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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michaeli et al. (US 2011/0301421) in view of Stone et al. (US 2011/0237898).
Regrading claim 1, Michaeli discloses an expandable access port, comprising: an expandable conduit (see tine assembly 20 and sleeve 23 in fig. 14d); a housing (60b; fig. 44a) coupled to the expandable conduit, (noting that “coupled” does not require a direct connection; rather, two elements can be considered coupled by way of their common connection to one or more intermediate members) the housing having a threaded region (61ba; fig. 44a), wherein the housing includes a cap region (best shown in fig. 30 as 10’’) with a plurality of attachment regions (e.g., pins 11j in fig. 23) projecting radially outward therefrom, an adjustment mechanism (48; fig. 26) coupled directly to one of the plurality of attachment regions, and an actuation member (66; fig. 44a) threadably engaged with the threaded region ([0384], [0795]), the actuation member being configured to shift the expandable conduit between a first configuration and an expanded configuration by shifting the actuation member relative to the threaded region ([0793]).
Regarding claim 13, Michaeli discloses an expandable access port, comprising: an expandable sheath comprising a plurality of tines (21) and an elastic sleeve (23; [0624]-[0625]) disposed along the plurality of tines (fig. 14d); wherein the expandable sheath has a proximal end region; a hub (60b) disposed at the proximal end region, the hub comprising a threaded region (61ba) and a cap (best shown in fig. 30 as 10’’), an actuation member (66) threadably engaged with the threaded region, the actuation member being configured to shift the expandable sheath between a first configuration and an expanded configuration, wherein the cap includes an attachment region (pins 11j; fig. 26) projecting radially outward therefrom; and an adjustment mechanism (48) coupled to the attachment region.
Regarding claim 20, Michaeli discloses an expandable access port, comprising: an expandable sheath (21,23) comprising an elastic sleeve (23) and a proximal end region, a hub (10’’ in fig. 30, with 60b; fig. 44a,b) disposed at the proximal end region, the hub comprising a threaded region (61ba; fig. 44a) , a cap (best shown as 10’’ in fig. 30), and an attachment region (11j; fig. 26) projecting radially outward from the cap, a nut (66) threadably engaged with the threaded region, the nut being configured to shift the expandable sheath between a first configuration and an expanded configuration, an adjustment mechanism coupled to the attachment region.
Regarding claims 1, 13, and 20, Michaeli does not expressly disclose that the adjustment mechanism (48; fig. 26) includes a depressible release member for releasably coupling and securing the adjustment mechanism directly to the one of the one or more attachment regions.
Stone discloses another expandable access port comprising an expandable conduit formed by a plurality of tines (1300; fig. 16), the port including a cap (500; fig. 17) having one or more attachable regions (1100) and an adjustment mechanism (30) releasably coupled directly to one of the one or more attachment regions (fig. 56). The adjustment mechanism includes an elastic member (spring 3500; fig. 53) and a depressible release member in the form of a depressible lever (3300; fig. 53 and par. [0162]) for releasably coupling the adjustment mechanism directly to the one of the one or more attachment regions (note at least movement of lever 3300 from the configuration shown in fig. 51 to the configuration shown in fig. 50 considered a depression of the lever). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Michaeli to include an adjustment mechanism that includes an elastic member and lever member as taught by Stone in place of the adjustment mechanism (48) disclosed by Michaeli because such a modification can be considered a simple substitution of one adjustment mechanism that couples directly to one or more attachment regions of a cap to couple the access port to a table or operation bed for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claims 2 and 14, the cap region includes a substantially planar rounded base (e.g., element 13’’ in fig. 30).
Regarding claims 3 and 14, the plurality of attachment regions (11j; fig. 26) project laterally outward from the substantially planar rounded base.
Regarding claims 4 and 15, the one or more attachment regions (11j; fig. 26) of Michaeli extends radially outward relative to the substantially planar rounded base and has an end surface at an end region of the attachment region, but does not include two substantially parallel side surfaces as claimed. However, Stone discloses that the one or more attachment regions (1100; fig. 21) to which the adjustment mechanism (30; fig. 56)) releasably couples may include two substantially parallel side surfaces (1110) that extend radially outward relative to the rounded base and an end surface at an end region of the two substantially parallel side surfaces. The substantially parallel side surfaces form a drive feature ([0132]). It would have been obvious to one of ordinary skill in the art to have modified the prior art attachment regions of Michaeli to include two substantially parallel side surfaces that extend radially outward relative to the rounded base as taught by Stone in order to provide a drive feature on the attachment regions to facilitate gripping and/or manipulation of the attachment regions by a gripping/driving tool.
Regarding claim 5, the actuation member of Michaeli includes a nut (66).
Regarding claim 6, the expandable conduit of Michaeli includes a plurality of tines (21).
Regarding claims 7 and 16, the plurality of tines includes a first tine secured to the housing (wherein the housing may include 61b,63b,65, 65, 65c of Michaeli) with a pivot member (15a) and wherein the pivot member includes a pivot pin (15j, which secures tine to slider 15, which is secured to housing; figs. 10d-10g, fig. 31a, figs. 40 and 41 of Michaeli).
Regarding claims 8 and 17, the plurality of tines includes a first tine, wherein the first tine includes an angled surface, and wherein the actuation member (66) includes an actuation surface (threaded inner surface; 66b) designed to engage (via housing 61b, arms 62/63, slides 64, slider members 15, and surface 21 of the tine of Michaeli) the angled surface. It is noted that the term "engage" does not require that the actuation surface contacts the angled surface. Rather, the term "engage" is given its broadest reasonable interpretation of "to interlock with; to cause mechanical parts to mesh', https:/Awww.merriam-webster.com/dictionary/engage). Rotation of the actuation member (66) causes arms ring (62), arms (63) and sliders (64) to move, which causes slider member 15 to move, which then causes the angled surface of the tine to move. Thus, the actuation surface of the actuation member is considered designed to engage the angled surface of the tine.
Regarding claim 9, the port further comprising a sleeve (e.g., 23, wherein the conduit can be considered the tines) disposed along the plurality of tines.
Regarding claim 10, the sleeve is elastic (23; [0622], [0624]-[0625] of Michaeli).
Regarding claims 11 and 18, as taught by Stone, the depressible release member (3300; figs. 50-53 and 56) includes a lever.
Regarding claims 12 and 19, as taught by Stone, the adjustment mechanism includes an elastic member (spring 3500).
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 (1-4, 6, 11-12), 5, 7, 8, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 2, 3, 4, and 5, respectively, of U.S. Patent No. 11,707,294 in view of Stone et al. Claims (1), 2, 3, 4, and 5 of ‘294 claim the invention of claims (1-4, 6, 11-12), 5, 7, 8, and 9, respectively, including a release member comprising a lever, but does not expressly disclose that the release member is depressible. Stone discloses another expandable excess port (see fig. 16), the excess port including an adjustment mechanism (30: figs. 50-59) releasably coupled to one of the plurality of attachment regions (1100) of the access port. The adjustment mechanism includes a depressible lever (3300; see movement from fig. 51 to fig. 50 for example) and an elastic member (spring 3500) that facilitates movement of the adjustment mechanism between the open and closed configurations to alternate between a released and secured configuration. It would have been obvious to one of ordinary skill in the art to have modified the invention of claims (1), 2, 3, 4, and 5 of ‘294 to include a release lever that is depressible and an elastic member (biasing spring) as taught by Stone for the predictable result of providing an easily actuatable lever that can switch between secured and released positions to secure or release the adjustment mechanism relative to the attachment regions.
Claims (13-15,18-19), 20, 16, 17, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 2, 3, 4, and 5, respectively, of U.S. Patent No. 11,707,294 in view of Michaeli et al. and Stone et al. Claims (1), 2, 3, 4, and 5 of ‘294 claim the invention of claims (13-15,18-19), 20, 16, 17, and 10, respectively, including an expandable conduit having a plurality of tines, and a release member comprising a lever, but does not expressly disclose that the conduit comprises an elastic sleeve and the release member is depressible. Michaeli discloses another expandable excess port and teaches that the expandable conduit of the port comprises an elastic sleeve (23; fig. 14d) disposed over the plurality of tines to prevent entry of surrounding tissue into the working channel of the port ([0036],[0624]-[0625]; fig. 14d). It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1, 2, 3, 4, and 5 of ‘294 to include an elastic sleeve as taught by Michaeli in order to prevent entry of surrounding tissue into the working channel of the port. Stone discloses another expandable excess port (see fig. 16), the excess port including an adjustment mechanism (30: figs. 50-59) releasably coupled to one of the plurality of attachment regions (1100) of the access port. The adjustment mechanism includes a depressible lever (3300; see movement from fig. 51 to fig. 50 for example) and biasing spring (3500) that facilitates movement of the adjustment mechanism between the open and closed configurations. It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1, 2, 3, 4, and 5 of ‘294 to include a release lever that is depressible and an elastic member (biasing spring) as taught by Stone for the predictable result of providing an easily actuatable lever that can switch between secured and released positions to secure or release the adjustment mechanism relative to the attachment regions.
Claims (1-4, 6, 11, 12), 5, 7, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 2, 3, and 4, respectively, of U.S. Patent No. 12,232,765 in view of Stone et al. Claims (1), 2, 3, and 4 of ‘765 claim the invention substantially including an expandable conduit having a plurality of tines, and a release member comprising a lever, but does not expressly disclose that the release member is depressible. Stone discloses another expandable excess port (see fig. 16), the excess port including an adjustment mechanism (30: figs. 50-59) releasably coupled to one of the plurality of attachment regions (1100) of the access port. The adjustment mechanism includes a depressible lever (3300; see movement from fig. 51 to fig. 50 for example) and an elastic member (spring 3500) that facilitates movement of the adjustment mechanism between the open and closed configurations. It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1-4 of ‘765 to include a release lever that is depressible and an elastic member (biasing spring) as taught by Stone for the predictable result of providing an easily actuatable lever that can switch between secured and released positions to secure or release the adjustment mechanism relative to the attachment regions.
Claims (9,10,13-15,18,19), 16, 17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims (1), 3, 4, and 2, respectively, of U.S. Patent No. 12,232,765 in view of Michaeli et al. and Stone et al. Claims (1), 3, 4, and 2 of ‘765 claims the invention of claims (9, 10, 13-15, 18, 19), 16, 17, and 20, respectively, substantially including an expandable conduit having a plurality of tines, and a release member comprising a lever, but does not expressly disclose that the conduit comprises an elastic sleeve and the release member is depressible. Michaeli discloses another expandable excess port and teaches that the expandable conduit of the port comprises an elastic sleeve (23; fig. 14d) disposed over the plurality of tines to prevent entry of surrounding tissue into the working channel of the port ([0036],[0624]-[0625]; fig. 14d). It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1-4 of ‘765 to include an elastic sleeve as taught by Michaeli in order to prevent entry of surrounding tissue into the working channel of the port. Stone discloses another expandable excess port (see fig. 16), the excess port including an adjustment mechanism (30: figs. 50-59) releasably coupled to one of the plurality of attachment regions (1100) of the access port. The adjustment mechanism includes a depressible lever (3300; see movement from fig. 51 to fig. 50 for example) and elastic member (biasing spring 3500) that facilitates movement of the adjustment mechanism between the open and closed configurations. It would have been obvious to one of ordinary skill in the art to have modified the invention of claims 1-4 of ‘765 to include a release lever that is depressible and an elastic member (biasing spring) as taught by Stone for the predictable result of providing an easily actuatable lever that can switch between secured and released positions to secure or release the adjustment mechanism relative to the attachment regions.
Conclusion
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KSH 8/4/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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