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 .
Response to Amendment
This office action is responsive to the preliminary amendments filed on January 9, 2024, January 23, 2024, October 16, 2024, October 25, 2024, and January 10, 2025. As directed by the amendment: no claims have been amended, claims 59-78 have been added, claims 1-58 have been canceled. Thus claims 59-78 are presently pending in this application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 27, 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on June 12, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on August 16, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on October 24, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 59-63, 69, 72, and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 6, and 16 of U.S. Patent No. 11612692 in view of Brewer et al. (US 20200352497), hereinafter Brewer. See analyses below:
Regarding instant claim 59, claim 1 of the patent discloses all limitations of the instant claim except wherein the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas, and the first opening being located distal to a proximal end of the volume displacing member. However, Brewer discloses to wherein the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas (Fig. 25A and [0083], insert is secured within the luer 110 of the syringe 100, and therefore reduced the volumetric capacity within cavity of luer tip 110), and the first opening being located distal to a proximal end of the volume displacing member (Annotated Fig. 25C (see Figure below), first opening is distal to proximal end of insert 700-2).
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Annotated Fig. 25C of Brewer
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe such that the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas, and the first opening being located distal to a proximal end of the volume displacing member. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings (Brewer, [0083]).
Regarding instant claim 60, patent claim 1, in view of Brewer, discloses all limitations of the instant claim, except wherein the interior cavity of the male nozzle has an open proximal end portion and a distal end portion, the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member. However, Brewer further discloses wherein the interior cavity of the male nozzle has an open proximal end portion (Annotated Fig. 25A, proximal end of luer tip 110 which is open and connects to a passage to barrel 105 (see Fig. 3)) and a distal end portion (Fig. 3 and annotated Fig. 25A, distal end of luer tip 110 ), the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member (Fig. 25C and [0084], fluid passes about the circumference of the insert 700, therefore the proximal end of luer tip 110 has an inside diameter greater than the exterior diameter of the proximal end of the insert).
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Annotated Fig. 25A of Brewer
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe such that the interior cavity of the male nozzle has an open proximal end portion and a distal end portion, the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings (Brewer, [0083]).
Regarding instant claim 61, patent claim 1, in view of Brewer, discloses all limitations of the instant claim, except wherein a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle, the flowpath being located proximal to the first opening of the through passage. However, Brewer further discloses wherein a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle (Fig. 25C and [0084],a flow path for the fluid passes about the circumference of the insert 700 (between exterior wall of insert 700 and interior wall of luer tip 110), the flowpath being located proximal to the first opening of the through passage (Annotated Fig. 25C and [0084], at least a portion of the flow path is proximal to the first opening).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to comprise a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle, the flowpath being located proximal to the first opening of the through passage. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings (Brewer, [0083]).
Regarding instant claim 62, patent claim 7, in view of Brewer (see instant claim 59 rejection above), discloses all limitations of the instant claim.
Regarding instant claim 63, patent claim 7, in view of Brewer, discloses all limitations of the instant claim, except wherein the first liquid-tight and air-tight seal is located distal to the first opening of the through passage of the volume displacing member. However, Brewer further wherein the first liquid-tight and air-tight seal is located distal to the first opening of the through passage of the volume displacing member (Annotated Fig. 25C, a first fluid/air tight seal may be positioned distal to first opening).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to comprise a first liquid-tight and air-tight seal located distal to the first opening of the through passage of the volume displacing member. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings and fluid path designs (Brewer, [0083]).
Regarding instant claim 69, patent claim 6, in view of Brewer (see instant claim 59 rejection above), discloses all limitations of the instant claim.
Regarding instant claim 72, patent claim 16, in view of Brewer (see instant claim 59 rejection above), discloses all limitations of the instant claim.
Regarding claim 74, patent claim 1, in view of Brewer, discloses all limitations of the instant claim, except wherein the syringe is a luer-lock syringe comprising: a distal collar with inside locking threads formed around the male nozzle; and a female luer hub with at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle. However, Brewer further discloses wherein the syringe is a luer-lock syringe (Fig. 1, syringe 100 is luer-lock syringe) comprising: a distal collar with inside locking threads formed around the male nozzle (Fig. 1 and 5, male luer tip 110 has collar with internal locking threads surrounding male nozzle); and a female luer hub (Fig. 16, female luer hub configured to be connected to the male tip 110 of syringe 100) with at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle (Fig. 7 and 16 and [0086,0089], female component comprises exterior thread to engage with interior thread of male luer tip 110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to comprise a distal collar with inside locking threads formed around the male nozzle; and a female luer hub with at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle. Doing so would provide a syringe which is compatible with various needleless connectors thus providing a versatile syringe assembly that can permit connection to various different components and be used for various purposes (Brewer, [0086]).
Claims 59-63, 72, and 74 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11612693 in view of Brewer (US 20200352497). See analyses below:
Regarding instant claim 59, claim 6 of the patent discloses all limitations of the instant claim except wherein the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas. However, Brewer discloses to wherein the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas (Fig. 25A and [0083], insert is secured within the luer 110 of the syringe 100, and therefore reduced the volumetric capacity within cavity of luer tip 110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe such that the volume displacing member is configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings and flow paths (Brewer, [0083]).
Regarding instant claim 60, patent claim 6, in view of Brewer, discloses all limitations of the instant claim, except wherein the interior cavity of the male nozzle has an open proximal end portion and a distal end portion, the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member. However, Brewer further discloses wherein the interior cavity of the male nozzle has an open proximal end portion (Annotated Fig. 25A, proximal end of luer tip 110 which is open and connects to a passage to barrel 105 (see Fig. 3)) and a distal end portion (Fig. 3 and annotated Fig. 25A, distal end of luer tip 110 ), the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member (Fig. 25C and [0084], fluid passes about the circumference of the insert 700, therefore the proximal end of luer tip 110 has an inside diameter greater than the exterior diameter of the proximal end of the insert).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe such that the interior cavity of the male nozzle has an open proximal end portion and a distal end portion, the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings (Brewer, [0083]).
Regarding instant claim 61, patent claim 6, in view of Brewer, discloses all limitations of the instant claim, except wherein a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle, the flowpath being located proximal to the first opening of the through passage. However, Brewer further discloses wherein a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle (Fig. 25C and [0084],a flow path for the fluid passes about the circumference of the insert 700 (between exterior wall of insert 700 and interior wall of luer tip 110), the flowpath being located proximal to the first opening of the through passage (Annotated Fig. 25C and [0084], at least a portion of the flow path is proximal to the first opening).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to comprise a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle, the flowpath being located proximal to the first opening of the through passage. Doing so would provide the syringe with a fluid de-accelerator which serves to control fluid flow into and out of the syringe via its side openings (Brewer, [0083]).
Regarding instant claim 62, patent claim 6, in view of Brewer (see instant claim 59 rejection above), discloses all limitations of the instant claim.
Regarding instant claim 63, patent claim 6, in view of Brewer (see instant claim 59 rejection above), discloses all limitations of the instant claim.
Regarding instant claim 72, patent claim 6, in view of Brewer, discloses all limitations of the instant claim, except a plunger moveable in a distal direction and/or a proximal direction inside the interior cavity of the hollow barrel. However, Brewer further discloses a plunger (fig. 1-2 plunger 200) moveable in a distal direction and/or a proximal direction inside the interior cavity of the hollow barrel (Fig. 1 and [0007], plunger moveable within cylindrical barrel 105).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to a plunger moveable in a distal direction and/or a proximal direction inside the interior cavity of the hollow barrel. Doing so would provide an effective syringe for infusing fluid to a cannula for delivery to the veins (Brewer, [0077]).
Regarding claim 74, patent claim 6, in view of Brewer, discloses all limitations of the instant claim, except wherein the syringe is a luer-lock syringe comprising: a distal collar with inside locking threads formed around the male nozzle; and at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle. However, Brewer further discloses wherein the syringe is a luer-lock syringe (Fig. 1, syringe 100 is luer-lock syringe) comprising: a distal collar with inside locking threads formed around the male nozzle (Fig. 1 and 5, male luer tip 110 has collar with internal locking threads surrounding male nozzle); and at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle (Fig. 7 and 16 and [0086,0089], female component comprises exterior thread to engage with interior thread of male luer tip 110).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the syringe to comprise a distal collar with inside locking threads formed around the male nozzle; and at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle. Doing so would provide a syringe which is compatible with various needleless connectors thus providing a versatile syringe assembly that can permit connection to various different components and be used for various purposes (Brewer, [0086]).
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 73 is 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 73 recites the limitation "the distal facing exterior end wall of the volume displacing member". There is insufficient antecedent basis for this limitation in the claim, as claim 73, nor any claim that claim 73 depends on, does not define the limitation of a ” distal facing exterior end wall” for the volume displacing member. For examining purposes, "the distal facing exterior end wall of the volume displacing member" will be interpreted as a new claim limitation.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 59-63, 72, and 74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brewer (US 20200352497).
Regarding claim 59, Brewer discloses a syringe (syringe 100) comprising: a hollow barrel (Fig. 3, barrel 105) configured to store a liquid or gas in an interior cavity therein (Barrel 105 has fluid chamber 130 therein); a male nozzle extending distally from the hollow barrel (Fig. 3, male luer tip 110) and having an interior cavity defined by an interior wall of the male nozzle (Fig. 3 and 5, interior cavity of male luer tip 110); and a volume displacing member (Fig. 25C, insert 700-2) disposed inside the interior cavity of the male nozzle and configured to reduce the cubic volumetric capacity inside the interior cavity of the male nozzle available for accommodating the liquid or gas (Fig. 25A and [0083], insert is secured within the luer 110 of the syringe 100, and therefore reduced the volumetric capacity within cavity of luer tip 110), the volume displacing member including a body (Fig. 25C, insert 700-2 body) having a through passage (Fig. 25C, interior through passage of insert 700-2) that includes a first opening (Annotated Fig. 25C, first opening) and a second opening distal to the first opening (Annotated Fig. 25C, second opening, distal to first opening), the first opening being in fluid communication with the interior cavity of the hollow barrel (Annotated Fig. 25C and [0083], insert and its side ports, such as first opening controls fluid flow into/out of syringe, therefore is in fluid communication with the barrel), the first opening being located distal to a proximal end of the volume displacing member (Annotated Fig. 25C, first opening is distal to proximal end of insert 700-2).
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Annotated Fig. 25C of Brewer
Regarding claim 60, Brewer discloses the syringe according to claim 59, wherein the interior cavity of the male nozzle has an open proximal end portion (Annotated Fig. 25A, proximal end of luer tip 110 which is open and connects to a passage to barrel 105 (see Fig. 3)) and a distal end portion (Fig. 3 and annotated Fig. 25A, distal end of luer tip 110 ), the open proximal end portion having an inside diameter greater than the outside diameter of a proximal end portion of the body of the volume displacing member (Fig. 25C and [0084], fluid passes about the circumference of the insert 700, therefore the proximal end of luer tip 110 has an inside diameter greater than the exterior diameter of the proximal end of the insert).
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Annotated Fig. 25A of Brewer
Regarding claim 61, Brewer discloses the syringe according to claim 60, wherein a flowpath configured to accommodate a flow of the liquid or gas exists between an exterior wall of the proximal end portion of the body of the volume displacing member and a portion of the interior wall of the male nozzle (Fig. 25C and [0084],a flow path for the fluid passes about the circumference of the insert 700 (between exterior wall of insert 700 and interior wall of luer tip 110), the flowpath being located proximal to the first opening of the through passage (Annotated Fig. 25C and [0084], at least a portion of the flow path is proximal to the first opening).
Regarding claim 62, Brewer discloses the syringe according to claim 59, wherein a first liquid-tight and air-tight seal exists between an exterior wall of the body of the volume displacing member and the interior wall of the male nozzle (Fig. 25A and annotated Fig. 25C and [0083], fluid must flow through the flow ports of the insert in order to pass through the circumference of the insert, therefore the insert 700-2 is able to make a fluid/air-tight seal between its exterior-most wall and the interior wall of luer tip 110).
Regarding claim 63, Brewer discloses the syringe according to claim 62, wherein the first liquid-tight and air-tight seal is located distal to the first opening of the through passage of the volume displacing member (Annotated Fig. 25C, a first fluid/air tight seal may be positioned distal to first opening).
Regarding claim 72, Brewer discloses the syringe according to claim 59, further comprising a plunger (fig. 1-2 plunger 200) moveable in a distal direction and/or a proximal direction inside the interior cavity of the hollow barrel (Fig. 1 and [0007], plunger moveable within cylindrical barrel 105).
Regarding claim 74, Brewer discloses the syringe according to claim 59, wherein the syringe is a luer-lock syringe (Fig. 1, syringe 100 is luer-lock syringe) comprising: a distal collar with inside locking threads formed around the male nozzle (Fig. 1 and 5, male luer tip 110 has collar with internal locking threads surrounding male nozzle); and a female luer hub (Fig. 16, female luer hub configured to be connected to the male tip 110 of syringe 100) with at least one proximal flange or threaded portion configured to mechanically engage with the locking threads of the distal collar when the female luer hub is rotated onto the male nozzle (Fig. 7 and 16 and [0086,0089], female component comprises exterior thread to engage with interior thread of male luer tip 110).
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.
Claims 64-65, 67, 70, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US 20200352497), in view of Shaw (US 20230052321).
Regarding claim 64, Brewer discloses the--- syringe according to claim 63, further comprising an exterior wall of the male nozzle (Fig. 3 and 25A, exterior wall of luer tip 110).
Brewer fails to disclose a female luer hub including an interior cavity in which resides at least a portion of the male nozzle, the female luer hub having an interior sidewall that surrounds and abuts an exterior wall of the male nozzle such that a second liquid-tight and air-tight seal is formed between the interior wall of the female luer hub and the exterior wall of the male nozzle. However, Shaw discloses a female luer hub (Fig. 3, chamber luer 44) including an interior cavity in which resides at least a portion of the male nozzle (Fig. 3, cavity of chamber luer 44 wherein a portion of nose 24 resides), the female luer hub having an interior sidewall (Fig. 3, surface 70) that surrounds and abuts the exterior wall of the male nozzle such that a second liquid-tight and air-tight seal is formed between the interior wall of the female luer hub and the exterior wall of the male nozzle (Fig. 3 and [0020], surface 70 surrounds and abuts surface 72 to provide a fluid/air-tight seal between the two surfaces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer to incorporate the disclosures of Shaw and modify the syringe to include a female luer hub including an interior cavity in which resides at least a portion of the male nozzle, the female luer hub having an interior sidewall that surrounds and abuts an exterior wall of the male nozzle such that a second liquid-tight and air-tight seal is formed between the interior wall of the female luer hub and the exterior wall of the male nozzle. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to a needle for delivery to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Regarding claim 65, Brewer in view of Shaw, discloses the--- syringe according to claim 64, wherein the male nozzle has a distal facing exterior end wall (Fig. 3 and 25A, distal facing exterior end of luer tip 110).
As noted above Brewer fails to disclose a female luer hub, and is thus silent to the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub. However, Shaw further discloses the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub (Fig. 3, distal exterior wall 83 faces the proximal facing interior end wall of chamber luer 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to further incorporate the disclosures of Shaw and modify the distal facing exterior end wall to face a proximal facing interior wall of the female luer hub. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to a needle for delivery to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Regarding claim 67, Brewer in view of Shaw, discloses the--- syringe according to claim 64, wherein the volume displacing member includes a distal end portion having a distal end wall (Fig.25C, insert 700-2 has a distal end with a distal end wall).
As noted above Brewer fails to disclose a female luer hub, and is thus silent to the distal end wall facing a proximal facing interior wall of the female luer hub. However, Shaw further discloses the distal end wall facing a proximal facing interior wall of the female luer hub (Fig. 3, distal end of nose 24 (which is equivalent to luer tip 110 of Brewer, wherein the distal ends of the luer tip 110 and the insert 700-2 face the same direction, see fig. 25A of Brewer) faces the proximal facing interior end wall of chamber luer 44, thus the distal end wall of the insert faces the interior end wall of chamber luer 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to further incorporate the disclosures of Shaw and modify the distal end wall of the volume displacing member to face a proximal facing interior wall of the female luer hub. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to a needle for delivery to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Regarding claim 70, Brewer in view of Shaw, discloses the--- syringe according to claim 64, wherein the male nozzle has a distal facing exterior end wall (Fig. 3 and 25A, distal facing exterior end of luer tip 110), and the volume displacing member includes a distal end portion having a distal end wall (Fig.25C, insert 700-2 has a distal end with a distal end wall).
As noted above Brewer fails to disclose a female luer hub, and is thus silent to the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub, and the distal end wall facing a proximal facing interior wall of the female luer hub. However, Shaw further discloses the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub (Fig. 3, distal exterior wall 83 faces the proximal facing interior end wall of chamber luer 44), and the distal end wall facing a proximal facing interior wall of the female luer hub (Fig. 3, distal end of nose 24 (which is equivalent to luer tip 110 of Brewer, wherein the distal ends of the luer tip 110 and the insert 700-2 face the same direction, see fig. 25A of Brewer) faces the proximal facing interior end wall of chamber luer 44, thus the distal end wall of the insert faces the interior end wall of chamber luer 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to further incorporate the disclosures of Shaw and modify the distal facing exterior end wall and the distal end wall of the volume displacing member to both face a proximal facing interior wall of the female luer hub. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to a needle for delivery to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Regarding claim 75, Brewer discloses the--- syringe according to claim 59, further comprising an exterior wall of the male nozzle (Fig. 3 and 25A, exterior wall of luer tip 110).
Brewer fails to disclose wherein the syringe is attached to a female luer hub cap that includes an interior cavity in which resides at least a portion of the male nozzle, the female luer hub cap having an interior wall that surrounds and abuts an exterior wall of the male nozzle such that a liquid-tight and air-tight seal is formed between the interior wall of the female luer hub cap and the exterior wall of the male nozzle. However, Shaw discloses wherein the syringe is attached to a female luer hub cap (Fig. 2-3, syringe 10 is attached to chamber luer 44) that includes an interior cavity in which resides at least a portion of the male nozzle (Fig. 3, cavity of chamber luer 44 wherein a portion of nose 24 resides), the female luer hub cap having an interior wall (Fig. 3, surface 70) that surrounds and abuts the exterior wall of the male nozzle such that a liquid-tight and air-tight seal is formed between the interior wall of the female luer hub cap and the exterior wall of the male nozzle (Fig. 3 and [0020], surface 70 surrounds and abuts surface 72 to provide a fluid/air-tight seal between the two surfaces).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer to incorporate the disclosures of Shaw and modify the syringe to include a female luer hub cap that includes an interior cavity in which resides at least a portion of the male nozzle, the female luer hub cap having an interior wall that surrounds and abuts an exterior wall of the male nozzle such that a liquid-tight and air-tight seal is formed between the interior wall of the female luer hub cap and the exterior wall of the male nozzle. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to a needle for delivery to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Claims 66, 68, 71, 73, and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US 20200352497), in view of Shaw (US 20230052321), as applied to claims 64, 67, 70, and 75 above, and further in view of Agian et al. (US 20110282298), hereinafter Agian.
Regarding claim 66, Brewer in view of Shaw, discloses the--- syringe according to claim 64.
Brewer, in view of Shaw, fails to disclose wherein the distal facing exterior end wall of the male nozzle is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal facing exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub. However, Agian discloses wherein the distal facing exterior end wall of the male nozzle is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal facing exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub (Fig. 1A-C, the distal facing exterior wall of male fitting 20 is spaced from an interior proximal facing end wall of female fitting 30, thus forming a cavity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to incorporate the disclosures of Agian and modify the connection between the male nozzle and the female luer hub such that the distal facing exterior end wall of the male nozzle is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal facing exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub. Doing so would provide space within the connection for a more effective insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection (Agian,[0061-0062]).
Regarding claim 68, Brewer in view of Shaw, discloses the--- syringe according to claim 67.
Brewer, in view of Shaw, fails to disclose wherein the distal end portion of the volume displacing member comprises a resilient material and is arranged with respect the proximal facing interior wall of the female luer hub to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub. However, Agian discloses the distal end portion of the volume displacing member comprises a resilient material (Fig. 1D and [0067], insert 40 has a head 42 and may be made of resilient materials rubber or silicone) and is arranged with respect the proximal facing interior wall of the female luer hub to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub (Fig. 1C, and [0054, 0063, and 0067], insert 40 head 42 arranged is configured to fully fill the ‘triangular” space within the female hub 30 when the male nozzle 20 is inserted to a full friction fit, thus forming a seal within the triangular space between the insert and the interior wall of the female hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to incorporate the disclosures of Agian and modify the volume displacing member to comprise a resilient material and is arranged with respect the proximal facing interior wall of the female luer hub to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub. Doing so would provide an insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection and aid in prevention of fluid leakage within the syringe (Agian, [0054, 0061-0062]).
Regarding claim 71, Brewer in view of Shaw, discloses the--- syringe according to claim 70.
Brewer, in view of Shaw, fails to disclose wherein the distal exterior end wall of the male nozzle faces and is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub. However, Agian discloses wherein the distal exterior end wall of the male nozzle faces and is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub (Fig. 1A-C, the distal facing exterior wall of male fitting 20 is spaced from an interior proximal facing end wall of female fitting 30, thus forming a cavity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to incorporate the disclosures of Agian and modify the connection between the male nozzle and the female luer hub such that the distal exterior end wall of the male nozzle faces and is spaced apart from the proximal facing interior wall of the female luer hub such that a cavity exists between the distal exterior end wall of the male nozzle and the proximal facing interior wall of the female luer hub. Doing so would provide space within the connection for a more effective insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection (Agian,[0061-0062]).
Regarding claim 73, Brewer in view of Shaw, discloses the--- syringe according to claim 64, wherein the male nozzle has a distal facing exterior end wall (Fig. 3 and 25A, distal facing exterior end of luer tip 110).
As noted above, Brewer fails to disclose the female luer hub, and is thus silent to a needle attached to the female luer hub, the needle having a lumen open to the interior cavity of the female luer hub, forming an internal flowpath configured between the lumen of the needle, the through passage of the body of the volume displacing member and the interior cavity of the hollow barrel, and the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub. However, Shaw further discloses a needle attached to the female luer hub (Fig. 2-3 and [0022], needle 56, attached to chamber luer 44 via needle holder 58), the needle having a lumen open to the interior cavity of the female luer hub (Fig. 2-3, needle 56 has lumen open to the interior cavity of chamber luer 44), forming an internal flowpath configured between the lumen of the needle, the through passage of the body of the volume displacing member and the interior cavity of the hollow barrel (Fig. 2-3, internal flow path exists between needle 56 lumen, the internal cavity of luer 44 and thus the internal cavity of male nose 24 (equivalent to luer tip 110 of Brewer, which contains the insert having the through passage, see Figs. 25A and 25C of Brewer), and the interior space of barrel 12 (equivalent to barrel 105 of Brewer)), and the distal facing exterior end wall faces a proximal facing interior wall of the female luer hub (Fig. 3, distal exterior wall 83 faces the proximal facing interior end wall of chamber luer 44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to further incorporate the disclosures of Shaw and modify the syringe to have a needle attached to the female luer hub, the needle having a lumen open to the interior cavity of the female luer hub, forming an internal flowpath configured between the lumen of the needle, the through passage of the body of the volume displacing member and the interior cavity of the hollow barrel; and modify the distal facing exterior end wall to face a proximal facing interior wall of the female luer hub. Doing so would provide the syringe with a passage which communicates the fluid with the barrel to the needle for delivery of the fluid to the patient in a fashion which ensures a sealed connection between the components of the device (Shaw, [0020-0021]).
Brewer, in view of Shaw, fails to disclose wherein a third liquid-tight and air-tight seal exists between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub. However, Agian discloses wherein a third liquid-tight and air-tight seal exists between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub (Fig. 1C, and [0054, 0063, and 0067], insert 40 head 42 is configured to fully fill the ‘triangular” space within the female hub 30 when the male nozzle 20 is inserted to a full friction fit, thus forming a seal within the triangular space between the insert and the interior wall of the female hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to incorporate the disclosures of Agian and modify the volume displacing member to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub. Doing so would provide an insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection and aid in prevention of fluid leakage within the syringe (Agian, [0054, 0061-0062]).
Regarding claim 76, Brewer in view of Shaw, discloses the--- syringe according to claim 75.
Brewer, in view of Shaw, fails to disclose wherein a distal end portion of the volume displacing member comprises a resilient material and has a distal end wall facing and abutting the proximal facing interior wall of the female luer hub cap to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub cap. However, Agian discloses a distal end portion of the volume displacing member comprises a resilient material (Fig. 1D and [0067], insert 40 has a head 42 and may be made of resilient materials rubber or silicone) and has a distal end wall facing and abutting the proximal facing interior wall of the female luer hub cap to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub cap (Fig. 1C, and [0054, 0063, and 0067], insert 40 head 42 has a distal end wall that is configured to abut the proximal facing interior wall of the female luer hub and fully fill the ‘triangular” space within the female hub 30 when the male nozzle 20 is inserted to a full friction fit, thus forming a seal within the triangular space between the end wall of the insert and the interior wall of the female hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, to incorporate the disclosures of Agian and modify the volume displacing member to comprise a resilient material and have a distal end wall facing and abutting the proximal facing interior wall of the female luer hub cap to form a third liquid-tight and air-tight seal between the distal facing exterior end wall of the volume displacing member and the proximal facing interior wall of the female luer hub cap. Doing so would provide an insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection and aid in prevention of fluid leakage within the syringe (Agian, [0054, 0061-0062]).
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US 20200352497), in view of Agian (US 20110282298).
Regarding claim 69, Brewer discloses the--- syringe according to claim 59.
Brewer fails to disclose wherein a distal end portion of the volume displacing member includes a radial protrusion having a proximal face that abuts a distal exterior end wall of the male nozzle, wherein a liquid-tight and air-tight seal exists between the proximal face of the radial protrusion and the distal exterior end wall of the male nozzle. However, Agian discloses wherein a distal end portion of the volume displacing member includes a radial protrusion (Fig. 1D, insert 40 has a head 42 which protrudes radially) having a proximal face that abuts a distal exterior end wall of the male nozzle (Fig. 1C, proximal face of head 42 abuts the distal exterior end of male fitting 20), wherein a liquid-tight and air-tight seal exists between the proximal face of the radial protrusion and the distal exterior end wall of the male nozzle (Fig. 1C, and [0054, 0063, and 0067], head 42 is configured to abut the proximal facing interior wall of the female luer hub and the distal exterior end of male fitting 20, such that it contracts upon contact from the distal end of the male fitting 20 to fully fill the ‘triangular” space within the female hub 30 when the male nozzle 20 is inserted to a full friction fit, thus forming a seal within the triangular space between the end wall of the insert and the distal exterior end of male fitting).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer to incorporate the disclosures of Agian and modify the a distal end portion of the volume displacing member to include a radial protrusion having a proximal face that abuts a distal exterior end wall of the male nozzle, wherein a liquid-tight and air-tight seal exists between the proximal face of the radial protrusion and the distal exterior end wall of the male nozzle. Doing so would provide an insert configured to reduce dead space both within the female luer hub and male syringe nozzle, thus further minimizing the fluid remaining in both the syringe and female hub after injection and aid in prevention of fluid leakage within the syringe (Agian, [0054, 0061-0062]).
Claims 77-78 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US 20200352497), in view of Shaw (US 20230052321) and Agian (US 20110282298), as applied to claim 76 above, and further in view of Jiang et al. (US 20220273931), hereinafter Jiang.
Regarding claim 77, Brewer in view of Shaw and Agian, discloses the--- syringe according to claim 76, as explained above. Brewer, in view of Shaw, is silent to wherein the distal end portion of the volume displacing member has a distal end wall facing a proximal facing interior wall of the female luer hub cap, the female luer hub cap including a projection that extends proximally from the proximal facing interior wall into the through passage of the volume displacing member. However, Agian further discloses wherein the distal end portion of the volume displacing member has a distal end wall facing a proximal facing interior wall of the female luer hub cap (Fig. 1A-B, head 42 of insert 40 has a distal end wall which faces the proximal facing interior wall of female fitting 30), the female luer hub cap including a projection that extends proximally from the proximal facing interior wall into the through passage of the volume displacing member (Fig. 6A-C, female fitting 430 (similar to fitting 30 of Fig. 1) comprises pipe 434 which extends proximally from interior wall through the center of the male fitting 420 (which is equivalent to male tip 110 of Brewer which at its center axis is the internal passage of insert 700-2, therefore pipe 434 would extend into passage of the insert)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw and Agian, to further incorporate the disclosures of Agian and modify the distal end portion of the volume displacing member to have a distal end wall facing a proximal facing interior wall of the female luer hub cap, modify the female luer hub cap to include a projection that extends proximally from the proximal facing interior wall into the through passage of the volume displacing member. Doing so would provide a continuous sealed flow path which bypasses any exterior dead space within the female fitting of the syringe device (Agian, [0088]).
Brewer, in view of Shaw and Agian, fails to disclose the volume displacing member including a collar that has an interior wall that surrounds and abuts an exterior wall of the projection. However, Jiang discloses the volume displacing member including a collar that has an interior wall that surrounds and abuts an exterior wall of the projection (Fig. 2 and 11, insert 150 comprises a collar portion at its distal end, defined by prongs 162, which has interior wall 158 that surround and abut the exterior wall of projection 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw and Agian, to incorporate the disclosures of Jiang and modify the distal end of the volume displacing member to comprise a collar that has an interior wall that surrounds and abuts an exterior wall of the projection. Doing so would ensure a snap fit engagement between the projection of the female luer and the interior passage of the volume displacing member (Jiang, [0105]).
Regarding claim 78, Brewer, in view of Shaw, Agian, and Jiang, discloses the--- syringe according to claim 767 as explained above. Brewer, in view of Shaw and Agian, fails to disclose the collar and is thus silent to wherein the projection is press-fit into the collar. However, Jiang further discloses wherein the projection is press-fit into the collar (Fig. 11 and [0105, 1018], prongs 162 allow a snap-fit connection between insert 150 and projection 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer, in view of Shaw, Agian, and Jiang, to further incorporate the disclosures of Jiang and modify the projection to be press-fit into the collar. Doing so would provide a snap-fit connection between the projection of the female luer and the interior passage of the volume displacing member which prevents any relative movement between the components, ensuring a secure connection between components (Jiang, [0105, 0123]).
Conclusion
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783