DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim Objections
Claim 6 is objected to because of the following informalities: The term “and” should be inserted after the comma on 3 in order to be grammatically correct; this would result in the claim setting forth that the “closed container” comprises an “open distal end” and a “sidewall”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 38 recites that the notches “form a beveled or curved edge to the distal end of the tip adjacent to the outside surface of the tip that forms an aperture in the sidewall at the distal end of the tip”. Although this limitation is recited in the originally-filed Specification and Applicant’s remarks filed 11/13/2025 attempted to clarify what is meant by this limitation, the scope is still unclear. Specifically, the remarks (page 7) state that the claim describes the notch having a surface that slants upward or downward or is cut at a curve as it extends from the outside surface of the body wall to the inside surface of the body wall. The Examiner recognizes that this explanation defines what is meant by “wherein the notches form a beveled or curved edge” and that this means that the phrase “to the distal end of the elongate tip adjacent to the outside surface of the elongate tip” means that this slanted/curved surface extends is located adjacent to the outside surface of the elongate tip (but not necessarily through the entirety of the side wall) and that this edge extends to the distal end of the elongate tip. However, the passage “that forms an aperture in the side wall at the distal end of the elongate tip” still remains unclear since the notches (and apertures) are formed in the “non-luer connector” while the “sidewall” is formed in the “closed container” (as set forth in the last Office Action). For the sake of examination, claim 38 is interpreted as referring to the “apertures” of the “body wall” instead of the “aperture in the side wall”. Accordingly, it is suggested to amend claim 38 to recite “wherein the notches form a beveled or curved edge extending to the distal end of the elongate tip and being adjacent to the outside surface of the elongate tip to form the apertures at the distal end of the elongate tip”.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6, 7, 9-11, 17, 25, 26, 28-29, 33-36 and 38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shaughnessy et al. (PG PUB 2007/0060898) in view of Owens (PG PUB 2008/0103486) or, alternatively, as being unpatentable over Shaughnessy et al. (PG PUB 2007/0060898) in view of Owens (PG PUB 2008/0103486) and Bickford Smith (Bickford Smith et al. (WO 2004/037335).
Re claim 6, Shaughnessy discloses a drug delivery device 69+33 (Fig 1; it is noted that all reference characters cited below refer to Fig 1 unless otherwise noted) comprising: a closed container consisting essentially of a syringe 69 (Para 23), the container having an open distal end including a distal wall (from which tip 33 extends in Fig 1; this end must be open since Para 24 discloses that fluid flows from the syringe 69 through the tip 33), and a sidewall (the portion extending proximally from tip 33 in Fig 1 and including indicia markings) including an inside surface defining a fluid chamber for retaining fluids (“the enteral feeding source 16 is a syringe 69”, Para 24); and a non-luer connector 33 comprising an integrally formed, linearly tapered, male, non-luer elongate tip (“unlike a luer connector”, “having a tapered or stepped shape”, Para 24) extending in a distal direction from the distal wall (as seen in Fig 1, the distal direction is downward in Fig 1), the elongate tip including a distal end (the downward-most end in Fig 1), a body wall (the structure forming the tip 33 itself), and an opening on the distal end of the elongate tip for providing access to the fluid chamber (“fluid flows directly from the syringe 69 through the tapered connector 33”, Para 24). Shaughnessy discloses that the tip 33 is “unlike a connector for an IV system” and is “an oral tip connector […] having a tapered or stepped shape”, but does not disclose that the distal end includes four notches disposed at 90 degree intervals, which radiate outwardly from the opening through a body wall of the elongate tip to form a plurality of apertures in the body wall of the elongate tip at the distal end of the elongate tip, wherein the notches prevent fluid-tight connection of a standard female luer connector to the container, and wherein the notches are in fluid communication with the opening on the distal end of the elongate tip for extending the opening across the distal end of the elongate tip to an outside surface of the body wall of the elongate tip, the notches form a path to provide an outlet for leakage of the fluid from the fluid chamber to escape from the opening to the outside surface of the elongate tip when the elongate tip is connected to the standard female luer connector.
Owens, however, teaches a linearly tapered, male, non-luer elongate tip (Fig 1B,3; it is noted that all reference characters cited below refer to Fig 1B and/or Fig 3 unless otherwise noted) having a distal end (to the right in Fig 1B,3) with an opening 20 (Fig 2B) and four notches 15 (“indentation or gap”, Para 23; “there may be more than one indentation made, such that four separated sections are located around the central opening”, Para 23; as seen in Fig 2B, two notches form two separated sections and, therefore, one of ordinary skill in the art would recognize that four separated sections would be formed by four notches), which radiate outward from the opening through a body wall of the elongate tip to form a plurality of apertures in the body wall of the elongate tip at the distal end of the elongate tip (as seen in Fig 2B,3), wherein the notches prevent fluid-tight connection of a standard female luer connector to the tip (Para 23), and wherein the notches are in fluid communication with the opening on the distal end of the elongate tip for extending the opening across the distal end of the elongate tip to an outside surface of the body wall of the elongate tip, the notches form a path to provide an outlet for leakage of the fluid from the fluid chamber to escape from the opening to the outside surface of the elongate tip when the elongate tip is connected to the standard female luer connector (Para 23); Owens discloses that the design of their tip eliminates the possibility of potentially harmful connection with central IV catheters, central venous pressure ports, infusion ports, balloon ports, introducer ports, peritoneal dialysis catheters, distal ports for pulmonary artery catheters, IV luer connectors, rigid female luer connectors, IV catheter sets, and many other similar type fittings known within the medical industry since it will result in leaking between the elongate tip and any of these structures (Para 6,23). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Shaughnessy’s elongate tip to have four notches that radiate outwardly from the opening through a body wall of the elongate tip to form a plurality of apertures to extend the opening across the distal end of the elongate tip, as taught by Owens, for the purpose of eliminating the possibility of potentially harmful connection with central IV catheters, central venous pressure ports, infusion ports, balloon ports, introducer ports, peritoneal dialysis catheters, distal ports for pulmonary artery catheters, IV luer connectors, rigid female luer connectors, IV catheter sets, and many other similar type fittings known within the medical industry since it will result in leaking between the elongate tip and any of these structures (Para 6,23). Owens is silent as to the spacing of the four notches relative to each other and, therefore, does not teach that they are disposed at 90 degree intervals.
However, it would have been an obvious matter of design choice to modify Shaughnessy/Owens to include the four notches so that they are “disposed at 90 degree intervals” since Applicant has not disclosed that having such a spacing solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Further, absent a teaching as to the criticality of this spacing, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected result) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7,9 (CCPA 1975).
Alternatively, Bickford Smith teaches a non-luer connector 60 (Fig 5a-5b; it is noted that all reference characters cited below refer to Fig 5a and/or Fig 5b unless otherwise noted) having a tip (extending to the right in Fig 5a) with an opening at the end thereof (as seen in Fig 5b,7a, the opening is surrounded by the four castellations 90) and four notches 92 that radiate outward from the opening through a body wall to form a plurality of apertures in the body wall (as seen in Fig 5b), are disposed at 90 degree intervals (as seen in Fig 5b), and extend the opening across the end to an outer surface of the body wall to form a path to provide an outlet for leakage of fluid from the connector to escape from the opening to the outside surface of the tip when the tip is connected to a standard luer connector (Page 20, Lines 25-31); Bickford Smith teaches that providing four notches that are disposed at 90 degree intervals ensures that the notches remain unblocked and are successful in leaking fluid from the non-luer connector if a user attempts to mate the tip with a standard luer fitting to effect a transfer of fluid (Page 20, Lines 27-31). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Shaughnessy/Owens to include the four notches of Owens so that they are disposed at 90 degree intervals, as taught by Bickford Smith, for the purpose of ensuring that the notches will remain unblocked and successfully leak fluid when intended (Para 20, Lines 27-31).
Re claim 7, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Shaughnessy disclosing that the body wall extends from the distal end of the elongate tip to the distal wall of the container (as seen in Fig 1).
Re claim 9, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses a system comprising: the drug delivery device of claim 7 (see the rejection of claim 7 above) with Shaughnessy further disclosing a female non-luer connector 34 being removably attached to the elongate tip of the container (Para 26), the female non-luer connector including a hub body (the entire structure forming connector 34) including an open proximal end (at mating port 36, Para 26), an interior surface defining a second cavity 38 (the “interior surface” is the surface that forms lumen 38, Para 26) dimensioned for fluid-tight connection of the female non-luer connector to the elongate tip (Para 26) and a needle cannula 32 attached to the hub body (as seen in Fig 1, Para 26), the needle cannula including an open distal end 78 in fluid communication with the opening of the container (Para 26).
Re claim 10, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that upon attachment of the female non-luer connector to the container, the notches are in contact with the interior surface of the hub body and a fluid-tight seal is formed between the distal end of the elongate tip and the female non-luer connector (Para 23).
Re claim 11, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that upon attachment of a standard female luer connector to the elongate tip of the container, the notches are disposed at a distance from an inside surface of the standard female luer connector, preventing formation of a fluid-tight seal between the distal end of the elongate tip and the standard female luer connector (Para 23).
Re claim 17, Shaughnessy discloses that a cross-sectional dimension of the second cavity is selected to form a fluid-tight seal with the outside surface of the elongate tip (Para 26).
Re claim 25, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that the notches have a dimension or shape that prevents an inside surface of the standard female luer connector from enclosing or sealing the notches (Para 23).
Re claim 26, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that the elongate tip has a dimension or taper that allows the notches to be positioned in a manner in which an inside surface of the standard female luer connector cannot enclose or seal the notches (Para 23).
Re claim 28, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Shaughnessy disclosing that the body wall extends from the distal end of the elongate tip to the distal wall of the container (as seen in Fig 1).
Re claim 29, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 28 above discloses a system comprising: the drug delivery device of claim 28 (see the rejection of claim 28 above) with Shaughnessy further disclosing a female non-luer connector 34 being removably attached to the elongate tip of the container (Para 26), the female non-luer connector including a hub body (the entire structure forming connector 34) including an open proximal end (at mating port 36, Para 26), an interior surface defining a second cavity 38 (the “interior surface” is the surface that forms lumen 38, Para 26) dimensioned for fluid-tight connection of the female non-luer connector to the elongate tip (Para 26) and a needle cannula 32 attached to the hub body (as seen in Fig 1, Para 26), the needle cannula including an open distal end 78 in fluid communication with the opening of the container (Para 26).
Re claim 30, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that upon attachment of the female non-luer connector to the container, the notches are in contact with the interior surface of the hub body and a fluid-tight seal is formed between the distal end of the elongate tip and the female non-luer connector (Para 23).
Re claim 31, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that upon attachment of a standard female luer connector to the elongate tip of the container, the notches are disposed at a distance from an inside surface of the standard female luer connector, preventing formation of a fluid-tight seal between the distal end of the elongate tip and the standard female luer connector (Para 23).
Re claim 34, Shaughnessy discloses that a cross-sectional dimension of the second cavity is selected to form a fluid-tight seal with the outside surface of the elongate tip (Para 26).
Re claim 35, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that the notches have a dimension or shape that prevents an inside surface of the standard female luer connector from enclosing or sealing the notches (Para 23).
Re claim 36, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that the elongate tip has a dimension or taper that allows the notches to be positioned in a manner in which an inside surface of the standard female luer connector cannot enclose or seal the notches (Para 23).
Re claim 38, Shaughnessy as modified by Owens, or alternatively Shaughnessy as modified by Owens and Bickford Smith, in the rejection of claim 6 above discloses all the claimed features with Owens teaching that the distal end of the tip is beveled or curved at the outer surface adjacent the apertures (as seen best in the up-close cross section in Fig 1B).
Claims 12, 13, 32 and 33 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shaughnessy et al. (PG PUB 2007/0060898)/Owens (PG PUB 2008/0103486) in view of Bickford Smith (Bickford Smith et al. (WO 2004/037335).
Re claim 12 and 13, Shaughnessy discloses that the outside surface of the elongate tip includes a taper in a proximal to distal direction and an outer cross-sectional dimension sized to prevent connection of a standard female luer connector to the container (Para 24), but Shaughnessy/Owens does not explicitly disclose that the taper is 5% (as required by claim 12); additionally, Shaughnessy discloses that the interior surface of the hub body is intended to mate with the elongate tip, but also does not disclose that the interior surface of the hub body has a 5% taper in a proximal to distal direction (as required by claim 13). Bickford Smith, however, teaches providing an elongate tip with a taper of 5% prevents fluid tight mating of the tip with a standard luer connector (Page 6, Lines 23-29). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Shaughnessy/Owens to include the taper of both the outside surface of the elongate tip and the interior surface of the hub body to be 5%, as taught by Bickford Smith, for the purpose of ensuring that a fluid tight mating with a standard luer connector is prevented (Page 6, Lines 23-29).
Re claim 32 and 33, Shaughnessy discloses that the outside surface of the elongate tip includes a taper in a proximal to distal direction and an outer cross-sectional dimension sized to prevent connection of a standard female luer connector to the container (Para 24), but Shaughnessy/Owens does not explicitly disclose that the taper is 5% (as required by claim 32); additionally, Shaughnessy discloses that the interior surface of the hub body is intended to mate with the elongate tip, but also does not disclose that the interior surface of the hub body has a 5% taper in a proximal to distal direction (as required by claim 33). Bickford Smith, however, teaches providing an elongate tip with a taper of 5% prevents fluid tight mating of the tip with a standard luer connector (Page 6, Lines 23-29). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Shaughnessy/Owens to include the taper of both the outside surface of the elongate tip and the interior surface of the hub body to be 5%, as taught by Bickford Smith, for the purpose of ensuring that a fluid tight mating with a standard luer connector is prevented (Page 6, Lines 23-29).
Response to Arguments
Applicant’s arguments filed 11/13/2025 have been fully considered but are not persuasive.
Applicant argues that it is Shaughnessy’s downstream connectors 46 and 24 – not non-luer connector 33 of syringe 69 – that are configured to obstruct connection with an incorrect source and, therefore, there is no teaching, suggestion or motivation to modify connector 33 in view of Owens (or, alternatively, Owens and Bickford Smith). This is not persuasive because Fig 1 shows reference characters 30 and 33 being used interchangeable for the connector at the distal end of syringe 69 and Para 24 explicitly states that connector 30 is an “enteral connector”. Since Owens also discloses that their connector is an enteral connector (Abstract), it would have been obvious to modify Shaughnessy’s enteral connector in view of Owens enteral connector.
Applicant asserts that Owens relates to adapters that can be attached to a medical device used in enteral feeding systems and “thus, like Shaughnessy, Owens fails to relate to” a device as claimed. Besides this assertion, no arguments toward Owens is presented. The Examiner notes that Owens is only used to teach features of a non-luer connector and modifying the non-luer connector 33 of Shaughnessy; Owens connector being an “adaptor” does not negate the obviousness rejection.
Applicant refers to their previous argument against Bickford Smith regarding its notches 92 being disposed on a proximal, rather than a distal, end. This argument was addressed in the last Office Action (dated 8/13/2025) and the Examiner’s position in maintained. In brief, the location of the castellation/indentations at the proximal end of Bickford Smith (instead of at the distal end like in Owen) does not negate the fact that the even spacing of four indentations at 90 degree intervals ensures that the indentations remain unblocked and are successful in leaking fluid from the connector if an attempt to mate the connector with a standard luer fitting is made (as taught on Page 20, Lines 27-31 of Bickford Smith).
The Examiner notes that a couple of ways to amend the claims to overcome the Owen reference were suggested in the 11/10/2025 interview. The Examiner encourages the Applicant to revisit the interview summary and consider making such amendments in order to overcome the current rejections.
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783