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 .
This action is in response to the Applicant’s amendment filed on March 13, 2026
Claims 1 and 8 are currently amended.
Claims 1-20 are being examined in this Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of
the invention specified in the claims. Therefore, the “monitoring system” and “grip lock” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to for the following reasons:
The background appears to be gray and pixilated. Figures should be on a white background in order to show a clear contrast.
The figures appear to be pixilated and blurry. All lines should be solid, dark, and continuous. See Figs. 7-9
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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, 2, 5, 7-9, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mench et al. (U.S. 10722662 B1, herein Mench).
Regarding Claim 1, Mench discloses a medical connection protector (Fig. 4A) for protecting a connection point (902B) of a first conveying device (line to the right of 902B in Fig. 9A) and a second conveying device (line to the left of 902B in Fig. 9A), comprising:
a first cover portion (402, Figs. 4A-4D) and a second cover portion (404), a combination of which forms an internal compartment configured to enclose a connection point of the first conveying device and the second conveying device (Col. 12 Lines 21-30), wherein the internal compartment encloses the connection point independently of engagement with structural features of the first or second conveying device (Fig. 9A-B, Col. 13 Lines 46-59);
a hinge coupled to a first side of each of the first and second cover portions, the hinge configured to enable the first cover portion and the second cover portion to be in an open or closed position (Fig. 4A, Col. 12 Lines 21-30),
two openings (416) formed on both ends of the first and second cover portions (Fig. 4A), allowing the first and second conveying devices to pass respectively therethrough (Col. 13 Lines 56-59); and
a first tamper-proof locking assembly (408, 412, Col. 12 Line 65 through Col. 13 Line 2) attached to a second side of each of the first (412 on second side of 402) and second cover portions (408 on second side of 404), the first tamper-proof locking assembly configured to lock the first cover portion to the second cover portion (Col. 12 Lines 64-65).
Regarding Claim 2, Mench discloses the medical connection protector of claim 1, wherein the first tamper-proof locking assembly includes a first female component (412) attached to the second side of the first cover portion (402, Fig. 4A) and a first male component (408) attached to the second side of the second cover portion (404, Fig. 4A), the first female component and the first male component being configured to snap together in locked position (Col. 13 Lines 39-45).
Regarding Claim 5, Mench discloses the medical connection protector of claim 1, wherein the first tamper-proof locking assembly has a safety-lock, an engageable lock, or a releasable lock (Col. 13 Lines 18-30).
Regarding Claim 7, Mench discloses the medical connection protector of claim 1, wherein the hinge is a mechanical hinge attached to the first sides of the first and second cover portions (Fig. 4A, Col. 12 Lines 21-30).
Regarding Claim 8, Mench discloses the medical connection protector of claim 1, wherein the openings have a diameter smaller than an outer dimension of the connection point such that the connection point is retained within the internal compartment when the first and second cover portions are closed (902B retained within clamping box due to outer dimension being larger than blood vessel line opening 918 in Fig. 9A).
Regarding Claim 9, Mench discloses the medical connection protector of claim 1, further comprising color coding provided on the first cover portion indicating a type of conveying device (Col. 27 Lines 16-25).
Regarding Claim 16, Mench discloses the medical connection protector of claim 1, further comprising a visual access formed on the first cover portion, allowing the connection point of the first and second conveying devices to be visually accessed from external the medical connection protector (Col. 2 Lines 51-54).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 3, 4, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Lyons et al. (Pub. No. US 20100210990 A1, herein Lyons).
Regarding Claim 3, Mench discloses the medical connection protector of claim 2.
Mench does not expressly disclose further comprising a second tamper-proof locking assembly that includes a second female component attached to the second side of the first cover portion and a second male component attached to the second side of the second cover portion, the second female component and the second male component configured to snap together in locked position.
Lyons teaches a second tamper-proof locking assembly (32a, 32b) that includes a second female component (32b, see annotated Fig. 2 below) and a second male component (32a, annotated Fig. 2), the second female component and the second male component configured to snap together in locked position (Paragraph [0009]).
It would have been obvious to one of ordinary skill within the art at the time of the
invention to move a second female component so that it is attached to the second side of the
first cover portion and a second male component so that it is attached to the second side of the second cover portion, since rearranging parts of invention involves only routine skill within the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The motivation being that a user would be able to manually disengage the male and female elements in one respective direction (Lyons, Paragraph [0009]).
Therefore, 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 medical connection protector disclosed by Mench further comprising a second tamper-proof locking assembly that includes a second female component attached to the second side of the first cover portion and a second male component attached to the second side of the second cover portion, the second female component and the second male component configured to snap together in locked position as taught by Lyons so that a user would be able to manually disengage the male and female elements in one respective direction (Lyons, Paragraph [0009]).
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Regarding Claim 4, Mench discloses the medical connection protector of claim 2.
Mench does not expressly disclose further comprising a second tamper-proof locking assembly that includes a second female component attached to the second side of the second cover portion and a second male component attached to the second side of the first cover portion, the second female component and the second male component configured to snap together in locked position.
Lyons teaches further comprising a second tamper-proof locking assembly (32a, 32b, annotated Fig. 2) that includes a second female component attached to the second side of the second cover portion (32b, annotated Fig. 2) and a second male component attached to the second side of the first cover portion (32a, annotated Fig. 2), the second female component and the second male component configured to snap together in locked position (Paragraph [0009]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical connection protector disclosed by Mench further comprising a second tamper-proof locking assembly that includes a second female component attached to the second side of the second cover portion and a second male component attached to the second side of the first cover portion, the second female component and the second male component configured to snap together in locked position as taught by Lyons so that the medical connection protector is properly locked (Lyons, Paragraph [0044]).
Regarding Claim 10, Mench discloses the medical connection protector of claim 1.
Mech does not expressly disclose further comprising an inner core received in the internal compartment, the inner core configured to accommodate the connection point of the first and second conveying devices.
Lyons teaches further comprising an inner core (123a-b) received in the internal compartment (Fig. 6), the inner core configured to accommodate the connection point of the first and second conveying devices (Paragraph [0052]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical connection protector disclosed by Mench further comprising an inner core received in the internal compartment, the inner core configured to accommodate the connection point of the first and second conveying devices as taught be Lyons so that the inner core seals to the connection point (Lyons, Paragraph [0051]).
Regarding Claim 11, modified Mench in view of Lyons discloses the medical connection protector of claim 10, wherein the inner core has a same configuration of a shape of the connection point of the first and second conveying devices (Lyons, Fig. 6, Paragraph [0051]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical connection protector disclosed by Mench wherein the inner core has a same configuration of a shape of the connection point of the first and second conveying devices as taught by Lyons so that the inner core may properly seal to the connection point (Lyons, Paragraph [0055]).
Regarding Claim 12, modified Mench in view of Lyons discloses the medical connection protector of claim 10, wherein the inner core is a rigid inner core (Lyons, Paragraph [0011]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical connection protector disclosed by Mench wherein the inner core is a rigid inner core as taught by Lyons so that the core is suitable for contact with medical fluids (Lyons, Paragraph [0011]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Christie et al. (US 10518076 B2, herein Christie).
Regarding Claim 6, Mench discloses the medical connection protector of claim 1.
Mench does not expressly disclose wherein the hinge is a living hinge integrated with the first sides of the first and second cover portions.
Christie teaches wherein the hinge is a living hinge integrated with the first sides of the first and second cover portions (Col. 2 Lines 4-7).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench so that the hinge is a living hinge integrated with the first sides of the first and second cover portions as taught by Christie so that the enclosing compartments may be made of a single continuous material (Christie, Col. 11 Lines 53-56).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Smith (Pub. No. US 20200222680 A1)..
Regarding Claim 13, Mench discloses the medical connection protector of claim 1.
Mench does not expressly disclose further comprising a monitoring system configured to monitor a state of the tamper-proof locking assembly and/or the first and second cover portions and transmit a signal based on the state.
Smith teaches further comprising a monitoring system (“the device includes an information portion, either as part of the body of the device or as a part of a tag, which provides information to a user about instructions and notices relevant to the medical tube.” – Paragraph [0007]) configured to monitor a state of the tamper-proof locking assembly (“The instructions and notices can include information relevant to a medical tube's insertion date, medical tube's expected removal date, medical tube's expected replacement date, medical tube's operational instructions, patient treatment protocol, doctor's contact information, a location of a patient chart, evidence of tampering or manipulation of the device or medical tube, or a combination thereof.” – Paragraph [0007]) and/or the first and second cover portions and transmit a signal based on the state (“via signal technology (e.g., wireless link, radiofrequency, telemetry, other electromagnetic techniques, or an on-device memory module), or any combinations thereof.” Paragraph [0007]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench so that the medical connection protector comprises a monitoring system configured to monitor a state of the tamper-proof locking assembly and/or the first and second cover portions and transmit a signal based on the state as taught by Smith so that providers are able to access information relevant to the device (Smith, Paragraph [0007]).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Peters et al. (US 6217564 B1, herein Peters).
Regarding Claim 14, Mench discloses the medical connection protector of claim 1.
Mench does not expressly disclose further comprising a fence closure disposed in the internal compartment, the fence closure configured to enclose the first conveying device and prevent the first conveying device from disconnection with the second conveying device.
Peters teaches further comprising a fence closure (90, Fig. 24) disposed in the internal compartment (Fig. 24), the fence closure configured to enclose the first conveying device and prevent the first conveying device from disconnection with the second conveying device (Col. 7 Lines 14-16).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench so that the medical connection protector further comprises a fence closure disposed in the internal compartment, the fence closure configured to enclose the first conveying device and prevent the first conveying device from disconnection with the second conveying device as taught by Peters so that the conveying device is secured around the entry (Peters, Col. 7 Lines 14-16).
Regarding Claim 15, modified Mench in view of Peters discloses the medical connection protector of claim 14, wherein the fence closure includes two walls installed on the first and second cover portions, respectively (Peters, 90, Fig. 24), the two walls overlapping when the first and second cover portions is in the closed position (Peters, Col. 7 Lines 14-16).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench wherein the fence closure includes two walls installed on the first and second cover portions, respectively, the two walls overlapping when the first and second cover portions is in the closed position as taught by Peters so that the conveying device is secured around the entry (Peters, Col. 7 Lines 14-16).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of O'Neil (Pub. No. US 20190217076 A1).
Regarding Claim 17, Mench discloses the medical connection protector of claim 1.
Mench does not expressly disclose wherein the first cover portion is made of a transparent material.
O’Neil teaches wherein the first cover portion is made of a transparent material (Paragraph [0027]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench wherein the first cover portion is made of a transparent material as taught by O’Neil so that providers may have visual access to the connector status during use (O’Neil. Paragraph [0027]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Werth (Pub. No. US 20090208277 A1)..
Regarding Claim 18, Mench discloses the medical connection protector of claim 1.
Mench does not expressly disclose wherein the medical connection protector is made of a biocompatible and/or antimicrobial material.
Werth teaches wherein the medical connection protector is made of a biocompatible material (“The sanitary clamp 10… can be made of a high molecular weight thermoplastic polymer such as a polyvinylidene difluoride (PVDF) polymer” – Paragraph [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench so that the medical connection protector is made of a biocompatible material as taught by Werth to provide a cost-effective medical connection protector (Werth, Paragraph [0006]).
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Bailey et al. (Pub. No. US 20170326339 A1, herein Bailey).
Regarding Claim 19, Mench discloses a medical securement system comprising the medical connection protector of claim 1.
Mench does not expressly disclose at least one securing patch, the at least one securing patch configured to secure the medical connection protector and/or the first conveying device to an object.
Bailey teaches at least one securing patch, the at least one securing patch (9, Fig. 1B) configured to secure the medical connection protector and/or the first conveying device to an object (“The junction can include a circumferentially recessed portion about an outer diameter of the junction configured to interlock with a securement device to inhibit movement of the junction when the PICC is inserted in a pediatric patient such as a neonatal patient.” – Paragraph [0003]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Mench so that the medical securement system comprises at least one securing patch, the at least one securing patch configured to secure the medical connection protector and/or the first conveying device to an object as taught by Bailey so that movement of the device is limited when secured with the securement device (Bailey, Paragraph [0003]).
Regarding Claim 20, Modified Mench in view of Bailey discloses the medical securement system of claim 19, wherein the securing patch is a stat lock (Bailey, Paragraph [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the medical connection protector disclosed by Lyons wherein the securing patch is a stat lock as taught by Bailey in order to inhibit movement of the device (Bailey, Paragraph [0003]).
Response to Arguments
Applicant’s arguments filed March 13, 2026 have been fully considered.
In regards to Applicant’s argument that
“The Action rejected Claim 1 under 35 U.S.C. § 112(b) as allegedly lacking clarity regarding whether later recitations of the first and second conveying devices referred to previously introduced elements. In the response, Claim 1 has been amended to replace subsequent references to "a first conveying device" and "a second conveying device" with "the first conveying device" and "the second conveying device," thereby providing explicit antecedent basis and clarifying that the same conveying devices define the enclosed connection point throughout the claim.”
This argument is persuasive and the 35 U.S.C. § 112(b) rejection for claim 1 and resulting dependent claims has been withdrawn.
In regards to Applicant’s argument that
“The Action has rejected Claims 1-20 under 35 U.S.C. § 102(a)(1) as anticipated by
Lyons. Without conceding the merits of the rejection of independent Claim 1 under 35 U.S.C. § 102(a)(1), and solely to expedite prosecution, Applicant has amended independent Claim 1. “
And “Lyons fails to disclose amended Claim 8”
These arguments are persuasive and the 35 U.S.C. § 102(a)(1) has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Mench.
In regards to Applicant’s argument that
“The Action further rejects dependent claims as allegedly obvious over Lyons in view of Christie, O'Neil, Mench, Smith, Peters, Werth, and Bailey. However, as discussed above, Lyons fails to disclose or suggest a medical connection protector in which an internal compartment encloses a connection point independently of engagement with structural features of conveying devices, as now required by amended Claim 1.”
This argument is persuasive and the 35 U.S.C. § 103 has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Mench.
Conclusion
THIS ACTION IS MADE FINAL. 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 Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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