DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Final Office Action is in Reply to the arguments/amendment (hereinafter “Response”) dated 03/26/2026. Claim(s) 1-21 are presently pending. Claim(s) 1, 11, 13, and 16 is/are amended.
Response to Amendment
The rejection of claim(s) 1-5, 9, 11-13, and 16-19 under 35 U.S.C. 102(a)(1) as being anticipated by Hasted (U.S. Pat. Pub. No. 2010/0152665 A1), of claim(s) 6 and 20 under 35 U.S.C. 103 as being unpatentable over Hasted in view of Lampropoulos (U.S. Pat. No. 10638964), of claim(s) 8, 10, and 15 under 35 U.S.C. 103 as being unpatentable over Hasted, and of claim 21 under 35 U.S.C. 103 as being unpatentable over Hasted in view of Balceta (U.S. Pat. No. 6093173 A1) is/are withdrawn in light of the submitted amendment to the claims and in view of applicant(s) arguments, which are respectfully considered persuasive. However, new grounds of rejection (necessitated by applicant(s) amendment introducing newly claimed subject matter) are presented in regards claims 1, 8-9, 11, and 15, whereupon Shah (U.S. Pat. Pub. No. 2016/0367332 A1) alone or as modified by Dutch Technology (NPL, “Dilators and Introducer Sheaths”) or Marble (U.S. Pat. No. 8,591,471 B1) teaches the claimed subject matter of these claims, including the newly claimed subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "a button of the buttons" in lines 4-5. There is insufficient antecedent basis for the limitation “the buttons” in the claim, since a set of buttons is not introduced in claim 13, nor in claim 11, upon which claim 13 depends. It is thus unclear whether the “the buttons” of claim 13 refers to a structure of the sheath-and-stabilizer assembly, or some other structure, thereby rendering the claim indefinite. Appropriate clarification is required. Claim 14 is also rendered indefinite by virtue of being dependent upon claim 13.
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)(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.
Claim(s) 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shah (U.S. Pat. Pub. No. 2016/0367332 A1).
Regarding claim 1, Shah discloses a sheath stabilizer (device 1), comprising: a housing (adjustment mechanism 40) including: a sheath passageway (passageway 43 formed within spherical body 41 of adjustment mechanism 40) longitudinally extending through the housing, the sheath passageway extending entirely through the sheath stabilizer (see Fig. 1-6 and [0040-0042]); and a base (base 10) having a patient contact surface (feet 18, comprising patient contacting under-foot surfaces 15) oblique to the sheath passageway (see Fig. 1-6 and [0041-0043], wherein the housing/adjustment mechanism 40 may be oriented obliquely to the feet 18 of base 10 within a range of angles varying from nearly perpendicular, as shown in Fig. 4 and 6, to nearly parallel, as shown in Fig. 1-3 and 5, in order to facilitate percutaneous access at a wide range of angles); a clamp (securement mechanism 70) in a proximal-end portion of the housing around the sheath passageway (see Fig. 1 and 11-18, and [0044-0070], wherein the clamp/securement mechanism 70 is externally mounted to the collar portion 42 of the housing 40 to thereby form part of – i.e. be included in – the proximal-end portion of the housing); and an adhesive pad (under-foot surfaces 15 being coated with an adhesive layer - see [0038] and [0043], ln 20-27) disposed on the base configured for adhering the sheath stabilizer to at least a patient's skin ([0038] and [0043], ln 20-27).
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) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shah.
Regarding claim 11, Shah discloses a sheath stabilizer (device 1) including: a housing (adjustment mechanism 40) including a sheath passageway (passageway 43 formed within spherical body 41 of adjustment mechanism 40) longitudinally extending through the housing (see Fig. 1-6 and [0040-0042]) and a base (base 10) oblique to the sheath passageway (see Fig. 1-6 and [0041-0043], wherein the housing/adjustment mechanism 40 may be oriented obliquely to the feet 18 of base 10 within a range of angles varying from nearly perpendicular, as shown in Fig. 4 and 6, to nearly parallel, as shown in Fig. 1-3 and 5, in order to facilitate percutaneous access at a wide range of angles); a clamp (securement mechanism 70) in a proximal-end portion of the housing around the sheath passageway (see Fig. 1 and 11-18, and [0044-0070]), the clamp including laterally displaceable opposing clamp pieces (C-shaped notches/jaws 74 and 75 in the plug 72 and shell 71 respectively) biased toward each other (see Fig. 11 and [0044], ln 1-30); and an adhesive pad (under-foot surfaces 15 being coated with an adhesive layer - see [0038] and [0043], ln 20-27) disposed on the base configured for adhering the sheath stabilizer to at least a patient's skin ([0038] and [0043], ln 20-27). Shah further teaches that the sheath stabilizer is intended to be used in combination with percutaneous access devices, including a catheter/sheath configured for percutaneous access, as part of a sheath-and-stabilizer assembly ([0014] and [0035]). It would thus have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to utilize the sheath stabilizer of Shah as part of a sheath-and-stabilizer assembly including a sheath configured for percutaneous access, as suggested by Shah.
Claim(s) 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Dutch Technology (NPL, “Dilators and Introducer Sheaths”).
Regarding claim 8, Shah discloses the sheath stabilizer of claim 1. While Shah teaches that the sheath stabilizer may accommodate access devices (including catheters/sheaths – see [0014]) of different sizes and diameters ([0036]), Shah fails to explicitly teach that the sheath passageway is configured to accept up to a 16-Fr sheath inserted therein. Yet, it is well known within the art that sheaths configured for percutaneous access – i.e. of the kind suggested by Shah – are typically configured with diameters of up to 16-Fr. Dutch Technology, for example, describes introducer sheaths for percutaneous access of the type suggested by Shah (pg. 1, ln 1-2 and pg. 2, ln 6-16), and teaches that such introducer sheaths are produced in an extensive range of diameters (gauge sizes), such as ranging from 4 Fr to 16 Fr (pg. 2, ln 6-7 and ln 15-16). Thus, based on the teachings and example of Dutch Technology, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the sheath passageway of Shah to accept up to a 16-Fr sheath inserted therein, this range being standard within the art for sheaths for percutaneous access.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Marble (U.S. Pat. No. 8,591,471 B1).
Regarding claim 9, Shah discloses the sheath stabilizer of claim 1. While Shah fails to explicitly teach that the adhesive pad includes a ready-to-peel backing thereon configured to expose an adhesive when the backing is peeled off the adhesive pad, such a configuration is well-known within the art. For example, Marble exhibits a percutaneous catheter assembly (catheter assembly 10) configured with an adhesive pad (adhesive flexible pad 20) for removably attaching the assembly to a patient’s skin (see Fig. 3-6, Col. 1, ln 15-29, and Col. 7, ln 49-55) in the same manner as in Shah, and teaches that such an adhesive pad may include a ready-to-peel backing (peelable sheet material 28) thereon configured to expose an adhesive when the backing is peeled off the adhesive pad (see Fig. 3-6, Col. 1, ln 15-29, Col. 6, ln 9-46, and Col. 7, ln 63 – Col. 8, ln 23). Marble further teaches that such a configuration beneficially allows for efficient, one-hand attachment of the adhesive pad to the patient (Col. 1, ln 15-29 and Col. 7, ln 64 – Col. 8, ln 2). Thus, based on the teachings and example of Marble, and since such a configuration is common knowledge within the art, 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 pad of Shah to include a ready-to-peel backing thereon configured to expose an adhesive when the backing is peeled off the adhesive pad, in a similar manner to that of Marble, thereby beneficially allowing for efficient, one-hand attachment of the adhesive pad (and thus the sheath stabilizer) to the patient, as described by Marble.
Allowable Subject Matter
Claim(s) 16-21 are allowed.
The following is an examiner’s statement of reasons for allowance:
The prior art cited in this office action and any prior office actions represents the closest art to the claimed invention as found by the examiner. Regarding the above cited claims, none of these references teach or suggest the claimed invention as a whole, and it would not have been obvious to one of ordinary skill in the art at the time of filing to combine teachings from these references to obtain the claimed invention. In support of this finding, a comparison of the present claim limitations to the closest prior art is presented below.
Regarding claim 16, the amended claim now recites the limitation “opening a clamp of the sheath stabilizer by pressing a pair of opposing buttons toward each other, the buttons disposed in buttonholes in a proximal-end portion of a housing of the sheath stabilizer, wherein pressing the pair of opposing buttons displaces opposing clamp pieces of the clamp away from each other”, which alongside the remainder of the claim renders the claim patentably distinct over the prior art. While Shah teaches a sheath stabilizer similar to that claimed, with spring-loaded laterally displaceable opposing clamp pieces biased towards each other (see in re claim 11), Shah fails to teach or suggest that such clamp pieces may be actuated by a pair of opposing buttons in the manner claimed. A review of the prior art within the field of sheath/catheter stabilizers and other tubing securement fields revealed no references which remedied this shortcoming in Shah or anticipated the claimed configuration. Since the cited references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation, it is thus concluded that this claim and all dependent claims is patentably distinct over prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim(s) 2-7, 10, and 12 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art cited in this office action and any prior office actions represents the closest art to the claimed invention as found by the examiner. Regarding the above cited claims, none of these references teach or suggest the claimed invention as a whole, and it would not have been obvious to one of ordinary skill in the art at the time of filing to combine teachings from these references to obtain the claimed invention. In support of this finding, a comparison of the present claim limitations to the closest prior art is presented below.
Regarding claim 2, the claim recites the limitation “the clamp includes a pair of opposing buttons disposed in buttonholes of the housing, the buttons configured to open the clamp when the buttons are pressed into the housing toward each other,” which alongside the remainder of the claim and any intervening claims renders the claim patentably distinct over the prior art. While Shah teaches a sheath stabilizer similar to that claimed, with spring-loaded laterally displaceable opposing clamp pieces biased towards each other (see in re claim 11), Shah fails to teach or suggest that such clamp pieces may be actuated by a pair of opposing buttons in the manner claimed. A review of the prior art within the field of sheath/catheter stabilizers and other tubing securement fields revealed no references which remedied this shortcoming in Shah or anticipated the claimed configuration. Since the cited references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation, it is thus concluded that this claim and all dependent claims is patentably distinct over prior art.
Regarding claim 10, the claim recites the limitation “the housing includes molded mirrored-imaged halves of the housing pressed or adhered together over the clamp,” which alongside the remainder of the claim and any intervening claims renders the claim patentably distinct over the prior art. Here, the manner in which the sheath stabilizer assembly of Shah is constructed does not allow for the housing to be assembled “over the clamp”, the clamp being externally mounted to the collar portion 42 of the housing to thereby form part of (be included in the) proximal-end portion of the housing. A review of the prior art within the field of sheath/catheter stabilizers and other tubing securement fields revealed no references which remedied this shortcoming in Shah or anticipated the claimed configuration. Since the cited references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation, it is thus concluded that this claim and all dependent claims is patentably distinct over prior art.
Regarding claim 12, the claim recites the limitation “the clamp includes a pair of opposing buttons disposed in buttonholes of the housing, the buttons configured to open the clamp when the buttons are pressed into the housing toward each other and close the clamp when the buttons are released and allowed to move away from each other,” which alongside the remainder of the claim and any intervening claims renders the claim patentably distinct over the prior art. While Shah teaches a sheath stabilizer similar to that claimed, with spring-loaded laterally displaceable opposing clamp pieces biased towards each other (see in re claim 11), Shah fails to teach or suggest that such clamp pieces may be actuated by a pair of opposing buttons in the manner claimed. A review of the prior art within the field of sheath/catheter stabilizers and other tubing securement fields revealed no references which remedied this shortcoming in Shah or anticipated the claimed configuration. Since the cited references represent the closest prior art to the claimed configuration, and since no other reference was found by the examiner which discloses or teaches this limitation, it is thus concluded that this claim and all dependent claims is patentably distinct over prior art.
While no rejections over the prior art are presently presented for claims 13-14, any indication of allowability regarding these claims is reserved until the respective rejections under 35 U.S.C. 112(b) are overcome.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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