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 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.
Claims 9, 24 and 31-36 are rejected under 35 U.S.C. 103 as being unpatentable over Cobb; Jennifer West (US 20230320753 A1) in view of Van Dam; Jacques et al. (US 20090143713 A1).
Regarding claim 9, Cobb discloses a method for evacuating fluid from a uterus of a patient following pelvic surgery (¶ [0002], systems, devices, and methods for monitoring and controlling postpartum hemorrhage and excessive uterine bleeding; ¶ [0043], the postpartum hemorrhage mitigation devices … treat uterine wounds with negative pressure (i.e., wound therapy) including the hysterotomy incision (i.e., C/S incision) and accreta (uterine defects));
the method comprising: placing a surgical drain with a positioning mechanism (¶ [0050], the anchoring mechanism 120 being proximate to the suction line extension 110 along the flexible tube, the anchoring mechanism 120 being configured for maintaining the suction line extension 110 in a desired position within the uterine cavity 190. For example, the anchoring mechanism 120 may be a collapsible anchoring mechanism 450 … is shown in FIG. 10 including a plurality of wings; ¶ [0064] FIG. 4 … the collapsible anchoring mechanism being configured for an open state when the collapsible anchoring mechanism 450 is positioned within the uterine cavity 190 and for a collapsed state (e.g., collapsible anchoring mechanism 450) during positioning of the postpartum hemorrhage mitigation device 410 within the uterine cavity 190; ¶ [0071], For example, illustration 620 of FIG. 6B shows the collapsible anchoring mechanism 450 of FIG. 4 shown in the open configuration positioned covering a cervical canal (e.g., the cervical canal 180) of a mammal who recently gave birth either vaginally or via cesarean section);
in the patient's body so that a drainage component of the surgical drain extends into a uterine cavity of the patient; the positioning mechanism sits in the uterine cavity; and a portion of a tube of the surgical drain extends through a cervical canal and a vaginal canal of the patient (¶ [0048], the postpartum hemorrhage mitigation devices disclosed herein may be placed within a mammal's uterus via a surgical opening caused by a hysterotomy during cesarean delivery of her child; ¶ [0049], FIG. 1 … hemorrhage mitigation device 100 positioned within a uterine cavity 190 bounded by a uterine wall 170 of a uterus 160 of a mammal; ¶ [0054], The inflatable anchoring mechanism 220 in a deflated state 225 as shown in FIG. 2B may be inserted into cervical canal 180 either vaginally or via a surgical opening caused by a cesarean delivery of the mammal's baby or babies; ¶ [0058], the postpartum hemorrhage mitigation device 200 is placed within the uterus 160 of a mammal, with the suction line extension 210 extending through the cervical canal 180 following a cesarean delivery of her child while the abdomen and uterus 160 are surgically open; ¶ [0061], the postpartum hemorrhage mitigation device 300 is placed within the uterus of a mammal, with the suction line 130 extending through cervical canal 180 following a cesarean delivery of her child while the abdomen and the uterus 160 are surgically open);
wherein the drainage component includes a drain lumen (¶ [0049], Postpartum hemorrhage mitigation device 100 includes … a suction line 130);
in communication with a tube lumen of the tube (¶ [0049], suction line extension 110);
the drainage component includes at least one opening configured to allow fluid to enter the drainage lumen to be evacuated from the uterus via the tube lumen (¶ [0066], The ports may also be round pores 465 and/or slits 485 and/or oval pores 475 to allow for suction by connection to the suction line extension 110. In some embodiments, multiple ports (e.g., four ports to ten ports) may be used to, for example, distribute force attributable to the negative pressure over a particular surface area and/or maintain functioning of the device if one or more of the ports becomes occluded by, for example, a blood clot; ¶ [0068] In some embodiments, the postpartum hemorrhage mitigation device 410 includes oval pores 475 and the postpartum hemorrhage mitigation device 420 includes round ports 465); and
the positioning mechanism includes a plurality of extensions that extend from a shaft that encircles a portion of an exterior surface of the tube (¶ [0065] In some embodiments the collapsible anchoring mechanism 450 is an umbrella configuration comprising a plurality of wings. For example, an exemplary collapsible anchoring mechanism 450 is shown in FIG. 10 including a plurality of wings in the umbrella configuration).
Cobb does not explicitly disclose whether the plural extensions are configured to move independently of one another and do not touch adjacent extensions. Van Dam discloses devices and methods for treating biliary disease (¶ [0023], [0024], [0052], [0058], implantable device 420, such as those illustrated in FIG. 4; ¶ [0062], As shown in FIG. 5, the tubular portion 530 … device 520; ¶ [0065], device 720);
the method comprising: placing a tube with a positioning mechanism in the patient's body; wherein the tube includes a tube lumen (¶ [0062] The preferred embodiment of the conduit is that of a short tube that is flared into hemispherical bowl-like shapes at both ends, as depicted in FIG. 4. The flared bowl-like shapes at the distal end 422 and the proximal end 425 secure the conduit device 420 in the desired location … The conduit 420 forms the proposed passageway 424; ¶ [0065], FIG. 7C(1) … most or all of the fluid inside the lumen where it resides (e.g. the gallbladder 14) may pass into the conduit 720); and
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the positioning mechanism includes a plurality of extensions; each extension separately, and approximately orthogonally, extending from a shaft that encircles a portion of an exterior surface of the tube (¶ [0065], Another embodiment of the retaining feature 722 at the end(s) of the conduit's tubular portion resembles the shape and organization of a flower's petals 740 … in FIG. 7E);
wherein each extension is not joined to an adjacent extension of the plurality (Fig. 7E(2) shows that the petals 740 are not joined to each other);
does not touch an adjacent extension of the plurality when the positioning mechanism is in an open configuration (Fig. 7E(2) shows that the petals 740 do not touch or overlap); and
is configured to move independently of an adjacent extension of the plurality (¶ [0065], The petals 740 are joined at the point where they contact the tube 730 (similar to the flower's stem), and spread outwards when unconstrained, as shown in FIG. 7E).
Van Dam compresses a positioning mechanism more compactly when delivering it (¶ [0065], These may also be reconfigured in order to reduce the cross-sectional area, which may be useful during delivery of the device 720, and then caused to spread outwards once the device 720 is delivered and in a suitable orientation for its final configuration). Van Dam also constructs the positioning mechanism from soft materials (¶ [0070] Embodiments of retaining features 722, 822 may be comprised of compliant polymeric material (e.g. silicone). If they are comprised of soft, compliant materials, the retaining features 722, 822 can readily bend and deform to accommodate the passage of large items through the conduit 724, 824 formed between a first body lumen and a second body lumen, e.g. the gallbladder 14 and the duodenum 30).
One would be motivated to modify Cobb with Van Dam’s positioning mechanism and its independently moving extensions since Cobb calls for a self-expanding positioning mechanism comprising a soft material (¶ [0052], The anchoring mechanism 120 may be made from a soft, flexible, material such as silicon and/or plastic and, some occasions, the anchoring mechanism 120 may open or otherwise spread apart to cover the cervical opening after being properly place into position). Cobb also calls for several embodiments of a positioning mechanism (¶ [0049], anchoring mechanism 120; ¶ [0054] FIG. 2A … inflatable anchoring mechanism 220; ¶ [0059], FIG. 3 … anchoring mechanism 320; ¶ [0064] FIG. 4 … anchoring mechanism 450; ¶ [0066], placement anchor 470). Therefore, it would have been obvious to modify Cobb with Van Dam’s flower-shaped positioning mechanism in order to protect the patient and to provide an alternative self-expanding positioning mechanism.
Regarding claim 24, Cobb discloses a method for applying suction tamponade to a uterus of a patient following pelvic surgery (¶ [0002], [0043], the postpartum hemorrhage mitigation devices … treat uterine wounds with negative pressure (i.e., wound therapy) including the hysterotomy incision (i.e., C/S incision) and accreta (uterine defects));
the method comprising: placing a surgical drain (¶ [0049], FIG. 1 … hemorrhage mitigation device 100 positioned within a uterine cavity 190 bounded by a uterine wall 170 of a uterus 160 of a mammal);
with a positioning mechanism (¶ [0050], the anchoring mechanism 120 being proximate to the suction line extension 110 along the flexible tube, the anchoring mechanism 120 being configured for maintaining the suction line extension 110 in a desired position within the uterine cavity 190
in the patient's body so that a drainage component of the surgical drain extends into a uterine cavity of the patient, the positioning mechanism sits in the uterine cavity, and a portion of a tube of the surgical drain extends through a cervical canal and a vaginal canal of the patient (¶ [0048], the postpartum hemorrhage mitigation devices disclosed herein may be placed within a mammal's uterus via a surgical opening caused by a hysterotomy; ¶ [0049], FIG. 1 … hemorrhage mitigation device 100 positioned within a uterine cavity 190 bounded by a uterine wall 170 of a uterus 160 of a mammal; ¶ [0054], The inflatable anchoring mechanism 220 … via a surgical opening caused by a cesarean delivery; ¶ [0058], the suction line extension 210 extending through the cervical canal 180 following a cesarean delivery of her child while the abdomen and uterus 160 are surgically open; ¶ [0061], the postpartum hemorrhage mitigation device 300 is placed within the uterus of a mammal, with the suction line 130 extending through cervical canal 180 following a cesarean delivery of her child while the abdomen and the uterus 160 are surgically open);
wherein the drainage component includes a drain lumen (¶ [0049], Postpartum hemorrhage mitigation device 100 includes … a suction line 130);
in communication with a tube lumen of the tube (¶ [0049], suction line extension 110);
the drainage component includes at least one opening configured to allow fluid to enter the drainage lumen to be evacuated from the uterus via the tube lumen (¶ [0066], The ports may also be round pores 465 and/or slits 485 and/or oval pores 475 to allow for suction by connection to the suction line extension 110. In some embodiments, multiple ports (e.g., four ports to ten ports) may be used to, for example, distribute force attributable to the negative pressure over a particular surface area and/or maintain functioning of the device if one or more of the ports becomes occluded by, for example, a blood clot; ¶ [0068] In some embodiments, the postpartum hemorrhage mitigation device 410 includes oval pores 475 and the postpartum hemorrhage mitigation device 420 includes round ports 465); and
coupling the first end of the tube to a source of suction; and applying an amount of negative pressure to the tube using the source of suction (¶ [0051] In various embodiments, the suction line 130 may be configured to couple to a source of negative pressure, such as a vacuum pump (not shown) so that negative pressure may be applied to the suction line 130; ¶ [0052], the suction line 130 extends from a base of the anchoring mechanism 120 through the cervical canal 180 and out of the mammal's body via the vagina to be coupled to the vacuum pump and/or collection receptacle);
the amount of negative pressure being sufficient to contract the patient's uterus (¶ [0066], Application of negative pressure via the ports in the suction line extension 110 may facilitate the application of negative pressure to the inner surface of uterine wall 170, thereby contracting the inner surface area uterine wall 170 and thereby causing mechanical hemostasis of potentially bleeding blood vessels positioned within the uterine wall 170);
wherein the negative pressure is communicated to the uterine cavity via the tube lumen, drain lumen, and the at least one opening drainage holes (¶ [0066], The ports may also be round pores 465 and/or slits 485 and/or oval pores 475 to allow for suction by connection to the suction line extension 110. In some embodiments, multiple ports (e.g., four ports to ten ports) may be used to, for example, distribute force attributable to the negative pressure over a particular surface area and/or maintain functioning of the device if one or more of the ports becomes occluded by, for example, a blood clot; ¶ [0068] In some embodiments, the postpartum hemorrhage mitigation device 410 includes oval pores 475 and the postpartum hemorrhage mitigation device 420 includes round ports 465).
Cobb lacks plural extensions that move independently of one another without touching adjacent extensions. Van Dam discloses devices and methods for treating biliary disease (¶ [0023], [0024], [0052], [0058], [0062], [0065], device 720);
comprising placing a tube with a positioning mechanism in the patient's body; wherein the tube includes a tube lumen (¶ [0062], The conduit 420 forms the proposed passageway 424; ¶ [0065], FIG. 7C(1) … most or all of the fluid inside the lumen … may pass into the conduit 720); and
wherein each extension separately and approximately orthogonally extends from a shaft that encircles a portion of an exterior surface of the tube, does not touch an adjacent extension of the plurality when the positioning mechanism is in an open configuration, and is configured to move independently of an adjacent extension of the plurality (¶ [0065], Another embodiment of the retaining feature 722 at the end(s) of the conduit's tubular portion resembles the shape and organization of a flower's petals 740).
Van Dam compresses a positioning mechanism more compactly when delivering it and constructs the positioning mechanism from soft materials (¶ [0065], [0070]). Regarding the rationale and motivation to modify Cobb with Van Dam’s independently moving extensions, see the discussion of claim 9 above.
Regarding claims 31-36, Cobb discloses a method wherein a portion of the tube extends through an introitus of the patient (¶ [0048], the postpartum hemorrhage mitigation devices disclosed herein may be placed within a mammal's uterus via a surgical opening caused by a hysterotomy during cesarean delivery of her child and following delivery of the baby and placenta. The postpartum hemorrhage mitigation devices disclosed herein may be configured to be placed within the lower-uterine segment and, following placement of the postpartum hemorrhage mitigation device, a suction line (e.g., semi-flexible catheter) may be fed through the cervix and out the vagina for coupling to an external vacuum source);
the method further comprising: extracting the drainage component from the uterine cavity by pulling on the portion of the tube that extends through the introitus of the patient (¶ [0048], The postpartum hemorrhage mitigation devices disclosed herein may be configured to be placed within the lower-uterine segment and, following placement of the postpartum hemorrhage mitigation device, a suction line (e.g., semi-flexible catheter) may be fed through the cervix and out the vagina for coupling to an external vacuum source);
wherein the plurality of extensions are configured to fold when pulled through the cervix as the drainage component is removed from the uterine cavity (¶ [0049], FIG. 1 … an anchoring mechanism 120; ¶ [0065] In some embodiments the collapsible anchoring mechanism 450 is an umbrella configuration comprising a plurality of wings. For example, an exemplary collapsible anchoring mechanism 450 is shown in FIG. 10 including a plurality of wings in the umbrella configuration; ¶ [0061], The first wing 315A and the second wing 315B and/or the anchoring mechanism 320 may be configured to enable extraction of the postpartum hemorrhage mitigation device 300 from uterine cavity 190 via pulling on the suction line 330 so that first wing 315A and the second wing 315B and/or the anchoring mechanism 320 collapse enough to allow passage thereof through the cervical canal and the vagina (not shown) and eventually extracted from the mammal's body);
wherein the surgical drain includes a stylet configured to add stiffness to the surgical drain as it is placed in the uterine cavity (¶ [0045], postpartum hemorrhage mitigation devices of the present technology include … a guidewire or stylet for proper positioning … The stylet may be used to add stiffness to the catheter during insertion; ¶ [0073] FIG. 8 is an illustration 800 of an exemplary stylet 810 … FIG. 8 shows the stylet 810 attached to an exemplary postpartum hemorrhage mitigation device for proper positioning of the postpartum hemorrhage mitigation device);
the method further comprising: removing the stylet from the surgical drain thereby opening an end of the tube extending through an introitus of the patient (¶ [0048] In various embodiments, the postpartum hemorrhage mitigation devices disclosed herein may be placed within a mammal's uterus via a surgical opening caused by a hysterotomy during cesarean delivery of her child and following delivery of the baby and placenta. The postpartum hemorrhage mitigation devices disclosed herein may be configured to be placed within the lower-uterine segment and, following placement of the postpartum hemorrhage mitigation device, a suction line (e.g., semi-flexible catheter) may be fed through the cervix and out the vagina for coupling to an external vacuum source; ¶ [0073], the stylet 810 may be a small, malleable plastic-coated metal rod that may be placed inside a suction line to reinforce or pre-shape the lumen of the tube to aid in directing the suction line towards the uterus … the guidewire (e.g., stylet 810) may be used to properly position an anchoring mechanism in the uterus of a female woman who recently gave birth either vaginally or via cesarean); and
coupling the end of the tube to a source of suction (¶ [0051] In various embodiments, the suction line 130 may be configured to couple to a source of negative pressure, such as a vacuum pump (not shown) so that negative pressure may be applied to the suction line 130; ¶ [0052], Often times, the desired position for the suction line extension 110 is at the base of uterine cavity 190 directly above cervical canal 180 so that the suction line 130 extends from a base of the anchoring mechanism 120 through the cervical canal 180 and out of the mammal's body via the vagina to be coupled to the vacuum pump and/or collection receptacle);
wherein the positioning mechanism sits proximate to an internal cervical os of the patient (¶ [0049], FIG. 1 is an illustration of an exemplary postpartum hemorrhage mitigation device 100 positioned within a uterine cavity 190 bounded by a uterine wall 170 of a uterus 160 of a mammal).
Response to Arguments
The objections to claims 31-34 for minor informalities and improper dependence are withdrawn in view of the amendments filed 23 January 2026.
Applicant’s arguments filed 23 January 2026 regarding the rejection of claims 9, 24 and 31-36 as amended, under 35 USC § 103 over Cobb and Cracauer, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Cobb and Van Dam (see above).
Applicant’s arguments regarding Cracauer have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that Cracauer's flanges are joined together and do not separately, and approximately orthogonally, extend from a shaft that encircles a portion of an exterior surface of a tube as required by amended independent claim 9. In addition, each Cracauer's flanges 6 are joined to adjacent flanges (see the area below goove 20 of FIG. 1, above) and, consequently do disclose or suggest extensions that are not joined to an adjacent extensions or extensions that do not touch adjacent extensions when in an open configuration as required by amended claim 9 (remarks p. 6). Examiner responds that Cobb and Van Dam are cited in the new grounds of rejection as teaching all features of amended claims 9 and 24. Van Dam explicitly discloses a flower-shaped positioning mechanism comprising independently moving extensions (¶ [0065], The petals 740 are joined at the point where they contact the tube 730 (similar to the flower's stem), and spread outwards when unconstrained, as shown in FIG. 7E).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eigler, Neal L. et al. US 20050288722 A1
Cohen; Stanley A. US 20110313359 A1
Zarnegar; Rasa et al. US 20200397667 A1
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 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781