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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 10/10/2025. Claims 1-2 are amended. Claim 6 is cancelled. Claims 1-5 and 7-9 are currently pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed 10/10/2025, with respect to the rejection(s) of claim(s) 1-3, 5 and 7-8 under 35 U.S.C. 103 as being unpatentable over Buckman in view of Rosen and Heim; claim 4 under 35 U.S.C. 103 as being unpatentable over Buckman in view of Rosen, Heim, and Tanaka; and claim 9 under 35 U.S.C. 103 as being unpatentable over Buckman in view of Rosen, Heim, and Skakoon, have been fully considered but are not persuasive.
Applicant argues none of the cited references disclose the smooth-walled cavity passage (Remarks, pgs. 4-6).
In response to applicant’s argument, it is respectfully submitted Buckman and Heim are not relied upon to teach the smooth-walled cavity passage as claimed, therefore applicant’s arguments regarding Buckman and Heim are moot. Further, as discussed below, Rosen teaches an internally threaded opening which corresponds to the threaded portions of catheter 120 depicted as having smooth portions in between the threads, such that Rosen is considered to teach smooth portions in between the threads of the internally threaded opening. Applicant argues Rosen’s flange is not an obturator assembly mounting base for securing an obturator, however, Buckman is relied on to teach the base being an obturator assembly receiving base as claimed. Rosen teaches the base configured to receive a catheter, such that one of ordinary skill would’ve understood the device of Rosen to be capable of receiving an obturator and therefore within the same field of endeavor. Applicant further argues Rosen lacks any teaching of a smooth, unthreaded cavity for receiving an obturator, however, applicant’s arguments are narrower than the claim limitations. The claim language does not preclude smooth portions of a threaded structure from meeting the limitation of a smooth-walled cavity passage. The claim language also does not describe how the smooth-walled cavity extends, or the smooth-walled cavity passage being smooth along the entire portion of the aperture. Further, the terms “smooth” and “threaded” are not mutually exclusive. As depicted in fig. 2 of Rosen, the threaded structure contains portions of a smooth wall in between the threads, such that the claimed limitation is met.
Applicant further argues there is no suggestion of a smooth, thread-free cavity for direct obturator placement among the references (Remarks, pgs. 7-8).
In response to applicant’s argument, Buckman and Heim are not relied on to teach a smooth-walled cavity passage as discussed above. Further, applicant argues the result of the combination of Buckman and Rosen would result in a base plate with a threaded port as opposed to a smooth, direct-receiving cavity, however, the claim language does not recite a specific fit of the obturator assembly relative to the cavity passage. The claim language recites no further structure to how the obturator assembly fits within the cavity passage (snug fit, direct fit, etc.). In contrast, the claim recites structure of a base, as opposed to a system claim including the base in conjunction with the obturator assembly. Further, as previously discussed, Rosen teaches smooth portions in between the threads, which would provide the same benefit of more precise control and placement of the inserted device within the aperture.
Applicant further argues there is no motivation to add Rosen’s threaded rim to Buckman, because introducing a check valve from Rosen into Buckman would defeat one of Buckman’s stated features (Remarks, pgs. 9-10).
In response to applicant’s argument, it is respectfully submitted the arguments are narrower than the claim limitations. As previously discussed, the valve assembly is not positively recited, no seal is positively recited, and the claim is not a system claim. Therefore, the threaded rim as claimed only needs to be capable of receiving a valve assembly operable to seal an aperture, however, the claim language is otherwise silent to any fluid flow or prevention of fluid/air leakage or structure of a seal as argued. Accordingly, the claim limitation is met, because the threaded rim is capable of receiving the valve assembly located on the catheter of Rosen, which is received within the opening of the disk as discussed below.
Applicant further argues there is no motivation to add Heim’s angled rim to Buckman/Rosen, because Buckman’s straps hold the tube firmly so an angled interface is moot, and Buckman’s straps already provide some give (Remarks, pg. 10).
In response to applicant’s argument, it is respectfully submitted applicant’s argument cannot take the place of evidence (MPEP 2145(I)). Applicant further appears to be arguing the actual, physical substitution of elements from Buckman, Rosen and Heim are not combinable, however, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference, rather what the combined teachings would have suggested to those of ordinary skill in the art (MPEP 2145(III)). Heim teaches a benefit of providing an angled rim for an inserted instrument, increasing stability of the inserted instrument depending on the access site and type of tissue being accessed. One of ordinary skill would’ve understood that a rim supported above a wall of varying height as claimed would provide the benefit of alleviating stress depending on the type of tissue being accessed and the angle the user wants to access the tissue. Applicant argues Buckman already provides some give, however, this does not preclude providing an angled entry point to tissue when desired. Accordingly, the claimed limitation is met.
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.
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) 1-3, 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Buckman (US 2005/0234390 A1) in view of Rosen (US 6517519 B1) and Heim (US 5807341) (all references previously of record).
Regarding claim 1, Buckman discloses (abstract; paras. [0052]-[0083]; figs. 1-5b) an obturator assembly receiving base (66, para. [0079]) which, in use, receives an obturator assembly (receives chest tube 10 which includes obturator 24, para. [0052]) for establishing and maintaining an opening to an anatomical space of a body (obturator inserted within chest tube 10 into incision, considered to contribute to establishing and maintaining incision within body, paras. [0016] and [0067]), the base comprising a plate (66, para. [0079]; fig. 5a) for placement on a patient external and adjacent the anatomical space (placed against patient, para. [0080]), the plate having an aperture (62, paras. [0079]-[0080]) configured to receive the obturator assembly (receives chest tube 10, paras. [0079]-[0083]).
However, Buckman fails to disclose the plate having the aperture which leads to a smooth-walled cavity passage, wherein the plate further comprises a threaded rim located about the aperture for receiving a valve assembly operable to seal the aperture, and wherein the rim is supported above a wall of varying height such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the plate.
Rosen teaches (col. 4 line 66-col. 5 line 10; figs. 2-7), in the same field of endeavor, a base (140) comprising a plate (flange 140 is a disk) having an aperture (centrally-located opening), the aperture leading to a smooth-walled cavity passage (wall of opening considered to have smooth portions corresponding to smooth portions of inserted device in between threaded portions, annotated fig. 2), wherein the plate further comprises a threaded rim (internal threading of opening) located about the aperture (considered to be located about the opening to match external threading of threaded portion 122) for receiving a valve assembly operable to seal the aperture (receives check valve 134 which prevents inflow/outflow of fluids, note the valve assembly is not positively recited and therefore not required by the claim limitations, col. 5 lines 10-15 of Rosen), for the purpose of adjusting the position of the flange along the tube to be closer to or farther from the distal end of the tube inserter (col. 4 line 66-col. 5 line 10).
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 penetration region of Buckman to include internal threading to match external threading on chest tube 10, in order to provide adjustability of the position of the chest tube within the penetration region 62 to adjust the position of the distal end of the chest tube 10 within the body, providing securement within the penetration region itself in addition to securement via hold down straps, based on the suggestions and teachings of Rosen (col. 4 line 66-col. 5 line 10).
Buckman (as modified) still fails to teach wherein the rim is supported above a wall of varying height such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the plate.
Heim teaches (col. 2 lines 46-58, col. 5 lines 13-15 and col. 8 lines 1-13; figs. 1 and 8), in the same field of endeavor, a base (collar 8) comprising a rim (annotated fig. 8), wherein the rim is supported above a wall of varying height (wall of retaining collar 8 which is oriented at an acute angle and therefore considered to have varying height, since at least one side of the wall has a shorter height than an opposite side of the wall, which appears to be consistent with para. [0106] and fig. 5b of the published application, fig. 8 of Heim) such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the base (fig. 8), for the purpose of alleviating excessive stress on the access wound and surrounding tissue, providing stability in certain applications where an artery, vein or body cavity is oriented more parallel to the skin surface (col. 8 lines 1-13).
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 rim of Buckman (as modified) to be supported above a wall of varying height such that the plane of the rim is inclined as claimed, in order to alleviate excessive stress on the access wound and surrounding tissue, and provide more stability for applications in which the body cavity being accessed is oriented more parallel to the skin surface, based on the suggestions and teachings of Heim (col. 8 lines 1-13).
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Annotated Figure 2 of Rosen
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Annotated Figure 8 of Heim
Regarding claim 3, Buckman (as modified) teaches the base of claim 1. Buckman further discloses wherein an underside of the plate is provided with adhesive means for securing the plate to the patient (adhesive region 64, paras. [0079]-[0080] and [0082]).
Regarding claim 5, Buckman (as modified) teaches the base of claim 1. Buckman further discloses further comprising an alignment indicator (pull tabs 72, para. [0079]) extending from the plate (fig. 5a) for assisting a user with placement of the plate external and adjacent or above the anatomical or an intercostal space (considered to assist a user in placement of patch 60 due to being used to hold chest tube 10 in place, therefore considered to be capable of being held by user for placement in correct position for chest tube 10, para. [0083]).
Regarding claim 7, Buckman (as modified) teaches the base of claim 1. Buckman (as modified) further teaches wherein the aperture is configured to be at an angle inclined to an axis perpendicular to the plane of the plate (combination further teaches penetration region of Buckman inclined relative to plate, col. 8 lines 1-13 of Heim).
Regarding claim 8, Buckman (as modified) teaches the base of claim 1. Buckman further discloses further comprising resilient side portions (straps 68 which may be formed of polyester, considered to be a resilient material as evidenced in para. [0049] of US 2004/0010280 A1 to Adams, describing polyester as a resilient material, para. [0079] of Buckman) extending in opposite directions from the plate (fig. 5a) for stabilising the plate from movement when applied to the patient (considered to be capable of stabilizing plate 66 due to user’s ability to pull on straps to assist in positioning and connection to chest tube 10, paras. [0079]-[0083]).
Regarding claim 2, Buckman discloses (abstract; paras. [0052]-[0083]; figs. 1-5b) an obturator assembly receiving base (66, para. [0079]) which, in use, receives an obturator assembly (receives chest tube 10 which includes obturator 24, para. [0052]) for the treatment of simple and/or tension pneumothorax (treats chest drainage, abstract), comprising a plate (66, para. [0079]; fig. 5a) for placement on a patient above an intercostal space (placed against patient, paras. [0065] and [0080]), the plate having an aperture (62, paras. [0079]-[0080]) configured to receive the obturator assembly (receives chest tube 10, paras. [0079]-[0083]).
However, Buckman fails to disclose the plate having the aperture which leads to a smooth-walled cavity passage, wherein the plate further comprises a threaded rim located about the aperture for receiving a valve assembly operable to seal the aperture, and wherein the rim is supported above a wall of varying height such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the plate.
Rosen teaches (col. 4 line 66-col. 5 line 10; figs. 2-7), in the same field of endeavor, a base (140) comprising a plate (flange 140 is a disk) having an aperture (centrally-located opening), the aperture leading to a smooth-walled cavity passage (wall of opening considered to have smooth portions corresponding to smooth portions of inserted device in between threaded portions, annotated fig. 2), wherein the plate further comprises a threaded rim (internal threading of opening) located about the aperture (considered to be located about the opening to match external threading of threaded portion 122) for receiving a valve assembly operable to seal the aperture (receives check valve 134 which prevents inflow/outflow of fluids, note the valve assembly is not positively recited and therefore not required by the claim limitations, col. 5 lines 10-15 of Rosen), for the purpose of adjusting the position of the flange along the tube to be closer to or farther from the distal end of the tube inserter (col. 4 line 66-col. 5 line 10).
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 penetration region of Buckman to include internal threading to match external threading on chest tube 10, in order to provide adjustability of the position of the chest tube within the penetration region 62 to adjust the position of the distal end of the chest tube 10 within the body, providing securement within the penetration region itself in addition to securement via hold down straps, based on the suggestions and teachings of Rosen (col. 4 line 66-col. 5 line 10).
Buckman (as modified) still fails to teach wherein the rim is supported above a wall of varying height such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the plate.
Heim teaches (col. 2 lines 46-58, col. 5 lines 13-15 and col. 8 lines 1-13; figs. 1 and 8), in the same field of endeavor, a base (collar 8) comprising a rim (annotated fig. 8), wherein the rim is supported above a wall of varying height (wall of retaining collar 8 which is oriented at an acute angle and therefore considered to have varying height, since at least one side of the wall has a shorter height than an opposite side of the wall, which appears to be consistent with para. [0106] and fig. 5b of the published application, fig. 8 of Heim) such that the plane of the rim is inclined relative to an axis perpendicular to the plane of the base (fig. 8), for the purpose of alleviating excessive stress on the access wound and surrounding tissue, providing stability in certain applications where an artery, vein or body cavity is oriented more parallel to the skin surface (col. 8 lines 1-13).
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 rim of Buckman (as modified) to be supported above a wall of varying height such that the plane of the rim is inclined as claimed, in order to alleviate excessive stress on the access wound and surrounding tissue, and provide more stability for applications in which the body cavity being accessed is oriented more parallel to the skin surface, based on the suggestions and teachings of Heim (col. 8 lines 1-13).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Buckman in view of Rosen and Heim as applied to claim 3 above, and further in view of Tanaka (US 2010/0204707 A1).
Regarding claim 4, Buckman (as modified) teaches the base of claim 3.
However, Buckman (as modified) fails to teach wherein the adhesive means is foam-backed adhesive.
Tanaka teaches (paras. [0197]-[0198]; figs. 12a-c), in the same field of endeavor, a base (1200) provided with adhesive means, wherein the adhesive means is a foam-backed adhesive (adhesive backing 1202 is a foam pad), for the purpose of allowing the pad to conform somewhat to the chest of the patient (para. [0198]).
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 adhesive region 64 of Buckman (as modified) to be a foam-backed adhesive, in order to allow the adhesive region to conform more readily to the chest of the patient, based upon the suggestions and teachings of Tanaka (para. [0198]).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Buckman in view of Rosen and Heim as applied to claim 1 above, and further in view of Skakoon (US 2002/0052610 A1).
Regarding claim 9, Buckman (as modified) teaches the base of claim 1.
However, Buckman (as modified) fails to teach further comprising an electrode embedded in the plate configured for outputting physiological data to an external monitoring device.
Skakoon teaches (paras. [0005]-[0007] and [0049]-[0052]; fig. 1), in the same field of endeavor, a base (104) comprising a plate (para. [0048]), and further comprising an electrode (100) embedded in the plate (received within groove 202 of base plate 104, considered to be embedded by being surrounded by plate 104, para. [0051]) configured for outputting physiological data to an external monitoring device (considered to be capable of outputting data, because electrode 100 may be used for electrical mapping, stimulation, ablation, and treatment of severe tremor, such that one of ordinary skill would’ve understood electrode 100 to be configured for outputting data, paras. [0007] and [0050]), for the purpose of allowing imaging and treatment of severe disorders via electrical stimulation (paras. [0007] and [0050]).
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 plate of Buckman (as modified) to include an electrode, in order to allow imaging and treatment of severe disorders via electrical stimulation when desired, based on the suggestions and teachings of Skakoon (paras. [0007] and [0050]).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771