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
This action is in response to the preliminary amendment filed on 12/3/2024. In the amendment, claims 1-40 have been cancelled and claims 41-60 have been added.
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.
Claims 41-46, 48, 49, & 55-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire et al. (US Pub. No. 2017/0354421 A1).
Regarding claim 41, Maguire et al. disclose a vascular occlusion device 200 (Fig. 18), comprising: a mesh portion 102 (Fig. 18) having a radially compressed configuration and a radially expanded configuration, wherein the mesh portion 102 comprises a first bulb 202 (one of the four shown in Fig. 18) having a first interior and a second bulb 202 (another of the four shown in Fig. 18) having a second interior; a first membrane 104 (paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’) positioned within the first interior of the first bulb; and a second membrane 104 (paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’) positioned within the second interior of the second bulb.
Regarding claim 42, Maguire et al. further disclose a support frame 106 positioned within the mesh portion 102 (support frame 106 for membrane 104 - discussed in paragraph [0040]).
Regarding claim 43, Maguire et al. further disclose wherein the support frame 106 includes a first membrane support 106 and wherein the first membrane 104 is supported by the first membrane support 106 (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within).
Regarding claim 44, Maguire et al. further disclose wherein the support frame 106 includes a second membrane support 106 and wherein the second membrane 104 is supported by the second membrane support 106 (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within).
Regarding claim 45, Maguire et al. further disclose wherein the first membrane 104 is substantially the same dimensions as the second membrane 104 (since the membranes are duplicated among the bulbs, and the bulbs 202 are dimensioned the same according to Fig. 18, the membranes would be substantially the same dimensions as one another).
Regarding claim 46, Maguire et al. further disclose wherein the first membrane 104 is substantially the same shape as the second membrane 104 (since the membranes are duplicated among the bulbs, and the bulbs 202 are shaped the same according to Fig. 18, the membranes would be substantially the same shape as one another).
Regarding claim 48, Maguire et al. further disclose wherein the first membrane 104 and the second membrane 104 are each comprised of a circular shape (paragraph [0052]; see rejection of claim 46 regarding membrane duplication).
Regarding claim 49, Maguire et al. disclose a vascular occlusion device, comprising: a mesh portion 102 (Fig. 18) having a radially compressed configuration and a radially expanded configuration, wherein the mesh portion comprises a first bulb 202 having a first interior (one of the four shown in Fig. 18) having a first interior and a second bulb 202 (another of the four shown in Fig. 18), a support frame 106 (paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’, this would include the support frame 106 associated therewith; support frame 106 for membrane 104 - discussed in paragraph [0040]) located within the mesh portion 102, the support frame 106 including a first membrane support and a second membrane support (one per membrane 104 - paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within); wherein the first membrane support 106 is positioned within the first interior of the first bulb 202 (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within); wherein the second membrane support 106 is positioned within the second interior of the second bulb 202 (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within); a first membrane 104 supported by the first membrane support 106 106 (paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’, this would include the support frame 106 associated therewith; support frame 106 for membrane 104 - discussed in paragraph [0040]); and a second membrane 104 supported by the second membrane support 106 (paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’, this would include the support frame 106 associated therewith; support frame 106 for membrane 104 - discussed in paragraph [0040]).
Regarding claim 55, Maguire et al. further disclose wherein the first membrane support comprises a first ring 106C (discussed throughout as ‘ring portion 106C’ - shown in Fig. 16; paragraph [0056] - ‘a flexible membrane 104 can be fixed within all of the bulbs 202’, this would include the support frame 106 associated therewith; support frame 106 for membrane 104 - discussed in paragraph [0040]) and wherein the second membrane support comprises a second ring 106C (see prior parenthetical statement above).
Regarding claim 56, Maguire et al. further disclose wherein the first membrane 104 and the second membrane 104 each comprise a flexible membrane (referred to throughout disclosure as ‘flexible membrane 104’; i.e. paragraph [0039]).
Regarding claim 57, Maguire et al. further disclose wherein the first membrane 104 is substantially the same size and shape as the second membrane 104 (since the membranes are duplicated among the bulbs, and the bulbs 202 are dimensioned/shaped the same according to Fig. 18, the membranes would be substantially the same dimensions/shape as one another).
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 47, 50-54, & 58-60 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire et al. (US Pub. No. 2017/0354421 A1) in view of Zajarias et al. (US Pub. No. 2019/0307438 A1).
Regarding claim 47, Macguire et al. fails to explicitly disclose a medial support arm connected between the first membrane and the second membrane. However, as seen in Fig. 15, the membrane support 106 includes proximal and distal support arms 106A,B which extend to the terminal ends of the singular bulb shown. It is considered that when applied to multiple bulbs, the support arms would still exist and would attach to one another to provide the proper support needed to maintain the support frame’s integrity. This is evidenced by Zajarias et al. which teaches a support system for two membranes comprising two ring members 110, 120 (Figs. 6, 10, & 11; similar to the ring members 106C in Macguire) that each support a membrane 114, 124, wherein the ring members 110, 120 are interconnected by a medial support art 130 (Figs. 6, 10, & 11; paragraph [0066]), thereby providing the rings with support of one another for the membranes to remain in their proper positioning with respect to one another. It would have been beneficial to one of ordinary skill in the art before the effective filing date of the claimed invention based on the already provided structure of Macguire et al.’s support 106 (having proximal and distal arms intended to fix the support ring to the ends of the bulb) and the teachings of a similar ring support system for membrane fixation of Zajarias et al. to provide the claimed ‘medial support arm’ between the membranes since this would be the most logical way to provide the membranes 104 within all of the bulbs 202 of Fig. 18 to ensure they remain in their fixed positioning. Without such a medial arm, the membranes would be freely floating within the bulbs and would not function as intended.
Regarding claims 50-52, Macguire fails to explicitly disclose wherein the support frame comprises a medial support arm connected between the first membrane support and the second membrane support [claim 50]; wherein the medial support arm is comprised of an S-shape [claim 51]; and wherein a proximal side of the medial support arm is positioned at a first radial half of the first membrane support, wherein a distal side of the medial support arm is positioned at a second radial half of the second membrane support, and wherein the first radial half is opposite to the second radial half [claim 52]. With respect to claim 50, the same rejection is applied as that made above regarding claim 49 (see above). Furthermore, with this rejection, claim 52’s limitations would be met via the interconnection of the already existing proximal and distal support arms in the support frame 106 of Macquire’s device. Regarding claim 51, an s-shape is seen in the teaching reference Zajarias et al.’s medial arm teaching Figs. 6, 10, 11).
Regarding claim 53, Macquire et al. further disclose wherein the support frame 106 comprises a proximal support arm 106B (paragraph [0042]) connected to and extending from a proximal side of the first membrane support 106C (Fig. 15).
Regarding claim 54, Macquire et al. further disclose wherein the support frame 106 comprises a distal support arm 106A (paragraph [0042]) connected to and extending from a distal side of the second membrane support 106C (Fig. 15)0
Regarding claim 58, Macquire et al. disclose a support frame 106 (paragraphs [0040]-[0042] for a vascular plug, comprising: a first ring portion 106C (Figs. 15 & 16) and a proximal support arm 106B (Figs. 15 & 16) connected to and extending from a proximal side of the first ring portion 106C (paragraphs [0040]-[0042]). Macquire et al. further disclose a multiple bulb embodiment (Fig. 18) described as being configured to contain a membrane 104 within all of the bulbs 202 (which includes a support frame 106; paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within). Since there would be a support frame 106 in each bulb 202, there would inherently be a second ring portion 106C in another bulb member 202, having a distal support arm 106A connected to and extending from a distal side of the second ring portion 106C (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within). Macguire et al. fails to explicitly disclose a medial support arm connected between the first ring portion and the second ring portion.
However, as seen in Fig. 15, the membrane support 106 includes proximal and distal support arms 106A,B which extend to the terminal ends of the singular bulb shown. It is considered that when applied to multiple bulbs, the support arms would still exist and would attach to one another to provide the proper support needed to maintain the support frame’s integrity. This is evidenced by Zajarias et al. which teaches a support system for two membranes comprising two ring members 110, 120 (Figs. 6, 10, & 11; similar to the ring members 106C in Macguire) that each support a membrane 114, 124, wherein the ring members 110, 120 are interconnected by a medial support art 130 (Figs. 6, 10, & 11; paragraph [0066]), thereby providing the rings with support of one another for the membranes to remain in their proper positioning with respect to one another. It would have been beneficial to one of ordinary skill in the art before the effective filing date of the claimed invention based on the already provided structure of Macguire et al.’s support 106 (having proximal and distal arms intended to fix the support ring to the ends of the bulb) and the teachings of a similar ring support system for membrane fixation of Zajarias et al. to provide the claimed ‘medial support arm’ between the membranes since this would be the most logical way to provide the membranes 104 within all of the bulbs 202 of Fig. 18 to ensure they remain in their fixed positioning. Without such a medial arm, the membranes would be freely floating within the bulbs and would not function as intended.
Regarding claim 59, Macguire et al. further disclose a first membrane 104 supported by the first ring portion 106C and a second membrane 104 supported by the second ring portion 106C (paragraph [0040] details the support of membrane 104 within mesh 102 & paragraph [0056] details how each bulb 202 can have the described membrane fixed within).
Regarding claim 60, Zajarias et al.’s medial support arm 130 further teaches having a proximal side of the medial support arm is positioned at a first radial half of the first ring portion 110, wherein a distal side of the medial support arm is positioned at a second radial half of the second ring portion 120, and wherein the first radial half is opposite to the second radial half (seen in Figs. 7 & 9).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 February 6, 2026