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 amendment filed 09/30/2025 has been entered. Claims 34, 41, 45-48 have been amended. Claims 1-33, 43 and 51-53 are cancelled. Claims 34-42, 44-50 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 34 have been considered but are moot because the new ground of rejection relies on a different interpretation of Langell for any teaching or matter specifically challenged in the argument.
Applicant argues that Langell does not disclose maintaining an isobaric condition within the uterus after activating a vacuum. However, as discussed in the rejection above, such limitation is inherent to the method of Langell in light of the specification ¶ 0071. Accordingly, claim 34 remains anticipated and obvious over Langell.
Applicant argues that Loske fails to disclose maintaining an isobaric condition within any of the ranges of claims 38-40. However, claims 38-40 do not recite that activating vacuum comprises producing a pressure range within the uterus. Accordingly, Loske discloses the vacuum pump producing a pressure between 20 and 200 mmHg which overlaps with the claimed ranges of claims 38-40.
Regarding claim 44, a new grounds of rejection is made citing Greener.
Regarding claim 45, applicant argues that the vacuum port 150 of Sporri is proximal to the seal location and that in contrast, to control uterine hemorrhaging, the vacuum port is located distal to the seal. Applicant argues that Sporri teaches away since the vacuum element is not placed inside the target space. A new interpretation of Sporri is applied. Sporri teaches determining whether there is a leak in a seal (inflatable members 80, 85). Thus, claim 45 is obvious over Langell in view of Sporri.
Regarding claims 47-48, a new grounds of rejection is made over Langell in view of Loske. Burbank is no longer relied upon.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 34-37, 42 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langell et al. (Pub. No.: US 2017/0281231 A1).
Regarding claim 34, Langell discloses a method of reducing postpartum bleeding (¶ 0004) comprising:
Positioning a device (uterine contraction device 400) comprising a vacuum element (catheter 402) at least partially within a uterus (fig. 13, ¶ 0018);
Sealing the uterus with a seal (pressure seal 404) of the device (¶ 0018);
Activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed (¶ 0027); and
Collapsing an inner surface of the uterus with the vacuum to reduce postpartum bleeding (¶ 0016).
Langell fails to explicitly disclose collapsing endometrial trumpet-shaped arteries.
However, Langell discloses that the reduction in postpartum bleeding is achieved by uterine contraction which compresses and closes local blood vessels (¶ 0002).
Thus, collapsing endometrial-trumpet shaped arteries is suggested by the method of Langell since the collapse of endometrial trumpet-shaped arteries is part of the compression and closing of local blood vessels.
Langell fails to explicitly disclose maintaining an isobaric condition within the uterus after activating vacuum.
Turning to Applicant’s Specification, Applicant discloses that the seal can hinder the flow of air into the uterus while vacuum is being applied in order to achieve a therapeutic isobaric level of vacuum throughout most if not all of the uterus (see Specification ¶ 0071).
Langell discloses that the seal (pressure seal 404) hinders the flow of air into the uterus while vacuum is being applied (¶ 0018, ¶ 0030).
Accordingly, placing a seal, as disclosed by Langell, should result in the creation of the isobaric condition and thus, Langell uses the same process to create an isobaric condition as Applicant.
Regarding claim 35, Langell discloses collapsing the uterus with the vacuum to cause contraction of uterine muscles and reduce postpartum bleeding (¶ 0016).
Regarding claim 36, Langell fails to disclose wherein activating vacuum comprises supplying vacuum from a pump at between 1L/min and 20 L/min.
However, Langell discloses that activating vacuum comprises supplying vacuum from a pump at a level suitable to assist in contracting the uterus without causing or aggravating injury to the uterus and surrounding anatomy (¶ 0055). Thus, Langell discloses that the level of vacuum supplied from the pump is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the level of vacuum supplied from the pump such that it is between 1 L/min and 20 L/min in order to provide a level suitable to assist in contracting the uterus without causing or aggravating injury to the uterus and surrounding anatomy (¶ 0055).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 37, Langell fails to disclose wherein activating vacuum comprises supplying vacuum from a pump at between 10 L/min and 15 L/min.
However, Langell discloses that activating vacuum comprises supplying vacuum from a pump at a level suitable to assist in contracting the uterus without causing or aggravating injury to the uterus and surrounding anatomy (¶ 0055). Thus, Langell discloses that the level of vacuum supplied from the pump is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the level of vacuum supplied from the pump such that it is between 10 L/min and 15 L/min in order to provide a level suitable to assist in contracting the uterus without causing or aggravating injury to the uterus and surrounding anatomy (¶ 0055).
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Regarding claim 42, Langell discloses wherein sealing the uterus comprises sealing so as to hinder a flow of air into the uterus while vacuum is applied in order to achieve a therapeutic isobaric level of vacuum throughout the uterus (sealing enables the application of differential negative pressure to the uterus ¶ 0018, see claim 34 above).
Regarding claim 50, Langell discloses wherein a leak rate past the seal is less than a pump rate of a pump supplying the vacuum (the seal formed by the seal is capable of maintaining the negative pressure within the uterus, abstract).
Claim(s) 38-40 and 47-49 is/are rejected under 35 U.S.C. 103 as obvious over Langell, as applied to claim 34 above, in view of Loske (Pub. No.: US 2017/0035949 A1).
Regarding claim 38, Langell fails to disclose wherein activating vacuum comprises producing a pressure of 40-160 mmHg.
Loske teaches a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, comprising: activating vacuum in the uterus (abstract), wherein activating vacuum comprises producing a pressure of between 20 and 200 mmHg (¶ 0013), which encompasses the claimed range of 40-160 mmHg.
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell such that activating vacuum comprises producing a pressure of 40-160 mmHg, as taught by Loske, as such pressure is suitable for reducing bleeding (Loske ¶ 0007-¶ 0008).
Regarding claim 39, Langell fails to disclose wherein activating vacuum comprises producing a pressure of 50-100 mmHg.
Loske teaches a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, comprising: activating vacuum in the uterus (abstract), wherein activating vacuum comprises producing a pressure of between 20 and 200 mmHg (¶ 0013), which encompasses the claimed range of 50-100 mmHg.
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell such that activating vacuum comprises producing a pressure of 50-100 mmHg, as taught by Loske, as such pressure is suitable for reducing bleeding (Loske, ¶ 0007-¶ 0008).
Regarding claim 40, Langell fails to disclose wherein activating vacuum comprises producing a pressure of 70-90 mmHg.
Loske teaches a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, comprising: activating vacuum in the uterus (abstract), wherein activating vacuum comprises producing a pressure of between 20 and 200 mmHg (¶ 0013), which encompasses the claimed range of 70-90 mmHg.
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell in view of Loske such that activating vacuum comprises producing a pressure of 70-90 mmHg, as taught by Loske, as such pressure is suitable for reducing bleeding (Loske ¶ 0007-¶ 0008).
Regarding claim 47, Langell fails to disclose wherein the steps of positioning, sealing, activating, collapsing, and maintaining result in postpartum bleeding within 5 hours.
Loske teaches (fig. 1) a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, wherein the intrauterine vacuum therapy duration is a few minutes or a few hours (¶ 0035), which overlaps with the claimed range of within 5 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the method of Langell such that the steps of positioning, sealing, activating, collapsing, and maintaining result in postpartum bleeding within 5 hours, as taught by Loske, as such duration is sufficient for treating uterine atony (Loske ¶ 0035).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Regarding claim 48, Langell fails to disclose wherein the steps of positioning, sealing, activating, collapsing, and maintaining result in postpartum bleeding within 2 hours.
Loske teaches (fig. 1) a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, wherein the intrauterine vacuum therapy duration is a few minutes or a few hours (¶ 0035), which overlaps with the claimed range of within 2 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the method of Langell such that the steps of positioning, sealing, activating, collapsing, and maintaining result in postpartum bleeding within 2 hours, as taught by Loske, as such duration is sufficient for treating uterine atony (Loske ¶ 0035).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Regarding claim 49, Langell fails to disclose confirming that a cervix is dilated to greater than 3 cm prior to the positioning step.
Loske teaches (fig. 1) confirming that a cervix is dilated prior to the positioning step (¶ 0016). Loske further teaches that prior to positioning, the cervix is sufficiently wide (¶ 0016). Loske further teaches that the cervix is dilated in order to introduce the fluid-collecting element into the uterine cavity (¶ 0016) and that the fluid-collecting element has a transverse diameter from 1 cm to 15 cm (¶ 0015). Thus, Loske suggests that a cervix is dilated to greater than 3 cm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell such that it includes that a cervix is dilated to greater than 3 cm prior to the positioning step, as taught by Loske, in order to allow the vacuum element to be transvaginally introduced into the uterine cavity (Loske ¶ 0016).
Claim(s) 41 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langell in view of Sporri et al. (Pub. No.: US 2005/0240211 A1).
Regarding claim 45, Langell discloses a method of reducing postpartum bleeding (¶ 0004) comprising:
Positioning a device (uterine contraction device 400) comprising a vacuum element (catheter 402) at least partially within a uterus (fig. 13, ¶ 0018);
Sealing the uterus with a seal (pressure seal 404) of the device (¶ 0018);
Activating vacuum in the uterus with the vacuum element of the device while the uterus is sealed (¶ 0027); and
Collapsing an inner surface of the uterus with the vacuum to reduce postpartum bleeding (¶ 0016).
Langell fails to explicitly disclose collapsing endometrial trumpet-shaped arteries.
However, Langell discloses that the reduction in postpartum bleeding is achieved by uterine contraction which compresses and closes local blood vessels (¶ 0002).
Thus, collapsing endometrial-trumpet shaped arteries is suggested by the method of Langell since the collapse of endometrial trumpet-shaped arteries is part of the compression and closing of local blood vessels.
Langell fails to disclose detecting air in a tube connected to the vacuum element to determine if there is a leak in the seal.
Sporri teaches (fig. 9) a method of treating a uterus (abstract) and thus in the same field of endeavor comprising: a seal (inflatable members 80, 85); and detecting air in a tube (vacuum tubing 98) to determine if there is a leak in the seal (¶ 0100).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell such that it includes detecting air in a tube to determine if there is a leak in the seal, as suggested by Sporri, the tube connected to the vacuum element of Langell, in order to determine whether a good seal is present (Sporri ¶ 0100).
Regarding claim 41, Langell discloses wherein sealing the uterus comprises placing the seal in the lower uterus, cervix, vaginal canal, or at the vulva (vaginal introitus ¶ 0031).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langell, as applied to claim 34 above, in view of Greener (Pub. No.: US 2013/0296816 A1).
Regarding claim 44, Langell fails to disclose wherein activating vacuum comprises activating a pump having a vacuum reservoir therein so as to enable a consistent flow of vacuum to the uterus.
Greener teaches (fig. 2) a method comprising activating vacuum (abstract) and thus in the same field of endeavor, wherein activating vacuum comprises activating a pump (29) having a vacuum reservoir (22) therein (¶ 0089) so as to enable a consistent flow of vacuum (¶ 0001).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the step of activating vacuum of Langell such that it comprises activating a pump having a vacuum reservoir therein so as to enable a consistent flow of vacuum, as taught by Greener, to the uterus, in order to allow negative pressure to be provided for an extended period of time without requiring operation of a powered source of negative pressure, thus enabling a user to sleep undisturbed (Greener, ¶ 0013).
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langell in view of Sporri, as applied to claim 45 above, and further in view of Loske.
Regarding claim 46, Langell in view of Sporri fail to disclose visualizing a flow of blood from the uterus through a translucent or transparent tube connected to the vacuum element.
Loske teaches (fig. 1) a method of reducing postpartum bleeding (abstract, ¶ 0007) and thus in the same field of endeavor, comprising: a translucent or transparent tube (tubular-fluid communication element 2, ¶ 0013) connected to a vacuum element (fluid collecting element 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Langell in view of Sporri such that it includes visualizing a flow of blood from the uterus through a translucent or transparent tube connected to the vacuum element, as suggested by Loske, in order to monitor the flow of blood from the uterus of the patient.
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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
25 November 2025