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 .
Detailed Action
This is in response to the non-provisional application filed 04/25/2025
Claim Objections
Claim 17 is objected to because of the following informalities: claim 17 recites “the tube of the medical system a first tube”, whereas the Office respectfully submits, “the tube of the medical system is a first tube” is more appropriate. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,672,601
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the current patent generally recite an adapter comprising a first coupling lumen, a second coupling lumen, which is not patentably distinct from the adapter comprising a first coupling lumen, a second coupling lumen generally recited in claims 1-15 of the patent.
It is clear that all the elements of claims 1-20 of the patent are to be found in claims 1-15. The difference between claims 1-20 of the application and claims 1-15 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 1-15 of the patent is in effect a “species” of the “generic” invention of claims 1-20 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,303,194
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the current patent generally recite an adapter comprising a first coupling lumen, a second coupling lumen, which is generally recited in claims 1-18 of the patent.
It is clear that all the elements of claims 1-20 of the patent are to be found in claims 1-15. The difference between claims 1-20 of the application and claims 1-18 of the patent lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claims 1-18 of the patent is in effect a “species” of the “generic” invention of claims 1-20 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication Number 2016/0228113 (WEITZNER et al.)
Regarding claim 1, WEITZNER et al. discloses as shown in Figure 4B, an adapter (cap 80, see paragraph [0165]) for a medical system, comprising: a first coupling lumen (passageway 82a, see paragraph [0165]), the first coupling lumen sized to receive a distal end of a tube of a medical system, the tube comprising at least one lumen; and a second coupling lumen (passageway 82b, see paragraph [0165]), the second coupling lumen sized to receive a distal end of a delivery shaft of the medical system, the delivery shaft comprising at least one lumen, wherein the first coupling lumen and/or the second coupling lumen are sized to couple to the distal end of the delivery shaft and distal end of the tube via a friction fit, wherein the first coupling lumen and/or the second coupling lumen are sized to couple to the distal end of the delivery shaft and the distal end of the tube via an adhesive, wherein the first coupling lumen and the second coupling lumen are sized to couple to the distal end of the delivery shaft and the distal end of the tube and retain the distal end of the delivery shaft and the distal end of the tube a distance away from the distal end of the adapter.
Regarding claim 7, WEITZNER et al. discloses the tube of the medical system a first tube arranged to couple at a proximal end to a source of irrigation fluid, the adapter comprising a third coupling lumen (main channel 42, see paragraph [0165]), the third coupling lumen sized to receive a distal end of a second tube of the medical system, the second tube comprising at least one lumen and arranged to couple at a proximal end to a source of suction.
Regarding claims 11, 14, 17 Weitzner et al. discloses as shown in Figure 4B, a medical system comprising: a delivery device (tubular bodies 50b, see paragraph [0145]) comprising at least one lumen; a tube (tubular bodies 50a, see paragraph [0145]) comprising at least one lumen; and an adapter(cap 80, see paragraph [0165]), the adapter comprising: a first coupling lumen (passageway 82a, see paragraph [0165]), the first coupling lumen sized to receive a distal end of the tube; and a second coupling lumen (passageway 82b, see paragraph [0165]), the second coupling lumen sized to receive a distal end of the delivery device, wherein the first coupling lumen and the second coupling lumen are sized to couple to the distal end of the delivery shaft and the distal end of the tube and retain the distal end of the delivery shaft and the distal end of the tube a distance away from the distal end of the adapter, the tube of the medical system a first tube arranged to be capable of coupling at a proximal end to a source of irrigation fluid, the adapter comprising a third coupling lumen (main channel 42, see paragraph [0165]), the third coupling lumen sized to be capable of receiving a distal end of a second tube of the medical system, the second tube comprising at least one lumen and arranged to be capable of coupling at a proximal end to a source of suction.
Regarding claim 13, Weitzner et al. discloses wherein the first coupling lumen and/or the second coupling lumen are sized to couple to the distal end of the delivery shaft and the distal end of the tube via an adhesive. See paragraph [0359].
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(s) 9, 10, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0228113 (Weitzner et al.) in view of U.S. Patent Publication Number 2016/0174819 (Ouyang et al.)
Regarding claims 9, 10 Weitzner et al. fails to disclose an o-ring, wherein the lumen of the delivery shaft is arranged to receive an insertion device and wherein the o-ring is configured to form a seal around a portion of the insertion device extending beyond a distal end of the delivery shaft.
Ouyang et al., from the same field of endeavor teaches a similar adapter as shown in Figure 1, where the adapter includes an o-ring, for the purpose of preventing fluid in the conduit from contacting the interior surfaces of the multiple-use portion. See paragraphs [0057], [0102].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify adapter disclosed by Weitzner et al. to include the o-ring, such that the lumen of the delivery shaft is arranged to receive an insertion device and wherein the o-ring is configured to form a seal around a portion of the insertion device extending beyond a distal end of the delivery shaft, in order to prevent fluid in the lumen around where an insertion device could be inserted.
Regarding claim 19, Weitzner et al. discloses the lumen of the delivery shaft is capable of receiving an insertion device.
Weitzner et al. fails to disclose wherein the adapter comprises an o-ring disposed in the second coupling lumen, the o-ring configured to form a seal around a portion of the insertion device extending beyond the distal end of the delivery shaft.
Ouyang et al., from the same field of endeavor teaches a similar adapter as shown in Figure 1, where the adapter includes an o-ring, for the purpose of preventing fluid in the conduit from contacting the interior surfaces of the multiple-use portion. See paragraphs [0057], [0102].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify adapter disclosed by Weitzner et al. to include the o-ring, such it was disposed in the second coupling lumen, the o-ring configured to form a seal around a portion of the insertion device extending beyond the distal end of the delivery shaft, in order to prevent fluid in the second lumen around where an insertion device could be inserted, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0228113 (Weitzner et al.) in view of U.S. Patent Publication Number 2009/0192350 (Mejia)
Regarding claim 12, Weitzner fails to disclose wherein the first coupling lumen and/or the second coupling lumen are sized to couple to the distal end of the delivery shaft and distal end of the tube via a friction fit.
Mejia, from the same field of endeavor teaches a similar medical system where the medical system includes a similar adapter that is secured to a delivery shaft with a friction fit. See paragraph [0083].
It would have been obvious to one of ordinary skill in the art, at the time the invention to modify the system disclosed by Weitzner by substituting the means the adapter is attached to the distal ends of the delivery shaft and the tube via a friction fit for the friction fit means disclosed by Mejia because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2016/0228113 (Weitzner et al.) in view of U.S. Patent Publication Number 2008/0249357 (Soetermans)
Regarding claims 20 Weitzner et al. fails to disclose wherein the delivery device comprises a visualization device.
Soetermans, from the same field of endeavor teaches a similar system as shown Figure 1a, where the delivery shaft includes a visualization device (camera, see paragraph [0028]), wherein the adaptor includes a visualization opening at least partially aligned with the visualization device for the purpose of allowing the system to take pictures.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the system disclosed by Weitzner to include the visualization device within the delivery shaft and the visualization opening at least partially aligned with the visualization device for the purpose of allowing the system to take pictures in order to allow the system to take pictures, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771