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 of Claims
Claims 1-20 are currently pending. Claims 1, 4, 11, 13, and 16-17 are currently amended. No new subject matter is added.
Response to Arguments
Applicant’s arguments, see pg. 1, filed 03/06/2026, with respect to Claim 4 have been fully considered and are persuasive. The objection of Claim 4 has been withdrawn.
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive.
Specifically, applicant argues in independent Claims 1, 11 and 16 that neither the upper support nor the lower support of the gastric diverted includes any portion which is inverted. The examiner agrees with the applicant that Zou alone does not teach an inverted portion of the retention member. However, Claims 1,11, and 16 are newly rejected in view of Burnett (US 20060020278 A1) under 103 to read on these limitations.
Specifically, applicant argues that prior art of Burnett fails to teach inverting an end of a tubular member to a midsection of the tubular member. The applicant further states that Burnett identifies a “shell” rather than an end of a tubular member. The examiner respectfully disagrees with the applicant that Burnett only identifies a “shell”. As see in Figure 19A, the shell (204) is apart of the entire tubular pyloric valve obstructing device (200). The shell makes up a tubular outer portion at a first end that acts as a tubular member of the entire device. Therefore, inverting the shell 204 would be inverting a portion of the tubular pyloric valve obstructing device (200). Claims 1-20 would remain rejected in view of Zou (US 20210038414 A1) and Burnett et al. (US 20060020278 A1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Zuo (US 20210038414 A1) in view of Burnett et al. (US 20060020278 A1), hereinafter referred to as "Burnett".
Regarding Claim 1, Zuo teaches an implantable medical device (see Abstract; Figure 10) comprising:
a body having a first end (see below), a second end (see below), and a midsection therebetween (connecting member 3);
a first retention member (upper support 1) extending from the first end of said body; and
a second retention member (lower support 2) extending from the second end of said body;
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wherein: said first retention member (1) extends radially outwardly from the first end of said body (see Figure 10) and toward the midsection of said body to define a tissue-contacting surface (see below) with a surface area and flexibility sufficient to absorb radially-inwardly directed anatomical forces applied thereto (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract; and the stent can provide a certain supporting force, but also has a certain flexibility, see Paragraph [0059]); and
said first retention member is configured to resist being inverted into a configuration with a free end thereof extending away from the first end of said body and inverted towards the midsection of said body (the stent can provide a certain supporting force, but also has a certain flexibility. It can be ensured by the stent that the opening of the upper segment of the membrane tube which is an extension segment is fixed at the duodenal bulb and can be opened and closed with the opening and closing of the intestinal tract without causing damage to the intestinal wall, see Paragraph [0059]).
However, Zuo does not explicitly disclose said retention member is configured to resist being inverted into a configuration with a free end thereof extending away from the first end of said body and inverted towards the midsection of said body.
Burnett teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a first retention member (support portion 206) wherein at least said first retention member is formed by inverting a free end of the tubular member (inverted outer shell 204 having a free end, see Figure 19B; Paragraph [0111]); and said retention member is configured to resist being inverted into a configuration with the free end thereof extending away from the first end of said body and inverted towards the midsection of said body (the shell 204 may "self-invert" from its constrained/collapsed state to its expanded state without using an actuator 216 or the distal end of a delivery device 214. Self-inverting may be achieved by shape-memory or spring loaded materials or the like, or by a shell geometry that creates a bias in the stiffness of the device, see Paragraph [0116]; Figure 19B).
Zuo and Burnett are analogous art because both teach an implantable medical device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first retention member of Zuo and further include wherein at least said retention member is configured to resist being inverted into a configuration with a free end thereof extending away from the first end of said body and inverted towards the midsection of said body, as taught by Burnett. Burnett teaches an inverting an end of the tubular member is beneficial for effective, relatively non-invasive treatments for obesity. Ideally, such treatments would be relatively easy to use and deploy in a patient and would help treat obesity without a high risk of side effects or severe complications. Such treatments would also ideally be reversible (see Paragraph [0012]).
Regarding Claim 2, Zuo and Burnett teach all of the limitations as discussed above in claim 1 and Zuo further teaches wherein said first retention member (1) is formed of a compliant material capable of flexing (the upper support and the lower support are woven from elastic wires, and the outer surface of the elastic wire are covered with membrane, or the entire outer surfaces of the upper support and the lower support are covered with membranes, see Paragraph [0071]) with radially-inwardly directed anatomical forces applied thereto (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Paragraph [0059]; therefore the stomach naturally applies a radially inwardly force to the retention member).
Regarding Claim 3, Zuo and Burnett teach all of the limitations as discussed above in claim 2 and Zuo further teaches wherein said first retention member (1) is compressible from an initial expanded configuration in response to application of radially- inwardly forces applied thereto (the structure allows the stent to be compressed freely in the transverse and longitudinal directions, see Paragraph [0071]), and is formed of a resilient material returning said first retention member to the expanded configuration upon the force subsiding (expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]).
Regarding Claim 4, Zuo and Burnett teach all of the limitations as discussed above in claim 3 and Zuo further teaches wherein said first retention member presents a convex tissue-contacting surface to tissue at a deployment site (the upper support 1 can have multiple shapes and the exposed corners of the upper support may be rounded to avoid damage to tissue, see Paragraph [0064]; see Figure 13), and is configured and dimensioned to resist migration from the deployment site (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Paragraph [0059]).
Regarding Claim 5, Zuo and Burnett teach all of the limitations as discussed above in claim 1 and Zuo further teaches wherein said body is formed of a tubular member (the upper support 1 and the lower support 2 may each be woven from an elastic wire material or cut from a tubular material, see Paragraph [0075]). Burnett further teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a first retention member (support portion 206) wherein at least said first retention member is formed by inverting an end of the tubular member (inverted outer shell 204, see Figure 19B; Paragraph [0111]) and extending the free end of the inverted end toward the midsection of the tubular member a sufficient distance to cause the inverted end of the tubular member to resist returning to its initial uninverted tubular configuration (the shell 204 may "self-invert" from its constrained/collapsed state to its expanded state without using an actuator 216 or the distal end of a delivery device 214. Self-inverting may be achieved by shape-memory or spring loaded materials or the like, or by a shell geometry that creates a bias in the stiffness of the device, see Paragraph [0116]; Figure 19B).
Regarding Claim 6, Zuo and Burnett teach all of the limitations as discussed above in claim 5 and Zuo further teaches wherein said tubular member is formed from a plurality of interwoven filaments (upper and lower supports are in mesh structures, wherein both the upper support and the lower support are woven from elastic wires, see Paragraph [0022]).
Regarding Claim 7, Zuo and Burnett teach all of the limitations as discussed above in claim 1 and Zuo further teaches wherein said first retention member is formed from a bowl-shaped element separate from said body (the upper and lower supports are in mesh structures and may be formed by a process of weaving or cutting, see Paragraph [0071]; the upper support can have spherical shape, see Paragraph [0017]).
Regarding Claim 8, Zuo and Burnett teach all of the limitations as discussed above in claim 7 and Zuo further teaches wherein said first retention member (1) is movable with respect to said body (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions, see Paragraph [0071]).
Regarding Claim 9, Zuo and Burnett teach all of the limitations as discussed above in claim 7 and Zuo further teaches wherein said body is formed from an elastic material allowing said first retention member to be moved away from said second retention member (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]).
Regarding Claim 10, Zuo teaches all of the limitations as discussed above in claim 1 and Zuo further teaches wherein the tissue-contacting surface of said first retention member is convex (the upper support 1 can have multiple shapes and the exposed corners of the upper support may be rounded to avoid damage to tissue, see Paragraph [0064]; see Figure 13).
Regarding Claim 11, Zuo teaches an implantable medical device (a gastrointestinal stent of a gastric diverter, see Abstract; Figure 10 and 13) configured to be implanted with respect to a pylorus of a patient (see Paragraph [0012]), the implantable medical device comprising:
a body having a first end (see below), a second end (see below), and a midsection extending therebetween (connecting member 3);
a gastric retention member extending radially-outwardly from the first end of said body (upper support 1); and
a duodenal retention member (lower support 2) extending radially-outwardly from the second end of said body (see Figure 10 and 13);
wherein: said gastric retention member has a tissue-contacting surface (see below) extending radially outwardly from the first end of said body and toward the midsection of said body to a free edge (see below) of said gastric retention member, the free edge extending away toward the midsection of said body a sufficient extent to remain in such configuration when said implantable medical device is implanted with respect to the patient's pylorus with said gastric retention member positioned within the patient's stomach (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Paragraph [0059]); and
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said gastric retention member is resiliently compliant to contract from an expanded configuration to a compressed configuration (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]) upon application of peristaltic forces thereto from the antrum of the patient's stomach (the antrum of the stomach naturally applies a radially inwardly force to the retention member when contracting, see Figure 13), and to return to the expanded configuration upon passing of a peristaltic wave from said gastric retention member (the stent can be freely stretched and compressed in the transverse and longitudinal directions and can spontaneously restore to a predetermined shape and size, see Paragraph [0076]).
However, Zuo does not explicitly disclose said gastric retention member having a free edge extending away from the first end of said body in a direction inverted toward the midsection of said body.
Burnett teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a gastric retention member (support portion 206) wherein at least said gastric retention member having a free edge (inverted outer shell 204 having a free end, see Figure 19B; Paragraph [0111]) extending away from the first end of said body in a direction inverted toward the midsection of said body (the shell 204 may "self-invert" from its constrained/collapsed state to its expanded state without using an actuator 216 or the distal end of a delivery device 214. Self-inverting may be achieved by shape-memory or spring loaded materials or the like, or by a shell geometry that creates a bias in the stiffness of the device, see Paragraph [0116]; Figure 19B).
Zuo and Burnett are analogous art because both teach an implantable medical device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first retention member of Zuo and further include wherein at least said retention member is configured to resist being inverted into a configuration with a free end thereof extending away from the first end of said body and inverted towards the midsection of said body, as taught by Burnett. Burnett teaches an inverting an end of the tubular member is beneficial for effective, relatively non-invasive treatments for obesity. Ideally, such treatments would be relatively easy to use and deploy in a patient and would help treat obesity without a high risk of side effects or severe complications. Such treatments would also ideally be reversible (see Paragraph [0012]).
Regarding Claim 12, Zuo and Burnett teach all of the limitations as discussed above in claim 11 and Zuo further teaches wherein said gastric retention member presents a convex tissue-contacting surface to the antrum of the patient's stomach (the upper support 1 can have multiple shapes and the exposed corners of the upper support may be rounded to avoid damage to tissue, see Paragraph [0064]; see Figure 13).
Regarding Claim 13, Zuo and Burnett teach all of the limitations as discussed above in claim 11 and Zuo further teaches wherein: said implantable medical device is formed from a tubular member (the upper support 1 and the lower support 2 may each be woven from an elastic wire material or cut from a tubular material, see Paragraph [0075]) having a first end (see Figure 10), a second end (see Figure 10), and a midsection (3) therebetween; and said gastric retention member is implanted with respect to the antrum of the patient's stomach and compressed by a peristaltic wave of the antrum (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Figure 13; Paragraph [0059]). Burnett teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a gastric retention member (support portion 206), wherein said gastric retention member is formed by inverting the first end of the tubular member and pulling a free edge thereof towards the second end of the tubular member a sufficient distance to remain in the inverted configuration (inverted outer shell 204, see Figure 19B; Paragraph [0111]).
Regarding Claim 14, Zuo and Burnett teach all of the limitations as discussed above in claim 11 and Zuo further teaches wherein said body and at least said gastric retention member are formed separately (the upper and lower supports are in mesh structures and may be formed by a process of weaving or cutting, see Paragraph [0071]) and coupled together to allow relative movement therebetween (coupled to each other from a connecting thread 3 therebetween, so that the displacement range will not exceed the range of the connecting thread, see Paragraph [0096]).
Regarding Claim 15, Zuo and Burnett teach all of the limitations as discussed above in claim 14 and Zuo further teaches wherein said body is formed of an elastic material allowing said gastric retention member to move away from said duodenal retention member (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]).
Regarding Claim 16, Zuo teaches all of the limitations as discussed above in claim 1 and Zuo further teaches a method of at least partially occluding flow of materials through a pylorus of a patient (a method for releasing a gastric diverter, see Abstract; Paragraph [0088]), said method comprising:
deploying a body of an implantable medical device across the pylorus (see Paragraph [0012]; Figures 10 and 13));
deploying a gastric retention member (upper support 1) of the implantable medical device in the antrum of the patient (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Paragraph [0059]; see Figure 13), the gastric retention member having a tissue-contacting surface (see above) extending radially- outwardly from a first end of the body of the implantable medical device (see Figure 10) and towards a midsection of the body (towards connecting thread 3), the gastric retention member being formed of a compliant material compressing in response to peristaltic contractions of the antrum (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]; the antrum of the stomach naturally applies a radially inwardly force to the retention member when contracting, see Figure 13) and returning to an expanded configuration upon passing of a peristaltic contraction of the antrum (the stent can be freely stretched and compressed in the transverse and longitudinal directions and can spontaneously restore to a predetermined shape and size, see Paragraph [0076]); and
deploying a duodenal retention member (lower support 2) of the implantable medical device in the duodenum of the patient (see Figure 13), the duodenal retention member extending radially-outwardly from a second end of the body (see above) of the implantable medical device (see Figure 10).
However, Zuo does not explicitly disclose the gastric retention member having a free edge, the free edge extending away from the first end and inverted towards the midsection.
Burnett teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a gastric retention member (support portion 206) wherein at least said gastric retention member having a free edge (inverted outer shell 204 having a free end, see Figure 19B; Paragraph [0111]) extending away from the first end of said body in a direction inverted toward the midsection of said body (the shell 204 may "self-invert" from its constrained/collapsed state to its expanded state without using an actuator 216 or the distal end of a delivery device 214. Self-inverting may be achieved by shape-memory or spring loaded materials or the like, or by a shell geometry that creates a bias in the stiffness of the device, see Paragraph [0116]; Figure 19B).
Zuo and Burnett are analogous art because both teach an implantable medical device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first retention member of Zuo and further include wherein at least said retention member is configured to resist being inverted into a configuration with a free end thereof extending away from the first end of said body and inverted towards the midsection of said body, as taught by Burnett. Burnett teaches an inverting an end of the tubular member is beneficial for effective, relatively non-invasive treatments for obesity. Ideally, such treatments would be relatively easy to use and deploy in a patient and would help treat obesity without a high risk of side effects or severe complications. Such treatments would also ideally be reversible (see Paragraph [0012]).
Regarding Claim 17, Zuo and Burnett teach all of the limitations as discussed above in claim 16 and Zuo further teaches wherein the implantable medical device is formed from a tubular member having a first end and a second end (the upper support 1 and the lower support 2 may each be woven from an elastic wire material or cut from a tubular material, see Paragraph [0075]; Figure 10), and said method comprising placing the first end in contact with the antrum with the free edge of the tubular member positioned inwardly of the first end of the tubular member in a direction toward the second end of the tubular member (the upper support is fixed at the pyloric orifice of the stomach, so that the upper end of the membrane tube is firmly positioned in the digestive tract during peristalsis of the digestive tract, see Figure 13; Paragraph [0059]). Burnett further teaches an implantable medical device (a pyloric valve obstructing device 200, see Figure 19A-20C) comprising a gastric retention member (support portion 206) with a first end inverted to form the gastric retention member of the implantable medical device (inverted outer shell 204, see Figure 19B; Paragraph [0111]).
Regarding Claim 18, Zuo teaches all of the limitations as discussed above in claim 16 and Zuo further teaches wherein the gastric retention member presents a convexly curved tissue-contacting surface (the upper support 1 can have multiple shapes and the exposed corners of the upper support may be rounded to avoid damage to tissue, see Paragraph [0064]; see Figure 13), said method comprising placing the concavely-curved tissue- contacting surface in contact with the patient's antrum for contracting in response to peristaltic waves applied thereto (see Figure 13).
Regarding Claim 19, Zuo teaches all of the limitations as discussed above in claim 18 and Zuo further teaches wherein the gastric retention member (1) extends a sufficient distance from the first end of the body to the midsection of the body to resist inversion causing the gastric retention member to extend away from the midsection of the body (see Figure 10).
Regarding Claim 20, Zuo teaches all of the limitations as discussed above in claim 16 and Zuo further teaches wherein the implantable medical device is formed from a body separate from the gastric retention member (the upper and lower supports are in mesh structures and may be formed by a process of weaving or cutting, see Paragraph [0071]) such that upon placement of the implantable medical device with respect to the patient's pylorus (see Figure 13), the gastric retention member is capable of movement with respect to the body of the implantable medical device (the structure allows the stent to be compressed and expanded freely in the transverse and longitudinal directions and to have good elasticity, see Paragraph [0071]).
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 ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC RASSAVONG/ (7/2/2026)Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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