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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to a cranial shunt, classified in A61M 27/006.
II. Claim18-27, drawn to a medical device, classified in A61M 2205/3592.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different mode of operation in that the invention of Group II is directed to implanted elements and external charging and communication while Group I makes no distinction and does not appear to comprise any external elements. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
the groups have diverging subject matter and features (i.e. the searching of Group I would be unlikely to yield the elements of Group II).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Todd Benni on 7/28/2026 a provisional election was made without traverse to prosecute the invention of Group II, claims 18-27. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-19 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of Claims
Claims 1-27 are pending in the present application. Claims 1-17 are withdrawn from consideration. Claims 18-27 are examined on the merits.
Drawings
The drawings are objected to because Fig. 1 appears to be a color drawing that has been converted to grayscale. This does not enable differentiation of elements, such as the valve assembly 140, proximal catheter 106, and distal catheter 103.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Reference character “280” has been used to designate both valve assembly and tethered capsule in paragraph 63 of Applicant’s specification.
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.
Claim 21 is 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.
The term “potentially undesirable condition” in claim 21 is a relative term which renders the claim indefinite. The term “potentially undesirable” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
While Applicant’s specification does provide examples of “potentially undesirable” conditions in the form of catheter blockages, the term requires subjectivity. In an effort to promote compact prosecution, any condition which triggers an alarm is interpreted as being “potentially undesirable”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 18-27 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
While the claims do not explicitly recite implantation into a human organism, it is clear from Applicant’s specification the invention is intended for implantation into a human subject as Applicant’s disclosure references only human tissue.
Appropriate correction is required. In an effort to promote compact prosecution, the limitations of elements being “implanted”, and similarly those described as being “external” are interpreted as intended use.
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.
Claims 18-26 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar et al. (US 2020/0289803 A1), which is cited in Applicant’s IDS, in view of Elbadry et al. (US 2024/0207499 A1) and Kamen (US 2012/0238851 A1).
Regarding claim 18, Iskandar teaches a medical device comprising (Fig. 12; Abstract):
an implanted catheter (proximal catheter 18; ¶ 48 indicates implanted);
an implanted valve assembly operatively coupled with the catheter (valve 22), the valve assembly comprising an inlet and a microcontroller (¶ 50 indicates the valve is couples the proximal catheter 18 and distal catheter 20; ¶ 51 indicates a valve driver 24 being a microcontroller), wherein the catheter transfers cerebrospinal fluid (CSF) to the inlet (¶s 10-11 and 47-51 describe CSF drainage from proximal catheter 18, through the valve 22, to distal catheter 20);
an implanted pressure sensor configured to provide intracranial pressure (ICP) of a patient to the microcontroller (pressure sensor 26; ¶ 52), wherein the valve assembly passes or blocks the CSF based on instructions from the microcontroller (¶ 88 describes how the valve controller 24 receives signals from the pressure sensor 26 to determine whether the valve should be on or off);
an implanted rechargeable electromechanical storage cell operatively coupled to the microcontroller (battery 30 in Fig. 1; ¶s 53-54; ¶s 25-26 indicate the valve being electrically actuated, thus the battery is interpreted as providing electromechanical energy);
an external charging device configured to charge the implanted rechargeable electromechanical energy storage cell wirelessly through derma (¶s 54-55 describe telemeter device 14, which provides electrical charging to the battery; Fig. 12); and
an external communication device in wireless data communication with the microcontroller, wherein the external communication device is configured to receive and send information from and to the microcontroller (¶s 53-57).
Iskandar does not explicitly teach an external docking station configured to charge rechargeable batteries located within said external charging device and said external communications device; and a clinical software application installed on a device, the clinical software application in communication with the external communication device.
However, Elbadry teaches an implanted medical device (Fig. 1A; Abstract and ¶ 3), thus being in the same field of endeavor, comprising an implanted catheter (catheter 12) comprising an external communication device (server 29, mobile device applications 31) configured to send and receive information to and from a microcontroller (patient monitoring device 00 comprising a controller as per ¶s 20, 123 and 390) comprising a clinical software application installed on a device, the clinical software application in communication with the external communication device (i.e. web access portal 41; ¶s 124-125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Iskandar to comprise the external communications device and clinical software application installed on a device as taught by Elbadry. Doing so would thus comprise an external communication device in wireless data communication with the microcontroller, wherein the external communications device is configured to receive and send information from and to the microcontroller; and a clinical software application installed on a device, the clinical software application in communication with the external communication device. Doing so would be advantageous in allowing for remote monitoring and feedback by a clinician (as in ¶s 6-8, 124-125 of Elbadry).
The combination of Iskandar and Elbadry still do not explicitly teach the use of an external docking station configured to charge rechargeable batteries located within said external charging device and said external communication device.
In addressing the same problem as Applicant, the problem being the charging of a medical device and communications device system, Kamen teaches a medical device system (Figs. 3, 8, and 9A; Abstract) comprising an external docking station (recharge station 1304; ¶ 392).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Iskandar and Elbadry to comprise the external docking station of Kamen. Doing so would be advantageous in allowing for charging and transfer of data while a user is sleeping or remaining in a single area (¶ 392 of Kamen).
Further, limitations of the docking station being “configured to charge rechargeable batteries located within said external charging device and said external communications device” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the docking station of Iskandar, Elbadry, and Kamen has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the external docking station of Kamen would be capable of charging rechargeable electronic devices).
Regarding claim 19, Iskandar further teaches the device comprises measuring pressure of an environment of the patient (¶ 10 describes ambient pressure being measured by an external reader).
Elbadry teaches using the external communication device to send and receive sensor information relating to the device function (¶s 18, 20, 118, 123, 187 and 390).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Iskandar to comprise the external communications device and clinical software application installed on a device as taught by Elbadry. Doing so would thus comprise the information received and sent by the external communication device comprises ambient pressure of an environment of the patient. Doing so would be advantageous in allowing for remote monitoring and feedback by a clinician (as in ¶s 6-8, 124-125 of Elbadry).
Regarding claim 20, Elbadry further teaches the external communication device provides alerts indicating a potentially undesirable condition for the patient, wherein such alerts are communicated to the external communications device wirelessly from the microcontroller (¶s 121, 175-176 339, and 390).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Iskandar, Elbadry, and Kamen to comprise the alert as taught by Elbadry. Doing so would thus comprise the external communication device providing alerts indicating a potentially undesirable condition for the patient, wherein such alerts are communicated to the external communications device wirelessly from the microcontroller. Doing so would be advantageous in allowing for remote monitoring and feedback by a clinician (as in ¶s 6-8, 124-125 of Elbadry).
Regarding claim 21, Elbadry further teaches the alarm conditions being for catheter blockages (¶s 2, 288, and 390).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Iskandar, Elbadry, and Kamen to comprise the blockage alert as taught by Elbadry. Doing so would be advantageous in allowing for remote monitoring and feedback by a clinician (as in ¶s 6-8, 124-125 of Elbadry).
Regarding claim 22, Iskandar further teaches the device comprises measuring pressure of an environment of the patient (¶ 10 describes ambient pressure being measured by an external reader).
Elbadry teaches using the external communication device to send and receive sensor information relating to the device function (¶s 18, 20, 118, 123, 187 and 390).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Iskandar to comprise the external communications device and clinical software application installed on a device as taught by Elbadry. Doing so would thus the external communication device providing a measurement of ambient pressure to the microcontroller. Doing so would be advantageous in allowing for remote monitoring and feedback by a clinician (as in ¶s 6-8, 124-125 of Elbadry).
Regarding claim 23, limitations of the external communications device being “configured to be stored on the external docking station” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the external device of Iskandar, Elbadry, and Kamen has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the external device would be configured to be stored on the external docking station as suggested in ¶ 420 of Kamen, such as in recharge area 1306).
Regarding claim 24, Iskandar teaches the microcontroller using ambient pressure to adjust the ICP based on environmental surroundings of the patient (¶ 10 describes how ICP is the differential with ambient pressure, and that CSF is drained based on monitoring these pressures).
Regarding claims 25-26, Elbadry teaches the (claim 25) the external communications device comprises a wearable device, and (claim 26) wherein the wearable device comprises a wrist worn device (¶ 403 specifically indicates the use of internet connected watches).
Kamen also teaches the (claim 25) the external communications device comprises a wearable device, and (claim 26) wherein the wearable device comprises a wrist worn device (¶ 431 specifically indicates the use of smartwatches).
Thus, Elbadry and Kamen both show that a (claim 25) external communications device comprising a wearable device, (claim 26) wherein the wearable device comprises a wrist worn device is an equivalent structure known in the art. Therefore, because these external communications devices were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute specifically a wrist worn external communications device for a generic external communications device.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Iskandar, Elbadry, and Kamen as applied to claim 18 above, and further in view of Swoboda et al. (US 2017/0219450 A1).
Regarding Claim 27, Iskandar does teach the use of a tilt sensor (accelerometer in ¶ 86), but the combination still does not explicitly disclose said tilt sensor being configured to provide an angle of orientation relative to gravity of a cranium of the patient to the microcontroller to provide correctional offsets due to posture of the patient to the microcontroller.
However, Swoboda teaches a sensor system for CSF drainage (Fig. 3A; Abstract and ¶ 12), thus being in the same field of endeavor, comprising a tilt sensor (¶s 54-55 describe an orientation sensor used to adjust the valve via a controller).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Iskandar, Elbadry, and Kamen to comprise the orientation sensor of Swoboda. Doing so would be advantageous in compensating for changes in patient position.
Further, limitations of the tilt sensor “configured to provide an angle of orientation relative to gravity of a cranium of the patient to the microcontroller to provide correctional offsets due to posture of the patient to the microcontroller” are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device and tilt sensor of Iskandar, Elbadry, Kamen, and Swoboda has all the structure of the device as claimed. As such, it is capable of performing the functions as claimed (i.e. the orientation sensor of Swoboda would be capable of providing an angle of orientation as claimed, which would be in line with the operations described in ¶s 54 and 55).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Krishnan et al. (US 20230248306 A1) discloses patient position strongly affects CSF hydrodynamics (¶ 106).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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