DETAILED ACTION
The amendment filed on 12/16/25 has been received and considered. By this amendment, claims 15, 17, 21, 22, 24-28 are amended and claims 30-34 are added. Claims 15-34 are pending in the application.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 12/16/25, with respect to the rejection(s) of claim(s) 15, 21, and 27 under 35 USC 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 Therefore, the rejection has been withdrawn.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 Rodriguez-Llorente (PG Pub. 2014/0073861).
The double patenting rejections will be held in abeyance until the claims are otherwise in condition for allowance and are repeated here as maintained until that point.
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 15-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10213121 in view of Ramey et al. (PG Pub. 2012/0094370). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a sensor, memory, a port, and processing circuitry operating via two executable code segments. Although the current application requires two separate memories, it would be obvious to have a memory that is shared, dedicated, or group (see par. 96) because Ramey teaches it is a matter of design choice as it does not affect the overall functionality or purpose of the system.
Claims 15-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10993631 in view of Ramey et al. (PG Pub. 2012/0094370). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a sensor, memory, a port, and processing circuitry operating via two executable code segments. Although the current application requires two separate memories, it would be obvious to have a memory that is shared, dedicated, or group (see par. 96) because Ramey teaches it is a matter of design choice as it does not affect the overall functionality or purpose of the system.
Claims 15-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11806118 in view of Ramey et al. (PG Pub. 2012/0094370). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a sensor, memory, a port, and processing circuitry operating via two executable code segments. Although the current application requires two separate memories, it would be obvious to have a memory that is shared, dedicated, or group (see par. 96) because Ramey teaches it is a matter of design choice as it does not affect the overall functionality or purpose of the system.
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 15-20 and 30 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.
Claim 15 discloses “a first memory device storing a first executable code segment”… “a second memory device storing at least a second executable code segment”…and “maintain the first executable segment in the second memory device.” The term “maintain” implies “keep”. However, the first code segment was never in the second memory device. This adds further confusion in the last step because it is unclear if the “executing the first executable code” is the first executable code from the first memory device or the second memory device.
Claim 21 recites the limitation "the at least one configurable algorithm stage" in line 7. There is insufficient antecedent basis for this limitation in the claim.
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(s) 15, 17-22, 24-29, and 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (PG Pub. 2011/0196211) in view of Rodriguez-Llorente (PG Pub. 2014/0073861).
Regarding Claim 15, Al-Ali discloses a medical monitoring system, comprising: a sensor (see sensor 150, 201, 350) configured to generate a sensor signal (see par. 48, 57), the sensor comprising a first memory device (see information element 364; par. 68 and Fig. 3B) storing a first executable code segment; and a monitor (see physiological monitor 310), comprising: an interface (see connector 319) configured to communicatively couple to the sensor (see Fig. 3B); a second memory device (see storage device; par. 153 and 248) that stores a second executable code segment (see par. 248-249); and processing circuitry (see DSP 516 and 717) configured to perform operations, wherein the operations comprise: receive, from the sensor, the sensor signal and the first executable code segment (see par. 37, 67, and 112-113); and determine a physiological parameter based on the sensor signal by executing the first executable code segment and the second executable code segment (see Fig. 6 and Claim 1). Al-Ali discloses storing the same information in multiple locations (see par. 70 and 72) to provide data redundancy, but does not explicitly disclose maintaining the received first executable code segment in the second memory device. Rodriguez-Llorente discloses a similar monitoring system in which the monitor receives, from the sensor, sensor signals (see PPG; par. 3) and a first executable code segment (see encoder 42 information; par. 201-202). It would have been obvious to one of ordinary skill in the art at the time of the invention to maintain the first executable code segment in the second memory device because Rodriguez-Llorente teaches these encoded information helps translate the physiological parameters to establish analysis thresholds (see par. 206).
Regarding Claims 17 and 24, Al-Ali discloses wherein the operations comprise: maintain the first and second executable code segments in the second memory device of the monitor after the sensor is disconnected from the interface (see par. 206 and 248). It would have been obvious to one of ordinary skill in the art at the time of the invention to maintain the first executable code segment in the second memory device because Rodriguez-Llorente teaches these encoded information helps translate the physiological parameters to establish analysis thresholds (see par. 206).
Regarding Claim 18, Al-Ali discloses wherein the operations comprise: deactivate the first executable code segment after the sensor is disconnected from the port (see par. 111 and 142).
Regarding Claim 20, Al-Ali discloses the first executable code segment is encrypted (see par. 112), and wherein the operations comprise: decrypt the first executable code segment. The examiner considers that if the monitor is executing encrypted code, then it is necessarily configured to decrypt.
Regarding Claims 21 and 27, see rejection of Claim 15 above. Al-Ali further discloses algorithm configuration data stored in the memory devices (see par. 112 and 248-249) from which the operations can select an alternative code segment based on the algorithm configuration data to determine a physiological parameter (see par. 81 and 245-246). The examiner considers the processor is selecting the alternative code segment as a result of automatically calibrating the algorithm (see par. 80). Al-Ali does not explicitly disclose activation flags for activating a first alternative executable code segment and inactivating the second alternative executable code segment. Rodriguez-Llorente discloses assigning status indicators, or flags, to activate certain algorithms and keeping others inactive (see par. 257 and 259). It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize activation flags because Rodriguez-Llorente teaches that it helps determine which algorithm or mode to use for preventing locking on to noise in the physiological signal (see par. 252).
Regarding Claim 22, Al-Ali discloses wherein based on the algorithm configuration data, the operations comprise one or more of: reorder the sequence of algorithm stages, modify at least one algorithm stage of the sequence of algorithm stages, create an additional algorithm stage (see par. 242). Again, the examiner considers the steps are a reflection of the algorithm.
Regarding Claim 25, Al-Ali discloses wherein the operations comprise: determine an additional physiological parameter by executing an unselected alternative executable code segments of the plurality of alternative executable code segments (see par. 134). It would have been obvious to one of ordinary skill in the art at the time of the invention to utilize activation flags because Rodriguez-Llorente teaches that it helps determine which algorithm or mode to use for preventing locking on to noise in the physiological signal (see par. 252).
Regarding Claim 26, Al-Ali discloses wherein each of the sequence of algorithm stages comprises a digital conditioning algorithm stage, a decimation algorithm stage, an interpolation algorithm stage, a filtering algorithm stage, or an ambient subtraction algorithm stage (see par. 237 and 247).
Regarding Claim 28, Rodriguez-Llorente discloses any one of the number of executable code segments may be held in the second memory device and selected for execution based on the sensor signal (see par. 206) to appropriately determine the thresholds.
Regarding Claim 29, Al-Ali discloses wherein the sensor comprises a pulse oximetry sensor (see par. 51).
Regarding Claims 30-32, Al-Ali discloses the interface is wired or wireless (see par. 67 and line 340 in Fig. 3B).
Regarding Claims 33-34, Rodriguez-Llorente discloses the algorithm configuration data includes instructions for setting a first activation flag to active for the first alternative executable code segment and a second activation flag to inactive for the second alternative executable code segment (see par. 247). It would have been obvious to include instructions on which code segments to activate since Rodriguez-Llorente teaches using certain segments for specific scenarios helps to allow the algorithm to appropriately perform signal processing while minimize noise levels (see par. 249 and 265).
Claim(s) 16 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (PG Pub. 2011/0196211) and Rodriguez-Llorente (PG Pub. 2014/0073861) as applied to claims 15 and 21 above, in view of Wessel (PG Pub. 2003/0050537).
Regarding Claims 16 and 23, Al-Ali does not explicitly disclose operability of the code segments independently. Wessel discloses a similar sensor system (see Fig. 13 and par. 58) wherein the second executable code segment is operable without the first executable code segment (see par. 38). It would have been obvious to one of ordinary skill in the art at the time of the invention to allow the sensor to function entirely by itself so that the controller is not subject to US FDA approval (see par. 38).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali et al. (PG Pub. 2011/0196211) and Rodriguez-Llorente (PG Pub. 2014/0073861), as applied to claim 15 above, in view of Schlottau et al. (PG Pub. 2013/0104288).
Regarding Claim 19, AI-Ali discloses the at least one processor is configured to delete the first executable code segment or deactivate the first executable code segment after the sensor becomes communicatively disconnected from the port (see par. 111 and 142), but does not disclose that it is deleted or deactivated after a threshold amount of time has elapsed after the sensor is disconnected from the port. Schlottau discloses a time-out functionality (see par. 49). It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate a time-out when the sensor is disconnected in order to facilitate the operability of the sensor (see par. 49).
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.
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/N.P/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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