DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 01/15/25.
The examiner acknowledges the amendments to the claims.
Claims 1-20 are pending in this application.
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 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 and 12-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “a first recess in which two ends of the suture are knotted to form an exposed knot”. It is unclear if “the suture” is being positively recited. For examination purposes, the suture limitation will be interpreted as being only functionally recited, and therefore be read as --a first recess in which two ends of the suture can be knotted to form an exposed knot--.
Claim 3 recites “a second recess in which a part of the suture is exposed”. It is unclear if “the suture” is being positively recited. For examination purposes, the suture limitation will be interpreted as being only functionally recited, and therefore be read as --a second recess in which a part of the suture can be exposed--.
Claim 3 also recites “a second recess”. Claim 3 and claim 1, upon which claim 3 depends, do not positively recite a first recess, and therefore it is unclear if a first recess is included.
Claim 12, b. recites “enabling closure of a suture”. It is unclear if “a suture” is referring to the suture recited in claim 1 or a separate suture. For examination purposes, the limitation will be read as referring back to the suture in claim 1, and therefore read as –enabling closure of the suture--. Claims 13-20 are rejected due to their dependency on claim 12.
Claim 14 recites a second recess”. Claim 14 and claim 12, upon which claim 14 depends, do not positively recite a first recess, and therefore it is unclear if a first recess is included.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by House et al., hereinafter “House” (WO 2022/055838 A1), cited in IDS filed 01/15/2025.
Regarding claim 1, House discloses a device (including knot tube 50) for locking during cerclage (Figures 3, 6-8), the device comprising a passage 54 to guide a suture 14 therethrough and enable closure thereof around a distal end of a cervix in a female subject ([0063]), the device adapted to remain engaged around the cervix over a period of time until the suture is cut (the device is capable of remaining engaged with the cervix via the knot tube 50 for a time period until removal or cutting).
Regarding claim 3, House discloses a second recess (opening leading into passage 54, near a first recess 74) in which a part of the suture 14 is/can be exposed to enable easy cutting thereof after the period of time.
Regarding claim 4, House discloses the device can be introduced and removed from the cervix without surgery (knot tube 50 is of a size that can be introduced and removed from the cervix via vagina without altering or cutting tissue; Figure 3).
Regarding claim 5, House discloses holding means (teeth 64/step 68 limit movement of suture 14; [0062]-[0063]) for said suture in place around the cervix.
Regarding claim 6, House discloses entry and exit orifices (opposite openings of knot tube 50 leading into passage 54) for said suture 14.
Regarding claim 7, House discloses an inner element, middle element and outer element (portion of knot tube 50 facing cervical canal 501 is the inner element [as in Figure 3], portion of knot tube facing away from cervical canal is the outer element, and the portion between the inner and outer elements is the middle element).
Regarding claim 8, House discloses said middle element holds the holding means (Figure 8; teeth 64/step 68 are within the middle element).
Regarding claim 9, House discloses the device is adapted to hold the suture 14 in a generally circular shape around the cervix (a purse-string suture arrangement, or ring, as in Figures 3, 6).
Regarding claim 10, House discloses said suture 14 is a suture band (as it forms a ring, as in Figures 3, 6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over House (WO 2022/055838 A1) in view of Dreyfuss et al., hereinafter “Dreyfuss” (U.S. Pub. No. 2015/0297274).
Regarding claim 2, House discloses the device, as discussed above, including a first recess 74 (Figure 8), however does not teach the first recess in which two ends of the suture can be knotted to form an exposed knot.
Dreyfuss teaches in Figure 1 a first recess 70 in which two ends of a suture can be knotted to form an exposed knot (similar to knot 15 being exposed and fixed within first recess 70 as in Figure 1).
It would have been obvious to one of ordinary skill before the effective filing date to modify House where two ends of the suture can be knotted to form an exposed knot in the first recess, as taught by Dreyfuss, since House acknowledges that a knot may be become buried within tissue ([0005]-[0006]) and a first recess in which a knot is knotted and exposed may facilitate visualizing and cutting the suture when it needs to be removed.
Claims 11-12, 14, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over House (WO 2022/055838 A1).
Regarding claim 11, House discloses the device, as discussed above, except for said device 50 being polymeric and lightweight.
However, in another embodiment of House, device 20 is polymeric ([0050]; polyethylene is known in the art as a relatively lightweight material).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the knot tube of House such that it is polymeric and lightweight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. It is noted that the device is disclosed as being constructed of any suitable material for inserting into and use within a human body; [0043] of instant specification), wherein polymeric and lightweight materials are old and well known in the art as being biocompatible and suitable for use within a human body.
Regarding claim 12, House discloses a method for performing cervical cerclage ([0062]-[0066]), the method comprising:
a. introducing a device (including knot tube 50; Figures 7-8) according to claim 1 into a female subject (as discussed above);
b. enabling closure of a suture 14 around a distal end of a cervix in the female subject ([0063]); and
c. retaining said device around the cervix (via device 50 locking the suture 14) over a period of time.
However, House does not expressly teach retaining said device around the cervix over a period of time until the suture 14 is cut, although teaches that when it becomes time for a suture to be removed, the suture can be cut ([0005]-[0006]). It would have been obvious to one of ordinary skill before the effective filing date to modify the method such that the suture 14 is cut after a period of time to initiate and facilitate removal of the device from the cervix.
Regarding claim 14, House discloses exposing a part of the suture 14 at a second recess (opening leading into passage 54, near a first recess 74 in Figure 8) to enable easy cutting thereof after the period of time.
Regarding claim 16, House discloses further comprising holding said suture 14 in place around the cervix by holding means (teeth 64/step 68 limit movement of suture 14; [0062]-[0063]).
Regarding claim 17, House discloses further comprising entry and exit orifices (opposite openings of knot tube 50 leading into passage 54) for said suture 14.
Regarding claim 18, House discloses further comprising holding the suture 14 in a generally circular shape around the cervix ([0062]; a purse-string suture arrangement, or ring, as in Figures 3, 6).
Regarding claim 19, House discloses said suture is a suture band (Id.; as it forms a purse-string suture arrangement, or ring, as in Figures 3, 6).
Regarding claim 20, House discloses the claimed invention, as discussed above, except for said device being polymeric and lightweight.
However, in another embodiment of House, device 20 is polymeric ([0050]; polyethylene is known in the art as a relatively lightweight material).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the knot tube of House such that it is polymeric and lightweight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. It is noted that the device is disclosed as being constructed of any suitable material for inserting into and use within a human body ([0043] of instant specification), wherein polymeric and lightweight materials are old and well known in the art as being biocompatible and suitable for use within a human body.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over House (WO 2022/055838 A1) in view of Dreyfuss (U.S. Pub. No. 2015/0297274).
Regarding claim 13, House discloses the invention, as discussed above, including knotting two ends of suture ([0011], [0064], [0066]) and a first recess 74 (Figure 8), however does not teach the first recess in which two ends of the suture can be knotted to form the exposed knot.
Dreyfuss teaches in Figure 1 a first recess 70 in which two ends of a suture can be knotted to form an exposed knot (similar to knot 15 being exposed and fixed within first recess 70 in Figure 1).
It would have been obvious to one of ordinary skill before the effective filing date to modify House where two ends of the suture are knotted to form an exposed knot in the first recess, as taught by Dreyfuss, since House acknowledges that a knot may be become buried within tissue ([0005]-[0006]) and a first recess in which a knot is knotted and exposed may facilitate visualizing and cutting the suture when it needs to be removed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over House (WO 2022/055838 A1) in view of Brown (U.S. Pub. No. 2013/0103044), cited in IDS filed 01/15/2025.
Regarding claim 15, House discloses the claimed invention, as discussed above, except does not expressly teach introducing into and removing the device from the cervix without surgery.
Brown teaches a cervical cerclage device 100 (Figure 5) which can be introduced into and removed from the cervix without surgery ([0024]; via forceps, clamps or other medical instruments known in the art without causing damage to the cervix)
It would have been obvious to one of ordinary skill before the effective filing date to modify the method of House such that the device can be introduced into and removed from the cervix without surgery, as taught by Brown, in order to prevent or minimize trauma and damage to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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