DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 03/09/26 have been fully considered but they are not persuasive.
On page 6, regarding 112 rejections, Applicant argues amendments overcome the 112 rejections.
The Examiner respectfully disagrees, noting the amendment to claims 1 and 14 has not clarified whether or not the two surgeries referred to are the same or not. This rejection is accordingly maintained.
On page 7 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully disagrees, noting Thompson teaches a flared truncated cone portion with cylindrical portions as is seen in Figure 17a.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: first cylindrical portion, second cylindrical portion, truncated cone portion, of each of the proximal and distal end segments.
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 first cylindrical portion, second cylindrical portion, and truncated cone portion of the proximal end segment and distal end segment 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7, 9-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1 and 14 are indefinite for claiming the gastric pouch is formed consequent “a bariatric surgery involving an anastomosis” on the patient, but it is unclear how, if at all, this bariatric surgery relates to the previously claimed anastomosis surgery (“post-anastomosis surgery leak”). The Examiner believes the surgeries might actually be the same, making this unclear.
Remaining claims are rejected for depending on an indefinite claim.
Claims 5 and 7 are indefinite for claiming the proximal (and distal) end segment, which includes the first and second cylindrical portions and truncated cone portion also includes a flared flange. The figures/description of the flange (Figure 5 items 20, 24) appear to indicate that the flange and the cylindrical/flared portions are actually the same element, making it unclear how the claim is indicating that they are all separate elements. For the purposes of examination, the Examiner will interpret the claims consistently with the specification and figures as opposed to the claims.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 9-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson et al. (US 20090012544 A1) hereinafter known as Thompson in view of Melanson et al. (US 20080208357 A1) hereinafter known as Melanson.
Regarding claim 1, Thompson discloses a method of repairing a post-anastomosis surgery (Figure 6 shows the post-anastomosis surgery; [0039] various unacceptable outcomes from the surgery are repaired) comprising:
positioning a stent (Figure 9 item 100; [0096] the sleeve includes a stent) in a gastrointestinal tract of a patient (Abstract) with the stent having a proximal end segment ([0003] proximal attachment element) in an esophagus of the patient ([0047]) and a distal end segment ([0003] distal end) in a jejunum of the patient ([0003]), and
the proximal end segment separated from the distal end segment by an expandable middle segment (part of the stent 100 between the proximal end segment and distal end segment; [0018] expandable stent), wherein the proximal end segment includes a first (188) and second (186) cylindrical portion separated by a truncated cone portion (Figure 17a shows the outwardly flared cone between the two cylindrical portions), wherein the second cylindrical portion has a diameter larger than a diameter of the first cylindrical portion (Figure 17a), and
expanding the middle segment of the stent in a gastric pouch of the patient (Figures 13-16 show the middle of the stent in the neo-stomach 160; [0058] figure 16 shows the middle portion being expandable; [0096]), the pouch being formed consequent a bariatric surgery involving an anastomosis on the patient ([0003], [0032], Figure 6),
but is silent with regards to the method being to repair a post-anastomosis surgery leak,
and with regards to the proximal end segment including two cylindrical portions having different diameters separated by the truncated cone portion.
However, regarding claim 1 Melanson teaches that leaks post-bariatric surgery can be repaired via insertion of a sleeve (Abstract). Thompson and Melanson are involved in the same field of endeavor, namely weight loss surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Thompson by using the sleeve to repair a leak as is taught by Melanson in order to utilizes the sleeve to fix both the unacceptable outcomes described by Thompson ([0039]) as well as a leak.
Regarding claim 2 the Thompson Melanson Combination teaches the method of claim 1 substantially as is claimed,
wherein Thompson further discloses the middle segment expands to fill the gastric pouch (Figure 15 shows the expansion of the middle segment 184 filling the pouch 160).
Regarding claim 9 the Thompson Melanson Combination teaches the method of claim 1 substantially as is claimed,
wherein Thompson further discloses the middle segment is substantially spherically shaped (Figure 16 item 184).
Regarding claim 10 the Thompson Melanson Combination teaches the method of claim 1 substantially as is claimed,
wherein Thompson further discloses the stent includes an elongated tube (100) formed of one or more interwoven filaments ([0058] woven shape memory portion; Figure 16 item 184).
Claim(s) 3-5, 7, 14-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson, Melanson as is applied above, further in view of Schurr (DE 10158785 A1).
Regarding claim 3 the Thompson Melanson Combination teaches the method of claim 1 substantially as is claimed,
wherein Thompson further discloses expanding the proximal end segment to an expanded diameter in the esophagus (Figure 10 item 174; [0051] the proximal portion can be an expandable stent; [0047] the proximal end can be attached to the esophagus),
and wherein the distal end segment is in the jejunum ([0003]),
but is silent with regards to whether or not the distal segment is expanded.
However, regarding claim 3 Schurr teaches that bariatric-surgery sleeves can include a mechanism to attach the distal end of the sleeve to the intestine (page 2, paragraph 11 “on the first and the second tubular end sections 2, 3 there are fixing devices (not shown), by means of which the end sections 2, 3 can be fixed to organ parts of the patient; Abstract teaches the distal end 3 connects to the intestine). Thompson and Schurr are involved in the same field of endeavor, namely weight loss surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Combination by having the distal end of the tube include a mechanism to prevent movement and leakage around the distal end of the sleeve in addition to the proximal end of the sleeve, as is taught by Schurr in order to ensure both ends are securely implanted and non-moving thus increasing the security of the device after implantation and increasing patient safety.
Further, regarding claim 14 it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the distal end connection mechanism (“fixing devices”) of the Combination so that it is expandable, since Thompson already teaches this type of connection is known in the art (Figure 10 item 174; [0051] the flared proximal portion can be an expandable stent), and the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection mechanism would have been obvious to try.
Regarding claim 4 the Thompson Melanson Schurr Combination teaches the method of claim 3 substantially as is claimed,
wherein the Combination further teaches the middle segment has an expanded diameter greater than the expanded diameter of the proximal end segment and the expanded diameter of the distal end segment (Schurr teaches the middle section of the device is bulged relative to the end sections (page 2 paragraph 4 “a hollow middle section between the first and second end portion that is relative to the end portions is bulged and connected to them”.).
Regarding claim 5 the Thompson Melanson Schurr Combination teaches the method of claim 3 substantially as is claimed,
wherein Thompson further teaches the proximal end segment includes the first and second cylindrical portions separated by the truncated cone portion (Figure 17a), and the proximal end portion defines a flared flange that is expanded against a wall of the esophagus (Figure 10 item 174; [0051] the proximal portion can be a flared expandable stent; [0047] the proximal end can be attached to the esophagus).
Regarding claim 7 the Thompson Melanson Schurr Combination teaches the method of claim 3 substantially as is claimed,
wherein Thompson further discloses the distal end segment is positioned within the jejunum ([0003])
and Schurr further teaches the end section can be positioned against the wall (page 2 paragraph 11 “fixing devices (not shown), by means of which the end sections 2, 3 can be fixed to organ parts of the patient”),
but is silent with regards to the distal end segment including the two cylindrical portions and truncated portion and flared flange.
However, regarding claim 7 it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the distal end connection mechanism (“fixing devices”) of the Combination so that it is flared and expandable, with a first and second cylindrical portion of differing diameters separated by a truncated cone with a flared flange, since Thompson already teaches this type of connection is known in the art (Figure 10 item 174; [0051] the flared proximal portion can be an expandable stent; Figure 17a shows first and second cylindrical sections 188, 186, with a flared truncated cone therebetween), and the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection mechanism in the distal end section would have been obvious to try.
Regarding claim 14 Thompson discloses a method of repairing a post-anastomosis surgery (Figure 6 shows the post-anastomosis surgery; [0039] various unacceptable outcomes from the surgery are repaired) comprising:
positioning a stent (Figure 9 item 100; [0096] the sleeve includes a stent) in a gastrointestinal tract of a patient (Abstract), the stent having a flared proximal end segment ([0003] proximal attachment element with an outwardly biased funnel) in an esophagus of the patient ([0047]), and a distal end segment ([0003] distal end) in a jejunum of the patient ([0003]),
the flared proximal end segment separated from the distal end segment by an expandable middle segment (part of the stent 100 between the proximal end segment and distal end segment; [0018] expandable stent), wherein the proximal end segment includes a first (188) and second (186) cylindrical portion separated by a truncated cone portion (Figure 17a shows the outwardly flared cone between the two cylindrical portions), wherein the second cylindrical portion has a diameter larger than a diameter of the first cylindrical portion (Figure 17a), and
expanding the flared proximal end segment in the esophagus to an expanded diameter (Figure 10 item 174; [0051] the flared proximal portion can be an expandable stent),
placing the distal end segment in the jejunum ([0003]), and
expanding the middle segment of the stent to an expanded diameter in a gastric pouch of the patient (Figures 13-16 show the middle of the stent in the neo-stomach 160; [0058] figure 16 shows the middle portion being expandable; [0096]), the gastric pouch being formed consequent a bariatric surgery involving an anastomosis on the patient ([0003], [0032], Figure 6),
but is silent with regards to the method being to repair a post-anastomosis surgery leak,
and the distal end being flared and expandable.
However, regarding claim 14 Melanson teaches that leaks post-bariatric surgery can be repaired via insertion of a sleeve (Abstract). Thompson and Melanson are involved in the same field of endeavor, namely weight loss surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of Thompson by using the sleeve to repair a leak as is taught by Melanson in order to utilizes the sleeve to fix both the unacceptable outcomes described by Thompson ([0039]) as well as a leak.
Further, regarding claim 14 Schurr teaches that bariatric-surgery sleeves can include a mechanism to attach the distal end of the sleeve to the intestine (page 2, paragraph 11 “on the first and the second tubular end sections 2, 3 there are fixing devices (not shown), by means of which the end sections 2, 3 can be fixed to organ parts of the patient; Abstract teaches the distal end 3 connects to the intestine). Thompson and Schurr are involved in the same field of endeavor, namely weight loss surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Combination by having the distal end of the tube include a mechanism to prevent movement and leakage around the distal end of the sleeve in addition to the proximal end of the sleeve, as is taught by Schurr in order to ensure both ends are securely implanted and non-moving thus increasing the security of the device after implantation and increasing patient safety.
Further, regarding claim 14 it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the distal end connection mechanism (“fixing devices”) of the Combination so that it is flared and expandable, since Thompson already teaches this type of connection is known in the art (Figure 10 item 174; [0051] the flared proximal portion can be an expandable stent), and the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known connection mechanism would have been obvious to try.
Regarding claim 15 the Thompson Melanson Schurr Combination teaches the method of claim 14 substantially as is claimed,
wherein the Combination further teaches the expanded diameter of the middle segment is greater than the expanded diameter of the proximal end segment and distal end segment (Schurr teaches the middle section of the device is bulged relative to the end sections (page 2 paragraph 4 “a hollow middle section between the first and second end portion that is relative to the end portions is bulged and connected to them”.).
Regarding claim 16 the Thompson Melanson Schurr Combination teaches the method of claim 14 substantially as is claimed,
wherein the Combination further teaches the flared distal end segment includes the first and second cylindrical segments, the first cylindrical segment extending between the flared distal end segment and the middle segment, wherein the first cylindrical segment has an expanded diameter less than the expanded diameter of the flared distal end segment and the expanded diameter of the middle segment (As can be seen in Thompson, the proximal connection of Thompson (modified to be placed on a distal end of the sleeve as well in the rejection to claim 14) is seen to have a cylindrical segment extending between a middle area and a flared end segment, so the cylindrical segment has an expanded diameter less than both (Thompson Figure 17a item 188).).
Regarding claim 17 the Thompson Melanson Schurr Combination teaches the method of claim 14 substantially as is claimed,
wherein Thompson further discloses the flared proximal end segment includes the first and second cylindrical segments, the first cylindrical segment extending between the flared proximal end segment and the middle segment, wherein the first cylindrical segment has an expanded diameter less than the expanded diameter of the flared proximal end segment and the middle segment (Figure 17a item 188).
Regarding claim 18 the Thompson Melanson Schurr Combination teaches the method of claim 14 substantially as is claimed,
wherein Thompson further discloses the middle segment expanded to fill the gastric pouch (Figure 15 shows the expansion of the middle segment 184 filling the pouch 160).
Regarding claim 19 the Thompson Melanson Schurr Combination teaches the method of claim 18 substantially as is claimed,
wherein Thompson further discloses the middle segment is substantially spherically shaped (Figure 16 item 184).
Claim(s) 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson and Melanson as is applied above, further in view of Levine et al. (US 20060161172 A1), hereinafter known as Levine.
Regarding claim 11 the Thompson Melanson Combination teaches the method of claim 10 substantially as is claimed,
wherein Thompson further discloses the stent includes a polymer cover extending along an exterior surface of the tube ([0045] Harmony coating from Surmodics),
but is silent with regards to the cover extending along the entire exterior surface of the tube, and it being configured to prevent tissue-ingrowth into the tube.
However, regarding claim 11 Levine teaches that intestinal tube coatings can coat an entire exterior surface of a tubular implant ([0069] the outer layer covers the exterior of the stent) and can be configured to prevent tissue ingrowth into the tube ([0066], [0071] the exterior surface outer layer prevents tissue ingrowth). Thompson and Levine are involved in the same field of endeavor, namely removeable gastrointestinal implants. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Combination to have the outer coating be polymer, along the entire exterior surface, and being able to prevent ingrowth as is taught by Levine in order to ensure the device in question is able to adequately act as a conduit without leaking, and also ensuring that once the device is no longer needed (Thompson [0078]), it is easily removeable since it prevents ingrowth.
Claim(s) 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson, Melanson, and Levine as is applied above, further in view of Dann et al. (US 20070010866 A1) hereinafter known as Dann.
Regarding claim 12 the Thompson Melanson Levine Combination teaches the method of claim 11 substantially as is claimed,
but is silent with regards to the polymer cover comprises or is coated with a material that swells in-situ.
However, regarding claim 12 Dann teaches that implants can be coated with a material that swells in-situ ([0127]). Thompson and Dann are involved in the same field of endeavor, namely gastrointestinal implants. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Levine Combination so that the areas of the implant that attach to adjacent tissue create an enhanced sealing in those areas, thus ensuring direct and secure connection to adjacent tissue, and ultimately increasing safety for the patient.
Claim(s) 13, 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson and Melanson as is applied above, further in view of Kagan et al. (US 20040092892 A1) hereinafter known as Kagan.
Regarding claim 13 the Thompson Melanson Combination teaches the method of claim 1 substantially as is claimed,
but is silent with regards to there being a valve configure to prevent reflux through the tube.
However, regarding claim 13 Kagan teaches wherein bariatric surgical sleeves ([0033]) can include a valve ([0308]) configured to prevent reflux through the sleeve ([0308]). Thompson and Kagan are involved in the same field of endeavor, namely weight loss surgeries. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Combination so that there is a valve within the stent as is taught by Kagan in order to prevent the commonly experienced reflux, thus ensuring increased patient comfort and safety.
Regarding claim 21 the Thompson Melanson Kagan Combination teaches the method of claim 13 substantially as is claimed,
wherein Kagan further teaches the valve is disposed in the proximal segment ([0308]).
Claim(s) 20, 22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thompson, Melanson, and Schurr as is applied above, further in view of Kagan as is applied above.
Regarding claim 20 the Thompson Melanson Schurr Combination teaches the method of claim 14 substantially as is claimed,
but is silent with regards to there being a valve configure to prevent reflux through the tube.
However, regarding claim 20 Kagan teaches wherein bariatric surgical sleeves ([0033]) can include a valve ([0308]) configured to prevent reflux through the sleeve ([0308]). Thompson and Kagan are involved in the same field of endeavor, namely weight loss surgeries. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method of the Thompson Melanson Combination so that there is a valve within the stent as is taught by Kagan in order to prevent the commonly experienced reflux, thus ensuring increased patient comfort and safety.
Regarding claim 22 the Thompson Melanson Schurr Kagan Combination teaches the method of claim 20 substantially as is claimed,
wherein Kagan further teaches the valve is disposed in the proximal segment ([0308]).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 03/16/26