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
Applicant’s amendments to claim 3 filed on 08/26/2025 are acknowledged by the Examiner.
Claims 8, 9, 11, 15, and 17 remain cancelled.
Claims 1-7, 10, 12-14, 16, and 18-28 are currently pending and are under examination.
Response to Arguments
Applicant's arguments filed 08/26/2025 have been fully considered but they are not persuasive.
Applicant’s argument: Independent claims 1 and 12 recite a plurality of devices configured and/or dimensioned to self-aggregate by magnetic forces without distorting the uterine lumen. At the outset, it is noted that the Examiner's comments regarding the disclosures of the cited references are inconsistent. While addressing claim 1, the Examiner contends that Ekvall discloses a medical implant that upon implementation into a uterus the plurality of devices are dimensioned to maintain the uterine lumen undistorted when self-aggregated. However, the Examiner's interpretation appears to be inconsistent with the actual disclosure of the reference. In a later rejection addressing claim 18, the Examiner admits Ekvall does not disclose the limitation of maintaining the uterine lumen undistorted. Additionally, the Examiner does not dispute that Ekvall is silent on a method of implanting into the uterus the plurality of devices without disturbing the uterine lumen in regard to claim 12. Thus, Ekvall does not disclose the limitation of maintaining the uterine lumen undistorted as recited by independent claims 1 and 12.
Examiner’s response: Claims 12 and 18 are both method claims, whereas claim 1 is an apparatus claim. Therefore, claim 1 is treated differently from both claims 12 and 18. Ekvall is capable of being dimensioned to maintain the uterine lumen undistorted when self-aggregated, and thus since claim 1 is an apparatus claim, Ekvall still reads on the claim as it is capable. However, for method claims applying this same capability is incorrect, therefore, it is addressed for claims 12 and 18.
Applicant’s argument: The devices of Bar-am do not maintain the uterine lumen undistorted when self-aggregated. The method disclosed in Bar-am to implant into the uterus the plurality of devices and the self-aggregation of the devices requires distortion of the uterine lumen. As disclosed by Bar-am, "device 10 applies an elastic counterforce to the walls of the uterine cavity thus firmly securing device 10 into position" [0077]). In order to successfully insert the plurality of devices, the uterine lumen must be disturbed, otherwise the intrauterine device (IUD) would be expelled. The IUD is partially collapsable to conform to the shape of the uterus during uterine contractions and the "crush force is at least 15 grams/cm2 and no more than 60 grams/cm2” ([0010]). Uterine contractions can exert inward forces of 67-82 grams/cm2 or higher, which would cause the IUD to partially collapse during contraction, however the uterine walls only exert 13.5 grams/cm2 of force when in a relaxed state" ([0049]). Thus, the IUD by Bar-am does not disclose an IUD that maintains the uterine lumen undistorted nor does it disclose a method to implant into the uterus the plurality of devices without distorting the uterine lumen.
Examiner’s response: The three-dimensional structure of the IUD of Bar-am can elastically contract and expand in response to contraction and expansion of the uterine, see [0009] of Bar-am. Therefore, this adjustability of the IUD allows for it to be read on the claims. Although the IUD applies an elastic counterforce to the walls of the uterus, this is a force that is applied in counter of the force that the uterus applies on the IUD when undergoing contractions, meaning this force is being applied in response to the uterus, and thus the IUD is not the cause for the distortion.
Applicant’s argument: Ekvall fails to teach or suggest an IUD for modulating fertility in a subject. The devices disclosed by Ekvall are intended to replace existing medical implants placed around tissue or body structures so that a magnetic field resulting from MRI does not reduce or eliminate the functionality of the implant. Ekvall is silent in regard to inserting a device into a uterus for the purpose of affecting reproductive functions. The examiner cites Hassan and Bar-am as allegedly compensating for this deficiency. Applicant argues it would not have been obvious to combine the systems of Ekvall and Hassan or Bar-am as they are non-analogous art. As previously explained, Ekvall is not directed to a system for modulating fertility in a subject. The motivation to modify the device of Ekvall proposed by the examiner is defective. There are a multitude of different medical fields, with obstretics and gynecology being its own discipline. It would not have been obvious to one of ordinary skill in the art of obstretics and gynecology to modify the medical implant of Ekvall to be an intrauterine device for modulating fertility in a subject. Moreover, the modification proposed by the examiner would improperly change the principle of operation of the device disclosed in Ekvall. The medical implants disclosed by Ekvall consist of “magnetic material placed around a tissue or body structure” with the intent of making existing types of implants “more compatibile with competing magnetic fields, such as those present during MIR, by employing ‘floating’ magnets” to eliminate poor or none function of the implant as a result of the MRI (col. 1 lines 14-19 of Ekvall).
Examiner’s response: In response to applicant's argument that Ekvall is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Ekvall is still considered analogous art as Ekvall is a magnetic medical device that self-aggregates by magnetic forces and thus is reasonably pertinent to the particular problem with which the inventor was concerned. Further, Ekvall states that the medical implant device is to be placed around a tissue or body structure, and a uterus is made up of tissues and is a body structure. Further, the device is called a medical implant, which is by definition something that is implanted or inserted into the body, and thus although the specification of Ekvall discloses that the magnetic material is placed around a tissue or body structure, it is also implanted into the body structure. Modifying the medical implant to more specifically be an intrauterine device would not change the principle operation as the magnetic forces of the magnetic material of the medical implants would still function to retain functionality after exposure to an external magnetic field resulting from an MRI.
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.
Claim(s) 1, 4, 10, 19, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall et al. (referred to as “Ekvall”) (US 8,734,475 B2) in view of Hasson (US 3,467,089).
Regarding claim 1, Ekvall discloses a system in a subject, comprising a plurality of devices (702, 706) (see Figs. 7A, 7B; plurality of housings 702, 706 are a plurality of devices, as each of the housings are a medical implant that may be implanted into the body of a subject, see Col. 1 lines 14-15 and Col. 1 lines 62-65), each device (702, 706) having an elliptical shape (see Figs. 7A, 7B; each of the plurality of housings 702, 706 are circular in shape, and thus is an elliptical shape a circle is an ellipse), and comprising a core of magnetic material (see Figs. 7A, 7B, and 1, and Col. 4 lines 36-37; each of the housings 702, 706 comprise a core of magnetic material, as best shown in Fig. 1 via magnetic element 106 which is encased in housing 100 and thus is a core of magnetic material as it is the central part of the device) and a coating or covering on the core (see Figs. 7A, 7B, 1; the plurality of housings 702, 706 each have a core of magnetic material which is magnetic element 106 shown in Fig. 1, and a covering or housing that encapsulates the magnetic material, which is best shown in Fig. 1 as spherical half 102, 104), wherein upon implantation into a uterus the plurality of devices (702, 706) are configured to self-aggregate by magnetic forces generated by the magnetic material of the core and dimensioned to maintain the uterine lumen undistorted when self-aggregated (see Figs. 7A, 7B, 1, and Col. 10 lines 22-28, and Col. 2 lines 26-30; upon implantation into the subject’s body, the plurality of housings 702, 706 are configured to self-aggregate by magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within the housings 702, 706 attract the housings to one another or self-aggregate, and is capable of maintaining the uterine lumen undistorted when self-aggregated).
Ekvall is silent on an intrauterine device (IUD) for modulating fertility in a subject, and a coating or covering on the core comprising an inert material, copper or a combination thereof.
However, Hasson teaches an analogous core of magnetic material (see Fig. 4 and Col. 2 lines 2-5 and Col. 3 lines 51-53; the core of IUD 10 is a magnetic spring stainless steel material, as wires 26, 28 form the central part of the IUD), and an intrauterine device (IUD) for modulating fertility in a subject (see Fig. 5; IUD 10 is an intrauterine device as it is placed in the uterus of a subject to modulate fertility), and a coating or covering on the core comprising an inert material, copper or a combination thereof (see Fig. 4 and Col. 2 lines 5-10; silicone rubber covers the magnetic spring stainless steel material, and thus is a coating or covering on the core and silicone rubber is an inert material, as it is non-reactive), providing a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10 of Hasson).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Ekvall to be an intrauterine device (IUD) for modulating fertility in a subject, and to have modified the coating or covering of Ekvall to comprise an inert material as taught by Hasson, as Ekvall contemplates any material for the covering, see Col. 5 lines 27-28 of Ekvall, to have provided an improved system for modulating fertility that has a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10 of Hasson).
Regarding claim 4, Ekvall in view of Hasson discloses the invention as discussed in claim 1. Ekvall in view of Hasson further discloses wherein the coating or covering comprises polytetrafluoroethylene (PTFE), silicon, polymer, or elastomer (see Col. 2 lines 5-10 of Hasson; the coating or covering comprises a silicone rubber material, as previously modified above, see claim 1, and silicone rubber is a polymer).
Regarding claim 10, Ekvall in view of Hasson discloses the invention as discussed in claim 1. Ekvall in view of Hasson further discloses wherein the system comprises 2 or 3 devices (see Fig. 7A, 7B of Ekvall; the plurality of housings 702, 706 of Ekvall are each devices and thus the system 700 of Ekvall comprises 2 or 3 devices).
Regarding claim 19, Ekvall in view of Hasson discloses the invention as discussed in claim 1. Ekvall in view of Hasson further discloses a kit comprising the plurality of devices (702, 706 of Ekvall) of claim 1 (see claim 1, and see Figs. 7A, 7B of Ekvall; the plurality of housings 702, 706 of Ekvall form a kit).
Regarding claim 26, Ekvall in view of Hasson discloses the invention as discussed in claim 1. Ekvall in view of Hasson further discloses wherein the plurality of devices (702, 706 of Ekvall) are held together by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B, 1 of Ekvall, and Col. 10 lines 22-28 of Ekvall and Col. 2 lines 26-30 of Ekvall; the plurality of housings 702, 706 of Ekvall are held together by magnetic forces generated by the magnetic material of the core).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of Hasson further in view of Shulan (CN 1228297 A).
Regarding claim 2, Ekvall in view of Hasson discloses the invention as discussed in claim 1.
Ekvall in view of Hasson is silent on wherein the core comprises iron, nickel, cobalt, an alloy of rare earth metal, or a naturally occurring mineral.
However, Shulan teaches an analogous IUD (Fig. 1) with an analogous magnetic component (2) which comprises an alloy of rare earth metal (the magnet is a neodymium, iron, boron rare earth permanent magnet; see page 2 of the translation, paragraph 2 and Figs. 1-2) providing a magnet with a large/strong magnetic field (see page 2 of the translation, paragraph 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the core of magnetic material in the device of Ekvall in view of Hasson to comprise an alloy of rare earth metal as taught by Shulan, as Ekvall also contemplates the core of magnetic material to be any material including neodymium, see Col. 4 lines 43-45 of Ekvall, to have provided an improved system for modulating fertility that provides a magnet with a large/strong magnetic field (see page 2 of the translation, paragraph 3).
Regarding claim 3, Ekvall in view of Hasson further in view of Shulan discloses the invention as discussed in claim 2. Ekvall in view of Hasson further in view of Shulan further discloses wherein the rare earth metal comprises neodymium (see page 2 of the translation, paragraph 2, as previously modified above, see claim 2, the rare earth metal is neodymium).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of Hasson further in view of Abramson (US 3,777,748).
Regarding claim 5, Ekvall in view of Hasson discloses the invention as discussed in claim 4.
Ekvall in view of Hasson is silent on wherein the polymer is polyethylene or polypropylene.
However, Abramson teaches an analogous intrauterine device and an analogous coating (160) comprising of a polymer, wherein the polymer is polyethylene or polypropylene (see Figs. 1-2 and 5-7, and Col. 2 lines 9-10, Col. 4 lines 26-31, Col. 5 lines 24-28; coating 160 of the intrauterine device may be polyethylene or polypropylene), providing a rigid but flexible physiologically inert material (see Col. 4 lines 26-31).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating or covering of Ekvall in view of Hasson to be polyethylene or polypropylene material as taught by Abramson to have provided an improved system for modulating fertility in a subject that is a rigid but flexible and physiologically inert material (see Col. 4 lines 26-31).
Claim(s) 6 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall et al. (referred to as “Ekvall”) (US 8,734,475 B2) in view of Hasson (US 3,467,089) further in view of BAR-AM et al. (referred to as “BAR-AM”) (US 2017/0246027 A1).
Regarding claim 6, Ekvall in view of Hasson discloses the invention as discussed in claim 1.
Ekvall in view of Hasson is silent on wherein the coating or covering further comprises a pharmaceutical agent selected from progesterone, progestogen, copper or a combination thereof.
However, BAR-AM teaches an analogous plurality of IUDs (22, 24, 26) (see Fig. 4 and [0086], and [0057]; device 10 which is made up of beads 22, 24,26 are implanted in the uterine cavity and thus is an intrauterine device), wherein the coating or covering further comprises a pharmaceutical agent selected from progesterone, progestogen, copper or a combination thereof (see [0027], [0070]; progesterone, which is a pharmaceutical agent, can be released from the coatings made of hormone-containing polymers on the beads 22, 24, 26), providing to further help modulate fertility and regulate menstrual cycles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating or covering in the device of Ekvall in view of Hasson to comprise a pharmaceutical agent (progesterone) as taught by BAR-AM to have provided an improved system for modulating fertility in a subject that further helps to modulate fertility and regulate menstrual cycles.
Regarding claim 21, Ekvall in view of Hasson discloses the invention as discussed in claim 19.
Ekvall in view of Hasson is silent on the kit further comprising an inserter.
However, BAR-AM teaches an analogous kit comprising a plurality of devices (22, 24, 26) (see Fig. 4; beads 22, 24, 26 are a plurality of devices that form a kit), further comprising an inserter (50) (see Figs. 4-5 and [0088]-[0090]; guide 50 is an inserter as guide 50 is used to insert the beads 22, 24, 26 into a uterus), providing an insertion aid to safely implant the medical device into the subject.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit comprising the plurality of devices (702, 706 of Ekvall) in the device of Ekvall in view of Hasson to further comprise an inserter (50) as taught by BAR-AM to have provided an improved kit that has an insertion aid to safely implant the medical device into the subject.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of Hasson in view of BAR-AM further in view of Higuchi et al. (referred to as “Higuchi”) (US 3,903,880).
Regarding claim 7, Ekvall in view of Hasson further in view of BAR-AM discloses the invention as discussed in claim 6.
Ekvall in view of Hasson further in view of BAR-AM is silent on wherein the pharmaceutical agent is slow releasing.
However, Higuchi teaches an analogous pharmaceutical agent (progesterone) wherein the pharmaceutical agent is slow releasing (see Col. 6 lines 9-33 and Fig. 4; device 10 is an analogous intrauterine device that may release progesterone over a prolonged period of time by slow diffusion and thus progesterone is interpreted as a slow releasing pharmaceutical agent), providing to control fertility for long periods of time (see Col. 6 lines 29-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pharmaceutical agent of Ekvall in view of Hasson further in view of BAR-AM to be slow releasing as taught by Higuchi to have provided an improved system for modulating fertility in a subject to control fertility for long periods of time (see Col. 6 lines 29-33) so that a user does not have to frequently replace the device.
Claim(s) 12-14, 16, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of BAR-AM further in view of Hasson.
Regarding claim 12, Ekvall discloses a method in a subject comprising inserting into the subject a plurality of devices (702, 706) (see Figs. 7A, 7B; the plurality of housings 702, 706 are a plurality of devices as each of the housings are a medical implant, and may be implanted or inserted into the body of the subject, see Col. 1 lines 14-15 and Col. 1 lines 62-65), each device (702, 706) having an elliptical shape (see Figs. 7A, 7B; the plurality of housings 702, 706 are each circular in shape, and thus is an elliptical shape as a circle is an ellipse), and comprising a core of magnetic material (see Figs. 7A, 7B, 1, and Col. 4 lines 36-37; each of the housings 702, 706 comprise a core of magnetic material, as best shown in Fig. 1 via magnetic element 106, which is encased in housing 100 and thus is a core of magnetic material as it is the central part of the device) and a coating or covering on the core (see Figs. 7A,7B, and 1; the plurality of housings 702, 706 each have a core of magnetic material which is magnetic element 106 as shown in Fig. 1, and a covering or housing that encapsulates the magnetic material, which is best shown in Fig. 1 as spherical half 102, 104), wherein upon implantation the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B, 1, and Col. 10 lines 22-28, and Col. 2 lines 26-30; upon implantation into the subject’s body, the plurality of housings 702, 706 are configured to self-aggregate by magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within housings 702, 706 attract the housings to one another or self-aggregate).
Ekvall is silent on a method to modulate fertility in a subject comprising inserting into a uterus a plurality of devices, a coating or covering on the core comprising an inert material, copper, or a combination thereof, and implanting into the uterus the plurality of devices without distorting the uterine lumen.
However, BAR-AM teaches an analogous plurality of devices (22, 24, 26) (see Fig. 4; each of the beads 22, 24, 26 are analogous plurality of devices), and a method to modulate fertility in a subject comprising inserting into a uterus of the subject a plurality of devices (22, 24, 26) (see Fig. 4, and [0086]-[0093]; beads 22, 24, 26 are inserted into the uterine cavity via guide 50 in order to modulate fertility in a subject), and implanting into the uterus the plurality of devices (22, 24, 26) without distorting the uterine lumen (see Fig. 4 and [0086]-[0093]; the beads 22, 24, 26 are implanted into the uterus without distorting the uterine lumen, as the beads elastically contract and expand in response to contraction and expansion of the uterine cavity, see Abstract and [0009]), providing a method that is safer for the subject as the uterine lumen remains unchanged.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Ekvall to comprise inserting into a uterus of the subject the plurality of devices and implanting into the uterus the plurality of devices without distorting the uterine lumen as taught by BAR-AM to have provided an improved method to modulate fertility that is safer for the subject as the uterine lumen remains unchanged.
Ekvall in view of BAR-AM discloses the method as discussed above.
Ekvall in view of BAR-AM is silent on a coating or covering on the core comprising an inert material, copper, or a combination thereof.
However, Hasson teaches an analogous core of magnetic material (see Fig. 4 and Col. 2 lines 2-5 and Col. 3 lines 51-53; the core of IUD 10 is a magnetic spring stainless steel material, as wires 26, 28 form the central part of the IUD), and an intrauterine device (IUD) for modulating fertility in a subject (see Fig. 5; IUD 10 is an intrauterine device as it is placed in the uterus of a subject to modulate fertility), and a coating or covering on the core comprising an inert material, copper or a combination thereof (see Fig. 4 and Col. 2 lines 5-10; silicone rubber covers the magnetic spring stainless steel material, and thus is a coating or covering on the core and silicone rubber is an inert material, as it is non-reactive), providing a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10 of Hasson).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating or covering of Ekvall in view of BAR-AM to comprise an inert material as taught by Hasson, as Ekvall contemplates any material for the covering, see Col. 5 lines 27-28 of Ekvall, to have provided an improved system for modulating fertility that has a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10 of Hasson).
Regarding claim 13, Ekvall in view of BAR-AM further in view of Hasson discloses the invention as discussed in claim 12.
BAR-AM further teaches an analogous plurality of devices (22, 24, 26), wherein the coating or covering further comprises a pharmaceutical agent selected from progesterone, progestogen, copper or a combination thereof (see [0027], [0070]; progesterone, which is a pharmaceutical agent, can be released from the coatings made of hormone-containing polymers on the beads 22, 24, 26), providing to further modulate fertility and regulate the menstrual cycle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating or covering in the device of Ekvall in view of BAR-AM further in view of Hasson to comprise a pharmaceutical agent (progesterone) as taught by BAR-AM to have provided an improved system for modulating fertility in a subject that further helps to modulate fertility and regulate the menstrual cycle.
Regarding claim 14, Ekvall in view of BAR-AM further in view of Hasson discloses the method as discussed in claim 12.
BAR-AM further teaches an analogous plurality of devices (22, 24, 26) wherein a retention of the plurality of devices (22, 24, 26) is weeks, months, or years (see [0057] of BAR-AM; the plurality of IUDs 22, 24, 26 of BAR-AM are configured to be retained for any length of time including weeks, months or years), providing to not have to frequently replace the device.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices (702, 706 of Ekvall) in the device of Ekvall in view of BAR-AM further in view of Hasson wherein a retention of the plurality of devices is weeks, months, or years as taught by BAR-AM to have provided an improved method for modulating fertility in a subject such that the subject does not have to frequently replace the device.
Regarding claim 16, Ekvall in view of BAR-AM further in view of Hasson discloses the invention as discussed in claim 12. Ekvall in view of BAR-AM further in view of Hasson further discloses comprising 2 or 3 devices (702, 706 of Ekvall) (see Figs. 7A, 7B of Ekvall; the plurality of housings 702, 706 of Ekvall are each devices and thus comprises 2 or 3 devices), wherein the devices (702, 706 of Ekvall) are configured to self-aggregate after insertion into the uterus (see Figs. 7A, 7B, 1of Ekvall; as previously modified above, see claim 12, after insertion into the uterus, the plurality of devices 702, 706 of Ekvall self-aggregate via the magnetic element 106 of Ekvall, see Col. 10 lines 22-28 of Ekvall and Col. 2 lines 26-30 of Ekvall).
Regarding claim 27, Ekvall in view of BAR-AM further in view of Hasson discloses the invention as discussed in claim 12. Ekvall in view of BAR-AM further in view Hasson further discloses wherein the plurality of devices are free of a monofilament, thread, and string (see Figs. 7A, 7B of Ekvall; each housing of the plurality of housings 702, 706 of Ekvall is being interpreted as the plurality of devices and thus each individual housing is free of a monofilament, thread, and string).
Claim(s) 18, 22, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansari (US 3,805,777) in view of Ekvall in view of Hasson further in view of BAR-AM.
Regarding claim 18, Ansari discloses a method to remove a device (10) from a uterus of a subject having the device (10) inserted (see Figs. 1-2 and 5-6, and Col. 4 lines 14-28; device 10 is an intrauterine device and may be removed from a uterus of a subject when device 10 is inserted as shown in sequence in Figs. 5-6), the method comprising inserting a magnetic retrieving wand (30) into the uterus of the subject to retrieve the device (10) (see Figs. 1-2 and 4-6; removing tool 30, which is magnetic as it has a magnetic probe 34, is inserted into the uterus of the subject to retrieve device 10, see Col. 4 lines 14-28), wherein a diameter of the wand (30) is configured such that the wand (30) can pass into the uterus of said subject (see Figs. 4-6 and Col. 4 lines 14-28; a diameter of removing tool 30 is such that it can pass into the uterus of said subject as seen in Figs. 5-6).
Ansari is silent on a plurality of devices, wherein each device has an elliptical shape, and comprises a core of magnetic material and a coating or covering on the core comprising an inert material, copper, or a combination thereof, wherein prior to retrieval from the uterus the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material of the core without distorting the uterine lumen.
However, Ekvall teaches an analogous implantable plurality of devices (702, 706), wherein each device (702, 706) has an elliptical shape (see Figs. 7A, 7B; the plurality of housings 702, 706 are circular in shape, and thus are elliptical as a circle is an ellipse), and comprises a core of magnetic material (see Figs. 7A, 7B, and 1, and Col. 4 lines 36-37; each of the plurality of housings 702, 706 have a core of magnetic material, as best shown in Fig. 1 via magnetic element 106, which is encased in the housing, and thus is a core of magnetic material as it is the central part of the devices) and a coating or covering on the core (see Figs. 7A, 7B, and 1; the plurality of housings 702, 706 each have a core of magnetic material which is magnetic element 106 as shown in Fig. 1, and a covering or housing that encapsulates the magnetic material, which is best shown in Fig. 1 as spherical half 102, 104), wherein prior to retrieval the plurality of devices (702,706) are self-aggregated by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B,1, and Col. 10 lines 22-28 and Col. 2 lines 26-30; prior to retrieval, the plurality of housings 702, 706 are configured to self-aggregate by magnetic by magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within the housings 702, 706 attract the housings to one another or self-aggregate), providing magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place inside a user’s body and remove from a user’s body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the device of Ansari to be a plurality of devices (702, 706) that has an elliptical shape, and comprises a core of magnetic material and a coating or covering on the core, and wherein prior to retrieval the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material of the core as taught by Ekvall to have provided an improved method to remove a plurality of devices from a uterus of a subject that provides magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place inside a user’s body and remove from a user’s body.
Ansari in view of Ekvall discloses the method as discussed above.
Ansari in view of Ekvall is silent on a coating or covering on the core comprising an inert material, copper, or a combination thereof, and wherein prior to retrieval from the uterus the plurality of devices are self-aggregated without distorting the uterine lumen.
However, Hasson teaches an analogous core of magnetic material (see Fig. 4 and Col. 2 lines 2-5 and Col. 3 lines 51-53; the core of IUD 10 is a magnetic spring stainless steel material, as wires 26, 28 form the central part of the IUD), and a coating or covering on the core comprising an inert material, copper, or a combination thereof (see Fig. 4 and Col. 2 lines 5-10; silicone rubber covers the magnetic spring stainless steel material, and thus is a coating or covering on the core and silicone rubber is an inert material, as it is non-reactive), providing a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating or covering of the plurality of devices (702, 706 of Ekvall) in the device of Ansari in view of Ekvall to comprise an inert material as taught by Hasson to have provided an improved plurality of devices that has a biocompatible material that is non-reactive and non-toxic (see Col. 2 lines 5-10).
Ansari in view of Ekvall further in view of Hasson discloses the method as discussed above.
Ansari in view of Ekvall further in view of Hasson is silent on wherein prior to retrieval from the uterus the plurality of devices are aggregated without distorting the uterine lumen.
However, BAR-AM teaches an analogous plurality of devices (22, 24, 26), and wherein prior to retrieval from the uterus the plurality of devices (22, 24, 26) are aggregated without distorting the uterine lumen (see Fig. 4 and [0086], [0093], Abstract, and [0009]; prior to retrieval from the uterus, the beads 22, 24,26 are aggregated without distorting the uterine lumen, as beads 22 are clustered together or aggregated, and the beads elastically contract and expand in response to contraction and expansion of the uterine cavity), providing devices that is safer for the subject as the uterine lumen remains unchanged.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices (702, 706 of Ekvall) in the device of Ansari in view of Ekvall further in view of Hasson to aggregate without distorting the uterine lumen prior to retrieval from the uterus as taught by BAR-AM to have provided an improved plurality of devices that is safer for the subject as the uterine lumen remains unchanged.
Regarding claim 22, Ansari in view of Ekvall in view of Hasson further in view of BAR-AM discloses the method as discussed in claim 18. Ansari in view of Ekvall in view of Hasson further in view of BAR-AM further discloses comprising 2 or 3 devices (702, 706 of Ekvall) (as previously modified above, see claim 18, the plurality of housings 702, 706 of Ekvall comprise 2 or 3 devices, see Figs. 7A, 7B of Ekvall).
Regarding claim 28, Ansari in view of Ekvall in view of Hasson further in view of BAR-AM discloses the method as discussed in claim 18. Ansari in view of Ekvall in view of Hasson further in view of BAR-AM further discloses wherein the plurality of devices (702, 706 of Ekvall) are free of a monofilament, thread, and string (see Figs. 7A, 7B of Ekvall; each housing of the plurality of housings 702, 706 of Ekvall is being interpreted as the plurality of devices and thus each individual housing is free of a monofilament, thread, and string).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of Hasson further in view of Ansari.
Regarding claim 20, Ekvall in view of Hasson discloses the invention as discussed in claim 19.
Ekvall in view of Hasson is silent on further comprising a magnetic retrieving wand, wherein a diameter of the wand is configured such that the wand can pass into the uterus of the subject.
However, Ansari teaches an analogous device (10) comprising a magnetic retrieving wand (30) (see Figs. 1 and 4-6; removing tool 30 is a magnetic retrieving wand as removing tool 30 comprises a magnetic probe 34 to retrieve device 10), wherein a diameter of the wand (30) is configured such that the wand (30) can pass into the uterus of the subject (see Figs. 4-6 and Col. 4 lines 14-28; a diameter of removing tool 30 is such that it can pass into the uterus of the subject as seen in Figs. 5-6), providing to facilitate the removal of the device and eliminating irritation and side effects associated with an IUD string or tail (see Col. 3 lines 24-31 and Col. 5 lines 24-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the kit with the plurality of devices (702, 706 of Ekvall) in the device of Ekvall in view of Hasson with a magnetic retrieving wand (30) that can pass into the uterus of the subject as taught by Ansari to have provided an improved kit comprising the plurality of devices that facilitates the removal of the device and eliminating irritation and side effects associated with an IUD string or tail (see Col. 3 lines 24-31 and Col. 3 lines 24-33).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of Hasson further in view of Gruber et al. (referred to as “Gruber”) (US 2008/0249534 A1).
Regarding claim 23, Ekvall in view of Hasson discloses the invention as discussed in claim 10.
Ekvall in view of Hasson is silent on wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of Gruber and [0196] of Gruber; wherein upon implantation Gruber teaches a plurality of devices 3801 that self-aggregate into a triangular triad shape as seen in Fig. 38 of Gruber, as the devices 3801 of Gruber are being held together on their own by the opposing poles of the magnetic forces), providing a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices (702, 706 of Ekvall) in the device of Ekvall in view of Hasson to form a triangular triad shape upon implantation as taught by Gruber to have provided an improved method for modulating fertility that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ekvall in view of BAR-AM in view of Hasson further in view of Gruber.
Regarding claim 24, Ekvall in view of BAR-AM further in view of Hasson discloses the method as discussed in claim 12.
Ekvall in view of BAR-AM further in view of Hasson is silent on wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of Gruber and [0196] of Gruber; wherein upon implantation Gruber teaches a plurality of devices 3801 that self-aggregate into a triangular triad shape as seen in Fig. 38 of Gruber, as the devices 3801 of Gruber are being held together on their own by the opposing poles of the magnetic forces), providing a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices (702, 706 of Ekvall) in the device of Ekvall in view of BAR-AM further in view of Hasson to form a triangular triad shape upon implantation as taught by Gruber to have provided an improved method for modulating fertility that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ansari in view of Ekvall in view of Hasson in view of BAR-AM further in view of Gruber.
Regarding claim 25, Ansari in view of Ekvall in view of Hasson further in view of BAR-AM discloses the method as discussed in claim 22.
Ansari in view of Ekvall in view of Hasson further in view of BAR-AM is silent on wherein prior to retrieval from the uterus the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein prior to retrieval from the uterus the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of and [0196]; prior to retrieval from the uterus, Gruber further teaches a plurality of devices 3801 that self-aggregate into a triangular triad shape as seen in Fig. 38, as the devices 3801 are being held together on their own by the opposing poles of the magnetic forces), providing a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the uterus.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices (702, 706 of Ekvall) in the device of Ansari in view of Ekvall in view of Hasson further in view of BAR-AM to self-aggregate to form a triangular triad shape prior to retrieval from the uterus as taught by Gruber to have provided an improved method for removing a plurality of IUDs that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
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 1-7, 10, 19-21, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,389,325 B2 in view of Ekvall further in view of BAR-AM.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 1 of patent ‘325 recites the limitations of a device for modulating fertility or estrus behavior in an animal comprising a plurality of devices, each device comprising an elliptical shape, and a core of magnetic material and a coating on the core comprising an inert material or copper.
The patent ‘325 fails to recite wherein upon implantation into a uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core and dimensioned to maintain the uterine lumen undistorted when self-aggregated.
However, Ekvall teaches an analogous plurality of devices (702, 706) that are implanted in user’s body, the plurality of devices (702, 706) are configured to self-aggregate by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B, 1, and Col. 10 lines 22-28, and Col. 2 lines 26-30; the plurality of housings 702, 706 are magnetic beads, as each of the housings 702, 706 have magnets inside of them, as better shown in Fig. 1, and thus each device comprises a core of magnetic material, and upon implantation into a user’s body, the plurality of housings 702, 706 are configured to self-aggregate by the magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within the housings 702, 706 attract the housings to one another or self-aggregate), providing magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place inside a user’s body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the core of magnetic material of patent ‘325 to be of a magnetic material such that upon implantation into the uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core as taught by Ekvall to have provided an improved method to modulate fertility in a subject that provides magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place inside a user’s body. Therefore, the combination of patent ‘325 in view of Ekvall results in wherein upon implantation into the uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core (as previously modified above, the beads 22, 24, 26 of BAR-AM are placed or implanted into the uterus and each of the beads 22, 24, 26 of BAR-AM are configured to bond to opposing poles when implanted, and thus are interpreted to self-aggregate by magnetic forces generated by the magnetic material of the core of patent ‘325 as previously modified, as they are being held together on their own by the magnetic forces (opposing poles), see Col. 10 lines 22-28 of Ekvall),
The patent ‘325 in view of Ekvall discloses the invention as discussed above.
The patent ‘325 in view of Ekvall fails to recite wherein upon implantation into a uterus the plurality of devices are dimensioned to maintain the uterine lumen undistorted when self-aggregated.
However, BAR-AM teaches an analogous plurality of devices (22, 24, 26) (see Fig. 4 and Abstract), wherein upon implantation into a uterus the plurality of devices (22, 24, 26) are dimensioned to maintain the uterine lumen undistorted when self-aggregated (see Abstract and [0009]; upon implantation into a uterus, each of the beads 22, 24, 26 are dimensioned to maintain the uterine lumen undistorted, as the beads are capable of elastically contracting and expanding in response to contraction and expansion of the uterine cavity when the beads slide along the wire and self-aggregate), providing devices that are more comfortable and safer for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices of patent ‘325 in view of Ekvall to be dimensioned to maintain the uterine lumen undistorted as taught by BAR-AM to have provided an improved system for modulating fertility that provides devices that are more comfortable and safer for a user.
With respect to claim 2 of the instant application, all of the limitations are found in claim 2 of patent ‘325.
With respect to claim 3 of the instant application, all of the limitations are found in claim 3 of patent ‘325.
With respect to claim 4 of the instant application, all of the limitations are found in claim 4 of patent ‘325.
With respect to claim 5 of the instant application, all of the limitations are found in claim 5 of patent ‘325.
With respect to claim 6 of the instant application, all of the limitations are found in claims 6-7 of patent ‘325.
With respect to claim 7 of the instant application, all of the limitations are found in claim 8 of patent ‘325.
With respect to claim 10 of the instant application, all of the limitations are found in claim 1 of patent ‘325 in view of Ekvall further in view of BAR-AM.
The patent ‘325 in view of Ekvall further in view of BAR-AM further teaches wherein the system (10 of BAR-AM) comprises 2 or 3 devices (22, 24, 26 of BAR-AM) (see Fig. 4 and [0070] of BAR-AM; beads 22, 24, 26 of BAR-AM make up a plurality of IUDs as each bead is an individual IUD, and thus there are 3 devices), providing a sufficient number of IUDs to properly modulate fertility in a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of plurality of devices of patent ‘325 in view of Ekvall in view of BAR-AM to be 2 or 3 as taught by BAR-AM to have provided an improved system for modulating fertility in a subject that provides a sufficient number of IUDs to properly modulate fertility in a user.
With respect to claim 19 of the instant application, all of the limitations are found in claim 12 of patent ‘325.
With respect to claim 20 of the instant application, all of the limitations are found in claim 13 of patent ‘325.
With respect to claim 21 of the instant application, all of the limitations are found in claim 1 of patent ‘325 in view of Ekvall further in view of BAR-AM.
The patent ‘325 in view of Ekvall further in view of BAR-AM teaches an inserter (50 of BAR-AM) (see Figs. 4-5 and [0088]-[0090] of BAR-AM; guide 50 of BAR-AM is an inserter as guide 50 BAR-AM is used to insert the IUDs 22, 24, 26 of BAR-AM into a uterus), providing a device that helps facilitate the insertion of the plurality of IUDs into the uterus so that it is easier and more comfortable to insert.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the kit of patent ‘325 in view of Ekvall further in view of BAR-AM with an inserter (50 of BAR-AM) as taught by BAR-AM to have provided an improved kit that provides a device to help facilitate the insertion of the plurality of IUDs into the uterus so that it is easier and more comfortable to insert.
With respect to claim 26 of the instant application, all limitations are found in claim 1 of patent ‘325 in view of Ekvall further in view of BAR-AM. The patent ‘325 in view of Ekvall further in view of BAR-AM further discloses wherein the plurality of devices are held together by magnetic forces generated by the magnetic material of the core (see Fig. 38 of Ekvall and [0196] of Ekvall; as previously modified above, see claim 1, each of the devices of patent ‘325 are held together by magnetic forces generated by the magnetic material of the core, as Ekvall teaches devices 3801 of Ekvall are configured to bond to opposing poles, and thus are held together by magnetic forces (opposing poles) generated by the magnetic material).
Claim 12-14, and 16 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 11,389,325 B2 in view of BAR-AM further in view of Ekvall.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 14 of patent ‘325 recites the limitations of a method to suppress estrus in a subject comprising inserting a plurality of devices into a uterus of the subject, wherein each of the plurality of devices have an elliptical shape and consist essentially of a core of magnetic material and a coating on the core comprising an inert material or copper.
The patent ‘325 fails to recite wherein upon implantation into the uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core without distorting the uterine lumen.
However, BAR-AM teaches an analogous plurality of devices (22, 24, 26) (see Fig. 4 and Abstract), wherein upon implantation into the uterus the plurality of devices aggregate without distorting the uterine lumen (upon implantation into a uterus, each of the beads 22, 24, 26 are dimensioned to maintain the uterine lumen undistorted, as the devices elastically contract and expand in response to contraction and expansion of the uterine cavity, and thus beads 22 aggregate or gather together without distorting the uterine lumen, as eight of the beads 22 are gathered together in Fig. 4), providing to be more comfortable and safe for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices of patent ‘325 upon implantation into the uterus to aggregate without distorting the uterine lumen as taught by BAR-AM to have provided an improved method to modulate fertility in a subject so that the devices are more comfortable and safer for a user.
The patent ‘325 in view of BAR-AM discloses the invention as discussed above.
The patent ‘325 in view of BAR-AM fails to recite the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core.
However, Ekvall teaches an analogous plurality of devices (702, 706) that are implanted in a user’s body, the plurality of devices (702, 706) self-aggregate by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B, 1, and Col. 10 lines 22-28, and Col. 2 lines 26-30; the plurality of housings 702, 706 are magnetic beads, as each of the housings 702, 706 have magnets inside of them, as better shown in Fig. 1, and thus each device comprises a core of magnetic material, and upon implantation into a user’s body, the plurality of housings 702, 706 are configured to self-aggregate by the magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within the housings 702, 706 attract the housings to one another or self-aggregate), providing magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place in a user’s body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the core of magnetic material of patent ‘325 in view of BAR-AM to be of a magnetic material such that upon implantation into the uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core as taught by Ekvall to have provided an improved method to modulate fertility in a subject that provides magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place in a user’s body. Therefore, the combination of patent ‘325 in view of BAR-AM further in view of Ekvall results in wherein upon implantation into the uterus the plurality of devices self-aggregate by magnetic forces generated by the magnetic material of the core (as previously modified above, see Col. 10 lines 22-28 of Ekvall; the beads 22, 24, 26 of BAR-AM are placed or implanted into the uterus and each of the beads 22, 24, 26 of BAR-AM are configured to bond to opposing poles when implanted, and thus are interpreted to self-aggregate by magnetic forces generated by the magnetic material of the core of patent ‘325 as previously modified, as they are being held together on their own by the magnetic forces (opposing poles)),
With respect to claim 13 of the instant application, all of the limitations are found in claim 14 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall further teaches wherein the coating comprises a pharmaceutical agent selected from progesterone, progestogen, copper or a combination thereof (see [0027], [0070] of BAR-AM and Fig. 4 of BAR-AM; progesterone, which is a pharmaceutical agent, can be released from the coatings made of hormone-containing polymers on the beads), providing to prevent pregnancy or treat uterine related disorders and conditions (see [0065] of BAR-AM).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating of patent ‘325 in view of BAR-AM further in view of Ekvall to be progesterone which is a pharmaceutical agent as taught by BAR-AM to have provided an improved method to modulate fertility so that the device prevents pregnancy or treats uterine related disorders and conditions (see [0065]).
With respect to claim 14 of the instant application, all of the limitations are found in claim 14 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of Ekvall further teaches wherein a retention of the plurality of devices (22, 24, 26) is weeks, months, or years (see Fig. 4 and [0057] of BAR-AM; the plurality of devices 22, 24, 26 of BAR-AM are configured to be retained for any length of time including weeks, months, or years), providing to prevent pregnancy or to treat a uterine disorder for any length of time (see [0057] of BAR-AM).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the retention length of the plurality of IUDs of patent ‘325 in view of BAR-AM further in view of Ekvall to be weeks, months, or years as taught by BAR-AM to have provided an improved method to modulate fertility in a subject so that the device prevents pregnancy or treats a uterine disorder for any length of time (see [0057] of BAR-AM).
With respect to claim 16 of the instant application, all of the limitations are found in claim 14 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall further teaches comprising 2 or 3 devices (22, 24, 26 of BAR-AM) (see Fig. 4; beads 22, 24, 26 make up a plurality of IUDs as each bead is an individual IUD, and thus there are 3 devices), providing a sufficient number of IUDs to properly modulate fertility in a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of plurality of IUDs of patent ‘325 in view of BAR-AM further in view of Ekvall to be 2 or 3 as taught by BAR-AM to have provided an improved system for modulating fertility in a subject that provides a sufficient number of IUDs to properly modulate fertility in a user.
Claim 18 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,389,325 B2 in view of BAR-AM further in view of Ekvall.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 15 of patent ‘325 recites the limitations of a method to remove a plurality of devices from a uterus of a subject having previously had the plurality of devices inserted, the method comprising retrieving each of the plurality of devices with a magnetic retrieving wand, wherein the magnetic retrieving wand has a diameter such that it can pass into the uterus of said subject, wherein each of the plurality of devices has an elliptical shape and consists essentially of a core of magnetic material and a coating on the core, wherein the coating comprises a pharmaceutical agent, copper, an inert material, or a combination thereof.
The patent ‘325 fails to recite wherein prior to retrieval from the uterus the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material of the core without distorting the uterine lumen.
However, BAR-AM teaches an analogous plurality of devices (22, 24, 26) (see Fig. 4 and Abstract), wherein prior to retrieval from the uterus the plurality of devices (22, 24, 26) are self-aggregated without distorting the uterine lumen (see [0009] and Fig. 4; prior to retrieval from the uterus, each of the beads 22, 24, 26 are dimensioned to maintain the uterine lumen undistorted, as the devices elastically contract and expand in response to contraction and expansion of the uterine cavity, and thus beads 22 aggregate or gather together without distorting the uterine lumen, as eight of the beads 22 are gathered together as seen in Fig. 4), providing to be more comfortable and safer for a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices of patent ‘325 prior to retrieval from the uterus to be aggregated without distorting the uterine lumen as taught by BAR-AM to have provided an improved method to remove a plurality of devices from a uterus so that the devices are more comfortable and safer for a user.
The patent ‘325 in view of BAR-AM discloses the invention as discussed above.
The patent ‘325 in view of BAR-AM fails to recite the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material of the core.
However, Ekvall teaches an analogous plurality of devices (702, 706) that are implanted in user’s body, wherein prior to retrieval from the uterus the plurality of devices (702, 706) are self-aggregated by magnetic forces generated by the magnetic material of the core (see Figs. 7A, 7B, 1, and Col. 10 lines 22-28, and Col. 2 lines 26-30; the plurality of housings 702, 706 are magnetic beads, as each of the housings 702, 706 have magnets inside of them, as better shown in Fig. 1, and thus each device comprises a core of magnetic material, and upon implantation into a user’s body, the plurality of housings 702, 706 are configured to self-aggregate by the magnetic forces generated by the magnetic material of the core, as the magnetic fields of the magnetic elements within the housings 702, 706 attract the housings to one another or self-aggregate), providing magnetic beads that stay intact more securely as the magnets help hold the beads in place, reducing wear and tear, and forming a more compact, organized cluster such that it is easier to place in a user's body.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the core of magnetic material in the patent ‘325 in view of BAR-AM to be of a magnetic material such that prior to retrieval from the uterus the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material as taught by Ekvall to have provided an improved method to remove a plurality of devices that provides an easy attachment mechanism that requires minimal structure. Therefore, the combination of patent ‘325 in view of BAR-AM further in view of Ekvall results in prior to retrieval from the uterus the plurality of devices are self-aggregated by magnetic forces generated by the magnetic material of the core (as previously modified above, the devices of patent ‘325 are configured to bond to opposing poles when implanted into the uterus, and thus are interpreted to self-aggregate by magnetic forces generated by the magnetic material of the core of patent ‘325 as they are being held together on their own by the magnetic forces prior to retrieval from the uterus).
With respect to claim 22 of the instant application, all of the limitations are found in claim 15 of patent ‘325 in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall further discloses comprising 2 or 3 devices (22, 24, 26 of BAR-AM) (see Fig. 4 of BAR-AM; beads 22, 24, 26 of BAR-AM make up a plurality of IUDs as each bead is an individual IUD, and thus there are 3 devices), providing a sufficient number of IUDs to properly modulate fertility in a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the number of plurality of devices of patent ‘325 in view of BAR-AM further in view of Ekvall to be 2 or 3 as taught by BAR-AM to have provided an improved system for modulating fertility in a subject that provides a sufficient number of IUDs to properly modulate fertility in a user.
Claim 23 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 of U.S. Patent No. 11,389,325 B2 in view of Ekvall in view of BAR-AM further in view of Gruber.
With respect to claim 23 of the instant application, all limitations are found in claim 10 of patent ‘325 in view of Ekvall further in view of BAR-AM.
The patent ‘325 in view of Ekvall further in view of BAR-AM fails to recite wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of Ekvall and [0196] of Ekvall; upon implantation the plurality of devices self-aggregate into a triangular triad shape as seen in Fig. 38 of Ekvall, as the IUDs are held together on their own by the opposing poles of the magnetic forces).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices of patent ‘325 in view of Ekvall further in view of BAR-AM to self-aggregate to form a triangular triad shape upon implantation into the uterus as taught by Gruber to have provided an improved system for modulating fertility in a subject that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Claim 24 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 of U.S. Patent No. 11,389,325 B2 in view of BAR-AM in view of Ekvall further in view of Gruber.
With respect to claim 24 of the instant application, all limitations are found in claim 10 of patent ‘325 in view of Ekvall further in view of BAR-AM.
The patent ‘325 in view of Ekvall further in view of BAR-AM fails to recite wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein upon implantation the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of Ekvall and [0196] of Ekvall; upon implantation the plurality of devices self-aggregate into a triangular triad shape as seen in Fig. 38 of Ekvall, as the IUDs are held together on their own by the opposing poles of the magnetic forces).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of devices of patent ‘325 in view of Ekvall further in view of BAR-AM to self-aggregate to form a triangular triad shape upon implantation into the uterus as taught by Gruber to have provided an improved system for modulating fertility in a subject that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Claim 25 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 of U.S. Patent No. 11,389,325 B2 in view of BAR-AM in view of Ekvall further in view of Gruber.
With respect to claim 25 of the instant application, all limitations are found in claim 15 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall fails to recite wherein prior to retrieval from the uterus the plurality of devices self-aggregate into a triangular triad shape.
However, Gruber teaches an analogous plurality of devices (3801) (see Fig. 38; magnet blocks 3801 are interpreted as analogous plurality of devices as the magnet blocks 3801 are placed inside a uterine cavity), and wherein prior to retrieval from the uterus the plurality of devices self-aggregate into a triangular triad shape (see Fig. 38 of Gruber and [0196] of Gruber; upon implantation the plurality of devices 3801 self-aggregate into a triangular triad shape as seen in Fig. 38 of Gruber, as the devices 3801 are held together on their own by the opposing poles of the magnetic forces).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of IUDs of patent ‘325 in view of BAR-AM further in view of Ekvall to self-aggregate to form a triangular triad shape upon implantation into the uterus as taught by Gruber to have provided an improved system for modulating fertility in a subject that provides a shape that is similar to a shape of a uterus so that the device is more comfortable and suited for the user.
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 of U.S. Patent No. 11,389,325 B2 in view of Ekvall further in view of Ansari.
With respect to claim 27 of the instant application, all limitations are found in claim 14 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall fails to recite wherein the plurality of devices are free of a monofilament, thread, and string.
However, Ansari teaches an analogous device (10) wherein the device is free of a monofilament, thread, and string (see Figs. 1-2; device 10 is free of a monofilament, thread, and string), providing to eliminate irritation and associated side effects due to the present of a string or tail (see Col. 5 lines 30-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the plurality of devices of patent ‘325 in view of BAR-AM further in view of Ekvall to be free of a monofilament, thread, and string as taught by Ansari to have provided an improved intrauterine device that eliminates irritation and associated side effects due to the presence of a string or tail (see Col. 5 lines 30-33). Therefore, the combination of the patent ‘325 in view of BAR-AM in view of Ekvall further in view of Ansari results in the plurality of devices being free of a monofilament, thread, and string.
Claims 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 of U.S. Patent No. 11,389,325 B2 in view of Ekvall further in view of Ansari.
With respect to claim 28 of the instant application, all limitations are found in claim 15 of patent ‘325 in view of BAR-AM further in view of Ekvall.
The patent ‘325 in view of BAR-AM further in view of Ekvall fails to recite wherein the plurality of devices are free of a monofilament, thread, and string.
However, Ansari teaches an analogous intrauterine device (10) wherein the IUD is substantially free of a monofilament, thread, and string (see Figs. 1-2; device 10 is free of a monofilament, thread, and string), providing to eliminate irritation and associated side affects due to the present of a string or tail (see Col. 5 lines 30-33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each of the plurality of IUDs of patent ‘325 to be substantially free of a monofilament, thread, and string as taught by Ansari to have provided an improved intrauterine device that eliminates irritation and associated side affects due to the presence of a string or tail (see Col. 5 lines 30-33). Therefore, the combination of the patent ‘325 in view of Ansari results in the plurality of IUDs being substantially free of a monofilament, thread, and string.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786