DETAILED ACTION
This Office Action is in response to the Amendment filed 16 March 2026. Claim(s) 1-18 and 20 are currently pending. The Examiner acknowledges the amendments to claim(s) 1 and 13, cancelled claim(s) 19.
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 .
CLAIM INTERPRETATION
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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
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, 3-5, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley (US 2008/0319472A1) in view of Wallace et al. (US 4,966,161, “Wallace”).
Regarding claims 1, 4, 5, 9, and 13, Shelley discloses a cervical dilator including a balloon catheter having a balloon (16) that is capable of being inserted above a cervix of a pregnant woman and a catheter tube (10) having a first end connected to the balloon and a second end. A passageway (15) extends from the first end to the second end and is connected to the balloon. The balloon is capable of being inflated with a fluid to apply dilatative pressure against the cervix via lumen (14). A variable tensioning system (tape) capable of temporarily affixing to a leg of the pregnant woman (14; Fig. 3). However, Shelley does not disclose a variable tensioning system including a fastener and a pad, wherein pad is capable of temporarily affixing to a leg of the pregnant woman such that the pad is configured to remain in substantially the same affixed location on the leg of the pregnant women during a cervical ripening procedure, the fastener connected to the second end of the catheter tube and capable of selectively coupling to the pad in at least a first position to apply a first traction force on the balloon to apply a dilatative pressure against the cervix and to be configured to uncoupled from the first position and recouple at a second position on the pad to apply a second traction force greater than the first traction force on the balloon to apply dilatative pressure against the cervix.
In the same field of endeavor, catheters with fasteners, Wallace teaches a catheter (12; Fig. 10) that is secured to a patient using a pad (22) having an adhesive backing (C12:L47-55) and a pile (loop) type component that is capable of coupling with a fastener (24; strap) and capable of temporarily being affixed to a leg of a patient. The fastener includes the complementary hook component and is connected to the second end of the catheter tube and capable of selectively coupling to the pad in a plurality of positions to selectively vary a traction force of the balloon to apply dilatative pressure against the cervix, wherein a user may remove the fastener from the pad and replace the fastener in another location on the pad to vary the traction force. 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 variable tensioning system of Shelley with the variable tensioning system, as taught by Wallace, as this modification involves the simple substitution of one variable tensioning system for another for the predictable result of facilitating the desired placement of a catheter [0034]. With this modification, the user is capable of uncoupling the fastener from the pad and moving the fastener to a different location on the pad, recoupling the fastener to the pad such that a greater traction force is on the balloon and applies dilatative pressure against the cervix.
Claim(s) 2, 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley in view of Wallace, as applied to claims 1 and 13 above, and further in view of Condon et al. (US 5,188,596, “Condon”).
Regarding claims 2 and 16, the combination of Shelley and Wallace does not disclose that the catheter tube is not transparent. In the same field of endeavor, catheters, Condon teaches a balloon catheter that may be transparent (C3:L32-35) or non-transparent (C6:L43-44). 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 formed the catheter tube of the combination of Shelley and Wallace to be non-transparent, as taught by Condon, as a person of ordinary skill has good reason to pursue the known options within their technical grasp with a reasonable expectation that at least one would be successful.
Regarding claim 3, the combination of Shelley, Wallace and Condon does not disclose that the catheter tube is teal. There is no evidence that changing the color of the catheter tube would result in a difference in function of the device of the combination of Shelley and Wallace. Further a person having ordinary skill in the art, being faced with modifying the color of the catheter tube of the combination of Shelley, Wallace and Condon, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed color. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the color of the catheter tube of the combination of Shelley, Wallace and Condon to be teal as an obvious matter of design choice within the skill of the art.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley in view of Wallace, as applied to claim 5 above, and further in view of Lavia (US 5,068,886).
Regarding claims 6 and 7, the combination of Shelley and Wallace does not disclose that at least one of the loop side or hook side includes a plurality of distance indicators. In the same field of endeavor, catheters, Lavia teaches a catheter position indicator. Lavia teaches a catheter that is adhesively coupled to a patient via a sheet material (12). The sheet material includes a rule formed therein and having radiopaque graduations along its surface. 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 a rule and graduations along the surface of the pad of the combination of Shelley and Wallace, as taught by Lavia, for the predictable result of providing means for measuring distance of the catheter. With this modification, at least one of the loop side and hook side includes a reference line in the form of a terminal end or side.
Claim(s) 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley in view of Wallace, as applied to claim 1 and 13 above, and further in view of Russo (US 2012/0226237A1).
Regarding claims 8 and 14, the combination of Shelley and Wallace discloses that the pad but does not disclose the pad having a ladder including a plurality of rungs. In the same field of endeavor, catheter anchoring devices, Russo teaches an anchoring device including a pad (24; [0030]) formed of velcro. The pad included a ladder having a plurality of rungs formed of rows of loops or hooks. A fastener is complementary and is capable of coupling to the respective loop or hook of a rung of the ladder (Fig. 4). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have substituted the pile of the pad of the combination of Shelley and Wallace with the ladder formed pile pad, as taught by Russo, as this modification involves the simple substitution of one pad for another for the predictable result of providing a pad that is complementary to a fastener.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley in view of Wallace, as applied to claim 1 above, and further in view of Cowan (US 5,947,991).
Regarding claims 10 and 12, the combination of Shelley and Wallace does not disclose that the catheter tube terminates at the balloon and that there is only one passageway extending from the first end to second end. In the same field of endeavor, balloon catheters, Cowan teaches a balloon catheter used to dilate the cervix. The balloon catheter includes a catheter tube (30) that terminates at the balloon (40, Fig. 2; C2:L19-21). The catheter tube only includes one passageway, wherein inflation fluid passes therethrough to inflate the balloon. 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 catheter tube of the combination of Shelley and Wallace with a single passageway catheter tube that terminates at the balloon, as taught by Cowan, as this modification involves the simple substitution of one catheter tube for another for the predictable result of inflating a balloon within a cervix.
Claim(s) 11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelley in view of Wallace, as applied to claims 1 and 13 above, and further in view of Fukaya et al. (US 6,613,066, “Fukaya”).
Regarding claims 11 and 15, the combination of Shelley and Wallace does not disclose a force gauge positioned to measure the traction force on the balloon. In the same field of endeavor, catheters, Fukaya teaches a balloon catheter coupled to a force gauge (65) that is capable of measuring traction force on a balloon (C24;L20-30). 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 device of the combination of Shelley and Wallace with a force gauge, as taught by Fukaya, to provide means for measuring force.
Allowable Subject Matter
Claim(s) 17, 18 and 20 are allowed. The prior art of record does not disclose or suggest a method for inducing dilation of a cervix including inserting a balloon of a balloon catheter above the cervix, a catheter tube extends through a vaginal canal, the balloon being at a first end of the balloon catheter, a fastener connected to the catheter tube, inflating the balloon, temporarily affixing a pad to a leg, after affixing the pad selectively coupling the fastener to the pad in a first position to apply a first traction force on the inflated balloon, uncoupling the fastener from the pad in the first position, the pad remaining temporarily affixed to the leg, coupling the fastener to the pad in a second position to apply a second traction force on the inflated balloon that is greater than the first traction force, in combination with the other claimed limitations.
Response to Arguments
Applicant's arguments filed 16 March 2026 have been fully considered but they are not persuasive. The Applicant's arguments do not clearly point out the patentable novelty the claims present in view of the state of the art disclosed by the references cited. Further, the arguments do not show how the amendments avoid such references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lavia (US 5,068,886) discloses a pad with hook fasteners to stabilize a catheter.
THIS ACTION IS MADE FINAL. 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 JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771