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
Applicant’s election of species II and III in the reply filed on 07/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 11, and 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species I, IV-XI, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
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 1-9, 12, and 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 anchoring member” in lines 5-9. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. Appropriate correction is required.
Claim 2 recites “the anchoring member” in lines 1, 4, and 6. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. Appropriate correction is required.
Claim 3 recites “the anchoring member” in line 3. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. Appropriate correction is required.
Claim 6 recites “the anchoring member” in lines 1-5. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. Appropriate correction is required.
Claim 7 recites “the anchoring member” in line 2. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. Appropriate correction is required.
Claim 8 is unclear because it reads as a method but is a device claim. Appropriate correction is required.
Claim 20 recites the limitation "the other" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 20 recites “the anchoring member” in line 4. Since the claim recites two anchoring members, it is unclear which of the two anchoring members “the anchoring member” is referring to. For examination purposes, the limitation will be interpreted as “one of the two anchoring members”. 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.
Claims 1, 2, 4-9, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maahs et al. (US 20060217762 A1).
Regarding claim 1 Maahs discloses (fig. 1-2B) an anchoring device, wherein the anchoring device comprises a coupling member 38 and two anchoring members (54, 56), the two anchoring members (54, 56) are arranged on the coupling member 28 at intervals along a first direction (see fig. 2B and [0076]), a dimension of the coupling member 38 in a second direction is a first dimension, and the second direction is perpendicular to the first direction (see annotated fig. below); the anchoring member (54, 56) is configured to switch between a first configuration and a second configuration (see fig. 2A-2B, [0074] and [0076]), and when the anchoring member is in the first configuration (configuration of fig. 2A), a dimension of the anchoring member in a direction perpendicular to the first direction is a second dimension (see annotated fig. 2A below); when the anchoring member is in the second configuration (configuration of fig. 2B), a dimension of the anchoring member in the second direction is a third dimension, and the third dimension is greater than the second dimension and the first dimension (see annotated fig. 2A-2B below).
PNG
media_image1.png
724
698
media_image1.png
Greyscale
Regarding claim 2 Maahs further discloses (fig. 1-2B) the anchoring member comprises a wire portion (52, 62, see fig. 2B and [0079]), and the wire portion (52, 62) is configured to switch between a compression state and a deployed state (see fig. 2A-2B), the anchoring member is in the first configuration when the wire portion is in the compression state (see fig. 2A), the anchoring member is in the second configuration when the wire portion is in the deployed state (see fig. 2B).
Regarding claim 4 Maahs further discloses (fig. 1-2B) the wire portion (52, 62) is made of a shape memory metal (see [0079]).
Regarding claim 5 Maahs further discloses (fig. 1-2B) at least one 56 of the two anchoring members is movably arranged on the coupling member 38 (see [0078]).
Regarding claim 6 Maahs further discloses (fig. 1-2B) when the anchoring member is in the second configuration, the anchoring member is configured to extend and retract in the first direction (see fig. 2A-2B and [0078]-[0079]), and the second dimension decreases during a process of the anchoring member extending in the first direction, and the second dimension increases during a process the anchoring member being compressed in the first direction (see fig. 2A-2B and [0078]-[0079]).
Regarding claim 7 Maahs further discloses (fig. 1-2B) the coupling member 38 is flexibly coupled with the anchoring member (see [0078]); wherein the coupling member is a flexible coupling wire (see fig. 2B and [0076]).
Regarding claim 8 Maahs further discloses (fig. 1-2B) the anchoring device is configured to anchor a target tissue (see fig. 2B and [0064]); the target tissue comprises an esophageal wall, a left limb of right crus of diaphragm and a gastric fundic wall, the left limb of right crus of diaphragm is positioned between the esophageal wall and the gastric fundic wall;
The language “the anchoring device is configured to anchor a target tissue; the target tissue comprises an esophageal wall, a left limb of right crus of diaphragm and a gastric fundic wall, the left limb of right crus of diaphragm is positioned between the esophageal wall and the gastric fundic wall” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Maahs meets the structural limitations of the claim, and the anchoring device is capable of anchoring a target tissue where the target tissue comprises an esophageal wall, a left limb of right crus of diaphragm and a gastric fundic wall, the left limb of right crus of diaphragm is positioned between the esophageal wall and the gastric fundic wall because Maahs discloses the anchor is used in the gastrointestinal lumen (see [0064]).
before the anchoring device is anchored to the target tissue, an included angle between a medial surface of a target area of the esophageal wall and a medial surface of a target area of the gastric fundic wall is a first included angle;
The language “the anchoring device is configured to anchor a target tissue…before the anchoring device is anchored to the target tissue, an included angle between a medial surface of a target area of the esophageal wall and a medial surface of a target area of the gastric fundic wall is a first included angle” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Maahs meets the structural limitations of the claim, and the anchoring device is capable of anchoring a target tissue such that before the anchoring device is anchored to the target tissue, an included angle between a medial surface of a target area of the esophageal wall and a medial surface of a target area of the gastric fundic wall is a first included angle because the anchor is used in the gastrointestinal lumen (see [0064]) and could be positioned at an included angle.
after the anchoring device is secured to the target tissue, the target tissue forms a piercing hole, and the coupling member penetrates through the esophageal wall, the left limb of right crus of diaphragm, and the gastric fundic wall along the piercing hole;
The language “the anchoring device is configured to anchor a target tissue…after the anchoring device is secured to the target tissue, the target tissue forms a piercing hole, and the coupling member penetrates through the esophageal wall, the left limb of right crus of diaphragm, and the gastric fundic wall along the piercing hole” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Maahs meets the structural limitations of the claim, and the anchoring device is capable of anchoring a target tissue such that after the anchoring device is secured to the target tissue, the target tissue forms a piercing hole, and the coupling member penetrates through the esophageal wall, the left limb of right crus of diaphragm, and the gastric fundic wall along the piercing hole because the anchor is used in the gastrointestinal lumen (see [0064]) and is shown to be positioned at a piercing hole of the target tissue (see fig. 2B).
one of the two anchoring members is configured to abut against the medial surface of the target area of the gastric fundic wall, and the other is configured to abut against the medial surface of the target area of the esophageal wall, an included angle between the medial surface of the target area of the gastric fundic wall and the medial surface of the target area of the esophageal wall is a second included angle, the second included angle is smaller than the first included angle.
The language “one of the two anchoring members is configured to abut against the medial surface of the target area of the gastric fundic wall, and the other is configured to abut against the medial surface of the target area of the esophageal wall, an included angle between the medial surface of the target area of the gastric fundic wall and the medial surface of the target area of the esophageal wall is a second included angle, the second included angle is smaller than the first included angle” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Maahs meets the structural limitations of the claim, and one of the two anchoring members is capable of abutting against the medial surface of the target area of the gastric fundic wall, and the other is configured to abut against the medial surface of the target area of the esophageal wall (fig. 2B shows both anchors abutting a wall and Maahs discloses use in the gastrointestinal lumen, see [0064]), an included angle between the medial surface of the target area of the gastric fundic wall and the medial surface of the target area of the esophageal wall is a second included angle, the second included angle is smaller than the first included angle (the device can be positioned to form a second included angle that is smaller than the first included angle).
Regarding claim 9 Maahs further discloses (fig. 1-2B) at least one anchoring member in the anchoring device closes a port of the piercing hole after the anchoring device is secured to the target tissue (see fig. 2B with the anchors positioned at both side of the piercing hole).
Regarding claim 20 Maahs further discloses (fig. 1-2B) one of the two anchoring members 52 is fixedly coupled with a first end of the coupling member 38 (see fig. 2B and [0077]), the other has a first through-hole (see fig, 2B), the second end of the coupling member 28 passes through the first through-hole and is in slide-fit with the anchoring member (see fig. 2B and [0078]); the coupling member is cooperated with the locking mechanism (see [0078]), the locking mechanism is configured to switch between an unlocking state and a locking state; when the locking mechanism is in the unlocking state, the locking mechanism is in slide-fit with the coupling member; when the locking mechanism is in the locking state, the locking mechanism is in limiting-fit with the coupling member in an extension direction of the coupling member (See [0078]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Maahs in view of Dale et al. (US 20210169645 A1).
Regarding claim 3, Maahs discloses the claimed invention substantially as claimed, as set forth above for claim 2. Maahs is silent regarding the wire portion forms a foldable mesh structure; wherein the anchoring member further comprises a protective layer, the protective layer covers the wire portion and blocks mesh openings formed by the wire portion.
However Dale, in the same field of endeavor, teaches (fig. 13) of an anchor 210 formed of a wire structure (see fig. 13 and [0042]), wherein the wire portion forms a foldable mesh structure; wherein the anchoring member further comprises a protective layer, the protective layer covers the wire portion (see [0042]) and blocks mesh openings formed by the wire portion (the cover covers the mesh thus it would block the mesh openings; see [0042]).
Furthermore, To provide the device of Maahs with the wire portion forms a foldable mesh structure; wherein the anchoring member further comprises a protective layer, the protective layer covers the wire portion and blocks mesh openings formed by the wire portion would have been obvious to one of ordinary skill in the art, in view of the teachings of Dale, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention, i.e., one skilled in the art would have recognized that covered mesh used in Dale would allow the device of Maahs to be deployed to target tissue to secure tissue folds. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Allowable Subject Matter
Claim 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious the distal end of the anchoring device is arranged with a piercing head, the piercing head comprises a thermal-insulation member and a conductor, and the conductor is arranged on the thermal-insulation member.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
Prosecution Insights