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 .
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.
Claims 5-14 and 23-24 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. Claim 5 is rejected because “the scatting member” lacks proper antecedent basis.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2022/0265426 to Cortez Jr. et al. “Cortez”.
As for Claim 18, Cortez discloses a medical device (e.g. flexible catheter, sheath, other tubular and/or lumen forming devices; Paragraph [0229]) including a catheter shaft with an inner layer, outer layer and separate undulating layer disposed between the inner and outer layers (Figs. 24A-B and corresponding descriptions). Cortez explains where an undulating layer can include a helical coil or tube wrapped around an outer working shaft to provide improved visibility to trap fluids/air between the helical wrapped sections (Paragraphs [0170]-[0174]). Examiner notes the helical coil or tube wrap extends circumferentially around the entire circumference of the catheter shaft between the inner and outer layers in its broadest reasonable interpretation. Furthermore, the aforementioned “trapped fluids/air” would read on air pockets between the inner and outer layers to enhance the visualization of the catheter shaft in its broadest reasonable interpretation.
With respect to Claims 19-20, Examiner notes the helical coil or tubular spiral is both axially and radially extending in its broadest reasonable interpretation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1-2, 5-8, 10-14 and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2025/0367405 to Sano et al. “Sano” in view of U.S. Publication No. 2025/0177613 to Bauer et al. “Bauer” or U.S. Publication No. 2022/0265426 to Cortez Jr. et al. “Cortez”.
As for Claims 1, 5, 7, 22 and 24, Sano discloses a medical device with enhanced echogenicity (Paragraphs [0001] and [0006]) comprising a polymeric catheter shaft (e.g. medical tubular body device) having a distal region and including a resin layer (Paragraphs [0081]-[0082]). In one embodiment, the resin layer includes a radiopaque filler (e.g. “hyperechoic particles” Paragraphs [0081]-[0093]).
However, Sano does not expressly disclose wherein the hyperechoic particles include hollow glass microspheres in the resin.
Bauer teaches from within a similar field of endeavor with respect to enhancing the visualization of medical devices (Abstract) where hollow glass microspheres may be used for sonographic or x-ray visibility (Paragraphs [0025] and [0044]).
Cortez teaches from within a similar field of endeavor with respect to catheters with enhanced echogenicity characteristics (Paragraph [0229]) where hollow glass microspheres are used (Paragraphs [0227] and [0257]).
Accordingly, one skilled in the art would have been motivated to have modified the resin described by Sano to also include hollow glass microspheres described by Bauer/Cortez in order to enhance the medical device’s echogenicity. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claims 2 and 14, Examiner notes the modified device includes hyperechoic particles as described above. Cortez explains the medical instrument includes echogenic air pockets (Paragraphs [0072] and [0227]). Examiner notes the manner in which the air pockets are formed is a matter of pure design choice and one skilled in the art would have been motivated to have used any conventional technique such as sodium chloride disposed in the resin.
As for Claim 6, Sanos medical device includes an access cannula (Figs. 1-3).
Regarding Claims 8 and 10, Sanos discloses wherein the medical device can include a balloon catheter configured to deploy a stent (Paragraph [0190]).
As for Claims 11-13, Cortez teaches an embodiment where a shaft includes an inner layer, outer layer and an undulating layer disposed between the inner and outer layers (Figs. 24A-B and corresponding descriptions). Cortez explains where an undulating layer can include a helical coil or tube wrapped around an outer working shaft to provide improved visibility to trap fluids/air between the helical wrapped sections (Paragraphs [0170]-[0174]).
With respect to Claims 21 and 23, Cortez discloses where the device may include one or more of chambers, gaps, channels, lumens, or other compartments associated with the shaft which can be filled with air to improve clarity (Paragraph [0176]). Accordingly, skilled in the art would have been motivated to have provided a channel/compartment into the wall of the catheter shaft with air/gas in order to enhance the visibility of the device.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonos and Cortez as applied to claims 1 and 11 above, and further in view of U.S. Patent No. 6,506,156 to Jones et al. “Jones”.
As for Claims 2 and 14, Sonos and Cortez disclose a medical device with enhanced echogenic properties as described above. Cortez explains the medical instrument includes echogenic air pockets (Paragraphs [0072] and [0227]). Examiner notes the manner in which the air pockets are formed is a matter of pure design choice and one skilled in the art would have been motivated to have used any conventional technique such as sodium chloride disposed in the resin.
Nonetheless, Jones teaches from within a similar field of endeavor with respect to echogenic coatings (Abstract) where salt is used to create a void (e.g. air pocket) (Column 5, Lines 25-40).
Accordingly, one skilled in the art would have been motivated to have used salt in the echogenic coating process described by Jones in order to create additional air pockets in the resin described by Sonos and Cortez. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Claim(s) 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sonos and Bauer/ Cortez as applied to claim 5 above, and further in view of U.S. Publication No. 2014/0207000 to Vriezema et al. “Vriezema”.
As for Claims 9, Sonos and Bauer/ Cortez discloses a catheter with enhanced echogenicity as described above but fails to specify where the catheter includes a retrieval basket or retrieval snare.
Vriezema teaches from within a similar field of endeavor with respect to improving ultrasound visibility of medical devices (Abstract) wherein the device may include a biopsy needle, guidewire, stent, catheter, retrieval snare (Paragraph [0142]).
Accordingly, one skilled in the art would have been motivated to have modified the catheter described by Sonos and Bauer/ Cortez to include a retrieval snare as described by Vriezema in order to perform additional intravascular procedures. In addition, such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Regarding Claim 6, Vriezema teaches where the device may include a cannula (Paragraph [0058]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 5-14 and 18-24 have been considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. NPL “Developing Echogenic Materials as Catheters for use with Ultrasound” to Contreras et al. “Contreras” which discloses incorporating gas microspheres into catheter to produce echogenic effects (Abstract). Contreras explains where extrusion may be used to produce the glass filled microspheres (“Results”).
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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