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 1-6, 11-16, and 21-23, drawn to a cannula, classified in A61B 17/3421.
II. Claims 24, 25, and 27-29, drawn to a method, classified in A61B 17/3462.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another and materially different process; for example, the cannula can be made by additive manufacturing the entire cannula in one process.
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.
This application contains claims directed to the following patentably distinct species of:
Cannula and seal cartridge engagement:
Species A, FIGS. 24-29, seal cartridge tilted to allow fluid port to enter window in cannula funnel
Species B, FIGS. 30-31, fluid port of seal cartridge inserted into slot in cannula funnel
Species C, FIGS. 32-41, fluid port integral to cannula funnel
Obturator latching means:
Species D, FIGS. 32-41, obturator latches to window in cannula funnel
Species E, FIGS. 42-45, obturator latches to seal cartridge
The species are independent or distinct because the makeup of the devices including their shape and structure are substantially different allowing them to function in different manners. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claim 1 is considered generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or this field of art is crowded with a large number of publications and patents; and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species 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 a species to be examined (one species from each underlined group, e.g. Species A and Species D) even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve 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 election of species 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 on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them 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 species 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 species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Andrew Khouzam on 26 February 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-6, 11-16, and 21-23; Species A, FIGS. 24-29; and Species D, FIGS. 32-41. Affirmation of this election must be made by applicant in replying to this Office action. Claims 4, 14-16, 21-25, and 27-29 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 24, 25, and 27-29 are directed to nonelected Group II, and claims 4, 14-16, and 21-23 are directed to nonelected Species B.
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 10 April 2020.
Claim Objections
Claims 12 is objected to because of the following informalities: grammar. Appropriate correction is required. The following amendments is suggested:
Claim 12 / line 2: “a catch”
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, 5, 6, and 11-13 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 5,871,471 to Ryan et al. (hereinafter, “Ryan”).
As to claim 1, Ryan discloses a cannula, FIG. 11, comprising: a funnel portion (1114; wider at top 1145) having a sidewall; a tubular portion (1143) extending distally from the funnel portion, FIG. 11; and one or more voids (1180a, 1144, 1195) in the sidewall of the funnel portion that permit access to a seal cartridge (1116, 162, 163) through the sidewall (interpreted as language of intended use without positive recitation of a seal cartridge) (col. 12 / line 51 – col. 13 / line 7).
As to claim 2, Ryan discloses the cannula of Claim 1, wherein the one or more voids include a void (1180a) that permits access to a fluid port (1180) of the seal cartridge through the sidewall (interpreted as language of intended use) (col. 12 / lines 53-54).
As to claim 3, Ryan discloses the cannula of Claim 1, wherein the one or more voids include a void (1195) that permits access to a latch release (1168) of the seal cartridge through the sidewall (interpreted as language of intended use) (col. 12 / line 55 – col. 13 / line 7).
As to claim 5, Ryan discloses the cannula of Claim 1, wherein the one or more voids include a hole (1144) circumscribed by the sidewall, FIG. 11.
As to claim 6, Ryan discloses the cannula of Claim 1, wherein the one or more voids include a void (1180a) having a notch (distal curved end of 1180a that forms an indentation at that end of the void) that guides rotational alignment of the seal cartridge with respect to the cannula funnel portion about a longitudinal axis of the cannula (interpreted as language of intended use without positive recitation of a seal cartridge; the notch is fully capable of guiding rotational alignment of the seal cartridge with respect to the cannula funnel portion about a longitudinal axis of the cannula because the fluid port of the seal cartridge nests into the void and its notch at the desired rotational position of the seal cartridge with respect to the cannula funnel portion).
As to claim 11, Ryan discloses the cannula of Claim 1, wherein the funnel portion comprises a stop (distal surface/edge of 1195) that blocks distal motion of the seal cartridge (interpreted as language of intended use; 1168 of the seal cartridge abuts the stop to block further distal motion of the seal cartridge).
As to claim 12, Ryan discloses the cannula of Claim 1, wherein the funnel portion comprises catch (surface/edge of 1144) that engages a latch (1166) of the seal cartridge (interpreted as language of intended use).
As to claim 13, Ryan discloses the cannula of Claim 1, wherein, when the funnel portion is engaged with the seal cartridge, a proximal end (proximal surface of 1166; comprises the proximal end of 1166 of the seal cartridge) of the seal cartridge does not extend proximally beyond a proximal end (proximal rim of top 1145) of the funnel portion (interpreted as language of intended use).
Claims 1, 3, 5, 6, and 11-13 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 8,137,318 to Schweitzer et al. (hereinafter, “Schweitzer).
As to claim 1, Schweitzer discloses a cannula, FIGS. 1-4, comprising: a funnel portion (16) having a sidewall (col. 10 / lines 53-55), FIG. 4; a tubular portion (18) extending distally from the funnel portion (col. 10 / lines 53-55); and one or more voids (46, 50, 56) in the sidewall of the funnel portion that permit access to a seal cartridge (76) through the sidewall (interpreted as language of intended use without positive recitation of a seal cartridge) (col. 13 / lines 35-53).
As to claim 3, Schweitzer discloses the cannula of Claim 1, wherein the one or more voids include a void (46) that permits access to a latch release (136) of the seal cartridge through the sidewall (interpreted as language of intended use) (col. 13 / lines 45-53), FIGS. 1 and 4.
As to claim 5, Schweitzer discloses the cannula of Claim 1, wherein the one or more voids include a hole (56) circumscribed by the sidewall, FIG. 2.
As to claim 6, Schweitzer discloses the cannula of Claim 1, wherein the one or more voids include a void (46) having a notch (48) that guides rotational alignment of the seal cartridge with respect to the cannula funnel portion about a longitudinal axis of the cannula (interpreted as language of intended use).
As to claim 11, Schweitzer discloses the cannula of Claim 1, wherein the funnel portion comprises a stop (distal surface/edge of 46) that blocks distal motion of the seal cartridge (interpreted as language of intended use; 136 of the seal cartridge abuts the stop to block further distal motion of the seal cartridge).
As to claim 12, Schweitzer discloses the cannula of Claim 1, wherein the funnel portion comprises catch (extension above and forming 48) that engages a latch (132) of the seal cartridge (interpreted as language of intended use).
As to claim 13, Schweitzer discloses the cannula of Claim 1, wherein, when the funnel portion is engaged with the seal cartridge, a proximal end of the seal cartridge does not extend proximally beyond a proximal end (44) of the funnel portion (interpreted as language of intended use), FIGS. 1-2.
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 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. US 11,944,347. A latching window in ‘347 anticipates one or more voids in the instant application; a lower cannula portion that defines a cannula lumen in ‘347 anticipates a tubular portion in the instant application; and a release button in ‘347 anticipates a latch release in the instant application. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the “generic” invention is anticipated by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 13 of U.S. Patent No. U.S. 12,232,767. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the “generic” invention is anticipated by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Instant claims 19/031,366
Patent claims U.S. 12,232,767
A cannula comprising:
a funnel portion having a sidewall;
a tubular portion extending distally from the funnel portion; and
one or more voids in the sidewall of the funnel portion that permit access to a seal cartridge through the sidewall.
The cannula of Claim 1, wherein the one or more voids include a void that permits access to a latch release of the seal cartridge through the sidewall.
a latching window defined in a funnel portion of a cannula
a cannula lumen of the cannula (i.e. forming a tubular portion)
a latching window (i.e. a void) defined in a funnel portion of a cannula
actuating a release button of the seal cartridge through the latching window
actuating a release button (i.e. latch release) of the seal cartridge through the latching window
A cannula comprising:
a funnel portion having a sidewall;
a tubular portion extending distally from the funnel portion; and
one or more voids in the sidewall of the funnel portion that permit access to a seal cartridge through the sidewall.
3.The cannula of Claim 1, wherein the one or more voids include a void that permits access to a latch release of the seal cartridge through the sidewall.
7.
positioning a seal cartridge within a funnel portion of a cannula
a lumen of the cannula (i.e. forming a tubular portion)
10. positioning the release button of the seal cartridge with respect to a window (i.e. a void) of the cannula such that the release button (i.e. latch release) of the seal cartridge is accessible through the window
A cannula comprising:
a funnel portion having a sidewall;
a tubular portion extending distally from the funnel portion; and
one or more voids in the sidewall of the funnel portion that permit access to a seal cartridge through the sidewall.
3.The cannula of Claim 1, wherein the one or more voids include a void that permits access to a latch release of the seal cartridge through the sidewall.
13.
positioning a seal cartridge within a funnel portion of a cannula
a lumen of the cannula (i.e. forming a tubular portion)
extending a release button (i.e. latch release) of the seal cartridge through a window (i.e. a void) in a sidewall of the cannula
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775