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 .
Claim Objections
Claim 1 is objected to. Claim 1 requires the limitation of the sheath “is advanced into an internal abdominal cavity”. The examiner suggests amending to configured to be advanced. In the same claim, the examiner suggests amending “whereupon…pliable members are fully deployed” to pliable members are configured to be deployed. In the same claim the examiner suggests amending “sheath is withdrawn” to sheath is configured to be withdrawn.
Response to Arguments
Applicant's arguments filed 06 have been fully considered but they are not persuasive.
First, applicant states that the disclosure of Balasubramaniam merely states that an ileus can be caused by laparoscopic surgery and no that the reference teaches a specific use with laparoscopy (or minimally invasive surgery). The examiner respectfully disagrees. Balasubramaniam discloses a device for preventing the onset and progression of POI (post operative ileus) per the abstract. Therefore as applicant states that Balasubramaniam only teaches that laparoscopic surgeries cause an ileus, and per the abstract the device treats an ileus it can be inferred that the device of Balasubramaniam would function as intended when used with a laparoscopic surgery. The examiner further notes that as detailed in the previous office actions Balasubramaniam , per paragraph 0027 specifically lines 1-6, disclose that the surgery performed that the device is then used with to aid in preventing POI can involve any manipulation of the GI tract including laparoscopic surgeries. The examiner thus understands that the device of prior art Balasubramaniam is being used with minimally invasive surgeries.
Second applicant argues that the device of the prior art rejection is not inserted into an internal abdomen cavity. The examiner respectfully disagrees and directs to Balasubramaniam para. 0040 where the device of the present disclosure is “intended to be placed around the bowels so as to surround and encompass them within the abdominal cavity.
Applicant argues that the device of Jervis 1) is designed to create an anatomic space rather than be inserted into a cavity and 2) Jervis and Balasubramaniam are not in the same area of endeavor and thus are not properly combined.
Regarding 1) Jervis was previously applied to show that an insertable device for laparoscopic surgery may be delivered through a sheath which is then removed upon deployment. The examiner notes that while Jervis does disclose dissect layers of the fascia, the examiner notes that the combination of arts found that it was obvious to one having ordinary skill in the art to provide a means of introducing a device into a minimally invasive surgical location through a sheath and therefore providing a sheath for introducing the device of Balasubramaniam would have been obvious to one having ordinary skill. Should applicant argue still that Jervis does not teach the insertable component (the balloon) being inserted into the abdominal cavity, the examiner points to column 21 lines 1-17 of Jervis where in operation the balloon is extended out through the sheath into the abdominal cavity. As such it is interpreted that as Jervis is used for laparoscopic procedures (abstract), Jervis does teach inserting its disclosed device (balloon) into an internal cavity (Abdominal) through a minimally invasive access port (dissected fascia where a sheath is placed and the balloon is then inserted through the sheath, where said procedure is said to laparoscopic and thus a minimally invasive operation with a port), and as such Jervis is proper to combine.
Regarding 2) the examiner notes that as detailed in the previous paragraph Jervis teaches a device for laparoscopic surgery when an insertable device is inserted through a sheath into the abdominal cavity. Further, Balasubramaniam, as detailed above under the first paragraph also teaches a device to be introduced into the abdominal cavity in conjunction with laparoscopic surgeries. Thus it is understood that the prior art devices are in the same field of endeavor and thus are properly combined.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balasubramaniam US 2017/0049943 in view of Jervis US 6432121, hereafter Jervis, where both Balasubramaniam and Jervis were provided in the previous office action.
Regarding Claim 1, Balasubramaniam discloses
An apparatus for improving post-operative recovery from minimally invasive surgery (Laparoscopy per paragraph 0027), comprising: one or more pliable members (Fig. 2, wedge
foam/sponge strips (105)) having a main stem portion {connecting sponge region ({106)) and one or more primary branch portions extending from the main stem portion (Where the sponge strips (105) are seen branching off from the connecting portion (106)); one or more layers encompassing the one or more pliable members and having a curved configuration (Polyethylene Bilayer (101), Para. 0050), wherein the one or more layers and the one or more pliable members has a deployed configuration when positioned and a retracted configuration (Retracted state see Fig. 3A, deployed state see Fig. 3B); and a connecting tube connected to and in fluid communication with and coupled to the one or more layers at a periphery of the one or more layers (Tubing section (107)). Below is an annotated figure of the prior art Fig. 2.
However, Balasubramaniam does not specifically disclose the use of a sheath where the retracted configuration allows the members or layers to be disposed within said sheath.
Jervis teaches a device and method for inserting a device to be used with minimally invasive surgical procedure and is thus considered analogous to the claimed invention. Jervis further teaches that the apparatus comprises a cannula (Fig. 39, cannula (303)) where said cannula comprises a tunneling device (303) and introducer member (307) to dissect layers of fascia between the skin aid in the introduction of balloon assembly (312) (Column 24, lines 1-14). The examiner notes that the cannula is interpreted as an access port. Jervis further teaches that said laparoscopic procedures may include the use of a trocar instead of a cannula (Column 39 lines 49-67) in which the laparoscopic apparatus is inserted through the trocar. Further, Jervis teaches the user of a sheath (fig. 2 removable sleeve (106)). Per column 16, lines 11-30 Jervis teaches that the insertable device is rolled/folded and enclosed within the removable sheath (fig. 2), where said sheath is then carried by the tunneling shaft/rod. Therefore it is interpreted that the implantable device of Jervis is placed within a removable sheath, placed within a trocar, and then inserted, where the sheath is then removed (column 16, lines 64-67 and column 17, lines 1-35). Column 21 lines 40-67 and Column 22, lines 1-7 disclose the same operation with another type of laparoscopic device/procedure.
Therefore, as Balasubramaniam teaches a insertable device used for laparoscopic procedures, and Jervis teaches that it is known to use a sheath and trocar to deploy devices for laparoscopic procedures it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide a removable sheath and a trocar with an introducer member and tunneling device to introduce the device of Balasubramaniam in order to help dissect layers of fascia between the skin by hand to aid in the introduction of the recovery device. The examiner notes that as seen in figure 2 of Jervis the device is deployed within the sheath, the sheath has at least one layer (106), upon combination with Balasubramaniam the pliable members would be within the sheath, advanced into the cavity, where the sheath is removed and the pliable members would thus be deployed. Should applicant disagree that the device of Balasubramaniam and Jervis teach these steps of operation, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as the combination of arts teaches a recovery apparatus applied through a sheath to an abdominal cavity, where the sheath is removed, where the apparatus structure is disclosed in Balasubramaniam and it is interpreted that the movement of the components with regard to the body and sheath is functional language, Balasubramaniam in view of Jervis reads to the claimed limitation.
The examiner notes that per the amendments filed 03/04/2026, the claims require the device inserted within an internal abdominal cavity. The examiner notes that while Balasubramaniam as per the previous rejections discloses the device within the abdomen, paragraph 0040 states clearly that it is within an internal cavity of said abdomen, and thus Balasubramaniam, as previously applied, reads to the claimed limitation.
Regarding Claim 2, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the main stem portion extends from a proximal end to a distal end of the one or more layers. The examiner notes that as the branch portions of Balasubramaniam are directly connected to the main stem potion, it is interpreted that the main stem portion extends from a proximal to a distal end, as the entire sponge extends from a proximal to distal end, best seen in figure 2 of Balasubramaniam.
Regarding Claim 3, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the one or more primary branch portions extend from the main stem portion in a symmetrical pattern about a longitudinal axis. The examiner notes that as seen in Fig. 2 of Balasubramaniam, the one or more primary branch portions (sponge (105)) extend in a symmetrical pattern from the main stem.
Regarding Claim 4, Balasubramaniam and Jervis teach
The apparatus of claim 1 further comprising one or more secondary branch portions extending from the one or more primary branch portions (Balasubramaniam Fig. 2).
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Regarding Claim 5, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the one or more pliable members comprise porous or open cell members. The examiner notes that as detailed under the rejection of claim 1, the pliable members of Balasubramaniam are disclosed to be made of foam or sponge, and are thus interpreted as comprising pores. Further, per Fig. 2 of Balasubramaniam the sponge portions (105) may optionally comprise perforations (104).
Regarding Claim 6, Balasubramaniam and Jervis teach
The apparatus of claim 1 further comprising a plurality of openings distributed throughout the one or more layers (Balasubramaniam: Perforations (102) located in the bilayer, which as detailed under the rejection of claim 1 is interpreted as the one or more layers, para. 0051).
Regarding Claim 7, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the one or more pliable members are fluidly connected to the connecting tube. The examiner notes that as seen in figure 2 of Balasubramaniam, the pliable members
connect to connecting portion (106) which is directly connected to tubing portion (107). Therefore the pliable members are fluidly connected to the tubing.
Regarding Claim 8, Balasubramaniam and Jervis teach
The apparatus of claim 1 further comprising a negative pressure mechanism that is in fluid communication with the one or more pliable members through the connecting tube (Balasubramaniam Para. 0061).
Regarding Claim 9, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the one or more layers are constructed from a material selected from the group consisting of polyethylene and polyurethane (Balasubramaniam Para. 0050). The examiner notes that as detailed under the rejection of claim 1, the bilayer of Balasubramaniam, interpreted as the one or more layers, is made of polyethylene.
Regarding Claim 10, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the one or more pliable members are constructed from a material selected from the group consisting of polyurethane (PU), polyethylene (PE) and polyvinyl alcohol (PVA) foam (Balasubramaniam Para 0044). The examiner notes that as detailed under the rejection of claim 1, the one or more pliable members be made of foam, where paragraph 0044 of Balasubramaniam further discloses that polyurethane medical foams are preferred. Further paragraph 0045 of Balasubramaniam details other foam types that are common in the art including PVA, and PU.
Regarding Claim 11, Balasubramaniam and Jervis teach
The apparatus of claim 1 wherein the apparatus is configured to be reconfigured into a low profile compact configuration (Balasubramaniam Fig. 3A, para. 0055).
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 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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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