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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al. (US 2005/0151105), hereinafter referred to as D Ryan, in view of Felt (US 2008/0132876) and Ryan (US 2021/0187266), hereinafter referred to as K Ryan.
Regarding claim 1, D Ryan discloses a needle free connector (Figure 4) comprising:
a first component (Figure 2, 100) comprising:
a housing (106) having a proximal end (upper part of figure) and a distal end (lower part of figure) opposite the proximal end, the housing defining an interior volume (area within 106);
a center post (104) disposed in the interior volume extending proximally in the interior volume (Figure 2);
a valve (108) disposed in the interior volume at the proximal end of the first component surrounding at least a portion of the center post (Figure 2); and
a lubricant disposed between the center post and the valve (claim 7 describes lubricant between the spike, i.e. center post 104, and the resilient barrier, i.e. valve 108); and
a plug (112) disposed in the fluid path (when the two components are connected a fluid path is opened between them as seen in figure 5) at the distal end of the first component (Figure 2);
a second component (Figure 4, 10) comprising:
a casing (10a) having a proximal end (upper part of figure) and a distal end (lower part of figure) opposite the proximal end, the casing defining a fluid path (Figure 5 shows a fluid path from 104 into the interior of 10) therein.
D Ryan is silent on the plug disposed in the fluid path at the distal end of the second component;
wherein the lubricant comprises an antimicrobial component.
Felt teaches the plug (Figure 1B, 500) disposed in the fluid path (Figure 3 shows the flow path through 280) at the distal end (lower end of second component 100 in figure 1B) of the second component (100).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan’s invention to include the plug disposed in the fluid path at the distal end of the second component in order to aseptically seal the second component and prevent unwanted penetration of external contaminants into the sterile interior of the second component as suggested and taught by Felt in paragraph 23.
D Ryan in view of Felt is silent on wherein the lubricant comprises an antimicrobial component.
K Ryan teaches, among other aspects, a first component (Figure 7, 100) with a center post (116) and an element (150) surrounding the center post; and a lubricant (paragraph 63 describes a fluid or a gel, i.e. a lubricant) disposed between the center post and the element (Figure 7); wherein the lubricant comprises an antimicrobial component (paragraph 63 describes chlorohexidine gluconate).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan in view of Felt’s invention to include wherein the lubricant comprises an antimicrobial component in order to disinfect an IV needleless connector during syringe use to save clinician time and reduce working steps while preventing contamination as suggested and taught by K Ryan in paragraph 7.
Regarding claim 2, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the plug is a deformable member (paragraph 48 describes the plug 112 is made of a rubber like material, i.e. deformable).
Regarding claim 3, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the plug comprises a septum extending therethrough (paragraph 48 describes plug 112 as a septum).
Regarding claim 4, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the septum is sized and shaped to receive a portion of the center post (Figure 5 shows the septum is sized and shaped to receive the tip of the center post 104).
Regarding claim 5, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the septum is coated with the lubricant when the center post is disposed therethrough (paragraph 20 describes the septum being coated with the lubricant when the center post is disposed therethrough).
Regarding claim 6, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the proximal end of the first component and the distal end of the second component are spaced apart in a disconnected configuration (paragraph 50 describes the two components as spaced apart when disconnected and brought together into the mated position and pushed together along the arrows as shown in figure 4).
Regarding claim 7, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the proximal end of the first component and the distal end of the second component are removably coupled in a connected configuration (claim 11 describes the two components as removably coupled and figure 5 shows the connected configuration).
Regarding claim 8, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the first component and the second component are in fluid communication in the connected configuration (Figure 5 shows the two components are in fluid communication through 104 and 10a in the connected configuration).
Regarding claim 9, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the valve deforms longitudinally in the distal direction to expose the center post in the connected configuration (Figure 5 shows the valve 108 deforms in the distal direction and exposes the enter post to the plug 112 in the connected configuration).
Regarding claim 10, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the center post is a rigid member (paragraph 48 describes the body 102 of center post 104 is made of hard plastic, such as polycarbonate, i.e. a rigid member).
Regarding claim 11, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. K Ryan further teaches wherein the antimicrobial component comprises chlorohexidine gluconate (paragraph 63 describes chlorohexidine gluconate).
Regarding claim 13, D Ryan discloses a method of reducing a presence of microbes (paragraph 13) in a needle free connector (Figure 4), the method comprising:
providing a first component (Figure 2, 100) comprising a valve (108) and a center post (104):
providing a second component (Figure 4, 10);
providing a plug (112)
providing a lubricant to an area between the center post and the valve (claim 7 describes lubricant between the spike, i.e. center post 104, and the resilient barrier, i.e. valve 108);
connecting the first component and the second component such that the plug displaces the valve and surrounds the center post (Figure 5),
wherein the lubricant is transferred to the plug when the first component is connected to the second component (paragraph 20 describes the surface of the center post as being coated in lubricant, when the center post penetrates the plug it will necessarily transfer some of the lubricant to the plug).
D Ryan is silent on the second component comprising the plug; and
wherein the lubricant comprises an antimicrobial component.
Felt teaches the second component (Figure 1B, 100) comprising the plug (Figure 1B, 500).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan’s invention to include the second component comprising the plug in order to aseptically seal the second component and prevent unwanted penetration of external contaminants into the sterile interior of the second component as suggested and taught by Felt in paragraph 23.
D Ryan in view of Felt is silent on wherein the lubricant comprises an antimicrobial component.
K Ryan teaches, among other aspects, a first component (Figure 7, 100) with a center post (116) and an element (150) surrounding the center post; and a lubricant (paragraph 63 describes a fluid or a gel, i.e. a lubricant) disposed between the center post and the element (Figure 7); wherein the lubricant comprises an antimicrobial component (paragraph 63 describes chlorohexidine gluconate).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan in view of Felt’s invention to include wherein the lubricant comprises an antimicrobial component in order to disinfect an IV needleless connector during syringe use to save clinician time and reduce working steps while preventing contamination as suggested and taught by K Ryan in paragraph 7.
Regarding claim 14, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the first component further comprises:
a housing (106) having a proximal end (upper part of figure) and a distal end (lower part of figure) opposite the proximal end, the housing defining an interior volume (area within 106);
the center post disposed in the interior volume extending proximally in the interior volume (Figure 2); and
the valve disposed in the interior volume at the proximal end of the first component surrounding at least a portion of the center post (Figure 2).
Regarding claim 15, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the second component further comprises:
a casing (10a) having a proximal end (upper part of figure) and a distal end (lower part of figure) opposite the proximal end, the casing defining a fluid path (Figure 5 shows a fluid path from 104 into the interior of 10) therein; and
the plug disposed in the fluid path at the distal end of the second component (Figure 5 shows the plug 112 at the distal end of the second component, lower end of 10 in the figure, in the fluid path that extends between 104 and 10).
Regarding claim 16, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the plug comprises a septum extending therethrough (paragraph 48 describes plug 112 as a septum).
Regarding claim 17, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the septum is sized and shaped to receive a portion of the center post (Figure 5 shows the septum is sized and shaped to receive the tip of the center post 104).
Regarding claim 18, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. D Ryan further teaches wherein the septum is coated with the lubricant when the center post is disposed therethrough (paragraph 20 describes the septum being coated with the lubricant when the center post is disposed therethrough).
Regarding claim 19, D Ryan in view of Felt and K Ryan teach the invention as claimed and described above. K Ryan further teaches wherein the antimicrobial component comprises chlorohexidine gluconate (paragraph 63 describes chlorohexidine gluconate).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al. (US 2005/0151105), hereinafter referred to as D Ryan, in view of Felt (US 2008/0132876) and Ryan (US 2021/0187266), hereinafter referred to as K Ryan, and further in view of Christiansen et al. (US 2019/0126022).
Regarding claim 12, D Ryan in view of Felt and K Ryan teach all the essential features of the claimed invention except wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant.
Christiansen teaches wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant (paragraph 21 describes a chlorohexidine gluconate concentration of 4%).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan in view of Felt and K Ryan’s invention to include wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant in order to disinfect medical equipment as suggested and taught by Christiansen in paragraphs 20-21.
Regarding claim 20, D Ryan in view of Felt and K Ryan teach all the essential features of the claimed invention except wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant.
Christiansen teaches wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant (paragraph 21 describes a chlorohexidine gluconate concentration of 4%).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify D Ryan in view of Felt and K Ryan’s invention to include wherein a concentration of the antimicrobial component is between 4%-6% wt/wt of the lubricant in order to disinfect medical equipment as suggested and taught by Christiansen in paragraphs 20-21.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katheryn Malatek whose telephone number is (571)272-5689. The examiner can normally be reached Monday - Thursday, 9 am - 6 pm.
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/KATHERYN A MALATEK/Primary Examiner, Art Unit 3741
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