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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 4/23/2026 is acknowledged. The traversal is on the ground(s) that claim 1 contains features which are not disclosed in Pereia (US 2018/0078283 A1), more particularly, Pereira does not disclose or suggest a hemostatic device wherein the membrane has at least two opposite faces, each face comprising a plurality of folds extending in at least one first direction. This is not found persuasive because the bumps 130 shown in Figs. 1 and 6 are equivalent to the claimed folds. While Fig. 1 shows the bumps 130 as substantially circular in shape, Fig. 6 shows the bumps 130 as folds comprising undulating peaks and valleys, similar to the peaks and valleys shown in applicant’s Fig. 4. Accordingly, Pereia does disclose all of the limitations of claim 1.
The requirement is still deemed proper and is therefore made FINAL.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/23/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the cavity” in line 7 which should read “the body cavity” for consistency purposes. Appropriate correction is required.
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 1-6 and 8-17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the chamber” in lines 5 and 6. It is unclear if “the chamber” is further limiting only a single one or the previously recited “at least one chamber” or if it applies to all of the chambers.
Claim 14 recites “a vacuum source” in lines 2-3. Claim 14 depends from claim 1 which recites “a vacuum source” in line 3. It is unclear if the vacuum source of claim 14 is intended to be the same or in addition to that of claim 1.
Claim 14 recites “the chamber” in line 4. It is unclear if “the chamber” is further limiting only a single one or the previously recited “at least one chamber” of claim 1 or if it applies to all of the chambers.
Claims 2-6, 8-13 and 15-17 are rejected due to their dependency on a rejected claim as discussed above.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8-9, 11-12 and 14-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ott et al. (US 2022/0354507 A1).
Regarding claim 1, Ott discloses a hemostatic device (hemostatic system for treating a hemorrhage into a natural body cavity; [0080]; Figs. 14A-14C) comprising at least one chamber (first chamber 100, second chamber 200) delimited by a membrane (first membrane 201, second membrane 202), each chamber being configured to be fluidically connected to a vacuum source (vacuum source; abstract), the membrane being configured to be placed so as to face, at least partially, a bleeding area of a body cavity (abstract), the membrane comprising a plurality of holes (holes 203) leading into the chamber (200) and configured to induce a negative pressure in the body cavity when a negative pressure is applied in the chamber by the vacuum source (abstract), the induced negative pressure being configured so that walls of the cavity are attracted to the membrane (abstract), wherein the membrane has at least two opposite faces (opposing sides of device of Fig. 14A), each face comprising a plurality of folds (corrugated shape such that the first and second membranes are foldable in at least one direction when a compressive force is applied to the hemostatic device; [0019]; [0162]-[0163]) extending in at least one first direction (fig. 14A).
Regarding claim 2, Ott discloses wherein the folds form a plurality of successive peaks (at trays 202a) and valleys (at recesses 202b) extending on either side of a normal plane (Figs. 14A-14C), wherein each side of the folds is oriented at an angle lower than 45 degrees with respect to the normal plane (as the angle α of the accordion structure may be about 30 degrees and a normal plane bisects the angle; thus, cutting the angle in half i.e., the angle is 15 degrees; [0166]; Fig. 14C).
Regarding claim 3, Ott disclose wherein each side of the folds is oriented at an angle lower than 30 degrees with respect to the normal plane (as the angle α of the accordion structure may be about 30 degrees and a normal plane bisects the angle; thus, cutting the angle in half i.e., the angle is 15 degrees; [0166]; Fig. 14C).
Regarding claim 4, Ott discloses wherein the valleys (202b) of a first face of the membrane are arranged so as to face the valleys (202b) of a second face of the membrane (see for example, Fig. 14B).
Regarding claim 5, Ott discloses wherein at least part of the plurality of holes (203) are located on the peaks (202a, as the through holes 203 are located in the flat trays 202a; [0164]; Fig. 14A).
Regarding claim 8, Ott discloses wherein the at least two opposite faces of the membrane are linked in a linking area (area between opposing sides of the hemostatic device; Fig. 14A).
Regarding claim 9, Ott discloses wherein the holes (203) are arranged in the membrane according to a constant pattern (as holes are arranged at regular interface over the circumference of the hemostatic device; Fig. 14A; [0164]).
Regarding claim 11, Ott discloses a single chamber (200) configured to be fluidically connected to the vacuum source (abstract; [0096]).
Regarding claim 12, Ott discloses wherein each face of the membrane is closed on itself (because membrane 200 is continuous, the opposing sides thereof are closed on themselves; Figs. 14A-14C).
Regarding claim 14, Ott discloses a base (base 300) comprising a primary channel (see for example connecting tube 302 of Fig. 1) configured to be connected to a vacuum source ([0142]) and to secondary channels (channels of 203 between membranes 202, 201; Fig. 14B), the secondary channels being fluidically connected to the chamber (200).
Regarding claim 15, Ott discloses wherein the base (300) comprises holes (holes at ends of 302) leading to the secondary channels (Figs. 1, 14).
Regarding claim 16, Ott discloses wherein the membrane (101, 202) is made of a flexible biocompatible polymer ([0092]).
Regarding claim 17, Ott discloses wherein the hemostatic device is configured to be inserted in a uterus ([0002]).
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) 6, 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ott et al. (US 2022/0354507 A1) in view of Filloux et al. (US 2018/0263550 A1).
Regarding claims 6, 10 and 13, Ott discloses the plurality of holes (203) being located circumferentially entirely around the hemostatic device (Fig. 14A) but fails to disclose wherein each face of the membrane extends according to a plane, wherein the membrane comprises two lateral sides connecting two of the at least two opposite faces of the membrane, at least part of the plurality of holes of the plurality of holes being located on the lateral sides, and the hemostatic device having a trapezoidal shape.
However, Filloux teaches a device (expandable body 115; Figs. 1 and 2) for insertion into a uterine cavity (abstract), wherein the device (115) comprises at least two opposing faces (top and bottom faces of 115; Fig. 2), wherein each face extends according to a plane (parallel planes of opposing faces; Fig. 2), two lateral sides (lateral sides connecting top and bottom faces of 115; Fig. 2) connecting the at least two opposing faces, and the device having a trapezoidal shape (Figs. 1-2). The device is shaped to fit within the uterine cavity (Fig. 6A).
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 bulbous shape of the hemostatic device of Ott to be trapezoidal with opposing sides extending along parallel planes and two lateral sides therebetween as taught by Filloux in order for the device to fit more preciously with the uterine cavity. Because the holes (203) of Ott extend circumferentially around the entirety of the hemostatic device they would continue to do so when the shape of the device is modified by Filloux. Thus, holes (203) would be positioned on the lateral sides of modified Ott.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shikhman et al. (US 2020/0261707 A1), Kochem et al. (US 2014/0216467 A1), and Whetham et al. (US 2008/0243103 A1) are noted for teaching similarly shaped uterine devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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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.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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