DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 54-58, 61-64, 68-73 & 76) and furthermore Species (A)(vi) and B(ii) in the reply filed on 2/9/2026 is acknowledged. Claims directed to Group II, namely claims 77 & 80-82, have been withdrawn by Applicant.
Applicant indicates that all claims in Group I are generic to the elected species. However, Examiner notes that species (A)(vi) is directed to wirelessly operating a motor unit associated with a hydraulic reservoir and hydraulic valve shifting device in order to non-invasively regulate the filtering device, whereas claims 55 & 56 clearly recites manually pressing a subcutaneous switch or manually pressing the hydraulic reservoir, thus these do not pertain to the elected species. Similarly, species (B)(ii) is directed to releasing electromagnetic energy to the filtering device but claim 71 clearly states non-magnetic energy is released.
As such, Examiner further withdraws claims 55-56 & 71 from examination.
Claims 54, 57-58, 61-64, 68-70, 72-73 and 76 are examined on the merits. Claims 54 & 68 are independent.
Claim Objections
Claims 54, 68 & 73 are objected to because of the following informalities:
Re Claim 54, there are multiple typographical errors. The second clause should be corrected to: “a filter connected to the tube for filtering any [[particles]]particle passing through the tube, wherein said filter is adapted to move any [[particles]]particle away from the fluid passageway, when the filter being implanted in the [[patients]]patient’s body …”
Re Claim 68, there are multiple typographical errors. In the preamble, “devicefor” should be “device for”. The second clause should be corrected to: “said filter is adapted to move any [[particles]]particle away from the fluid passageway, when the filter being implanted in the [[patients]]patient’s body …”
Re Claim 73, for better consistency in claim terms, “the filtering apparatus” and “the apparatus” should be “the filtering device”. Additionally, Claim 73 is written to be dependent from Claim 68 but the preamble has changed. Examiner is treating “for postoperatively and non-invasively regulating the filtering device” as typographical error and removing it from consideration.
Appropriate correction is required.
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 54, 57-58, 68, & 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. 9,789,290. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 21 implies the limitations of all of said claims by reciting a filtering device having the same structures as the current claims and said filtering device also being configured to perform the same steps as the current claims. As such, the steps in the current method claims are obvious in view of patented claim 21.
Claims 54, 57-58, 61-63, 68, 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3, 13 of U.S. Patent No. 10,384,042. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 1 & 13, each individually, recites the limitations of current claims 54, 57-58, 61-62, 68 & 73, including a filtering device having a tube forming and passageway and a filter connected to the tube for filtering particles that pass through the tube. The currently recited steps are recited as functional language in said patented device claims and are therefore obvious. Patented claim 3 reads on the current claim 63.
Claims 54 & 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 or 20 of U.S. Patent No. 11,660,562. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 14 or 20 recited the same limitations of current claims 54 & 57, including a filtering device having a tube and a filter to remove particles passing through the tube, and non-invasively regulating by wireless remote control.
Claims 54 & 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11,826,690. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 7 recited the same limitations of current claims 54 & 57, including a filtering device having a tube and a filter to remove particles passing through the tube, and non-invasively regulating by wireless remote control.
Claims 54, 57, 68 & 73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 5, 16 of U.S. Patent No. 12,558,528. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claim 2, including a method to remove particles from a fluid of a patient using a filtering device, the filtering device being implantable and comprising a tube having a passageway, a filter connected to the tube to filter particles and move the particles away from the fluid passageway, and non-invasively regulating the filtering device from outside the patient’s body. Patented claim 5 reads on the current claim 57. Patented claim 16 reads on the limitations in current claim 68, including a method of using a filtering device, wherein the filtering device comprises a tube and a filter, the method comprises providing an external source of energy, providing an operation device (implied because patented claim 16 recites releasing energy for operating the filtering device), controlling the external source of energy to release wireless energy, and using the released wireless energy to operate. Limitations of current claim 73 can be found in patented claim 7, from which patented claim 16 depends.
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 57-58 & 61-64 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.
Re Claims 57-58, the term “apparatus” lacks antecedent basis. It cannot be readily determined if “apparatus” is referring back to the “filtering device” recited in Claim 54. If that were intended by Applicant, one would find it difficult to believe that a wireless remote control and/or a wireless energy transmitter would be part of the filtering device that is implanted inside the patient’s body. That would render the wireless remote control and wireless energy transmitter inoperable for their intended functions, i.e., they cannot wirelessly regulate the filtering device from outside the patient’s body. For examination, Examiner removes “wherein the apparatus comprises a wireless remote control” and “wherein the apparatus comprises a wireless energy transmitter.
Specifically, Claim 61 depends from canceled Claim 60. For examination, it is assumed that Claim 61 reads: “The method according to claim [[60]]54, further comprising an internal energy source, wherein the internal energy source is associated with an external energy source adapted to transmit wireless energy.”
Claims 62-64 are rejected for being dependent on Claim 61.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 54, 57-58, 61-64, 68-70, 72-73 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Salch (US 2002/0165575).
Re Claim 54, Salch discloses a method of controlling a filtering device for removing particles from a fluid of a patient, the filtering device (e.g., Figs. 4 & 11) being implantable in the patient's body and comprising:
- a tube (e.g., blood inflow tube and blood outflow tube shown in Fig. 4) forming a fluid passageway,
- a filter (filter 12) connected to the tube for filtering any particle passing through the tube, wherein said filter is adapted to move any particle away from the fluid passageway (shown in Fig. 4 where blood clots are removed to be stored in clot retention reservoir 40), when the filter being implanted in the patient’s body (e.g., Abstract, [0051]), wherein the method comprises the step of:
- non-invasively regulating at least one function of the filtering device from outside the patient's body (see Fig. 11 and [0049], where sensor 14 is part of the filtering device and it is powered non-invasively by electromagnetic induction, thus the function of sensor 14 is non-invasively regulated).
Re Claim 57, Salch discloses claim 54, and further discloses wherein the step of non-invasively regulating is performed using a wireless remote control (implied by [0050] where a microprocessor of sensor 14 can be positioned remotely).
Re Claim 58, Salch discloses claim 54, and further disclosing wherein the apparatus comprises a wireless energy transmitter (implied by [0049]), and wherein the step of non-invasively regulating is performed using said wireless energy transmitter.
Re Claim 61, Salch discloses claim 54, and further disclosing an internal energy source (“battery of powering sensor 14”, [0049]), wherein the internal energy source is associated with an external energy source adapted to transmit wireless energy ([0049]).
Re Claim 62, Salch discloses claim 61, and further disclosing the step of transmitting energy from the external energy source for charging the internal energy source ([0049] “the recharge of the battery powering sensor 14”).
Re Claim 63, Salch discloses claim 62, and further discloses the step of sending feedback information ([0058] “generates a clot accumulation signal” and [0059] “the receiver may itself communicate the patient’s condition to medical professionals at a remote location”) from inside the patient's body to the outside the patient's body for providing feedback related to a functional parameter of the device (e.g., [0058] “detects a desired threshold clot accumulation level”) or a physical parameter of the patient.
Re Claim 64, Salch discloses claim 63, and further discloses wherein the functional parameter of the device is correlated to the transfer of energy for charging the internal energy source (the sensor 14 is powered by the battery that receives electromagnetic energy from outside the body, the sensor would not be able to detect clot accumulation within the filtering device or transmit such a signal to an outside receiver or to a medical professional).
Re Claim 68, Salch discloses a method of using a filtering device for removing particles from a fluid of a patient (e.g., Abstract), the filtering device (e.g., Figs. 4 & 11) being implantable in the patient's body and comprising:
- a tube (e.g., blood inflow and blood outflow shown in Fig. 4) forming a fluid passageway,
- a filter (filter 12) connected to the tube for filtering any particle passing through the tube, wherein said filter is adapted to move any particle away from the fluid passageway (see Figs. 4 & 11), when the filter being implanted in the patient’s body (e.g., Abstract, [0051]), wherein the method comprises the steps of:
- providing an external source of energy ([0049] where the battery of the sensor 14 is charged by electromagnetic induction) outside the patient's body,
- providing an operation device for operating the filtering device (sensor 14 has microprocessors and/or transmitter subcomponents, see [0050]),
- controlling the external source of energy from outside the patient's body to release wireless energy (implied in [0049]), and
- using said released wireless energy for operating the operation device (see Fig. 11 and [0049], where sensor 14 is part of the filtering device and it is powered non-invasively by electromagnetic induction, thus the function of sensor 14 is non-invasively regulated).
Re Claim 69, Salch discloses claim 68, and further discloses the steps of transforming the wireless energy into electrical energy ([0049] where the sensor’s battery is charged by electromagnetic energy) inside the patient's body using an implanted energy-transforming device (at least subcutaneous induction coil 62) and using said electrical energy when operating the filtering device (the battery allows sensor 14 to operate).
Re Claim 70, Salch discloses claim 69, and further disclosing directly using the electrical energy in connection with operation of the filtering device using a transformer adapted to transform wireless energy into the electrical energy (induction coil 62 transforms electromagnetic energy into electrical energy that is stored in the battery).
Re Claim 72, Salch discloses claim 68, and further discloses the steps of:
- controlling the external source of energy from outside the patient's body to release electromagnetic wireless energy (implied in [0049]), and
- using direct or indirect released electromagnetic wireless energy for operating the filtering device ([0049] discloses electromagnetic energy is transformed by induction coil 62 to electric energy stored in battery of sensor 14).
Re Claim 73, Salch discloses claim 68, and further disclosing the steps of:
- moving any cleaned matter, which have been accumulated in the filtering apparatus of the patient's body, away from the fluid passageway (see Figs. 4 & 11 where blood clots are collected in clot retention reservoir 40 that is off the fluid passageway), and
- placing the cleaned matter outside the apparatus (e.g., [0009] “manual removal of the offending clot(s)”).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 76 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salch.
Re Claim 76, Salch discloses claim 73, and further discloses that wherein the steps of moving any cleaned matter away from the filtering device and placing the cleaned matter outside the filtering device are at least partly controlled by an internal control unit (e.g., [0039] & [0059], sensor 14 would alert the patient and/or medical professional that clot accumulation has exceeded a threshold, thus prompting the clot-removal step) receiving an input signal from a sensor (14) sensing at least one physical parameter of the patient and/or at least one functional parameter (i.e., the extent of clot accumulation) of the device. Salch does not disclose that the steps are repeated. However, since the filtering device is already implanted in the vasculature of the patient and blood clots are continuously collected in the clot retention reservoir (40), one skilled in the art can easily foresee that even after reducing/removing the collected clots from the reservoir, more clots will again build up over time, thus a repeat removal process is, more likely than not, necessary. As such, one skilled in the art at the time of filing would find it obvious to repeat the steps recited in this claim to maintain the patient’s health.
Conclusion
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/SUSAN S SU/ Primary Examiner, Art Unit 3781
16 March 2026