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 .
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.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-13, drawn to a delivery system, classified in A61F2/2466.
II. Claims 14-20, drawn to a method for simulating treatment of a simulated patient, classified in A61F2250/0096.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case with the apparatus can be used to practice another and materially different process – for example, instead of delivering the device to a heart and deploying the needles through leaflets, the device can be delivered to another organ such as the stomach, the needles deployed through the stomach to reshape the stomach with sutures for gastric reduction.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Different search queries, different search strategies and different areas of search are required for each different group as claimed. For example, Group I would require a search in at least A61F2/2466, along with a unique text search. Group II would require a search in at least A61F2250/0096, along with a unique text search. Group III would require a search in at least A61F2/2433, along with a unique text search..
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Pui Tong on 2/2/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 8 is 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.
Regarding Claim 8, the claim is rendered indefinite, as it contradicts the claim from which it depends. Claim 1 states that each anchor is delivered via one of the needles, and claim 8 states that one needle delivers both anchors. Further clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140214152 A1 (hereafter --Bielefeld--).
Regarding Claim 1, Bielefeld discloses a delivery system (10) comprising: two or more needles including at least a first needle comprising a distal tip configured to pierce a valve leaflet of a heart (see annotated needles and sharp distal ends in Figure 2 below, see also paragraph [0043]); two or more leaflet anchors, each of the two or more leaflet anchors (40) configured to be delivered via one of the two or more needles (see paragraph [0044]); and a shaft comprising a first interior lumen configured to slidably receive the two or more needles (see paragraph [0041], see also annotated shaft in Figure 2 below), the shaft having a first opening into the first interior lumen at a distal end of the shaft (see annotated first opening in Figure 2 below), the first opening configured to allow at least the first needle to exit the shaft (see annotated shaft, first opening, and needles in Figure 2 below, see also paragraph [0043]).
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Regarding Claim 4, Bielefeld discloses the delivery system of claim 1, wherein a first leaflet anchor of the two or more leaflet anchors is configured to be delivered via the first needle and a second leaflet anchor of the two or more leaflet anchors is configured to be delivered via a second needle of the two or more needles (see paragraphs [0044] and [0046]).
Regarding Claim 7, Bielefeld discloses the delivery system of claim 1, further comprising a plunger configured to move the two or more needles out of the shaft (see paragraph [0043] denoting the needles can be connected to a slide button or other actuator so that movement of the actuator distally extends needle out from hollow body 11).
Regarding Claim 8, Bielefeld discloses the delivery system of claim 1, wherein the first needle comprises a second interior lumen (29a) and a second opening into the second interior lumen at the distal tip of the first needle (see annotated second opening in Figure 2 above), the second interior lumen configured to carry the two or more leaflet anchors (see paragraph [0045] denoting that a needle can hold multiple anchors in its lumen).
Regarding Claim 9, Bielefeld discloses the delivery system of claim 8, wherein the first needle comprises an elongate aperture into the second interior lumen (see annotated elongated aperture in Figure 2) the elongate aperture extending along at least a portion of a first side of the first needle to the second opening (see annotated second opening and the first side in Figure 2 above).
The limitation “configured to allow one or more suture tails of the two or more leaflet anchors to exit the first needle via the elongate aperture” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the reference disclosing that anchors and sutures extend through the lumens of the needles, and exit out of the lumen when deployed, the second opening is capable of allowing one or more suture tails of the two or more leaflet anchors to exit the first needle via the elongate aperture (see paragraph [0050]).
Regarding Claim 10, Bielefeld discloses delivery system of claim 9, wherein the elongate aperture is configured to prevent the two or more leaflet anchors from entirely exiting the first needle via the elongate aperture (see paragraphs [0045] and [0046]) denoting that the system has a pushrod that pushes the anchors out of the aperture, as the anchors would not fall out without the pressure of the pushrod).
Regarding Claim 11, Bielefeld discloses the delivery system of claim 9, wherein a second needle of the two or more needles comprises a third interior lumen configured to receive the one or more suture tails (see paragraphs [0045] and [0046], [0046] denoting that the second needle can have the same structure as 30a, see also annotated third interior lumen in Figure 2 above).
Regarding Claim 12, Bielefeld discloses the delivery system of claim 8, wherein the two or more leaflet anchors are pre-formed suture knots (see paragraph [0052] denoting that the sutures may be secured against the leaflet tissue using a conventional surgical knot (not shown), which may be advanced and secured using the pusher 65 as a knot pusher, this surgical “knot” once formed acting as anchor).
Regarding Claim 13, Bielefeld discloses the delivery system of claim 8, wherein the two or more leaflet anchors are configured to be situated in a single-file orientation within the first needle (see paragraph [0044] denoting that multiple anchors can be placed end-to-end in a line within a single needle).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140214152 A1 (hereafter --Bielefeld--), in view of US 5836912 A (hereafter –Kusleika--)
Regarding Claim 2, Bielefeld discloses the delivery system of claim 1.
Bielefeld fails to disclose wherein the first interior lumen has a non-constant diameter that gradually decreases from a maximal diameter of the first interior lumen to a minimal diameter at the first opening that is less than the maximal diameter of the first interior lumen.
Kusleika discloses a guide catheter for delivery of an implant to the heart with a first interior lumen (see Abstract, see also annotated first interior lumen in Figure 1 below). Kusleika teaches wherein the first interior lumen has a non-constant diameter that gradually decreases from a maximal diameter of the first interior lumen to a minimal diameter at the first opening that is less than the maximal diameter of the first interior lumen (see annotated minimal diameter and maximal diameter in Figure 1 below, see also column 4, lines 23-29).
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Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to have the first interior lumen has a non-constant diameter that gradually decreases from a maximal diameter of the first interior lumen to a minimal diameter at the first opening that is less than the maximal diameter of the first interior lumen, since such a modification would have involved a mere change in the shape of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding Claim 3, Bielefeld as modified the delivery system of claim 2.
The limitation “wherein the first opening is configured to allow only one of the two or more needles to exit the shaft at a time” is treated as functional language, that is not given full patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the reference disclosing the needles can be used one after the other and not at the same time, meaning the prior art is capable of only one of the needles exiting out of the shaft to deploy the anchor at the same time, the system is capable of “allowing” only one of the two or more needles to exit the shaft at a time (see paragraph [0051]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140214152 A1 (hereafter --Bielefeld--), in view of US 20180214269 A1 (hereafter --Wilson--).
Regarding Claim 5, Bielefeld discloses a suture configured to form a knot anchor when removed from the two or more needles (see paragraphs [0052] and [0053]).
Bielefeld fails to disclose wherein each of the two or more leaflet anchors comprises a suture wrapped at least partially around a distal portion of one of the two or more needles.
Wilson discloses an anchor delivery device with a needle, a pusher, and a handle for delivering an anchor into the leaflet of the heart (see Abstract). Wilson teaches wherein each of the two or more leaflet anchors comprises a suture wrapped at least partially around a distal portion of one of the two or more needles (see annotated needle and suture in Figure 11 below).
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Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have each of the two or more leaflet anchors comprises a suture wrapped at least partially around a distal portion of one of the two or more needles, since the modification would merely involve the substitution of one known element (anchor of Bielefeld) for another (suture knot anchor of Wilson) would have yielded predictable results, namely, a suture anchor pretied around the distal end of the needles of Bielefeld.
Regarding Claim 6, Bielefeld as modified discloses delivery system of claim 5, further comprising two or more pushers (32), each of the two or more pushers having interior lumens and configured to: be disposed at least partially within the first interior lumen of the shaft; slidably receive one of the two or more needles; and press against one of the two or more leaflet anchors to remove the leaflet anchor from one of the two or more needles (see paragraphs [0045] and [0046]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20210186481 A1: This reference discloses an anchor delivery device with multiple needles inside of a shaft.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774