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 .
Response to Amendment
The amendment filed 09/30/2025 has been entered. Claims 1-11, 14, 16-19, 21-28, 30, and 34-38 remain pending in the application, claims 12-13, 15, 20, 29 and 31-33 are cancelled, and claims 1-11, 14, 16-18 and 34-37 have been withdrawn. Applicant’s amendments to the claims have overcome the interpretation of the rejection previously set forth in the Non-Final Office Action mailed 06/30/2025, however a new rejection is applied as outlined below in light of the claim amendments.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
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.
Claim 30 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 30 recites “wherein the occlusion member is an expandable balloon,” however is dependent off of claim 19 in which the occlusion member is claimed to comprise “a basket coupled to the shaft and a membrane disposed around the basket to facilitate occlusion when inserted in the vessel.” Therefore, there is no recitation of the occlusion member being both the basket/membrane configuration as well as the balloon configuration.
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 30 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.
Claim 30 recites “wherein the occlusion member is an expandable balloon” and is unclear how the occlusion member can be both the basket/membrane as claimed in claim 19 AND the balloon. For the purposes of examination, the Office will interpret the claim to mean “wherein the occlusion member is an expandable basket.”
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.
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.
Claims 19, 23-24, 30, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Tegels (US PGPub 2014/0194918) in view of Kapur (US PGPub 2017/0049946), and further in view of Kipperman et al. (US PGPub 2014/0066895), hereinafter known as “Tegels,” “Kapur,” and “Kipperman,” respectively.
With regards to claim 19, Tegels discloses (Figures 1-2H and 4) wire assembly 12 configured to occlude a vessel 70 (paragraph 29), comprising:
a shaft 20 that is elongate along a longitudinal axis, the shaft 20 having a proximal end portion 34, a distal end portion (most distal end of shaft 20) spaced from the proximal end portion 34 along the longitudinal axis, a lumen 36 that extends from the proximal end portion 34 toward the distal end portion (paragraph 24), and a cross-sectional dimension that is perpendicular to the longitudinal axis (any shaft with a lumen will have some cross-sectional dimension that is perpendicular to the longitudinal axis), wherein the distal end portion defines a distal tip 32; and
an occlusion member 28 positioned at or toward the distal tip 32 of the shaft 20, the occlusion member 28 configured to transition between a collapsed configuration (figures 1B and 2B) and an expanded configuration (figure 2C; paragraph 33), wherein the occlusion member 28 in the collapsed configuration (figures 1B and 2B) has a first cross-sectional dimension that is less than the cross-sectional dimension of the shaft 20 (figure 1B – distal end 44 of the occlusion member 28 has a cross-sectional dimension that is less than a proximal end portion 34 of the shaft 20) such that the occlusion member 28 is contracted for insertion into the vessel 70 (figure 2B), and the occlusion member 28 in the expanded configuration (paragraph 33; figure 2C) has a second cross-sectional dimension that is greater that the first cross-sectional dimension and the cross-sectional dimension of the shaft 20 (figure 2B; paragraph 32);
a removable hub 62 positioned at the proximal end portion 34 of the shaft 20 (figures 2D-2E; paragraph 34); and
a control device 19 coupled to the removable hub 62, the control device 19 configured to transition the occlusion member 28 from the collapsed configuration (figure 2B) into the expanded configuration (figure 2C; paragraphs 27 and 33).
Tegels is silent the occlusion member comprising a basket coupled to the shaft and a membrane disposed around the basket to facilitate occlusion when inserted in the vessel; and
a wire coupled to the basket at one end of the wire and to the control device at an opposite end of the wire, the control device configured to transition the occlusion member from the collapsed configuration into the expanded configuration by pulling the wire in a proximal direction causing the basket to compress along the longitudinal axis and expand along a radial direction that is angularly offset with respect to the longitudinal axis.
However, in a similar field of endeavor of expandable members, Kapur teaches (Figures 4 and 6-7) the occlusion member 50 comprising a basket (paragraph 65) coupled to the shaft 31 (figure 4; although occlusion member 32 is shown in figure 4, paragraphs 65-66 disclose the occlusion member 50 and the shaft 31) and a membrane (paragraph 65) disposed around the basket 50 to facilitate occlusion when inserted in the vessel; and
a wire 54 coupled to the basket 50 at one end 53 of the wire 54 and to the control device 33/36 at an opposite end of the wire 54 (paragraph 68), the control device 33/36 configured to transition the occlusion member 50 from the collapsed configuration into the expanded configuration (figure 6) by pulling the wire 54 in a proximal direction causing the basket 50 to compress along the longitudinal axis and expand along a radial direction that is angularly offset with respect to the longitudinal axis (figure 6; paragraphs 65-66).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the occlusion member of Tegels for the occlusion member as taught by Kapur. The difference between the prior art and the claimed invention is that Tegels does not teach a basket and a wire controlling the expansion/compression of the basket. Kapur teaches (see Figs. 4 and 6-7) a similar occlusion member comprising a basket and a wire controlling the expansion/compression of the basket. Accordingly, the prior art references teach that it is known that the occlusion member of Tegels and the occlusion member of Kapur are elements that are functional equivalents for providing occlusion to the vessel. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the occlusion member taught by Kapur for the occlusion member of Tegels because both elements were known equivalents for providing, and would have resulted in the predictable results of providing occlusion to the vessel within the art.
Tegels/Kapur are silent wherein the occlusion member in the collapsed configuration has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft such that that occlusion member is contracted for insertion into the vessel.
However, in a similar field of endeavor of expandable members, Kipperman teaches (Figures 9-14) wherein the occlusion member 18 in the collapsed configuration (figure 9) has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft 44 such that that occlusion member 18 is contracted for insertion into the vessel (figures 13-14; Abstract – “the distal end having an expandable portion that expands from a compressed condition when inside of a delivery tube or catheter to an expanded condition when outside of the delivery tube or catheter. A method is also disclosed of performing a percutaneous procedure within a vessel or cavity of a tissue or organ of a subject”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wire assembly of Tegels/Kapur to include wherein the occlusion member in the collapsed configuration has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft as taught by Kipperman for the purpose of contracting the occlusion member for insertion into the vessel so that the occlusion member is within the shaft and does not accidentally damage while navigating the vessel.
With regards to claim 23, Tegels/Kapur/Kipperman disclose the wire assembly as claimed in claim 19. Tegels/Kapur/Kipperman are silent to explicitly disclosing wherein the cross-sectional dimension of the shaft is no greater than 0.040 in.
However, there is no evidence of record that establishes that changing the cross-sectional dimension of the shaft would result in a difference in function of the Tegels/Kapur/Kipperman device. Further, a person having ordinary skill in the art, being faced with modifying the shaft of Tegels/Kapur/Kipperman, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed cross-sectional dimension. Lastly, applicant has not disclosed that the claimed dimension solves any stated problem, indicating that the cross-sectional dimension “may” be within the claimed dimension, and offering other acceptable dimensions (e.g., 0.014 in., 0.018 in., 0.035 in., specification at para. [0021]) and therefore there appears to be no criticality placed on the dimension as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the shaft of Tegels/Kapur/Kipperman to have a cross-sectional dimension no greater than 0.040 in. as an obvious matter of design choice within the skill of the art.
With regards to claim 24, Tegels/Kapur/Kipperman further disclose wherein the shaft (Tegels: 20) includes a step-down region proximal to the distal tip of the shaft (Tegels: 20) upon which the occlusion member (Kapur: 50; akin to the occlusion member 28 of Tegels) is disposed (Tegels: figure 1B – occlusion member 28 is disposed slightly proximal to the most distal end of the shaft 20 and therefore is disposed on the step-down region of the shaft 20).
With regards to claim 30, as rejected above, it would be obvious to substitute the occlusion member of Tegels for the occlusion member of Kapur. Kapur further discloses wherein the occlusion member 50 is an expandable basket (see 112(a) and 112(b) rejection above; paragraph 65). Thus, when incorporating the expandable basket as taught by Kapur, the claimed limitation is considered obvious.
With regards to claim 38, Tegels further discloses wherein the wire assembly 12 is configured to be used in combination with a vascular closure device 14 configured to seal a puncture in a vessel wall (paragraphs 29-30 and 34-36; figures 2F-2H).
Claims 19 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts et al. (US PGPub 2020/0093498), hereinafter known as “Roberts,” in view of Kapur, and further in view of Kipperman.
With regards to claim 19, Roberts discloses (Figures 1-11) wire assembly 2 configured to occlude a vessel (functional limitation - paragraph 33 – “capable of expanding or otherwise conforming to the uterine cavity” therefore is capable of occluding a vessel), comprising:
a shaft 8 that is elongate along a longitudinal axis, the shaft 8 having a proximal end portion 13, a distal end portion 15 spaced from the proximal end portion 13 along the longitudinal axis, a lumen 14/16 that extends from the proximal end portion 13 toward the distal end portion 15 (paragraphs 25 and 33), and a cross-sectional dimension that is perpendicular to the longitudinal axis (any shaft with a lumen will have some cross-sectional dimension that is perpendicular to the longitudinal axis), wherein the distal end portion 15 defines a distal tip 19 (paragraph 28); and
an occlusion member 6 positioned at or toward the distal tip 19 of the shaft 8, the occlusion member 6 configured to transition between a collapsed configuration (figures 1 – phantom lines; paragraph 21) and an expanded configuration (figure 1 – solid lines; paragraph 21), wherein the occlusion member 6 in the collapsed configuration has a first cross-sectional dimension such that the occlusion member 6 is contracted for insertion into the vessel (figure 1 – uterine cavity), and the occlusion member 6 in the expanded configuration has a second cross-sectional dimension that is greater that the first cross-sectional dimension and the cross-sectional dimension of the shaft 8 (figure 1; paragraph 21 – solid lines);
a removable hub 22 positioned at the proximal end portion 13 of the shaft 8 (figure 6; paragraph 48); and
a control device 20 coupled to the removable hub 22, the control device 20 configured to transition the occlusion member 6 from the collapsed configuration into the expanded configuration (paragraph 48).
Roberts is silent the occlusion member comprising a basket coupled to the shaft and a membrane disposed around the basket to facilitate occlusion when inserted in the vessel; and
a wire coupled to the basket at one end of the wire and to the control device at an opposite end of the wire, the control device configured to transition the occlusion member from the collapsed configuration into the expanded configuration by pulling the wire in a proximal direction causing the basket to compress along the longitudinal axis and expand along a radial direction that is angularly offset with respect to the longitudinal axis.
However, in a similar field of endeavor of expandable members, Kapur teaches (Figures 4 and 6-7) the occlusion member 50 comprising a basket (paragraph 65) coupled to the shaft 31 (figure 4; although occlusion member 32 is shown in figure 4, paragraphs 65-66 disclose the occlusion member 50 and the shaft 31) and a membrane (paragraph 65) disposed around the basket 50 to facilitate occlusion when inserted in the vessel; and
a wire 54 coupled to the basket 50 at one end 53 of the wire 54 and to the control device 33/36 at an opposite end of the wire 54 (paragraph 68), the control device 33/36 configured to transition the occlusion member 50 from the collapsed configuration into the expanded configuration (figure 6) by pulling the wire 54 in a proximal direction causing the basket 50 to compress along the longitudinal axis and expand along a radial direction that is angularly offset with respect to the longitudinal axis (figure 6; paragraphs 65-66).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the occlusion member of Roberts for the occlusion member as taught by Kapur. The difference between the prior art and the claimed invention is that Roberts does not teach a basket and a wire controlling the expansion/compression of the basket. Kapur teaches (see Figs. 4 and 6-7) a similar occlusion member comprising a basket and a wire controlling the expansion/compression of the basket. Accordingly, the prior art references teach that it is known that the occlusion member of Roberts and the occlusion member of Kapur are elements that are functional equivalents for providing occlusion to the vessel. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the occlusion member taught by Kapur for the occlusion member of Roberts because both elements were known equivalents for providing, and would have resulted in the predictable results of providing occlusion to the vessel within the art.
Roberts/Kapur are silent wherein the occlusion member in the collapsed configuration has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft such that the occlusion member is contracted for insertion into the vessel.
However, in a similar field of endeavor of expandable members, Kipperman teaches (Figures 9-14) wherein the occlusion member 18 in the collapsed configuration (figure 9) has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft 44 such that that occlusion member 18 is contracted for insertion into the vessel (figures 13-14; Abstract – “the distal end having an expandable portion that expands from a compressed condition when inside of a delivery tube or catheter to an expanded condition when outside of the delivery tube or catheter. A method is also disclosed of performing a percutaneous procedure within a vessel or cavity of a tissue or organ of a subject”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wire assembly of Roberts/Kapur to include wherein the occlusion member in the collapsed configuration has a largest first cross-sectional dimension perpendicular to the longitudinal axis that is less than the cross-sectional dimension of the shaft as taught by Kipperman for the purpose of contracting the occlusion member for insertion into the vessel so that the occlusion member is within the shaft and does not accidentally damage while navigating the vessel.
With regards to claim 25, Roberts further discloses wherein the removable hub 22 is connected to a proximal tip (see proximal end of proximal end portion 13) of the shaft 8 (figure 6; paragraph 48).
With regards to claim 26, Roberts further discloses wherein the hub 22 is threadably coupled to the shaft 8 (paragraph 46).
With regards to claim 27, Roberts further discloses wherein the hub 22 and the shaft 8 form a fluid tight connection (paragraphs 48 and 53).
With regards to claim 28, Roberts further discloses wherein the hub 22 and the shaft 8 are coupled via a barbed fitting (paragraph 46).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tegels in view of Kapur in view of Kipperman, and further in view of Zadno-Azizi (US PGPub 2002/0065507).
With regards to claim 21, Tegels/Kapur/Kipperman disclose the wire assembly as claimed in claim 19. Tegels/Kapur/Kipperman are silent wherein the shaft is a guide wire.
However, in a field of being reasonably pertinent to the particular problem in which Applicant is concerned with, namely to guide the shaft through vasculature, Zadno-Azizi teaches (Figures 4-6 and 9) wherein the shaft 10 is a guide wire (paragraphs 139-140, 142, and 150).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of Tegels/Kapur/Kipperman to be a guide wire as taught by Zadno-Azizi for the purpose of providing "anchorable" guidewires, which generally feature some structure on their distal ends to releasably secure the guidewire at a particular location in the patient for the duration of the medical procedure (paragraph 7 of Zadno-Azizi).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Tegels in view of Kapur in view of Kipperman, and further in view of Karrowni et al. (US PGPub 2022/0202423), hereinafter known as “Karrowni.”
With regards to claim 22, Tegels/Kapur/Kipperman disclose the wire assembly as claimed in claim 19. Tegels/Kapur/Kipperman are silent wherein the distal end portion has a pigtail shape.
However, in a similar field of endeavor of expandable members, Karrowni teaches (Figure 1) wherein the distal end portion 22 has a pigtail shape (paragraph 41).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wire assembly of Tegels/Kapur/Kipperman to include the distal end portion having a pigtail shape as taught by Karrowni for the purpose of helping prevent vascular damage during movement of the device into position and further can facilitate repositioning of the catheter (paragraph 41 of Karrowni).
Conclusion
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMMED S ADAM/Examiner, Art Unit 3771 11/19/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771