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 Applicant’s RCE filed 08/05/2026
Claims 1, 16, and 20 are amended.
Claims 13-15 are cancelled.
Claims 1-12 and 16-20 are being examined in this Office Action.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/05/2026 has been entered.
Claim Objections
Claims 8 and 20 are objected to because of the following informalities:
Claim 8 recites the limitation “the openings” in lines 1-2, Examiner recommends keeping the language consistent, as claim 1 recites “a first opening” and “a second opening”. For example, “wherein the first opening and the second opening have a diameter smaller than…”.
Claim 20 recites the limitation “wherein the securing patch” when claim 19 recites the limitation “at least one securing patch”. Examiner recommends keeping the language consistent for example, “wherein the at least one securing patch is a stat lock.”
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 1-20 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 1 recites the limitation “two openings formed on both ends of the first and second cover portions” in line 11, it is unclear if there are two openings on each end of medical connection protector, or if there is a single opening on each end of the medical connection protector. Examiner interprets that there is a proximal and distal opening on each respective end of the medical connection protector.
Additionally, claim 1 recites the limitation “both ends” in line 11, it is unclear what constitutes an end. Furthermore, it is unclear how would an end be defined if the cover portions were not rectangular in shape, i.e. a circular or triangular shaped cover portion would have an unclear “both ends”. For the purposes of examination, Examiner interprets “both ends” to be the lefthand and righthand most sides of the medical connection protector.
All remaining claims are rejected by virtue of their dependence on a rejected claim.
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) 1, 2, 5, 7-9, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench et al. (U.S. 10722662 B1, herein Mench) in view of Filz (Pub. No. US 20170065808 A1).
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);
a first tamper-proof locking assembly (408, 412, Col. 12 Line 65 through Col. 13 Line 8) 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).
Mench does not expressly disclose a first fence closure disposed within the internal compartment between the connection point and a first opening and a second fence closure disposed within the internal compartment between the connection point and a second opening.
Filz teaches a first fence (left groove 24 in Fig. 3) closure disposed within the internal compartment (Fig. 3) between the connection point (IV manifold, Paragraph [0041]) and a first opening (left opening tubing runs through in Fig. 3) and a second fence closure (right groove 24 in Fig. 3) disposed within the internal compartment (Fig. 3) between the connection point (IV manifold) and a second opening (right opening tubing runs through in Fig. 3).
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 to include a first fence closure disposed within the internal compartment between the connection point and a first opening and a second fence closure disposed within the internal compartment between the connection point and a second opening as taught by Filz in order to secure the tubing within the securement system (Filz, Paragraph [0041]).
Regarding Claim 2, modified Mench in view of Filz discloses the medical connection protector of claim 1, wherein the first tamper-proof locking assembly includes a first female component (Mench, 412) attached to the second side of the first cover portion (Mench, 402, Fig. 4A) and a first male component (Mench, 408) attached to the second side of the second cover portion (Mench, 404, Fig. 4A), the first female component and the first male component being configured to snap together in locked position (Mench, Col. 13 Lines 39-45).
Regarding Claim 5, modified Mench in view of Filz 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 (Mench, Col. 13 Lines 18-30).
Regarding Claim 7, modified Mench in view of Filz 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 (Mench, Fig. 4A, Col. 12 Lines 21-30).
Regarding Claim 8, modified Mench in view of Filz 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 (Mench, 902B retained within clamping box due to outer dimension of the connection point being larger than blood vessel line opening 918 in Fig. 9A).
Regarding Claim 9, modified Mench in view of Filz discloses the medical connection protector of claim 1, further comprising color coding provided on the first cover portion indicating a type of conveying device (Mench, Col. 27 Lines 16-25).
Regarding Claim 16, modified Mench in view of Filz 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 outside the medical connection protector (Mench, Col. 2 Lines 51-54).
Claim(s) 3, 4, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Filz, further in view of Lyons et al. (Pub. No. US 20100210990 A1, herein Lyons).
Regarding Claim 3, modified Mench in view of Filz discloses the medical connection protector of claim 2.
Modified Mench in view of Filz 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) attached to the second side of the second cover portion and a second male component (32a, annotated Fig. 2) 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 (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 to move 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).
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 modified Mench in view of Filz 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.
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Regarding Claim 4, modified Mench in view of Filz discloses the medical connection protector of claim 2.
Modified Mench in view of Filz 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 modified Mench in view of Filz 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, modified Mench in view of Filz discloses the medical connection protector of claim 1.
Modified Mech in view of Filz 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 modified Mench in view of Filz 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 Filz and 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 modified Mench in view of Filz 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 Filz and 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 modified Mench in view of Filz 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 Filz, further in view of Christie et al. (US 10518076 B2, herein Christie).
Regarding Claim 6, modified Mench in view of Filz discloses the medical connection protector of claim 1.
Modified Mench in view of Filz 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 modified Mench in view of Filz 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) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mench in view of Filz, further in view of O'Neil (Pub. No. US 20190217076 A1).
Regarding Claim 17, modified Mench in view of Filz discloses the medical connection protector of claim 1.
Modified Mench in view of Filz 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 modified Mench in view of Filz 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 Filz, further in view of Werth (Pub. No. US 20090208277 A1).
Regarding Claim 18, modified Mench in view of Filz discloses the medical connection protector of claim 1.
Modified Mench in view of Filz 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], PVDF being an example of a biocompatible polymer).
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 modified Mench in view of Filz 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 Filz, further in view of Bailey et al. (Pub. No. US 20170326339 A1, herein Bailey).
Regarding Claim 19, modified Mench in view of Filz discloses a medical securement system comprising the medical connection protector of claim 1.
Modified Mench in view of Filz 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], Paragraph [0073]).
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 modified Mench in view of Filz 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 Filz and 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 modified Mench in view of Filz 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 July 8, 2026 have been fully considered.
In regards to Applicant’s argument that
“The Action has rejected Claims 1, 2, 5, 7-9 and 16 under 35 U.S.C. § 102(a)(1) as anticipated by Mench. 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.”
This argument is persuasive and the 35 U.S.C. § 102(a)(1) rejection for claims 1, 2, 5, 7-9, and 16 have been withdrawn. However, after further search and consideration, a new ground of rejection is made in view of Mench in view of Filz.
In regards to Applicant’s argument that
“Because the remaining cited references are relied upon for features unrelated to the fence closure arrangement, they likewise do not cure the deficiencies of Mench and Peters with respect to amended Claim 1. Therefore, the rejection under 35 U.S.C. § 103 should be withdrawn.”
This argument is persuasive and the 35 U.S.C. § 103 rejection has been for the remaining claims has been withdrawn. However, after further search and consideration. A new ground of rejection is made in view of Mench in view of Filz. Filz teaching a first and second fence closure.
Conclusion
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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