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 .
Status
As Applicant’s argument alone overcame the previous rejection of claim 1 and new rejections are provided herein, the present office action is a second, non-final office action.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 8/31/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 8/20/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s amendments to both the specification and drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see page 7, with respect to Applicant’s claim amendments to claim 51 adding sufficient structure to overcome the previous §112(f) interpretation of “a mechanism configured to actuate an axial folding” have been fully considered and are persuasive. The previous §112(f) interpretation in claim 51 has been withdrawn.
Applicant’s arguments, see page 7, with respect to Applicant’s claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments (regarding claim 41), see pages 7-9, with respect to Gupta failing to expressly disclose wherein compression of the coil causes rotation of the curved distal tip have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new ground(s) of rejection are made under Burkett (US 2014/0180028).
Applicant's arguments (regarding claim 51), see pages 9-10, with respect to Dubrul failing to expressly disclose its wire having at a distal end a mechanism comprising a flange, bump or annular bulge configured to actuate an axial folding have been fully considered but they are not persuasive. The Examiner respectfully disagrees. It is the Examiner’s position that flange is defined as “a rib or rim for strength, for guiding, or for attachment to another object” (see https://www.merriam-webster.com/dictionary/flange); bump is defined as “a relatively abrupt convexity or protuberance on a surface” (see https://www.merriam-webster.com/dictionary/bump)” (see https://www.merriam-webster.com/dictionary/bump); and bulge is defined as “a protuberant” (see https://www.merriam-webster.com/dictionary/bulge). The distal end structure 17 (as shown in augmented Figs. 4A-4B below (with braid 9 removed) is expressly depicted as either a protuberance/protuberant and/or a rim for attachment to the distal end of the braid. Applicant’s arguments appear to contradict the disclosure of Dubrul. For at least these reason, Applicant’s arguments are not persuasive.
PNG
media_image1.png
310
674
media_image1.png
Greyscale
Applicant's arguments (regarding claim 58), see pages 10-11, with respect to the embodiment of Figs. 4A-4B of Dubrul failing to expressly disclose first and second braided portion separated by a non-braided portion have been fully considered and they are persuasive. Therefore, the previous 102 rejection of claim 58 has been withdrawn. However, upon further consideration, a new ground of 103 rejection is made further in view of the embodiment of Figs. 2-3B of Dubrul, as set forth below.
Applicant's arguments (regarding claim 57), see page 12, with respect to Dubrul failing to expressly disclose “the braided distal portion comprises a symmetrical mixture of thicker and thinner stands” have been fully considered but they are not persuasive. It is the Examiner’s position that symmetrical is defined as “capable of division by a longitudinal plane into similar halves” (see https://www.merriam-webster.com/dictionary/symmetrical). Dubrul expressly discloses the braided distal portion comprising symmetrical strands (as shown in annotated Figs. 4A-4B below), and Chin also expressly depicts the braided distal portion comprising symmetrical strands (as expressly shown in Figs. 1-7 of Chin). Chin was further cited for its teaching of incorporating a mixture of thicker and thinner strands in order to beneficially provide for altering the flexibility characteristics of the mesh portion as needed to vary and/or change the configuration to any desired shape ([0040]). Applicant’s arguments appear to contradict both the express disclosure of Dubrul and the teachings of Chin. For at least these reason, Applicant’s arguments are not persuasive.
PNG
media_image2.png
396
644
media_image2.png
Greyscale
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 55 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.
Regarding claim 55, the phrase "a flange, bump or annular bulge" in lines 1-2 renders the claim(s) indefinite because a flange, bump or annular bulge was already introduced in line 5 of claim 51, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the flange, bump or annular bulge of claim 51 or introduce a new, additional flange, bump or annular bulge. To move prosecution forward, the examiner assumed applicant intended to refer back to the flange, bump or annular bulge of claim 51. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 41-42, 44-45 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkett (US 2014/0180028).
Burkett discloses (see Fig. 5) a guidewire with adjustable tip comprising the following claim limitations:
(claim 41) A medical guide wire for improved blood vessel navigation, comprising: a wire (150, Fig. 5) having a curved distal tip (110, Fig. 5) (as shown in Fig. 5; [0026]; wire 150 expressly fixed to curved distal tip 110 having a distal end radius of curvature); a shaft (116, Fig. 5) covering at last part of the wire (150) (as expressly shown in Fig. 5); a coil (112, disposed in distal portion 150c of Fig. 5) affixedly covering a portion of the wire (150) proximal to the distal tip (110) and distal to the shaft (116) (as expressly shown in Fig. 5), wherein moving the shaft (116) linearly toward the coil (112) compresses the coil (112) and rotates the distal tip (110) (as shown in Fig. 5; see Abstract and claim 1; [0008]; [0010]; [0028]-[0029]; [0031]; “movement of the elongate member translates the elongate member relative to the core member and compresses the coil segment”; axial movement of the shaft 116 relative to the core wire 115 causes rotation of the distal tip 110 (i.e., rotation about axis transverse to the longitudinal axis of the shaft 116)) (as expressly shown in Fig. 5 (i.e., rotation shown between solid line position and ghost line positions));
(claim 42) wherein moving the shaft (116) linearly away from the coil (112) releases the coil (112) and rotates the distal tip (110) in an opposite direction (as shown in Fig. 5; see Abstract; [0040]-[0041]; axial movement W (in both directions) of the shaft 116 relative to the core wore 115 causes rotation of the distal tip 110 (i.e., rotation shown between solid line position and ghost line positions in Fig. 5));
(claim 44) wherein compressing the coil (112) rotates the distal tip (110) from 90 to 720 rotational degrees (as expressly shown in Fig. 5; rotational of coil 112 to 90 degrees (i.e., solid line position) and greater than 90 degrees (i.e., ghost line position depicted at bending position Z) is expressly disclosed);
(claim 45) wherein the distal tip (110) is radiopaque ([0025]; distal tip 110 of wire 150 is radiopaque as both the elements of the shaft 116 and wire 150 may expressly be composed of stainless steel or Nitinol); and
(claim 50) wherein the wire (150) is substantially straight other than the curved distal tip (110) (see Abstract and claim 1; see exemplary Figs. 1, 3A and 4A; [0008]; [0029]).
Claim(s) 51-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dubrul (US 2004/0236369).
Dubrul discloses (see Figs. 4A-4B) an expandable particle removal device comprising the following claim limitations:
(claim 51) A microcatheter (19, Figs. 4A-4B) and guide wire (20, Figs. 4A-4B) combination (as shown in Figs. 4A-4B), comprising: the microcatheter (19) comprising a tube having a braided distal portion (9, Figs. 4A-4B) that is foldable axially (as shown in Fig. 4B); the guide wire (20) inside the microcatheter (19) (as shown in Figs. 4A-4B) and comprising a having at a distal end a mechanism comprising a flange, bump or annular bulge (3, Figs. 4A-4B) (as expressly shown in augmented Figs. 4A-4B provided in the Response to Arguments section above with the arguments repeated herein) configured to (i.e., capable of) actuate an axial folding of the braided distal portion (9) of the microcatheter (19) (as shown in Fig. 4B; [0064]-[0065]);
(claim 52) wherein the braided distal portion (9) in an unfolded position has a first outer diameter (as shown in Fig. 4A) and in a folded position has a second outer diameter (as shown in Fig. 4B) such that the second outer diameter is larger than the first outer diameter (as expressly shown in Figs. 4A-4B; [0064]-[0065]; [0068]);
(claim 53) wherein the braided distal portion (9) in an unfolded position has a maximum first outer diameter (as shown in Fig. 4A) and in a folded position has a maximum second outer diameter (as shown in Fig. 4B) such that the maximum second outer diameter is larger than the maximum first outer diameter (as expressly shown in Figs. 4A-4B; [0064]-[0065]; [0068]);
(claim 54) wherein the braided distal portion (9) in an unfolded position has an average first outer diameter (as shown in Fig. 4A) and in a folded position has a maximum second outer diameter (as shown in Fig. 4B) such that the maximum second outer diameter is at least twice the average first outer diameter (as expressly shown in Figs. 4A-4B; [0064]-[0065]; [0068]; embodiment with average first outer diameter of 0.020 inches and maximum second diameter of 0.500 inches expressly disclosed); and
(claim 55) wherein the mechanism (3) comprises a flange, bump or annular bulge (i.e., flange/bump/annular bulge 3 attached to inner guidewire 20, as shown in Figs. 4A-4B) such that pulling the guide wire (20) proximally induces the flange, bump or annular bulge to press against a distal end (17) of (i) the braided distal portion (9) (as shown in Figs. 4A-4B; [0054]; [0064]-[0065]) (as expressly shown in augmented Figs. 4A-4B provided in the Response to Arguments section above with the arguments repeated herein) or (ii) a portion distal to the braided distal portion.
Claim Rejections - 35 USC § 103
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over Burkett, as applied to claim 41 above.
Burkett, as applied above, expressly discloses a medical guidewire with an adjustable tip comprising all the limitations of the claim except for wherein a radius of the distal tip is about 3 mm. It would have been an obvious matter of design choice to construct the radius of the distal tip of Burkett to be about 3 mm, since such a modification would have involved a mere change in the size of a component. A mere change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Burkett as applied to claim 41 above, and further in view of Gupta (US 2019/0192828).
Burkett, as applied above, discloses a medical guidewire with an adjustable tip comprising all the limitations of the claim except for a tube inside the shaft and the device being in combination with a microcatheter.
However, Gupta teaches (see Figs. 3-5 and 22-25) a similar guidewire (10) having an outer shaft (40) covering a core wire (20) and further comprising a tube inside the outer shaft (40) ([0049]; a tubular layer is expressly taught inside the outer shaft 40) in order to beneficially facilitate axial movement of the core wire within the outer shaft ([0049]), and the device being in combination with a microcatheter (80) (as expressly shown in Figs. 22-25; [0067]-[0071]) in order to beneficially provide vascular navigation through desired branch vessels thereby allowing the microcatheter to deliver medical devices such as stents, embolic coils, and the like to the desired target location ([0067]-[0071]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Burkett to incorporate a tube inside the shaft in order to beneficially facilitate axial movement of the core wire within the outer shaft, and the device being in combination with a microcatheter in order to beneficially provide vascular navigation through desired branch vessels thereby allowing the microcatheter to deliver medical devices such as stents, embolic coils, and the like to the desired target location, as taught by Gupta.
Claim(s) 48 is rejected under 35 U.S.C. 103 as being unpatentable over Burkett as applied to claim 41 above, and further in view of Northrop (US 2008/0262474).
Burkett, as applied above, discloses a medical guidewire with an adjustable tip comprising all the limitations of the claim except for the coil being made of a metal alloy of nickel and titanium.
However, Northrop teaches (see Figs. 1-2) a similar guidewire (10) having coil (24) made of a metal alloy of nickel and titanium ([0036]; coil formed from nickel-titanium alloy expressly taught) in order to beneficially provide a device composed of a well-known biocompatible material that provides superior “pushability” around tortuous anatomy ([0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Burkett to incorporate the coil being made of a metal alloy of nickel and titanium in order to beneficially provide a device composed of a well-known biocompatible material that provides superior “pushability” around tortuous anatomy, as taught by Northrop.
Claim(s) 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Dubrul as applied to claim 51 above, and further in view of Chin et al. (US 20050021077).
Dubrul, as applied above, discloses (see Figs. 4A-4B) an expandable particle removal device comprising the following claim limitations:
(claim 57) wherein the braided distal portion comprises symmetrical strands (as expressly shown in annotated Figs. 4A-4B, provided in the Response to Arguments section above for claim 57)
Dubrul fails to expressly disclose the symmetrical braided distal portion comprising a mixture of thicker and thinner strands.
However, Chin teaches (see Figs. 1-7) a similar expandable occlusion device (10) comprising a braided portion (16) comprising both symmetrical strands and a mixture of thicker and thinner strands (as expressly shown in Figs. 1-2A; [0040]) in order to beneficially provide for altering the flexibility characteristics of the mesh portion as needed to vary and/or change the configuration to any desired shape ([0040]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Dubrul to have the symmetrical braided distal portion comprising a mixture of thicker and thinner strands in order to beneficially provide for altering the flexibility characteristics of the mesh portion as needed to vary and/or change the configuration to any desired shape, as taught by Chin.
Claim(s) 58 is rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figs. 4A-4B of Dubrul as applied to claim 51 above, further in view of the embodiment of Figs. 2-3B of Dubrul.
The embodiment of Figs. 4A-4B of Dubrul, as applied above, discloses a medical device comprising all the limitations of the claim except for the braided distal portion comprising a first braided portion and a second braided portion separated by a non-braided portion.
However, the embodiment of Figs. 2-3B of Dubrul expressly teaches a highly similar device comprising a first braided portion (4, Figs. 2-3B) ([0054]; dual dilation embodiments of Dubrul expressly may comprises a mixture of two dilation mechanisms or two of the same dilation mechanisms) and a second braided portion (9, Figs. 2-3B) separated by a non-braided portion (at 8, Figs. 3A-3B) in order to beneficially allow for multiple therapies to be provided with a single device wherein balloon angioplasty of a stenotic lesion in the vasculature and deployment of a device for propping open the vessel are performable with that same device ([0015]-[0016]; [0020]; [0043]; [0054]; [0073]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the embodiment of Figs. 4A-4B of Dubrul to incorporate a first braided portion and a second braided portion separated by a non-braided portion in order to beneficially allow for multiple therapies to be provided with a single device wherein balloon angioplasty of a stenotic lesion in the vasculature and deployment of a device for propping open the vessel are performable with that same device, as taught by the embodiment of Figs. 2-3B of Dubrul.
Allowable Subject Matter
Claims 43 and 59 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
