DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 04/28/2025.
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 Rejections - 35 USC § 112
The rejection of claim(s) 1-12 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment.
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.
Claim(s) 1-5 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0167478 A1 to Mooney et al. (hereinafter “Mooney”).
Regarding claim 1, Mooney discloses (see abstract; Figs. 16-20; and [0091]-[0125]) a modular assembly (400, Fig. 16), comprising: a main body (402) having a proximal end (440) and a distal end (near #415, Fig. 19) and defining a longitudinal axis therebetween, the main body comprising: a first lumen (446) extending from the proximal end of the main body to the distal end of the main body (see Fig. 20 and [0125]); and a second lumen (444) extending from the proximal end of the main body to the distal end of the main body along the longitudinal axis of the main body (see Fig. 20 and [0125]); and a dual-lumen catheter (404) attached to the distal end of the main body (see [0123] and Fig. 16), the dual-lumen catheter comprising a shaft (422) and a first lumen (428) and a second lumen (426) disposed within the shaft, wherein the first lumen of the main body is contiguous with the first lumen of the dual-lumen catheter (see Fig. 20) and the second lumen of the main body is contiguous with the second lumen of the dual-lumen catheter (see Fig. 20), and wherein the second lumen of the main body extends along the longitudinal axis of the main body from the proximal end of the main body to the distal end of the main body (see Figs. 19-20).
Mooney further discloses (claim 2) wherein the first lumens of the main body and the dual-lumen catheter are configured to receive a first endoscopic instrument therethrough, and wherein the second lumens of the main body and the dual- lumen catheter are configured to receive a second endoscopic instrument therethrough (see Figs. 10-20 and [0125], the continuous lumens are open lumens which are fully capable of accommodating endoscopic instruments if one desired to do so - note that the limitations of claim 2 are merely functional limitations and do not affect the structure of the claimed invention - 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. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) -see also MPEP 2114(11), which states that the manner of operating a device does not differentiate apparatus claims from the prior art); (claim 3) further comprising an attachment member (412) formed at a proximal end of the second lumen of the main body, wherein the attachment member is fully capable of receiving a handle assembly of the second endoscopic instrument in a snap-lock configuration (see Fig. 16 and [0123]); (claim 4) further comprising a first support structure (414) attached to the proximal end of the main body at a proximal end of the first lumen (see Figs. 16-20 and [0123]-[0125]); (claim 5) further comprising a second support structure (420) attached to the distal end of the main body at a distal end of the first lumen (see Figs. 16-20 and [0123]-[0125]); and (claim 21) wherein a first portion of the first lumen of the main body defined from the proximal end of the main body and continuing distally for a first distance extends along a second longitudinal axis that is parallel with the longitudinal axis, wherein a second portion of the first lumen of the main body defined from the distal end of the main body and continuing proximally for a second distance extends along the longitudinal axis, and wherein the sum of the first distance and the second distance is less than a length of the first lumen of the main body (see Fig. 36 and [0184], an embodiment is envisaged where the outer extension tubes adopt a slanted middle section as shown in Fig. 36 within the housing 402 similar to how it slants in housing 656 in Fig. 36).
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.
Claim(s) 6, 8-12, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0253088 A1 to Chow et al. (hereinafter “Chow”) (previously of record) in view of Mooney.
Regarding claim 6, Chow discloses (see abstract; Figs. 12A-16; and [0028]-[0056]) a system (as shown in Fig. 12A), comprising: a modular assembly (200, Fig. 12A), comprising: a main body (214 + 216 + 280, see Fig. 12A and [0051]-[0055]) having a proximal end and a distal end and defining a longitudinal axis therebetween, the main body comprising; a first lumen (282) extending from the proximal end of the main body to the distal end of the main body (see Fig. 12A and [0052]) and a second lumen (284)extending from the proximal end of the main body to the distal end of the main body (see Fig. 12A and [0052]); and a dual-lumen (see [0051]) catheter (202) attached to a distal end of the main body (as shown in Fig. 12A), the dual-lumen catheter comprising a shaft (indicated by #202, Fig. 12A) and a first lumen (204) and a second lumen (206) disposed within the shaft (see Fig. 12A/14 and [0051]), wherein the first lumen of the main body is contiguous with the first lumen of the dual-lumen catheter (see [0052]) and the second lumen of the main body is contiguous with the second lumen of the dual-lumen catheter (see [0052]); a first endoscopic instrument (208) extending through the first lumen of the main body and the first lumen of the dual-lumen catheter (see Fig. 12A and [0051]-[0055] & [0028]); and a second endoscopic instrument (210) extending through the second lumen of the main body and the second lumen of the dual-lumen catheter (see Fig. 12A and [0051]-[0055] & [0028]).
Chow further discloses (claim 8) wherein the second endoscopic instrument is configured to move laterally between a first and second position within the dual-lumen catheter (see [0053]); (claim 9) the modular assembly further comprising an attachment member (262) formed within the main body at a proximal end of the second lumen (of the main body) (see Fig. 12A and [0056]); wherein the second endoscopic instrument comprises a handle assembly (needle assembly shown in Fig. 12A has syringe plungers shown proximal to adaptors 262, which are a handle assembly), and wherein the attachment member is configured to receive the handle assembly of the second endoscopic instrument in a snap- lock configuration (via female luer housing of adaptor 262, see [0056]); (claim 10) wherein the handle assembly is configured to move laterally along the main body of the modular assembly (e.g., by inserting or removing the needle or other instrument ([0028]) from the device); (claim 11) wherein the handle assembly is configured to move from a first position in which a distal end of the second endoscopic instrument is disposed within the second lumen of the dual-lumen catheter, and a second position in which the distal end of the second endoscopic instrument extends beyond a distal end of the dual-lumen catheter (see [0051]-[0055]); and (claim 12) wherein the handle assembly includes a plunger configured to move the second endoscopic instrument between the first and second position (see Fig. 12A showing plunger of needle).
Regarding claim 6, Chow fails to specifically disclose wherein the second lumen of the main body extends along the longitudinal axis of the main body from the proximal end of the main body to the distal end of the main body. Further regarding claim 22, Chow fails to specifically disclose wherein a first portion of the first lumen of the main body defined from the proximal end of the main body and continuing distally for a first distance extends along a second longitudinal axis that is parallel with the longitudinal axis, wherein a second portion of the first lumen of the main body defined from the distal end of the main body and continuing proximally for a second distance extends along the longitudinal axis, and wherein the sum of the first distance and the second distance is less than a length of the first lumen of the main body. Instead, both the first and second lumens of Chow extend at angles away from the longitudinal axis of the main body. Note that Chow does not disclose any importance as to the specific arrangement or angle.
Mooney discloses (see abstract; Figs. 1 and 16-20; and [0091]-[0125]) a modular assembly (400, Fig. 16), comprising: a main body (402) having a proximal end (440) and a distal end (near #415, Fig. 19) and defining a longitudinal axis therebetween, the main body comprising: a first lumen (446) extending from the proximal end of the main body to the distal end of the main body (see Fig. 20 and [0125]); and a second lumen (444) extending from the proximal end of the main body to the distal end of the main body along the longitudinal axis of the main body (see Fig. 20 and [0125]); and a dual-lumen catheter (404) attached to the distal end of the main body (see [0123] and Fig. 16), the dual-lumen catheter comprising a shaft (422) and a first lumen (428) and a second lumen (426) disposed within the shaft, wherein the first lumen of the main body is contiguous with the first lumen of the dual-lumen catheter (see Fig. 20) and the second lumen of the main body is contiguous with the second lumen of the dual-lumen catheter (see Fig. 20), and wherein the second lumen of the main body extends along the longitudinal axis of the main body from the proximal end of the main body to the distal end of the main body (see Figs. 19-20); and further wherein a first portion of the first lumen of the main body defined from the proximal end of the main body and continuing distally for a first distance extends along a second longitudinal axis that is parallel with the longitudinal axis, wherein a second portion of the first lumen of the main body defined from the distal end of the main body and continuing proximally for a second distance extends along the longitudinal axis, and wherein the sum of the first distance and the second distance is less than a length of the first lumen of the main body (see Fig. 36 and [0184], an embodiment is envisaged where the outer extension tubes adopt a slanted middle section as shown in Fig. 36 within the housing 402 similar to how it slants in housing 656 in Fig. 36) in the same field of endeavor for the purpose of making the lumens parallel to each other and the long. axis of the housing in order to allow the housing to have a low profile body which reduces the bulkiness of the proximal end of the device (see [0095]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange Chow’s proximal main body lumens so that the lumens extend along the longitudinal axis parallel to each other, as taught by Mooney, in order to allow the housing to have a low profile body which reduces the bulkiness of the proximal end of the device.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chow in view of Mooney, as applied to claim 6 above, and further in view of US 2013/0225997 A1 to Dillard et al. (hereinafter “Dillard”) (previously of record).
Regarding claim 7, the combination of Chow and Mooney discloses the invention substantially as claimed, as discussed above, however, the combination fails to specifically disclose wherein the first endoscopic instrument is a radial ultrasound probe and the second endoscopic instrument is a biopsy needle. Note that Chow discloses that the inventive device is used to deliver more than one device to a treatment site, wherein the device includes needles, imaging devices, ablation devices, cameras, diagnostic devices, and the like, and further that the inventive device allows these devices to be delivered at the treatment site simultaneously/sequentially, to substantially the same spot with minimal trauma to the entrance site.
Dillard discloses (see abstract; Fig. 11C; and [0120]) a multi-lumen catheter (1100) comprising a radial ultrasound probe (1116) disposed in a first lumen (1102) and a biopsy needle (1114) disposed in a second lumen (1104) for use in visualizing and conducting a biopsy on a target nodule (see [0120]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use Chow's device (as modified above) in a procedure such as a biopsy, by using a radial ultrasound probe and a biopsy needle as the two endoscopic instruments disposed in Chow's device, as taught by Dillard, since Chow's device would provide a multi-lumen catheter suitable for use in visualizing and biopsing a target nodule by providing these devices to be delivered at the treatment site simultaneously/sequentially, to substantially the same spot with minimal trauma to the entrance site.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim(s) 6-12 and 22, as amended, have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Wilson is no longer cited as a teaching reference, so Applicant’s arguments regarding Wilson in the 103 rejection are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771