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
The claims filed on May 5th, 2026, have been entered. Claims 38-57 remain pending in the Application. The claim amendments overcome the previous claim objections and 112(b) rejections.
Response to Arguments
Some of Applicant's arguments filed May 5th, 2026, have been fully considered but they are not persuasive.
Regarding the rejections under Gronberg et al. (Pub. No. 2017/0281301), Applicant argues that Gronberg et al. does not disclose the new claim limitation “a pump…configured to temporarily apply a negative pressure to the cavity to aid a healing process of the anastomosis” because the vacuum applied by Gronberg et al. is used for diagnostic leakage testing or as a remedial measure to manage an existing leak ([0089]). Examiner respectfully disagrees. Gronberg et al. states in [0006] that “a major issue regarding anastomosis healing is blood circulation of the anastomosis during the healing process,” that “ischemia and inflammation, which are natural parts of the healing process, may cause leakage,” and that “by relieving pressure and faecal stream from the anastomosis during the healing process, the leakage incident may be reduce and fatal consequences of anastomotic dehiscence can be avoided,” so even if all Gronberg et al. does is to apply a negative pressure to manage an existing leak, the pressure is aiding in the healing process of the anastomosis.
Applicant’s arguments regarding the combination of Gronberg et al. in view of Bonde (Pub. No. 2016/0151553), see Remarks, filed May 5th, 2026, with respect to the rejection(s) of claim(s) 39-41 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gronberg et al.
Claim Rejections - 35 USC § 102
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) 38-46 and 48-56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gronberg et al. (Pub. No. 2017/0281301).
Regarding claim 38, Gronberg et al. discloses a system for anastomosis of a tubular structure ([0061]), the system comprising: a device (10; FIG. 1A) configured such that, when the device is arranged in the tubular structure (90), an anastomosis is obtained in the tubular structure ([0074] an anastomosis is formed when 10 is fitted into 90; FIG. 9) and a cavity (203) is formed between the device and the tubular structure (FIG. 20A: 203 is between 10 and 90); and a pump ([0089] a pump can be connected to the ends of 16) in fluid communication with the cavity ([0089] the pump is in fluid communication to 203) and configured to temporarily apply a negative pressure to the cavity to aid a healing process of the anastomosis ([0089] the pump can apply a vacuum, which is a negative pressure system, to 203; [0006] the vacuum can be used to address leaks which may cause health problems and thereby aids the healing process).
Regarding claim 39, Gronberg et al. further discloses the pump is configured to apply the negative pressure to the cavity periodically (since this limitation is functional language, the pump only needs to be capable of periodic negative pressure; since [0089] discloses the pump can be turned on and off to apply vacuums to cavities as needed, the pump can provide a vacuum, then be turned off to be moved, then can be turned on again to apply a vacuum to a new anastomosis region).
Regarding claim 40, Gronberg et al. further discloses the period at which the pump is configured to apply the negative pressure to the cavity is inversely proportional to the heart rate of a patient having the tubular structure (as explained in claim 39, this limitation is functional, and an operator can turn the pump on and off at a rate which is inversely proportional to the heart rate of the patient being operated on).
Regarding claim 41, Gronberg et al. further discloses the period at which the pump is configured to apply the negative pressure to the cavity is an integer multiple of the time between consecutive heartbeats of a patient having the tubular structure (as explained in claim 39, this limitation is functional, and an operator can turn the pump on and off at a rate which is an integer multiple of the time between consecutive heartbeats of a patient).
Regarding claim 42, Gronberg et al. further discloses the magnitude of the negative pressure is lower than the magnitude of the diastolic pressure of a patient having the tubular structure ([0089] the pump is capable of applying a vacuum, which is inherently a negative pressure system and significantly lower than the diastolic pressure of a patient, to 203).
Regarding claim 43, Gronberg et al. further discloses at least one catheter (16) in fluid communication with the cavity at a first end (FIG. 20B: 16 are fluidly connected to 203 at the distal end), and in fluid communication with the pump at a second end ([0089] the proximal ends of the 16 are fluidly connected to the pump).
Regarding claim 44, Gronberg et al. further discloses the at least one catheter comprises at least two catheters ([0063] four catheters 16; FIG. 1B).
Regarding claim 45, Gronberg et al. further discloses a first catheter of the at least two catheters is configured as an inlet to the cavity for a contrast medium ([0089] one of 16 can be used to supply contrast medium to 203), and a second catheter of the at least two catheters is configured as an outlet from the cavity for the contrast medium ([0089] another of 16 is capable of being used to provided suction in the form of a vacuum to remove the liquids present, which inherently includes any contrast medium).
Regarding claim 46, Gronberg et al. further discloses the at least two catheters comprise four catheters ([0063] four catheters 16; FIG. 1B).
Regarding claim 48, Gronberg et al. further discloses the tubular structure comprises a first part (FIG. 20B: the part of 90 corresponding to 11) and a second part (FIG. 20B: the part of 90 corresponding to 13), and the device is configured such that, when the device is arranged in the tubular structure: the anastomosis is obtained at a contact area between the first part of the tubular structure and the second part of the tubular structure (FIGs. 20A-20B: the anastomosis between two parts of 90 is created at the contact between 11 and 13); and the cavity is formed between the device, the first part of the tubular structure and the second part of the tubular structure (FIG. 20B: the cavity is formed between the parts of 90 corresponding to 11 and 13, and 10).
Regarding claim 49, Gronberg et al. further discloses the device comprises a first member (11) and a second member (13) of generally hollow open configurations (FIG. 1A) such that, when the device is arranged in the tubular structure, the anastomosis is obtained at a contact area between the first and second members and the cavity is formed between the first and second members (FIGs. 20A-20B: the anastomosis between two parts of 90 is created at the contact between 11 and 13) and the tubular structure (FIG. 20B: the cavity is formed between 11, 13, and 10).
Regarding claim 50, Gronberg et al. discloses a method for anastomosis of a tubular structure ([0061]), the method comprising: arranging a device (10) in a tubular structure (90; [0074] 10 is arranged in 90; FIG. 20A) such that an anastomosis is obtained in the tubular structure (FIG. 20A: anastomosis is formed between two parts of 90) and a cavity (203) is formed between the device and the tubular structure (FIG. 20A: 203 is between 10 and 90); and applying a negative pressure to the cavity temporarily using a pump in fluid communication with the cavity to aid a healing process of the anastomosis ([0089] a pump can apply a vacuum, which is a negative pressure system, to 203; [0006] the vacuum can be used to address leaks which may cause health problems and thereby aids the healing process).
Regarding claim 51, Gronberg et al. further discloses applying the negative pressure to the cavity periodically ([0089] discloses the pump can be turned on and off to apply vacuums to cavities as needed, the pump can provide a vacuum, then be turned off to be moved, then can be turned on again to apply a vacuum to a new anastomosis region).
Regarding claim 52, Gronberg et al. further discloses the period at which the pump is configured to apply the negative pressure to the cavity is inversely proportional to the heart rate of a patient having the tubular structure (this limitation is functional, and an operator can turn the pump on and off at a rate which is inversely proportional to the heart rate of the patient being operated on).
Regarding claim 53, Gronberg et al. further discloses the period at which the pump is configured to apply the negative pressure to the cavity is an integer multiple of the time between consecutive heartbeats of a patient having the tubular structure (this limitation is functional, and an operator can turn the pump on and off at a rate which is an integer multiple of the time between consecutive heartbeats of a patient).
Regarding claim 54, Gronberg et al. further discloses the magnitude of the negative pressure is lower than the magnitude of the diastolic pressure of a patient having the tubular structure ([0089] the pump is capable of applying a vacuum, which is inherently a negative pressure system and significantly lower than the diastolic pressure of a patient, to 203).
Regarding claim 55, Gronberg et al. further discloses arranging at least one catheter between the pump and the cavity ([0063] four catheters 16; FIG. 1B), such that a first end of the catheter is in fluid communication with the cavity (FIG. 20B: 16 are fluidly connected to 203 at the distal end), and a second end of the catheter is in fluid communication with the pump ([0089] the proximal ends of the 16 are fluidly connected to the pump).
Regarding claim 56, Gronberg et al. further discloses providing a contrast medium to the cavity via a first catheter of the at least one catheter ([0089] one of 16 can be used to supply contrast medium to 203), and removing the contrast medium from the cavity via a second catheter of the at least one catheter ([0089] another of 16 is capable of being used to provided suction in the form of a vacuum to remove the liquids present, inherently including any contrast medium).
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) 47 and 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gronberg et al. in view of Shan et al. (Pub. No. 2024/0024152).
Regarding claims 47 and 57, Gronberg et al. discloses the invention as claimed in claims 38 and 50, as discussed above. Gronberg et al. is silent regarding a pressure sensor configured to measure the pressure in the cavity.
Shan et al. discloses using a pressure sensor (81; FIGs. 24-25; [0130]) to measure the pressure between the device and the abdominal wall ([0037]) for the purpose of avoiding putting too much pressure on the abdominal wall, which may block blood flow and cause tissue necrosis ([0004]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Gronberg et al. to include a pressure sensor, as taught by Shan et al., for the purpose of avoiding putting too much pressure on the intestinal wall, which may block blood flow and cause tissue necrosis.
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 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, Elizabeth Houston can be reached at 571-272-7134. 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.
/JAMES R MCGINNITY/Examiner, Art Unit 3771
Prosecution Insights