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 .
Election/Restrictions
Claims 4-7, 9, 29 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/17/2026.
Applicant's election with traverse of Species V (Figs. 19A-19F) in the reply filed on 08/17/2026 is acknowledged. The traversal is on the grounds that “a medical article securement device comprising a medical article engaging member comprising a base defining at least one medical article engaging portion configured to receive a medical article, and a securing arrangement for reversibly securing the medical article to the base, the securing arrangement defining an open configuration and a closed configuration” does not constitute a special technical feature in view of Peterson et al. (USPGPub 2014/0066856). In support of this argument, applicant argues the special technical feature should include a locking mechanism “configured to allow rotation of the base of the medical article engaging member relative to the body engaging member about a rotational axis of the base when the securing arrangement is in the open configuration;” and the locking mechanism “configured to prevent rotation of the base of the medical article engaging member relative to the body engaging member about the rotational axis of the base when the securing arrangement is in the closed configuration.”
Examiner respectfully disagrees for the following reasons. First, what applicant insists is the special technical feature in the eight embodiments of the present case is the entirety of Claim 1. It hardly seems possible that the special technical feature would be the entirety of applicant’s sole independent claim. Secondly, rotation of the medical article engaging member relative to the body engaging member differs among embodiments in the present case. For instance, the rotational axis of the base in the embodiment of Species I and II occurs perpendicular to the base whereas the rotational axis of the base in Species V occurs perpendicular to the base or parallel to the base (wherein the medical article engaging member 1650 pivots with posts 1669 in relation to body engaging member 1648 - ¶ 0236). Because the manner in which rotation occurs is not shared among all species of the present case, it cannot be said to be a special technical feature upon which the species are linked as a single general inventive concept.
Finally, all of the species of the present case do not comprise a locking mechanism “configured to prevent rotation of the base of the medical article engaging member relative to the body engaging member about the rotational axis of the base when the securing arrangement is in the closed configuration.” For instance, the securing arrangement of Species V does not comprise an open or closed arrangement upon which a medical device is secured. The open and closed arrangement of the securing arrangement in Species V operates independently of securing a medical device and in no way acts to secure a medical device therein.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1650” has been used to designate both the medical article engaging member and the base (See ¶ 0232-0244). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: Line 1 reading “to-claim” should read –to claim--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 1 reading “to-claim” should read –to claim--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Line 1 reading “to-claim” should read –to claim--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Line 3 reading “the distance” should read –a distance--. 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.
Claims 1-3, 12, 14, 16-18, 20 and 30-32 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. Applicant has elected Species V in the present case, directed to Figs. 19A-19F. Claim 1 recites the limitation “a securing arrangement for reversibly securing the medical article to the base” in Lines 5-6. However, in Species V of Figs. 19A-19F, the securing arrangement 1630 has no part in securing a medical article to the base of the medical article engaging member 1650. Applicant has elected an embodiment that is not compatible with the limitations of Claim 1. For purposes of examination, examiner will examine Claim 1 without the aforementioned limitation. Appropriate correction and/or clarification is required.
Claim 20 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. Claim 20 recites the limitation "the locking member" in Line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction and/or clarification is required.
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.
Claims 1-3, 12, 16-18, 30 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beran (USPGPub 2016/0243339).
Re Claim 1, Beran teaches a medical article securement device (70) (Beran Fig. 8), the medical device (70) comprising: a medical article engaging member (54) comprising: a base defining at least one medical article engaging portion (formed by engagement of brackets 56, 56’ with tabs 58, 58’) configured to receive a medical article (Beran ¶ 0034); and a securing arrangement (56, 58), the securing arrangement (56, 58) defining an open configuration and a closed configuration; a body engaging member (30) configured to affix the medical article securement device to a body part of a human or animal (Beran ¶ 0034); and a locking mechanism (62, 72) comprising a locking element (74) disposed between the base of the medical article engaging member (54) and the body engaging member (30) (as seen in Beran Fig. 8), the locking mechanism (62, 72) being operatively coupled to the base of the medical article engaging member (54) and to the securing arrangement (56, 58), wherein the securing arrangement (56, 58) is connected to the locking element (74) (Beran Fig. 8); wherein the locking mechanism (62, 72) is configured to allow rotation of the base of the medical article engaging member relative to the body engaging member about a rotational axis (R) of the base when the securing arrangement (56, 58) of the medical article engaging member (54) is in the open configuration, and wherein the locking mechanism (62, 72) is configured to prevent rotation of the base of the medical article engaging member (54) relative to the body engaging member (30) about the rotational axis (R) of the base when the securing arrangement (56, 58) of the medical article engaging member (54) is in the closed configuration (Beran ¶ 0034).
Re Claim 2, Beran teaches wherein the securing arrangement is a quick-release/quick-set securing arrangement, and/or wherein the securing arrangement is a non-screw fastening securing arrangement (Beran ¶ 0034).
Re Claim 3, Beran teaches wherein the securing arrangement (56, 58) of the medical article engaging member (54) defines a longitudinal axis (L) and wherein the longitudinal axis (L) of the securing arrangement is substantially perpendicular to the rotational axis (R) of the base when the securing arrangement of the medical article engaging member (54) is in the closed configuration (as seen in Beran Fig. 8).
Re Claim 12, Beran teaches wherein the body engaging member (30) comprises a flexible material and a reinforced segment or insert (52) resistant to stretching (Beran ¶ 0030, 0033).
Re Claim 16, Beran teaches wherein the medical article engaging portion (formed by engagement of brackets 56, 56’ with tabs 58, 58’) comprises a channel, or a snap fit mechanism configured to engage a portion of the medical article and prevent longitudinal displacement of the medical article with respect to the base (as seen in Beran Fig. 8).
Re Claim 17, Beran teaches wherein the locking mechanism (62, 72) comprises a first lock component (62) and a second lock component (72), and wherein the distance between the first lock component (62) and the second lock component (72) is greater when the securing arrangement is in the open configuration than when the securing arrangement is in the closed configuration (Beran ¶ 0034; Fig. 8).
Re Claim 18, Beran wherein the locking mechanism (62, 72) comprises a series of teeth in the first lock component (62) and a corresponding series of teeth on the second lock component (72) (Beran ¶ 0034-0035; Fig. 8).
Re Claim 30, Beran teaches wherein the locking element (74) comprises a second lock component (72), configured to engage with a first lock component (62) disposed on the base or on the body engaging member when the securing arrangement is in the closed configuration and not to engage with the first lock component (62) when the securing arrangement is in the open configuration (Beran ¶ 0034-0035; Fig. 8).
Re Claim 32, Beran teaches wherein the locking element (74) has two posts (58, 58’) which engage the base of the medical article engaging member (54) and act as pivot points about which the locking element is allowed to pivot when moving from the open configuration to the closed configuration (Beran ¶ 0034-0035; Fig. 8).
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 31 is rejected under 35 U.S.C. 103 as being unpatentable over Beran (USPGPub 2016/0243339) in view of Smith et al. (USPGPub 2021/0023342).
Re Claim 31, Beran teaches all of the limitations of Claim 1. However, Beran fails to teach wherein the base of the medical article engaging member is snap fitted on the base or insert of the body engaging member between raised annular lips. Smith teaches a medical article securement device (104) (Smith Figs. 1 and 3), comprising a medical article engaging member (112) and a body engaging member (114), wherein a base of the medical article engaging member (112) is snap fitted on the base or insert of the body engaging member (114) between raised annular lips for releasing the medical article engaging member and changing its location without having to also remove the body engaging member (Smith Fig. 3; ¶ 0042). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the base of the medical article engaging member of Beran to be snap fitted on the base or insert of the body engaging member between raised annular lips as disclosed by Smith for releasing the medical article engaging member and changing its location without having to also remove the body engaging member (Smith Fig. 3; ¶ 0042).
Allowable Subject Matter
Claim 14 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. In the present case, the prior art of record fails to teach wherein the base defines at least one aperture, slit or channel configured to receive the securing arrangement and allow movement of the securing arrangement along a longitudinal axis (L) of the securing arrangement through the at least one aperture, slit, or channel when the securing arrangement is in the open configuration. Examiner strongly recommends applicant contact examiner to discuss the present case, particularly steps in resolving drawing objections, indefinite rejections, and issues of rejoinder.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
