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 .
Claim Objections
Claims 1-16 are objected to because of the following informalities: claim 1 recites “frame having including a plurality” in which only one of “having” or “including” is needed. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is 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.
Regarding claim 9, the term “substantially flat” is a term of degree with an unclear scope. Essentially, it is unclear what shapes are or are not substantially flat. The examiner will interpret this limitation as requiring a width greater than a height and/or at least one planar surface.
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.
Claim(s) 1, 3-4-6, 9-10 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2009/0192467 to Hansen et al. (Hansen hereinafter).
Regarding claim 1, Hansen teaches a catheter retention device (see Fig. 5e) comprising: an expandable support frame (1, 2, 4, 6) having including a plurality of members, the plurality of members including a base member (1), an upper member (4) and a plurality of middle members (6) disposed between the base member and the upper member, the expandable support frame configured to linearly extend (as illustrated in Figs. 3a-3d) to an expanded state (as shown in Figs. 1 and 5e) from a collapsed state (as in Fig. 3a) with respect to the base member so that the plurality of middle members and the upper member are disposed above the base member when in the expanded state; a retention member (3 or inner circumference of 4) disposed on the upper member, the retention member configured to securely hold and surround a medical article (5); and an anchor member disposed on the base member, the anchor member including an adhesive layer (see paragraph 78) disposed on a bottom face of the anchor member.
Regarding claim 3, Hansen teaches a circular cross section when viewed from above, which is equivalent to two opposed U-shapes. The examiner notes that this limitation is not tied to any insertion functionality.
Regarding claim 4, Hansen teaches concentric rings (6) with differing diameters.
Regarding claim 5, Hansen teaches that the base member is larger in diameter than the upper member and middle members.
Regarding claim 6. Hansen teaches that the upper member has a smaller diameter than the middle and lower members.
Regarding claim 9, as best understood by the examiner, Hansen teaches a substantially flat collapsed state.
Regarding claim 10, Hansen teaches a circular cross section viewed from above, which is equivalent to two opposed U-shapes. The examiner notes that this limitation is not tied to any insertion functionality.
Regarding claim 15, Hansen teaches that the device may be a catheter. Paracentesis constitutes an intended use which does not confer any particular structure on the claimed invention and as such the examiner holds that Hansen anticipates claim 11.
Regarding claim 16, Hansen teaches removably applied adhesive (paragraph 78).
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) 7-8 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of US Pre-Grant Publication 2023/0218864 to Walter-Engelsma (Walter-Engelsma).
Regarding claim 7, Hansen teaches the limitations of claim 1 as discussed above, but does not teach a separate opening of the frame corresponding to the opening of the retention member. Walter-Engelsma teaches another catheter securement device generally, and particularly teaches a separate retention member (83) within a corresponding aperture (87) of a support frame (80). Walter-Engelsma teaches that this provides a height adjustment capability (paragraph 86). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a retention member as taught by Walter-Engelsma to the securement of Hansen in order to provide further support and height adjustment therein.
Regarding claim 11, Walter-Engelsma teaches a body (83) having an aperture (92) forming a U-shape to receive the medical article therein (see Fig. 2). Walter-Engelsma further teaches a spring hinge (activated by 24) and a fastener member (87) surrounding an outer surface and the opening of the body.
Regarding claim 12, Walter-Engelsma teaches a locking member (86).
Regarding claim 13, Walter-Engelsma teaches that the locking member secures the position of the fastener member (see e.g. Fig. 5a).
Regarding claim 14, Walter-Engelsma teaches a friction member (89).
Allowable Subject Matter
Claim 2 is 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 limitations of a wireframe configured as in claim 2 are not shown in or fairly suggested by the prior art of record in combination with the remaining limitations of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 3,166,819 teaches a wireframe (16) securing a catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 22 September 2026
Prosecution Insights