describing the activation member in claim 16 (“operably associated or connected with the distal end region of the vascular access tube, wherein the activation member is configured for operation by a user at a proximal end region of the vascular access tube to activate or operate the fixation mechanism during or upon insertion of the tip of the vascular access tube into the blood vessel”) fails to include sufficient structure to perform the recited function of "activation". The specification describes the activation member as a sheath or sleeve (para. 0031), a flexible member, such as a cord or line, to be drawn (i.e. pulled under tension) by an operator (para. 0032), a rigid member, such as a rod or tube, to be pressed or moved by an operator” (para. 0033). Therefore, the activation member is interpreted as the following structures listed above or any structural equivalent thereof that is operably associated or connected with the distal end region of the vascular access tube and is configured for operation by a user at a proximal end region of the vascular access tube to activate or operate the fixation mechanism during or upon insertion of the tip of the vascular access tube into the blood vessel.
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 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 1, 4, 9, 10, 13, 14, 16-18, 21-25, 36, and 38-40 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.
Claims 1 and 4 recite “wherein the fixation mechanism operates to position and to secure or fix the opening at or adjacent the wall of the blood vessel at the point of insertion of the tip without the tip intruding into a lumen of the blood vessel” (claim 1) and “wherein the fixation mechanism positions and fixes the opening of the tip at the wall of the blood vessel at a point of insertion of the tip such that the tip does not project into a lumen of the blood vessel” (claim 4). In the remarks filed 05/04/2026, applicant cites para. 0009 of the specification for support, stating the subject matter is designed for “[m]inimising intrusion of the access tube into the blood vessel thus reduces flow disturbances and restrictions in the accessed blood vessel, as well as the surface area of foreign device materials exposed to circulating blood”. The specification further describes the claimed device in para. 0134-0135 stating “a vascular access tube 2, e.g. a cannula, having a distal end region 3 terminating in a tip 4 that is inserted into the blood vessel V of a patient…the fixation mechanism 10 is configured to secure or fix the tip 4 (and thus the opening 6) of the vascular access tube 2 within the blood vessel V positioned at a location adjacent a wall W of the blood vessel at a location where the tip is inserted; i.e. with minimal intrusion into the vessel lumen L. By engaging with an inner surface of the blood vessel wall W, and/or an outer surface of the blood vessel wall W, and/or the subcutaneous tissue T at the positions marked "X", the fixation mechanism 10 operates or acts to inhibit or prevent withdrawal of the tip 4 from the blood vessel V and/or to inhibit or prevent over-insertion of the tip 4 into the blood vessel V”. Therefore, the written description states that the tip of the claimed device is inserted into the blood vessel and secured within the blood vessel with minimal intrusion into the vessel lumen, while the claim states no intrusion/projecting into the lumen of the blood vessel.
The specification further states in para. 0137 “The disc or flange member or element 13 is movable between a retracted or non-deployed position, as shown in Fig. 3a, where it is collapsed to lie flat against the transcutaneous and trans-vascular cannula 2 of the device 1 during introduction via the delivery sheath 20 for insertion of the tip 4 through the vascular wall W, and an extended or deployed position, as shown in Fig. 3b, for engaging an inner surface of the wall W of the blood vessel V to inhibit or prevent withdrawal of the tip 4”. If the intravascular part engages the inner surface of the wall of the blood vessel (which defines the lumen of the blood vessel), then a portion of the tip 4 is intruding into the lumen of the blood vessel as stated in para. 0135 of the instant application. This is further supported in figures 3b-c, which illustrate the intravascular part 13 engaging the inner wall of the blood vessel and the tip 4 intruding into the lumen of the blood vessel V. Therefore, claims 1 and 4 are rejected under 112(a) for lack of support in the written description.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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