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 .
Election/Restrictions
Claims 14 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/01/2026.
Applicant’s election without traverse of Invention I, claims 1-20, drawn to a method of fixation of an intraluminal device to an inner surface of a hollow organ and species A (Figs. 1-4) directed to an intraluminal device with a body with one or more fasteners in the reply filed on 06/01/2026 is acknowledged.
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 “wherein said open pattern comprises a floral pattern” and “explanting the intraluminal device by removing the first self-expanding portion comprising grasping a distal end portion of the flexible shaft and retracting the flexible shaft into a removal conduit” 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 § 112
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.
Claims 1-13 and 15-20 are 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 1 recites the limitation "the distal first portion of a flexible shaft" in line 7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination this limitation will be interpreted as “a distal first portion of a flexible shaft”. Appropriate correction is required.
Claims 2-5, 11-13, and 16-19 are rejected as being dependent on claim 1.
Claim 6 recites the limitation "the distal first portion of a flexible shaft" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination this limitation will be interpreted as “a distal first portion of a flexible shaft”. Appropriate correction is required.
Claim 7 recites the limitation "the distal end portion of the flexible shaft" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim and furthermore it is not clear if this refers to the “the distal first portion of a flexible shaft” in claim 6, or a different distal portion. For the purpose of prior art examination this limitation will be interpreted as “the distal first portion of the flexible shaft”. Appropriate correction is required.
Claims 8-9 are rejected as being dependent on claim 7.
Claim 20 recites the limitation "the distal first portion of a flexible shaft" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim. For the purpose of prior art examination this limitation will be interpreted as “a distal first portion of a flexible shaft”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 6-9, 11-12, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stack et al (US 20080208355 A1), herein referenced to as “Stack”.
Claim 1
Stack discloses: A method of fixation (see Figs. 1-5, [0011]) of an intraluminal device 14 + 16 + 22 (see Figs. 1-5, [0013]) to an inner surface stomach wall (see Figs. 1-2, [0113]) of a hollow organ through a shaft guide 12 (see Figs. 1-5, [0013]), said method comprising: positioning a distal end portion distal portion of 12 (see Fig. 1, [0013]) of a shaft guide 12 adjacent the outer surface of the hollow organ (see Fig. 1, [0014], positioned adjacent to the stomach wall which is adjacent to its outer surface to drive the intraluminal device through onto the outer surface); forming a contact distribution member 14 (see Figs. 1-5, [0013]-[0014]) that is adapted to distribute physical contact (see Figs. 1-5, [0015], engage with the surrounding tissue) across an enlarged area of an outer surface of the hollow organ wall (see [0015]), comprising feeding at least the distal first portion 18 (see Figs. 1-5, [0015]) of a flexible shaft 16 (see Figs. 1-5, [0015], flexible as it can lengthen, see Fig. 1, and then shorten, see Fig. 2) through said shaft guide 12 out the distal end portion distal portion of 12 of the shaft guide 12; wherein the first portion 18 (see Figs. 1-5, [0015]) of the flexible shaft 16 has elastic properties (see [0015], 18 can expand after 14 leaves 12, and is compressed in 12, see [0013]) that allow it to be collapsed to fit within the shaft guide 12 and self-expand (see [0015]) to a first memory-induced configuration (see Figs. 1-2) when deployed from the distal end portion the distal end of 12 of the shaft guide 12 outside of the hollow organ (see Fig. 1, [0015], 18 expands after it has been pushed through the stomach wall), wherein the first memory-induced configuration (see Fig. 1) of said flexible shaft 16 forms a pattern (see Figs. 1-2, [0015], the pattern formed by 18) outside of the hollow organ wall the stomach wall (see Fig. 1) to define said contact distribution member 14; positioning a biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) against a wall 22 (see Figs. 1-5, [0015]-[0017]) of the intraluminal device 14; and biasing the biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) toward the contact distribution member 14 thereby biasing the intraluminal device 14 + 16 + 22 toward the hollow organ wall stomach wall (see Figs. 1-5, from Fig. 1 to Fig. 2, 14 + 16 + 22 is drive closer to the outer and inner stomach wall).
Claim 2
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further discloses: including selectively positioning the distal first end portion the distal end of 12 of the shaft guide 12 within the hollow organ the stomach wall (see Figs. 1-5, 12 is positioned towards an area of the stomach) and feeding the distal end portion 18 of the flexible shaft 16 through the organ wall (see Figs. 1-2, [0015]-[0017]).
Claim 3
Stack discloses: The method as claimed in claim 2, see 102 rejection above. Stack further discloses: wherein said biasing member 24 + 28 is biased toward the contact distribution member 14 by being joined (see Figs. 1-5, 24 + 28 is joined at 22, and joined to 14 across the stomach wall) to the contact distribution member 14 at the organ wall.
Claim 4
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further discloses: wherein said contact distribution member 14 forms an open pattern with uncovered spaces the uncovered spaces between the barbs of 18 (see Figs. 1-5) between adjacent portion portions of 18 (see Figs. 1-5) of the flexible shaft 16.
Claim 6
Stack discloses: A method of fixation (see Figs. 1-5, [0011]) of an intraluminal device 14 + 16 + 22 (see Figs. 1-5, [0013]) to an inner surface stomach wall (see Figs. 1-2, [0113]) of a hollow organ through a shaft guide 12 (see Figs. 1-5, [0013]), said method comprising: positioning a distal end portion distal portion of 12 (see Fig. 1, [0013]) of a shaft guide 12 from within the hollow organ through a wall of the hollow organ to a position adjacent the outer surface of the hollow organ (see Fig. 1, [0014], positioned adjacent to the stomach wall which is adjacent to its outer surface to drive the intraluminal device through onto the outer surface); forming a contact distribution member 14 (see Figs. 1-5, [0013]-[0014]) that is adapted to distribute physical contact (see Figs. 1-5, [0015], engage with the surrounding tissue) across an enlarged area of an outer surface of the hollow organ wall (see [0015]), comprising feeding at least the distal first portion 18 (see Figs. 1-5, [0015]) of a flexible shaft 16 (see Figs. 1-5, [0015], flexible as it can lengthen, see Fig. 1, and then shorten, see Fig. 2) through said shaft guide 12 out the distal end portion distal portion of 12 of the shaft guide 12; wherein the first portion the barbs of 18 (see Figs. 1-5, [0015]) of the flexible shaft 16 has elastic properties (see [0015], 18 can expand after 14 leaves 12, and is compressed in 12, see [0013]) that allow it to be collapsed to fit within the shaft guide 12 and self-expand (see [0015]) to a first memory-induced configuration (see Figs. 1-2) when deployed from the distal end portion the distal end of 12 of the shaft guide 12 outside of the hollow organ (see Fig. 1, [0015], 18 expands after it has been pushed through the stomach wall); positioning a biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) against a wall 22 (see Figs. 1-5, [0015]-[0017]) of the intraluminal device 14; and biasing the biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) toward the contact distribution member 14 thereby biasing the intraluminal device 14 + 16 + 22 toward the hollow organ wall stomach wall (see Figs. 1-5, from Fig. 1 to Fig. 2, 14 + 16 + 22 is drive closer to the outer and inner stomach wall), wherein said biasing member 14 comprising a proximal second portion the joining portion between 16 and the barbs of 18 (see Figs. 1-2) of said flexible shaft 16 extending from a distal portion the tip of 18 (see Figs. 1-2) of said first portion 18 of said flexible shaft 16, wherein the second portion joining portion between 16 and the barbs of 18 of the flexible shaft 16 has elastic properties that allow it to be collapsed to fit within the shaft guide 12 and self-expand to a memory-induced configuration (see [0015], the portion joining the barbs of 18 can expand after 14 leaves 12, and is compressed in 12, see [0013]) when deployed from the distal end portion distal end of 12 of the shaft guide 12 adjacent the intraluminal device 14 + 16 + 22.
Claim 7
Stack discloses: The method as claimed in claim 6, see 102 rejection above. Stack further discloses: including feeding the distal end portion the barbs of 18 (see 112b rejection above, interpreted as “the distal first portion”) of the flexible shaft 16 through the organ wall (see Figs. 1-2, [0015]-[0017]) including guiding the distal end portion the distal end of 12 of the shaft guide 12 to a desired location within the hollow organ the stomach wall (see Figs. 1-5, 12 is positioned towards an area of the stomach).
Claim 8
Stack discloses: The method as claimed in claim 7, see 102 rejection above. Stack further discloses: including penetrating (see Figs. 1-2, [0014], 14 penetrates through the stomach wall) the hollow organ wall stomach wall at the desired location with a needle point the needle point of 14 (see Figs. 1-2, [0014], on the distal end of the flexible shaft 16) at the distal end of the shaft guide (will not be examined here due to being an optional claim limitation) or flexible shaft 16.
Claim 9
Stack discloses: The method as claimed in claim 7, see 102 rejection above. Stack further discloses: wherein said guiding comprises positioning the distal end the distal end of 12 of said shaft guide 12 with a steerable endoscope 10 (see [0012]-[0017], the distal end of 12 is positioned using a flexible/steerable endoscope).
Claim 11
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further discloses: wherein said biasing member 24 + 28 (see Figs. 1-5, [0015], 24 is threaded onto a tether extending from 16, hence is separate from 16) is separate from said flexible shaft 16.
Claim 12
Stack discloses: The method as claimed in claim 11, see 102 rejection above. Stack further discloses: wherein said biasing member 24 + 28 comprises a T-shaped fastener 24 (see Figs. 4-5, 24 is a T-shaped fastener).
Claim 16
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further discloses: including adjusting amount of stress (see Figs. 1-4, [0015], by applying pressure the cinching of 14 + 22 + 24, applies more stress onto the inner surface of the hollow organ wall) applied by the intraluminal device 14 + 16 + 22 (see Figs. 1-5, [0013]) to the inner surface of the hollow organ wall.
Claim 18
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further discloses: wherein said shaft guide 12 comprises a hollow opening (see Figs. 1-5, 12 has a lumen with an opening of a tube) through a tube or a conduit connected to the outside of said tube (see Figs. 1-5, [0013]-[0017], 12 is a catheter, hence has an opening on distal and proximal sides).
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) 5, 10, 17, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stack in view of Kagan et al (US 20060020247 A1), herein referenced to as “Kagan”.
Claim 5
Stack discloses: The method as claimed in claim 2, see 102 rejection above. Stack further does not explicitly disclose: wherein said open pattern comprises a floral pattern, a circular pattern or a spiral coil pattern.
However, Kagan in a similar field of invention teaches a method of fixation of an intraluminal device to an inner surface of a hollow organ (see 4A-9) with a flexible shaft 790 (see Figs. 7-8) with a first portion 788 (see Figs. 7-9) that forms an open pattern 794 (see Figs. 7-9) outside of the hollow organ wall the stomach wall (see Fig. 9) to define a contact distribution member 794 (see Figs. 7-9). Kagan further teaches: wherein said open pattern comprises a floral pattern (will not be examined here due to being an optional claim limitation), a circular pattern (see Figs. 7-9, [0135], a circle or spiral), or a spiral coil pattern (see Figs. 7-9, [0135], a circle or spiral).
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 open pattern of Stack to incorporate the teachings of Kagan and teach a method of fixation of an intraluminal device to an inner surface of a hollow organ with said open pattern comprises a circular pattern or a spiral coil pattern. Motivation for such can be found in Kagan as this allows for the device to removed to reverse or revise the surgical procedure (see [0137]).
Claim 10
Stack discloses: The method as claimed in claim 6, see 102 rejection above. Stack further does not explicitly disclose: wherein the first and second memory-induced configurations jointly define a spiral pattern, with the first memory-induced configuration defining outer turns of the spiral pattern and the second memory-induced configuration defining inner turns of the spiral pattern.
However, Kagan in a similar field of invention teaches a method of fixation of an intraluminal device to an inner surface of a hollow organ (see 4A-9) with a flexible shaft 790 (see Figs. 7-8) with a distal first portion a portion of 788 (see annotated Fig. 7 below) and a proximal second portion a portion of 788 (see annotated Fig. 7 below). Kagan further teaches: wherein the first and second memory-induced configurations (see annotated Fig. 7 below) jointly define a spiral pattern 794 (see Figs. 7-9, spiral), with the first memory-induced configuration (see annotated Fig. 7 below) defining outer turns of the spiral pattern the distal first portion forms the outer turns of the spiral (see annotated Fig. 7 below) and the second memory-induced configuration defining inner turns the proximal second portion forms the inner turns of the spiral (see annotated Fig. 7 below) of the spiral pattern.
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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 open pattern of Stack to incorporate the teachings of Kagan and teach a method of fixation of an intraluminal device to an inner surface of a hollow organ with said the first and second memory-induced configurations jointly define a spiral pattern, with the first memory-induced configuration defining outer turns of the spiral pattern and the second memory-induced configuration defining inner turns of the spiral pattern. Motivation for such can be found in Kagan as this allows for the device to removed to reverse or revise the surgical procedure (see [0137]).
Claim 17
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further does not explicitly disclose: wherein said flexible shaft is made from at least one material selected from (i) a metal, (ii) a polymer, and (iii) a carbon fiber material.
However, Kagan in a similar field of invention teaches a method of fixation of an intraluminal device to an inner surface of a hollow organ (see 4A-9) with a flexible shaft 790 (see Figs. 7-8). Kagan further teaches: wherein said flexible shaft 790 is made from at least one material selected from (i) a metal (see [0135], NiTi, which is a nickel titanium alloy, which is a metal), (ii) a polymer (the alternatives to “a metal” will not be examined here due to being optional claim limitations), and (iii) a carbon fiber material.
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 Stack to incorporate the teachings of Kagan and have a flexible shaft of an intraluminal device with a metal material. This is due to using NiTi (see [0135]) nickel titanium for flexible shafts of an intraluminal device is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 20
Stack discloses: A method of fixation (see Figs. 1-5, [0011]) of an intraluminal device 14 + 16 + 22 (see Figs. 1-5, [0013]) to an inner surface stomach wall (see Figs. 1-2, [0113]) of a hollow organ through a shaft guide 12 (see Figs. 1-5, [0013]), said method comprising: positioning a distal end portion distal portion of 12 (see Fig. 1, [0013]) of a shaft guide 12 adjacent the outer surface of the hollow organ (see Fig. 1, [0014], positioned adjacent to the stomach wall which is adjacent to its outer surface to drive the intraluminal device through onto the outer surface); forming a contact distribution member 14 (see Figs. 1-5, [0013]-[0014]) that is adapted to distribute physical contact (see Figs. 1-5, [0015], engage with the surrounding tissue) across an enlarged area of an outer surface of the hollow organ wall (see [0015]), comprising feeding at least the distal first portion 18 (see Figs. 1-5, [0015]) of a flexible shaft 16 (see Figs. 1-5, [0015], flexible as it can lengthen, see Fig. 1, and then shorten, see Fig. 2) through said shaft guide 12 out the distal end portion distal portion of 12 of the shaft guide 12; wherein the first portion 18 (see Figs. 1-5, [0015]) of the flexible shaft 16 has elastic properties (see [0015], 18 can expand after 14 leaves 12, and is compressed in 12, see [0013]) that allow it to be collapsed to fit within the shaft guide 12 and self-expand (see [0015]) to a first memory-induced configuration (see Figs. 1-2) when deployed from the distal end portion the distal end of 12 of the shaft guide 12 outside of the hollow organ (see Fig. 1, [0015], 18 expands after it has been pushed through the stomach wall), wherein the first memory-induced configuration (see Fig. 1) of said flexible shaft 16 forms a pattern (see Figs. 1-2, [0015], the pattern formed by 18) outside of the hollow organ wall the stomach wall (see Fig. 1) to define said contact distribution member 14; positioning a biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) against a wall 22 (see Figs. 1-5, [0015]-[0017]) of the intraluminal device 14; and biasing the biasing member 24 + 28 (see Figs. 1-5, [0015]-[0017]) toward the contact distribution member 14 thereby biasing the intraluminal device 14 + 16 + 22 toward the hollow organ wall stomach wall (see Figs. 1-5, from Fig. 1 to Fig. 2, 14 + 16 + 22 is drive closer to the outer and inner stomach wall).
Stack does not explicitly disclose: and explanting the intraluminal device by removing the first self-expanding portion comprising grasping a distal end portion of the flexible shaft and retracting the flexible shaft into a removal conduit.
However, Kagan in a similar field of invention teaches a method of fixation of an intraluminal device 780 (see Figs. 7-9) to an inner surface of a hollow organ (see 4A-9) with a flexible shaft 790 (see Figs. 7-8) with a first portion 788 (see Figs. 7-9) that forms an open pattern 794 (see Figs. 7-9) outside of the hollow organ wall the stomach wall (see Fig. 9) to define a contact distribution member 794 (see Figs. 7-9). Kagan further teaches: and explanting the intraluminal device 780 by removing the first self-expanding portion 79 comprising grasping a distal end portion 794 (see Figs. 7-9, [0135]-[0137]) of the flexible shaft 790 and retracting the flexible shaft 790 into a removal conduit 752/756 (see Fig. 9, [0137], rivet tube retaining tool, the gap between the pliers of 756).
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 Stack to incorporate the teachings of Kagan and teach a method of fixation of an intraluminal device to an inner surface of a hollow organ with explanting the intraluminal device by removing the first self-expanding portion comprising grasping a distal end portion of the flexible shaft and retracting the flexible shaft into a removal conduit. Motivation for such can be found in Kagan as this allows for the device to removed to reverse or revise the surgical procedure (see [0137]).
Claim(s) 13 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stack in view of Baker et al (US 20100030017 A1), herein referenced to as “Baker”.
Claim 13
Stack discloses: The method as claimed in claim 11, see 102 rejection above. Stack further discloses: wherein said biasing member 24 is connected with the contact distribution pattern 18 by a filament 20 (see Figs. 1-5, [0015], 20 connects 24 to 14, hence connects 20 to 18).
Stack does not explicitly disclose: the filament is a non-metallic filament.
However, Baker in a similar field of invention teaches a method of fixation of an intraluminal device 10 (see Figs. 1-7) to an inner surface of a hollow organ 12 (see Figs. 1-7) with a biasing member 98 (see Fig. 7) and a contact distribution pattern 12 (see Figs. 1-7) connected by a filament 26 (see Figs. 1-7). Baker further teaches: the filament 26 is a non-metallic filament (see [0009], the tether, 26, is a non-coated silk, which is non-metallic).
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 Stack to incorporate the teachings of Baker and have a filament of an intraluminal device with a non-metallic material. This is due to using a non-coated silk (see [0009]) for filaments of an intraluminal device is common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 19
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further does not explicitly disclose: used to fix an intraluminal device having a baroreceptor stimulating surface to the cardiac portion of the stomach in order, to stimulate baroreceptors, wherein said deploying comprises trans-oral positioning of the intraluminal device to the stomach and positioning a distal end portion of a shaft guide adjacent the outer surface of the stomach percutaneously or laparoscopically to the abdominal cavity or trans-orally through the stomach wall.
However, Baker in a similar field of invention teaches a method of fixation of an intraluminal device 10 (see Figs. 1-7) to an inner surface of a hollow organ 12 (see Figs. 1-7) with a biasing member 98 (see Fig. 7) and a contact distribution pattern 12 (see Figs. 1-7) connected by a filament 26 (see Figs. 1-7). Baker further teaches: used to fix an intraluminal device 10 having a baroreceptor stimulating surface 22 (see Figs. 1-7, [0105]) to the cardiac portion (see [0105], baroreceptors, the cardiac surface) of the stomach in order, to stimulate baroreceptors (see [0105]), wherein said deploying comprises trans-oral positioning (see Figs. 1-7 and 15a-15b, [0104]-[0105], navigating the device transorally to the stomach to the cardiac portion of the stomach) of the intraluminal device 10 to the stomach and positioning a distal end portion of a shaft guide (see Figs. 15a-15b, [0104]-[0105]) adjacent the outer surface of the stomach percutaneously or laparoscopically to the abdominal cavity or trans-orally through the stomach wall (see [0104]-[0105]).
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 Stack to incorporate the teachings of Baker and teach a method of fixation of an intraluminal device with fixing an intraluminal device having a baroreceptor stimulating surface to the cardiac portion of the stomach in order, to stimulate baroreceptors, wherein said deploying comprises trans-oral positioning of the intraluminal device to the stomach and positioning a distal end portion of a shaft guide adjacent the outer surface of the stomach percutaneously or laparoscopically to the abdominal cavity or trans-orally through the stomach wall. Motivation for such can be found in Stack as this can stimulate the baroreceptors to stimulate the neurohormonal feedback mechanism to cause weight loss (see [0106])
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stack in view of Sawyer et al (US 20190142539 A1), herein referenced to as “Sawyer”.
Claim 15
Stack discloses: The method as claimed in claim 1, see 102 rejection above. Stack further does not explicitly disclose: wherein biasing the biasing member toward the contact distribution member comprises one of said contact distribution member or said biasing member defining a magnet and the other of said contact distribution member or said biasing member being magnetically attracted to the magnet.
However, Sawyer in a similar field of invention teaches a method of fixation of an intraluminal device 131 + 133 (see Figs. 4-6) with a contact distribution member 133 (see Figs. 1-6) and a biasing member 131 with biasing the biasing member 131 toward the contact distribution member 133 (see Figs. 1-6). Sawyer further discloses: comprises one of said contact distribution member 166 (see Fig. 7, [0038], is a magnet) or said biasing member (will not be examined here due to being an optional claim limitation) defining a magnet 166 (see [0038], magnet) and the other of said contact distribution member (will not be examined here due to being an optional claim limitation) or said biasing member 131 (see [0038], magnetically attracted, hence being fixed via 166) being magnetically attracted to the magnet 166.
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 Stack to incorporate the teachings of Sawyer and teach a method of fixation of an intraluminal device with one of said contact distribution member or said biasing member defining a magnet and the other of said contact distribution member or said biasing member being magnetically attracted to the magnet. Motivation for such can be found in Sawyer as this allows the magnet to be introduced to the body in a minimally invasive method and allow for fixation of a intraluminal device while minimizing tissue damage (see [0016]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Saadat et al (US 20040122456 A1) teaches a method of fixation of an intraluminal device with using a separate needle to deploy the intraluminal device and the contact distribution member
Wallsten (US 20090177288 A1) teaches a method of fixation of an intraluminal device with a spring/coiled device
Abbott et al (US 20080015633 A1) teaches a method of fixation of an intraluminal device with a coiled contact distribution member
Birk (US 20120203061 A1) teaches a method of fixation of an intraluminal device with a coiled contact distribution member with multiple coils (see Fig. 13D)
Zhang et al (US 20230125480 A1) teaches a method of fixation of an intraluminal device with a biasing member and a contact distribution member
Huntley (US 9451960 B2) teaches a method of fixation of an intraluminal device with a tether connecting a biasing member with a contact distribution member
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 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
Prosecution Insights