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 without traverse of Invention I, claims 1-11 in the reply filed on 20 January 2026 is acknowledged.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 January 2026.
Claim Objections
Claims 1, 3, and 9 are objected to because of the following informalities:
in lines 7 and 14 of claim 1, “the arms” should be “the plurality of arms”;
in line 17 of claim 1, “the elongate elements configured to” should be “the plurality of elongated elements are configured to” for proper grammar;
in line 1 of claim 3, “wherein rotation of the first knob causing translation” should read “wherein rotation of the first knob causes translation”;
in line 2 of claim 3, “delivery system” should be “system”;
in line 3 of claim 9, “the first and second tabs” should read “the first and second retaining tabs”;
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: locking mechanism in claim 4; needle pushing mechanism in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL. —The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, and 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described below, the disclosure does not provide adequate structure to perform the claimed functions of: in claim 4, to lock the position of the handle; in claim 7, to advance a needle element forward through the pylorus and through the distal portion of the gastrointestinal device. The specification does not demonstrate that Applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
The remaining claim(s) is/are rejected due to dependency upon a rejected claim.
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 1-11 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 capsule". There is insufficient antecedent basis for this limitation in the claim. The capsule was previously introduced as the “locator capsule”. Applicant should amend claim 1 to read “the locator capsule” for proper antecedent basis. Claims 2-11 are rejected based on their dependency on claim 1.
Claim 1 also recites the limitation "an anti-mitigation anchor". There is insufficient antecedent basis for this limitation in the claim. An anti-mitigation anchor was already introduced in line 1, and the claim is unclear if these are the same anchor or different anchors. Applicant should amend claim 1 to read “the anti-mitigation anchor” for proper antecedent basis. For the purposes of examination, the anchors will be presumed to be the same anchor.
Claim 1 also recites the limitation "the locator system arm". There is insufficient antecedent basis for this limitation in the claim. The locator system was previously disclosed to have a plurality of arms, and the claim is unclear on if only a single arm of the plurality of arms has an anchor delivered to the arm, if the plurality of arms has a single anchor delivered to them, or if each arm of the plurality of arms receives a separate anchor. Applicant should amend claim 1 to read “the plurality of arms” for proper antecedent basis. For the purposes of examination, the limitation will be presumed to be the plurality of arms have a single anchor delivered to them.
Claim 1 also recites the limitation "a guidewire". There is insufficient antecedent basis for this limitation in the claim. A guidewire was functionally introduced, and the claim is unclear on whether the guidewire that the locator system, catheter, and handle are advanced over is the same guidewire that is engaged by the first knob, or if they are different guidewires. Applicant should amend claim 1 to read “the guidewire” for proper antecedent basis. For the purposes of examination, the guidewires will be presumed to be the same guidewire.
Claim 2 recites the limitation "a guidewire" in line 1. There is insufficient antecedent basis for this limitation in the claim. A guidewire was functionally introduced in claim 1, and the claim is unclear on whether this guidewire is the same one which the locator system, catheter, and handle are advanced over and that is engaged by the first knob, or if there are multiple guidewires. Applicant should amend claim 2 to read “the guidewire” for proper antecedent basis. For the purposes of examination, the guidewires will be presumed to be the same guidewire.
Claim 4 recites the limitation “a locking mechanism” in line 1, which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states that the claimed function of “locking the position of the handle” is performed by a locking element ([0092]). There is no disclosure of any particular structure, either explicitly or inherently, to perform the locking. The use of the terms “element” or “mechanism” are not sufficient structure for performing the locking function because it does not describe a particular structure for performing the function. As would be recognized by those of ordinary skill in the art, there are many different ways to lock a handle. The specification does not provide sufficient details such that one of ordinary skill in the art would understand which mechanical structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 4 recites the limitation "the position of the handle" in line 2. There is insufficient antecedent basis for this limitation in the claim. No position of the handle has been previously introduced. Applicant should amend claim 4 to read “a position of the handle.”
Claim 5 recites the limitation "the locator system includes three arms" in line 1. The claim is unclear on if the three arms are part of the previously introduced plurality of arms or if the three arms are separate from the plurality of arms. Applicant should amend claim 5 to read “the plurality of arms includes three arms” for clarity. For the purposes of examination, the three arms will be considered part of the plurality of arms.
Claim 6 recites the limitation "the locator system arm" in line 2. There is insufficient antecedent basis for this limitation in the claim. The locator system was previously disclosed to have a plurality of arms of claim 1, and the claim is unclear on if only a single arm of the plurality of arms has an anchor delivered to the arm, if the plurality of arms has a single anchor delivered to them, or if each arm of the plurality of arms receives a separate anchor. Applicant should amend claim 6 to read “the plurality of arms” for proper antecedent basis. For the purposes of examination, the limitation will be presumed to be the plurality of arms have a single anchor delivered to them. Claims 7-11 are rejected based on their dependency on claim 6.
Claim 7 recites the limitation “a needle pushing mechanism” in line 1, which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states that the claimed function of “advancing a needle element forward through the pylorus and through the distal portion of the gastrointestinal device” is performed by an external needle pushing element ([00100]). There is no disclosure of any particular structure, either explicitly or inherently, to perform the advancing. The use of the terms “element” or “mechanism” are not sufficient structure for performing the advancing function because it does not describe a particular structure for performing the function. As would be recognized by those of ordinary skill in the art, there are many different ways to advance a needle. The specification does not provide sufficient details such that one of ordinary skill in the art would understand which mechanical structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 8 is further rejected for their dependency on claim 7.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 8 recites the limitation “a suture tether coupled inside the needle element” in lines 2-3. The needle element was only functionally introduced in claim 7, but is now positively claimed, and the claim is unclear if the combination of the needle element and the suture tether has been claimed, or just the subcombination of the suture tether.
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.
Claims 1-2, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al. (Pub. No. 2006/0155312).
Regarding claim 1, Levine et al. discloses a system (1200; [0089]; FIGs. 12-17) for delivering an anti-migration anchor to a gastrointestinal device including a proximal portion, a distal portion and a neck portion, the anti-migration anchor including a first end for contacting the proximal portion and a tether portion for extending through a pylorus, the delivery system comprising:
a locator system (1206; [0092]; FIGs. 14A-B) having a head portion adapted to mate with the neck portion of the gastrointestinal device (1302; [0090]; FIG. 14B), a locator capsule coupled to the head portion (FIG. 14A: 1304), and a plurality of arms coupled to the head portion and the locator capsule (202; FIG. 14A), the arms having a collapsed configuration for delivery to the pylorus ([0093]: the stent is initially collapsed) and an extended configuration for deployment of the anti-migration anchor ([0093] the stent self-expands when the implant is being deployed);
a catheter (1202 and 1226; [0090]; FIG. 12) having a distal portion coupled to and extending from the head portion (FIG. 12: 1202 is coupled to 1302), the catheter including an outer member (1202) coupled to the head portion and an inner member (1226) coupled to the capsule;
a handle (1600; [0100]; FIGs. 16A-C) coupled to a proximal portion of the catheter, the handle having a first knob (FIG. 16A: a knob around 1212 as part of 1600 engages with the guidewire) configured to engage a guidewire and a second knob (1214; FIG. 16A) configured to effect relative motion between the inner member and the outer member of the catheter, so as to cause the arms to transition from the collapsed configuration to the extended configuration ([0100] 1214 transitions from delivery to deploy); and
a plurality of elongate elements (FIGs. 14A-B: 1210 and FIG. 16B: 1214) having a proximal end and a distal end coupled the locator system arm (FIGs. 14A-B: 1210 is coupled to 1304), the elongate elements configured to facilitate the delivery of an anti-migration anchor to the locator system arm (FIG. 12: as part of 1200, the elements help facilitate the delivery of the anchor); wherein each of the locator system, the catheter, and the handle are configured to be advanced over a guidewire (1212; FIG. 12; [0089]).
Regarding claim 2, Levine et al. further discloses a guidewire (1212; FIG. 12; [0089]) extending through each of the locator system, the catheter, and the handle, the guidewire including a distal coupling element for coupling to the gastrointestinal device ([0102] the guidewire is coupled to the implant device through ball 1800; FIG. 17).
Regarding claim 6, Levine et al. further discloses a deployment element ([0111] the distal end of the delivery system is used to deploy the anchor; while this is a separate embodiment, the difference between the embodiments is the focus of the elements provided, where the previously referred to embodiment focused on the catheter section while the present embodiment focuses on the anchor section) configured to be delivered through one of the plurality of elongate elements to the locator system arm ([0111] the needle is delivered on the end of 1210).
Regarding claim 7, Levine et al. further discloses the deployment element is a needle pushing mechanism adapted to advance a needle element (because adequate structure has not been identified in the specification for performing the claimed function, the mechanism only needs to be any structure capable of advancing a needle element; [0111] the hollow distal end of the delivery device is a sharp needle to penetrate pylorus muscle; FIGs. 25A-25E) forward through the pylorus and through the distal portion of the gastrointestinal device ([0111]).
Regarding claim 8, Levine et al. further discloses a suture tether (2510; FIG. 25E) coupled inside the needle element and configured to deploy after the needle element is advanced through the pylorus ([0112] 2510 is pushed through the needle and into the tissue after the needle has advanced through the pylorus).
Regarding claim 9, Levine et al. further discloses the suture tether includes a first retaining tab (2506; [0110]) for coupling with the proximal portion of the gastrointestinal device and a second retaining tab (2504; FIG. 25E; [0110]) for coupling with the distal portion of the gastrointestinal device, the first and second tabs connected by a flexible tether (2502; [0110]).
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 non-obviousness.
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 3-5 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. in view of Gupta et al. (Pub. No. 2019/0298401).
Regarding claim 3, Levine et al. discloses the invention as claimed in claim 2, as discussed above, and further discloses translation of the first knob causes translation of the delivery system with respect to the guidewire (FIG. 16A: the knob around the proximal end of 1212 allows for longitudinal movement of the entire system relative to 1212). Levine et al. does not disclose rotation of the first knob causing translation of the delivery system with respect to the guidewire.
Gupta et al. teaches in the same field of endeavor of devices for delivery of gastrointestinal implants ([0095]) and discloses a delivery system (FIGs. 14A-15C) with a guidewire (DW; [0093]; FIG. 15C) and a first knob (1525; [0093]; FIGs. 15A-15C), where the rotation of the first knob causes translation of the delivery system with respect to the guidewire ([0093] an operator can rotate 1525 about DW to move the end effector at the end of DW).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the translation system of Levine et al. (linear movement of the first knob) for the translation system of Gupta et al. (rotation of the first knob) because both systems are disclosed as equivalent structures for providing translation of the delivery system relative to the guidewire, and substitution of one for the other would have resulted in the predictable result of allowing for movement of the delivery system relative to the guidewire.
Regarding claim 4, Levine et al. as modified by Gupta et al. further discloses the handle further comprises a locking mechanism (because adequate structure has not been identified in the specification for performing the claimed function, the mechanism only needs to be any structure capable locking the position of the handle with respect to the guidewire; 1214 is capable of causing relative motion between 1202 and 1226 by pulling back 1202; [0090]Gupta et al.: 1535; FIG. 15C; [0094]) to lock the position of the handle with respect to the guidewire ([0094] 1535 can lock the handle 1500 in place to prevent rotation and longitudinal movement of the handle along DW).
Regarding claim 5, Levine et al. discloses the invention as claimed in claim 1, as discussed above. Levine et al. does not disclose the locator system includes three arms, each angularly spaced at an angle of about 120 degrees about a circumference of the head portion.
Gupta et al. teaches in the same field of endeavor of devices for delivery of gastrointestinal implants ([0095]) and discloses a locator system (1200; FIG. 12B; [0077]) with three arms (1205a, 1205b, and 1205c; FIG. 12B), each angularly spaced at an angle of about 120 degrees about a circumference of a head portion of the implant (FIG. 12B: the arms 1205a, 1205b, and 1205c are spaced equidistantly apart from each other, which would result in angles of 120 degrees, about the opening 1230 which would grab onto the head portion of the implant).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the arms of Levine et al. (undisclosed number of arms) for the arms of Gupta et al. (three) because both systems are disclosed as equivalent structures for grabbing onto the head portion of the implant, and substitution of one for the other would have resulted in the predictable result of holding the head portion of the implant during delivery.
Regarding claim 10, Levine et al. discloses the invention substantially as claimed in claim 1, as discussed above. Levine et al. does not disclose the deployment element is a helix delivery element adapted to advance a helix anchor into the pylorus.
Gupta et al. teaches in the same field of endeavor of devices for delivery of gastrointestinal implants ([0095]) and discloses a helical anchor implant (800; [0064]; FIGs. 8A-8C) which is deployed by a helix delivery element (FIGs. 14A-15C show delivery systems which deploy 800) for the purpose of more firmly securing the implant within the tissue ([0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the delivery system of Levine et al. be adapted to advance a helical anchor into the pylorus, as taught by Gupta et al., for the purpose of more firmly securing the implant within the tissue.
Regarding claim 11, Levine et al. as modified by Gupta et al. further discloses the helix anchor includes a helical portion (Gupta et al.: 825; FIG. 8B) configured to embed within the pylorus (Gupta et al.: [0064] 825 is embedded in pylorus 110) and a retaining tab (Levine et al.: 2504; FIG. 25E; [0110]) for coupling with the proximal portion of the gastrointestinal device
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781