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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 has been amended to recite “such that the male luer taper directly engages a female luer port when the casing is connected to the female luer port” (lines 13-15); since the “female luer port” is only functionally recited, this limitation should be amended to recite “such that the male luer taper is configured to directly engage[[s]] a female luer port when the casing is connected to the female luer port”. Appropriate correction is required.
Claims 15-18 and 20 are objected to because of the following informalities: Each of these claims have incorrectly utilized the term “wall” – “inner wall of the casing” in claims 15, 16, 17 and 18, “outer wall of the retaining member” in claim 17, and “inner wall of the elastomeric surface” in claim 20 – when they should have used the term “surface”. Accordingly, the term “wall” in each of these phrases should be replaced with the term “surface”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18, 19 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Newly presented claim 18 recites that the inner wall/surface of the casing that forms the hollow interior “has a constant diameter between the distal opening and the rim”. This limitation is narrower than what is supported by the original disclosure since the original disclosure did not state that such a “constant diameter” exists nor did the originally-filed Specification state that the Drawings are to scale (and, therefore, any measurement of the diameter in Fig 3A cannot be relied on for support).
Newly presented claim 19 recites that the casing “has a cylindrical shape between the proximal opening and the distal opening”. This limitation is narrower than what is supported by the original disclosure since the original disclosure did not state that the casing has “a cylindrical shape” nor did the originally-filed Specification state that the Drawings are to scale (and, therefore, the rounded shape of Fig 3 and the sides of Fig 3A cannot be relied on for support for disclosing that the casing meets the geometrical definition1 of being “cylindrical”).
Newly presented claim 20 recites that an inner wall/surface of the elastomeric member that forms the lumen “has a constant diameter”. This limitation is narrower than what is supported by the original disclosure since the original disclosure did not state that such a “constant diameter” exists nor did the originally-filed Specification state that the Drawings are to scale (and, therefore, any measurement of the diameter in Fig 3A or 4A cannot be relied on for support).
Allowable Subject Matter
Claims 1, 5, 7-9 and 11-17 would be allowable if amended to overcome the objections set forth above; claims 18 and 20 would be allowable if amended to overcome the objections and 35 U.S.C. 112(a) rejections set forth above; and claim 19 would be allowable if amended to overcome the 35 U.S.C. 112(a) rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claim could not be found nor was suggested in the prior art of record. Independent claim 1 has been substantially amended (in the 4/2/2026 filing) to require: (1) the casing of the PRN adapter to have (a) a hollow interior forming a proximal opening and a distal opening and (b) a rim that forms the proximal opening and (2) the elastomeric member of the PRN adapter to have (a) a proximal end formed by a septum, (b) a neck that extends distally from the septum, (c) a retaining member that extends distally from the neck, and (d) a distal end formed by a male luer taper that extends distally from the retaining member, wherein (i) the neck has a reduced diameter relative to a diameter of the septum and a diameter of the retaining member, (ii) the elastomeric member is coupled to the casing by the neck being positioned within the rim such that the septum is positioned proximal to the proximal opening of the casing and the retaining member being positioned distal to the rim, and (iii) wherein the male luer taper extends distally beyond the distal opening of the casing when the neck is positioned within the rim such that the male luer taper directly engages a female luer port when the casing is connected to the female luer port.
The McKinnon reference cited in the last Office Action (dated 1/9/2026) remains the closest prior art of record. However, McKinnon does not disclose that the male luer taper (labeled in annotated Fig B in the last Office Action) “extends distally beyond the distal opening of the casing when the neck is positioned within the rim such that the male luer taper [is configured to] directly engage a female luer port when the casing is connected to the female luer port” as claimed. Rather, as seen in Fig 2 of McKinnon and annotated Fig B in the last Office Action, the male luer taper ends substantially proximal to the distal opening of the casing and resides within the casing such that it would not be capable of directly engaging a female luer port. Additionally, it would not have been obvious to one of ordinary skill to modify McKinnon to extend the male luer taper distal of the distal opening of the casing as doing so would disrupt the ability of the casing to engage a complimentary connection.
Additionally, an adapter comprising all of the features recited in claim 1 could not be found nor was suggested elsewhere in the prior art of record.
Response to Arguments
Applicant’s arguments filed 4/2/2026 have been fully considered but are moot in view of the present Office Action that indicates claim 1 as comprising allowable subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 “cylindrical” : relating to or having the form or properties of a cylinder.
“cylinder” : the surface traced by a straight line moving parallel to a fixed straight line and intersecting a fixed planar closed curve
“cylindrical”. Merriam-Webster Online Dictionary. http://www.merriam-webster.com/dictionary/cylindrical
“cylinder”. Merriam-Webster Online Dictionary. http://www.merriam-webster.com/dictionary/cylinder
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