DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed December 31, 2025.
Status of Claims
1. Claims 40-47, 49, 50, 52 and 54-59 are pending and currently under consideration for patentability.
Claims 48, 51, and 53 are cancelled as of the December 31, 2025 amendment.
Response to Arguments
2. Applicant’s arguments with respect to claim(s) 40-47, 49, 50, 52 and 54-59 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Priplata et al (US PGPUB 2013/0267886), which was previously utilized in rejecting claims 54-58 in the most recent Office action and is not specifically challenged within applicant’s arguments, is being utilized as the primary reference in the instant rejection of amended claim 40 and its dependent claims.
Claim Objections
3. Claims 40 and 49 are objected to because of the following informalities:
Claim 40, at lines 1-2 recites “…for insertion into the gastro-intestinal tract…”; however, the gastro-intestinal tract has not been provided antecedent basis. While not rising to the issue of a 35 USC 112(b) rejection for not providing structural antecedent basis, the limitation should read as ---… for insertion into [[the]] a gastro-intestinal tract…---.
Claim 40 at line 2 recites “…for anchoring a tube…”; however, line 1 of the claim already provides antecedent basis for “a tube”. Accordingly, the limitation should read as ---…for anchoring the [[
Claim 49 at lines 1-3 recites “…wherein the gastric bulb further comprises a fluid-tight chamber, and an inlet port for allowing fluid to be admitted into the chamber…”; however, this limitation is already presented in claim 40, as presently amended. Accordingly, it is suggested that claim 49 read as ---The tube anchor of claim 45, .---.
Appropriate correction is required.
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.
4. Claim(s) 40, 43 and 54-58 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Priplata et al (US PGPUB 2013/0267886).
5. With regard to claims 40, Priplata discloses a tube (hollow sleeve, 608) configured for insertion into the gastro-intestinal tract (abstract), the tube (608) comprising an anchor (obesity device, 600) for anchoring the tube (608) with respect to a pylorus of a patient (Figs. 29, 30, 35-38; [0166]), the anchor (600) comprising a gastric bulb (flow restrictor, 602) coupled or couplable to a proximal end of the tube (608; [0163-0165]), the gastric bulb (602) expandable from a collapsed condition (Fig. 35) for introduction into the stomach (30), to an operative condition within the stomach (Figs. 29, 36; abstract; [0011]; [0164-0165]), wherein the gastric bulb (602) comprises a fluid tight chamber (hollow interior, 612; Fig. 29), and an inlet port (inflation tube, 620) for (i) allowing fluid to be drawn into the chamber (612) as the gastric bulb (602) expands to its operative condition (Fig. 29), and/or (ii) admitting fluid into the chamber (612) for inflating the gastric bulb (602; Figs. 29, 36; [0164-0165]), wherein the bulb (602) comprises a passage (through center of hollow tube, 622) configured for allowing chyme to pass through the bulb (602; Fig. 30; [0165]), wherein the gastric bulb (602) is coupled to the tube (608) by one or more tethers and/or struts (plurality of flexible silicone tethers or pyloric columns, 606; Fig. 29; [0163]), and wherein the tube (608) comprises a cuff or stent (internal support ring, 632 and support funnel, 634) for resisting displacement from the implanted position towards the stomach ([0079]; [0166-0167]).
6. With regard to claims 43, Priplata discloses that the gastric bulb (602) is configured to partly collapse in response to stomach contractions ([0017]; [0065]; [0079]; [0093-0094]; [0097]; [0143-0144]; [0166]; claim 6).
9. With regard to claims 54-58, Priplata discloses that the anchor (600) comprises a first ring (distal flange, 618) for fitting against a stomach-side of a pyloric sphincter ([0163]), and a second ring (inflatable annular tube, 630) for fitting against a duodenal-side of the pyloric sphincter (Figs. 29, 36; [0166-0167]), the first (618) and second (630) rings coupled to one another (via pyloric columns, 606) for clamping the pyloric sphincter between the rings (Figs. 29, 36; [0163]; [0165-0167]), the first and second rings (618, 630) having different inner and/or outer diameters from each other (Fig. 29; [0015-0016]; [0163]; [0166]); wherein at least one of the first and second rings (618, 630) are collapsible to a collapsed condition for introduction to the pylorus (Figs. 35, 36; abstract; [0011]; [0163]; [0166]; [0172]; [0176]; [0178]); further comprising connecting elements (606) between the rings (618, 630), and coupled to the rings (102, 104) for selectively drawing the rings closer to one another for clamping the pyloric sphincter (Figs. 29, 36; [0091]; [0167]; [0173]); at least one inner ring (internal support ring, 632) for corralling an inner peripheral edge of the pyloric sphincter (Fig. 29; [0166]); and wherein at least one of the first and second ring (618, 630) comprises one or more of: a shape memory alloy ([0084]), and a plastic ([0018]; [0154]; [0163]; [0165]).
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.
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.
10. Claim(s) 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Priplata.
11. With regard to claims 41-42, while Priplata suggests inflating the bulb (602) to variable pressure levels sufficient to withstand peristalsis forces without compressing to a size that would allow the anchor to pass through pyloric sphincter ([0093]), making the bulb (602) fully capable of being inflated to a pressure not greater than atmospheric pressure or surrounding pressure within the stomach, Priplata fails to explicitly disclose that the tube is configured such that in the expanded condition a pressure within the bulb is not greater than atmospheric pressure or surrounding pressure within the stomach.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pressure within the gastric bulb disclosed by Priplata to not be greater than atmospheric pressure or surrounding pressure within the stomach in the expanded condition, in order to withstand peristalsis forces without compressing to a size that would allow the anchor to pass through pyloric sphincter, as suggested by Priplata in paragraph [0093], and additionally one having ordinary skill in the art would be motivated to limit the pressure within the bulb in the expanded condition in order to minimize potential for overpressure failure leading to potential injury to the patient.
12. Claim(s) 44-47, 49, 50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Priplata in view of Albrecht et al (WO 2013/023675 A1).
13. With regard to claims 44-46 and 49-50, Priplata is silent in regard to the gastric bulb comprising a self-expandable structure that is self-expandable from the collapsed condition to the operative condition; wherein the self- expanding structure comprises at least one of a frame structure and a mesh structure; wherein the self-expanding structure and the fluid-tight chamber are nested one at least partly within the other; and wherein the fluid-tight chamber is nested at least partly within the self-expanding structure.
However, within the same field of endeavor, Albrecht discloses an anchor (endoluminal sleeve device, 1) for anchoring a tube (sleeve, 2) with respect to a pylorus of a patient (abstract; Fig. 5; page 3, lines 16-35), the anchor (1) comprising a gastric bulb (anchoring component, 8) coupled or couplable to a proximal end of the tube (2, via tether, 9), the gastric bulb (8) expandable from a collapsed condition for introduction into the stomach, to an operative condition within the stomach (page 4, lines 5-22); wherein the gastric bulb (8) comprises a self-expandable structure that is self-expandable from the collapsed condition to the operative condition, comprising at least one of a frame structure and a mesh structure (“internal frame (not shown)”; page 8, line 16 – page 9, line 10); wherein the gastric bulb (8) further comprises a fluid-tight chamber (volume within balloon for filling with air/saline), and an inlet port (connected to filling catheter, 15) for allowing fluid to be admitted into the chamber (of 8; Fig. 5), wherein the fluid-tight chamber is nested at least partly within the self-expanding structure (page 8, line 16 – page 9, line 10).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastric bulb disclosed by Priplata to include a nested self-expanding frame structure, similar to that disclosed by Albrecht, in order to preserve the expanded shape of the bulb independently from inflation fluid, assuring a longer live cycle of the bulb, as suggested by Albrecht on page 8, lines 16-25.
14. With regard to claim 47, Priplata discloses that the gastric bulb (602; Fig. 30) has communication apertures (620, 622, 624) allowing chyme to pass into the interior of the bulb ([0164]).
Similarly, Albrecht discloses that the gastric bulb (8; Fig. 5) has communication apertures (through hole, 13) allowing chyme to pass into the interior of the bulb (8; page 7, line 29 – page 9, line 10).
15. With regard to claim 52, while the bulb cutouts (626; Fig. 30) give the bulb (602) a somewhat tulip petal-shaped appearance, Priplata is silent in regard to the bulb having or comprising a shape that is at least one selected from: bell-shaped and tulip-shaped.
However, Albrecht discloses that the bulb (8) is bell-shaped (Fig. 5).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gastric bulb disclosed by Priplata to be bell-shaped, similar to that disclosed by Albrecht, in order to provide a gastric bulb dimensioned to occupy a substantial volume of the stomach, thereby combining the weight loss effect due to stomach reduction with the function of anchoring the tube, as suggested by Albrecht on page 7, line 31 – page 8, line 1.
16. Claim(s) 59 is rejected under 35 U.S.C. 103 as being unpatentable over Priplata in view of Thompson et al (US PGPUB 2012/0184893).
17. With regard to claim 59, while Priplata discloses that the anchor (600) comprises at least one resilient element (internal support ring, 632), expandable from a collapsed condition for introduction into a stomach (Figs. 29, 36; [0166]), Priplata is silent in regard to the resilient element having an at least partially helical shape in an expanded operative condition.
However, within the same field of endeavor, Thompson discloses an anchor (expandable anchor, 110) for anchoring a tube (111) with respect to a pylorus of a patient (abstract; Figs. 1, 4, 5, 33C), the anchor comprising at least one resilient element (spring arms, 143 or toroidal-shaped coil compression spring, 282; [0145]), expandable from a collapsed condition for introduction into the stomach (Figs. 4, 5), and an expanded operative condition in which the resilient element (143, 282) has an at least partly helical shape ([0178]; Fig. 33C; “the spring is wound to have double helices that are 180 degrees offset from each other”).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the resilient element of the anchor disclosed by Priplata to have an at least partly helical shape in an expanded operative condition, similar to that disclosed by Thompson, in order to well-known compression springs/coils as an expandable reinforcement/resilient element capable of reducing its diameter for delivery to operative position, as suggested by Thompson in paragraphs [0177-0178].
Conclusion
18. 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.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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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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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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