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 .
Acknowledgment
Claims 1, 7-9, 15, 19-20 are amended and field on 8/24/2026,
Claims 16-18 are canceled.
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.
Claims 7, 15 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 18 recites a step of making /molded. It is unclear if the claim is a method of claiming of a device claim. The examiner will interpret the limitation as a device claim.
Claim 15 recites a step of making /molded. It is unclear if the claim is a method of claiming of a device claim. The examiner will interpret the limitation as a device claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8-11, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansour et al. (US 20230397861 A1) (“Mansour”).
Re claim 1, Mansour discloses an adaptor (Fig. 1 c shows the details of the overall connection with iv set connected to the adaptor 10 and Fig. 14b show the details of the adaptor 1540 , Fig. 1-14d, ¶0190) configured to modify a separately manufactured delivery system through which an injectable treatment material is delivered to a patient’s body (the system is capable to deliver IV fluid see Fig. 9c, 17, ¶0102, ¶0131), said adaptor comprising an adaptor body (1544) extending from a proximal end (1541) to a distal end (1542), wherein: a lumen is defined through said adaptor body (1543, ¶0190), extending between the proximal end and the distal end of said adaptor body (Fig. 14a); the adaptor is sized, shaped, configured, and/or dimensioned to fit within a lumen defined through a manifold of the delivery system (1510, Fig. 14a) to reduce the dimensions of the manifold lumen to facilitate flow of the injectable treatment material therethrough from a proximal end (right end of 1510) of the manifold to a distal end of the manifold (left end of 1510, ¶0190, Note, 17 as in Fig.9c show that the device can be used to delivery treatment, ¶0102); the proximal end of the adaptor is configured to mate with a male fitting of an administration set (1545, and the male fitting 1522, ¶0191, Fig. 14a) configured to deliver the injectable treatment material through the manifold (¶0102); and the distal end of the adaptor is configured to be positioned within the manifold lumen upstream of the proximal end of a catheter within the manifold lumen (1570, Fig. 1c, Fig. 14a, top end of catheter 60 in Fig. 9c is connected to left end of 1510, ¶0194).
Re claim 2, Mansour discloses wherein the adaptor lumen includes a tapered segment (¶0192, at least 1540, Fig. 14a).
Re claim 3, Mansour discloses wherein the tapered segment is adjacent the proximal end of said adaptor body (¶0192, at least 1540, Fig. 14a).
Re claim 8, Mansour discloses wherein the proximal end of said adaptor is configured to mate against the face of a fitting of the administration set upstream of the manifold of the delivery system, or to accept the male fitting of the administration set therein (1520, Fig. 14b).
Re claim 9, Mansour discloses an adaptor (Fig. 1 c shows the details of the overall connection with iv set connected to the adaptor 10 and Fig. 14b show the details of the adaptor 1540 , Fig. 1-14d, ¶0190) configured to modify a manifold through which an injectable treatment material flows for delivery to a patient’s body (Fig. 9c, the system capable to deliver IV fluid 17, ¶0102, ¶0131), said adaptor (1540) comprising an adaptor body extending from a proximal end (1541) to a distal end (1542), wherein: a lumen (1543, ¶0190) is defined through said adaptor body extending between the proximal end and the distal end of said adaptor body (Fig. 14a); the adaptor is sized, shaped, configured, and/or dimensioned to be inserted into a lumen (lumens of 1510) defined through the manifold (1510) to reduce the dimensions of the manifold lumen to facilitate flow of the injectable treatment material therethrough from a proximal end of the manifold to a distal end of the manifold (Fig. 14a, ¶0190); the adaptor is at least partially formed of a pliable material to conform to the manifold lumen to fill space within the manifold lumen (¶0191, the material is flexible/compressible); and the adaptor is sized, shaped, configured, and/or dimensioned and formed of a material so that the adaptor body maintains patency of the adaptor lumen when positioned within the manifold (Fig. 14a).
Re claim 10, Mansour discloses wherein the adaptor lumen includes a tapered segment (¶0192, at least 1540, Fig. 14a).
Re claim 11, Mansour discloses wherein the tapered segment is adjacent the proximal end of said adaptor body (¶0192, at least 1540, Fig. 14a).
Re claim 19, Mansour discloses a method of reconfiguring a system for delivering an injectable treatment material (Fig. 1-14d, ¶0190), said method comprising: inserting a pliable adaptor (1540) into a lumen of a pre-existing manifold (lumen1510) formed separately and independently of the adaptor (Fig, 14b); and fitting the adaptor within the manifold lumen to occupy space therein to reduce a volume within the manifold lumen to facilitate flow of the injectable treatment material through the manifold and into a patient’s body (Fig, 14a, ¶0102, ¶0190).
Re claim 20, Mansour discloses, further comprising providing a tubular element (1520) within a lumen of the adaptor to maintain patency of the adaptor lumen to facilitate flow of the injectable treatment material therethrough (Fig, 14a).
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.
Claim(s) 4-7, 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansour in view of Enomoto et al. (US 20030171721 A1) (“Enomoto”).
Re claim 4, Mansour fails to disclose wherein the adaptor lumen has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (342, ,Fig. 6, Fig. 10, ¶0128, 312 next to taper portion 311, ¶0152).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour so that the adaptor lumen has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 5, Mansour fails to disclose further comprising a tubular element extending within the constant-diameter segment of the adaptor lumen.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (314, ,Fig. 6, Fig. 10, ¶0128, 312 next to taper portion 311, ¶0152) and comprising a tubular element (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour to include a tubular element extending within the constant-diameter segment of the adaptor lumen as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 6, Mansour discloses wherein said adaptor body is formed of a pliable material (¶0190, flexible and compressible) , but it fails to disclose that said tubular element is formed of a material more rigid than the adaptor body material.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (32, ¶0118, made from elastic rubber) and said tubular element is formed of a material more rigid than the adaptor body material. (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour to include a tubular element formed of a material more rigid than the adaptor body material as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 7, Mansour fails to disclose wherein said adaptor body is an over-molded component that is molded over said rigid tubular element.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (32, ¶0118, made from elastic rubber) and said tubular element is formed of a material more rigid than the adaptor body material. (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) and wherein said adaptor body is molded over said rigid tubular element (¶0121).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour so that said adaptor body is an over-molded component that is molded over said rigid tubular element as taught by Enomoto for the purpose of using of making flexible structure form a resin (Enomoto. ¶0129) .
Re claim 12, Mansour fails to disclose wherein the adaptor lumen has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (314, ,Fig. 6, Fig. 10, ¶0128, 312 next to taper portion 311, ¶0152) and comprising a tubular element (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour so that the adaptor lumen has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 13, Mansour fails to disclose further comprising a tubular element extending within the constant-diameter segment of the adaptor lumen.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (314, ,Fig. 6, Fig. 10, ¶0128, 312 next to taper portion 311, ¶0152) and comprising a tubular element (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour to include a tubular element extending within the constant-diameter segment of the adaptor lumen as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 14, Mansour discloses wherein said adaptor body is formed of a pliable material (¶0190, flexible and compressible), but it fails to disclose that said tubular element is formed of a material more rigid than the adaptor body material.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (32, ¶0118, made from elastic rubber) and said tubular element is formed of a material more rigid than the adaptor body material. (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) .
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour to include a tubular element formed of a material more rigid than the adaptor body material as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) .
Re claim 15, Mansour fails to disclose wherein said adaptor body is an over=molded component that is molded over said rigid tubular element.
However, Enomoto discloses an adaptor (3’, Fig. 6-10. 32, 34, 35, ¶0128) and wherein the adaptor has a lumen (341, 342) has a constant-diameter segment extending from the tapered segment to the distal end of said adaptor body (32, ¶0118, made from elastic rubber) and said tubular element is formed of a material more rigid than the adaptor body material. (holder 34, 342, ¶0142, made from metal, ¶0028 extending within the constant-diameter segment of the adaptor lumen (342, (Fig. 6) and wherein said adaptor body is molded over said rigid tubular element (¶0121).
Thus, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modify the adaptor lumen of Mansour so that said adaptor body is an over-molded component that is molded over said rigid tubular element as taught by Enomoto for the purpose of using of making flexible structure form a resin (Enomoto. ¶0129).
Response to Arguments
Applicant's arguments filed 8/24/2026 have been fully considered but they are not persuasive.
The argument with regards to claim 1 in page 7-10 that Mansour’s device is related to hemolysis- reduction accessories for blood draw. This is found not persuasive as “hemolysis- reduction accessories” was not claimed.
The applicant argues that flow restriction of Mansour is as compressible valve member which fails to disclose the limitation “sized, shaped …to fit within a lumen defined through…”. This is found not persuasive as the limitation means that the device is capable to be match in size to connect with a manifold lumen see Fig. 9c, Fig. 14a.
The applicant argues to the claim 1 with regards to injection the material ..et. This is found not persuasive as it is capable to deliver/inject the material to the patient see ¶0102. Note the applicant is advised to amend the term “configured” to positively recited limitation such as “the proximal end of the adaptor he injectable treatment material through the manifold.’
The applicant argues with regards to claim 9 in page 9 that a blood is collected with the devices not injected to the adapter. This is found not to be persuasive as in ¶0102 shows that the device is capable to be used in iv delivery system wherein the iv flow in the opposite direction as the blood drawing.
The applicant argues with regards to claim 19 in pages 9-10 that a blood is collected with the devices not injected to the adapter. This is found not persuasive as in ¶0102 shows that the device is capable to be used in iv delivery system wherein the iv flow in the opposite direction as the blood drawing.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. 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 HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
