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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-11) in the reply filed on 10/14/2025 is acknowledged. The traversal is on the ground(s) that claim 17 is amended to be dependent on claim 1. This is not found persuasive because the special technical features of Group III are a method of operating a transfer set, the method comprising: receiving, via an opening in a first end portion of the transfer set, a solution from a source bag of a disposable set of a peritoneal dialysis (PD) system, the source bag fluidly coupled to the first end portion of the transfer set; filtering the solution using a filter of the transfer set positioned along the first end portion of the transfer set; and transferring, via the first end portion of the transfer set and a second end portion of the transfer set, the solution to a catheter fluidly coupled to the second end portion of the transfer set, which are not present in Group I or II.
Group I-III lack unity of invention because even though the inventions of these groups require the technical feature of a transfer set, a catheter that is part of a peritoneal dialysis system; and a filter positioned to filter contaminants from a flowing solution, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 6,234,992 81 to Haight et al. (hereinafter “HAIGHT”). HAIGHT discloses a transfer set (a disposable peritoneal dialysis transfer set; see claim 1 of HAIGHT), a catheter that is part of a peritoneal dialysis system (an indwelling patient catheter tube in a peritoneal dialysis system; see claim 1 of HAIGHT); and a filter positioned to filter contaminants from a flowing solution (a biofilter configured to filter contaminants from dialysate flowing; see claim 1 of HAIGHT). The requirement is still deemed proper and is therefore made FINAL.
Claims 12-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/14/2025.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6,234,992 B1 to Haight, Let al. (hereinafter "HAIGHT").
As per claim 1, HAIGHT discloses a transfer set (a disposable peritoneal dialysis transfer set; see col. 4, line 63 – col. 5, line 20; col. 5, line 47 – col. 6, line 50; claim 1), comprising:
a first connector configured to be coupled to a disposable set of a peritoneal dialysis "PD" system (a second coupling configured to be coupled to a dialysate containment system of a peritoneal dialysis system; see claim 1);
a second connector configured to be coupled to a catheter of the PD system (a first coupling connected to an indwelling patient catheter tube; see claim 1);
a fluid channel extending between the first connector and the second connector (a length of medical tubing between the second and first coupling; see claim 1); and
a filter positioned within the fluid channel and configured to filter contaminants from solution flowing within the fluid channel between the first connector and the second connector (a biofilter in within a first travel path within the length of medical tubing configured to filter contaminants from dialysate flowing within the length of medical tubing between the second and first coupling; see claim 1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-11 are rejected under 35 U.S.C. 103 as being unpatentable over HAIGHT as applied to claim 1 above, and further in view of US 2019/0167884 A1 to Baxter International, Inc. et al. (hereinafter "BAXTER").
As per claim 2, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose wherein the first connector includes the filter.
BAXTER discloses a therapy delivery manifold wherein the first connector includes the filter (the first connector of line 88 includes filter 90; figure 2; paragraphs [0055-0056]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include the first connector including the filter, as taught by BAXTER, in order to gain the advantages of providing means of removing smaller particles including bacteria yeast, fungi, viruses, endotoxins, and proteins (see BAXTER paragraph [0056]).
As per claim 3, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose that the filter includes a first end portion; a second end portion opposite the first end portion; and a filtering element having a first end and a second end opposite the first end, wherein the filtering element extends at least partway between the first end portion and the second end portion of the filter, and wherein the first end and the second end of the filtering element are both positioned at the first end portion of the filter.
BAXTER discloses wherein the filter includes:
a first end portion (a first end portion located on the right side of the filter 90; figure 2);
a second end portion opposite the first end portion (a second end portion on the left side of the filter 90; figure 2); and
a filtering element having a first end and a second end opposite the first end (filter 90 shown in figure 2 with an external housing, houses a filtering element having a first end at the bottom of filter 90 and a second end at the top of filter 90 opposite the first end; figure 2; paragraph [0056]), wherein the filtering element extends at least partway between the first end portion and the second end portion of the filter (the filtering element extends at least partway between the first end portion and the second end portion of the filter 90; figure 2; paragraph [0056]), and wherein the first end and the second end of the filtering element are both positioned at the first end portion of the filter (wherein the bottom first end and the top second end of the filtering element are both positioned at the right side first end portion of the filter 90; figure 2; paragraph [00056]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include the filter including a first end portion; a second end portion opposite the first end portion and a filtering element having a first end and a second end opposite the first end, wherein the filtering element extends at least partway between the first end portion and the second end portion of the filter, and wherein the first end and the second end of the filtering element are both positioned at the first end portion of the filter, as taught by BAXTER, in order to gain the advantages of providing the filter in the fluid line with the correct orientation.
As per claim 4, HAIGHT in view of BAXTER discloses the transfer set of claim 3. HAIGHT fails to disclose that the filtering element includes a semi-permeable membrane; the tillering element is configured to receive the solution and the contaminants into an interior of the filtering element via the first end or the second end; and the filtering element is configured to a) permit the solution to flow through the semipermeable membrane and continue flowing toward the second end portion of the filter and b) prevent the contaminants from flowing through the semi-permeable membrane.
BAXTER discloses that the filtering element includes:
a semi-permeable membrane (the filtering element includes a semi-permeable membrane with pores allowing fluid to flow through but to remove small particles; paragraph [0056]);
the filtering element is configured to receive the solution and the contaminants into an interior of the filtering element via the first end or the second end (the filtering element is configured to receive the solution and the contaminants into an interior of the element via the bottom end when the solution and contaminants enter the housing through filtration line 88; figure 2; paragraphs [0055-0056]); and
the filtering element is configured to a) permit the solution to flow through the semi-permeable membrane and continue flowing toward the second end portion of the filter (the filtering element ls configured to permit the solution to flow through the semipermeable membrane and continue flowing up the left second end portion of the filler 90; figure 2; paragraph [0056]) and b) prevent the contaminants from flowing through the semi-permeable membrane (prevent the contaminants such as east, fungi, bacteria or proteins from flowing through the semi-permeable membrane; figure 2; paragraph [0056]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the transfer set of HAIGHT to provide the filtering element including a semi-permeable membrane; the filtering element is configured to receive the solution and the contaminants into an interior of the filtering element via the first end or the second end; and the filtering element is configured to a) permit the solution to now through the semipermeable membrane and continue flowing toward the second end portion of the filter and b) prevent the contaminants from flowing through the semi-permeable membrane, as taught by BAXTER, in order to provide a finer filtration system to remove a larger number of contaminants from the solution.
As per claim 5, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose wherein the filter is an ultrafilter.
BAXTER discloses that the filter is an ultrafilter (the filter 90 is an ultrafilter; figure 2; paragraph [0056]).
It would have been obvious to one or ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include an ultrafilter, as taught by BAXTER, in order to gain the advantages of providing the capacity of removing smaller particles than can microfilters (see BAXTER paragraph [0056]).
As per claim 6, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose further comprising a one-way valve i) positioned between the filter and the second connector, ii) configured to permit a fluid to flow through the one-way valve in a first direction toward the second connector, and iii) prevent the fluid from flowing through the one-way valve in a second direction toward the filter.
BAXTER discloses further comprising a one-way valve i) positioned between the filter and the second connector (a one-way valve 112 as shown in figures 1 and 2 positioned between the filter 90 and the connector to line 106; figures 1-2; paragraph [0077]), ii) configured to permit a fluid to flow through the one-way valve in a first direction toward the second connector (as shown in figures 1-2, permitting a fluid to flow through the one-way valve 112 in a first direction toward the connector to line 106; figures 1-2; paragraph [0077]), and iii) prevent the fluid from flowing through the one-way valve in a second direction toward the filter (as shown in figures 1-2, preventing the fluid from flowing through the one-way valve in a second direction toward the filter 90; figures 1-2; paragraph [0077]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include a one-way valve i) positioned between the filter and the second connector, ii) configured to permit a fluid to now through the one-way valve in a first direction toward the second connector, and iii) prevent the fluid from flowing through the one-way valve in a second direction toward the filter, as taught by BAXTER, in order to gain the advantages of providing a means of maintaining the proper flow through the fluids circuit to keep contaminants out of the fluid.
As per claim 7, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose further comprising an injection port positioned within the fluid channel and configured to receive a fluid from a fluid delivery device when the fluid delivery device is removably coupled to the injection port.
BAXTER discloses further an injection port positioned within the fluid channel and configured to receive a fluid from a fluid delivery device when the fluid delivery device is removably coupled to the injection port (see a cap 108 (injection port) of union 109 within substitution fluid manifold 100 within the fluid channel is configured to receive an injectable quality fluid from a substitution line (fluid delivery device) which is rnanuallv removably coupled to the substitution fluid manifold 100; figures 1-2; paragraph [0077]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT lo include an injection port positioned within the fluid channel and configured to receive a fluid from a fluid delivery device when the fluid delivery device is removably coupled to the injection port, as taught by BAXTER, in order to gain the advantages of having greater control over the fluids entering a patient connected to the system (see BAXTER paragraph [0077]).
As per claim 8, HAIGHT in view of BAXTER discloses the transfer set of claim 7. HAIGHT fails to disclose a one-way valve within the fluid channel and positioned between the filter and the second connector, wherein the injection port is positioned between the filter and the one-way valve.
BAXTER discloses a one-way valve within the fluid channel and positioned between the filter and the second connector, wherein the injection port is positioned between the filter and the one-way valve (as shown in figure 2, a one-way valve 112 is within the fluid channel and positioned between the filter 90 and the connector of line 106, wherein the cap 108 of union 109 is position between the filter 90 and the one-way valve 112; figure 2; paragraph [0077]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the transfer set of HAIGHT to provide a one-way valve within the fluid channel and positioned between the filter and the second connector, wherein the injection port is positioned between the filter and the one-way valve, as taught by BAXTER, in order to gain the advantages of having greater control over the fluids entering a patient connected to the system (see BAXTER paragraph [0077]).
As per claim 9, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose that the fluid channel is a first fluid channel; the transfer set includes a first branch and a second branch; the first branch includes the first connector, the filter, and a first portion of the first fluid channel; the second branch includes the second connector and a second portion of the first fluid channel; the transfer set further includes: a third connector configured to be coupled to the disposable set of the PD system, and a third branch including the third connector and a second fluid channel; and the first branch, the second branch, and the third branch are connected to one another such that the first portion of the first fluid channel, the second portion of the first fluid channel, and the second fluid channel are fluidly coupled to one another.
BAXTER discloses that the fluid channel is a first fluid channel (the fluid channel is a first fluid channel extending from line 88 to line 106; figure 2; paragraph [0055]); the transfer set includes a first branch and a second branch (the post dilution manifold 100 includes a first branch including line 88 and a second branch including line 106; figure 2); the first branch includes the first connector, the filter, and a first portion of the first fluid channel (the first branch includes the first connector, the filter 90, and a line 92 (first portion) of the line 92; figure 2); the second branch includes the second connector and a second portion of the first fluid channel (the second branch includes the connector of line 106 and a portion of line 106 (second portion); figure 2); the transfer set further includes: a third connector configured to be coupled to the disposable set of the PD system, and a third branch including the third connector and a second fluid channel (the post dilution manifold 100 further includes a third connector configured to be coupled to the system 10, and a third branch including the third connector and a line 104 (second fluid channel); figures 1-2); and the first branch, the second branch, and the third branch are connected to one another such that the first portion of the first fluid channel, the second portion of the first fluid channel, and the second fluid channel are fluidly coupled to one another (the first branch, the second branch, and the third branch are connected to one another such that the line 92 of the line 88, the line 106, and the line 104 are fluidly coupled to one another via Y-connector 102; figure 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include wherein the fluid channel is a first fluid channel; the transfer set includes a first branch and a second branch; the first branch includes the first connector, the filter, and a first portion of the first fluid channel; the second branch includes the second connector and a second portion of the first fluid channel; the transfer set further includes: a third connector configured to be coupled to the disposable set of the PD system, and a third branch including the third connector and a second fluid channel; and the first branch, the second branch, and the third branch are connected to one another such that the first portion of the first fluid channel, the second portion of the first fluid channel, and the second fluid channel are fluidly coupled to one another, as taught by BAXTER, in order to gain the advantages of providing the capability of the system to perform pre- and post-dilution HF and HOF as desired (see BAXTER paragraph [0057]).
As per claim 10, HAIGHT in view of BAXTER discloses the transfer set of claim 9. HAIGHT fails to disclose further comprising a one-way valve positioned within the second fluid channel and configured to prevent a fluid from flowing through the one-way valve away from the third connector.
BAXTER discloses a one-way valve positioned within the second fluid channel and configured to prevent a fluid from flowing through the one-way valve away from the third connector (as shown in figure 2, a check valve 110 positioned within the line 104, configured to prevent fluid from flowing back through the check valve 110 away from the third connector; paragraph [0072]; figure 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include a one-way valve positioned within the second fluid channel and configured to prevent a fluid from flowing through the one-way valve away from the third connector, as taught by BAXTER, in order to gain the advantages of providing a means of delivering a bolus volume via venous access line to patient.
As per claim 11, HAIGHT discloses the transfer set of claim 1. HAIGHT fails to disclose a clamp positioned between the filter and the second connector, wherein the clamp has (a) an open configuration in which a fluid is permitted to flow in a first direction through the clamp toward the second connector and (b) a closed configuration in which the fluid is prevented from flowing in the first direction and in a second direction through the clamp toward the filter.
BAXTER discloses further comprising a clamp positioned between the filter and the second connector (as shown in figure 2 a pinch clamp 116 positioned between the filter and the connector of line 106; figure 2; paragraph [0060]), wherein the clamp has (a) an open configuration in which a fluid is permitted to flow in a first direction through the clamp toward the second connector (the pinch clamp 116 has an open configuration in which a fluid is permitted to flow in a first direction through the clamp and toward the connector of line 106; figure 2; paragraph [0060]) and (b) a closed configuration in which the fluid is prevented from flowing in the first direction and in a second direction through the clamp toward the filter (a closed configuration in which the fluid is prevented from flowing in the first direction and in a second direction through the clamp 116 toward the filter 90; figure 2; paragraph [0060]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the transfer set of HAIGHT to include a clamp positioned between the filter and the second connector, wherein the clamp has (a) an open configuration in which a fluid is permitted to flow in a first direction through the clamp toward the second connector and (b) a closed configuration in which the fluid is prevented from flowing in the first direction and in a second direction through the clamp toward the filter, as taught by BAXTER, in order to gain the advantages of providing more control of flow of fluid (see BAXTER: paragraphs [0060-0061]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
11/24/25