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
Claim(s) 12-15 and 19-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 March 2026. This traversal is on the grounds that “no serious burned exists” because the species “include common elements”. However, this is not persuasive. While the instant species do include common elements the divergence of the disclosed (and claimed) structure is significant with the prior art (see as applied below) suggesting that these “common elements” are trivial and do not contribute to any supposed distinction or contribution over the prior art suggesting that any of these embodiments, which might be patentable over the prior art, would be patentable only by virtue of the distinguishing features. Examination of each invention, simultaneously, would require a substantial application of various references and/or combinations of references creating a complex patchwork of rejections to account for each set of divergent features. Examiner submits that if any of these “common elements” are not superficial then logically they will present as generic limitations whereby rejoinder of unelected inventions generic to any allowable claims can be considered without any imposition upon Applicant. Streamlining review of the instant application to generic features and divergent features of only one species ensures compact prosecution in contrast to requiring separate searches and rejections for each independent and distinct connector assembly to account for the divergent features.
Information Disclosure Statement
The information disclosure statement filed 02 January 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copy of NPL citation No. 1 has been received.
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, 2, 6, 7-9, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 5,405,323 (“Rogers”).
Regarding Claims 1, 9, and 16, Rogers discloses a vascular access system configured for delivery of a tube or probe into a patient’s vascular system, the system comprising:
A catheter adapter (15) comprising a distal portion (55) and a proximal portion (53), wherein a catheter (16) extends from the distal portion and a septum assembly (14, 51) is housed within the proximal portion (see Fig. 3); and
A connector assembly (13, 11), wherein the connector assembly comprises:
a coupling interface (11) configured to couple the connector assembly to the proximal portion of the catheter adapter (see Fig. 3),
a cannula (12A), wherein the cannula is configured to extend through the septum assembly of the catheter adapter when the connector assembly is coupled to the proximal portion of the catheter adapter (see Fig. 4); and
a proximal interface (46), wherein the proximal interface is configured for coupling to a blood draw device having an elongated core extending from a distal end thereof (re: 46 is a “luer lock fitting” which can receive any variety of standardized devices inclusive to, but not limited to, a blood draw device having an elongated core extending distally therefrom, wherein the blood draw device is not a positively required part of the claimed workpiece).
Regarding Claims 2 and 17, Rogers discloses at least a portion of the cannula is slidable within the connector assembly (see Fig. 3 and 4 in series).
Regarding Claim 6, Rogers discloses the cannula is configured to at least partially extend through an opening (see generally 24) formed in a distal end portion of the connector assembly.
Regarding Claim 7, Rogers discloses an O-ring seal (26) surrounding the opening formed in the distal end portion of the connector assembly (see Fig. 4).
Regarding Claim 8, Rogers discloses cannula comprises a proximal interface surface (see where the tapered cannula joins the luer fitting), and wherein the proximal interface surface is configured to receive at least a portion of a distal end of the elongated core of the blood draw device when the blood draw device is coupled to the connector assembly (the blood draw device not being positively required therefore no positive recitation by Rogers is necessary to particularly satisfy the functional language of the claim, rather the identification of a tapered, proximal, bearing surface of the cannula is sufficient to satisfy the metes and bounds of the claim).
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.
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.
Claim(s) 3 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) as applied above, and further in view of U.S. Publication No. 2020/0023176 (“Hu”)
Regarding Claims 3 and 18, Rogers discloses the invention substantially as claimed except that the connector assembly further comprises a biasing member configured to bias the cannula proximally within the connector assembly. However, related adapter/connectors are known such as those described by Hu (e.g. Fig. 2E), wherein a cannula (76) is proximally biased by a spring (74) in order to assume a naturally retracted position with respect to a catheter seal/septum (44 – Par. 55). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide a biasing member to the invention of Rogers to maintain the cannula in a naturally retracted position, as disclosed by Hu, in order to ensure that the septum is normally closed to prevent the egress of fluids.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) and U.S. Publication No. 2020/0023176 (“Hu”) as applied above, and further in view of U.S. Patent No. 9,636,278 (“Sanders”).
Regarding Claim 4, Rogers, as modified in view of Hu, discloses the invention substantially as claimed except that for disclosing the material of which is the biasing member/spring is formed. However, Sanders discloses a related spring (42) which is formed of a “steel portion” (see Par. 117 – DSTX). It would have been obvious for one having ordinary skill in the art at the time the invention was made to form the spring of modified Rogers of steel, as disclosed by Sanders, such a materially being a commonplace and well-known material for the construction of biasing springs. It has been held that selecting a known material based upon its recognized suitability for a purpose is obvious, requiring only routine levels of skill and knowledge in the art to effect an expected and predictable outcome, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) and U.S. Publication No. 2020/0023176 (“Hu”) as applied above, and further in view of JP 2011/115630 (“Nakajima”).
Regarding Claim 5, Rogers, as modified in view of Hu, discloses the invention substantially as claimed except that for disclosing that the biasing member is a “rubber bellow”, rather Hu uses a coil spring to effect biasing of the cannula. However, rubber bellows a well-known, suitable alternatives for springs. For example, Nakajima discloses that in similar applications (see Fig. 4-12) a coil spring (7) can be replaced with an elastic rubber bellows (8) in order to effect a proximal spring force against a cannula to retain the cannula in a retracted position with respect to a sealing septum in a catheter hub (see Fig. 10-12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to replace the coil spring of modified Rogers with a rubber, elastic bellows, as disclosed by Nakajima, as it has been found obvious to apply simple substitution of know equivalents to effect only expected and predictable results in the art as an obvious design choice, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) as applied above, and further in view of U.S. Patent No. 11,097,083 (“Burkholz”).
Regarding Claim 8, Rogers discloses the invention substantially as claimed except that system includes a split septum positioned at a proximal end portion of the connector assembly. However, Burkholz discloses a related connector assembly (44) configured to selectively penetrate a catheter adapter septum (16, 18), wherein the connector assembly can include, at a proximal end portion thereof, a split septum (59) to serve as an additional valve to prevent fluid egress when the cannula has penetrated the septum (see Fig. 4B – compare with Fig. 4A). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the connector assembly proximal, end of Rogers with a split septum valve, as disclosed by Burkholz, in order to provide a configuration wherein the septum of the adapter can be penetrated by the septum while the connector assembly continues to ensure that fluids to not leak through the connector.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) as applied above, and further in view of U.S. Patent No. 5,607,392 (“Kanner”).
Regarding Claim 10, Rogers discloses the invention substantially as claimed except that that the coupling interface comprises a plurality of extensions projecting distally therefrom. Rather, Rogers does not particularly disclose the coupling interface to be separable from the catheter hub. However, it is well-known that constructing a formerly integrated device as a plurality of separable pieces is obvious, requiring only routine and customary skill in the art to obtain a predictable and expected outcome, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). Such, suitable connection interfaces known to the art includes, for example, configurations comprising a plurality of extension (see i.e. the two distal sides of connector 22 which establish the two halves of the bayonet connector 116) as described by Kanner, whereby a related coupling interface of a connector can be affixed to a septum containing catheter adapter (see Fig. 3). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the coupling interface of Rogers to comprise a separable interface comprising a plurality of extensions projecting therefrom in order to create a suitable bayonet connection with the catheter adapter, as disclosed by Kanner, in order to allow the two components to be separated from one another for servicing or cleaning.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,405,323 (“Rogers”) as applied above, and further in view of U.S. Publication No. 2021/0213268 (“Scherich”).
Regarding Claim 11, Rogers discloses the invention substantially as claimed except that that the connector assembly further comprises a groove formed in a sidewall thereof, and wherein the groove is configured to receive a distal end of one or more clips of a coupler member of the blood draw device. Rather, Rogers envisions the use of luer lugs to provide for the connection interface. However, the use of a groove formed in a sidewall corresponding to clips of a coupler member is a well-known, alternative connection interface in the art (see Scherich – Par. 80). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the device of Rogers with a groove such that a corresponding luer-type clip may be affixed thereto, as disclosed by Scherich, in order to provide a well-known art-recognized alternative interface known to be suitable and useful in the art for providing operative interconnection of medical fluid handling devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 04/16/2026
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