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 Amendment
The Amendment filed 05/02/2025 has been entered. Claims 1-20 are pending in the application. Claims 7 & 11-20 are withdrawn.
Information Disclosure Statement
The Examiner notes that the Information Disclosure Statement (IDS) submissions (see previous attachments) are extremely long, citing close to 400 references for consideration. The Examiner has considered all of the references submitted as part of the Information Disclosure Statements, but has not found any to be of particular relevance. If Applicant is aware of pertinent material in the references, it should be stated in a response to this Office action. Applicant is reminded of MPEP § 2004, paragraph 13:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Moreover, an IDS should comply with 37 CFR 1.56 (b) which states that "information is material to patentability which is not cumulative to information already of record or being made of record in the application …" [emphasis added]. The cited references, in addition to being extensive in volume, also appear to be largely cumulative, therefore, based upon the large number of references cited, the initialed references have been considered in a cumulative manner. Examiner further notes that numerous cited references appear to have little or no relevance at all to the disclosed/claimed invention.
Claim Objections
Claims 1-6 & 8-10 are objected to because of the following informalities.
Claim 1 should read –A rapidly insertable central catheter ("RICC") (20), comprising:
a first section of a catheter tube formed of a first polymeric material having a first durometer, the first section located in a distal-end portion of the catheter tube;
a second section of the catheter tube formed of a second polymeric material having a second durometer less than the first durometer, the second section located in the distal-end portion of the catheter tube proximal [[of]]to the first section; and
a junction joining the first and second sections of the catheter tube, the first section of the catheter tube having a proximal-end portion disposed in a receptacle of the junction and solvent bonded thereto.
Appropriate correction is required.
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 10 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.
As to Claim 10, the limitation “the RICC has a column strength sufficient to prevent buckling of the catheter tube when inserted into an insertion site and advanced through a vasculature of a patient” is indefinite. It is not clear how to determine the column strength in relation to advancement of the catheter through a vasculature of a patient, since the required column strength is relative to each particular patient, as well as the state of each particular patient. For example, a hydrated patient with stronger veins requires a lower columnar strength than a dehydrated patient with weaker veins. As such, the required columnar strength is situational dependent –i.e., is relative. The original disclosure has not provided 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 4, 6 & 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (U.S. Patent 5,207,650), in view of Hoshino (U.S. PGPub 2021/0353906), further in view of Jackson (U.S. PGPub 2016/0346503), further in view of Miller (U.S. PGPub 2002/0198492).
As to Claim 1, Martin teaches a rapidly insertable central catheter ("RICC") (20), comprising:
a first section (28, formed of preform 70, as described in Column 4, Line 50, to Column 5, Line 11) of a catheter tube (22/30/28) formed of a first material (the material of preform 70, which is used to form first section 28, as described in Column 5, Lines 26-38) having a first durometer (the durometer associated with the preform 70 material described in Column 5, Lines 26-38, which has a different durometer than second section 22), the first section (28) in (as shown in Figure 1) a distal-end portion (26) of the catheter tube (22/30/28);
a second section (22) of the catheter tube (22/30/28) formed of a second polymeric material (polyurethane; Column 5, Lines 26-38) having a second durometer (the durometer associated with the polyurethane described in Column 5, Lines 26-38, which has a different durometer than preform material 70 / first section 28), the second section (22) in (as shown in Figure 1) the distal-end portion (26) of the catheter tube (22/30/28) proximal of (as shown in Figure 1) the first section (28); and
a junction (30/78) joining (as shown in Figures 1/6) the first (28) and second (22) sections of the catheter tube (22/30/28), the first section (28) of the catheter tube (22/30/28) having a proximal-end portion (the left end of 70, as viewed in Figure 6) disposed in (as shown in Figure 6) a receptacle (the receptacle with 78 within which the left end of 70 sits) of the junction (30/78) and bonded (via heat and pressure; Column 4, Line 64, to Column 5, Line 11) thereto (the receptacle with 78 within which the left end of 70 sits).
Martin is silent on the material of the first section, so does not explicitly teach the first material is polymeric.
Martin continues to describe the durometers of the first and second section materials are different. However, Martin does not explicitly teach the second durometer is less than the first durometer.
Martin also continues to teach the use of heat and pressure to describe how the proximal-end portion of the first section and the junction receptacle are attached to each other, but does not teach the proximal-end portion of the first section and the junction receptacle are solvent bonded to each other.
Hoshino describes a similar catheter (see Figure 13), and teaches the first material (30/31) is polymeric (polyurethane; Paragraph 0036).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the first section, as taught by Martin, from polyurethane, as taught by Hoshino, since polyurethane is well-known, and yields predictable results, i.e., durable and flexible.
Additionally, it would have been obvious to one of ordinary skill in the art at the time of invention to make the first section, as taught by Martin, from polyurethane, as taught by Hoshino, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
Jackson describes a similar catheter (see Figure 6), and teaches the second durometer (the second durometer associated with section 40G in Figure 6 is about 35D; Paragraph 0262) is less than (35D < 55D) the first durometer (the first durometer associated with section 40I in Figure 6 is about 55D; Paragraph 0262).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the first and second sections and the junction, as taught by Martin, as modified, with each having a respective durometer, as taught by Jackson, “to obtain more or less flexibility, torqueability, and pushability for all or part of catheter body (Paragraph 0262)”.
Miller describes catheters and means of forming catheters (Paragraph 0059), and teaches the use of solvent welding/bonding (Paragraph 0059) to attach two layers of a catheter.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to attach the junction receptacle and first section proximal-end portion, as taught by Martin, as modified, via solvent welding/bonding, as taught by Miller, since solvent welding/bonding is well-known, and yields predictable results, i.e., durable and fluid tight seals.
As to Claim 2, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the junction (Martin 30/78) is a tapered (Martin 30 is shown as being tapered in Martin Figure 3) distal-end portion (the right end of Martin second section 22, as viewed in Martin Figure 3) of the second section (Martin 22) of the catheter tube (Martin 22/30/28).
As to Claim 4, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the junction (Martin 30/78) is a tapered (Martin 30 is shown as being tapered in Martin Figure 3) third section (Martin 30/78) of the catheter tube (Martin 22/30/28) bonded (Martin Column 4, Line 64, to Column 5, Line 11) or welded to the second section (Martin 22) of the catheter tube (Martin 22/30/28), the third section (Martin 30/78) of the catheter tube (Martin 22/30/28) formed of a third material (Martin silicone) having a third durometer (the Jackson third durometer associated with Jackson section 40H in Jackson Figure 6 is about 25D; Paragraph 0262) less than (25D < 55D) the first durometer (the first durometer associated with section 40I in Figure 6 is about 55D; Paragraph 0262).
As to Claim 6, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the RICC (Martin 20, as modified above) is a triluminal (Martin 54/56/58) catheter (Martin 20, as modified above) having a first lumen (Martin 54) terminating at (as shown in Martin Figure 3) an opening (the opening which Martin lead line 32 points to in Martin Figure 3) in a distal end (Martin 32) of the first section (Martin 28) of the catheter tube (Martin 22/30/28), a second lumen (Martin 56) terminating at (Column 4, Lines 27-30) a first eyelet (Martin 64) in (as shown in Martin Figure 3) the second section (Martin 22) of the catheter tube (Martin 22/30/28) adjacent (as shown in Martin Figure 3) the junction (Martin 30/78), and a third lumen (Martin 58) terminating at (as shown in Martin Figure 4) a second eyelet (Martin 66) in (as shown in Martin Figure 4) the second section (Martin 22) of the catheter tube (Martin 22/30/28) adjacent (as shown in Martin Figure 4) the junction (Martin 30/78).
As to Claim 8, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the first section (Martin 28) of the catheter tube (Martin 22/30/28) is polytetrafluoroethylene, polypropylene, or polyurethane (Hoshino Paragraph 0036).
As to Claim 9, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the second section (Martin 22) of the catheter tube (Martin 22/30/28) is polyvinyl chloride, polyethylene, polyurethane (Martin Column 5, Lines 26-38), or silicone.
As to Claim 10, Martin, as modified, teaches all the limitations of Claim 1, and continues to teach the RICC (Martin 20, as modified above) has a column strength sufficient to prevent buckling (see end of paragraph for clarification) of the catheter tube (Martin 22/30/28) when inserted into (as described in Martin Column 1, Lines 6-10) an insertion site (the locations in the patient’s vein, as described in Martin Column 1, Lines 6-10) and advanced through a vasculature (the patient’s vein, as described in Martin Column 1, Lines 6-10) of a patient (the patient, as described in Martin Column 1, Lines 6-10).
One of ordinary skill in the art would conclude the Martin RICC, as modified, has sufficient column strength to prevent buckling, since both Martin (Column 1, Lines 6-10) and Jackson (Paragraph 0304) describe inserting the catheter within vasculature. Additionally, the catheter would not operate as intended if the catheter buckled, since the buckling would prevent the administration of fluids through the catheter, as required by Martin (Column 1, Lines 6-10) and (Jackson (Paragraph 0195). Lastly, Martin Column 3, Lines 63-68, explicitly states the Martin catheter is strong enough to resist buckling.
Claims 3 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Martin, in view of Hoshino, further in view of Jackson, further in view of Miller, as evidenced by sciencedirect.com (see Solvent Welding – ScienceDirect pdf from sciencedirect.com/topics/chemical-engineering/thermoplastics – published in 2009).
As to Claim 3, Martin, as modified, teaches all the limitations of Claims 1-2, and continues to teach an abluminal transition (the transition between the outer surface of the left end of first section Martin 70/28 transitioning into the outer surface of the right end of Martin second section 22, as shown in Figures 3/4) between the tapered distal-end portion (the right end of Martin second section 22, as viewed in Martin Figure 3) of the second section (Martin 22) of the catheter tube (Martin 22/30/28) and the proximal-end portion (the left end of 70, as viewed in Figure 6) of the first section (Martin 28) of the catheter tube (Martin 22/30/28) is a smooth transition (this is being interpreted in light of the definition of “smooth” in instant application Paragraph 0051; Martin Figures 3/4 show the left end of first section 70/28 transitioning into the right end of Martin second section 22 with a “sufficiently small to negligible edge that precludes catching skin when the RICC is inserted into an insertion site of a patient”) of solvent-interdiffused polymeric material (see end of paragraph for clarification) of the first polymeric material (Hoshino polyurethane; Hoshino Paragraph 0036) and the second polymeric material (Martin polyurethane; Martin Column 5, Lines 26-38).
As described in the website sciencedirect.com, solvent bonding/welding produces a “solvent blend” of two thermoplastic polymers –i.e., polyurethanes—resulting in interdiffusement of the respective polymers with each other. As such, one of ordinary skill in the art would conclude the solvent bonding/welding between the first section and the junction, as taught in Claim 1, inherently results in the first and second sections being solvent-interdiffused with each other, as evidenced by the website sciencedirect.com.
As to Claim 5, Martin, as modified, teaches all the limitations of Claims 1 & 4, and continues to teach an abluminal transition (the transition between the outer surface of Martin 30/78 transitioning into the transition between the outer surface of the left end of first section Martin 70/28, as shown in Figures 3/4) between the tapered third section (Martin 30/78) of the catheter tube (Martin 22/30/28) and the proximal-end portion (the left end of 70, as viewed in Figure 6) of the first section (Martin 28) of the catheter tube (Martin 22/30/28) is a smooth transition (this is being interpreted in light of the definition of “smooth” in instant application Paragraph 0051; Martin Figures 3/4 show the left end of first section 70/28 transitioning into the right end of Martin second section 22, which includes Martin third section 30/78, with a “sufficiently small to negligible edge that precludes catching skin when the RICC is inserted into an insertion site of a patient”) of solvent-interdiffused polymeric material (see end of paragraph for clarification) of the first polymeric material (Hoshino polyurethane; Hoshino Paragraph 0036) and the second polymeric material (Martin polyurethane; Martin Column 5, Lines 26-38).
As described in the website sciencedirect.com, solvent bonding/welding produces a “solvent blend” of two thermoplastic polymers –i.e., polyurethanes—resulting in interdiffusement of the respective polymers with each other. As such, one of ordinary skill in the art would conclude the solvent bonding/welding between the first section and the junction, as taught in Claim 1, inherently results in the first and second sections being solvent-interdiffused with each other, as evidenced by the website sciencedirect.com.
Response to Arguments
Applicant's arguments filed 05/02/2025 have been fully considered but they are not fully persuasive.
Regarding relying on inherency for the material of the first section, Applicant’s arguments are persuasive. As such, another Non-Final Rejection is presented, which provides a 103 rejection for each of the claims, and does not rely on inherency for the material of the first section.
Regarding Martin silicone sleeve 78 not becoming part of the catheter, Examiner disagrees. Martin Column 5, Lines 3-8, states “With all of these parts in position, heat is applied to the silicon sleeve 78 by a pair of copper jaws 84, 86 which are brought into engagement to also apply peripheral pressure to the materials while heat flows to soften and transform the materials into the transition portion 30 shown in FIG. 3.” Additionally, both the cross-section pattern of silicone sleeve 78 in Figure 6 and the final cross-section pattern in Figures 3/4 are the same cross-section patterns, which would lead one of ordinary skill in the art to conclude the materials are the same material.
When reading the statement in Column 5, Lines 3-8, in combination with the cross-section patterns, one of ordinary skill in the art would conclude the silicone sleeve does become part of the catheter, since one of ordinary skill in the art would conclude silicone is one of the cited materials, and heat is applied directly to the silicone sleeve.
Regarding relying on the silicone as a solvent, Examiner agrees with Applicant, and a modifying reference was provided in place of the silicone being considered a solvent. As such, the rejection no longer relies on the silicone being a solvent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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