DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendments filed on 12/03/2025 has been entered. Claims 1, 2, and 5 have been amended; claims 7-8 have been added. Accordingly, claims 1-8 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every objection previously set forth in the Non-final Office action mailed on 06/03/2025. Therefore, all claim objections are hereby withdrawn.
Response to Arguments
Applicant’s arguments filed on 12/03/2025, with respect to the rejection(s) of claim(s) 1 and 5 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Schroers et al. US 2021/0187183 A1 (newly cited). See rejection of claims below.
Applicant's arguments filed on 12/03/2025 regarding claim 4 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “With respect to claim 4's negative limitation ("the hemodialysis system does not comprise a Heparin input device"), Applicant notes that silence in a prior art reference does not anticipate a negative limitation unless the reference teaches exclusion of that feature. See the Office Action's reliance on Jonsson's disclosure, which does not mention a Heparin input device; that absence is not an affirmative disclosure of non-inclusion. As such, Jonsson's failure to describe a Heparin input device cannot, by itself, satisfy claim 4's explicit "does not comprise" limitation. See, e.g., International Business Mach. Corp. V. lanacu, No. 2018-1065 (Fed. Cir. Apr. 1, 2019)” on page 5 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. While silence will not generally suffice to support a negative claim limitation, there may be circumstances in which it can be established that a skilled artisan would understand a negative limitation to necessarily be present in a disclosure, MPEP 2173.05(i). According to the disclosure of Jonsson, Jonsson’s dialyzer and its holder are intended to be used in a dialysis machine such as the Grambro AK 100 (Col. 1, line 9 of Jonsson), which is described in details in the disclosure of European Patent EP 0278100 B1 to Jonsson et al. (Col. 1, line 25-29 of Jonsson; hereinafter Jonsson EP). Jonsson EP does not suggest any implementation of anticoagulation composition nor a Heparin input device within the system. Therefore, in this instant case, it can be established that one of ordinary skill in the art would understand that the absence of a Heparin input device is likely. The rejection is maintained; see rejection of claims below.
Claim Rejections - 35 USC § 102
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 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 and 2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schroers et al. US 2021/0187183 A1 (newly cited, hereinafter Schroers).
Regarding claim 1, Schroers discloses a hemodialysis filter rotator 1 (Fig. 1 – an apparatus 1) comprising:
a hemodialysis filter holder 4 (Fig. 1-2 – bearing device 4); and
a rotator 5 (Fig. 1-2 – drive device 5) connected to the hemodialysis filter holder 4 (Fig. 1-2),
wherein the rotator 5 (Fig. 1-2) is configured to continuously or intermittently rotate the hemodialysis filter holder 4 (Fig. 1-2) during dialysis treatment (Par. 53 – “When, for instance, air bubbles are to be removed from the dialysate and/or the blood“, which indicates for use during blood treatment) according to a predetermined program schedule (Par. 53 – “a rotation of the dialyzer 2 around the longitudinal and/or transverse axis L, Q by means of the drive device 5… control the drive device 5 such that the dialyzer 2 is alternatingly rotated back and forth around the longitudinal axis L…”).
Regarding claim 2, Schroers discloses the invention of claim 1. Schroers further discloses further comprising a programmable motor controller 7 (Fig. 1 – control device 7) operably connected to the rotator 5 (Fig. 1-2), wherein the programmable motor controller 7 (Fig. 1) is configured to cause the rotator 5 (Fig. 1) to rotate and hold the hemodialysis filter holder 4 (Fig. 1-2) at a predetermined angle according to a predetermined program schedule (Par. 53 – “The control device 7 can also be configured to prompt a rotation of the dialyzer 2 around the longitudinal and/or transverse axis L, Q by means of the drive device 5”, and Par. 55 – “the bearing device 4… at least partly engaging around the dialyzer 2, and thus also dialyzer 2, to rotate about a transverse axis Q running perpendicular to the longitudinal axis L”) during dialysis treatment (Par. 53 as established above).
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jonsson et al. US 5,770,064 A (previously cited, hereinafter Jonsson).
Regarding claim 4, Jonsson discloses a hemodialysis system (Fig. 2 shows the dialysis machine, and Col. 4, line 50-51- “FIGS. 2, 3 and 4 show the same dialysis machine”), the system (Fig. 1) comprising:
a rotatable hemodialysis filter holder 29 (Fig. 5 – connector 29, and Col. 5, line 42-43 – “The outlet nipple 7 of the dialyser is put into a hole 31 in the connector 29”; Fig. 5 shows that as the shaft journal 28 rotates indicated by the arrow, the connector 29 also rotates);
a rotator 28 (Fig. 5 – shaft journal 28) connected to the hemodialysis filter holder 29 (Fig. 5 – connector 29 and shaft journal 28 are connected); and
wherein the hemodialysis system does not comprise a Heparin input device (the disclosure of Jonsson does not disclose any Heparin input device).
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.
The factual inquiries 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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Schroers in view of Jonsson, as cited in the IDS, and evidenced by Kollar et al. US 2008/0027368 A1 (previously cited, hereinafter Kollar).
Regarding claim 3, Schroers suggests the invention of claim 2. However, Schroers does not currently disclose wherein predetermined program schedule comprises: rotating the hemodialysis filter holder from a 12:00 o'clock position to a 2 o'clock position for 15 minutes; rotating the hemodialysis filter holder from the 2 o'clock position to the 12 o'clock position for 15 minutes; rotating the hemodialysis filter holder from the 12:00 o'clock position to a 10 o'clock position for 15 minutes; and rotating the hemodialysis filter holder from the 10 o'clock position to the 12 o'clock position for 15 minutes.
Jonsson, in the same field of holders intended for use in hemodialysis (Col. 1, line 5-10), teaches wherein predetermined program schedule (Col. 5, line 31-37 – “the priming process”) comprises:
rotating the hemodialysis filter holder 29 (Fig. 4) from a 12:00 o'clock position (Fig. 4 – the connector 29 is at a 12 o’clock position) to a 3 o'clock position (Fig. 2 – the connector 29 is at a 3 o’clock position, and Col. 5, line 14-16 – “From the position in FIG. 4, the shaft journal 28 can be rotated 90ᵒ clockwise to the position shown in FIG. 2”);
rotating the hemodialysis filter holder 29 from the 3 o'clock position (Fig. 2) to the 9 o'clock position (Fig. 3, and Col. 5, line 24-25– “The shaft journal 28 is then rotated an additional 180ᵒ. clockwise to the priming position as shown in FIG. 3”; thus moving the connector 29 to the 9 o’clock position) for 10 minutes (Col. 5, line 31-32 – “priming has been effected in this position, for a period of 10 minutes”);
rotating the hemodialysis filter holder 29 from the 9 o'clock position (Fig. 3) to a 12 o'clock position (Fig. 2, and Col. 5, line 32-34 – “the shaft journal 28 is rotated 180ᵒ counterclockwise back to the position shown in FIG. 2”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schroers to apply the rotation technique of Jonsson that is known for degassing air out of the dialyzer (Col. 4, line 44-49 of Jonsson), since the device of Schroers aims to remove air bubbles not only during priming, but also during blood treatment (Par. 53 of Schroers – “air bubbles are to be removed from the dialysate and/or the blood or if the user wants to prevent air bubbles from forming when filling the dialyzer 2 with blood and/or dialysate”). Therefore, this modification of Jonsson will further improve the safe operation of the blood treatment system (Par. 36 of Jonsson) with the predictable results of removing air bubbles present within the dialyzer. See MPEP 2143.I.D.
According to the discussion of Jonsson in Col. 5, line 31-35 reciting, “After priming has been effected in this position, for a period of 10 minutes, for example, the shaft journal 28 is rotated 180ᵒ. counterclockwise back to the position shown in FIG. 2, and priming is allowed to occur for an additional amount of time”, and as evidenced by the discussion of Kollar in Par. 87 reciting, “In order to enhance the efficiency of bubble removal during priming portion 761 is angled about 221/2ᵒ from the horizontal and portion 762 is angled about 45ᵒ from the horizontal to allow air to rise to the arterial filter purge outlet”, the period of time and angle would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention because sufficient time is required to achieve a complete air removal process, and the angle at which the filter holder is rotated will affect the efficacy of bubble removal. Therefore, a sufficient amount of rotating time and appropriate angle are desired to effectively purge air out of the dialysis filter. As such, without showing unexpected results, the claimed positions of 12 o’clock to 2 o’clock, 2 o’clock to 12 o’clock, 12 o’clock to 10 o’clock, 10 o’clock to 12 o’clock for 15 minutes cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the rotation positions of the filter holder at 15-minute interval in the device of Schroers in view of Jonsson to obtain the desired bubble removal effect as the device goes through the rotation process, as taught by Jonsson (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Thus, the limitation of claim 3 is met.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jonsson in view of Schroers.
Regarding claim 5, Jonsson suggests the invention of claim 4. Jonsson further discloses the rotator 28 (Fig. 5) to rotate and hold the hemodialysis filter holder 29 (Fig. 5) at a predetermined angle (Col. 5, line 4-5 – “The shaft journal 28 is rotatable into three different positions”, Col. 5, line 14-15 – “the shaft journal 28 can be rotated 90ᵒ clockwise”, and Col. 5, line 23-24 – “The shaft journal 28 is then rotated an additional 180ᵒ clockwise”) according to a predetermined program schedule (Col. 5, line 31-37 – “After priming has been effected in this position, for a period of 10 minutes, for example, the shaft journal 28 is rotated 180ᵒ counterclockwise back to the position shown in FIG. 2, and priming is allowed to occur for an additional amount of time, whereupon the priming process is terminated and treatment can take place”) according to a predetermined program schedule (Col. 5, line 31-37 – “After priming has been effected in this position, for a period of 10 minutes, for example, the shaft journal 28 is rotated 180ᵒ counterclockwise back to the position shown in FIG. 2, and priming is allowed to occur for an additional amount of time, whereupon the priming process is terminated and treatment can take place”).
However, Jonsson does not explicitly disclose further comprising a programmable motor controller operably connected to the rotator, wherein the programmable motor controller is configured to cause the rotator to rotate and hold the hemodialysis filter holder during dialysis treatment.
Examiner notes that while Jonsson does not explicitly disclose a programmable motor controller, Jonsson does disclose a holder for a dialyser which is motor-driven so that the dialyser can be placed in at least two positions, namely a priming position and a handling position, without intervention from personnel (Col. 2, line 15-20). In other words, the operating environment of Jonsson allows for electrical communication between the Jonsson’s rotator and a command unit.
Schroers, in the same field of endeavor of apparatus for holding a dialyzer (Abstract), teaches a programmable motor controller 7 (Fig. 1 – control device 7) operably connected to the rotator 5 (Fig. 1-2), wherein the programmable motor controller 7 (Fig. 1) is configured to cause the rotator 5 (Fig. 1) to rotate and hold the hemodialysis filter holder 4 (Fig. 1-2) during dialysis treatment (Par. 53 – “When, for instance, air bubbles are to be removed from the dialysate and/or the blood“, which indicates for use during blood treatment, and Par. 53 – “The control device 7 can also be configured to prompt a rotation of the dialyzer 2 around the longitudinal and/or transverse axis L, Q by means of the drive device 5”, and Par. 55 – “the bearing device 4… at least partly engaging around the dialyzer 2, and thus also dialyzer 2, to rotate about a transverse axis Q running perpendicular to the longitudinal axis L”).
Given that Jonsson allows integration of electrical communication from a command unit to the rotator as discussed above, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jonsson to further include a programmable motor controller for rotating and holding the holder during dialysis treatment as taught by Schroers, in order to not only remove air bubbles during priming process, but also during blood treatment (Par. 53 of Schroers).
Regarding claim 6, Jonsson in view of Schroers suggests the invention of claim 5. The combination further discloses wherein the hemodialysis filter holder 29 (Fig. 5 of Jonsson) comprises a hemodialysis filter 3 (Fig. 2 of Jonsson – dialyser 3, and Col. 5, line 18-19 of Jonsson – “dialyser 3 is placed with its outlet nipple 7 (see FIG. 1) in the connector 29”).
Regarding claim 7, Jonsson suggests the invention of claim 4. Jonsson further discloses rotating the hemodialysis filter holder 29 (Fig. 5) to at least three distinct angular positions (Col. 5, line 4-5– “rotatable into three different positions”).
However, Jonsson does not disclose wherein the predetermined program schedule comprises rotating the hemodialysis filter holder for predetermined time intervals during dialysis treatment.
Schroers, in the same field of endeavor of apparatus for holding a dialyzer (Abstract), teaches wherein the predetermined program schedule (Par. 53 – “a rotation of the dialyzer 2 around the longitudinal and/or transverse axis L, Q by means of the drive device 5… control the drive device 5 such that the dialyzer 2 is alternatingly rotated back and forth around the longitudinal axis L…”) comprises rotating the hemodialysis filter holder 4 (Fig. 1-2 – bearing device 4) for predetermined time intervals (Par. 29 – “the control device is preferably configured to trigger the forward and reverse rotation of the disposable item via the drive device at predetermined intervals of time or as a function of the volume of blood having flown through the disposable item”) during dialysis treatment ((Par. 53 – “When, for instance, air bubbles are to be removed from the dialysate and/or the blood“, which indicates for use during blood treatment).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Jonsson to further include a program schedule for rotating and holding the holder during dialysis treatment as taught by Schroers, in order to not only remove air bubbles during priming process, but also during blood treatment (Par. 53 of Schroers).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Schroers in view of Jonsson.
Regarding claim 8, Schroers suggests the invention of claim 1. Schroers further discloses wherein the predetermined program schedule (Par. 53) comprises rotating the hemodialysis filter holder 4 (Fig. 1-2, and Par. 55) to angular positions for predetermined time intervals (Par. 29 – “the control device is preferably configured to trigger the forward and reverse rotation of the disposable item via the drive device at predetermined intervals of time or as a function of the volume of blood having flown through the disposable item”) during dialysis treatment (Par. 53).
However, Schroers does not disclose at least three distinct angular positions.
Jonsson, in the same field of endeavor of holders intended for use in hemodialysis (Col. 1, line 5-10), teaches at least three distinct angular positions (Col. 5, line 4-5 – “rotatable into three different positions”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Schroers to apply the rotation technique with at least three distinct angular positions of Jonsson that is known for degassing air out of the dialyzer (Col. 4, line 44-49 of Jonsson), since the device of Schroers aims to remove air bubbles not only during priming, but also during blood treatment (Par. 53 of Schroers – “air bubbles are to be removed from the dialysate and/or the blood or if the user wants to prevent air bubbles from forming when filling the dialyzer 2 with blood and/or dialysate”). Therefore, this modification of Jonsson will further improve the safe operation of the blood treatment system (Par. 36 of Jonsson) with the predictable results of removing air bubbles present within the dialyzer. See MPEP 2143.I.D.
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781