DETAILED ACTION
This action is in response to the amendment filed 3/18/2026. Currently, claims 1-18 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No., filed on 3/16/2011.
Response to Arguments
Applicant’s arguments with respect to the objection to the drawings as failing to comply with 37 CFR 1.84(p)(5) because they include reference character(s) not mentioned in the description have been fully considered and are persuasive. The objection to the drawings as failing to comply with 37 CFR 1.84(p)(5) because they include reference character(s) not mentioned in the description has been withdrawn.
Applicant failed to amend the drawings and/or the claims to overcome the previous objection to the drawings as failing to show every feature of the invention specified in the claims. Further, Applicant failed to provide arguments to this objection. The objection to the drawings as failing to show every feature of the invention specified in the claims has therefore, been maintained.
Applicant’s amendment to the abstract is sufficient to overcome the previous objection to the specification.
Applicant’s amendments to claims 1 and 9 are not sufficient to overcome the previous objection to claims 1 and 9. Claims 1 and 9, therefore, remain objected to for the reason(s) below.
Applicant failed to amend claims 4 and 13 to overcome the previous rejection of claims 4, 8, 13 and 18 under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Further, Applicant failed to provide arguments to this rejection. The rejection of claims 4, 8, 13 and 18 under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph has therefore, been maintained.
Applicant’s arguments with respect to the prior art rejection(s) of the claim(s) have been considered but are moot in view of the modified interpretation of Wildemeersch (US 6,588,429 B1) presented below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the reservoir containing a hormone (see claims 1 and 9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the slider” should be amended to recite ---the movable slider---. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation “image enhancing means” (see claims 4 and 13) is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim limitation “image enhancing means” (see claims 4 and 13) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claims are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 8 depends on claim 4 and therefore, includes the same error. Claim 18 depends on claim 13 and therefore, includes the same error.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A) in view of Wildemeersch (US 6,588,429 B1).
In regards to claim 1, Macandrew et al. teaches in Figures 3A-5
an intrauterine system (IUD 40) comprising:
a reservoir containing a hormone (column 5, lines 24-33 teaches that the IUD 40 includes “an elongate member 45 having a jacket-like polymeric reservoir containing an active agent wound around it,” wherein the active ingredient can be “hormones used for the treatment of menopausal troubles or for contraception”); and
a removal string (withdrawal string(s) 41) attached to (as shown in Figure 3A) the intrauterine system (IUD 40); and
an inserter (inserter 10) comprising:
a handle (plunger 11, handle 20) comprising a movable slider (stop member/knob R; Figures 3A and 3B teach the position of the stop member/knob R being moved) arranged in a longitudinal opening (Figure 5 teaches the stop member/knob R being positioned within the opening in plunger 11 longitudinally extending between surface 21a and surface 21b);
a plunger (plunger 11) attached to (inasmuch as it is part of) the handle (plunger 11, handle 20);
an insertion tube (protective tube 12) attached to (as shown in Figures 3A and 3D; column 3, lines 44-45 teaches “the jacket of the protective tube has an attached stop member R”) the movable slider (stop member/knob R); and
a lock (locking device 15; column 3, lines 33-34 teaches “locking device (15) associated with the plunger 11”) arranged inside (claim 1 teaches “a locking device operatively attached to said plunger, said locking device adapted to lock a string attached to the IUD;” since the withdrawal string(s) 41 is positioned within the plunger 11 (as shown in Figures 3A and 3B), the locking device 15 must also be positioned within the plunger 11 in order to contact the withdrawal string(s) 41 to lock the withdrawal string(s) 41 in position) the handle (plunger 11, handle 20).
Macandrew et al. does not teach the lock being controllable by the movable slider, wherein the lock comprises: a main part; a first extension attached to the main part; and a counterpart, wherein the main part and the counterpart are arranged in a first position of the movable slider to form a blocking and lock the intrauterine system in relation to the plunger via the removal string, and wherein movement of the movable slider to a second position causes a part or a second extension of the slider to press against the first extension attached to the main part to separate the main part and the counterpart from each other and release the removal string and the intrauterine system.
However, Wildemeersch teaches in Figures 1-5 an analogous device with the lock (moving arm 10, projection 11, base 16, opening 17) being controllable by (when pressure 26 is released from thruster 9, thruster 9 is moved upward such that the part of thruster 9 that is attached to the top of moving arm 10 moves the moving arm 10 upward to lock pull thread 22; see Figures 1-5 and column 2, lines 61-67 teach the when pressure 26 is not applied to or is released from the thruster 9, projection 11 presses the pull thread 22 against opening 17, “blocking pull thread 22 in the tensioned state”; Figure 3 and column 3, lines 8-13 teach that the application of pressure on thruster 9 in the direction of arrow 26 causes the projection 11 to be moved out of contact with opening 17, consequently releasing pull thread 22) the movable slider (thruster 9; can be considered a “slider” inasmuch as thruster 9 moves smoothly downward, or slides downward, upon application of pressure 26 thereto, as taught in Figures 2 and 3 and column 3, lines 8-13), wherein the lock (moving arm 10, projection 11, base 16, opening 17) comprises: a main part (projection 11); a first extension (moving arm 10) attached to (as shown in Figures 2 and 3; column 2, lines 31-32 teaches “a moving arm 10 provided with a projection 11”) the main part (projection 11); and a counterpart (base 16, opening 17), wherein the main part (projection 11) and the counterpart (base 16, opening 17) are arranged in a first position (shown in Figure 2) of the movable slider (thruster 9) to form a blocking and lock (when pressure 26 is released from thruster 9, thruster 9 is moved upward such that the part of thruster 9 that is attached to the top of moving arm 10 moves the moving arm 10 upward to lock pull thread 22; see Figures 1-5 and column 2, lines 61-67 teach the when pressure 26 is not applied to or is released from the thruster 9, projection 11 presses the pull thread 22 against opening 17, “blocking pull thread 22 in the tensioned state”) the intrauterine system (intrauterine contraceptive device 15) in relation to the plunger (sheath 4) via the removal string (pull thread 22), and wherein movement of the movable slider (thruster 9) to a second position (shown in Figure 3) causes a part or a second extension (distal end of thruster 9 that connects to the proximal end of the moving arm 10) of the slider (thruster 9) to press against the first extension (moving arm 10) attached to (as shown in Figures 2 and 3; column 2, lines 31-32 teaches “a moving arm 10 provided with a projection 11”) the main part (projection 11) to separate the main part (projection 11) and the counterpart (base 16, opening 17) from each other and release (Figure 3 and column 3, lines 8-13 teach that the application of pressure on thruster 9 in the direction of arrow 26 causes the projection 11 to be moved out of contact with opening 17 via moving arm 10, consequently releasing pull thread 22) the removal string (pull thread 22) and (via release of the pull thread 22) the intrauterine system (intrauterine contraceptive device 15).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the lock of Macandrew et al. to include the lock being controllable by the movable slider, wherein the lock comprises: a main part; a first extension attached to the main part; and a counterpart, wherein the main part and the counterpart are arranged in a first position of the movable slider to form a blocking and lock the intrauterine system in relation to the plunger via the removal string, and wherein movement of the movable slider to a second position causes a part or a second extension of the slider to press against the first extension attached to the main part to separate the main part and the counterpart from each other and release the removal string and the intrauterine system as taught by Wildemeersch because this element is known to provide the device with a locking mechanism to effectively and reversibly lock and maintain the removal string in position to facilitate and “simplify” insertion of an intrauterine contraceptive device and “allow easy release of the pull thread without risk of breaking” the intrauterine contraceptive device, as Wildemeersch teaches in column 1, lines 51-54, column 2, lines 61-67, column 3, lines 8-13 and the abstract.
In regards to claim 9, Macandrew et al. teaches in Figures 3A-5
(a) providing (column 3, lines 29-30 teaches “an inserter 10 with an IUD 40 placed in the front end”) an intrauterine system (IUD 40) having a removal string (withdrawal string(s) 41) attached to (column 3, line 6 teaches “the T-shaped elongate member 45 of the IUD 40;” column 4, lines 41-43 teaches “the end 45b of the elongate member abutting the plunger is shaped like an eyelet, which has an attached string 41 for retracting”) the intrauterine system (IUD 40);
(b) holding an inserter (inserter 10) in one hand (column 3, line 50 teaches “holding the handle of the plunger,” which would require the plunger 11 to be held by at least one hand of the user), the inserter (inserter 10) comprising: a handle (plunger 11, handle 20) comprising a movable slider (stop member/knob R; Figures 3A and 3B teach the position of the stop member/knob R being moved) arranged in a longitudinal opening (Figure 5 teaches the stop member/knob R being positioned within the opening in plunger 11 longitudinally extending between surface 21a and surface 21b); a plunger (plunger 11) attached to (inasmuch as it is part of) the handle (plunger 11, handle 20); an insertion tube (protective tube 12) attached to (as shown in Figures 3A and 3D; column 3, lines 44-45 teaches “the jacket of the protective tube has an attached stop member R”) the movable slider (stop member/knob R); and a lock (locking device 15; column 3, lines 33-34 teaches “locking device (15) associated with the plunger 11”) arranged inside (claim 1 teaches “a locking device operatively attached to said plunger, said locking device adapted to lock a string attached to the IUD;” since the withdrawal string(s) 41 is positioned within the plunger 11 (as shown in Figures 3A and 3B), the locking device 15 must also be positioned within the plunger 11 in order to contact the withdrawal string(s) 41 to lock the withdrawal string(s) 41 in position) the handle (plunger 11, handle 20);
(c) introducing the inserter (inserter 10) into a uterus of the patient with the one hand (column 4, lines 8-9 teaches “the device [inserter 10] according to FIG. 3B is pushed into the uterus;” it is understood that this pushing is performed by at least one of the user’s hands); and
(d) moving the slider (stop member/knob R) with one digit of the one hand (column 4, lines 8-14 teach “retracting,” which is understood to be performed by at least one of the user’s hands), thereby releasing the removal string (withdrawal string(s) 41) and intrauterine system (IUD 40)within the uterus (column 4, lines 8-14 teaches that the IUD 40 (which includes withdrawal string(s) 41) is “released” in the uterus by retracting the stop member R “until the stop surface R3 abuts the stop member R4 attached to the plunger”).
Macandrew et al. does not teach the lock being controllable by the movable slider, wherein the lock comprises: a main part; a first extension attached to the main part; and a counterpart, wherein the main part and the counterpart are arranged in a first position of the movable slider to form a blocking and lock the intrauterine system in relation to the plunger via the removal string, and wherein movement of the movable slider to a second position causes a part or a second extension of the slider to press against the first extension attached to the main part to separate the main part and the counterpart from each other and release the removal string and the intrauterine system.
However, Wildemeersch teaches in Figures 1-5 an analogous device with the lock (moving arm 10, projection 11, base 16, opening 17) being controllable by (when pressure 26 is released from thruster 9, thruster 9 is moved upward such that the part of thruster 9 that is attached to the top of moving arm 10 moves the moving arm 10 upward to lock pull thread 22; see Figures 1-5 and column 2, lines 61-67 teach the when pressure 26 is not applied to or is released from the thruster 9, projection 11 presses the pull thread 22 against opening 17, “blocking pull thread 22 in the tensioned state”; Figure 3 and column 3, lines 8-13 teach that the application of pressure on thruster 9 in the direction of arrow 26 causes the projection 11 to be moved out of contact with opening 17, consequently releasing pull thread 22) the movable slider (thruster 9; can be considered a “slider” inasmuch as thruster 9 moves smoothly downward, or slides downward, upon application of pressure 26 thereto, as taught in Figures 2 and 3 and column 3, lines 8-13), wherein the lock (moving arm 10, projection 11, base 16, opening 17) comprises: a main part (projection 11); a first extension (moving arm 10) attached to (as shown in Figures 2 and 3; column 2, lines 31-32 teaches “a moving arm 10 provided with a projection 11”) the main part (projection 11); and a counterpart (base 16, opening 17), wherein the main part (projection 11) and the counterpart (base 16, opening 17) are arranged in a first position (shown in Figure 2) of the movable slider (thruster 9) to form a blocking and lock (when pressure 26 is released from thruster 9, thruster 9 is moved upward such that the part of thruster 9 that is attached to the top of moving arm 10 moves the moving arm 10 upward to lock pull thread 22; see Figures 1-5 and column 2, lines 61-67 teach the when pressure 26 is not applied to or is released from the thruster 9, projection 11 presses the pull thread 22 against opening 17, “blocking pull thread 22 in the tensioned state”) the intrauterine system (intrauterine contraceptive device 15) in relation to the plunger (sheath 4) via the removal string (pull thread 22), and wherein movement of the movable slider (thruster 9) to a second position (shown in Figure 3) causes a part or a second extension (distal end of thruster 9 that connects to the proximal end of the moving arm 10) of the slider (thruster 9) to press against the first extension (moving arm 10) attached to (as shown in Figures 2 and 3; column 2, lines 31-32 teaches “a moving arm 10 provided with a projection 11”) the main part (projection 11) to separate the main part (projection 11) and the counterpart (base 16, opening 17) from each other and release (Figure 3 and column 3, lines 8-13 teach that the application of pressure on thruster 9 in the direction of arrow 26 causes the projection 11 to be moved out of contact with opening 17 via moving arm 10, consequently releasing pull thread 22) the removal string (pull thread 22) and (via release of the pull thread 22) the intrauterine system (intrauterine contraceptive device 15).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. to include the lock being controllable by the movable slider, wherein the lock comprises: a main part; a first extension attached to the main part; and a counterpart, wherein the main part and the counterpart are arranged in a first position of the movable slider to form a blocking and lock the intrauterine system in relation to the plunger via the removal string, and wherein movement of the movable slider to a second position causes a part or a second extension of the slider to press against the first extension attached to the main part to separate the main part and the counterpart from each other and release the removal string and the intrauterine system as taught by Wildemeersch because this element is known to provide the device with a locking mechanism to effectively and reversibly lock and maintain the removal string in position to facilitate and “simplify” insertion of an intrauterine contraceptive device and “allow easy release of the pull thread without risk of breaking” the intrauterine contraceptive device, as Wildemeersch teaches in column 1, lines 51-54, column 2, lines 61-67, column 3, lines 8-13 and the abstract.
Claims 2, 10 and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1) and further in view of Holmes (US 4,143,656 A).
In regards to claim 2, Macandrew et al. and Wildemeersch teach the apparatus of claim 1. Macandrew et al. and Wildemeersch do not teach that the inserter further comprises an adjustable flange arranged on the insertion tube.
However, Holmes teaches in Figures 1 and 2 and column 5, lines 27-29 an analogous device wherein the inserter (intrauterine device insertion instrument assembly 10) further comprises an adjustable flange (stop means 12) arranged on (column 5, lines 27-29 teaches “located on the exterior of the flexible section of the inserter tube is a slidably adjustable stop means 12”) the insertion tube (inserter tube 11).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the inserter of Macandrew et al. as modified by Wildemeersch such that the inserter further comprises an adjustable flange arranged on the insertion tube as taught by Holmes because this element is known to enable the user to facilitate “proper depth of insertion” of the intrauterine system, as Holmes teaches in column 3, lines 31-36.
In regards to claim 10, Macandrew et al. and Wildemeersch teach the method of claim 9. Macandrew et al. and Wildemeersch do not teach that the inserter further comprises an adjustable flange arranged on the insertion tube.
However, Holmes teaches in Figures 1 and 2 and column 5, lines 27-29 an analogous method wherein the inserter (intrauterine device insertion instrument assembly 10) further comprises an adjustable flange (stop means 12) arranged on (column 5, lines 27-29 teaches “located on the exterior of the flexible section of the inserter tube is a slidably adjustable stop means 12”) the insertion tube (inserter tube 11).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch to include teach that the inserter further comprises an adjustable flange arranged on the insertion tube as taught by Holmes because this element is known to enable the user to facilitate “proper depth of insertion” of the intrauterine system, as Holmes teaches in column 3, lines 31-36.
In regards to claim 11, Macandrew et al., Wildemeersch and Holmes teach the method of claims 9 and 10. Macandrew et al. and Wildemeersch does not teach sounding the uterus to predetermine a depth for placement of the intrauterine system; and adjusting the flange to correspond to the predetermined depth.
However, Holmes teaches in Figures 1 and 2 an analogous method further comprising: sounding the uterus to predetermine a depth for placement of the intrauterine system (column 8, lines 24-30 teaches “the intended position or depth of insertion [of IUD 50] is determined with a uterine sound”); and adjusting the flange (stop means 12) to correspond to the predetermined depth (column 3, lines 31-36 teaches “the tube is provided with an externally mounted slidable stop means for engaging the cervical os which is located on the insertion section of the tube and is susceptible of being adjusted to a predetermined position for proper depth of insertion”).
It would have been obvious It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch and Holmes to further comprise sounding the uterus to predetermine a depth for placement of the intrauterine system; and adjusting the flange to correspond to the predetermined depth as taught by Holmes because this step is known to determine the “correct depth” in the uterus at which the intrauterine system should be positioned and to facilitate “proper depth of insertion” of the intrauterine system, as Holmes teaches in column 3, lines 31-36 and column 8, lines 24-30 and 54-56.
Claims 3 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1) and further in view of Basuyaux (US 4,655,204 A).
In regards to claim 3, Macandrew et al. and Wildemeersch teach the apparatus of claim 1. Macandrew et al. and Wildemeersch do not teach that the removal string is contained wholly within the insertion tube and handle.
However, Basuyaux teaches in Figures 2 and 3 and column 3, lines 32-33 an analogous device wherein the removal string (threads 3) is contained wholly within (Figures 2 and 3 teach the entirety of threads 3 being positioned within cannula 8; cannula 8 is capable of being grasped by a user’s hand and therefore, can be considered a handle) the insertion tube and handle (cannula 8).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the removal string of Macandrew et al. as modified by Wildemeersch to be contained wholly within the insertion tube and handle as taught by Basuyaux because this element is known to shield the removal string such that the removal string will not be inadvertently pulled by something in the surrounding environment.
In regards to claim 12, Macandrew et al. and Wildemeersch teach the method of claim 9. Macandrew et al. and Wildemeersch do not teach that the removal string is contained wholly within the insertion tube and handle.
However, Basuyaux teaches in Figures 2 and 3 and column 3, lines 32-33 an analogous method wherein the removal string (threads 3) is contained wholly within (Figures 2 and 3 teach the entirety of threads 3 being positioned within cannula 8; cannula 8 is capable of being grasped by a user’s hand and therefore, can be considered a handle) the insertion tube and handle (cannula 8).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch to include that the removal string is contained wholly within the insertion tube and handle as taught by Basuyaux because this element is known to shield the removal string such that the removal string will not be inadvertently pulled by something in the surrounding environment.
Claims 4 and 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1) and further in view of Tran et al. (US 2005/0274384 A1).
In regards to claim 4, Macandrew et al. and Wildemeersch teach the apparatus of claim 1. Macandrew et al. and Wildemeersch do not teach that the intrauterine system further comprises image enhancing means.
However, Tran et al. teaches in Figure 7A and [0090] an analogous device wherein the intrauterine system (delivery system 100; deployed into/through the user’s uterus in use) further comprises image enhancing means ([0090] teaches “FIG. 7A shows the delivery system 100 which includes a delivery sheath 101 and a marker 102 disposed on the delivery system 100. The marker 102 may be one or more of the various types of conventional markers such as an optically visible marker (e.g. a marker which is colored to distinguish from its surroundings) which is visible during a hysteroscopy by visible light and a camera or a radiopaque marker or an ultrasound marker (which is visible in an ultrasound image) or other known markers which allow the user of the system 100 to guide and place the distal end of the system at a proper deployment position.”).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the intrauterine system of Macandrew et al. as modified by Wildemeersch to further comprise image enhancing means as taught by Tran et al. because this element is known to “allow the user of the system 100 to guide and place the distal end of the system at a proper deployment position,” as Tran et al. teaches in [0090].
In regards to claim 13, Macandrew et al. and Wildemeersch teach the method of claim 9. Macandrew et al. and Wildemeersch do not teach that the intrauterine system further comprises image enhancing means.
However, Tran et al. teaches in Figure 7A and [0090] an analogous method wherein the intrauterine system (delivery system 100; deployed into/through the user’s uterus in use) further comprises image enhancing means ([0090] teaches “FIG. 7A shows the delivery system 100 which includes a delivery sheath 101 and a marker 102 disposed on the delivery system 100. The marker 102 may be one or more of the various types of conventional markers such as an optically visible marker (e.g. a marker which is colored to distinguish from its surroundings) which is visible during a hysteroscopy by visible light and a camera or a radiopaque marker or an ultrasound marker (which is visible in an ultrasound image) or other known markers which allow the user of the system 100 to guide and place the distal end of the system at a proper deployment position.”).
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch to include that the intrauterine system further comprises image enhancing means as taught by Tran et al. because this element is known to “allow the user of the system 100 to guide and place the distal end of the system at a proper deployment position,” as Tran et al. teaches in [0090].
Claims 5 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1) and further in view of Nabahi (US 6,103,256 A).
In regards to claim 5, Macandrew et al. and Wildemeersch teach the apparatus of claim 1. Macandrew et al. and Wildemeersch do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous device wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the hormone of Macandrew et al. as modified by Wildemeersch to be levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
In regards to claim 14, Macandrew et al. and Wildemeersch teach the method of claim 9. Macandrew et al. and Wildemeersch do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous method wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch to include that the hormone is levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
Claims 6, 15 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1), in view of Holmes (US 4,143,656 A) and further in view of Nabahi (US 6,103,256 A).
In regards to claim 6, Macandrew et al., Wildemeersch and Holmes teach the apparatus of claims 1 and 2. Macandrew et al., Wildemeersch and Holmes do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous device wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the hormone of Macandrew et al. as modified by Wildemeersch and Holmes to be levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
In regards to claim 15, Macandrew et al., Wildemeersch and Holmes teach the method of claims 9 and 10. Macandrew et al., Wildemeersch and Holmes do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous method wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch and Holmes to include that the hormone is levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
In regards to claim 16, Macandrew et al., Wildemeersch and Holmes teach the method of claims 9-11. Macandrew et al., Wildemeersch and Holmes do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous method wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch and Holmes to include that the hormone is levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
Claims 7 and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1), in view of Basuyaux (US 4,655,204 A) and further in view of Nabahi (US 6,103,256 A).
In regards to claim 7, Macandrew et al., Wildemeersch and Basuyaux teach the apparatus of claims 1 and 3. Macandrew et al., Wildemeersch and Basuyaux do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous device wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the hormone of Macandrew et al. as modified by Wildemeersch and Basuyaux to be levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
In regards to claim 17, Macandrew et al., Wildemeersch and Basuyaux teach the method of claims 9 and 12. Macandrew et al., Wildemeersch and Basuyaux do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous method wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch and Basuyaux to include that the hormone is levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
Claims 8 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Macandrew et al. (US 5,785,053 A), in view of Wildemeersch (US 6,588,429 B1), in view of Tran et al. (US 2005/0274384 A1) and further in view of Nabahi (US 6,103,256 A).
In regards to claim 8, Macandrew et al., Wildemeersch and Tran et al. teach the apparatus of claims 1 and 4. Macandrew et al., Wildemeersch and Tran et al. do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous device wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the hormone of Macandrew et al. as modified by Wildemeersch and Tran et al. to be levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
In regards to claim 18, Macandrew et al., Wildemeersch and Tran et al. teach the method of claims 9 and 13. Macandrew et al., Wildemeersch and Tran et al. do not teach that the hormone is levonorgestrel.
However, Nabahi teaches in column 7, lines 5-12 an analogous method wherein the hormone is levonorgestrel.
It would have been obvious to one having ordinary skill in the art at the time of invention to modify the method of Macandrew et al. as modified by Wildemeersch and Tran et al. to include that the hormone is levonorgestrel as taught by Nabahi because this element is known to be an “effective” contraceptive steroid, as Nabahi teaches in column 7, lines 5-12.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 4/7/2026
Prosecution Insights