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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 19-31 in the reply filed on 25 February 2026 is acknowledged.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19, 20, 21, 25-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) in view of U.S. Publication No. 2017/0303949 (“Ribo”).
Regarding Claims 19, 26-27, and 30, McFerran discloses a method of treating a patient with an access catheter (10), the method comprising:
Advancing an access catheter through a vessel toward an obstruction in the vessel (Par. 3 and 4 – re: “such devices can be used in conjunction with a guidewire to advance an… atherectomy catheter… or other such therapeutic device to select vascular regions within the body to treat vascular disease” … “to advance the catheter beyond a lesion or other obstruction within the body”), the access catheter comprising:
a distal microcatheter segment (18) extending proximally from a distal end of the access catheter and having an outer diameter of no more than 0.04 inches (see Par. 21 and 26 – re: “an inner diameter DI in the range of about 0.012 to 0.021 inches, and more specifically 0.014 to 0.019 inches” and “whereas the distal shaft section 18 may have a smaller wall thickness in the range of about 0.004 inches to 0.006 inches, and more specifically 0.0055 inches” – i.e. McFerran suggests a configurations ranging from 0.02” to 0.033” a range which anticipates the instantly claimed range and obviates specific implementations of “about 0.04 inches”);
a proximal shaft (14) segment extending distally from a proximal end (see at hub 32, 34) of the access catheter and having an outer diameter of no more than about 0.070 inches (Par. 21 and 26 – re: “an inner diameter DI in the range of about 0.012 to 0.021 inches, and more specifically 0.014 to 0.019 inches” and “the proximal shaft section 14 may have a wall thickness in the range of about 0.01 to 0.02 inches, and more specifically 0.015 inches” – i.e. McFerran contemplates configurations with an outer diameter ranging from 0.04” to 0.061”, a range which anticipates the instantly claimed range of “no more than about 0.070 inches” and obviates specific implementations of about 0.070 inches).
McFerran discloses the invention substantially as claimed except that that the method further comprises “advancing an aspiration catheter over the access catheter and through the vessel” followed by “aspirating the obstruction”. Specifically, while McFerran does contemplate that the device may be used in conjunction with a guidewire to advance an “atherectomy catheter” the disclosure is silent as to how that atherectomy catheter is advanced with respect to the access catheter and guide catheter and whether there is an aspiration procedure associated with performing the atherectomy.
However, Ribo discloses a related access catheter (5) used to cross an obstruction wherein an aspiration catheter (2, 4) can be advanced over the access catheter and through the vessel and used to aspirate the obstruction (Par. 67). It would have been obvious for one having ordinary skill in the art at the time the invention was made to pair the access catheter of McFerran with an aspiration catheter to be advanced therealong to a treatment site to assist in aspiration of an obstruction/thrombus, as disclosed by Ribo, in order to permit the aspiration of occlusive material to reduce the risks of thrombogenic materials being dislodged within the vascular system causing strokes and ischemia.
Regarding Claim 20, McFerran, as modified by Ribo, suggests that the access catheter can be removed from the vessel prior to aspirating the obstruction (Par. 28 - Ribo). It would have been obvious for one having ordinary skill in the art at the time the invention was made to remove the access catheter in the invention of modified McFerran, as disclosed by Ribo, in order to maximize the patent diameter of the aspiration catheter to thereby better removal the occlusive materials.
Regarding Claim 21, McFerran discloses advancing an intravascular device (e.g. guidewire 26) through the access catheter.
Regarding Claim 25, McFerran discloses that the length of the various segments of the catheter may vary depending on the particular location of the body to be traversed (Par. 19). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the distal microcatheter segment comprises a length of about 2 cm to about 10 cm in the invention of McFerran depending upon patient anatomy/physiology and the length of the occlusion to be traversed. It has been held that when affecting only expected and predictable results such changes in size constitute mere obvious design choices, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) and wherein carrying forward the general principle in design of a patented invention (re: the length of the distal catheter segment of McFerran), is obvious and constitutes a mere obvious design choice in perfecting the specific catheter to treat a specific patient suffering from a specific obstruction within a specific section of the vasculature, see In re Williams, 36 F.2d 436, 438 (CCPA 1929).
Regarding Claim 28, McFerran discloses the proximal shaft segment may comprise a length of 150cm (i.e. a length of “at least about 140cm”) (Par. 19).
Regarding Claim 29, discloses the access catheter comprises a tapered dilator segment (60) being positioned in between the distal microcatheter segment and the proximal shaft segment (see Fig. 2).
Regarding Claim 31, McFerran suggests that such a catheter system may be used in association with the ophthalmic artery (Par. 8)
Claim(s) 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) in view of U.S. Publication No. 2017/0303949 (“Ribo”) as applied above, and further in view of U.S. Publication No. 2017/0215890 (“Turjman”).
Regarding Claims 22 and 23, McFerran discloses the invention substantially as claimed except that that the intravascular device comprises a “stent retriever”. While Ribo does suggest that such systems may be used in association with “stent retrievers” (Par. 74), Ribo fails to explicitly disclose how the stent retriever system is advanced to the occlusion. However, Turjman discloses that such “stentrievers” can be advanced through the catheter via the guidewire lumen after removing the guidewire (Par. 68), the stent retrieval device being used to engage the obstruction and retracted to remove the obstruction. It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the guidewire lumen of the access catheter of McFerran to advance a stent retriever device, as disclosed by Turjman, in order to assist in removal of the occlusion.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2011/0112514 (“McFerran”) in view of U.S. Publication No. 2017/0303949 (“Ribo”) as applied above, and further in view of U.S. Publication No. 2022/0338888 (“Chou”).
Regarding Claim 24, McFerran, as modified by Ribo discloses advancing the aspiration catheter over the access catheter comprises forming a sliding fit between a distal end of the aspiration catheter and at least a portion of the access catheter. However, no discussion is made with respect to minimizing of a gap between the distal end of the aspiration catheter and the portion of the access catheter. However, Chou discloses that such gaps should be minimized to help in catheter guidance ensuring that the treatment catheter better tracks the access catheter (Par. 182). It would have been obvious for one having ordinary skill in the art at the time the invention was made to minimize the gap of the invention of modified McFerran, as disclosed by Chou, in order to assist in vascular navigation and permit better tracking of the aspiration catheter over the access catheter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/18/2026
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