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/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 05 June 2026 is acknowledged.
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 1-2, 8-9 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-11 and 15 of U.S. Patent No. 12053415. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are more specific and constitutes a species of the instant invention. The patented claims recite the protrusions extending laterally outward and a sidewall having the plurality of apertures on the hub in the independent claim. A nonstatutory double patenting rejection is appropriate where a claim in an application under examination claims subject matter that is different, but not patentably distinct, from the subject matter claimed in a prior patent or a copending application. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993). In this case, the patented claims (species) anticipates instant invention (genus) (In re Goodman) since the reference claims falls within the scope of the examined claims.
Instant claims
Patented Claims
1. (Original) A valved cannula assembly, comprising:a cannula, comprising:a hollow rod portion, the hollow rod portion having a first opening and a second opening at opposite ends thereof; anda head portion, the head portion having a plurality of protrusions extending from a surface of the head portion; anda valved hub, the valved hub having a plurality of apertures formed therein, the plurality of apertures configured to receive the plurality of protrusions for coupling the valved hub to the head portion.
1. A valved cannula assembly configured to reduce intraocular pressure, comprising: a cannula, comprising: a hollow rod portion, the hollow rod portion having a first opening and a second opening at opposite ends thereof and one or more openings along a length therebetween; and a head portion, comprising: a plurality of protrusions extending laterally outward from the head portion; and a valved hub, comprising: a sidewall having a plurality of apertures formed therein, the plurality of apertures configured to receive the plurality of protrusions to couple the valved hub to the head portion.
2. (Original) The valved cannula assembly of claim 1, wherein the hollow rod portion comprises:one or more openings along a length between the first opening and the second opening.
2. The valved cannula assembly of claim 1, wherein the hollow rod portion is fenestrated.
10. (Original) A trocar cannula system, comprising:a trocar assembly, comprising:a trocar blade; anda trocar handle coupled to the trocar blade; anda valved cannula assembly detachably coupled to the trocar assembly, comprising:a cannula, comprising:a hollow rod portion, the hollow rod portion having a first opening and a second opening at opposite ends thereof; anda head portion, the head portion having a plurality of protrusions extending from a sidewall of the head portion; anda valved hub, the valved hub having a plurality of apertures formed therein, the plurality of apertures configured to receive the plurality of protrusions for coupling the valved hub to the head portion.
8. A trocar cannula system configured to reduce intraocular pressure, comprising: a trocar assembly, comprising: a trocar blade; and a trocar handle coupled to the trocar blade; and a valved cannula assembly detachably coupled to the trocar assembly, comprising: a cannula, comprising: a hollow rod portion, the hollow rod portion having a first opening and a second opening at opposite ends thereof and one or more openings along a length therebetween; and a head portion, comprising: a plurality of protrusions extending laterally outward from the head portion; and a valved hub, comprising: a sidewall having a plurality of apertures formed therein, the plurality of apertures configured to receive the plurality of protrusions to couple the valved hub to the head portion.
11. (Original) The trocar cannula system of claim 10, wherein the hollow rod portion comprises:one or more openings along a length between the first opening and the second opening.
9. The trocar cannula system of claim 8, wherein the hollow rod portion is fenestrated.
15. (Original) The trocar cannula system of claim 10, wherein the valved hub comprises a valve aligned with the first opening and the second opening of the hollow rod portion, the valve configured to enable detachment of the trocar assembly from the valved cannula assembly.
12. The trocar cannula system of claim 8, wherein the valved hub comprises a valve located at a central portion thereof, which is aligned with the first opening and the second opening of the hollow rod portion.
Claim Rejections - 35 USC § 103
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 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) 1, 3-9, 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kerns (US 2012/0172668) in view of Hammack (US 2012/0271272).
Regarding claim 1, Kerns discloses a cannula assembly, comprising:
a cannula (106, figure 2), comprising:
a hollow rod portion (106 is a hollow rod), the hollow rod portion having a first opening and a second opening at opposite ends thereof (openings on opposite ends, figure 2); and
a head portion (142, figure 5), the head portion having a plurality of protrusions (114, 116, 118) extending from a surface of the head portion (figure 5); and
a hub (102), the valved hub having a plurality of apertures (150, figure 6, [0056]) formed therein, the plurality of apertures configured to receive the plurality of protrusions for coupling the valved hub to the head portion (150 receives the housing 104).
Kerns does not disclose the cannula has a valved hub.
Hammack discloses a valved cannula assembly and teaches a cannula having a valved hub (28), the valve (27) allowing the user to insert attachments into the cannula ([0041-0042]).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns with the valved hub of Hammack in order to insert attachments into the cannula ([0041-0042]).
Regarding claims 3-4, Kerns discloses the spacing of the plurality of apertures on the hub (figures 4-5) which appear to be equally spaced but does not disclose wherein the plurality of protrusions are disposed equidistantly from each other around a circumference of the head portion, and wherein the plurality of apertures are disposed equidistantly from each other around a circumference of the valved hub.
However, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns to have multiple plurality of protrusions that mate with the hub since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, duplicating the plurality of protrusions would only assist in more securely fastening the hollow rod with the hub and there does not appear to be a new and unexpected result from duplication. Since the Kerns apertures are equally spaced, it follows naturally that the plurality of protrusion would also be disposed equidistantly from each other around a circumference of the head portion, and wherein the plurality of apertures are disposed equidistantly from each other around a circumference of the valved hub.
Regarding claim 5, Kerns discloses wherein the plurality of protrusions (protrusions would include 116, which are angled outward) are angled relative to a longitudinal axis of the cannula (figure 5).
Regarding claims 6-7, Kerns discloses the protrusions can be a variety of shapes ([0046]) but does not disclose wherein the plurality of protrusions each have a shape that is at least partially semicircular, the plurality of protrusions each have two curved edges connected by a flat edge.
Since it has been held that a change in shape is a matter of design choice absent persuasive evidence that the particular configuration of the object was significant, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art to have the shape of the protrusions be semicircular or have two curved edges connected by a flat edge since it is a matter of design choice. Further, there is no evidence that the change in shape would hinder the device from functioning.
Regarding claims 8-9, Kerns does not disclose the valved hub further comprising: a first ring; and a second ring, wherein the first ring and the second ring are connected by a sidewall extending between the first ring and the second ring (claim 8), wherein: the first ring comprises a valve configured to provide a surgical instrument access through the valved hub and the cannula; and the second ring comprises a surface configured to prevent the valved cannula assembly from being inserted into an interior portion of an eye (claim 9).
Hammack discloses a valved cannula hub comprising a first ring (38); and a second ring (ring with flange at the end of the valved hub), wherein the first ring and the second ring are connected by a sidewall (sidewall between the first and second rings) extending between the first ring and the second ring (figure 7-8), wherein: the first ring comprises a valve (27) configured to provide a surgical instrument access through the valved hub and the cannula ([0040-0041]); and the second ring comprises a surface configured to prevent the valved cannula assembly from being inserted into an interior portion of an eye (figure 14 also shows the flange outside, edge of second ring flange can perform the intended use of preventing insertion due to the diameter of the device).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns with the valved hub of Hammack in order to insert attachments into the cannula ([0041-0042]).
Regarding claim 10, Kerns discloses a trocar cannula system, comprising:
a cannula assembly (100, figure 1) detachably coupled to the trocar assembly ([0039] the trocar assembly not shown), comprising:
a cannula (106, figure 2), comprising:
a hollow rod portion (106 is hollow), the hollow rod portion having a first opening and a second opening at opposite ends thereof (opening on opposite ends, figure 2); and
a head portion (142, figure 5), the head portion having a plurality of protrusions (114, 116, 118) extending from a sidewall of the head portion (sidewall of the head portion); and
a hub (102), the valved hub having a plurality of apertures (150, figure 6, [0056]) formed therein, the plurality of apertures configured to receive the plurality of protrusions for coupling the valved hub to the head portion (150 receives the housing 104).
Kerns does not disclose a trocar assembly, comprising:
a trocar blade; and
a trocar handle coupled to the trocar blade; and
a valved hub making up the valved cannula assembly.
Hammack teaches a valved cannula assembly and teaches a trocar assembly comprising a trocar blade (13); and
a trocar handle (12 attached to 13) coupled to the trocar blade; and
a cannula having a valved hub (28), the valve (27) allowing the user to insert attachments into the cannula ([0041-0042]).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns with the valved hub of Hammack in order to insert attachments into the cannula ([0041-0042]) such as the trocar of Hammack since Kerns already discloses use with a trocar ([0039]).
Regarding claim 12, Kerns discloses the plurality of protrusions extending laterally outward from the head portion (figure 2 shows at least 114 and 116 extended outward).
Regarding claims 13-14, Kerns discloses the spacing of the plurality of apertures on the hub (figures 4-5) which appear to be equally spaced but does not disclose wherein the plurality of protrusions are disposed equidistantly from each other around a circumference of the head portion, and wherein the plurality of apertures are disposed equidistantly from each other around a circumference of the valved hub.
However, it would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns to have multiple plurality of protrusions that mate with the hub since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, duplicating the plurality of protrusions would only assist in more securely fastening the hollow rod with the hub and there does not appear to be a new and unexpected result from duplication. Since the Kerns apertures are equally spaced, it follows naturally that the plurality of protrusion would also be disposed equidistantly from each other around a circumference of the head portion, and wherein the plurality of apertures are disposed equidistantly from each other around a circumference of the valved hub.
Regarding claim 15, Kerns does not disclose the valved hub comprises a valve aligned with the first opening and the second opening of the hollow rod portion, the valve configured to enable detachment of the trocar assembly from the valved cannula assembly.
a valve (27) aligned with the first opening and the second opening of the hollow rod portion (figure 7), the valve configured to enable detachment of the trocar assembly from the valved cannula assembly ([0040-0041]).
It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns with the valved hub of Hammack in order to insert attachments into the cannula ([0041-0042]).
Claim(s) 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kerns (US 2012/0172668) in view of Hammack (US 2012/0271272) further in view of Yaron (US 2010/0274259).
Regarding claim 2, Kerns and Hammack do not disclose wherein the hollow rod portion comprises: one or more openings along a length between the first opening and the second opening.
Yaron discloses an eye implant relatively pertinent to problem posed by Applicant of
moving fluid. Yaron teaches one or more openings (242, figure 2A, [0131]) along a length of the cannula (230).
Yaron provides openings aiding fluid flow, helping to prevent clogging, and potentially serving as markers ([0131]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns and Hammack the openings of Yaron in order to aid fluid flow and prevent clogging.
Regarding claim 10, Kerns and Hammack do not disclose wherein the hollow rod portion comprises: one or more openings along a length between the first opening and the second opening.
Yaron discloses an eye implant relatively pertinent to problem posed by Applicant of
moving fluid. Yaron teaches one or more openings (242, figure 2A, [0131]) along a length of the cannula (230).
Yaron provides openings aiding fluid flow, helping to prevent clogging, and potentially serving as markers ([0131]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Kerns and Hammack the openings of Yaron in order to aid fluid flow and prevent clogging.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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