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 .
Specification
The abstract of the disclosure is objected to because:
In line 7, “fluid flow” should be changed to “a flow of the fluid”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-2, 8-9, and 13-16 are objected to because of the following informalities:
In regards to claim 1, line 7, “fluid flow” should be changed to “a flow of the fluid”.
In regards to claim 2, line 2, “fluid” should be changed to “the fluid”.
In regards to claim 8, line 7, “and” should be changed to “or” to recite a disjunctive format of the options for the at least one filter membrane.
In regards to claim 9, line 2, “and” should be changed to “or” to recite a disjunctive format of the options for the at least one filter membrane.
In regards to claim 13, line 2, “and” should be changed to “or” to recite a disjunctive format of the options for the at least one filter membrane.
In regards to claim 14, line 2, “and” should be changed to “or” to recite a disjunctive format of the options for the at least one filter membrane.
In regards to claim 15, line 7, “fluid flow” should be changed to “a flow of the fluid”.
In regards to claim 16, line 2, “fluid” should be changed to “the fluid”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-7, 11-14, and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the two terms are the same component or different components. Claims 5-7 are rejected by virtue of being dependent upon claim 4.
In regards to claim 5, line 1 recites “a first filter membrane”. Claim 5 depends upon claim 4. Claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the three terms are the same component or different components. Claims 6-7 are rejected by virtue of being dependent upon claim 5.
In regards to claim 5, line 2 recites “a second filter membrane”. Claim 5 depends upon claim 4. Claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the three terms are the same component or different components. Claims 6-7 are rejected by virtue of being dependent upon claim 5.
In regards to claim 6, line 1 recites “a third filter membrane”. Claim 6 depends upon claim 5, which depends upon claim 4. Claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the three terms are the same component or different components. Claim 7 is rejected by virtue of being dependent upon claim 6.
In regards to claim 6, line 2 recites “a fourth filter membrane”. Claim 6 depends upon claim 5, which depends upon claim 4. Claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the three terms are the same component or different components. Claim 7 is rejected by virtue of being dependent upon claim 6.
In regards to claim 7, line 1 recites “a fifth filter membrane”. Claim 7 depends upon claim 6, which depends upon claim 5, which depends upon claim 4. Claim 4, line 1 recites “at least five filter membranes”. Claim 4 depends upon claim 3, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the three terms are the same component or different components.
In regards to claim 11, lines 1-2 recite “the filter membranes”. First, there is insufficient antecedent basis for this limitation in the claim. Second, claim 11 depends upon claim 10, which depends upon claim 9, which depends upon claim 1. Claim 1, line 6 recites “at least one filter membrane”. It is unclear whether the two terms are the same component or different components. Claims 12-14 are rejected by virtue of being dependent upon claim 11.
In regards to claim 18, line 2 recites “the first end”. There is insufficient antecedent basis for this limitation in the claim. Claims 19-20 are rejected by virtue of being dependent upon claim 18. Claim 20, line 2 also recites “the first end” for which there is insufficient antecedent basis.
In regards to claim 18, line 3 recites “the second end”. There is insufficient antecedent basis for this limitation in the claim. Claims 19-20 are rejected by virtue of being dependent upon claim 18. Claim 20, line 2 also recites “the second end” for which there is insufficient antecedent basis.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 18, and 20, as of June 27, 2025, of copending Application No. 18/088,019 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application claims and Application No. 18/088,019 claims, as of June 27, 2025, at least recite a catheter pump system, a catheter pump, a fluid system, at least one filter membrane, and a plurality of filter membranes (a first filter membrane and a second filter membrane).
The table below shows the present application claims 1-2 and 15-16 corresponding to claims 1-4, 18, and 20, as of June 27, 2025, of copending Application No. 18/088,019:
Present application claims
Application No. 18/088,019 claims
1
1-4, 18, 20
2
4, 20
15
1-4, 18, 20
16
4, 20
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-7, 9-13, and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jaehrling et al (US 4,936,831).
In regards to claim 1, Jaehrling et al teaches a catheter pump system (Figures 1-2) comprising:
a catheter pump (labeled in Figure 1 below) having a proximal end, a distal end, and an elongate body (2, 7, 8) extending therebetween, the elongate body defining at least an inner lumen (Figure 1)
a fluid system (labeled in Figure 1 below) located within the catheter pump, the fluid system configured to pressurize the catheter pump with fluid (Figure 1)(column 3, lines 10-12: the pressure at which the first bubble passes through the membrane, will occur at a pressure of 10-20 mbar)
at least one filter membrane (9/19/29)(column 2, lines 65-67: the filter 9 includes a housing containing a two-ply membrane filter having two membranes)(column 3, lines 28-37 states “in addition to the filter arrangement 9 of FIG. 1, a similar filter arrangement 19 can be placed between the septum 3 and the medication reservoir 1 on the line or hose 2 or the similar arrangement 29 can be placed on the discharge line 8 from the dosage pump 6 prior to reaching the catheter. Thus, the possibilities exist of… a combination of the filter arrangements 9, 19 and 29” from which it is understood that filter 19 has two membranes and filter 29 has two membranes, as being similar to filter 9 having two membranes) configured to reduce an amount of particles within the fluid of the fluid system (column 2, lines 15-22: all particles contained in the medication solution, due to manufacturer or that where formed therein due to storage of the solution in the reservoir or that are brought into the reservoir, are eliminated immediately before the pump even and particles formed in the filter itself, due to, for instance, the separation of fibers of the filter, are intercepted) and preserve fluid flow within the fluid system (flow direction 11)
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In regards to claim 2, Jaehrling et al teaches wherein the at least one filter membrane is further configured to filter fluid from the fluid system and trap debris included within the fluid from the fluid system (Figure 1)(column 2, lines 15-22: all particles contained in the medication solution, due to manufacturer or that where formed therein due to storage of the solution in the reservoir or that are brought into the reservoir, are eliminated immediately before the pump even and particles formed in the filter itself, due to, for instance, the separation of fibers of the filter, are intercepted).
In regards to claim 3, Jaehrling et al teaches wherein the fluid system spans from a first end to a second end within the catheter pump (Figure 1).
In regards to claim 4, Jaehrling et al teaches at least five filter membranes (column 2, lines 65-67 states “the filter 9 includes a housing containing a two-ply membrane filter having two membranes”, and column 3, lines 28-37 states “in addition to the filter arrangement 9 of FIG. 1, a similar filter arrangement 19 can be placed between the septum 3 and the medication reservoir 1 on the line or hose 2 or the similar arrangement 29 can be placed on the discharge line 8 from the dosage pump 6 prior to reaching the catheter. Thus, the possibilities exist of… a combination of the filter arrangements 9, 19 and 29” from which it is understood that filter 9 has two membranes, filter 19 has two membranes. and filter 29 has two membranes, as being similar to filter 9 having two membranes, resulting in six filter membranes).
In regards to claim 5, Jaehrling et al teaches wherein a first filter membrane (labeled in Figure 1 below) is located at the first end of the fluid system, and wherein a second filter membrane (labeled in Figure 1 below) is located at the second end of the fluid system.
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In regards to claim 6, Jaehrling et al teaches wherein a third filter membrane (labeled in second copy of Figure 1 above) is located proximate the second filter membrane, and wherein a fourth filter membrane (labeled in second copy of Figure 1 above) is located between the third filter membrane and the second filter membrane.
In regards to claim 7, Jaehrling et al teaches wherein a fifth filter membrane (labeled in second copy of Figure 1 above) is located between the first end and the second end of the fluid system.
In regards to claim 9, Jaehrling et al teaches wherein the at least one filter membrane is located proximate to at least one of (i) the distal end of the catheter pump and (ii) the fluid system (Figure 1).
In regards to claim 10, Jaehrling et al teaches wherein the inner lumen includes a guidewire guide (as filters 9/19/29 has flow-through openings, they are capable of functioning as guidewire guides receiving guidewires therethrough).
In regards to claim 11, Jaehrling et al teaches wherein at least one of the filter membranes are located proximate a septum (3) located at the distal end of the catheter pump (Figure 1).
In regards to claim 12, Jaehrling et al teaches wherein the septum and the at least one filter membrane (9) is configured to seal the inner lumen when the guidewire guide (19 or 29) is removed from the inner lumen (Figure 1).
In regards to claim 13, Jaehrling et al teaches wherein the at least one filter membrane includes a sealing wafer (12 or 13) (Figure 2).
In regards to claim 15, Jaehrling et al teaches a catheter pump system (Figures 1-2) comprising:
a catheter pump (labeled in first copy of Figure 1 above) having a proximal end, a distal end, and an elongate body (2, 7, 8) extending therebetween, the elongate body defining at least an inner lumen (Figure 1)
a fluid system (labeled in first copy of Figure 1 above) located within the catheter pump, the fluid system configured to pressurize the catheter pump with fluid (Figure 1)(column 3, lines 10-12: the pressure at which the first bubble passes through the membrane, will occur at a pressure of 10-20 mbar)
a plurality of filter membranes (9/19/29)(column 2, lines 65-67: the filter 9 includes a housing containing a two-ply membrane filter having two membranes)(column 3, lines 28-37 states “in addition to the filter arrangement 9 of FIG. 1, a similar filter arrangement 19 can be placed between the septum 3 and the medication reservoir 1 on the line or hose 2 or the similar arrangement 29 can be placed on the discharge line 8 from the dosage pump 6 prior to reaching the catheter. Thus, the possibilities exist of… a combination of the filter arrangements 9, 19 and 29” from which it is understood that filter 19 has two membranes and filter 29 has two membranes, as being similar to filter 9 having two membranes) located throughout the catheter pump configured to reduce an amount of particles within the fluid of the fluid system (column 2, lines 15-22: all particles contained in the medication solution, due to manufacturer or that where formed therein due to storage of the solution in the reservoir or that are brought into the reservoir, are eliminated immediately before the pump even and particles formed in the filter itself, due to, for instance, the separation of fibers of the filter, are intercepted) and preserve fluid flow within the fluid system (flow direction 11)
In regards to claim 16, Jaehrling et al teaches wherein the plurality of filter membranes are further configured to filter fluid from the fluid system and trap debris included within the fluid from the fluid system (Figure 1)(column 2, lines 15-22: all particles contained in the medication solution, due to manufacturer or that where formed therein due to storage of the solution in the reservoir or that are brought into the reservoir, are eliminated immediately before the pump even and particles formed in the filter itself, due to, for instance, the separation of fibers of the filter, are intercepted).
In regards to claim 17, Jaehrling et al teaches wherein the fluid system spans from a first end to a second end within the catheter pump (Figure 1).
In regards to claim 18, Jaehrling et al teaches wherein a first filter membrane (labeled in second copy of Figure 1 above) of the plurality of filter membranes is located at the first end of the fluid system, and wherein a second filter membrane (labeled in second copy of Figure 1 above) of the plurality of filter membranes is located at the second end of the fluid system.
In regards to claim 19, Jaehrling et al teaches wherein a third filter membrane (labeled in second copy of Figure 1 above) of the plurality of filter membranes is located proximate the second filter membrane, and wherein a fourth filter membrane (labeled in second copy of Figure 1 above) of the plurality of filter membranes is located between the third filter membrane and the second filter membrane.
In regards to claim 20, Jaehrling et al teaches wherein a fifth filter membrane (labeled in second copy of Figure 1 above) of the plurality of filter membranes is located between the first end and the second end of the fluid system.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jaehrling et al, as applied to claim 1 above, and further in view of Mao et al (US 2020/0061307).
In regards to claim 8, Jaehrling et al does not teach wherein the at least one filter membrane includes at least one of a plasma separation membrane, a glass fiber filter membrane, a sintered porous polyethylene filter, a nylon membrane, a hydrophilic polyethersulfone (PES) membrane, a surfactant-free membrane, a regenerated cellulose (RC) membrane, a cellulose acetate membrane, an ultra-high molecular weight polyethylene (UHMWP) microporous membrane, a hydrophobic PTFE membrane, an oleophobic PTFE membrane, a hydrophilic PTFE membrane, a hydrophilic PVDF membrane, a hydrophobic PVDF membrane, and a sensor protection membrane, as Jaehrling et al instead teaches wherein the at least one filter membrane includes a non-woven polypropylene fiber-fleece and a fabric of polypropylene (column 3, lines 2-15). Mao et al teaches a catheter pump system (Abstract: infusion devices) wherein at least one filter membrane includes a sintered porous polyethylene filter (70) (paragraph [0034]: The filter could be two pieces, the hydrophobic piece and a hydrophilic piece. The hydrophobic region (piece) can be sintered porous polyethylene). It would have obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one filter membrane, of the system of Jaehrling et al, to include a sintered porous polyethylene filter, as taught by Mao et al, as such is effective at stopping or greatly reducing transmission of air through the filter (paragraph [0001]) as it is generally desirable that the catheter delivery be air and bubble free, in order to prevent the introduction of dangerous air bubbles into the patient's system, wherein if air bubbles are allowed to enter a patient's blood stream while receiving administration of liquids, the air bubbles can form an air embolism or otherwise cause serious injury to the patient (paragraph [0003]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Jaehrling et al, as applied to claim 13 above, and further in view of Miller et al (US 2013/0245534).
In regards to claim 14, Jaehrling et al is silent about wherein the sealing wafer is biocompatible and bioresorbable. Miller et al teaches a system wherein a sealing wafer (55) is biocompatible and bioresorbable (paragraph [0074]: filter 55… may comprise… various polymers… which may be… bioresorbable)(it is known in the art that bioresorbable materials are biocompatible). It would have obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the sealing wafer, of the system of Jaehrling et al, to be biocompatible and bioresorbable, as taught by Miller et al, as such will prevent blood clots from getting to critical organs in the body (e.g., the heart, lungs, brain, etc.) while also dissolving over time (paragraph [0064]) to avoid the need for removal surgery.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783