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 .
Status of the Claims
The amendment filed 03/19/2024 has been entered. Claims 1-20 are pending and under consideration.
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 at least one dynamic section is substantially coextensive with portions of said intermediate section not comprising said at least one dynamic section. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Reference numbers in figure 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 5 and 17 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 5 recites “wherein said at least one dynamic section is substantially coextensive with portions of said intermediate section not comprising said at least one dynamic section”. It is unclear how the at least one dynamic section can be “substantially coextensive” with portion of the intermediate section that do not comprises the at least one dynamic section. The specification discloses the dynamic section as being substantially coextensive with the intermediate section, or the intermediate section may be considered to itself be the dynamic section ([0033]), but the specification does not illustrate how the dynamic section is substantially coextensive with the intermediate section does not comprising the dynamic section as claimed. In an effort to compact prosecution, the limitation is being interpreted as “wherein said at least one dynamic section is substantially coextensive with portions of said intermediate section”
Claim 17 recites the limitation "at least one of the retention members" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. In an effort to compact prosecution the limitation is being interpreted as “at least one of the first and second ends”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-11, 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al (US 20180280166 A1) in view of Gupta (US 20190298559 A1).
Regarding claim 1, Walsh teaches substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An implantable medical device (figures 1-2, elongate body 100) for implanting with respect to first and second anatomical structures, the implantable medical device comprising:
a first end (figures 1-2, first portion 110);
a second end (figures 1-2, second portion 120);
an intermediate section (figures 1-2, saddle region 130 defined between 110 and 120) defined between said first end and said second end; and
at least one dynamic section (figures 1b-c and [0024-0025] saddle region comprises a section formed of different filament pattern or different material) along at least a part of said intermediate section;
wherein:
said first end and said second end (figure 2 and [0019 and 0022] the first and second portions are configured to hold anatomical structures for example abdominal wall and common bile duct as shown figure 2 with the saddle region defines fluid passage 140 extending through the first and second anatomical structure) are configured to hold the first and second anatomical structures in apposition with said intermediate section extending through the first and second anatomical structures;
said first end of said implantable medical device is configured to be anchored with respect to the first anatomical structure (figure 2, first end 110 is configured to be anchored with the abdominal wall);
said second end of said implantable medical device is configured to be anchored with respect to the second anatomical structure (figure 2, second end 120 is configured to be anchored with the common bile duct);
said intermediate section is configured to hold the first and second anatomical structures in apposition, with said first end of the implantable medical device anchored with respect to the first anatomical structure and said second end of said implantable medical device anchored with respect to the second anatomical structure (figure 2 and [0019 and 0022] the saddle region 130 is configured to hold the first and second anatomical structures through the first and second ends); and
said at least one dynamic section is configured to allow movement of said first end of said implantable medical device relative to said second end of said implantable medical device ([0024-0025] the saddle region having flexibility which allows the movement of the first portion relative to the second portion).
Walsh does not teach the first, second and intermediate sections are configured to hold the first and second anatomical structures in apposition.
In the same field of endeavor, devices, systems, and methods for pyloric occlusion, Gupta teaches the first, second and intermediate sections are configured to hold the first and second anatomical structures in apposition (figure 2f and [0029] the stent 260 comprises first end, second end and intermediate sections are configured to hold the stomach and jejunum in apposition).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh to incorporate the teachings of Gupta and provides the medical device as claimed for the purpose of bypassing duodenum and facilitating delivery of stomach content from the stomach to the small intestine thereby promoting patient weight loss as taught by Gupta ([0025]).
Regarding claim 2, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further teaches wherein the dynamic section is substantially coextensive with the intermediate section (Walsh; figures 1b-c and [0024-0025] the dynamic section is coextensive with the saddle region 130).
Regarding claim 3, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further teaches wherein:
at least said first end and said second end of said implantable medical device are formed of interconnected filaments (Walsh; [0024] first and second portions formed of a woven or braided filament); and
said at least one dynamic section comprises a structure (Walsh; [0024-0025] and figures 1b-c, the dynamic section formed of a knitted filament, or polymeric material with braided or knitted filament) different from the interconnected filament structure of said first end and said second end.
Regarding claim 4, Walsh, as modified by Gupta, teaches the implantable medical device of claim 3.
The combination further teaches wherein said at least one dynamic section is formed of a substantially solid polymeric wall (Walsh; figure 1c and [0025] saddle region 130 comprising a cylindrical wall formed from a polymeric material).
Regarding claim 5, Walsh, as modified by Gupta, teaches the implantable medical device of claim 4.
The combination further teaches wherein said at least one dynamic section is substantially coextensive with portions of said intermediate section (Walsh; figure 1c and [0025], the cylindrical wall is substantially coextensive with the intermediate section)
Regarding claim 6, Walsh, as modified by Gupta, teaches the implantable medical device of claim 3.
The combination further teaches wherein:
said intermediate section includes a section formed of interconnected filaments (Walsh; [0024 and 0025] the intermediate section formed of knitted filament or polymeric material with woven, braided or knitted filament); and
said at least one dynamic section includes a first dynamic section coupling (Walsh; [0024 and 0027] coupling between end of the cylindrical saddle 130 with the proximal portion 110, i.e., bonding, interwoven, attaching) a first end of said interconnected filament section of said intermediate section to said first end of said implantable medical device, and a second dynamic section coupling (Walsh; [0024 and 0027] opposite coupling between end of the cylindrical saddle 130 with the distal portion 120, i.e., bonding, interwoven, attaching) a second end of said interconnected filament section of said intermediate section to said second end of said implantable medical device.
Regarding claim 7, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further teaches wherein:
a first retention member (Walsh; figures 1-2 and [0022] proximal retention member 112 extend perpendicular to a circumference of the elongate body 100) extends radially-outwardly along said first end of said implantable medical device;
a second retention member (Walsh; figures 1-2 and [0022] distal retention member 122 extend perpendicular to a circumference of the elongate body 100) extends radially-outwardly along said second end of said implantable medical device;
said first retention member and said second retention member are formed from filaments interconnected in a first pattern (Walsh; [0024] proximal and distal retention members 112 and 122 are formed of a woven or braided filament); and
at least a portion of said intermediate section is formed from filaments interconnected in a second pattern different from the first pattern (Walsh; [0024] cylindrical saddle region 130 is formed of a knitted filament).
Regarding claim 8, Walsh, as modified by Gupta, teaches the implantable medical device of claim 7.
The combination further teaches wherein the second pattern imparts a different degree of flexibility to said intermediate section than the flexibility imparted by the first pattern to said first retention member and to said second retention member (Walsh; [0024] the woven or braided pattern of first and second portions impart different degree of flexibility to the saddle region formed of knitted filament).
Regarding claim 9, Walsh, as modified by Gupta, teaches the implantable medical device of claim 8.
The combination further teaches wherein said at least one dynamic section comprises a first dynamic section coupling (Walsh; [0024 and 0027] coupling between end of the cylindrical saddle 130 with the proximal portion 110, i.e., bonding, interwoven, attaching) a first end of said portion of said intermediate section formed from interconnected filaments with said first retention member, and a second dynamic section coupling (Walsh; [0024 and 0027] opposite coupling between end of the cylindrical saddle 130 with the distal portion 120, i.e., bonding, interwoven, attaching) a second end of said portion of said intermediate section formed from interconnected filaments with said second retention member.
Regarding claim 10, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further wherein a lumen (Walsh; figure 2 and [0022] an interior passage 140 form an anastomosis between stomach and bile duct) is defined through said implantable medical device to form an anastomosis between the apposed anatomical structures.
Regarding claim 11, Walsh, as modified by Gupta, teaches the implantable medical device of claim 10.
The combination further teaches wherein said at least one dynamic section is reinforced to maintain the lumen through said implantable medical device in an open configuration (Walsh; [0025] “the cylindrical saddle region may include a variety of internal or external support structures”)
Regarding claim 13, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further teaches said implantable medical device is shiftable from a delivery configuration to an expanded deployed configuration (Walsh; [0022] device 100 is configured to move between a constrained configuration and an expanded configuration);
said first end of said implantable medical device expands when said implantable medical device shifts to said deployed configuration to define a radially-outwardly extending first retention member (Walsh; [0022] 110 is configured to expand and defines proximal retention member 112);
said second end of said implantable medical device expands when said implantable medical device shifts to the deployed configuration to define a radially-outwardly extending second retention member (Walsh; [0022] 120 is configured to expand and defines distal retention member 122);
a first end of said intermediate section is coupled to said first retention member (Walsh; figures 1 and 2, one end of 130 is coupled to 112); and
a second end of said intermediate section is coupled to said second retention member (Walsh; figures 1 and 2, opposite end of 130 is coupled to 122).
Regarding claim 14, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination further teaches wherein said intermediate section is sized, shaped, configured, and/or dimensioned to hold adjacent non-adherent anatomical structure in apposition (Gupta; figure 2f, the intermediate section of implant 260 is configured to hold adjacent stomach and jejunum in apposition).
Regarding claim 15, Walsh teaches an implantable medical device (figures 1-2, elongate body 100) configured to hold first and second anatomical structures in apposition,
said implantable medical device having a first end and a second end with an intermediate section extending therebetween (figures 1-2, the elongate body 100 having first and second portions 110 and 120 with saddle region 130), said implantable medical device comprising:
a first retention member (figures 1-2 and [0019], proximal retention member 112 is sized, shaped and configured to anchor the 110 to first anatomical structure, for example an abdominal wall) sized, shaped, configured, and/or dimensioned to anchor a first end of said implantable medical device with respect to the first anatomical structure;
a second retention member (figures 1-2, distal retention member 122 is sized, shaped and configured to anchor the 120 to second anatomical structure, for example bile duct) sized, shaped, configured, and/or dimensioned to anchor a second end of said implantable medical device with respect to the first anatomical structure; and
a dynamic section (figures 1b-c and [0024-0025] saddle region comprises at least one section formed of different filament pattern or different material) defined along said intermediate section to allow said intermediate section to be movable with respect to said first retention member and said second retention member.
Walsh does not teach the implantable medical device configured to hold the first and second anatomical structures in apposition.
In the same field of endeavor, devices, systems, and methods for pyloric occlusion, Gupta teaches the implantable medical device configured to hold the first and second anatomical structures in apposition (figure 2f and [0029] the stent 260 comprises first end, second end and intermediate sections are configured to hold the stomach wall and jejunum in apposition).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh to incorporate the teachings of Gupta and provides the medical device as claimed for the purpose of bypassing duodenum and facilitating delivery of stomach content from the stomach to the small intestine thereby promoting patient weight loss as taught by Gupta ([0025]).
Regarding claim 16, Walsh, as modified by Gupta, teaches the implantable medical device of claim 15.
The combination further teaches wherein:
said first retention member and said second retention member are formed from interconnected filaments (Walsh [0024-0025] 112 and 122 are formed of a woven or braided filament); and
said dynamic section comprises a structure ([0024-0025] the saddle region 130 is formed of knitted filament or polymeric material) different from the interconnected filament structure of said first retention member and said second retention member.
Regarding claim 17, Walsh teaches a method for holding a first anatomical structure of a patient in apposition with a second anatomical structure of the patient (figure 2 and [0019 and 0022]), said method comprising;
anchoring a first end of an implantable medical device (figure 2, anchoring first end 110 to the first anatomical structure, for example abdominal wall) with respect to the first anatomical structure;
extending an intermediate section (figure 2 and [0019 and 0022] extending the saddle region between the first anatomical structure and the second anatomical structure, for example between the stomach wall and bile duct) of the implantable medical device across the first anatomical structure and the second anatomical structure;
anchoring a second end (figure 2, anchoring the second end 120 to the second anatomical structure, for example bile duct) of the implantable medical device with respect to the second anatomical structure; and
allowing a dynamic section (figures 1b-c and [0024-0025] saddle region 130 comprises a flexible region allows the device flex with respect to proximal and distal retention members) of the implantable medical device to flex with respect to at least one of the first or second ends;
wherein:
the intermediate section is sized, shaped, configured, and/or dimensioned to hold the first and second anatomical structures in apposition with the first end of the implantable medical device anchored with respect to the first anatomical structure and the second end of the implantable medical device anchored with respect to the second anatomical structure ([0022] and figures 1 and 2, the saddle region 130 is configured to hold the first and second anatomical structures with 110, 120)
Walsh does not teach the method comprises holding the first and second anatomical structure in apposition.
In the same field of endeavor, devices, systems, and methods for pyloric occlusion, Gupta teaches holding the first and second anatomical structure in apposition (figure 2f and [0029] the stent 260 comprises first end, second end and intermediate sections are configured to hold the stomach wall and jejunum in apposition).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh to incorporate the teachings of Gupta and provides the method as claimed for the purpose of bypassing duodenum and facilitating delivering of stomach content from stomach to distal small intestine thereby promoting patient weight loss as taught by Gupta ([0025]).
Regarding claim 18, Walsh, as modified by Gupta, teaches the method of claim 17.
The combination further teaches wherein a lumen is defined through the implantable medical device, said method further comprising forming an anastomosis between the first and second anatomical structures (Walsh; figure 2 and [0019 and 0022] the saddle region defines interior passage and forming an anastomosis between body organs, lumens and spaces).
Regarding claim 19, Walsh, as modified by Gupta, teaches the method of claim 18.
The combination does not expressly teach wherein the first anatomical structure is the jejunum of the patient and the second anatomical structure is the stomach of the patient, said method further comprising forming a gastrojejunostomy.
In the same field of endeavor, namely devices, systems, and methods for pyloric occlusion, Gupta teaches wherein the first anatomical structure is the jejunum of the patient and the second anatomical structure is the stomach of the patient, said method further comprising forming a gastrojejunostomy ([0002 and 0029] figure 2f, stent 260 deployed to join patient’s stomach wall to jejunum forming a gastrojejunostomy).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh to incorporate the teachings of Gupta and provides the method as claimed for the purpose of bypassing duodenum and rapidly delivering of nutrients from stomach to distal small intestine thereby promoting patient weight loss as taught by Gupta ([0025]).
Regarding claim 20, Walsh, as modified by Gupta, teaches the method of claim 19.
The combination further teaches further comprising:
delivering the implantable medical device, in a delivery configuration, transluminally through the patient (Walsh; figure 2 and [0019, 0030-0032] the device 100 is delivered in constrained configuration);
deploying the first end of the implantable medical device in the first anatomical structure and allowing the first end of the implantable medical device to expand to form a first retention member anchored against a distal side of the first anatomical structure (figure 2 and [0019, 0030-0032] deploy the proximal portion 110 to abdominal wall and expand to form proximal retention member 112 anchored against inner side body organ, for example abdominal wall );
extending the intermediate section through a wall of the first anatomical structure and a wall of a second anatomical structure (figure 2 and [0030] extending cylindrical saddle region 130 between abdominal wall and bile duct); and
deploying the second end of the implantable medical device in the second anatomical structure and allowing the second end of the implantable medical device to expand to form a second retention member anchored against a proximal side of the second anatomical structure (figure 2 and [0019, 0030-0032] deploy the distal portion to bile duct and expand to form distal retention member 122 anchored against outer side of the body organ for example, bile duct).
The combination does not teach the implantable medical device, in a delivery configuration, is delivered transluminal.
In the same field of endeavor, namely devices, systems, and methods for pyloric occlusion, Gupta teaches, delivering the implantable medical device transluminally in a delivery configuration ([0025 and 0029] and figures 2a-f, anastomosis stent 260 is delivered transluminally in a compressed configuration) and allowing the first end of the anastomosis stent 260 anchored against a proximal side of the stomach and opposite second end of the stent anchored against a distal side of jejunum (figure 2f and [0029])
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh, as modified by Gupta, to incorporate the teachings of Gupta and provides the claimed method for the purpose allowing creating an anastomosis at jejunum that is not otherwise be reachable using other method, thereby creating the anastomosis that facilitates delivery of stomach content from the stomach to the small intestine and promoting patient weight loss as taught by Gupta ([0025].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Walsh et al (US 20180280166 A1) in view of Gupta (US 20190298559 A1), and in further view of Shin et al (KR 20100042478 A).
Regarding claim 12, Walsh, as modified by Gupta, teaches the implantable medical device of claim 1.
The combination does not teach wherein said intermediate section includes more than one dynamic sections.
In the same field of endeavor, namely a making method for the stent, Shin teaches wherein said intermediate section includes more than one dynamic sections (figures 3 and 4, plurality of dynamic sections disposed between the plurality of stent 8, wherein the dynamic sections are free of the stent material and are spanned only by a flexible polymer material, or elastic portions illustrated in figure 4).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Walsh, as modified by Gupta, to incorporate the teachings of Shin and provide the intermediate section as claimed for the purpose of increasing flexibility of the implanted device as taught by Shin (translation page 2). Such a modification would accommodate relative movement between the anatomical structures to which the device is anchored. Specifically, when the first and second anatomical structures, i.e., stomach and small intestine, move independently and potentially in different direction, the plurality of dynamic sections permits corresponding movement of the retention members. This enhanced flexibility allows the retention member to move relative to one another while maintaining apposition of the anatomical structure, thereby decreasing displacement of the device from the anatomical structure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Binmoeller (US 10952732 B2) and Bebb (US 20090030499 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/SETH HAN/Examiner, Art Unit 3781
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