CTNF 18/508,709 CTNF 95487 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. Drawings 06-22 AIA The drawings are objected to because of the following: Reference numerals 210 and 212 in Fig. 7A are incorrectly labeled. Currently, Fig. 7A the reference numerals 210 and 212 are inversed and should be corrected to properly label the barrier layer 210 and the slit 212. Reference numeral 182 in Fig. 9C should be amended to be reference numeral 186 as Fig. 9C is referring to the finger 186 rather than the edge 182 of Figs. 8A – 8G . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification 07-29 AIA The disclosure is objected to because of the following informalities: Paragraph [0016] should be amended to recite “and a clip having a first arms arm extending from an ends end of a rear wall of the clip, the first arms arm being resilient, where the first arm extends obliquely in a distal direction towards the needle such that a mid portion of the first arm crosses the needle causing a distal segment of the first arm to be biased against the needle” to resolve some grammatical errors. Paragraph [0018] should be amended to recite “wherein the first needle guard has a first anchor portion engagement surface and the second needle guard has a second engagement surface” to resolve some ambiguity about the language referred to throughout this paragraph. Paragraph [0070] should be amended to recite “The formation of the internal recess 222 results in a first and second contact surfaces 224 , 226 that are on either side of the slit 212 and internal recess 222” to add a comma between the reference numeral. Paragraph [0071] should be amended to recite “The barrier layer 210 also includes first and second contact surfaces 224 , 226” to add a comma between the reference numeral. Paragraph [0074] should be amended to recite “shown in Fig. 6A to 6C. [[.]] As noted above,” to remove the duplicate punctuation within the paragraph. Paragraph [0075] should be amended to recite “Figs. 7A to 7C illustrate another variation of a valve 104 having elongated protrusion 206 where the axial length 232 is greater than a width 234 in the circumferential direction 23 ” to remove the reference numeral referring to the circumferential direction as reference numeral 23 is not located within the current drawings. Paragraph [0077] should be amended to recite “As shown in Figs. 8B and 7C 8C , the first arm 152” to correct which figure is being referred to. Paragraph [0077] should be amended to recite “the needle extends through the opening 158 such that the first 162 and second ends 162, 164 are on opposite sides of the needle” to improve the grammar and clarity of the sentence of this paragraph. Paragraph [0078] should be amended to recite “and the mid portions 166 , 168 also extend in an oblique or lateral angle…towards the needle axis 126 such that the mid portions 166 , 168 intersect the longitudinal needle axis” to add a comma between reference numerals. Paragraph [0079] should be amended to recite “The distal segments/end portions 170 , 172 of the…respective needle guards that have ends 174 , 176 that bias…the resiliency of the arms 152 , 154 152 and/or clip 150…the distal portion or ends 174 , 176 of one or both of the distal segments 170 , 172 comprises…the arms 152 , 154 comprise regions…the arms 152 , 154” to add commas between reference numerals and resolve one incorrect reference numeral. Paragraph [0080] should be amended to recite “In the variation of Figs 8B and 8C, an edge 182 of the first needle guard” to further clarify the reference numeral for the edge of the first needle guard. Paragraph [0082] should be amended to recite “the ends of the needle guard 174 , 176 on the first 152 and second 154 arms 152, 154 …the edges 182 , 184 of the needle guards…the anchor portions 182 , 184 that are engaged…the anchor portions 182 , 184 engaging the valve wall” to resolve some language inconsistency with the reference numerals and to add commas between reference numerals. Paragraph [0083] should be amended to recite “The arms 152 , 154 of the clip 150…needle guard sections 170 , 172 of the clip 150” to add commas between reference numerals. Paragraph [0084] should be amended to recite “the needle guard sections 170 , 172. Since the arms 152 , 154 are resilient…the needle guards 170 , 172 to move…Since the arms 150 , 154 to pivot close together [[ ]] , they disengage” to add commas between reference numerals and remove an extra space between the word “together” and the comma. Paragraph [0086] should be amended to recite “a first and second arms 152 , 154 with needle guards 170 , 172 having…fingers 186 , 188…These anchor portions 186 , 188 provide reduced surface areas relative to the edges 182 , 184 of the clip” to add commas between reference numerals. Paragraph [0087] should be amended to recite “first and second arms 152 , 154 with needle guards 170 , 172 having one…the needle guards 170 , 172” to add commas between reference numerals. Paragraph [0089] should be amended to recite “The single arm 152 includes a single needle guard 170 t hat engages a wall” to correct the spelling of the word “that” . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim 18 is objected to because of the following informalities: Claim 18 recites “chamber.” The Examiner suggests amending this to recite “ interior chamber” to improve the consistency of the claim language . Appropriate correction is required. 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 Claim 5 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 5 recites (emphasis added): The catheter assembly of claim 1, further comprising a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer, the sealing ring having an exterior sealing surface that forms a seal between the valve and the interior chamber at the distal end, wherein an exterior diameter of the valve is smallest at a recessed portion located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface, the recessed portion being configured to provide deformation of the valve, and where a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer located proximally to the recessed portion . Claim 5 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention because it is unclear how a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer located proximally to the recessed portion when the recessed portion is located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface. Figure 3A, reproduced below, appears to show a thickness of the sidewall 204 at the recessed portion 208 being less than a thickness of the barrier layer 210 located distally to the recessed portion not proximally to the recessed portion. Therefore, the Examiner will interpret the term “proximally” to be “distally.” PNG media_image1.png 207 614 media_image1.png Greyscale The Examiner suggests amending Claim 5 to recite the following to clarify the claim language: The catheter assembly of claim 1, further comprising a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer, the sealing ring having an exterior sealing surface that forms a seal between the valve and the interior chamber at the distal end, wherein an exterior diameter of the valve is smallest at a recessed portion located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface, the recessed portion being configured to provide deformation of the valve, and where a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer located distally proximally to the recessed portion. 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, 2, 5 – 8, 10, 11, and 21 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Woehr (US 2014/0276453 A1) . With regards to claim 1 , Woehr discloses (Figs. 1, 3a – 3c, 10, and 11) a catheter assembly (100) (see [0063] “catheter assembly 100”) configured for use with a male luer (200) (see [0081] “a male implement 200”) , the catheter assembly comprising: a catheter hub (102) (see [0050]) having an interior chamber (122) (see [0051]) ; and a valve (124) (see [0051]) located in the interior chamber (see Fig. 1) and comprising a distal portion (see at 142 in Fig. 1) , a proximal portion (132) (see [0052] “proximal flange 132”) , and a sidewall (see at 158 in Fig. 1) extending therebetween to define a valve interior (154) (see [0056] “an enlarged interior bore section 154”) extending from the proximal portion to the distal portion (see Fig. 1) , the valve including a barrier layer (see Examiner annotated Fig. 1 below hereinafter referred to as “Fig. A”) that extends in the valve interior from the sidewall at the distal portion (see Fig. 1) , the barrier layer having a first contact surface (see Examiner annotated Fig. B below; hereinafter referred to as “Fig. B”) , a second contact surface (see Fig. B below) , and an interior recess therebetween (see Fig. B below) , a slit (152) (see [0082] “the valve body 146 recoils and closes off the through bore 152 upon removal of the male implement. In yet other examples, a syringe may be used to inject medicine through the catheter device or draw fluid out the catheter device. When the syringe is removed, the through bore 152 automatically closes.”) extending through the barrier layer at the interior recess (see Fig. 8) , wherein the slit is in a normally closed configuration that prevents a fluid from passing through the barrier layer (see [0082] “When the syringe is removed, the through bore 152 automatically closes.”) , wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit (see [0081] “The size of the male implement forces the through bore 152 to expand outwardly and part of the valve body 146 to expand and fill the interior cavity of the catheter hub and out the hub openings 80, 82.” and [0082]) . PNG media_image2.png 400 664 media_image2.png Greyscale PNG media_image3.png 377 826 media_image3.png Greyscale With regards to claim 2 , Woehr discloses the claimed invention of claim 1, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) where the barrier layer (see Fig. A above) is solid (see Fig. A above which shows the barrier layer being solid and [0082]) . With regards to claim 5 , Woehr discloses the claimed invention of claim 1, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) further comprising a sealing ring (142) (see [0052]) located circumferentially at a distal end (see at 124 in Fig. 1) of the valve (124) (see [0051]) distally to the barrier layer (see Fig. A above) , the sealing ring having an exterior sealing surface (see [0052] “a distal enlarged section 142, which can be an enlarged distal head or a ring projection extending radially outwardly of the valve body 146, is provided for engaging the catheter hub at the distal hub at the distal end of the elastic valve.”) that forms a seal between the valve and the interior chamber (122) (see [0051]) at the distal end (see [0052] which describes the seal formed) , wherein an exterior diameter of the valve is smallest at a recessed portion (see Examiner annotated Fig. 1 below; hereinafter referred to as “Fig. C”) located between the sidewall (see at 158 in Fig. 1) and the barrier layer (see Fig. 1 above) and proximally adjacent to the exterior sealing surface (see Fig. C below) , the recessed portion being configured to provide deformation of the valve (see Fig. 1 and 8 and the deformation of the valve and paragraph [0050]) , and where a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer located proximally to the recessed portion (see Fig. A above and Fig. C below which shows the thickness of the sidewall at the recessed portion being less than a thickness of the barrier layer located distally to the recessed portion) (see 35 U.S.C. § 112(b) above wherein “proximally” is interpreted at “distally”). PNG media_image4.png 329 695 media_image4.png Greyscale With regards to claim 6 , Woehr discloses the claimed invention of claim 5, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) wherein the sealing ring (142) (see [0052]) comprises a rounded edge along a sealing ring circumference (see [0052] “a distal enlarged section 142, which can be an enlarged distal head or a ring projection extending radially outwardly of the valve body 146, is provided for engaging the catheter hub at the distal hub at the distal end of the elastic valve” and see Fig. 1) . With regards to claim 7 , Woehr discloses the claimed invention of claim 5, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) wherein the sealing ring (142) (see [0052]) remains engaged with an inner surface of the interior chamber (122) (see [0051]) when the male luer (200) (see [0081] “a male implement 200”) engages the recessed portion (see Fig. C and Fig. 8) . With regards to claim 8 , Woehr discloses the claimed invention of claim 1, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) further comprising a plurality of protrusions (see at 80 and 146 in Fig. 8) on an exterior surface of the sidewall (see at 158 in Fig. 1) , wherein the plurality of protrusions each couple with a plurality of openings (80, 82) (see [0050] “the hub 102 is left exposed along an upper open section 80 and a lower open section 82”) within the interior chamber (122) (see [0051]) . With regards to claim 10 , Woehr discloses the claimed invention of claim 1, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) wherein the valve (124) (see [0051]) comprises a flange (132) (see [0052] “proximal flange 132”) at a valve proximal end (see at 130 in Fig. 3) , wherein the flange engages with a proximal end of the catheter hub (see at 134 in Fig. 1 and [0052]) . With regards to claim 11 , Woehr discloses the claimed invention of claim 1, and Woehr further discloses (Figs. 1, 3a – 3c, 10, and 11) where a thickness of the sidewall (see at 158 in Fig. 1) is less than the thickness of the barrier layer (see Fig. A above) (see Fig. 1 and compare the thickness at the sidewall shown at 158 and at the annotated barrier layer in Fig. A wherein this shows that the sidewall being less than the thickness of the barrier layer) . With regards to claim 21 , Woehr discloses (Figs. 1, 3a – 3c, 10, and 11) a valve (124) (see [0051]) for use with a catheter assembly (100) (see [0063] “catheter assembly 100”) that receives a male luer (200) (see [0081] “a male implement 200”) , the valve comprising: a distal portion (see at 142 in Fig. 1) , a proximal portion (132) (see [0052] “proximal flange 132”) , and a sidewall (see at 158 in Fig. 1) extending therebetween to define a valve interior (154) (see [0056] “an enlarged interior bore section 154”) , the valve including a barrier layer (see Fig. A reiterated below) that extends in the valve interior from the sidewall at the distal portion (see Fig. 1) , the valve interior extending from the proximal portion to the distal portion (see Fig. 1) , the barrier layer having a first contact surface (see Fig. B reiterated below) , a second contact surface (see Fig. B reiterated below) , and a recess therebetween (see Fig. B reiterated below) , a slit (152) (see [0082] “the valve body 146 recoils and closes off the through bore 152 upon removal of the male implement. In yet other examples, a syringe may be used to inject medicine through the catheter device or draw fluid out the catheter device. When the syringe is removed, the through bore 152 automatically closes.”) extending through the barrier layer at the recess (see Fig. 8) , wherein the slit is in a normally closed configuration to prevent a fluid from passing through the barrier layer (see [0082] “When the syringe is removed, the through bore 152 automatically closes.”) , wherein upon advancement the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit (see [0081] “The size of the male implement forces the through bore 152 to expand outwardly and part of the valve body 146 to expand and fill the interior cavity of the catheter hub and out the hub openings 80, 82.” and [0082]) . PNG media_image2.png 400 664 media_image2.png Greyscale PNG media_image3.png 377 826 media_image3.png Greyscale 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woehr in ivew of Guo et al. (US 2007/0254000 A1; hereinafter referred to as “Guo”) . With regards to claim 9 , Woehr discloses the claimed invention of claim 1, however Woehr is silent with regards to the catheter assembly further comprising a lubricant within the interior chamber. Nonetheless Guo, which is within the analogous art of valves with lubricants (see [0043]) , teaches the catheter assembly further comprising a lubricant (see [0043]) within the interior chamber (10) (see [0011]) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the interior chamber of the catheter hub of the catheter assembly of Woehr in view of a teaching of Guo such that the catheter assembly further comprising a lubricant within the interior chamber. One of ordinary skill in the art would have been motivated to make this modification because Guo teaches that the lubricant reduces the friction force between the valve and inserted medical devices (see [0043] of Guo). Additionally, Guo teaches that including a lubricant creates constant and predictable friction forces inside the catheter hub (see [0043] of Guo) . Double Patenting 08-33 AIA 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. 08-36 AIA Claim s 1 – 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 – 5, 7, and 8 of U.S. Patent No. 11,607,525 B1 (hereinafter referred to as “USPAT ’525”) in view of Woehr . With regards to claim 1 , Claim 1 of USPAT ’525 recites a catheter assembly configured for use with a male luer (see Col. 7, lines 65 – 66 of USPAT ’525) , the catheter assembly comprising: a catheter hub having an interior chamber (see Col. 7, line 67 of USPAT ’525) ; and a valve located in the interior chamber and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior extending from the proximal portion to the distal portion, the valve including a barrier layer that extends in the valve interior from the sidewall at the distal portion, a slit extending through the barrier layer at the interior recess, wherein the slit is in a normally closed configuration that prevents a fluid from passing through the barrier layer (see Col. 8, lines 1 – 32 of USPAT ’525) . However Claim 1 of USPAT ’525 is silent with regards to: the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. Nonetheless Woehr, which is within the analogous art of catheter assemblies (see abstract and title) , teaches the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween (see Fig. A and Fig. B both reiterated below) ; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit (see [0081] “The size of the male implement forces the through bore 152 to expand outwardly and part of the valve body 146 to expand and fill the interior cavity of the catheter hub and out the hub openings 80, 82.” and [0082]) . PNG media_image2.png 400 664 media_image2.png Greyscale PNG media_image3.png 377 826 media_image3.png Greyscale It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the barrier layer of the catheter assembly of Claim 1 of USPAT ’525 in view of a teaching of Woehr such that the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches that a barrier layer having multiple contact surfaces for the male luer allows for the valve to easily be opened (see [0081] of Woehr). Additionally, this structure allows for the valve to be repeatedly used. For example the male luer can be removed following use, such as for changing out the fluid source when emptied and replaced with a new fluid source or when a blood collection device is attached by a standard male luer taper (see [0082] of Woehr). The catheter assembly of Claim 1 of USPAT ’525 modified in view of a teaching of Woehr will hereinafter be referred to as the catheter assembly of USPAT ’525 and Woehr. With regards to claim 2 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 1 of USPAT ’525 further recites that the barrier layer is solid (see Col. 8, lines 1 – 32 of USPAT ’525) . With regards to claim 3 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 1 of USPAT ’525 further recites that the catheter assembly further comprises a first protrusion and a second protrusion located on an exterior surface of the sidewall, where each of the first protrusion and the second protrusion respectively nest within a first opening and a second opening in the interior chamber such that upon insertion of the male luer into the proximal portion of the valve, the first protrusion and the second protrusion reinforce a portion of the sidewall to reduce elastic deformation of the valve at the first protrusion and the second protrusion and causing increased outward elastic deformation of the sidewall at a recessed portion, wherein further distal advancement of the male luer causes elastic deformation of the barrier layer opening the slit such that the fluid can pass through the barrier layer (see Col. 8, lines 1 – 32 of USPAT ’525) . However, USPAT ’525 is silent with regards to the first and second protrusion being on opposite sides of the exterior surface of the sidewall. Nonetheless Woehr, which is within the analogous art of catheter assemblies (see abstract and title) , teaches the first and second protrusion being on opposite sides of the exterior surface of the sidewall (see at 80, 146 in Fig. 8) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the location of the first and second protrusion of the valve of the catheter assembly of USPAT ’525 and Woehr in view of a further teaching of Woehr such that the first and second protrusion being on opposite sides of the exterior surface of the sidewall. One of ordinary skill in the art would have been motivated to make this modification because locating the first and second protrusions on opposite sides of the exterior surface of the sidewall allows for a more secure coupling of the valve with the catheter hub. With regards to claim 4 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 3, however, Claim 1 of USPAT ’525 is silent with regards to where the interior recess extends in alignment between the first protrusion and the second protrusion. Nonetheless Woehr, which is within the analogous art of catheter assemblies (see abstract and title) , teaches the interior recess (see the area of the valve 142 in between 80, 146 in Fig. 8) extends in alignment between the first protrusion (see at 80 in Fig. 8) and the second protrusion (see at 146 in Fig. 8) . It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the invention of the catheter assembly of USPAT ’525 and Woehr in view of a further teaching of Woehr such that the interior recess extends in alignment between the first protrusion and the second protrusion. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches that this alignment allows for the valve to easily be opened (see [0081] of Woehr). Additionally, this structure allows for the valve to be repeatedly used. For example the male luer can be removed following use, such as for changing out the fluid source when emptied and replaced with a new fluid source or when a blood collection device is attached by a standard male luer taper (see [0082] of Woehr). With regards to claim 5 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 1 of USPAT ’525 further recites further comprising a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer, the sealing ring having an exterior sealing surface that forms a seal between the valve and the interior chamber at the distal end, wherein an exterior diameter of the valve is smallest at a recessed portion located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface, the recessed portion being configured to provide deformation of the valve, and where a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer located proximally to the recessed portion (see Col. 8, lines 9 – 20 of USPAT ’525) . With regards to claim 6 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 5, and Claim 2 of USPAT ’525 further recites wherein the sealing ring comprises a rounded edge along a sealing ring circumference (see Col. 8, lines 33 – 35 of USPAT ’525) . With regards to claim 7 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 5, and Claim 4 of USPAT ’525 further recites wherein the sealing ring remains engaged with an inner surface of the interior chamber when the male luer engages the recessed portion (see Col. 8, lines 38 – 40 of USPAT ’525) . With regards to claim 8 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 1 of USPAT ’525 further recites further comprising a plurality of protrusions on an exterior surface of the sidewall, wherein the plurality of protrusions each couple with a plurality of openings within the interior chamber (see Col. 8, lines 21 – 32 of USPAT ’525) . With regards to claim 9 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 3 of USPAT ’525 further recites further comprising a lubricant within the interior chamber (see Col. 8, lines 36 – 37 of USPAT ’525) . With regards to claim 10 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 8 of USPAT ’525 further recites wherein the valve comprises a flange at a valve proximal end, wherein the flange engages with a proximal end of the catheter hub (see Col. 8, lines 48 – 50 of USPAT ’525) . With regards to claim 11 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 1, and Claim 5 of USPAT ’525 further recites where a thickness of the sidewall is less than the thickness of the barrier layer (see Col. 8, lines 41 – 42 of USPAT ’525) . With regards to claim 12 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 3, and Claim 7 of USPAT ’525 further recites wherein the first protrusion and the second protrusion are aligned with a longitudinal direction of the slit (see Col. 8, lines 45 – 47 of USPAT ’525) . With regards to claim 13 , Claim 1 of USPAT ’525 a catheter assembly configured for use with a male luer (see Col. 7, lines 65 – 66 of USPAT ’525 ), the catheter assembly comprising: a catheter hub having an interior chamber (see Col. 7, line 67 of USPAT ’525) ; a valve located in the interior chamber and comprising a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer that extends in the valve interior from the sidewall at the distal portion, a slit extending through the barrier layer at the interior recess, wherein the slit is in a normally closed configuration that prevents a fluid from passing through the barrier layer (see Col. 8, lines 1 – 19 and 21 – 32 of USPAT ’525) , a sealing ring located circumferentially at a distal end of the valve distally to the barrier layer, the sealing ring having an exterior sealing surface that forms a seal between the valve and the interior chamber at the distal end, wherein an exterior diameter of the valve is smallest at a recessed portion located between the sidewall and the barrier layer and proximally adjacent to the exterior sealing surface, the recessed portion being configured to provide deformation of the valve, and where a thickness of the sidewall at the recessed portion is less than a thickness of the barrier layer (see Col. 8, lines 9 – 20 of USPAT ’525) ; and at least one protrusion on an exterior surface of the sidewall located proximally to the recessed portion, where the at least one protrusion nests within at least one opening in the interior chamber such that upon insertion of the male luer into the proximal portion of the valve, the at least one protrusion nested within the at least one opening reinforces a portion of the sidewall to reduce elastic deformation of the valve at the at least one protrusion and causing increased outward elastic deformation of the sidewall at the recessed portion, wherein further distal advancement of the male luer causes elastic deformation of the barrier layer opening the slit such that the fluid can pass through the barrier layer (see Col. 8, lines 21 – 32 of USPAT ’525) . However Claim 1 of USPAT ’525 is silent with regards to: the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. Nonetheless Woehr, which is within the analogous art of catheter assemblies (see abstract and title) , teaches the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween (see Fig. A and Fig. B both reiterated below) ; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit (see [0081] “The size of the male implement forces the through bore 152 to expand outwardly and part of the valve body 146 to expand and fill the interior cavity of the catheter hub and out the hub openings 80, 82.” and [0082]) . PNG media_image2.png 400 664 media_image2.png Greyscale PNG media_image3.png 377 826 media_image3.png Greyscale It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the barrier layer of the catheter assembly of Claim 1 of USPAT ’525 in view of a teaching of Woehr such that the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween; wherein upon insertion of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches that a barrier layer having multiple contact surfaces for the male luer allows for the valve to easily be opened (see [0081] of Woehr). Additionally, this structure allows for the valve to be repeatedly used. For example the male luer can be removed following use, such as for changing out the fluid source when emptied and replaced with a new fluid source or when a blood collection device is attached by a standard male luer taper (see [0082] of Woehr). The catheter assembly of Claim 1 of USPAT ’525 modified in view of a teaching of Woehr will hereinafter be referred to as the catheter assembly of USPAT ’525 and Woehr. With regards to claim 14 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 2 of USPAT ’525 further recites wherein the sealing ring comprises a rounded edge along a sealing ring circumference (see Col. 8, lines 33 – 35 of USPAT ’525) . With regards to claim 15 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 1 of USPAT ’525 further recites further comprising wherein the at least one protrusion comprises a plurality of protrusions on the exterior surface of the sidewall, wherein the at least one opening comprises a plurality of openings, wherein the plurality of protrusions each couple with the plurality of openings within the interior chamber such that upon insertion of the male luer into the proximal portion of the valve, the at least one protrusion reinforces an adjacent sidewall to reduce elastic deformation of the valve at the at least one protrusion and causing increased outward elastic deformation of the sidewall at the recessed portion (see Col. 8, lines 21 – 32 of USPAT ’525) . With regards to claim 16 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 15, and Claim 7 of USPAT ’525 further recites wherein the plurality of protrusions are aligned with a longitudinal direction of the slit (see Col. 8, lines 45 – 47 of USPAT ’525) . With regards to claim 17 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 3 of USPAT ’525 further recites further comprising a lubricant within the interior chamber (see Col. 8, lines 36 – 37 of USPAT ’525) . With regards to claim 18 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 4 of USPAT ’525 further recites wherein the sealing ring remains engaged with an inner surface of the interior chamber when the male luer engages the recessed portion (see Col. 8, lines 38 – 40 of USPAT ’525) . With regards to claim 19 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 8 of USPAT ’525 further recites wherein the valve comprises a flange at a proximal end, wherein the flange engages with a proximal end of the catheter hub (see Col. 8, lines 48 – 50 of USPAT ’525) . With regards to claim 20 , the catheter assembly of USPAT ’525 and Woehr teaches the claimed invention of Claim 13, and Claim 5 of USPAT ’525 further recites where a thickness of the sidewall is less than the thickness of the barrier layer (see Col. 8, lines 41 – 42 of USPAT ’525) . With regards to claim 21 , Claim 1 of USPAT ’525 recites a valve for use with a catheter assembly that receives a male luer (see Col. 8, line 1 of USPAT ’525) , the valve comprising: a distal portion, a proximal portion, and a sidewall extending therebetween to define a valve interior, the valve including a barrier layer that extends in the valve interior from the sidewall at the distal portion, the valve interior extending from the proximal portion to the distal portion, a slit extending through the barrier layer at the recess, wherein the slit is in a normally closed configuration to prevent a fluid from passing through the barrier layer (see Col. 8, lines 1 – 19 and 21 – 32 of USPAT ’525) . However, Claim 1 of USPAT ’525 is silent with regards to: the barrier layer having a first contact surface, a second contact surface, and a recess therebetween, wherein upon advancement the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. Nonetheless Woehr, which is within the analogous art of catheter assemblies (see abstract and title) , teaches the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween (see Fig. A and Fig. B both reiterated below) ; wherein upon advancement of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit (see [0081] “The size of the male implement forces the through bore 152 to expand outwardly and part of the valve body 146 to expand and fill the interior cavity of the catheter hub and out the hub openings 80, 82.” and [0082]) . PNG media_image2.png 400 664 media_image2.png Greyscale PNG media_image3.png 377 826 media_image3.png Greyscale It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the barrier layer of the valve of Claim 1 of USPAT ’525 in view of a teaching of Woehr such that the barrier layer having a first contact surface, a second contact surface, and an interior recess therebetween; wherein upon advancement of the male luer into the valve interior, the male luer engages the first contact surface and the second contact surface to deform the barrier layer resulting in opening of the slit. One of ordinary skill in the art would have been motivated to make this modification because Woehr teaches that a barrier layer having multiple contact surfaces for the male luer allows for the valve to easily be opened (see [0081] of Woehr). Additionally, this structure allows for the valve to be repeatedly used. For example the male luer can be removed following use, such as for changing out the fluid source when emptied and replaced with a new fluid source or when a blood collection device is attached by a standard male luer taper (see [0082] of Woehr) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Burkholz et al. (US 10,238,852 B2) see at least Fig. 5B. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT F ALLEN whose telephone number is (571)272-6232. The examiner can normally be reached Monday-Friday 8:00 AM - 4:30 PM ET. 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. /ROBERT F ALLEN/Examiner, Art Unit 3783 /WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/27/2026 Application/Control Number: 18/508,709 Page 2 Art Unit: 3783 Application/Control Number: 18/508,709 Page 3 Art Unit: 3783 Application/Control Number: 18/508,709 Page 4 Art Unit: 3783 Application/Control Number: 18/508,709 Page 5 Art Unit: 3783 Application/Control Number: 18/508,709 Page 6 Art Unit: 3783 Application/Control Number: 18/508,709 Page 7 Art Unit: 3783 Application/Control Number: 18/508,709 Page 8 Art Unit: 3783 Application/Control Number: 18/508,709 Page 9 Art Unit: 3783 Application/Control Number: 18/508,709 Page 10 Art Unit: 3783 Application/Control Number: 18/508,709 Page 11 Art Unit: 3783 Application/Control Number: 18/508,709 Page 12 Art Unit: 3783 Application/Control Number: 18/508,709 Page 13 Art Unit: 3783 Application/Control Number: 18/508,709 Page 14 Art Unit: 3783 Application/Control Number: 18/508,709 Page 15 Art Unit: 3783 Application/Control Number: 18/508,709 Page 17 Art Unit: 3783 Application/Control Number: 18/508,709 Page 18 Art Unit: 3783 Application/Control Number: 18/508,709 Page 19 Art Unit: 3783 Application/Control Number: 18/508,709 Page 20 Art Unit: 3783 Application/Control Number: 18/508,709 Page 21 Art Unit: 3783 Application/Control Number: 18/508,709 Page 22 Art Unit: 3783 Application/Control Number: 18/508,709 Page 23 Art Unit: 3783 Application/Control Number: 18/508,709 Page 24 Art Unit: 3783 Application/Control Number: 18/508,709 Page 25 Art Unit: 3783 Application/Control Number: 18/508,709 Page 26 Art Unit: 3783 Application/Control Number: 18/508,709 Page 27 Art Unit: 3783 Application/Control Number: 18/508,709 Page 28 Art Unit: 3783