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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, drawn to a cannula system, classified in A61B 17/3423.
II. Claims 13-20, drawn to a method, classified in A61B 17/3468.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process of using that product; for example, the cannula system can be used as a speculum.
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: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
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 Erica Schaefer on 23 July 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-20 are 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.
Priority
The priority date is 21 August 2024.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 9, and 12 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,775,642 to Azarbarzin et al. (hereinafter, “Azarbarzin”).
As to claim 1, Azarbarzin discloses a cannula system, comprising: a cannula (120 and 110) defining a central lumen (col. 1 / lines 62-66), FIG. 1; and a divider (400) removably coupled to the cannula, FIGS. 25-27, the divider having a divider shaft configured to separate the central lumen into at least two discrete working channels (col. 8 / line 57 – col. 9 / line 23; the divider 400 is principally the same as 300 other than the shape of the proximal portion).
As to claim 3, Azarbarzin discloses the cannula system of Claim 1, wherein the cannula further comprises a valve (160; where a valve is a device for controlling the passage of fluid or air; 160 is a valve because it grips around the divider 400 inserted therein, allowing its insertion but preventing its removal, col. 7 / lines 38-41) received within the central lumen, FIG. 1, and the divider shaft extends through the valve, FIG. 24.
As to claim 9, Azarbarzin discloses the cannula system of Claim 1, further comprising an obturator (410) configured to be removably coupled to the central lumen (via the divider 400), FIGS. 25-28.
As to claim 12, Azarbarzin discloses the cannula system of Claim 1, wherein the divider shaft includes at least two side channels (labelled in 300 as 306a-306d, FIG. 21; shown in 400 in FIG. 27) and each of the at least two side channels cooperate with a sidewall of the central lumen to define the at least two working channels (since the side channels are open on their sides), FIG. 24.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 11,559,328 to Richter et al. (hereinafter, “Richter”).
As to claim 1, Richter discloses a cannula system, comprising: a cannula (102) defining a central lumen, FIG. 119; and a divider (200) removably coupled to the cannula (col. 48 / lines 4-29), FIGS. 120-122, the divider having a divider shaft configured to separate the central lumen into at least two discrete working channels (204, 108), FIG. 122.
Claims 1, 2, 4, and 7-11 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 7,074,226 to Roehm, III et al. (hereinafter, “Roehm”).
As to claim 1, Roehm discloses a cannula system, comprising: a cannula (11) defining a central lumen, FIG. 5; and a divider (32 and 33) removably coupled to the cannula (via 14), FIG. 3, the divider having a divider shaft (32 and 33) configured to separate the central lumen into at least two discrete working channels (channels through 32 and 33, which receive wires 16 and 17 via 24-31) (col. 3 / line 59 – col. 4 / line 14).
As to claim 2, Roehm discloses the cannula system of Claim 1, wherein the central lumen is elliptical in cross-section (col. 3 / lines 22-24), FIG. 5.
As to claim 4, Roehm discloses the cannula system of Claim 1, wherein the cannula further comprises a cap (11F and 38), and the cap defines at least one suture retaining slot (interpreted as language of intended use; the slot in 38 is fully capable of retaining a suture), FIG. 5.
As to claim 7, Roehm discloses the cannula system of Claim 4, wherein the cap defines a central cap bore configured to be in communication with the central lumen, FIG. 5.
As to claim 8, Roehm discloses the cannula system of Claim 4, wherein the at least one suture retaining slot defines a slit configured to retain at least one flexible strand (interpreted as language of intended use).
As to claim 9, Roehm discloses the cannula system of Claim 1, further comprising an obturator (14) configured to be removably coupled to the central lumen, FIG. 3.
As to claim 10, Roehm discloses the cannula system of Claim 9, wherein an obturator shaft of the obturator has an elliptical cross-section (to match the central lumen of the cannula), FIG. 3.
As to claim 11, Roehm discloses the cannula system of Claim 1, wherein a center of a first one of the at least two working channels is spaced apart from a second center of a second one of the at least two working channels by at least one millimeter (since the working channels have a diameter of at least 5.3 mm, col. 5 / lines 46-51, and two working channels are adjacent to each other, their centers are spaced apart from each other by at least 2 x radius = 5.3 mm which is greater than 1 mm).
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 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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Azarbarzin.
As to claim 10, Azarbarzin discloses side channel 306a has an elliptical cross-section (col. 8 / line 66 – col. 9 / line 2), and the obturator (410) that is received in the side channel has an obturator shaft, but is silent as to wherein the obturator shaft of the obturator has an elliptical cross-section.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide an elliptical cross-section to the obturator shaft of the obturator that is received in the side channel that has an elliptical cross-section, to be complementary to the side channel in which it is received and to therefore snugly fit in the side channel without unintentional and undesirable wiggle for accurate tool guiding and to prevent any unwanted tissue from entering the side channel. Azarbarzin appears to show in FIGS. 25-27 that the obturator that is received in the elliptical cross-section/larger side channel is correspondingly larger in size itself.
Claim 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Richter in view of U.S. Patent No. US 7,993,355 to Morris et al. (hereinafter, “Morris”).
As to claim 4, Richter discloses the cannula system of Claim 1, wherein the cannula further comprises a cap (100p), FIG. 119.
As to claim 6, Richter discloses the cannula system of Claim 4, wherein the cap further defines a coupling groove (112) configured to receive a portion (302) of the divider (col. 47 / lines 57-61, col. 48 / lines 57-61), FIGS. 119-120.
As to claim 7, Richter discloses the cannula system of Claim 4, wherein the cap defines a central cap bore configured to be in communication with the central lumen (the central cap bore is a continuation of the central lumen).
Richter is silent as to the cap defines at least one suture retaining slot (claim 4); wherein the at least one suture retaining slot defines a tortuous path configured to retain at least one flexible strand (claim 5); the coupling groove is spaced apart from the at least one suture retaining slot about a perimeter of the cap (claim 6); wherein the at least one suture retaining slot defines a slit configured to retain at least one flexible strand (claim 8).
Morris teaches a cannula system, comprising: a cannula defining a central lumen, FIG. 20; wherein the cannula further comprises a cap, and the cap defines at least one suture retaining slot (144) (interpreted as language of intended use) (col. 7 / lines 5-8); wherein the at least one suture retaining slot defines a tortuous path configured to retain at least one flexible strand (interpreted as language of intended use; the slots 144 are tortuous paths because they have a turn that is fully capable of retaining a flexible suture strand); wherein the cap defines a central cap bore configured to be in communication with the central lumen; wherein the at least one suture retaining slot defines a slit configured to retain at least one flexible strand (interpreted as language of intended use).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide suture retaining slots/slits on Richter’s cap, since Richter contemplates using the cannula system to introduce sutures (Richter, col. 46 / lines 55-59), and as taught by Morris, the slots are useful to secure sutures during a surgical procedure so that multiple sutures can be placed at once without tangling or dropping. The suture retaining slots define a tortuous path as in Morris, and are fully capable of retaining at least one flexible strand. Since Richter discloses two coupling grooves and Morris teaches a plurality of (more than two) suture retaining slots, the coupling grooves would be circumferentially spaced apart from at least some of the suture retaining slots which are about the perimeter of the cap.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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