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 .
DETAILED ACTION
Status of Claims
This office action is in response to the amendment and remarks filed on 09/04/2025. In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 1-14 are currently pending and being examined.
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 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.
Claim Objections
Claim 7 is objected to because of the following informalities: Claim 7 recites “between the first and second end” in line 3 and 4. However, there is a lack of antecedent basis for “the first” limitation. Examiner suggests reciting “between the first end and second end”. Appropriate correction is required.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (USPAP 2019/0282794) in view of Platt (USPN 1,520,508).
In reference to independent claim 1, Carlsson teaches a device for producing dialysate comprising:
an adapter (X1, fig 4) having an outer wall (outer wall of X1) and having a first end (bottom side of fig 4) and a second end (top side of fig 4), wherein the outer wall defines an interior lumen (2) that extends between the first end (bottom) and second end (top) of the adapter (X1); wherein the interior lumen is configured to allow for the passage of dialysate (para 0087 discloses “the system may be used in potassium profiled dialysate (AFBK) to provide selectivity, where up to three different bags with solution to be administered should not be mixed up”)
wherein the first end (bottom) of the adapter includes a female coupling (bottom of the connector in fig 4 has female threading 6) is configured to be coupled to dialysis equipment (thru the connector Y1 to the dialysis equipment 28, 29, and the equipment connected to 35 and 36, fig 26) and wherein the second end (top side of fig 4) of the adapter includes a coupling (the top of 4 is configured to be attached to a line, see fig 26) and is configured to be coupled to a dialysate collection bag (30, a dialysate collection bag is interpreted to be any bag that is used in dialysis), such that dialysate from the dialysis equipment is transferred to the dialysate collection bag (para 0087 discloses “the system may be used in potassium profiled dialysate (AFBK) to provide selectivity, where up to three different bags with solution to be administered should not be mixed up”, however applicant is advised that it has been held that the 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 part Masham, 2 USPQ2d 1647 (1987). The intended use claim limitations have been examined to facilitate compact prosecution and inform the applicant of the state of the art),however
Carlsson is silent to the second end having a female coupling,
Platt, a similar coupling used in the medical field such as dialysis, teaches an end having a female coupling (the interior lumen of 2 is female threaded on both sides, fig 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling design taught by Platt in the device of Carlsson because it “enables the parts to be quickly assembled and disassembled for sterilizing without the aid of tools, and renders the same practical for use by doctors and dentists who operate without the aid of assistants.” page 2, lines 10-14; Platt.
In reference to independent claim 7, Carlsson teaches a product capable of a method comprising: generating an adapter (fig 4) having an outer wall (outer wall of X1) and having a first end (bottom side of fig 4) and a second end (top side of fig 4), wherein the outer wall defines an interior lumen (2) that extends between the first (bottom) and second end (top) of the adapter;
wherein the first end (bottom) of the adapter includes a female coupling and (bottom of the connector in fig 4 has female threading 6) is configured to be coupled to dialysis equipment (thru the connector Y1 to the dialysis equipment 28, 29, and the equipment connected to 35 and 36, fig 26) and wherein the second end (top side of fig 4) of the adapter includes a coupling (the top of 4 is configured to be attached to a line, see fig 26) and is configured to be coupled to a dialysate collection bag (30, a dialysate collection bag is interpreted to be any bag that is used in dialysis), such that dialysate from the dialysis equipment is transferred to the dialysate collection bag (para 0087 discloses “the system may be used in potassium profiled dialysate (AFBK) to provide selectivity, where up to three different bags with solution to be administered should not be mixed up”, however applicant is advised that it has been held that the 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 part Masham, 2 USPQ2d 1647 (1987). The intended use claim limitations have been examined to facilitate compact prosecution and inform the applicant of the state of the art),however
Carlsson is silent to the second end having a female coupling,
Platt, a similar coupling used in the medical field such as dialysis, teaches an end having a female coupling (the interior lumen of 2 is female threaded on both sides, fig 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling design taught by Platt in the device of Carlsson because it “enables the parts to be quickly assembled and disassembled for sterilizing without the aid of tools, and renders the same practical for use by doctors and dentists who operate without the aid of assistants.” page 2, lines 10-14; Platt.
In reference to dependent claim 2, Carlsson in view of Platt teaches the device of claim 1 wherein the adapter (X1, fig 26) comprises couplings for the dialysis equipment (thru the connector Y1 to the dialysis equipment 28, 29, and the equipment connected to 35 and 36, fig 26) and the collection bag (30) while maintaining sterility (functional language that Carlsson is capable of performing, furthermore the adapter of Carlsson would necessitate sterility to function as a dialysis adapter), however
Carlsson, does not teach a female coupling of the first end of the adapter and the female coupling of the second end of the adapter are disposed within an interior lumen of the adapter and are configured for coupling.
Platt, a similar coupling used in the medical field such as dialysis, teaches a female coupling of the first end of the adapter and the female coupling of the second end of the adapter are disposed within an interior lumen of the adapter and are configured for coupling (the interior lumen of 2 is threaded on both sides and configured for coupling two separate bodies, fig 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling design taught by Platt in the device of Carlsson in view of Carlsson because it “enables the parts to be quickly assembled and disassembled for sterilizing without the aid of tools, and renders the same practical for use by doctors and dentists who operate without the aid of assistants.” page 2, lines 10-14; Platt. To be clear the modification is done by putting threads on the interior of the respective lumens.
In reference to dependent claim 3, Carlsson in view of Platt teaches the device of claim 2, Platt further teaches a female coupling of the first end (left side of 2) of the adapter and the female coupling of the second end (right side of 2) of the adapter (2) are threaded couplings.(the interior lumen of adapter 2 is threaded on both sides, fig 1 and 2).
In reference to dependent claim 4, Carlsson in view of Platt teaches the device of claim 1, Carlsson further teaches a method wherein the adapter (X1) is formed from a plastic (para 0043 discloses “The connectors described herein may e.g. be made of plastic”).
In reference to dependent claim 6, Carlsson in view of Platt teaches a product capable of a method of producing dialysate using the adapter of claim 1 (X1), Carlsson further teaches a method to couple the dialysate collection bag (30) to the dialysis equipment (fig 26 shows the adapter X1 connecting to the rest of the dialysis equipment).
In reference to dependent claim 8, Carlsson in view of Platt teaches a product capable of the method of claim 7, Carlsson further discloses the adapter (X1, fig 26) comprises couplings for the dialysis equipment (thru the connector Y1 to the dialysis equipment 28, 29, and the equipment connected to 35 and 36, fig 26) and the collection bag (30) while maintaining sterility (functional language that Carlsson is capable of performing, furthermore the adapter of Carlsson would necessitate sterility to function as a dialysis adapter), however
Carlsson, does not teach a female coupling of the first end of the adapter and the female coupling of the second end of the adapter are disposed within an interior lumen of the adapter and are configured for coupling.
Platt, a similar coupling used in the medical field such as dialysis, teaches a female coupling of the first end of the adapter and the female coupling of the second end of the adapter are disposed within an interior lumen of the adapter and are configured for coupling (the interior lumen of 2 is threaded on both sides and configured for coupling two separate bodies, fig 1 and 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the coupling design taught by Platt in the device of Carlsson in view of Platt because it “enables the parts to be quickly assembled and disassembled for sterilizing without the aid of tools, and renders the same practical for use by doctors and dentists who operate without the aid of assistants.” page 2, lines 10-14; Platt. To be clear the modification is done by putting threads on the interior of the respective lumens.
In reference to dependent claim 9, Carlsson in view of Platt teaches a product capable of the method of claim 8, Platt further teaches an adapter (2) wherein the couplings are threaded couplings.(the interior lumen of adapter 2 is threaded on both sides, fig 1 and 2).
In reference to dependent claim 10, Carlsson in view of Platt teaches a product capable of the method of claim 7, Carlsson further teaches a method wherein the adapter is formed from a plastic (para 0043 discloses “The connectors described herein may e.g. be made of plastic”).
Claims 5, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (USPAP 2019/0282794) in view of Platt (USPN 1,520,508) further in view of Gammie (USPAP 2020/0246046).
In reference to dependent claim 5, Carlsson in view of Platt teaches the device of claim 1, however
Carlsson and Platt do not teach wherein the adapter is manufactured via three-dimensional printing.
Gammie, a similar medical devices for fluid exchange with the body, teaches wherein the device (fluid handling components in 300, fig 4B) is manufactured via three-dimensional printing (para 0249 discloses “the devices may be made using 3-dimensional (“3D”) printing or other additive manufacturing techniques”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 3D printing as taught by Gammie to make the adapter of Carlsson in view of Platt so “the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use” para 0329; Gammie. To be clear by using the 3D printing the adapter can be made very quickly on a need basis and does not need to be made in bulk and stocked.
In reference to dependent claim 11, Carlsson in view of Platt teaches a product capable of the method of claim 7, however
Carlsson and Platt do not teach wherein the adapter is manufactured via three-dimensional printing.
Gammie, a similar medical devices for fluid exchange with the body, teaches wherein the device (fluid handling components in 300, fig 4B) is manufactured via three-dimensional printing (para 0249 discloses “the devices may be made using 3-dimensional (“3D”) printing or other additive manufacturing techniques”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 3D printing as taught by Gammie to make the adapter of Carlsson in view of Platt so “the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use” para 0329; Gammie. To be clear by using the 3D printing the adapter can be made very quickly on a need basis and does not need to be made in bulk and stocked.
In reference to dependent claim 12, Carlsson in view of Platt teaches a product capable of the method of claim 7, however
Carlsson and Platt do not teach generating the adapter using a molding process.
Gammie, a similar medical devices for fluid exchange with the body, teaches generating the device (fluid handling components in 300, fig 4B) using a molding process (para 0249 discloses “components substantially comprising a plastic or polymer may be milled from a larger block, cast, or injection molded”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 3D printing as taught by Gammie to make the adapter of Carlsson in view of Platt so “the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use” para 0329; Gammie. To be clear by using the molding process, the adapter can be made in bulk at a very discounted price.
In reference to dependent claim 13, Carlsson in view of Platt teaches a product capable of the method of claim 7, however
Carlsson and Platt do not teach sculpting the adapter from a block of plastic.
Gammie, a similar medical devices for fluid exchange with the body, teaches sculpting the device (fluid handling components in 300, fig 4B) from a block of plastic (para 0249 discloses “components substantially comprising a plastic or polymer may be milled from a larger block, cast, or injection molded”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 3D printing as taught by Gammie to make the adapter of Carlsson in view of Platt so “the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use” para 0329; Gammie. To be clear by using the block machining process the adapter can be made very quickly on a need basis and does not need to be made in bulk and stocked.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Carlsson (USPAP 2019/0282794) in view of Platt (USPN 1,520,508) further in view of Shen (USPAP 2009/0197999).
In reference to dependent claim 14, Carlsson in view of Platt teaches a product capable of the method of claim 7, however
Carlsson and Platt do not teach wherein the adapter is formed from one selected from a group consisting of polylactic acid (PLA), nylon, and polycarbonate (PC).
Shen, a method of manufacturing medical devices (pare 0104) teaches wherein the medical device is formed from one selected from a group consisting of polylactic acid (PLA), nylon, and polycarbonate (PC) (para 0002 discloses a polycarbonate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polycarbonate taught in Shen in the device of Carlsson in view of Platt to provide an adapter that has “good mechanical and thermal properties, including excellent dimensional stability at high temperatures” para 0002; Shen.
Response to Arguments
Applicant's arguments filed on 09/04/2025 have been considered but, unless otherwise addressed below, are moot in view of the new ground(s) of rejection.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.W.N/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783