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
Applicant’s election without traverse of Group I in the reply filed on 01 July 2026 is acknowledged.
While Applicant’s election is indicated as being without traverse, Applicant does appear to traverse the separate grouping of Claims 1-16 and Claims 18-20.
Applicant argues “the withdrawn claims and the elected claims have relevance in design and effect, have the same search classes/subclasses, and involve the same technical field”. However, this is not persuasive.
Examiner submits that these arguments are presented without specific consideration for the detailed rationales provided in the 11 May 2026 requirement. Here the two inventions occur different statutory categories, the method of making a fluid connector is not properly classified in the subclasses of the device itself, but is rather classified based upon the specifics of the method steps used to form the apparatus, where the method requires express teachings of press-fitting the restrictor, carving a groove when forming the restrictor insert, and ultrasonic welding of the connector halves. In contrast, the apparatus claims are completely unconcerned with the method by which the device is formed and focuses on distinctive structural features of the assembly in an attempt to define patentability.
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) 1-5, 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2021/0228127 (“Burkholz”).
Regarding Claim 1, Burkholz discloses a fluid connector device (e.g. 55 – see Fig. 6C) comprising:
A first connector (16, 63);
A second connector (12, 14) that combines with the first connector to form a housing (see Fig. 6A, 6C); and
A flow restrictor insert (58) with an exterior flow channel (56), wherein the insert is fitted inside the housing (see Fig. 6C).
Regarding Claim 2, Burkholz discloses the exterior flow channel comprises a groove extending from a proximal end of the flow restrictor insert to a distal end of flow restrictor insert (see Fig. 6A).
Regarding Claim 3, Burkholz discloses the groove is a semi-parabolic cylinder (see Fig. 6C – i.e. the cross-section of the groove has a parabolic shape), wherein the phrase “cylinder” is not found to necessarily require a straight configuration (see Par. 50 of the instant specification, re: “An optimized fluid pathway… can have features including, but not limited to… a continuous non-linear channel, a groove, a fluid channel and the like”).
Regarding Claim 4, Burkholz discloses the first connector (16, 63) is a female luer (see Fig. 6C).
Regarding Claim 5, Burkholz discloses the second connector (12, 14) is a male luer (see Fig. 6C).
Regarding Claim 11, Burkholz discloses a fluid may flow through the exterior flow channel from the first connector towards the second connector (see Fig. 6C).
Regarding Claim 12, Burkholz discloses the fluid may be blood (Abstract).
Regarding Claim 13, Burkholz discloses the flow restrictor insert reduces hemolysis during blood draw (Par. 43).
Regarding Claim 14, Burkholz discloses the fluid connector device is configured to couple to a catheter assembly (Abstract).
Regarding Claim 15, Burkholz discloses the flow restrictor insert is contained within the first connector and the second connector (see Fig. 6C).
Regarding Claim 16, Burkholz discloses the flow restrictor insert is a solid cylinder with the exterior flow channel carved out of an exterior surface of the flow restrictor insert (see Fig. 6C).
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) 1-5 and 8-16 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0228127 (“Burkholz”) in view of U.S. Publication No. 2005/0245867 (“Olsen”).
Regarding Claims 1-5 and 11-16, Examiner notes that the invention is directed toward the invention only AFTER the first connector and the second connector have been “combined”, where there is significant question as to whether this “combined” limitation is a product-by-process limitation OR if the “combined” is only seeking to set forth the collective elements which define the housing irrespective of how (or when) the elements are associated with one another and is therefore permissive to constructions where the components are separately formed and then affixed together or would also be read upon by configurations where the two connectors are formed together in an integral fashion. Examiner submits that, without unnecessarily importing limitations from the specification into the claims, the phrase “combines” is not held to be a product-by-process limitation, but rather the broader indication that the housing is merely defined by the two connectors irrespective of how those two connectors are associated with one another.
However, should Applicant argue that the claim requires the first connector and insert to be physically separate components the following is presented. In Burkholz it is unclear if the first connector and the insert are formed integral or separately formed, although Examiner does note that the two components do have distinctive cross-hatching (see Fig. 6C note that the direction of the crosshatching of the insert runs counter to the direction of the cross-hatching of the connector implying that the two components are formed separately and then affixed). Furthermore, it has been held that constructing a formerly integral structure as a series of separately formed parts later affixed together is obvious, see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
For example, Olsen discloses a related flow restrictor (232) which may be configure as an independent insert (see Fig. 1) or provided in combination with an inlet connector (see Fig. 5B). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the insert of Burkholz to be separately formed from the first connector such that the insert is provided within the adapter body independently from the connector, as disclosed by Olsen, in order to allow the two components to be independently formed thereby allowing the use of different materials and manufacturing techniques and allow for separate replacement of the components should they become damaged or malfunction.
Regarding Claims 8-10, Burkholz discloses the invention substantially as claimed except for resolving any exemplary dimensions of the diameter of the flow restrictor insert, the diameter of the first connector, or the diameter of the second connector. However, such mere changes in size and proportion are considered an obvious design choice achieving only the expected and predictable results of scaling the invention of Burkholz to a workable size while also seeking to optimize the design for considerations such as material costs and size of the adapter with respect to its use in the medical theater. Here, the diameter of the flow restrictor merely correlates with the size of the device, particularly with respect to the size of the first and second connectors which would have been obvious to alter in size to permit the connectors to interface with known, commonplace medical appliances such as peripheral vascular access catheters, syringes, vacutainers, luer fittings, needless valves…etc. The ordinary artisan would understand that the size of the device is determined based upon its utility whereby the device should be sufficiently small so as to not be cumbersome, but large promote ease of manufacture, assembly, and handling, but also small enough to reduce material, shipping, and storage costs…etc.
As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the flow restrictor insert to have a maximum diameter of about 0.1 in., about 0.2 in., about 0.3 in., about 0.4 in., about 0.5 in., about 0.6 in., or about 0.7 in; the first connector have an inner diameter of about 0.1 in., about 0.2 in., about 0.3 in., about 0.4 in., about 0.5 in., about 0.6 in., or about 0.7 in.; the second connector to have an inner diameter of about 0.1 in., about 0.2 in., about 0.3 in., about 0.4 in., about 0.5 in., about 0.6 in., or about 0.7 in. in order to optimally size the device for attachment to catheters/syringes/valves/vacutainers…etc. in the medical theater, while optimizing its material costs, and ability to perform its intended function with respect to flow restriction,. Such mere changes in size and proportion are an obvious design choice when only expected and predictable results are to be obtained, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Claim(s) 3, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2021/0228127 (“Burkholz”) optionally in further view of U.S. Publication No. 2005/0245867 (“Olsen”) as applied above, and further in view of U.S. Publication No. 2023/0065702 (“Austin”).
Regarding Claim 3, Burkholz discloses the groove is a semi-parabolic cylinder (see Fig. 6C – i.e. the cross-section of the groove has a parabolic shape), wherein the phrase “cylinder” is not found to necessarily require a straight configuration (see Par. 50 of the instant specification, re: “An optimized fluid pathway… can have features including, but not limited to… a continuous non-linear channel, a groove, a fluid channel and the like”).
However, should Examiner’s arguments not be found persuasive the follow is presented. Austin discloses a related flow restrictor (150) comprising a straight, linear flow path (142) which is configured, like the groove of Burkholz, to cause flow restriction to thereby prevent hemolysis (Par. 11, 40-42). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the surface groove of Burkholz to comprise a straight, elongate geometry in place of the helical, non-linear geometry, as disclosed by Austin, whereby Austin establishes that a straight shaped channel can work accomplish the same stated purpose in a predictable and expected manner. It has been held that mere changes in shape which affect only expected results are obvious, see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and whereby the ordinary artisan would find construction of a straight channel to be an obvious design choice which will work equally as well as a helical shaped channel.
Regarding Claim 6-7, Burkholz discloses that the diameter of the flow channel is a result effective variable that may be altered depending upon the desired restriction to flow rate in association with the catheter to which the adapter is configured to be used (Par. 36). Burkholz fails to explicitly disclose any specific, exemplary diameters for the channel. Likewise Burkholz establishes length of the channel to be a result effective variable (Par. 36), but fails to provide an exemplary values.
However, it has been held that determining the workable or effective range of a result effective variable is obvious as a product of routine and customary experimentation and optimization, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, Austin discloses that flow restricting channels may have a workable range of at least 0.020 to 0.025 inches with a corresponding length of 1 to 1.3 inches (Par. 41).
As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the diameter and length of the channel of Burkholz to include examples of about 0.020” or 0.025” with lengths of about 1.0” or 1.30” and inclusive to values therebetween including about 1.10” or 1.20”, in order to affect known useful dimensions expected in the prior art to provide for sufficient restriction to flow to prevent hemolysis in a known and predictable manner as established by Austin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/ Primary Examiner, Art Unit 3783
08/24/2026
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