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 Arguments
The amendments/ arguments, dated 6/15/2026, have overcome:
The objection(s) to claim(s) 3, 6, 11, 13, 15-16, 18-19;
The rejection of claim(s) 1-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 1-3, 8-9, 11-14, 16, 18-19 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Abu Dayyeh (US 2020/0390580 A1 – as previously cited);
The rejection of claim(s) 1-5, 8-9 under 35 U.S.C. 103 based on Gupta et al. (US 2019/0298559 A1 – as previously cited) and Abu Dayyeh (US 2020/0390580 A1 – as previously cited);
The aforementioned objections/ rejections have been withdrawn.
Claim Objections
Claim(s) 13, 16, 19-20 is/are objected to because of the following informalities:
Within claim 13, line 2: “a length” should be replaced with --the length-- (to properly link with the length within claim 11, line 14).
Within claim 13, line 2: “the distant” should be replaced with --a distance--.
Within claim 16, line 4: “the stomach” should be replaced with --a stomach--.
Within claim 19, lines 2-3 (and claim 19, line 4): “the connector” should be replaced with --the elongate connector-- (to properly link with the elongate connector within claim 16 and maintain consistent claim terminology with claims 18-20).
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(s) 1-3, 8-9, 11-14, 16, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 2020/0390580 A1 – as previously cited) in view of Birk et al. (US 2012/0221037 A1).
With respect to claim 1:
Abu Dayyeh discloses the invention substantially as claimed. Specifically, Abu Dayyeh discloses a system, as can be seen in figs. 1-5, for forming a gastric bypass in a patient, said system comprising:
a first implantable medical device (bypass device 70) configured to form an anastomosis between a stomach and a portion of a jejunum of the patient (portions of anchor member 72 can be located in the stomach and the jejunum) (paragraphs [0042-0043]);
a second implantable medical device (occlusion member 56) configured to occlude a pylorus of the patient (paragraphs [0036, 0040]); and
a connector (expandable coil 100) coupling said first implantable medical device (bypass device 70) and said second implantable medical device (occlusion member 56) (paragraph [0050]);
Wherein said connector (expandable coil 100) has a length sufficient to extend between the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) in the stomach (paragraph [0050]).
However, Abu Dayyeh does not disclose the length of the connector (expandable coil 100) being incapable of/ without itself exerting force on either the first implantable medical device (bypass device 70) or the second implantable medical device (occlusion member 56) as a result of connecting the implantable medical devices (bypass device 70 and occlusion member 56).
Birk et al. teaches a system, as can be seen in figs. 12-14, comprising first and second implantable medical devices (cardiac and pyloric elements 12, 26) configured to be implanted within the stomach of a patient (paragraphs [0146-0149]). The first and second implantable medical devices (cardiac and pyloric elements 12, 26) are coupled to each other via either a “straight” (i.e. not coiled/ anatomy matching) or coiled connector (connecting element 25) which has a length sufficient to extend between the implantable medical devices (cardiac and pyloric elements 12, 26) while in the stomach without itself exerting a force on with the implantable medical devices (cardiac and pyloric elements 12, 26) as a result of the connection thereof (the length of the connecting element 25 is made to match the curvature of the body and hold the cardiac and pyloric elements 12, 26 in their desired positions (thus will not be pushing on them or pulling on them which would contribute to dislodgement/ migration)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” (i.e. not coiled/ anatomy matching) style connector (connecting element 25), as seen in fig. 12 of Birk et al., as Birk et al. teaches “straight” and coiled connectors can be used interchangeably within the stomach when holding two structures in spaced a relationship (where dislodgement/ migration is undesirable). In making the aforementioned combination, Examiner is merely replacing the shape of the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” shape of the connector (connecting element 25), as seen in fig. 12 of Birk et al., such that new connector will be straight and span between the implantable medical devices (bypass device 70 and occlusion member 56), as disclosed by Abu Dayyeh, and will have/ maintain a length which will match the distance between the implantable medical devices (bypass device 70 and occlusion member 56) (so as to reduce the risks of dislodgement) and will not naturally exert a force thereto due to the connection thereof.
With respect to claim(s) 2, 12:
Wherein said connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), has a connector configuration (“straight” structure), said first implantable medical device (bypass device 70) has a first configuration (structure defining the bypass device 70) and said second implantable medical device (occlusion member 56) has a second configuration (structure defining the occlusion member 56); and said connector a configuration (“straight” structure) distinct from the first configuration (structure defining the bypass device 70) of said first implantable medical device (bypass device 70) and the second configuration (structure defining the occlusion member 56) of said second implantable medical device (occlusion member 56), as can be seen in figs. 2-5 of Abu Dayyeh.
With respect to claim(s) 3, 13:
Wherein said connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), is elongated (“straight”) and has a length capable of extending from said first implantable medical device (bypass device 70) when implanted to create the anastomosis between the stomach and the jejunum and said second implantable medical device (occlusion member 56) when implanted across the pylorus when no migration force is exerted on (so as to reduce the risks of dislodgement) said implantable medical devices (bypass device 70 and occlusion member 56), as can be seen in figs. 4-5.
With respect to claim(s) 8, 14:
Wherein said connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), is formed separately from said first implantable medical device (bypass device 70) and said second implantable medical device (occlusion member 56). (Claim 8 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a connector which is separate from (has a distinct structure from) the first and second implantable medical devices. Manufacturing steps such as forming separately are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. In the instant case, the first and second implantable medical device (bypass device 70 and occlusion member 56) is considered “separate” from the connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), as they do not take up the same space as each other and are made from different structures.)
With respect to claim 9:
Wherein:
said first implantable medical device (bypass device 70) is configured to anchor, via said connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), said second implantable medical device (occlusion member 56) against migrating distally from the stomach (prevents migration) (paragraph [0050]); and
said second implantable medical device (occlusion member 56) is configured to anchor, via said connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), said first implantable medical device (bypass device 70) against migrating distally from the stomach (prevents migration) (paragraph [0050]).
With respect to claim 11:
Abu Dayyeh discloses the invention substantially as claimed. Specifically, Abu Dayyeh discloses a system, as can be seen in figs. 1-5, for maintaining a pair of implantable medical devices (bypass device 70 and occlusion member 56) in place with respect to respective deployment sites for said pair of implantable medical devices (bypass device 70 and occlusion member 56), said system comprising:
a first implantable medical device (bypass device 70) (paragraphs [0042-0043]);
a second implantable medical device (occlusion member 56) (paragraphs [0036, 0040]); and
a connector (expandable coil 100) coupling said first implantable medical device (bypass device 70) and said second implantable medical device (occlusion member 56) (paragraph [0050]);
wherein:
the deployment sites are at anatomical environments tending to drive said first implantable medical device (bypass device 70) and said second implantable medical device (occlusion member 56) apart from each other;
each of said implantable medical devices (bypass device 70 and occlusion member 56) is configured to hold the other of said implantable medical devices (bypass device 70 and occlusion member 56) in place via said connector (expandable coil 100) (prevents migration) (paragraph [0050]); and
Wherein said connector (expandable coil 100) has a length sufficient to extend between the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) in the stomach (paragraph [0050]).
However, Abu Dayyeh does not disclose the length of the connector (expandable coil 100) being incapable of/ without itself exerting force on either the first implantable medical device (bypass device 70) or the second implantable medical device (occlusion member 56) as a result of connecting the implantable medical devices (bypass device 70 and occlusion member 56).
Birk et al. teaches a system, as can be seen in figs. 12-14, comprising first and second implantable medical devices (cardiac and pyloric elements 12, 26) configured to be implanted within the stomach of a patient (paragraphs [0146-0149]). The first and second implantable medical devices (cardiac and pyloric elements 12, 26) are coupled to each other via either a “straight” (i.e. not coiled/ anatomy matching) or coiled connector (connecting element 25) which has a length sufficient to extend between the implantable medical devices (cardiac and pyloric elements 12, 26) while in the stomach without itself exerting a force on with the implantable medical devices (cardiac and pyloric elements 12, 26) as a result of the connection thereof (the length of the connecting element 25 is made to match the curvature of the body and hold the cardiac and pyloric elements 12, 26 in their desired positions (thus will not be pushing on them or pulling on them which would contribute to dislodgement/ migration)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” (i.e. not coiled/ anatomy matching) style connector (connecting element 25), as seen in fig. 12 of Birk et al., as Birk et al. teaches “straight” and coiled connectors can be used interchangeably within the stomach when holding two structures in spaced a relationship (where dislodgement/ migration is undesirable). In making the aforementioned combination, Examiner is merely replacing the shape of the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” shape of the connector (connecting element 25), as seen in fig. 12 of Birk et al., such that new connector will be straight and span between the implantable medical devices (bypass device 70 and occlusion member 56), as disclosed by Abu Dayyeh, and will have/ maintain a length which will match the distance between the implantable medical devices (bypass device 70 and occlusion member 56) (so as to reduce the risks of dislodgement) and will not naturally exert a force thereto due to the connection thereof.
With respect to claim 16:
Abu Dayyeh discloses the invention substantially as claimed. Specifically, Abu Dayyeh discloses a method of forming a gastric bypass, said method comprising:
implanting a first implantable medical device (bypass device 70) across an apposed portion of a stomach wall and portion of a jejunum to form an anastomosis between a stomach and the jejunum (portions of anchor member 72 can be located in the stomach and the jejunum) (paragraphs [0042-0043, 0046, 0048]);
implanting a second implantable medical device (occlusion member 56) in a pylorus to at least partially occlude the pylorus (paragraphs [0036, 0040, 0046-0047]); and
coupling the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) with an elongated connector (expandable coil 100) (paragraph [0050]) having a length sufficient to extend between the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) in the stomach (paragraph [0050]).
However, Abu Dayyeh does not disclose the length of the connector (expandable coil 100) being incapable of/ without itself exerting force on either the first implantable medical device (bypass device 70) or the second implantable medical device (occlusion member 56) as a result of connecting the implantable medical devices (bypass device 70 and occlusion member 56).
Birk et al. teaches a system, as can be seen in figs. 12-14, comprising first and second implantable medical devices (cardiac and pyloric elements 12, 26) configured to be implanted within the stomach of a patient (paragraphs [0146-0149]). The first and second implantable medical devices (cardiac and pyloric elements 12, 26) are coupled to each other via either a “straight” (i.e. not coiled/ anatomy matching) or coiled connector (connecting element 25) which has a length sufficient to extend between the implantable medical devices (cardiac and pyloric elements 12, 26) while in the stomach without itself exerting a force on with the implantable medical devices (cardiac and pyloric elements 12, 26) as a result of the connection thereof (the length of the connecting element 25 is made to match the curvature of the body and hold the cardiac and pyloric elements 12, 26 in their desired positions (thus will not be pushing on them or pulling on them which would contribute to dislodgement/ migration)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” (i.e. not coiled/ anatomy matching) style connector (connecting element 25), as seen in fig. 12 of Birk et al., as Birk et al. teaches “straight” and coiled connectors can be used interchangeably within the stomach when holding two structures in spaced a relationship (where dislodgement/ migration is undesirable). In making the aforementioned combination, Examiner is merely replacing the shape of the coiled style connector (expandable coil 100), as disclosed by Abu Dayyeh, with the “straight” shape of the connector (connecting element 25), as seen in fig. 12 of Birk et al., such that new connector will be straight and span between the implantable medical devices (bypass device 70 and occlusion member 56), as disclosed by Abu Dayyeh, and will have/ maintain a length which will match the distance between the implantable medical devices (bypass device 70 and occlusion member 56) (so as to reduce the risks of dislodgement) and will not naturally exert a force thereto due to the connection thereof.
With respect to claim 18:
Wherein coupling the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) with the elongated connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), is performed after implanting the first implantable medical device (bypass device 70) and the second implantable medical device (occlusion member 56) (the first and second implantable medical devices (bypass device 70 and occlusion member 56) are implanted in separate steps, as such the connection therebetween created by the elongated connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), must be done after the first and second implantable medical devices (bypass device 70 and occlusion member 56) are implanted) (paragraphs [0048, 0050]).
With respect to claim 19:
Further comprising anchoring the second implantable medical device (occlusion member 56) against migrating distally from the stomach via the connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), and the first implantable medical device (bypass device 70), and anchoring the first implantable medical device (bypass device 70) against migrating distally from the stomach via the connector, as disclosed by Abu Dayyeh as modified by Birk et al. (as discussed above), and the first implantable medical device (occlusion member 56) (paragraph [0050]).
Claim(s) 1-5, 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (US 2019/0298559 A1 – as previously cited) in view of Birk et al. (US 2012/0221037 A1).
With respect to claim 1:
Gupta et al. discloses the invention substantially as claimed. Specifically, Gupta et al. discloses
a system, as can be seen in figs. 2F, for forming a gastric bypass in a patient, said system comprising:
a first implantable medical device (anastomosis stent 260) configured to form an anastomosis between the stomach and a portion of the jejunum of the patient (paragraphs [0029-0030]);
a second implantable medical device (pyloric occlusion device 265/ 700), as can be seen in figs. 2F and 7, configured to occlude a pylorus of the patient (paragraphs [0030, 0035]).
However, Gupta et al. does not disclose a connector (nor the specifics thereof) coupling said first implantable medical device (anastomosis stent 260) and said second implantable medical device (pyloric occlusion device 265/ 700).
Birk et al. teaches a system, as can be seen in figs. 12-14, comprising first and second implantable medical devices (cardiac and pyloric elements 12, 26) configured to be implanted within the stomach of a patient (paragraphs [0146-0149]). The first and second implantable medical devices (cardiac and pyloric elements 12, 26) are coupled to each other via either a “straight” (i.e. not coiled/ anatomy matching) connector (connecting element 25) which has a length sufficient to extend between the implantable medical devices (cardiac and pyloric elements 12, 26) while in the stomach without itself exerting a force on with the implantable medical devices (cardiac and pyloric elements 12, 26) as a result of the connection thereof (the length of the connecting element 25 is made to match the curvature of the body and hold the cardiac and pyloric elements 12, 26 in their desired positions (thus will not be pushing on them or pulling on them which would contribute to dislodgement/ migration)).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to add the “straight” (i.e. not coiled/ anatomy matching) connector (connecting element 25), as seen in fig. 12 of Birk et al., between the first implantable medical device (anastomosis stent 260) and said second implantable medical device (pyloric occlusion device 265/ 700), as disclosed by Gupta et al., as Birk et al. teaches connectors can be used within the stomach to maintain the spacial relationship between two implantable structures to ais in the anchoring (where dislodgement/ migration is undesirable).
With respect to claim 2:
Wherein said connector, as taught by Birk et al. (as discussed above), has a connector configuration (“straight” structure), said first implantable medical device (anastomosis stent 260) has a first configuration (structure defining the anastomosis stent 260) and said second implantable medical device (pyloric occlusion device 265/ 700) has a second configuration (structure defining the pyloric occlusion device 265/ 700); and said connector a configuration (“straight” structure) distinct from the first configuration (structure defining the anastomosis stent 260) of said first implantable medical device (anastomosis stent 260) and the second configuration (structure defining the pyloric occlusion device 265/ 700) of said second implantable medical device (pyloric occlusion device 265/ 700).
With respect to claim 3:
Wherein said connector, as taught by Birk et al. (as discussed above), is elongated (“straight”) and has a length capable of extending from said first implantable medical device (anastomosis stent 260) when implanted to create the anastomosis between the stomach and the jejunum and said second implantable medical device (pyloric occlusion device 265/ 700) when implanted across the pylorus when no migration force is exerted on (so as to reduce the risks of dislodgement) said implantable medical devices (anastomosis stent 260 and pyloric occlusion device 265/ 700).
With respect to claim 4:
Wherein:
said first implantable medical device (anastomosis stent 260), as disclosed by Gupta et al., is a stent (anastomosis stent 260) configured to maintain patency of the anastomosis (paragraph [0029]), said stent (anastomosis stent 260) comprising a saddle region, as can be seen in fig. 2F, configured to extend through the stomach wall and a portion of a wall of the jejunum, a proximal retention member, as can be seen in fig. 2F, extending radially outwardly from a proximal end of said saddle region and configured to be seated within the stomach to inhibit distal migration of said first implantable medical device (anastomosis stent 260) away from the stomach, and a distal retention member, as can be seen in fig. 2F, extending radially outwardly from a distal end of said saddle region and configured to be seated within the jejunum to inhibit proximal migration of said first implantable medical device (anastomosis stent 260) into the stomach;
said second implantable medical device (pyloric occlusion device 265/ 700), as disclosed by Gupta et al., has a saddle region (saddle 715) configured to occlude flow of material therethrough, a proximal retention member (second flange 710) extending radially outwardly from a proximal end of said saddle region (saddle 715) and configured to be seated within the stomach to inhibit distal migration of said second implantable medical device (pyloric occlusion device 265/ 700) away from the stomach, and a distal retention member (first saddle 705) extending radially outwardly from a distal end of said saddle region (saddle 715) and configured to be seated within the duodenum of the patient to inhibit proximal migration of said second implantable medical device (pyloric occlusion device 265/ 700) into the stomach (paragraphs [0035, 0039]) ; and
said connector as taught by Birk et al. (as discussed above), is an elongated element coupling said first implantable medical device (anastomosis stent 260) and said second implantable medical device (pyloric occlusion device 265/ 700) (as discussed above).
With respect to claim 5:
Wherein said connector as taught by Birk et al. (as discussed above), is coupled to (connected directly or indirectly) at least one of the proximal retention members (as discussed above).
With respect to claim 8:
Wherein said connector, as taught by Birk et al. (as discussed above), is formed separately from said first implantable medical device and said second implantable medical device. (Claim 8 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a connector which is separate from the first and second implantable medical devices. Manufacturing steps such as forming separately are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. In the instant case, the first and second implantable medical device (anastomosis stent 260 and pyloric occlusion device 265/ 700), as disclosed Gupta et al., is considered “separate” from the connector as taught by Birk et al. (as discussed above), as they do not take up the same space as each other, thus they are “separate”.)
With respect to claim 9:
Wherein: said first implantable medical device (anastomosis stent 260), as disclosed by Gupta et al., anchors, via said connector, as taught by Birk et al. (as discussed above), said second implantable medical device (pyloric occlusion device 265/ 700), as disclosed by Gupta et al., against migrating distally from the stomach (as discussed above); and
said second implantable medical device (pyloric occlusion device 265/ 700), as disclosed by Gupta et al., anchors, via said connector, as taught by Birk et al. (as discussed above), said first implantable medical device (anastomosis stent 260), as disclosed by Gupta et al., against migrating distally from the stomach (as discussed above).
Allowable Subject Matter
Claim(s) 6-7, 10, 15, 17, 20 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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:
With respect to claim(s) 6, 10, 15, 17, 20: see the reasons for indicating allowable subject matter within the office action dated 4/1/2026.
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 REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
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