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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/9/2025 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 2 is amended and claim(s) 3 and 11-15 were previously canceled. Claims 1-2 and 4-10 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 9/9/2025 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant traverses the previous rejection under U.S.C. 103 over Reynolds (US 20020091394 A1) in view of Ransbury (US 20090198251 A1). Applicant argues Reynolds does not teach a “separate” double lumen end cap and wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion. Examiner agrees, as is stated in the previous Action, which is why Reynolds was modified by Ransbury to teach the missing limitations. Reynolds discloses most of the claimed elements aside from “separate double lumen end cap” and wherein the double lumen end cap comprises a connection portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion. Reynolds discloses the double lumen end cap (19) however, the end cap isn’t separate from the system as in the present invention. Ransbury is a medical device with a similar double lumen end cap (20) which is separate from the system. A person of ordinary skill in the art would be motivated to modify the end cap of Reynolds with the separability of the end cap of Ransbury as it would allow the end cap to be adjustable and removable.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Further, Reynolds doesn’t explicitly teach wherein the double lumen end cap comprises a connection portion and a double lumen portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion. The previous rejection relied Ransbury to teach this limitation, as Ransbury teaches the double lumen end cap comprises a connection portion (52) and a double lumen portion (34, 36) (Figure 1; Paragraph 0038), wherein one end of the connection portion (lower opening of 52) is connected with the outer tube (As shown in Figure 5, the sidecar 20 is located at the distal end of catheter 22) (Figure 1-2; 4-5; Paragraph 0040; 0044), and the other end of the connection portion (upper end of 52) is connected with the double lumen portion (as it is located within second bore 36) (Figure 2; Paragraph 0042). However, Applicant argues Ransbury doesn’t teach “said other lumen channel of the double lumen end cap together with the connected outer tube forms a passageway through which the mesh basket is extended and retracted, and the mesh basket passes through both ends of said other lumen channel.” The previous rejection indicated Reynolds discloses this limitation, not Ransbury. And although Ransbury is not directed to a mesh basket device, when the components of Reynolds are modified with the features of Ransbury, such as the connection portion, the resulting device would still be fully capable of allowing the mesh basket to pass through both ends of the other said lumen, as the end cap of Reynolds already allows this. The modifications made to the end cap of Reynolds does not replace the end cap with the end cap of Ransbury, as simply the features are combined to create a new system, i.e., wherein the double lumen end cap comprises a connection portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion so that said other lumen channel of the double lumen end cap together with the outer tube forms a passageway through which the mesh basket is extended and retracted, and the mesh basket passes through both ends of said other lumen channel.
Lastly, Applicant argues Ransbury fails to teach the technical problems to be solved by the present invention or the technical principle of the present invention. However, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. RAnsbury is directed to a medical device delivery system, which is analogous to a mesh basket delivery system such as that of Reynolds or the present invention, thus is combinable with Reynold. Further, Ransbury itself is not relied upon to teach any limitations that require a mesh basket, as the combination of Reynolds as modified by Ransbury is fully capable of performing such functions.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds et al. (US 20020091394 A1) (noted on IDS) in view of Ransbury et al (US 20090198251 A1) (previously of record).
Regarding claim 1, Reynolds discloses a stone extraction basket (10), comprising
a mesh basket (20) (Figure 1B-C; Paragraph 0038),
an outer tube (12) (Figure 1B-C; Paragraph 0038) and
an operation portion comprising a handle (30+32) and a core rod (40) (Figure 1A-C; Paragraph 0038; 0042), the mesh basket being connected to the operation portion (Figure 1B-C; Paragraph 0038; 0042), the operation portion controlling the mesh basket to move (Paragraph 0043),
a proximal end of the outer tube being connected to the operation portion (Figure 1B-C; Paragraph 0038),
the outer tube axially extending from the proximal end to a distal end (15) (Figure 1B-C),
the distal end of the outer tube being connected to a double lumen end cap (19) (Figure 1B; Paragraph 0041),
a guide wire (guidewire) passing through one lumen channel (19A) of the double lumen end cap (Figure 1B; Paragraph 0041),
the mesh basket passing through the other lumen channel (channel encompassing lumen 14 of sheath 12) of the double lumen end cap (Figure 1B-C),
wherein the double lumen end cap comprises a double lumen portion (19A+ channel encompassing lumen 14 of sheath 12), so that said other lumen channel of the double lumen end cap together with the outer tube forms a passageway through which the mesh basket is extended and retracted (Figure 1B; Paragraph 0043), and the mesh basket passes through both ends of said other lumen channel (Figure 1B-C).
Reynolds fails to explicitly disclose the distal end of the outer tube being connected to a separate double lumen end cap and wherein the double lumen end cap comprises a connection portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion.
However, Ransbury is directed to a medical device and teaches the distal end of the outer tube (22) being connected to a separate double lumen end cap (20) (Figure 4-5; Paragraph 0030; 0040; 0044); wherein the double lumen end cap comprises a connection portion (52) and a double lumen portion (34, 36) (Figure 1; Paragraph 0038), wherein one end of the connection portion (lower opening of 52) is connected with the outer tube (As shown in Figure 5, the sidecar 20 is located at the distal end of catheter 22) (Figure 1-2; 4-5; Paragraph 0040; 0044), and the other end of the connection portion (upper end of 52) is connected with the double lumen portion (as it is located within second bore 36) (Figure 2; Paragraph 0042).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reynolds with the teachings of Ransbury by incorporating the distal end of the outer tube being connected to a separate double lumen end cap and wherein the double lumen end cap comprises a connection portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion in order to easily adjust the attachment and removal of the end cap. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Reynolds such that the distal end of the outer tube being connected to a separate double lumen end cap and wherein the double lumen end cap comprises a connection portion, wherein one end of the connection portion is connected with the outer tube, and the other end of the connection portion is connected with the double lumen portion, as taught by Ransbury, as both references and the claimed invention are directed to medical device implant systems.
Regarding claim 2, Reynolds further discloses the handle sliding back and forth along the core rod to extend or retract the mesh basket (Figure 1A; Paragraph 0042-43).
Regarding claim 4, Reynolds further discloses wherein the lumen channels of the double lumen end cap are hollow structures (Figure 1B-C; Paragraph 0041).
Regarding claim 8, the claimed phrase “wherein the connection portion and the double lumen portion are connected in a plastic-coated mode, an adhesive mode or a shrinkage fit mode” is being treated as a product by process limitation; that is, the phrase will be examined as “wherein the connection portion and the double lumen portion are connected”. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. Ransbury teaches the connection portion and the double lumen potion of the end cap as components of the same end cap, thus the connection portion and double lumen portion are connected, as depicted in Figures 4-5.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 9, Reynolds further discloses wherein a distal end surface of the double lumen end cap has a guide bevel structure on one side of the lumen channel through which the guide wire passes (Paragraph 0041) (Reynolds states “The ends of the sidecar 19 are tapered to promote cannulation”, thus the distal end surface of the end cap comprises a bevel structure).
Regarding claim 10, Reynolds further discloses wherein an outer contour thickness of the lumen channel through which the mesh basket passes in the double lumen end cap is greater than an outer contour thickness of the lumen channel through which the guide wire passes (Figure 1B) (the guidewire lumen 19A is visibly smaller than the section of 19 encompassing lumen 14).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds in view of Ransbury, as applied to claim 1 above, and further in view of Stirnweiss et al. (EP 3066997 A1) (references correspond to attached Espacenet translation) (previously of record).
Regarding claim 5-6, Reynolds as modified by Ransbury discloses the stone extraction basket according to claim 1, but fails to disclose wherein an outer surface of one end of the connection portion has a spiral barb structure for connection with the outer tube, and an outer surface of the other end of the connection portion has a protrusion structure for connection with the double lumen portion, wherein the protrusion structure has a groove structure around it.
However, Stirnweiss is directed to a stone removal device and teaches wherein an outer surface of one end of the connection portion (11) has a spiral barb structure (26) for connection with the outer tube (2), and an outer surface of the other end of the connection portion has a protrusion structure (15) (Figure 3-4; Paragraph 0029); wherein the protrusion structure has a groove structure (35) around it (Figure 3; Paragraph 0030).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Reynolds as modified by Ransbury such that an outer surface of one end of the connection portion has a spiral barb structure for connection with the outer tube, and an outer surface of the other end of the connection portion has a protrusion structure, wherein the protrusion structure has a groove structure around it, as taught by Stirnweiss, as both references and the claimed invention are directed to stone removal devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reynolds as modified by Ransbury with the teachings of Stirnweiss by incorporating wherein an outer surface of one end of the connection portion has a spiral barb structure for connection with the outer tube, and an outer surface of the other end of the connection portion has a protrusion structure, wherein the protrusion structure has a groove structure around it, in order to ensure a secured attachment between the outer tube and the connection portion.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Reynolds in view of Ransbury and Stirnweiss, as applied to claim 5 above, and further in view of Galperin et al. (US 20140171735 A1) (previously of record).
Regarding claim 7, Reynolds as modified by Ransbury and Stirnweiss teaches the stone removal device of claim 5 but fail to teach wherein the protrusion structure is a quadrangle, hexagonal, or octagonal stop structure.
However, Galperin is directed to a stone removal device and teaches a hexagonal sheath (64) (Paragraph 0024).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Reynolds as modified by Ransbury and Stirnweiss by changing the shape of the protrusion structure to be hexagonal, as taught by Galperin, as the references and the claimed invention are directed to stone removal devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Reynolds as modified by Ransbury and Stirnweiss with the teachings of Galperin by incorporating a hexagonal protrusion structure in order to prevent the basket from axially rotating (Galperin Paragraph 0024). Further, it would have been obvious to one of ordinary skill in the art to use a hexagonal nut in place of Stirnweiss’s nut as hexagonal nuts are common and known in the art.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771