DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
An amendment was filed on 11/05/2025. Claim 1 has been amended, and new claim 8 has been added. Currently, claims 1-2, 4, and 6-8 are pending and are being examined on the merits.
Response to Arguments
Applicant's arguments filed 11/05/2025 have been fully considered but they are not persuasive.
In response to the applicant’s arguments with respect to claim 1, wherein Belhe is entirely silent regarding heating a portion of the second stent in situ to induce malleability, achieve conformation, and rely on cooling to body temperature for locking, the examiner notes that the claim merely states that the second stent comprises a material that assumes a flexible and malleable state when heated, and is capable of conforming to a shape of the first stent such that they are capable of being coupled when the material cools to body temperature. The instant specification notes that such a material is described as a thermoplastic material (paragraph 0050). Belhe teaches wherein the stent can be formed material such as polypropylene, which is a known thermoplastic material. As such, Belhe appears to teach the amended limitation.
Moreover, it is noted that the features upon which applicant relies (i.e., the portion of the second stent in situ to induce malleability) are not recited in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to the applicant’s arguments, notably wherein the remaining prior art does not teach the amended limitation, the new limitation has been rendered obvious by Belhe.
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 1-2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Belhe (US 20120253259) in view of Thompson (US 20120065571), and further in view of Kagan (EP 1555970) and Belhe ‘351 (US 20130030351). Polypropylene as a Promising Plastic: A Review (hereinafter Maddah) is utilized for extrinsic evidence in claims 1 and 8.
Regarding claim 1, Belhe discloses a device that is implantable in a gastrointestinal (GI) tract of a patient for reducing caloric uptake and weight of the patient or for improving insulin resistance and diabetes (abstract), the device comprising:
a first stent (fig. 23B, second docking element 183) comprising
a first self-expanding framework (paragraph 0006, “the stents may be balloon expandable or self-expanding”, and paragraph 0007 states that the docking implants comprise stents) and a first covering attached to the first self-expanding framework (para 0007, “the anchoring or docking implants comprise stents or covered stents”), the first self-expanding framework, when expanded, comprising:
a waist portion longitudinally extending between the proximal and distal ends (fig. 23B, waist portion of 183 defined by body between the proximal and distal ends), wherein the first stent (183) defines a first lumen extending between the proximal flange and the distal flange; and
a second stent (180) comprising a second self-expanding framework (fig. 23, first docking element 180, paragraph 0006) and a second covering attached to the second self-expanding framework (paragraph 0007), the second self-expanding framework, when expanded, comprising:
a distal end portion that is coupleable, in situ, with the first stent (fig. 23, distal end of first docking element 180 connected with second docking element 183) such that the second stent extends from the proximal flange, the distal end portion defining a distal opening (fig. 23B, distal end of docking element 180 defines a distal opening to communicate with third docking element 182);
a proximal end portion defining a proximal opening (fig. 23A, proximal end portion of first docking element 180 leading to esophagus to lead into lumen);
a tubular portion extending between the distal end portion and the proximal end portion (fig. 23B, remainder of body of first docking element 180 between the distal end portion and proximal end portion as a tubular portion); and
wherein the second stent (180) defines a second lumen extending between the proximal opening and the distal opening (fig. 23B), the second lumen being in fluid communication with the first lumen while the second stent is coupled with the first stent (fig. 23B, first docking element 180 and second docking element 183 are connected and in communication with each other),
wherein the second stent comprises a material that assumes a flexible and malleable state when heated (paragraph 0095 notes that the stents can be made of polypropylene (PP), and Maddah in pg. 2 notes that PP is the most widely used thermoplastic) that can conform to a shape of the first stent such that the first stent and the second stent are coupled when the material cools to body temperature (the limitation is interpreted as functional language; paragraph 0050 of the publication of the instant specification notes that the stent be made of thermoplastic material, which Belhe states that the stents can be made of thermoplastic material. Further, paragraph 0007 describes the anchoring implant portions as “stents”).
Belhe is silent to wherein the first stent comprises a proximal flange and a distal flange, wherein the waist extends between the proximal and distal flanges, wherein the waist portion is longitudinally longer than a longitudinal length of the proximal flange and longitudinally longer than a longitudinal length of the distal flange, wherein the waist portion is a stent frame work that is radially self-expanding, and fails to teach a collar extending radially outward from the tubular portion, wherein the collar has an outer diameter that is larger as compared to an outer diameter of the tubular portion to thereby configure the collar to engage and seal against a cardia of the patient, wherein the collar comprises a self-expanding framework.
However, Thompson teaches a pyloric anchor (abstract) with a stent comprising a proximal flange and a distal flange with a waist portion in between (fig. 11, pyloric center portion 141 with anchor rings 131 on either side of it), wherein the waist portion is longer than a length of both the proximal and distal flanges (fig. 11, central portion 141 longer than either of the anchor rings 131), wherein the waist portion is a stent frame work that is radially self-expanding (paragraph 0071, “The pyloric portion 141 may be self-expanding”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe such that the first sent comprises a proximal flange and a distal flange, wherein the waist extends between the proximal and distal flanges, wherein the waist portion is longitudinally longer than a longitudinal length of the proximal flange and longitudinally longer than a longitudinal length of the distal flange, wherein the waist portion is a stent frame work that is radially self-expanding, as taught by Thompson, for the purpose of providing a suitable structure that can anchor the sleeve by utilizing structures larger than the respective opening (see Thompson, paragraph 0071), thus granting a more secure fit than with just radial force alone.
Belhe fails to teach a collar extending radially outward from the tubular portion, wherein the collar has an outer diameter that larger as compared to an outer diameter of the tubular portion to thereby configure the collar to engage and seal against a cardia of the patient, wherein the collar comprises a self-expanding framework.
However, Kagan teaches an apparatus for treatment of morbid obesity (abstract) wherein a collar (424) extending radially outward from the tubular portion has an outer diameter substantially larger than the outer diameter of the tubular portion to thereby configured to collar to engage and seal against a cardia of the patient (fig. 24D, anchor support 424 for engaging the cardia, paragraph 0138).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe to include a collar extending radially outward from the tubular portion, wherein the collar has an outer diameter that is larger as compared to an outer diameter of the tubular portion to thereby configure the collar to engage and seal against a cardia of the patient, as taught by Kagan, for the purpose of providing a suitable additional structure that can be used to anchor the sleeve in position (see Kagan, paragraph 0138) instead of just radial force alone.
Belhe, as modified by Kagan, is silent to wherein the collar comprises a self-expanding framework.
However, Belhe ‘351 teaches a similar collar on an implant (abstract) wherein the collar comprises a self-expanding framework (paragraph 0091 describes the expandable anchor 110 being self-expanding, with the flanges thereof being analogous to the collar of Kagan).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe in view of Kagan such that the collar comprises a self-expanding framework, as taught by Belhe ‘351, for the purpose of providing a suitable structure that can be compressed when entering the body for easier insertion (see Belhe ‘351, paragraph 0091).
Regarding claim 2, Belhe fails to teach the device further comprising: a tubular member comprising a flexible tube that is coupleable, in situ, with the first stent such that the flexible tube extends from the distal flange, the tubular member defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen while the second stent and the flexible tube are coupled with the first stent.
However, another embodiment of Belhe teaches the device further comprising: a tubular member (215) comprising a flexible tube that is coupleable, in situ, with the first stent (fig. 63, tubular implant 215 coupled to first stent, with fig. 77 showing a similar tubular implant 111, paragraph 0147, “proximal (i.e., stomach side) and distal (i.e., duodenal side)”) such that the flexible tube extends from the distal flange (fig. 63, tubular implant 215 at the distal end), the tubular member defining a third lumen (fig. 77, tube 111 defines a lumen), the third lumen being in fluid communication with the first lumen (Fig. 77, lumen of the tube implant 111 in communication with lumen of stent connecting between stomach and small intestine). Further, because the embodiment in fig. 23B of Belhe has the first and second lumens in fluid communication with each other, the addition of the third lumen would also be in fluid communication with the second lumen while the second stent and the flexible tube are coupled with the first stent (fig. 23B shows the two docking elements 180 and 183 in communication with each other).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe such that it further comprises a tubular member comprising a flexible tube that is coupleable, in situ, with the first stent such that the flexible tube extends from the distal flange, the tubular member defining a third lumen, the third lumen being in fluid communication with the first lumen and the second lumen while the second stent and the flexible tube are coupled with the first stent, as shown in fig. 63 of Belhe, for the purpose of providing a suitable structure that acts as a restrictive element for food passage (paragraph 0148).
Regarding claim 8, Belhe discloses wherein the material that assumes a flexible and malleable state when heated is a thermoplastic material (paragraph 0049 notes the stents made of polypropylene, a known thermoplastic material confirmed by Maddah).
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view Thompson, Kagan, and Belhe ‘351, and further in view of Walke (WO 2006014496).
Regarding claim 4, Belhe, as modified by Thompson, Kagan, and Belhe ‘351, discloses a method for reducing weight and caloric uptake of a mammal (abstract), wherein said method comprises installing the implantable device of claim 1 (see analysis of claim 1 above), into a GI tract of the patient such that
the first stent (183) is coupled to a stomach (103) of the patient and to a first portion (112) of a small intestine of the patient (fig. 23B, second docking station 183 coupled to stomach 103 and duodenum 112 of small intestine, paragraph 112), and
the second stent (180) extends within the stomach from the proximal flange of the first stent (183) to an esophagus (101) of the patient (fig. 23B, first docking station 180 extends into stomach 103 and connects between the proximal flange of second docking station 183 and esophagus 101).
Belhe fails to teach wherein the first stent is coupled to a stomach of the patient and to a first portion of a small intestine of the patient to create an anastomosis therebetween.
However, Walke teaches wherein an anastomosis formed between a portion of the small intestine (606) and the stomach (600) is well known in the art (fig. 6, second region 606 of intestine and stomach 600 are attached via anastomosis). This anastomosis is formed by an adjustable opening (608) (fig. 6, adjustable opening 608), which is generally done through a device or implant (abstract, “The devices comprise an adjustable opening to adjust the fraction of food material passing through the gastrointestinal bypass”, also see figs. 4 and 5 using tubular implant 400 and ring implant 500, respectively, to create other anastomoses), thus suggesting that the first stent of Belhe can be used to create the claimed anastomosis.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Belhe in view of Thompson, Kagan, and Belhe ‘351, such that the first stent is coupled to a stomach of the patient and to a first portion of a small intestine of the patient to create an anastomosis therebetween, as suggested by Walke, for the purpose of providing a suitable method that bypasses sections of the gastrointestinal, which reduces the total amount of food material that is absorbed by the body, thus resulting in weight loss (see Walke, pg. 10, lines 9-24).
Claims 6-7 are being rejected under 35 U.S.C. 103 as being unpatentable over Belhe in view Thompson, Kagan, and Belhe ‘351, and further in view of Dayton (US 20180271530).
Regarding claim 6, Belhe does not teach wherein the proximal flange is configured to be positioned in a stomach of the patient, and the distal flange is configured to be positioned in a jejunum of the patient.
However, Dayton teaches a stent (162) whose proximal flange is configured to be positioned in a stomach of a patient (fig. 4F, stent 162 with proximal flange 164 within body lumen 140, paragraph 0026 describes first body lumen 140 as the stomach), and the distal flange is configured to be positioned in a jejunum of the patient (fig. 4F, stent 162 with distal end 166 within body lumen 150, paragraph 0026 describes lumen 150 as the jejunum).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe such that the proximal flange is configured to be positioned in a stomach of the patient, and the distal flange is configured to be positioned in a jejunum of the patient, as taught by Dayton, for the purpose of providing a suitable structure that allows the device of Belhe to be used in a gastrojejunostomy (see Dayton, paragraph 0015)
Regarding claim 7, Belhe does not teach wherein the waist portion is configured to extend through tissue walls of the stomach and the jejunum to form a gastrojejunostomy, such that the first lumen defines an anastomosis between the stomach and the jejunum.
However, Dayton teaches wherein the waist portion is configured to extend through tissue walls of the stomach and the jejunum to form a gastrojejunostomy, such that the first lumen defines an anastomosis between the stomach and the jejunum (paragraph 0015)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Belhe such that configured to extend through tissue walls of the stomach and the jejunum to form a gastrojejunostomy, such that the first lumen defines an anastomosis between the stomach and the jejunum, as taught by Dayton, for the purpose of providing a suitable structure that allows the device of Belhe to be used in a gastrojejunostomy (see Dayton, paragraph 0015).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 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, Nicholas Weiss can be reached on (571) 270-1775. 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.
/Brandon W. Levy/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781