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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/16/2026 has been entered.
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 07/16/2026. 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 07/16/2026, 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 and are persuasive, in combination with the amendments to the claims; specifically, Rosen does not teach an unthreaded cavity passage. Therefore, the rejection has been withdrawn. However, upon further consideration, a new rejection is made in view of Buckman in view of Matthews and Heim as discussed below.
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) (previously of record) in view of Matthews (US 3253594) and Heim (US 5807341) (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, unthreaded, 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.
Matthews teaches (col. 2 line 21-col 5 line 43; figs. 1-4), in the same field of endeavor, an insertion device receiving base (includes flange portion 40, col. 3 lines 53-65) comprising a plate (40) having an aperture (central opening, see figs. 2 and 4), the aperture leading to a smooth-walled, unthreaded, cavity passage (see fig. 2 depicting the central opening of 40 being unthreaded), wherein the plate further comprises a threaded rim (neck 44 including exterior threads 46, col. 3 lines 65-73) located about the aperture (depicted in figs. 2 and 4) for receiving a valve assembly operable to seal the aperture (receives cap 48 which secures O-ring 54, considered to seal the aperture, further note the valve assembly is not positively recited and therefore not required by the claim limitations, col. 4 lines 40-75; fig. 2), for the purpose of maintaining tubular member 12 firmly in place and providing a holding and constriction assembly that may be moved axially along the cannula to exert pressure against the flesh (col. 4 lines 18-55).
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 to include a threaded rim leading to an unthreaded cavity passage as claimed, in order to maintain the chest tube firmly in place and provide a holding and constriction assembly that may be moved axially along the chest tube then locked in a position in which the plate exerts pressure against the flesh, based on the teachings of Matthews (col. 4 lines 18-55). It is noted para. [0081] of Buckman describes adhesive region 70 of chest tube 10 being fastened to the chest tube to prevent the chest tube from being dislodged from the patient, however, the chest tube is still capable of undesirably moving within the aperture of the plate, such that the combination is considered to further provide a more stable position of the chest tube within the aperture itself.
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 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, unthreaded, 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.
Matthews teaches (col. 2 line 21-col 5 line 43; figs. 1-4), in the same field of endeavor, an insertion device receiving base (includes flange portion 40, col. 3 lines 53-65) comprising a plate (40) having an aperture (central opening, see figs. 2 and 4), the aperture leading to a smooth-walled, unthreaded, cavity passage (see fig. 2 depicting the central opening of 40 being unthreaded), wherein the plate further comprises a threaded rim (neck 44 including exterior threads 46, col. 3 lines 65-73) located about the aperture (depicted in figs. 2 and 4) for receiving a valve assembly operable to seal the aperture (receives cap 48 which secures O-ring 54, considered to seal the aperture, further note the valve assembly is not positively recited and therefore not required by the claim limitations, col. 4 lines 40-75; fig. 2), for the purpose of maintaining tubular member 12 firmly in place and providing a holding and constriction assembly that may be moved axially along the cannula to exert pressure against the flesh (col. 4 lines 18-55).
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 to include a threaded rim leading to an unthreaded cavity passage as claimed, in order to maintain the chest tube firmly in place and provide a holding and constriction assembly that may be moved axially along the chest tube then locked in a position in which the plate exerts pressure against the flesh, based on the teachings of Matthews (col. 4 lines 18-55). It is noted para. [0081] of Buckman describes adhesive region 70 of chest tube 10 being fastened to the chest tube to prevent the chest tube from being dislodged from the patient, however, the chest tube is still capable of undesirably moving within the aperture of the plate, such that the combination is considered to further provide a more stable position of the chest tube within the aperture itself.
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 Matthews and Heim as applied to claim 3 above, and further in view of Tanaka (US 2010/0204707 A1) (previously of record).
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 Matthews and Heim as applied to claim 1 above, and further in view of Skakoon (US 2002/0052610 A1) (previously of record).
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
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
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