DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 4 reading “male luer tip” should read --male Luer tip--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 5 reading “male luer tip” should read --male Luer tip--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 6 reading “female luer” should read --female Luer--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 13 reading “male luer tip” should read --male Luer tip--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 5 reading “female luer” should read --female Luer--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 9 reading “male luer tip” should read --male Luer tip--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 9 reading “female luer” should read --female Luer--. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 13 reading “male luer tip” should read --male Luer tip--. 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 1, 4-15 and 17 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. Claim 1 recites the limitation “wherein the v-shaped clip element, deformable container, and non-reversible locking element are incorporated into a single unitary construction.” The specification and figures fail to provide support for such a limitation. Applicant’s PGPub paragraph 0061 provides support for only a container assembly as having a unitary construction, not “the v-shaped clip element, deformable container, and non-reversible locking element are incorporated into a single unitary construction.” Appropriate correction and/or clarification is required.
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 1, 4-6, 12, 14-15 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lofgrer et al. (USPN 4,674,655) in view of Maskell (USPGPub 2003/0192909) and Landau et al. (USPN 4,692,157).
Re Claim 1, Lofgrer teaches a single use pre-filled delivery device (Lofgrer Fig. 9) comprising: a deformable container (37) including a side wall (37-1) having an inside surface defining a chamber (37-2) for retaining a pre-determined amount of sterile flush fluid (Lofgrer Annotated Fig. 9 below), a closed proximal end (29) and an open distal end (30) including a male Luer tip (38) having a passageway therethrough providing fluid communication with said chamber (37-2) (Lofgrer Col. 6 Lines 18-29), the male Luer tip (38) removably connectable to a female Luer connection of a vascular access device (as seen below in Lofgrer Annotated Fig. 9 - male Luer tip 38 has a female Luer connection to a needle connected thereto); a frangible seal configured to close the passageway of the chamber (37-2) (Lofgrer Col. 3 Lines 37-42); a v-shaped clip element (45) having two flat longitudinal surfaces connected at a first edge by a single pivot (45-1) (Lofgrer Annotated Fig. 9) located between a distal end of the v-shaped clip element (45) and a proximal end of the v-shaped clip element (45) (Lofgrer Annotated Fig. 9).
Lofgrer further teaches the pivot aligned parallel to the longitudinal axis of the male Luer tip (38) the v-shaped clip element (45) configured to compress the deformable container (37) by pressing the flat longitudinal surfaces together at a second edge opposite the first edge to deliver the sterile flush fluid from the chamber (Lofgrer Annotated Fig. 9 below); and a non-reversible locking element (59) configured to non-reversibly lock the two flat longitudinal surfaces of the v-shaped clip element (45) together (Lofgrer Col. 7 Lines 5-25) after the pre-determined amount of sterile flush fluid has been delivered from the chamber (Lofgrer Col. 7 Lines 5-25), the non-reversible locking element (59) having a ratcheting mechanism (60, 61) having a plurality of teeth (60) and a catch (61) (as seen in Lofgrer Fig. 21), the non-reversible locking element (59) manually activated and non-reversibly locked by a user after the catch (61) fully engages to the plurality of teeth (60) (Lofgrer Col. 7 Lines 5-25).
Lofgrer fails to teach the non-reversible locking element configured to non-reversibly lock the two flat longitudinal surfaces of the v-shaped clip element together at the second edge, the plurality of teeth disposed on one of the two flat longitudinal surfaces of the v-shaped clip element and the catch disposed on the opposite one of the two flat longitudinal surfaces of the v-shaped clip element. Maskell teaches a v-shaped clip element (10) (Maskell Figs. 2a-2b; Annotated Fig. 2a below) comprising a locking element (11), two flat longitudinal surfaces (12), a first edge (13) and a second edge (14), wherein the locking element (11) is configured to lock the two flat longitudinal surfaces (12) of the v-shaped clip element (10) together at a second edge (14), one portion of the locking element (11) on one of the two flat longitudinal surfaces (12) of the v-shaped clip element (10) and an other portion of the locking element (11) disposed on the opposite one of the two flat longitudinal surfaces (12) of the v-shaped clip element (10), the configuration for maintaining the two flat longitudinal surfaces in a fixed spatial position relative to each other (Maskell ¶ 0031).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the non-reversible locking element of Lofgrer to be placed at the second edge of the v-shaped clip element, the plurality of teeth disposed on one of the two flat longitudinal surfaces of the v-shaped clip element and the catch disposed on the opposite one of the two flat longitudinal surfaces of the v-shaped clip element, a similar configuration as disclosed by Maskell for maintaining the two flat longitudinal surfaces in a fixed spatial position relative to each other (Maskell ¶ 0031).
Lofgrer fails to teach the non-reversible locking element providing feedback to the user to confirm delivery of a desired volume of the pre-determined amount of sterile flush fluid from the chamber. Landau teaches a single use pre-filled delivery device (10) (as seen in Landau Fig. 1) comprising: a deformable container (12) and a locking element (14, 22) configured to secure a clip element (18, 32) in place after a pre-determined amount of fluid has been expelled from the chamber, the locking element (18, 32) providing feedback to the user to confirm delivery of a desired volume of the pre-determined amount of sterile flush fluid from the chamber (Landau Col. Lines 5-26 describing a ratchet, wherein ratchets are not only a device, but a sound), the configuration such that at any selected point in the travel of the proximal end toward the distal end, movement can be stopped, and the plurality of teeth which are co-engaged at that selected position will hold the proximal end in a fixed position relative to the distal end until pressure is again applied to the proximal end to continue its downward motion (Landau Col. 8 Lines 19-26).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have included with the pre-filled delivery device of Lofgrer, a locking element that provides feedback to the user to confirm delivery of a desired volume of the pre-determined amount of sterile flush fluid from the chamber as disclosed by Landau such that at any selected point in the travel of the proximal end toward the distal end, movement can be stopped, and the plurality of teeth which are co-engaged at that selected position will hold the proximal end in a fixed position relative to the distal end until pressure is again applied to the proximal end to continue its downward motion (Landau Col. 8 Lines 19-26).
Finally, Lofgrer teaches wherein the clip element (10) and the deformable container (37) are incorporated into a single unitary construction (Lofgrer Col. 2 Lines 55-68). However, Lofgrer fails to teach the wherein the clip element, the deformable container and the locking element are incorporated into a single unitary construction. Landau teaches the clip element (18, 32) and the locking element (14, 22) are incorporated into a single unitary construction (Landau Col. 6 Lines 51-54). Furthermore, Maskell teaches wherein the clip element (10), the deformable container and the locking element (11) are incorporated into a single unitary construction (Maskell ¶ 0008). The use of a one-piece construction as opposed to multiple separate parts is merely a matter of obvious engineering choice (See MPEP 2144.04(V)(A)).
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Re Claim 4, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. Lofgrer fails to teach wherein the non-reversible locking element is arranged to be manually activated by a user after the catch engages to one or more of the plurality of teeth. Landau teaches wherein the locking element (14, 22) (Landau Col. 8 Lines 5-36) is arranged to be manually activated by a user after the catch (44) engages to one or more of the plurality of teeth (42) (Landau Col. 98 Lines 5-36), the configuration such that at any selected point in the travel of the proximal end toward the distal end, movement can be stopped, and the plurality of teeth which are co- engaged at that selected position will hold the proximal end in a fixed position relative to the distal end until pressure is again applied to the proximal end to continue its downward motion (Landau Col. 8 Lines 19-26).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the locking element of Lofgrer in view of Maskell and Landau to be arranged to be manually activated by a user after the catch engages to one or more of the plurality of teeth, the configuration as disclosed by Landau such that at any selected point in the travel of the proximal end toward the distal end, movement can be stopped, and the plurality of teeth which are co-engaged at that selected position will hold the proximal end in a fixed position relative to the distal end until pressure is again applied to the proximal end to continue its downward motion (Landau Col. 8 Lines 19-26).
Re Claim 5, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. Lofgrer in view of Landau fail to explicitly teach wherein the non-reversible locking element minimizes reflux of solution in the passageway. However, the structure of Lofgrer in view of Landau possesses all of the functionally defined limitations of the claimed apparatus and thus, implicitly teach wherein the locking element minimizes reflux of solution in the passageway, see MPEP 2114-I).
Re Claim 6, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. Lofgrer further teaches wherein the vascular access device is an intravenous set (Lofgrer Col. 3 Lines 38-39 - fluid system or needle).
Re Claim 12, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. Lofgrer further teaches wherein the deformable container (1) is made of thermoplastic elastomers, polyolefin, polyester or other injection moldable or formable resin (Lofgrer Claim 8; Col. 3 Lines 19-22 and Lines 56-58).
Re Claim 14, Lofgrer in view of Maskell and Landau teach the pre-filled delivery device of Claim 1. Lofgrer further teaches a method of administering a fluid to a vascular access device comprising the steps of: providing a vascular access device having a proximal end, a distal end and a passageway therethrough (as seen in Lofgrer Annotated Fig. 9 above - needle), said proximal end having a female luer tip in fluid communication with said passageway (Lofgrer Col. 6 Lines 18-29); placing said distal end of said vascular access device in a blood vessel of a patient; engaging said male luer tip of said deformable container with said female luer tip of said vascular access device (Lofgrer Col. 6 Lines 18-29); applying force to the v-shaped clip element (45) (Lofgrer Col. 3 Lines 49-50) such that the catch (61) engages to one or more of the plurality of teeth (60) (Lofgrer Col. 7 Lines 5-25; wherein the modified device of Lofgrer in view of Landau would have the v-shaped clip element engaging the non-reversible locking element).
Landau fails to teach disengaging said male luer tip of said deformable container from said female luer tip of said vascular access device. Landau teaches disengaging a male luer tip (46) of said deformable container (12) from said female luer tip (48) of said vascular access device (50) (Landau Col. 11 Lines 31- 45), the configuration for controlled delivery of a medicament (Landau Abstract). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the method of Lofgrer in view of Maskell and Landau to include disengaging said male luer tip of said deformable container from said female luer tip of said vascular access device as disclosed by Lofgrer for controlled delivery of a medicament (Landau Abstract).
Re Claim 15, Lofgrer in view of Maskell and Landau teach the pre-filled delivery device of Claim 1. Lofgrer fails to teach wherein the catch is disposed at the second edge of a first of the two flat longitudinal surfaces of the v-shaped clip element and the plurality of teeth is disposed at the second edge of a second of the two flat longitudinal surfaces of the v-shaped clip element. Maskell teaches the v-shaped clip element (10) (Maskell Figs. 2a-2b; Annotated Fig. 2a below) comprising a locking element (11) having one portion of the locking element (11) on the second edge (14) of a first of the two flat longitudinal surfaces (12) of the v-shaped clip element (10) and a second portion of the locking element (11) disposed on the second edge (14) of a second of the two flat longitudinal surfaces (12) of the v-shaped clip element (10), the configuration for maintaining the two flat longitudinal surfaces in a fixed spatial position relative to each other (Maskell ¶ 0031).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the clip element of Lofgrer in view of Maskell and Maskell and Landau such that the catch is disposed at the second edge of a first of the two flat longitudinal surfaces of the v-shaped clip element and the plurality of teeth is disposed at the second edge of a second of the two flat longitudinal surfaces of the v-shaped clip element as disclosed by Maskell, the configuration for maintaining the two flat longitudinal surfaces in a fixed spatial position relative to each other (Maskell ¶ 0031).
Re Claim 17, Lofgrer in view of Maskell and Landau teach the pre-filled delivery device of Claim 1. Lofgrer fails to teach wherein at least one of the plurality of teeth is engaged with the catch in an initial uncompressed state of the deformable container. Landau teaches wherein at least one of the plurality of teeth (42) is engaged with the catch (44) in an initial uncompressed state of the deformable container (12) (as seen in Landau Fig. 7). It would have been an obvious matter of design choice to modify Lofgrer in view of Maskell and Landau wherein at least one of the plurality of teeth is engaged with the catch in an initial uncompressed state of the deformable container since applicant has not disclosed that having the aforementioned embodiment solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of at least one of the plurality of teeth is engaged with the catch in an initial uncompressed state of the deformable container, 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 results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555 ,188 USPQ 7, 9 (CCPA 1975).
Claims 7-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lofgrer et al. (USPN 4,674,655) in view of Maskell (USPGPub 2003/0192909) and Landau et al. (USPN 4,692,157) as applied to Claim 1 above, and further in view of Cornett (USPN 4,411,656).
Re Claim 7, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. However, Lofgrer in view of Maskell and Landau fail to teach the delivery device further comprising a pre-selected amount of sterile fluid in the chamber. Cornett teaches a compressible delivery device (Cornett Abstract) comprising a pre-selected amount of sterile fluid in a chamber of the compressible delivery device wherein sterile solutions are useful in medical procedures and are in wide spread use and application throughout the medical industry such as dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15- 30). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have configured the pre-filled delivery device of Lofgrer in view of Landau to include a pre-selected amount of sterile fluid in the chamber of the compressible delivery device as disclosed by Cornett wherein sterile solutions are useful in medical procedures and are in wide spread use and application throughout the medical industry such as dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15-30).
Re Claim 8, Lofgrer in view of Maskell and Landau as applied to Claim 1 above, and further in view of Cornett teach all of the limitations of Claim 7. Lofgrer in view of Maskell and Landau fail to teach wherein the pre-selected amount of sterile fluid in the chamber is from 0.5mL to 10mL. Cornett teaches prefilled delivery devices of 10mL which are useful in inflating Foley catheters, in dispensing lubricating jellies and in dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15-30). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the device of Lofgrer in view of Maskell and Landau as applied to Claim 1 above, and further in view of Cornett to include a sterile fluid volume of 10mL as taught by Cornett which is useful in inflating Foley catheters, in dispensing lubricating jellies and in dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15-30).
Furthermore, prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone V. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005) (anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of 10mL substantially overlaps and thus anticipates the claimed range of 0.5mL to 10mL.
Re Claims 9-11: Lofgrer in view of Maskell and Landau as applied to Claim 1 above, and further in view of Cornett teach all of the limitations of Claims 7 and 8. Lofgrer in view of Maskell and Landau fail to teach wherein the pre-selected amount of sterile fluid is a flush solution of saline, heparin, water or a combination thereof and the fluid comprises a medicament or drug. Cornett teaches a pre-selected amount of sterile fluid in the chamber of the compressible delivery device being a flush solution of saline or water or a medicament wherein sterile solutions are useful in medical procedures and are in wide spread use and application throughout the medical industry such as dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15-30).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have the pre-selected amount of sterile fluid of Lofgrer in view of Maskell and Landau as applied to Claim 1 above, and further in view of Cornett be saline or water or a medicament as disclosed by Cornett wherein sterile solutions are useful in medical procedures and are in wide spread use and application throughout the medical industry such as dispensing drugs into solutions for intravenous introduction into a patient or by other parenteral methods (Cornett Col. 1 Lines 15- 30).
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lofgrer et al. (USPN 4,674,655) in view of Maskell (USPGPub 2003/0192909) and Landau et al. (USPN 4,692,157) as applied to Claim 1 above, and further in view of Beal et al. (USPN 4,645,486).
Re Claim 13, Lofgrer in view of Maskell and Landau teach all of the limitations of Claim 1. Lofgrer in view of Maskell and Landau fail to teach a tip cap releasably connected to the tip. Beal teaches a tip cap (8) releasably connected to the tip (7) for protecting the tip when the delivery device is not in use (Beal Col. 4 Lines 22-24). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have had the tip of Lofgrer in view of Maskell and Landau comprise a tip cap releasably connected to the tip as disclosed by Beal for protecting the tip when the delivery device is not in use (Beal Col. 4 Lines 22-24).
Response to Arguments
Applicant’s arguments filed 12/30/2025 with respect to claim objection of Claim 1 have been fully considered and are persuasive. Due to clarifying amendment, objection to Claim 1 is hereinafter withdrawn.
Applicant’s arguments with respect to Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Examiner concedes the prior provided for in the non-final rejection dated 10/01/2025 fails to teach the Claim 1 limitations wherein the non-reversible locking element is configured to non-reversibly lock the two flat longitudinal surfaces of the v-shaped clip element together at the second edge, and the plurality of teeth disposed on one of the two flat longitudinal surfaces of the v-shaped clip element and the catch disposed on the opposite one of the two flat longitudinal surfaces of the v-shaped clip element. To obviate said limitation, examiner now relies upon Maskell.
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. At the top of Page 7 of the response, applicant argues the prior art fails to teach Claim 15 limitation, now amended into Claim1, “wherein the clip element, the deformable container and the locking element are incorporated into a single unitary construction.” However, such a limitation is not the basis for allowance where “the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.” See MPEP 2144.04-V-B. Furthermore, unitary construction is taught in Maskell ¶ 0008. Based on the teachings of the prior art, guidance via the MPEP, and well-settled case law, the present case will never be moved to allowance on the basis of unitary construction. On Page 10 of the response, applicant argues the v-shaped clip element in Lofgrer is configured to discharge contents of the syringe by pressing ears 45 away from each other. However, the ears 45 of Lofgrer can also be pressed together to expel contents from the syringe, as recited in Claim 1 of Lofgrer.
At the bottom of Page 11 of the response, applicant argues the Lofgrer disclosure of the locking element being both non-reversible and the delivery device being single use is “vague.” However, Lofgrer is explicit in that the lock element is “maintained” Col. 7 Lines 5-25. Furthermore, any device can be used only once. In the present case, nothing prevents the device of Lofgrer from being a single use device. At the bottom of Page 11 leading into Page 12 of the response, applicant argues that element 59, interpreted as the non-reversible locking element, is not discussed in conjunction anywhere in prior art Lofgrer. However, reference to the locking element 59 is in reference to container sidewalls 21, 24, which refers to every container in the Lofgrer reference. In the last paragraph of Page 12 of the response, applicant argues the device of Lofgrer teaches away from being non-reversible by citing to an embodiment that does not include the locking element. This argument is moot as it does not rely on the teachings from Lofgrer being cited in the rejection.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights