DETAILED ACTION
This is the initial Office action for non-provisional application 18/941,076 filed November 8, 2024, which is a continuation of non-provisional application 17/611,961 (now US Patent 12,156,830) filed November 17, 2021, which is a national stage entry of PCT/US2020/036906 filed June 10, 2020, which claims priority from provisional application 62/862,056. Claims 1-20, as presented in the preliminary amendments filed November 8, 2024, are currently pending.
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 . 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.
Information Disclosure Statement
The information disclosure statement filed November 8, 2024 fails to comply with 37 CFR 1.98(b)(5), which requires that each publication listed be identified with the date of publication. The date of publication supplied must include at least the month and year of publication, except that the year of publication (without the month) will be accepted if the applicant points out in the information disclosure statement that the year of publication is sufficiently earlier than the effective U.S. filing date and any foreign priority date so that the particular month of publication is not in issue. See MPEP 609.04(a). It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claims 5, 6, and 8-16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 5, 6, and 10-16 have been interpreted to depend from only claim 1, claim 8 has been interpreted to depend from only claim 5, and claim 9 has been interpreted to depend only from claim 6.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-7, 12, 13, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morris et al. (US 4,038,978).
Regarding claim 1, Morris discloses an intrauterine device (intrauterine device 10’) for preventing egg fertilization (Fig. 2; column 1, lines 34-37; column 2, lines 49-50; column 3, lines 27-28) comprising:
a) a membrane (membrane 30) (Fig. 2; column 1, lines 29-34; column 2, lines 63-68; column 3, lines 1-2);
b) a frame having a first arm (arm 14) and a second arm (arm 16) (Fig. 2; column 2, lines 49-52), the first and second arms (14, 16) movable from a first position (collapsed together) (Fig. 5; column 2, lines 39-42) to a second more expanded position (diverging upwardly and outwardly) (Fig. 2; column 2, line 51), the frame supporting the membrane (30) to move the membrane (30) between a first position (Fig. 5) to a second more expanded position (Fig. 2), wherein the first and second arms (14, 16) are non-planar and each arm (14, 16) has a proximal portion (closest to intersection 12), an intermediate portion (between intersection 12 and beans 18’, 20’), and a distal portion (closest to beads 18’, 20’), the first arm (14) has a bend at the intermediate portion thereof so the intermediate portion of the first arm (14) lies in a different plane than the proximal portion of the first arm (14), and the second arm (16) has a bend at the intermediate portion thereof so the intermediate portion of the second arm (16) lies in a different plane than the proximal portion of the second arm (16) (Fig. 2; column 2, lines 14-22); and
c) an elongated tail portion (intersection 12) positioned proximal of the membrane (30) (Fig. 2; column 2, lines 49-50).
Regarding claim 2, Morris discloses that the membrane (30) has a proximal portion closer to the tail portion (12) and a distal portion, the distal portion having a convex end (rounded side portions 40, 42) (Fig. 2; column 3, lines 31-35).
Regarding claim 4, Morris discloses that the frame is V-shaped (Fig. 2).
Regarding claim 5, Morris discloses that the first arm (14) terminates in a first bead (18’) and the second arm (16) terminates in a second bead (20’) (Fig. 2; column 2, lines 59-63; column 3, lines 27-31).
Regarding claim 6, Morris discloses that the frame has a silicone coating thereover (column 2, lines 54-57).
Regarding claim 7, Morris discloses that the intrauterine device is totally encased in silicone (column 2, lines 54-57) such that the frame and first and second beads (18’, 20’) would also have a silicone coating thereover.
Regarding claim 12, Morris discloses that the membrane (30) is sufficiently flexible that it will fold back upon itself to accommodate smaller uteri (column 1, lines 43-51; column 3, lines 8-14), wherein the function of the membrane (30) is to contact all or substantially all of the surface area of the uterus (column 1, lines 34-37) such that the membrane (30) is configured to lie in multiple planes when folded and conforming to the shape of the uterus.
Regarding claim 13, Morris discloses that the membrane (30) has an intermediate region extending inwardly with respect to a distal region (Fig. 2).
Regarding claim 15, Morris discloses that the membrane (30) extends between the first and second arms (14, 16) of the frame to provide a top cover, side covers, and bottom cover (Fig. 2).
Regarding claim 16, Morris discloses the intrauterine device (10’) in combination with a delivery system (inserter 43), the delivery system (43) having an inner tube (push rod 45) with an elongated slot to receive the tail portion (12) and an outer tube (tubular member 44), the inner tube (45) positioned within the outer tube (44), the outer tube (44) maintaining the frame in the first position (Fig. 5; column 3, line 65 – column 4, line 1).
Regarding claim 17, Morris discloses that the outer tube (44) and the inner tube (45) are relatively movable (column 3, line 67 – column 4, line 1).
Regarding claim 18, Morris discloses an intrauterine device (intrauterine device 10’) for preventing egg fertilization (Fig. 2; column 1, lines 34-37; column 2, lines 49-50; column 3, lines 27-28) comprising:
a) a membrane (membrane 30) (Fig. 2; column 1, lines 29-34; column 2, lines 63-68; column 3, lines 1-2);
b) an elongated tail portion (intersection 12) positioned proximal of the membrane (30) (Fig. 2; column 2, lines 49-50); and
c) a frame having a first arm (arm 14) and a second arm (arm 16) (Fig. 2; column 2, lines 49-52), the first and second arms (14, 16) movable from a first position (collapsed together) (Fig. 5; column 2, lines 39-42) to a second more expanded position (diverging upwardly and outwardly) (Fig. 2; column 2, line 51), the frame supporting the membrane (30) to move the membrane (30) between a first position (Fig. 5) to a second more expanded position (Fig. 2), wherein the first and second arms (14, 16) each have a proximal portion (closest to intersection 12), an intermediate portion (between intersection 12 and beans 18’, 20’), and a distal portion (closest to beads 18’, 20’) (Fig. 2; column 2, lines 14-22), the membrane (30) supported between the first and second arms (14, 16) and having a proximal portion closer to the tail portion (12) and a distal portion, the distal portion having a convex end (rounded side portions 40, 42) (Fig. 2; column 3, lines 31-35).
Regarding claim 19, Morris discloses that the first arm (14) terminates in a first bead (18’) and the second arm (16) terminates in a second bead (20’) (Fig. 2; column 2, lines 59-63; column 3, lines 27-31).
Regarding claim 20, Morris discloses that the intrauterine device is totally encased in silicone (column 2, lines 54-57) such that the frame would also have a silicone coating thereover.
Claim Rejections - 35 USC § 103
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claims 1 and 2 above, in view of Massouras (US 3,645,258).
Regarding claim 3, Morris discloses the invention substantially as claimed, as described above, and further teaches that the membrane (30) can be shaped to the size of a user’s uterus (column 1, lines 37-41; column 3, lines 2-8) and the function of the membrane (30) is to contact all or substantially all of the surface area of the uterus (column 1, lines 34-37).
However, Morris fails to expressly teach that the convex end of the membrane spans a width of the membrane from the first arm to the second arm.
Massouras discloses an intrauterine device comprising a membrane (membrane 4), a frame having a first arm (branch 2) and a second arm (branch 3), and a tail portion (leg 5), wherein the membrane (4) has a proximal portion closer to the tail portion (5) and a distal portion having a convex end, wherein the convex end spans a width of the membrane (4) from the first arm (2) to the second arm (3) (Fig. 1; column 1, lines 25-28).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the membrane of the intrauterine device taught by Morris such that the convex end spans a width of the membrane from the first arm to the second arm as taught by Massouras since Applicant has not disclosed that such a shape is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a membrane to fit the shape of a uterus and contact all or substantially all of the surface area of the uterus.
Regarding claim 4 (as it depends from claim 3), the combination of Morris and Massouras discloses the invention substantially as claimed, as described above, and Morris further discloses that the frame is V-shaped (Fig. 2).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claim 1 above, in view of Schwartz (US 3,628,530).
Morris discloses the invention substantially as claimed, as described above, but fails to teach that the first and second beads are radiopaque or that the silicone coating includes barium for radiopacity.
Schwartz discloses an intrauterine device (IUD 40) comprising a frame having a plurality of arms (rodlike members 42) each terminating in a bead (enlarged tip portions 70), wherein the intrauterine device (40) is formed of plastic with radiopaque material, such as barium sulfate or barium chloride, integral with the plastic (Figs. 6-7; column 2, lines 26-29 & 40-42; column 3, lines 51-59; column 4, lines 8-13 & 65-67) such that beads (70) are radiopaque.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intrauterine device taught by Morris to include a radiopaque material such as barium integrated in the material thereof as taught by Schwartz such that the beads will be radiopaque for the purpose of detecting the presence of the intrauterine device after insertion.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claim 1 above, in view of Soichet (US 3,923,051).
Morris discloses the invention substantially as claimed, as described above, but fails to teach that the membrane is composed on a non-copper material and a non-reactive material.
Soichet discloses an intrauterine device (IUD 10) comprising a membrane (chamber walls 20, 22), wherein the membrane (20, 22) is composed on a non-copper material and a non-reactive material (inert plastic) (column 2, lines 63-68).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intrauterine device taught by Morris to be composed of a non-copper and non-reactive material as taught by Soichet since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claim 1 above, in view of Nuwayser (US 3,703,896).
Morris discloses the invention substantially as claimed, as described above, but fails to teach a third arm supporting the membrane.
Nuwayser discloses an intrauterine device (device 10) comprising a membrane (fabric or lace 30) and a frame (elongated loops 14) having a first arm, a second, and a third arm supporting the membrane (30) (Figs. 1 & 4; column 2, line 58 – column 3, lines 12 & 38-67).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the intrauterine device taught by Morris to include a third arm supporting the membrane as taught by Nuwayser for the purpose of better enabling the device to expand with varying diameters along its axial length to intimately conform to the surface of the uterine cavity.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10-13, and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16 of US Patent 12,156,830 (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, all the limitations therein are substantially recited in claim 1 of the reference patent. The only difference between the claims is that claim 1 of the reference patent further requires that the first and second arms each have a curve extending outwardly and the membrane at an intermediate region curves inwardly toward a distal region due to the first and second bends of the first and second arms. However, claim 1 of the current application is broader than claim 1 of the reference patent as these limitations are not required by claim 1 of the current application. Therefore, claim 1 of the reference patent anticipates the limitations recites in claim 1 of the current application.
Regarding claim 2, the limitations therein are substantially recited in claim 2 of the reference patent.
Regarding claim 3, the limitations therein are substantially recited in claim 3 of the reference patent.
Regarding claim 4, the limitations therein are substantially recited in claim 4 of the reference patent.
Regarding claims 5 and 8, the limitations therein are substantially recited in claim 5 of the reference patent.
Regarding claim 6, the limitations therein are substantially recited in claim 7 of the reference patent.
Regarding claim 7, the limitations therein are substantially recited in claim 6 of the reference patent.
Regarding claim 10, the limitations therein are substantially recited in claim 8 of the reference patent.
Regarding claim 11, the limitations therein are substantially recited in claim 9 of the reference patent.
Regarding claim 12, the limitations therein are substantially recited in claim 10 of the reference patent.
Regarding claim 13, the limitations therein are substantially recited in claim 1 of the reference patent.
Regarding claim 15, the limitations therein are substantially recited in claim 11 of the reference patent.
Regarding claim 16, the limitations therein are substantially recited in claim 12 of the reference patent.
Regarding claim 17, the limitations therein are substantially recited in claim 13 of the reference patent.
Regarding claim 18, all the limitations therein are substantially recited in claim 14 of the reference patent. The only difference between the claims is that claim 14 of the reference patent further requires that the distal portion having a convex end is formed along a distalmost edge of the membrane extending across the membrane from a left side to a right side, the first arm terminating in a first bead and the second arm terminating in a second bead, and the distalmost edge terminating proximal of the first and second beads. However, claim 18 of the current application is broader than claim 14 of the reference patent as these limitations are not required by claim 18 of the current application. Therefore, claim 14 of the reference patent anticipates the limitations recites in claim 18 of the current application.
Regarding claim 19, the limitations therein are substantially recited in claim 14 of the reference patent.
Regarding claim 20, the limitations therein are substantially recited in claim 16 of the reference patent.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent 12,156,830 (reference patent) as applied to claim 1 above, in view of Schwartz (US 3,628,530).
Although the claims of the reference patent fail to recite that the silicone coating includes barium for radiopacity, this limitation is substantially taught by Schwartz as discussed above with respect to the rejection of claim 9 under 35 U.S.C. 103. Therefore, it would have been obvious to one having ordinary skill in the art to modify the silicone coating of the intrauterine device recited in the claims of the reference patent to include barium for radiopacity as taught by Schwartz for the same reason set forth above.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent 12,156,830 (reference patent) as applied to claim 1 above, in view of Nuwayser (US 3,703,896).
Although the claims of the reference patent fail to recite a third arm supporting the membrane, this limitation is substantially taught by Nuwayser as discussed above with respect to the rejection of claim 14 under 35 U.S.C. 103. Therefore, it would have been obvious to one having ordinary skill in the art to modify the intrauterine device recited in the claims of the reference patent to include a third arm supporting the membrane as taught by Nuwayser for the same reason set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached on 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 11/24/2025