CTNF 18/429,685 CTNF 91138 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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 1 recites the limitation "an administration set…to deliver an injectable treatment material" in lines 11-12. It is unclear if it is referring to the limitation in lines 1-2 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1, lines 1-2. 07-34-05 AIA Claim 1 recites the limitation " the proximal end of a catheter " in last line . There is insufficient antecedent basis for this limitation in the claim. Claim 8 recites the limitation "an administration set” in line 2. It is unclear if it is referring to the limitation in line 11 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1, line 11. Claim 8 recites the limitation "a male fitting of the administration set” in line 3. It is unclear if it is referring to the limitation in line 11 of claim 1 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 1, line 11. Claim 9 recites the limitation “a manifold" in last line It is unclear if it is referring to the limitation in line 1 of claim 9 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 9, line 1. Claim 16 recites the limitation “a tubular element" in line 1. It is unclear if it is referring to the limitation in line 1 of claim 13 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation as it is referring to the limitation in claim 13, line 1. 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 13, line 1. 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. 07-34-05 AIA Claim 19 recites the limitation " the lumen of a pre-existing manifold " in line3 . There is insufficient antecedent basis for this limitation in the claim. 07-34-05 AIA Claim 19 recites the limitation " the volume " in line 5 . There is insufficient antecedent basis for this limitation in the claim. 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim s 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 16-18 are depends on claim 13-15 without further defining the limitation ( claim 16 is the same as claim 13, claim 17 is the same as claim 14, claim 18 is the same as claim 18) Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA 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 an 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 an administration set upstream of the manifold of the delivery system, or to accept a 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 a 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 the 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 the 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 the adaptor lumen to maintain patency of the adaptor lumen to facilitate flow of the injectable treatment material therethrough (Fig, 14a) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 4-7, 12-18 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 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 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 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 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 16, Mansour fails to disclose further comprising a tubular element extending within the adaptor body 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 adaptor body lumen as taught by Enomoto for the purpose of allowing the fluid to pass through the lumen (Enomoto. ¶0129) . Re claim 17, Mansour discloses wherein said adaptor body is formed of a pliable material (Fig., 14a, ¶0191) and 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 18, Mansour discloses, wherein said adaptor body 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 molded over said rigid tubular element as taught by Enomoto for the purpose of using of making flexible structure form a resin (Enomoto. ¶0129) . Conclusion 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /HAMZA A DARB/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783 Application/Control Number: 18/429,685 Page 2 Art Unit: 3783 Application/Control Number: 18/429,685 Page 3 Art Unit: 3783 Application/Control Number: 18/429,685 Page 4 Art Unit: 3783 Application/Control Number: 18/429,685 Page 5 Art Unit: 3783 Application/Control Number: 18/429,685 Page 6 Art Unit: 3783 Application/Control Number: 18/429,685 Page 7 Art Unit: 3783 Application/Control Number: 18/429,685 Page 8 Art Unit: 3783 Application/Control Number: 18/429,685 Page 9 Art Unit: 3783 Application/Control Number: 18/429,685 Page 10 Art Unit: 3783 Application/Control Number: 18/429,685 Page 11 Art Unit: 3783 Application/Control Number: 18/429,685 Page 12 Art Unit: 3783 Application/Control Number: 18/429,685 Page 13 Art Unit: 3783 Application/Control Number: 18/429,685 Page 14 Art Unit: 3783
Prosecution Insights