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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 July 2025 has been entered.
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.
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) 9, 15, 24, and dependents thereof 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 Claims 9 and 15, the metes and bounds of the phrase “a hydrophilic coating located on an exterior surface of only a distal 10 centimeters of the access assist device” does not appear verbatim in the specification and therefore it is unclear as to what specific structures are permissible or impermissible in light of the claim. It is unclear if Applicant is attempting to define the length of the coating itself to a measurement of 10cm while isolating this 10cm coating to the distal portion of the catheter OR if Applicant is attempting to assert that the hydrophilic coating can be of ANY length as long as it is located on the distal 10 cm of the device and would therefore be permissible to a variety of lengths of discrete hydrophilic coatings as long as they were limited to any area found ONLY at the distal 10cm of the device, e.g. the coating is 1cm, 5cm, 7cm…etc.
Applicant in the remarks/arguments appears to infer that the limitation references “coating ‘only a distal 10 centimeter’” which is evocative of limiting the invention to one 10 centimeter long coating. Furthermore, Applicant’s remarks/arguments indicating that Garrison in providing ranges for the “working length” which include configurations “about 3 to 6 cm” “also teach away from the specific location of the hydrophilic coating” appear to suggest that Applicant infers the claim limitation to be limited to a hydrophilic coating measuring 10cm in length provided along a corresponding 10cm distal end of the access device. Specifically, if the claim were permissive to shorter coating lengths provided somewhere along the distal 10 cm of the device then the 3-6cm configuration of Garrison would meet this claim since the coating would be less than 3-6cm in length AND located along within the distal 10 centimeters of the device.
Support for Applicant’s claim language is not found verbatim in the specification, but appears to be evocative of an embodiment discussed in Par. 172, re: “the hydrophilic coating 136 may cover the distal 10 cm of the dilator”). This embodiment would appear to be consistent with Applicant’s arguments concerning a working length of 3-6cm in association with Garrison. However, Par. 172 also recites “The hydrophilic coating 136 may cover a portion of the distal portion 112 less than 10cm long” – which could logically be considered providing a coating on “only a distal 10 centimeters of the access assist device”. However, Applicant’s remarks concerning a working length of 3-6cm in Garrison “teaching away” from the claimed arrangement suggests that covering ONLY a portion of the distal 10cm would not read upon the instant claim. However, the grammar of this claim – given the multiple examples in the specification – and deviation in language between the claim and the specification is unclear. Again, the claim does not expressly concern itself with the length of the coating, per se, but rather the length of the segment upon which the coating may be received, where in light of the specification the coating applied somewhere on this 10cm distal segment could be of less than 10cm in length.
Regarding Claim 24, the issues discussed with Claim 9 are further exacerbated by Applicant’s recitation toward locating the coating on “two distinct portions of the exterior surface”, where “distinct” would appear to require a discontinuous coating, i.e. discrete sections of coating located on the shaft. But if Claim 9 prescribes the ONLY coating to be of a 10cm length and located ONLY over a corresponding 10cm distal end length then it is how a further distinct coating could be added without failing to achieve the “only” prohibition in Claim 9. If other words, Claim 9 (at least as interpreted in light of Applicant’s remarks and arguments) would appear to preclude Claim 24. Again, if the claim is merely specifying that the coating (or coatings) must be limited to a 10cm section of the distal end, but can be of any length as long as their cumulative length does not exceed 10cm then these limitations would be compatible. But such an arrangement would appear to be incongruous with Applicant’s assertion that the 3-6cm coating of Garrison (which would not exceed the length of the 10cm distal section upon which it is received) does not meet the claim.
As such, the record is unclear as to what configurations are or are not permissible.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 10 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites “wherein the hydrophilic coating is located on the distal portion of the access assist device”, whereby parent Claim 9 already establishes the coating to be located on “only a distal 10 centimeters of the access assist device”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 9-11, 24 and 29 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. 2019/0336149 (“Yang”).
Regarding Claims 9-11, Garrison discloses a vasculature navigation system, comprising:
an access assist device (2652) sized and configured for neurovascular use (see Background), the access assist device having a proximal end (see e.g. Fig. 16 – i.e. the portion retained external to the patient) and a distal end (Fig. 8) located opposite the proximal end, the access assist device comprising a guidewire lumen extending between the proximal end and the distal end (see Fig. 8) with the guidewire lumen having an inner diameter, the access assist device defining a proximal portion and a distal portion located opposite the proximal portion;
an access port (see e.g. Fig. 16 – note the insertion of the guidewire) located at the proximal end of the access assist device, the access port configured to receive a guidewire;
a distal port located at the distal end of the access assist device; the distal port configured to further receive the guidewire (see Fig. 8 – note the egress of the guidewire);
a tapered portion (see Fig. 8) defining at least part of the distal portion of the access assist device, wherein an outer surface of the tapered portion tapers downward toward the distal end; and
a hydrophilic coating located on an exterior surface of the access assist device, wherein the hydrophilic coating enables navigation of the access assist device through a patient’s vasculature by reducing friction between the access assist device and the patient’s vasculature (Par. 65 and 59). In the instant case the phrase “working portion of the arterial access device” is understood to include the tapered “inner member 2652” since this section is used to perform the function of tracking a guidewire and crossing vascular obstructions (see Par. 73-75 and compare the function of advancement associated with 2652 with the function of assisting advancement as attributed to the hydrophilic coating). As such, if not already provided, it would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the hydrophilic coating to the outer surface of BOTH (2030) and (2652) in order to improve the ease of advancing the access assist device (2652) within the lumen of (2030) as well as when crossing vascular obstructions (see Fig. 8, 9; Par. 73). Garrison provides devices with exemplary working lengths inclusive to 10cm and “11 cm or less” (Par. 60) which would appear to be suggestive of a configuration where the working length would be obvious to construct to be 10cm (i.e. a value within the stated range) and if the hydrophilic coating is provided on this working length then logically it would be provided on only a distal 10 cm.
Garrison discloses the invention substantially as claimed except that that the hydrophilic coating is provided on the surface of “only a distal 10 centimeters” of the access assist device (i.e. the coating covers a distal 10 cm – see Par. 172 of the instant specification). However, Yang discloses a related access assist device which like Garrison may be provided with a hydrophilic coating to help enable navigation of the device thorugh the patient’s vasculature, improving trackability of the device wherein the coating may be provided only to a discrete portion of the distal end (Par. 260), wherein Yang suggests discrete lengths of 1cm, about 5cm, about 10cm, about 15cm, or about 20cm (Par. 260). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the access assist device to have the hydrophilic coating limited to only a distal 10cm length of the device, a value “about 10cm” as suggested by Yang, in order to allow the device to gain the noted improvements to vascular navigation without using an excess amount of coating thereby reducing material costs.
Regarding Claim 24, in the instant case, as discussed above, Yang contemplates that an access device may have a hydrophilic coating provided on “about 10cm” from the distal end of the catheter, thereby obviating a 10cm long coating that extends from the distal terminus of the catheter proximally. Here, if “distinct portions” permits a 10cm long hydrophilic coating which merely extends over distinct regions of a distal end, i.e. a tapered section and a cylindrical section collectively defining the 10cm length, then Garrison, in view of Yang, obviates such a configuration. Specifically, Garrison suggests the “distal-most portion” “may have a length of about 3 to about 6cm” (Par. 60). In such instances when the hydrophilic coating is provided on the distal 10cm (see Yang) it will be covering a length of 10cm inclusive to distinct potions comprising the tapered section and non-tapered section of the device of Garrison.
Regarding Claim 29, Garrison discloses the guidewire lumen to define an inner diameter of 0.020” to 0.024” (Par. 73) – i.e. a range which is “at least 0.016 inches”.
Claim(s) 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. 2019/0336149 (“Yang”) as applied above, and further in view of U.S. Publication No. 2003/0212384 (“Hayden”).
Regarding Claim 12, Garrison discloses a hemostasis valve (2035) coupled to the proximal portion of the access assist device, the hemostasis valve being configured to control fluid flow between the proximal portion and the distal portion;
A flush port (2045) coupled to the proximal portion of the access assist device and located distal to the hemostasis valve (see Fig. 1). Garrison fails to explicitly suggest that the flush port has, coupled thereto, “a fluid supply source” configured to provide a fluid through the flush port in to the access assist device. Rather Garrison only particularly suggests aspirating via the port (2045) – although perfusion and coupling “flushing and aspiration” are contemplated by Garrison (Par. 105, 135). For example, Hayden describes that in related systems the aspiration ports and lumens may be adapted for infusion of fluid and pharmaceutical agents (Par. 93; Clm. 6, Clm. 12), i.e. coupled to a fluid supply source with a fluid located therewith configured to flow from the fluid supply source through the flush port into the catheter device. It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the system of Garrison to include a fluid supply source associable with the flush port of the invention of Garrison, as disclosed by Hayden, in order to allow for aspiration or infusion to be selectively applied to the catheter to assist in perfusing, disrupting thrombi, and aspirating fluids as needed.
Claim(s) 27-28 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. 2019/0336149 (“Yang”) as applied above, and further in view of U.S. Publication No. 2018/0193042 (“Wilson”).
Regarding Claims 27-28, Garrison discloses that the device may have a “radiopaque maker” located at its distal end (Par. 76). However, Garrison does not particularly resolve the location of the first maker band to be “about 1 millimeter proximal to the distal end” or particularly disclose a “second marker band” located proximal to the tapered portion. However, Wilson discloses a related catheter (e.g. 100) having a plurality of radiopaque marker bands distributed at various locations along the length of the catheter (see Fig. 2B) including g a first marker band (344a) located a distance proximal to the distal end of the tapered catheter tip (see Fig. 2b), a second marker band (e.g. 224a or 324b) located proximal to the tapered portion, and a third marker band (e.g. 344b) located between the first and second marker bands. Wilson discloses that these marker bands can vary in “size, shape and location” (Par. 158). 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 Garrison to have first, second, and third marker bands, as disclosed by Wilson, in order to provide multiple points of visualization under fluoroscopy to assist in positioning the distal end of the catheter within the proper location of the vasculature. It would have been obvious for one having ordinary skill in the art at the time the invention was made to locate the first marker band of modified Garrison to be a distance of “about 1 mm” proximal to the distal end, inasmuch as such a location is not asserted by the specification to provide any specific or particular benefit or convey any particular utility, whereby it would be expected that such a specification location of “about 1mm” constitutes a mere obvious design choice for locating the distal marker band of the type already known to the prior art, whereby a distance of “about 1mm” would be expected to work equally well as any other specifically resolvable location located “at the distal tip” (i.e. in near proximity to the distal end), it has been held that rearranging the working parts of an invention requires only routine and customary skill in the art, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 15, 17, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,830,181 (“Thorton”) in view of U.S. Publication No. 2019/0336149 (“Yang”).
Regarding Claim 15, Thorton discloses:
A vasculature navigation system (see Fig. 1), comprising:
an access assist device (10), the access assist device having a proximal end (see generally at 14 – i.e. the portions of assist device 10 maintained external to the patient’s vasculature) and a distal end (see Fig. 4) located opposite the proximal end, the access assist device comprising a guidewire lumen (20) extending between the proximal end and the distal end (see Fig. 1), the access assist device defining a proximal portion (i.e. the portion at the proximal end) and a distal portion (see Fig. 2 – i.e. the interventional portion) located opposite the proximal portion;
an access port (see generally 14 – i.e. the port which permits receipt of the guidewire 31) located at the proximal end of the access assist device, the access port configured to receive a guidewire (see Fig. 1);
a distal port (24 located at the distal end of the access assist device; the distal port configured to further receive the guidewire (see Fig. 1);
a tapered portion (25) defining at least part of the distal portion of the access assist device (see Fig. 1), wherein an outer surface of the tapered portion tapers downward toward the distal end (see Fig. 1); and
a plurality of microperforations (26, 28) located on an exterior surface of the access assist device (see Fig. 1).
Thorton discloses the invention substantially as claimed except that device comprises “a hydrophilic coating located on an exterior surface of only a distal 10 centimeters of the access assist device”. However, Yang discloses that in related access assist devices it is known to provide a hydrophilic coating on at least a portion of the device wall, wherein the coating may be placed along the distal most region of the device and the coating may extend “about 10cm… from the distal end”. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Thorton with a hydrophilic coating along only the distal 10cm of the catheter, as disclosed by Yang, in order to assist in improving the trackability of the catheter by lowering friction without using an excessive amount of hydrophilic material thereby saving on material costs.
Regarding Claim 17, Thorton discloses each microperforation of the plurality of microperforations defines an aperture (see Fig. 4 and 5).
Regarding Claim 30, Thorton discloses the plurality of microperforations are located on the distal portion of the access assist device (see Fig. 2)
Claim(s) 18-20, 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,830,181 (“Thorton”) in view of U.S. Publication No. 2019/0336149 (“Yang”) as applied above, and further in view of U.S. Publication No. 2016/0106501 (“Appling”).
Regarding Claim 18, Thorton discloses the invention substantially as claimed except for disclosing a hemostasis valve and a flush port. While Thorton is specifically configured to receive a flushing fluid through the guidewire lumen (see Summary of Invention) it is not specifically clear how the fluid is introduced into the lumen. However, Appling discloses a related vascular navigation system (1) wherein the proximal hub comprises a hemostasis valve (11, 15) coupled to the proximal portion to control fluid flow between the proximal and distal portion and to receive a guidewire (Par. 47) and a flush port (5, 14) coupled to the proximal portion and located distally to the hemostasis valve in order to provide a fluid from a fluid supply source coupled thereto and flow this fluid from the source through the flush port to be delivered from the distal end of the catheter (Par. 48). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the proximal hub of the invention of Thorton to comprise a branch hub comprising a proximal hemostasis valve for providing receipt of the guidewire and a flush port to receive the flushing fluid, as disclosed by Appling, in order to seal the proximal end of the catheter against the reflux of blood or other fluids about the guidewire while ensuring that the flushing fluid can be provided via its own dedicated port without interfering with the guidewire.
Regarding Claim 19, Examiner submits that the microperforations of Thorton are, themselves, configured to release a substantially continuous flow of fluid from the fluid supply source based upon the inherent fluid dynamics of the apertures.
Regarding Claim 20, in modified Thorton any fluid dispensed through the microperforations will flow distally over the hydrophilic coating located on the most extreme distal sections of the catheter.
Regarding Claims 31-32, Thorton discloses the fluid is configured to flow through the guidewire lumen of the access assist device simultaneously with receipt of the guidewire (see Fig. 1; Summary of Invention; see also the modifications in view of Appling).
Regarding Claim 33, Thorton discloses the diameter of the guidewire lumen is “about 0.033 inch”, i.e. a value of “at least 0.016 inches”.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive or are moot in view of the new grounds of rejection.
Applicant argues (Pg. 8) that “disclosing ‘various lengths’ [in Garrison] distinctly teaches away from coating ‘only a distal 10 centimeters’ as recited in amended Claim 9.” However, this is not persuasive. To the extent that Garrison suggests that the invention may comprise different embodiments having different sized working lengths inclusive to configurations “10-15cm” or alternate embodiments of “11cm or less” would obviate configurations having a working length of 10cm. To the extent that Garrison suggests providing the hydrophilic coating on the “working length” it stands to reason that, in obvious configurations having a working length of 10cm, that the hydrophilic coating would comprise 10cm. Furthermore, consideration of Yang demonstrates that a hydrophilic coating of 10cm is a suitable length for providing the necessary benefits of such a coating including improving navigation and trackability and as such a 10cm length hydrophilic coating constitutes merely one expected and predictable solution that the ordinary artisan would have found obvious in order to resolve the invention of Garrison to specific practice to treat a specific patient suffering from a specific malady whereby the dimensions are within ranges specifically contemplated by Garrison and whereby Yang establishes a 10cm long hydrophilic coating to be a useful length which would confer only predictable and expected results when paired with a suitably sized Garrison catheter. Examiner notes that Applicant’s analysis only appears to focus on two alternate embodiments wherein the working length is constructed larger than 10cm (i.e. 40-80cm) or smaller than 10 cm (i.e. 3-6cm) while ignoring the other embodiments of Garrison which include the instantly claimed dimension.
However, the above analysis relies upon assumptions as toward the intended meaning of the new claim limitation “a hydrophilic coating located on an exterior surface of only a distal 10 centimeters of the access device” which differs in language from both the instant specification as well as Applicant’s remarks and arguments. As noted above, it is unclear if the hydrophilic coating is required to comprise a 10 centimeter length along only a corresponding 10 centimeter length distal portion of the access assist device OR if the hydrophilic coating must be isolated to the distal 10 centimeters of the access assist device with the coating itself having an indeterminate length as long as it does not extend past this 10cm region. If the latter interpretation is permitted under the scope of the claims then configurations with a 3-6cm working length in Garrison where the hydrophilic coating is provided over some indeterminate length thereof would define a coating located [somewhere] along only a distal 10 centimeters of the device.
Examiner submits that the instant claim only explicitly concerns itself with the length of the distal segment, not the length of the coating, per se, and the structure of Claim 9 (further in consideration of Claim 24) creates confusion as to what such a limitation means for the length of the coating, e.g. Does the limitation require a 10cm coating (if so then how is Claim 24 compatible with Claim 9)? Is the limitation permissive to a coating (or plurality of coatings) having a length of less than 10cm as long as this coating (or discrete coating sections) are exclusively provided on the distal 10cm? The specification, presenting multiple embodiments with descriptive language that does not directly map to the instant claim language makes determination of the metes and bounds of the claims unclear.
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
10/21/2025