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
Claims 12-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 10-11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2019/0167884 A1 to Baxter International, Inc. et al. (hereinafter "BAXTER").
As per claim 1, Baxter teaches a transfer set comprising:
a first branch (a line extending from line 88 to line 106; figure 2; paragraph [0055]) comprising:
a first connector, the filter 90, and a line 92 (first portion) of the line 92 (see figure 2);
a second branch comprising a second connector of line 106 and a portion of line 106 (see figure 2);
a third branch comprising the third connector configured to be coupled to the system 10 and a line 104 (see figures 1-2);
wherein the first branch, the second branch, and the third branch are connected to one another such that the solution can flow from the first connector to the second connector through the first branch and the second branch, and such that a fluid can flow from the second connector to the third connector through the second branch and the third branch (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).
Recitations of “configured to be coupled to a disposable set of a peritoneal dialysis (PD) system”, “configured to be coupled to a catheter of the PD system” and “configured to be coupled to the disposable set of the PD system” are intended use of the transfer set. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
As per claim 2, 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]).
As per claim 3, 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]).
As per claim 4, 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]).
As per claim 5, BAXTER discloses that the filter is an ultrafilter (the filter 90 is an ultrafilter; figure 2; paragraph [0056]).
As per claim 6, 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]).
As per claim 10, BAXTER discloses a one-way valve positioned within the third branch 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).
As per claim 11, 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]).
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Baxter.
As per claim 7, Baxter discloses the transfer set of claim 1. Baxter fails to disclose further comprising an injection port positioned within the first branch 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 second branch 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 Baxter lo include an injection port positioned within the first branch 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, BAXTER discloses the transfer set of claim 7. Baxter fails to disclose a one-way valve within the first branch 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 second branch 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 Baxter to provide a one-way valve within the first branch 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]).
Allowable Subject Matter
Combination of claims 1, 6-8 and 10 would be allowable if amended.
Response to Arguments
Applicant’s arguments with respect to claims 1-8 and 10-11 have been considered but are moot.
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 JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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, IN SUK BULLOCK can be reached at 571-272-5954. 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.
/John Kim/Primary Examiner, Art Unit 1777
JK
5/12/26
Prosecution Insights