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 (Clm. 1-12) in the reply filed on 25 August 2025 is acknowledged.
Newly submitted claim(s) 20-26 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions III and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not require the access catheter to comprise, inter alia, a tapered dilator segment. The subcombination has separate utility such as providing delivery of an infusion or imaging apparatus through the vasculature, in contrast to the “aspiration catheter” expressly required in the combination.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);(d) the prior art applicable to one invention would not likely be applicable to another invention.
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(s) 12 is/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.
Regarding Claim 12, Applicant recites the limitation “the distal microcatheter segment comprises… a proximal section comprising an outer diameter of no more than about 0.070 inches”. However, such a limitation creates confusion as parent claim (Clm. 1) already requires that the distal microcatheter segment comprises “an outer diameter of no more than about 0.04 inches”. Specifically, “no more than about 0.070 inches” would include dimensions of 0.040…1 inches to about 0.070 inches, values “more than about 0.04 inches. As such, it would appear that Claim 12 contradicts the previous limitations of Claim 1 that the diameter of the distal microcatheter segment cannot exceed 0.04 inches.
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) 1, 5-7, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”).
Regarding Claims 1 and 12, Garrison discloses an access catheter (Fig. 9) comprising:
An elongate, flexible tubular body (inter alia 2652) comprising:
A proximal end (not shown – see generally Fig. 1, i.e. the end maintained external to the patient);
A distal end (see Fig. 9); and
A side wall at least partially defining a central lumen (not shown, note passage of the guidewire 2515), the central lumen extending axially therethrough (see Fig. 9 – i.e. the extent of the guidewire passing through the catheter establishes the axial extension of the central lumen);
A distal microcatheter segment (2653) extending proximally from the distal end (see Fig. 9; Par. 74) –
The distal microcatheter segment comprises a length and an outer diameter;
A proximal shaft segment (2652) extending distally from the proximal end, the proximal shaft segment comprising:
A length and an outer diameter;
A tapered dilator segment (see Fig. 9, not labeled – i.e. the tapered section between 2652 and 2653) positioned in between the distal microcatheter segment and the proximal shaft segment (see Fig. 9).
Garrison discloses the invention substantially as claimed except for disclosing the specific dimensions of the distal microcatheter segment and the length of the proximal shaft segment. However, Garrison does explicitly recite that the microcatheter segment (2653) is constructed to perform “some or all of the functions that a microcatheter would do” (Par. 74) and as such, the ordinary artisan would reasonably recognize and appreciate that such a requirement would necessitate the segment to share certain structural geometry with a microcatheter. For example, Garrison discloses that the outer diameter of a microcatheter is in the range of 0.030” to 0.040” (Par. 73). 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 diameter of the distal microcatheter segment to be no more than about 0.04”, as disclosed by Garrison, in order to affect a suitably dimensioned segment which is constructed in a manner which permits the segment to perform the typical microcatheter functions in a predictable and expected manner. It has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, 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).
Garrison 2 discloses that microcatheters can be longer than the length of the catheters into which they extend from by “at least about 5-10cm” (Par. 106). 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 of the invention of Garrison to have a distal extent of at 5-10cm, a range within Applicant’s claimed range, as disclosed by Garrison 2, in order to ensure that the segment extends a sufficient length beyond the tapered dilator segment in order to perform the requisite microcatheter functions in an expected and predictable manner. It has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, 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).
Garrison 2 discloses that the outer diameter of a dilator segment have be “0.003” to 0.10” smaller than the inner diameter” of the receiving catheter (Par. 91). In some embodiments Garrison discloses that a distal catheter may have “an inner diameter of 0.070” to 0.095”” (Par. 66). 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 outer diameter of the proximal shaft segment to be in the range of 0.060” to 0.092” so as to provide for maximized dilation for the passage of suitably large catheters (2030) depending upon the specific blood vessel to be accessed. It has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, 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).
Garrison discloses that microcatheters can have a working length of 100 and 140cm (Par. 95). However, it should be understood that in some instances greater lengths may be useful, particularly when encountering abnormally large patients (e.g. a patient suffering from acromegaly) who will have proportions far exceeding those of a the typical patient. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct configurations of the device of Garrison with lengths in excess of 140cm, in order to allow the catheter system to access more remote regions deeper within the vasculature while accounting for increasing patient physiological dimensions. It has been held that mere changes in size and proportion are generally obvious and require only routine and customary skill in the art where only expected and predictable results are to be obtained, 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).
Regarding Claim 5-7, Garrison discloses a radiopaque marker formed of a radiopaque dopant at the distal end (Par. 76) to permit the tapered dilator segment to be visible under fluoroscopy.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”) as applied above, and further in view of U.S. Publication No. 2015/0174368 (“Garrison 3”).
Regarding Claim 2, Garrison discloses the invention substantially as claimed except that that the side wall comprises a “coil” therein extending proximally through the distal microcatheter segment and at least partially through the tapered dilator segment. However, Garrison 3 discloses a related access catheter (105) which is comprised having a sidewall with a coil reinforcement layer laminated therein (Par. 20), wherein the coil extends from the proximal end through a tapered section and through the distal section (see Fig. 1B) in order to provide superior “pushability” (Par. 26). It would have been obvious for one having ordinary skill in the art at the time the invention was made to reinforce the catheter shaft of the invention of Garrison including, at least, the distal segment and the tapered segment, as disclosed by Garrison 3, in order to provide improved pushability to the catheter distal segment to ensure that it can adequately track through the vasculature.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”) and U.S. Publication No. 2015/0174368 (“Garrison 3”) as applied above, and further in view of U.S. Publication No. 2020/0155181 (“Yang”).
Regarding Claim 3, Garrison 3 discloses that the reinforcement layer can be varied throughout the catheter (Par. 26) to impart changes in strength and stiffness to different sections including configurations of wound coils and tubular braids (Par. 26). However, Garrison 3 fails to explicitly contemplate mixing a wound coil and tubular braid in the side wall with the tubular braid extending distally from the proximal end. Although Garrison 3 does suggest that details of the various inventions may be provided in “combinations thereof” (Par. 36) without departing from the scope of invention. However, Yang discloses a related catheter (3001) comprising a reinforcement structure which transitions from a proximal braid (3010) to a distal coil (3024) (see Fig. 30 – Par. 221) in order to impart a proximal stiffer portion with a higher flexibility distal portion (Par. 229). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the catheter of modified Garrison to comprise a proximal braid transitioning to a distal coil, as disclosed by Yang, in order to optimize stiffness allowing the proximal section to be stiffer to provide for high pushability while still allowing the distal section to be more flexible to impart some stiffness, while ensuring that it does not damage the vasculature during advancement and can properly track along a guidewire.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”), U.S. Publication No. 2015/0174368 (“Garrison 3”), and U.S. Publication No. 2020/0155181 (“Yang”) as applied above, and further in view of U.S. Publication No. 2017/0072163 (“Lim”).
Regarding Claim 4, Garrison, as modified, discloses the invention substantially as claimed except that at least a portion of the tubular braid extends over a proximal end of the coil. Rather Yang only illustrates an abrupt transition without any overlap. However, Lim discloses that in such reinforced catheters it is known to have the braid extend over a proximal end of the coil to create overlap therebetween (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the braid of modified Garrison to extend over the coil, as disclosed by Lim, in order to avoid an abrupt transition that might create a sudden change in stiffness where buckling or kinking might occur.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”) as applied above, and further in view of
U.S. Publication No. 2010/0114017 (“Lenker”)
Regarding Claim 8, Garrison discloses the invention substantially as claimed except that the invention further comprises a radiopaque marker being positioned adjacent a transition between the tapered dilator segment and the distal microcatheter segment. However, Lenker discloses that radiopaque markers may be provided at both distal ends and transition regions of such catheters to assist in navigation (Par. 138). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an additional radiopaque marker at the transition between the tapered distal segment and the distal microcather segment of Garrison, as disclosed by Lenker, in order to differentiate between the dilation section and the distal microcatheter section to assist in positioning of the catheter.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”) as applied above, and further in view of U.S. Publication No. 2016/0114138 (“Jahrmarkt”)
Regarding Claim 9-10, Garrison discloses the invention substantially as claimed except that for explicitly disclosing the wall thickness of the distal microcatheter segment. But Garrison does disclose that wall thickness may be “scaled down to be less than conventional wall thicknesses” (Par. 106). Jahrmarkt discloses that microcatheters may have wall thickness of “approximately 0.003 inches” (Par. 56). 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 to have a wall thickness of approximately 0.003 inches (a value within the instantly claimed range, as disclosed by Jahrmarkt, in order to minimize the diameter of the catheter without causing unnecessary reductions to the inner diameter of the lumen.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2013/0035628 (“Garrison”) in view of U.S. Publication No. 2016/0220741 (“Garrison 2”) as applied above, and further in view of U.S. Publication No. 2015/0173782 (“Garrison 4”).
Regarding Claim 11, Garrison, as modified discloses the invention substantially as claimed except that for explicitly disclosing the length of tapered section, i.e. the length of the tubular body between the distal microcatheter segment and the proximal shaft segment. However, Garrison 4 discloses that similar diameter transitions can occur over a length of 3mm to 10mm (i.e. 0.3cm to 1cm) (Par. 110) – a range which substantially overlaps with the instantly claimed range. It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the length of the intermediate dilating segment to be between 0.5cm and 2.5cm, inclusive to dimensions suggested by Garrison 4, in order to ensure that the change in diameter occurs over a suitably long length to avoid too abrupt of a change in diameter. It has been held that ranges which overlap or lie inside ranges disclosed by the prior art support a prima facie case of obviousness, see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
10/20/2025