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 § 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.
Claims 1-11, 23-29, and 31-35 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Polyak (US Patent 4,632,435).
Regarding claim 1, Polyak discloses a coupling system (Figure 2), comprising:
a catheter (left tube 21) defining a first diameter (dimension which extends from top to bottom in figure 2);
a port (right 21, 5, 3 and 100) including a port body (rightmost portion of right 21) and a shroud (100 and portion of right 21 closest to 100) extending axially from the port body (Figure 2 shows the shroud 100 and portion of right 21 closest to 100 extends axially away from port body rightmost portion of right 21) and defining a recess (Figure 1, 10) having a second diameter (dimension that extends top to bottom in figure 1) larger than the first diameter (Figure 2 shows the inner surface of 9 (ends of shroud 100) is radially outward of left 21, i.e. the second diameter is larger than the first diameter), the recess including a stem (5) extending axially and configured to engage a lumen of the catheter (Figure 2 shows the stem 5 extends to the left and engages the interior surface of left 21, i.e. the lumen of the catheter);
a collet lock (102) extending annularly about a stem axis (Figure 2) and configured to transition between an unlocked configuration (Figure 1) and a locked configuration (Figure 2) when an axial force is applied (col. 8, l. 50- col. 9, l. 3 describes the tool 104 providing an axial force to the collet lock 102); and
a tool (Figure 5, 104) configured to engage the shroud and the collet lock and apply the axial force to transition the collet lock from the unlocked configuration to the locked configuration (col. 8, l. 50- col. 9, l. 3 describes the tool 104 providing an axial force to the collet lock 102).
Regarding claim 2, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a portion of the collet lock (prongs 22) is retained within the recess in the unlocked configuration (Figure 1 shows the system before engagement, before the system is in the locking configuration. As the system transitions from figure 1 to the locked configuration shown in figure 2, the prongs 22 is retained within the recess 10), an outer surface of the collet lock (Annotated figure 1) engages an inner surface of the recess (Annotated figure 1) in one of an interference fit, press-fit, or snap-fit engagement (col. 5, l. 64- col. 6, l. 6 describe the prongs 22 of collet lock 102 press fit to the recess).
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Regarding claim 3, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the collet lock includes a plurality of fingers (prongs 22) configured to plastically deform radially inward when transitioned to the locked configuration (col. 5, l. 64- col. 6, l. 6).
Regarding claim 4, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the plurality of fingers impinge on a surface of the recess when the axial force is applied to transition the collet lock from the unlocked configuration to the locked configuration (col. 5, l. 64- col. 6, l. 6 describe the prongs 22 of collet lock 102 press fit to the recess).
Regarding claim 5, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a tip of a finger of the plurality of fingers (Figure 2, inside surface 25 of prong 22) engages an outer surface of the catheter (Figure 2 shows the prongs 22 engage the outer surface of the catheter at the surface marked 25) in the locked configuration (Figure 2), compressing the catheter onto the stem (Col. 5, ll. 50-54).
Regarding claim 6, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a tip of the plurality of fingers define a diameter that is larger than the first diameter of the catheter (Figure 1 shows the tip of the fingers 22 at 24 has a larger diameter than the first diameter of the catheter which is radially inward of 24).
Regarding claim 7, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the tool includes a first arm (Figure 5, left 50) hingedly coupled (via 53) to a second arm (Figure 5 right 50), a tip of the first arm includes a first fork (Figure 7 shows an exemplary fork that is applicable to each arm) configured to engage the port (col. 8, l. 50- col. 9, l. 3 describes the jaw 48 of one fork engaging collet lock 102 and the other bearing against the tubing, i.e. the port), and a tip of the second arm includes a second fork (Figure 7 shows an exemplary fork that is applicable to each arm) configured to engage the collet lock (col. 8, l. 50- col. 9, l. 3 describes the jaw 48 of one fork engaging collet lock 102 and the other bearing against the tubing, i.e. the port).
Regarding claim 8, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein one or both of the first fork and the second fork includes a first tine and a second tine (Figure 7, both tines are defined as 63) defining a notch (space between the two tines 63, shown best in figure 6) having a first width, the first width being equal to or larger than the first diameter of the catheter (col. 8, ll. 34-49 describe the u-shaped face 62 of the tines being placed around the tubing, i.e. the catheter, so the interior width is wider than the first diameter of the catheter in order to accommodate the catheter).
Regarding claim 9, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the shroud includes a channel (Annotated figure 2 shows a channel in the shroud between 100 and the portion of right 21 closest to 100) defining a third diameter being equal to or less than the first width (the third diameter is the exterior diameter of 21, which is equal to the first width), the first fork engaging the channel of the shroud in one of an interference fit, press-fit, or snap-fit engagement (col. 8, ll. 41-49).
Regarding claim 10, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein one or both of the first fork and the second fork includes an indentation (Figure 7, 65) extending along an edge of the notch (Figure 7) and defining a second width (width from left to right in figure 7), the second width being larger than an outer diameter of the collet lock (col. 8, ll. 41-49 describe the indentation 65 holding the connector assembly (which includes the collet lock 102) in a saddle or nest, i.e. the diameter of the indentation is larger than the diameter of the collet lock which it holds), a surface of the indentation engaging the collet lock with the axial force is applied (col. 8, ll. 41-49).
Regarding claim 11, Polyak discloses the invention as claimed and described above. Polyak further discloses further including an extension leg (Figure 2, 5) extending between the shroud and the port (Figure 2), formed integrally therewith (Figure 2 shows the extension leg, shroud and port form unit, i.e. formed integrally therewith), and providing fluid communication therebetween (Figure 2), the extension leg formed of a flexible material (col. 2, l. 62- col. 3, l. 4 describes the connectors (including extension leg 5) as made of plastics suitable for medical prosthetics, i.e. a flexible material).
Regarding claim 23, Polyak discloses a catheter and port coupling system (Figure 2), comprising:
a catheter (left 21) defining a first diameter (dimension which extends from top to bottom in figure 2);
a port (right 21, 5, 3 and 100) including a port body (rightmost portion of right 21) and a shroud (100 and portion of right 21 closest to 100) extending axially from the port (Figure 2 shows the shroud 100 and portion of right 21 closest to 100 extends axially away from port body rightmost portion of right 21) and defining a recess (Figure 1, 10) having a second diameter (dimension that extends top to bottom in figure 1) larger than the first diameter (Figure 2 shows the inner surface of 9 (ends of shroud 100) is radially outward of left 21, i.e. the second diameter is larger than the first diameter), the recess including a stem (5) extending axially and configured to engage a lumen of the catheter (Figure 2 shows the stem 5 extends to the left and engages the interior surface of left 21, i.e. the lumen of the catheter); and
a collet lock (102) extending annularly about the stem axis (Figure 2) and configured to transition between an unlocked configuration (Figure 1) and a locked configuration (Figure 2) when an axial force is applied to secure the catheter to the port (col. 8, l. 50- col. 9, l. 3 describes the tool 104 providing an axial force to the collet lock 102 to secure the port).
Regarding claim 24, Polyak discloses the invention as claimed and described above. Polyak further discloses further including an extension leg (Figure 2, 5) extending between the shroud and the port (Figure 2), formed integrally therewith (Figure 2 shows the extension leg, shroud and port form unit, i.e. formed integrally therewith), and providing fluid communication therebetween (Figure 2), the extension leg formed of a flexible material (col. 2, l. 62- col. 3, l. 4 describes the connectors (including extension leg 5) as made of plastics suitable for medical prosthetics, i.e. a flexible material).
Regarding claim 25, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a portion of the collet lock (prongs 22) is retained within the recess in the unlocked configuration (Figure 1 shows the system before engagement, before the system is in the locking configuration. As the system transitions from figure 1 to the locked configuration shown in figure 2, the prongs 22 is retained within the recess 10), an outer surface of the collet lock (Annotated figure 1) engages an inner surface of the recess (Annotated figure 1) in one of an interference fit, press-fit, or snap-fit engagement (col. 5, l. 64- col. 6, l. 6 describe the prongs 22 of collet lock 102 press fit to the recess).
Regarding claim 26, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the collet lock includes a plurality of fingers (prongs 22) configured to plastically deform radially inward when transitioned to the locked configuration (col. 5, l. 64- col. 6, l. 6).
Regarding claim 27, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the plurality of fingers impinge on a surface of the recess when the axial force is applied to transition the collet lock from the unlocked configuration to the locked configuration (col. 5, l. 64- col. 6, l. 6 describe the prongs 22 of collet lock 102 press fit to the recess).
Regarding claim 28, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a tip of a finger of the plurality of fingers (Figure 2, inside surface 25 of prong 22) engages an outer surface of the catheter (Figure 2 shows the prongs 22 engage the outer surface of the catheter at the surface marked 25) in the locked configuration (Figure 2), compressing the catheter onto the stem (Col. 5, ll. 50-54).
Regarding claim 29, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein a tip of the plurality of fingers define a diameter that is larger than the first diameter of the catheter (Figure 1 shows the tip of the fingers 22 at 24 has a larger diameter than the first diameter of the catheter which is radially inward of 24).
Regarding claim 31, Polyak discloses the invention as claimed and described above. Polyak further discloses a tool (Figure 5, 104) configured to engage the shroud and the collet lock and apply the axial force to transition the collet lock from the unlocked configuration to the locked configuration (col. 8, l. 50- col. 9, l. 3 describes the tool 104 providing an axial force to the collet lock 102).
Regarding claim 32, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the tool includes a first arm (Figure 5, left 50) hingedly coupled (via 53) to a second arm (Figure 5 right 50), a tip of the first arm includes a first fork (Figure 7 shows an exemplary fork that is applicable to each arm) configured to engage the port (col. 8, l. 50- col. 9, l. 3 describes the jaw 48 of one fork engaging collet lock 102 and the other bearing against the tubing, i.e. the port), and a tip of the second arm includes a second fork (Figure 7 shows an exemplary fork that is applicable to each arm) configured to engage the collet lock (col. 8, l. 50- col. 9, l. 3 describes the jaw 48 of one fork engaging collet lock 102 and the other bearing against the tubing, i.e. the port).
Regarding claim 33, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein one or both of the first fork and the second fork includes a first tine and a second tine (Figure 7, both tines are defined as 63) defining a notch (space between the two tines 63, shown best in figure 6) having a first width, the first width being equal to or larger than the first diameter of the catheter (col. 8, ll. 34-49 describe the u-shaped face 62 of the tines being placed around the tubing, i.e. the catheter, so the interior width is wider than the first diameter of the catheter in order to accommodate the catheter).
Regarding claim 34, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein the shroud includes a channel (Annotated figure 2 shows a channel in the shroud between 100 and the portion of right 21 closest to 100) defining a third diameter being equal to or less than the first width (the third diameter is the exterior diameter of 21, which is equal to the first width), the first fork engaging the channel of the shroud in one of an interference fit, press-fit, or snap-fit engagement (col. 8, ll. 41-49).
Regarding claim 35, Polyak discloses the invention as claimed and described above. Polyak further discloses wherein one or both of the first fork and the second fork includes an indentation (Figure 7, 65) extending along an edge of the notch (Figure 7) and defining a second width (width from left to right in figure 7), the second width being larger than an outer diameter of the collet lock (col. 8, ll. 41-49 describe the indentation 65 holding the connector assembly (which includes the collet lock 102) in a saddle or nest, i.e. the diameter of the indentation is larger than the diameter of the collet lock which it holds), a surface of the indentation engaging the collet lock with the axial force is applied (col. 8, ll. 41-49).
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 12 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Polyak (US Patent 4,632,435) in view of Sampson (US Patent 4,929,236).
Regarding claim 12, Polyak discloses all the essential features of the invention as claimed and described above except wherein the port includes a reservoir in fluid communication with the stem and having a needle penetrable septum thereover.
Sampson teaches wherein the port includes a reservoir (Figure 3, 12) in fluid communication with the stem (20) and having a needle penetrable septum (14) thereover (Figure 3).
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 Polyak’s invention to include wherein the port includes a reservoir in fluid communication with the stem and having a needle penetrable septum thereover in order to provide needle access for infusion of medication to a patient as suggested and taught by Sampson in col. 2, ll. 5-19.
Regarding claim 30, Polyak discloses all the essential features of the invention as claimed and described above except wherein the port includes a reservoir in fluid communication with the stem and having a needle penetrable septum thereover.
Sampson teaches wherein the port includes a reservoir (Figure 3, 12) in fluid communication with the stem (20) and having a needle penetrable septum (14) thereover (Figure 3).
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 Polyak’s invention to include wherein the port includes a reservoir in fluid communication with the stem and having a needle penetrable septum thereover in order to provide needle access for infusion of medication to a patient as suggested and taught by Sampson in col. 2, ll. 5-19.
Response to Arguments
Applicant's arguments filed 7/13/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 9-12 of the Arguments that the Office’s interpretation is not reasonable and argues that Polyak is not the same as the disclosed invention. This is a moot point as the features of the disclosed invention have not been claimed. Applicant further alleges that “merely citing to a disparate grouping of structures, or abstract portions of those structures, and collectively labeling them as a "port" is insufficient to establish an inherent teaching of the claimed "port." There is no indication naturally flowing from the art to suggest that one of ordinary skill might have grouped these structures, or abstract parts thereof, and considered them a "port" as asserted”. Applicant’s own original disclosure describes the port 108 as containing a port body 110, a reservoir 112, a needle penetrable septum 114, a stem 120, a stem lumen 122 in paragraphs 37-38 of the specification and shown as disparate parts in figures 1A-1B. Therefore, the Office’s interpretation of “port” is consistent with Applicant’s use of the term in the original disclosure and this argument is not persuasive.
Applicant argues on pages 12-13 that Polyak fails to teach the tool as engaging the asserted shroud as recited in claims 1 and 31. As described above and shown in Polyak’s figures, the tool engages the shroud via the intervening elements. Therefore this argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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