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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 4, 2025 has been entered.
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive in view of the rejection set forth below addressing the amendments to the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11, 25, 26 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “a set of deformable arms of the collet jaw secure the blood vessel between the collet jaw and the cannula” in lines 5-7 of the claim, which positively recites the blood vessel and therefore is directed to and encompasses a human organism. It is suggested the limitation be changed to “a set of deformable arms of the collet jaw are configured to secure the blood vessel between the collet jaw and the cannula” to functionally recite the tissue.
Claim 7 recites the limitation “the head of each deformable arm is in contact with the tissue such that the blood vessel is held in place between the collet jaw and the cannula” in the last lines of the claim. This limitation positively claims the tissue and the blood vessel which is directed to and encompasses a human organism. It is suggested the limitation be changed to “the head of each deformable arm is configured to be in contact with the tissue such that the blood vessel is held in place between the collet jaw and the cannula” to functionally recite the tissue.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wisman (US 20200094025) in view of Yoon (US 5676681).
Regarding claim 1, Wisman discloses a cannula insertion system for cannulating a blood vessel in a tissue, the cannula insertion system comprising: a cannula system including a cannula (36, see image above) that defines a cannula lumen therethrough, the cannula having a distal end and a proximal end opposite the distal end; and a cannula insertion device configured to couple with the cannula system, the cannula insertion device including: a dilator (16) having a dilator body that defines a dilator lumen (48) therethrough; a needle (18) having a needle body, the needle being translatable within the dilator lumen along a first direction; a dilator actuator (22) configured to be moved such that movement of the dilator actuator causes movement of the dilator along the first direction (paragraph 0071); a needle actuator configured to be moved such that movement of the needle actuator causes movement of the needle along the first direction (paragraph 0077); and a housing (32) defining a housing recess therein, the housing recess being configured to receive the cannula system, the dilator, and the needle (figure 3), wherein the needle and the dilator of the cannula insertion device are configured to be moved within the cannula lumen along the first direction (figure 4). Wisman does not disclose a collet jaw configured to be transitioned from an open position to a locked position in which a set of deformable arms of the collet jaw are configured to secure the blood vessel between the collet jaw and the cannula. Yoon teaches a tissue penetrating device with a tissue penetrating distal end to provide access to a surgical site (abstract, figure 1) comprising a collet jaw (34) configured to be transitioned from an open position (figure 14) to a locked position (figure 13) comprising a set of deformable arms (176) to form a continuous smooth profile during penetration into tissue with minimal tissue jamming (C:9, L:5-10, C:10, L:65-67; C:11, L:1-5). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make a collet jaw configured to be transitioned from an open position to a locked position comprising a set of deformable arms, as taught by Yoon, on the distal end of the cannula of Wisman, in order to form a continuous smooth profile during penetration into tissue with minimal tissue jamming. Subsequently, the deformable arms of the resulting device of Wisman in view of Yoon would be configured to secure a blood vessel between the collet jaw and the cannula since they can be transitioned such that the blood vessel fits between the gap defined between edges 177 in figure 14 of Yoon. Functional limitations are not given full patentable weight. As long as the prior art meets the structural limitations and is capable of performing the recited functions, the prior art meets the limitations. In the instant case, the device of Wiseman in view of Yoon would be capable of performing the recited functions.
Regarding claim 2, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Wisman teaches the needle actuator is configured to translate the needle from a first position, in which a distal end of the needle is positioned distally of a distal end of the dilator (figure 2), to a second position, in which the distal end of the needle is positioned proximally of the distal end of the dilator (figure 6).
Regarding claim 3, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Wisman teaches the cannula system includes a Y-connector (12) adjacent to the proximal end of the cannula, the Y-connector having a first proximal portion (28), which defines a first proximal channel, and a second proximal portion (28), which defines a second proximal channel, wherein the first and second proximal channels are configured to be in fluid communication with the cannula lumen (36, 28, it is noted that either 36 or 28 can be interchanged to meet the limitations ‘first proximal portion’ or ‘second proximal portion’, paragraph 0053, 0054).
Regarding claim 5, Wisman in view of Yoon teaches all of the limitations set forth in claim 3, wherein Wiseman further teaches a plug (stop cock) configured to be removably inserted into the first proximal channel (paragraph 0054).
Regarding claim 9, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Wisman further teaches it was known in the art at the time of the invention to make components of the device out of a translucent material in order to visualize blood flashback and visualizing fluids therein (paragraph 0064). Therefore, it would have been within the level of one with ordinary skill in the art to further make the housing of the device of Wisman in view of Yoon include a translucent portion configured to allow visibility through the housing into the housing recess in order to allow visualization of flashback of blood upon the needle cannulating the vasculature of the patient. Furthermore, this merely involves a modification in material properties of the device and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Regarding claim 10, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Wiseman teaches the cannula system is configured to be operatively connected to an extracorporeal membrane oxygenation (ECMO) system (as long as the prior art is capable of performing the recited functions, the prior art meets the limitations. Therefore, since an ECMO can be connected to the hub 12, the prior art meets the limitations).
Regarding claim 11, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Wiseman teaches the tissue includes an umbilical cord of a neonate (as long as the prior art is capable of performing the recited functions, the prior art meets the limitations. Since the prior art is disclosed for vascular access, the prior art would be capable of cannulating an arbitrary blood vessel in the tissue of a neonate, and the prior art meets the limitations).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wisman (US 20200094025) in view of Yoon (US 5676681), as applied to claim 3 above, and further in view of Solomon (US 20190060616).
Regarding claim 4, Wisman in view of Yoon teaches all of the limitations set forth in claim 3, but does not disclose the first proximal portion defines a slit seal. However, Solomon teaches a device for vascular access comprising a slit seal (190) having an open configuration upon application of force and a closed configuration nothing is extending therethrough, wherein when the slit seal is in the closed configuration, liquid from a cannula lumen is precluded from moving into a proximal channel thereof in order to prevent undesired leakage of fluids through the proximal end of the catheter (paragraph 0026, 0009, 0024, 0076, 0078). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to separate the first proximal channel (28) from the second proximal channel with a slit seal having an open configuration, in which the dilator and the needle are inserted therethrough, and a closed configuration, in which the needle and the dilator are not extending therethrough, as taught as known in the art by Solomon, in order to prevent leakage of fluid from the proximal end of the device, the modification would result in liquid from the cannula lumen being precluded from moving in to the first proximal channel when the slit seal is in the closed configuration.
Regarding claim 6, Wisman in view of Yoon teaches all of the limitations set forth in claim 1, wherein Solomon teaches a dilation system comprising a cannula system and a housing, wherein the cannula system includes a locking element thereon (156), and the housing includes a locking element (206) thereon, wherein the locking element of the cannula system is configured to releasably engage with the locking element of the housing such that the cannula system is affixed to the housing (figure 3, paragraph 0062) to prevent rotation and control needle positioning during catherization processes (paragraph 0002). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to include a locking element on the cannula system and the housing of the device of Wiseman in view of Yoon, wherein the locking element of the cannula system is configured to releasably engage with the locking element of the housing such that the cannula system is affixed to the housing in order to prevent rotation and control needle positioning during catherization processes, as taught by Solomon.
Allowable Subject Matter
Claims 7, 8, 25, and 26 would be allowable if rewritten to overcome the 101 rejection above and 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 prior art (See above) discloses all of the limitations set forth in claim 1, however, the claims have not been rejected over the body of prior art because no reference could be found that could be combined with the limitations set forth above teaching the collet jaw having a base with the deformable arms extending therefrom, and each deformable arm from the set of deformable arms including a head in combination with wherein when the collet jaw is in an open position, the head of each deformable arm is spaced away from the cannula, and when the collet jaw is in a locked position, the head of each deformable arm is configured to be in contact with the tissue such that the blood vessel is held in place between the collet jaw and the cannula. Therefore, claim 7 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, since there is no teaching, suggestion, or motivation to produce the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure with respect to the claimed collet jaw.
Erb et al (US 6436119)
Selmon et al (US 6638247)
Oritz et al (US 20070043380)
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/ANH T DANG/Primary Examiner, Art Unit 3771