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 office action is responsive to the amendment filed on 03/16/2026. As directed by the amendment: claims 1, 13, and 17 have been amended and claims 7-10, 12, and 17-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 03/16/2026, with respect to the rejection(s) of claim(s) 1 and 13 under 35 U.S.C. 103 as being unpatentable over Kagan et al (US 20040092892 A1), herein referenced to as “Kagan” in view of Binmoeller et al (US 20130109912 A1), herein referenced to as “Binmoeller” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite: “a double-walled retention member extending radially outwardly from at least one end of the support structure to retain the support structure with respect to a deployment site”.
The applicant has amended claim 13 to further recite: “a first double-walled retention member extending radially outwardly from a first end of the support structure, a second double-walled retention member extending radially outwardly from a second end of the support structure… the first and second double-walled retention members retain the support structure with respect to a deployment site“.
The examiner agrees that the combination of Kagan and Binmoeller does not explicitly teach the amended limitations.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kagan, Binmoeller, and Gobel et al (US 20200276040 A1).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a double-walled retention member” and “a first double-walled retention member” and “a second double-walled retention member” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-6, 11, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kagan et al (US 20040092892 A1), herein referenced to as “Kagan” in view of Binmoeller et al (US 20130109912 A1), herein referenced to as “Binmoeller” and Gobel et al (US 20200276040 A1), herein referenced to as “Gobel”.
Claim 1
Kagan discloses: An occlusion device 150 (see Figs. 9A-9B, and also reference to Figs. 7A-7B, [0236]) comprising: a support structure the structure of 150 (see Figs. 9A-9B, [0236]) having a lumen 152 (see Figs. 9A-9B, [0236]) defined therethrough; and an expandable occlusion element 154 (see Figs. 9A-9B. [0236]) formed separately (154 is defined as a separate element surrounded by an osmotic membrane 156, hence it is formed separated from the rest of 150) from the support structure the structure of 150 and held with respect to the support structure (see Figs. 9A-9B, 154 is within 150, hence it is held with respect to the support structure of 150), wherein the expandable occlusion element 154 is expandable (see [0236], 154 can swell, hence expand to shrink 152 to restrict food intake, hence occlude 152, in this case this meets the online Oxford Languages definition of occlude as “stop, close up, or obstruct (an opening, orifice, or passage)” as 152 is obstructed by shrinking enough to restrict food intake) radially inwardly (see Figs. 9A-9B, [0234], 154 expands radially inwardly to limit the lumen 166, from Fig. 9A to 9B, so that 166 becomes narrower) with respect to the support structure to occlude the support structure lumen.
Kagan does not explicitly disclose: a double-walled retention member extending radially outwardly from at least one end of the support structure to retain the support structure with respect to a deployment site; and is releasable from the support structure.
However, Binmoeller in a similar field of invention teaches an occlusion device 400 (see Fig. 6) with an expandable occlusion element filling material (see [0166], refers to ball, which Fig. 6 shows) and a support structure membrane of the ball (see [0166]). Binmoeller further discloses: the expandable occlusion element filling material is releasable (see [0166], “…the filling material and membrane may be selected to maintain a fill amount but also to leak out the filling material over time…”) from the support structure membrane of the ball.
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 Kagan to incorporate the teachings of Binmoeller and teach an occlusion device with the expandable occlusion element is releasable from the support structure. Motivation for such can be found in Binmoeller as this time release aspect of the membrane and filler materials permits the anchor to act as a drug delivery device by selecting therapeutically active ingredients as filler material (see [0166]).
The combination of Kagan and Binmoeller does not explicitly teach: a double-walled retention member extending radially outwardly from at least one end of the support structure to retain the support structure with respect to a deployment site.
However, Gobel in a similar field of invention teaches an occlusion device (see Fig. 6A, [0069], sealing occlusion) with a support structure 9 + inner sleeve (see Fig. 6A). Gobel further teaches: a double-walled retention member 24 + 6 (see Fig. 6A, [0171]) extending radially outwardly (see Fig. 6A, 6 + 24 extends radially outward from 9) from at least one end proximal end of 9 (see Fig. 6A) of the support structure 9 + inner sleeve to retain the support structure 9 + inner sleeve with respect to a deployment site (see [0171], improve transpyloric anchoring).
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 Kagan to incorporate the teachings of Gobel and teach an occlusion device with a double-walled retention member extending radially outwardly from at least one end of the support structure to retain the support structure with respect to a deployment site. Motivation for such can be found in Gobel as having a double retention member improves anchoring of the device, and the inner wall/layer can be non-compressible to ensure anchoring while the outer wall/layer can be compressible to reduce trauma and pressure on surrounding tissue (see [0171]).
Claim 2
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 1, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is formed from a self-expanding material (see [0236], 154 is made from polyacrylic acid hydrogel which expands with water, hence self-expanding).
Claim 3
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 2, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is formed from a hydrogel (see [0236], hydrogel).
Claim 4
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 2, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is held within a retainer 156 (see Figs. 9A-9B, [0236], 154 is surrounded by, hence held within, 156) associated with the support structure 150.
Claim 5
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 4, see 103 rejection above. Kagan further discloses: wherein the retainer 156 is formed of a porous or permeable material (see [0236], osmotic membrane, which is a material permeable to water, and has pores that water can move through).
Claim 6
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 1, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is held within a retainer 156 (see Figs. 9A-9B, [0236], 154 is surrounded by, hence held within, 156) associated with the support structure 150 and is selectively releasable from the retainer to return the support structure lumen to the unoccluded configuration.
The language, " is selectively releasable from the retainer to return the support structure lumen to the unoccluded configuration," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Kagan and Binmoeller meets the structural limitations of the claim, and is capable of selectively releasing 154 of Kagan, which is modified by Binmoeller to include releasable filler material that is selectable to be released overtime (see [0166] of Binmoeller), which in Kagan would cause the lumen to widen from as shown in Fig. 9B to Fig. 9B.
Claim 11
The combination of Kagan, Binmoeller, and Gobel teaches: The occlusion device of claim 1, see 103 rejection above. Kagan further discloses: wherein expansion of the expandable occlusion element 154 is reversible to allow passage (see [0236], 154 can be contracted to expel water, hence shrinking and causing 152 to open back up) of materials through the support structure lumen 152.
Claim 13
Kagan discloses: A system for occluding a body passage, the system comprising: a delivery device (see [0129], the invention includes a system of components that can be delivered with a flexible endoscope); and An occlusion device 150 (see Figs. 9A-9B, and also reference to Figs. 7A-7B, [0236]) comprising: a support structure the structure of 150 (see Figs. 9A-9B, [0236]) having a lumen 152 (see Figs. 9A-9B, [0236]) defined therethrough; and an expandable occlusion element 154 (see Figs. 9A-9B. [0236]) formed separately (154 is defined as a separate element surrounded by an osmotic membrane 156, hence it is formed separated from the rest of 150) from the support structure the structure of 150 and held with respect to the support structure (see Figs. 9A-9B, 154 is within 150, hence it is held with respect to the support structure of 150), wherein the expandable occlusion element 154 is radially inwardly (see Figs. 9A-9B, [0234], 154 expands radially inwardly to limit the lumen 166, from Fig. 9A to 9B, so that 166 becomes narrower) expandable (see [0236], 154 can swell, hence expand to shrink 152 to restrict food intake, hence occlude 152, in this case this meets the online Oxford Languages definition of occlude as “stop, close up, or obstruct (an opening, orifice, or passage)” as 152 is obstructed by shrinking enough to restrict food intake) with respect to the support structure to occlude the support structure lumen.
Kagan does not explicitly disclose: a first double-walled retention member extending radially outwardly from a first end of the support structure, a second double-walled retention member extending radially outwardly from a second end of the support structure, wherein the first and second double-walled retention members retain the support structure with respect to a deployment site; and is releasable from the support structure.
However, Binmoeller in a similar field of invention teaches an occlusion device 400 (see Fig. 6) with an expandable occlusion element filling material (see [0166], refers to ball, which Fig. 6 shows) and a support structure membrane of the ball (see [0166]). Binmoeller further discloses: the expandable occlusion element filling material is releasable (see [0166], “…the filling material and membrane may be selected to maintain a fill amount but also to leak out the filling material over time…”) from the support structure membrane of the ball.
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 Kagan to incorporate the teachings of Binmoeller and teach an occlusion device with the expandable occlusion element is releasable from the support structure. Motivation for such can be found in Binmoeller as this time release aspect of the membrane and filler materials permits the anchor to act as a drug delivery device by selecting therapeutically active ingredients as filler material (see [0166]).
However, Gobel in a similar field of invention teaches an occlusion device (see Fig. 6A, [0069], sealing occlusion) with a support structure 9 + inner sleeve (see Fig. 6A). Gobel further teaches: a first double-walled retention member 24 + 6 (see Fig. 6A, [0171]) extending radially outwardly (see Fig. 6A, 6 + 24 extends radially outward from 9) from a first end proximal end of 9 (see Fig. 6A) of the support structure 9 + inner sleeve, a second double-walled retention member 24 + 8 (see Fig. 6A, [0171]) extending radially outwardly (see Fig. 6A, 8 + 24 extends radially outward from 9) from a second end distal end of 9 (see Fig. 6A) of the support structure 9 + inner sleeve, the first 24 + 6 and second 24 + 8 doubled-walled retention members retain the support structure 9 + inner sleeve with respect to a deployment site (see [0171], improve transpyloric anchoring).
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 Kagan to incorporate the teachings of Gobel and teach an occlusion device with a double-walled retention member extending radially outwardly from at least one end of the support structure to retain the support structure with respect to a deployment site. Motivation for such can be found in Gobel as having a double retention member improves anchoring of the device, and the inner wall/layer can be non-compressible to ensure anchoring while the outer wall/layer can be compressible to reduce trauma and pressure on surrounding tissue (see [0171]).
Claim 14
The combination of Kagan, Binmoeller, and Gobel teaches: The system of claim 13, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is formed from a self-expanding material (see [0236], 154 is made from polyacrylic acid hydrogel which expands with water, hence self-expanding).
Claim 15
The combination of Kagan, Binmoeller, and Gobel teaches: The system of claim 14, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is formed from a hydrogel (see [0236], hydrogel).
Claim 16
The combination of Kagan, Binmoeller, and Gobel teaches: The system of claim 13, see 103 rejection above. Kagan further discloses: wherein the expandable occlusion element 154 is held within a retainer 156 (see Figs. 9A-9B, [0236], 154 is surrounded by, hence held within, 156) associated with the support structure 150 and is selectively releasable from the retainer.
The language, " is selectively releasable from the retainer" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Kagan and Binmoeller meets the structural limitations of the claim, and is capable of selectively releasing 154 of Kagan, which is modified by Binmoeller to include releasable filler material that is selectable to be released overtime (see [0166] of Binmoeller), which in Kagan would cause the lumen to widen from as shown in Fig. 9B to Fig. 9B.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sharma et al (US 20170266027 A1) (see Fig. 34A) an occlusion device with adjacent double-walled retention members 3401 + 3411
Errico et al (US 20130304231 A1) (see Figs. 12A-12C) an occlusion device with double-walled retention members 101 + 103
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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