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 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) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by.
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) 1-9 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,667,516 to Allen (Allen hereinafter) in view of U.S. Patent 5,178,624 to Kyun (Kyun).
Regarding claim 1, Allen teaches a device for assisting in the placement of an umbilical catheter in premature and newborn infants, comprising: a first leg (23) and a second leg (24), each of which comprises a first end (at 27/28) and a second end (at 25), wherein the first and second leg are connected to one another in a region of the second ends of each leg via a spring element (25), wherein the spring element holds the first and second legs by a spring force in a first operating state (Fig. 7) in which the respective first ends of the first and second leg are spaced apart from each other and wherein the first and second leg can be transferred against the spring force into a second operating state (Fig. 10) in which the respective first ends of the first and second leg are arranged directly adjacent to each other. Finally, Allen teaches that at least tips of the veins are accessible with the apparatus in the second position (as shown at 49 in Fig. 10). Allen does not teach that the first and second legs each comprise a semi-cylindrical recess in a region of the first ends of each leg which together form a cylindrical receptacle for an umbilical cord of an infant. Kyun teaches another umbilical cord cutting apparatus generally, and particularly teaches a shield (6) with semicylindrical cutouts (5a, 5b, 8a, 8b) for retaining the umbilical cord. Kyun teaches that this shield prevents splashing of blood. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a shield as taught by Kyun to at least one side of the clamp of Allen in order to prevent splashing of blood. Thus provided, the clamp would include a shield having the cylindrical recesses attached to an outer surface of the first (23) and second (24) legs of Allen’s clamp which would operate as claimed. That is to say, the examiner proposes a combination in which at least half of the shield of Kyun is added onto the device of Allen at the right side of Fig. 8 to hold the umbilical cord 31 on that side. Other possible combinations are possible.
Regarding claim 2, Allen teaches a locking device (29, 30).
Regarding claim 3, Allen teaches a releasable snap connection (29, 30).
Regarding claim 4, the examiner takes official notice that non-releasable connections are known in the art of surgical devices. The examiner bases this assertion on the lack of specific disclosure of such apparatus by the applicant and on the commercial availability of such devices before the effective filing date of the instant application. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a permanent connection as known in the art in order to permanently secure the clamp of Allen to an umbilical cord so as to e.g. prevent bleeding and/or infection.
Regarding claim 5, Allen teaches a first part of the locking device (30) is formed at the first end of the first leg, and a second part (29) is formed at the first end of the second leg.
Regarding claim 6, Allen teaches an elevation (1, 2, 3) on a distal side of the device.
Regarding claim 7, Allen teaches two parts (1, 2) arranged on the first and second legs, the two parts being adjacent in the second operating state (see Figs. 5 and 8).
Regarding claim 8, Kyun teaches that at a distal end of the elevation two semicircular elements (5a, 5b) are arranged, which are axially aligned with the semi-cylindrical recesses of the first and second legs, wherein the two semicircular elements form a circular receptacle when the device is in the second operating state, to fix the umbilical cord of the infant, the circular receptacle being axially aligned with and spaced from the cylindrical receptacle when the device is in the second operating state, so that a cutting channel (Allen, 4) remains between the cylindrical receptacle and the circular receptacle. It would have been obvious at the time of the effective filing date of the application to provide both sides of the guard (6) of Kyun in order to prevent splashing of blood on either side of the clamp of Allen.
Regarding claim 9, Allen teaches a breaking edge (18).
Regarding claim 12, Allen teaches wings (1, 2) forming finger protection.
Regarding claim 13, Allen teaches that the spring element (5) is circular, and opens and closes with the first and second operating states.
Regarding claim 14, Allen teaches that the device is formed in one piece.
Regarding claim 15, Allen teaches the use of plastics (col. 6, ln. 64-65).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Kyun as applied to claim 1 above, and further in view of CN 204798592 to Jiang et al. (Jiang, copy and machine translation attached).
Regarding claim 10, the previously applied references teach the limitations of claim 1 from which claim 10 depends, but do not teach a conical recess. Jiang teaches another umbilical clamp generally, and particularly teaches pair of conical recesses (31, 32) for clamping an umbilical cord while avoiding damage. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide conical recesses as taught by Jiang in the clamp of Allen to allow non-damaging clamping as taught by Jiang.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Kyun as applied to claim 1 above, and further in view of U.S. Patent 7,402,164 to Watson et al. (Watson).
Regarding claim 11, the previously applied references teach the limitations of claim 1 from which claim 10 depends, but do not teach grooved recesses. Watson teaches another umbilical clamp generally, and particularly teaches ridges (18) for gripping the cord, between which extend corresponding grooves. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide gripping ridges and grooves to the clamp of Allen in order to enhance its gripping of the cord.
Response to Arguments
Applicant's arguments filed 15 December 2025 have been fully considered but they are not persuasive.
With respect to the argument that Allen does not teach the claimed vessel access, the examiner disagrees. Access to vessels and the ability to cannulate them are not identical limitations. Since, in the second position, at least a stump of the umbilical cord remains uncompressed, accessible, and visible (see Fig. 10), this is sufficient for the current limitations of claim 1.
The examiner further notes the art cited below, and notes that in view of Coelho, it would be prima facie obvious to use semi-circular recesses as taught by Kyun for all contact points in the clamp of Allen specifically to allow insertion of medical devices such as probes and cannulae into the umbilical cord in order to infuse liquids into the infant or monitor its condition.
In view of the above, the examiner holds that the claimed invention is not patentable as currently drafted. The examiner notes that structural distinctions between the elevation as disclosed and the currently cited prior art could overcome the currently cited art, subject to consideration of particular drafting.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pre-Grant Publication 2012/0232357 to Coelho (Coelho) teaches a probe (200) inserted into an umbilical cord or stump through a clamp (18).
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 17 March 2026