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 .
Response to Arguments
Applicant's arguments filed 8/11/2025 have been fully considered but they are not persuasive.
The applicant has not presented any arguments against the double patenting rejection. It is therefore maintained.
Regarding the written description rejections, the applicant has two general arguments. First, the applicant argues that “each of the claims in question are originally filed, or at the least, each of these limitations was first presented in an originally filed claim. The rejections fail to consider or even observe this fact and the consequence that the claims presumptively comply with the written description requirement”. This argument is not persuasive because the applicant failed to consider or even observe that the examiner cited sections 2163.03(V) and 2161.01(I) of the MPEP which explain how original claims can be rejected for failing to comply with the written description requirement when the claims define the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved; the title of section 2163.03(V) is literally “Original Claim Not Sufficiently Described”.
Next the applicant makes the argument that “the Examiner failed to properly establish that there is any legitimate written description issues because he also believes that the claimed subject matter is sufficiently well known in the art that is anticipated”. This argument is not persuasive for a number of reasons. First, there is nothing stated in the MPEP that precludes a claim that is not adequately described and from also being anticipated by prior art; these are not mutually exclusive conditions. An invention could lack complete technical description of how the claimed functions are performed, as is the case with the current claims, but the breadth of the claims could also be anticipated by the prior art. Second, the applicant’s own disclosure suggests the limitations are not conventional or known in the art (see paragraphs 2 and 45) and therefore would need to be described. Third, on pages 13-17 of the applicant’s response, the applicant refutes the Examiner’s finding that the claimed invention is anticipated and made obvious by the prior art so the applicant is undermining their position that the claims did not need to be described if they are well known. All available evidence indicates the applicant believes the claimed invention is not well known and therefore would have to be described in a way that meets the requirements of describing a computer related invention described in section 2161.01(I) of the MPEP. If the applicant wants to start identifying undescribed subject matter as well known, the applicant is free to do so and such statements will need be considered as applicant admitted prior art.
On page 13, the applicant argues that, “Applicant first challenges the anticipation rejections on the grounds that the Examiner implicitly admits that several limitations of the claims are not known in the art”. This argument is factually incorrect. The applicant written description rejection of the applicant’s invention is a problem that is solely related to the content of the applicant’s disclosure. The rejection is stating that the disclosure does not meet the requirements of written description described in section 2161.01(I) of the MPEP. The rejection is stating that the applicant’s invention disclosure does not provide any technical detail for how the applicant is actually performing the translations that they are stating are not known. Clearly the applicant’s own lack of description of technology does not preclude others from having disclosed subject matter that would read on the breadth of the claims. Additionally, section 2152.02(b) describes how the requirements for written description of the entire scope of the claimed invention under 35 USC section 112(a) are not the same as the requirement in 35 USC 102(a)(1) or (2) where only single embodiment of the claimed invention needs to be described in prior art. Therefore, the applicant’s conclusions are based on faulty legal analysis.
Regarding the first argument about the Noonan reference, it is not persuasive because the applicant ignores the scope of the claims. The claim does not specify that the NSDP sensing device has “sensing function”; it only requires that it receives signals from “at least one sensor”. The “data router 106” in Noonan does this and therefore reads on the breadth of the limitation and is considered a “sensing” device in the same manner as the NSDP “sensing” device.
Regarding the second argument about the Noonan reference, the claimed “multi-function medical device” is claimed as being configured to receive and process self-describing protocol (SDP) data formatted according to an SDP. The information systems of Noonan are configured to receive and process data that reads on the breadth of SDP data and therefore reads on the functionality of the claimed “multi-function medical device”. The information system of Noonan is clearly implemented in a medical context and thus can be considered “medical” devices according to the breadth of the claim. If the applicant wants to recite specifically medical functionality for these devices, they should explicitly do so in a specific manner.
Regarding the third argument, the server 108, mapped to the “SDP translating device” is clearly between the data router 106 (mapped to the NSDP sensor device) and the information system 110 (mapped to the multi-function medical device) as is plainly evident from Figure 1.
Regarding the rejection of claims 4, 8-13, 16, 17, and 19, the applicant’s arguments do not specifically point out which limitations the applicant alleges are not taught, what the applicant defines as “the requisite expectation of success”, and why the applicant believes the references are improperly combined. The examiner cannot address these points because they are not explained in any detail with respect to the claims or details of the references.
Claim Objections
Claims 3, 4, 6, and 8-14 objected to because of the following informalities: they depend on claim 2, which is cancelled. For examination purposes, it will be assumed that they are intended to depend on claim 1, which featured the subject matter covered by claim 2. 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 1, 3, 4, and 6-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,120,196. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims cover the same limitations as those covered by the ‘196 patent. The current claims do not feature any patentably distinct subject matter from what was previously patented.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 4, and 6-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Written Description Issue #1
Claim 1 features the following limitation:
the SDP translating device is configured to receive the NSDP sensor data corresponding to at least one physiological condition of a patient, generate the SDP data based on the NSDP sensor data and an NSDP-to-SDP conversion algorithm by translating the NSDP sensor data into SDP data,
Claim 22 features the following limitation:
generating self-describing protocol (SDP) data based on the NSDP sensor data and an NSDP-to-SDP conversion algorithm, wherein the NSDP-to-SDP conversion alqorithm translates the NSDP sensor data into SDP data at a SDP translating device interposed between and in communication with the NSDP sensor device and a multi-function medical device;
Claim 23 features the following limitation:
at least one processor configured to generate SDP data by applying an NSDP-to-SDP conversion algorithm to the NSDP sensor data
The applicant’s disclosure regarding these claims is deficient for two reasons. First, the applicant did not provide a description of “self-describing protocol data”. Second, the applicant did not describe any conversion algorithms which translate between NSDP sensor data into SDP data. The disclosure states that the function of translating is performed but because of the two deficiencies identified, the applicant’s description of the invention fails to provide any description of how the claimed function of the generating SDP data is performed. As such, the applicant’s written description does not provide adequate support for the reasons explained in sections 2163.03(V) and 2161.01(I) of the MPEP.
The applicant does not provide any technical description of the applicant’s “self-describing protocol” or what SDP data would comprise. In paragraph 3, the applicant describes SDP as “a set of rules for communicating and understanding information of limited type using data structures, transmission formats, and defined codes such that a receiver of the information can use, report, or retransmit the information without a priori characterization of the specified received information”. Paragraph 43 repeats the same definition. The applicant’s disclosure does not describe any of the “set of rules” referred to. The applicant’s disclosure does not describe any “data structures, transmission formats, and defined codes”. The void of technical description regarding the applicant’s disclosure clearly renders it useless for defining the applicant’s “self-describing protocol” or the data that it produces.
The applicant does not describe any conversion algorithms. Paragraphs 44 and 45 provide a description of the benefits of having the “latest” algorithms but they do not describe any algorithms. Paragraph 76 states that software operating on the processor can perform translation but section 2161.01(I) of the MPEP is clear that stating that a computer can be programmed to execute a function is not a description of how to perform the function. Paragraphs 81, 121, and 122 state that a conversion algorithm may be selected from a catalog and that the algorithms may be stored in a library but this is not a description of the algorithms. Paragraph 131 states that “translation” software may be used that includes “algorithms, alarm logic, and calibration and configuration settings” but the applicant does not provide any description of any of these elements.
The applicant’s disclosure clearly fails to describe what the applicant’s invention does because it does not provide a description of a “self-describing” protocol or what data such a protocol would produce. The applicant’s disclosure that algorithms and/or software is used to perform the claimed generation of translated data function, without providing a description of algorithms and/or software, is clearly not sufficient to satisfy the written description requirement as it is explained in section 2161.01(I) of the MPEP.
Written Description Issue #2
Claim 12 features the following limitation:
the SDP translating device is configured to, while translating the NSDP sensor data into the SDP sensor data, generate settings information provided with the SDP sensor data as the enriched SDP data, wherein the settings information permits the multi-function medical device to change how the multi-function medical device processes at least one clinically-relevant quantity of the SDP sensor data.
While the applicant’s disclosure references settings that can be used to change what is collected, the applicant does disclose that the concept of generating settings information, that “permits the multi-function device to change how the multi-function device processes a clinically-relevant quantity of the SDP sensor data”, is performed while step of translating NSDP sensor data into SDP sensor data is executed, as claimed.
The translating is performed by the SDP translating device so it is not even clear what settings information generated by the SDP device would “permit the multi-function device to change how the multiple-function device processes at least one clinically-relevant quantity of the SDP sensor data” as the translated data is already processed according to settings related to quantity prior to its transmission to the multi-function device; what the multi-function device does not process a clinically relevant quantity would be a matter for the multi-function device once it receives the SDP data and not something that is part of translating at the translation device as claimed. The applicant clearly does not describe how to generate the “settings” claimed and fails to meet the standards of section 2161.01(I) of the MPEP.
Written Description Issue #3
Claim 15 features the following limitation:
the SDP is a set of rules for communicating and understanding information of limited type using data structures, transmission formats, and defined codes such that the multi-function medical device is enabled to use, report, or retransmit the information without a priori characterization of the SDP data.
As pointed out with respect to the first written description issue, the applicant does not provide any disclosure of a set of rules that give meaning to the SDP.
Written Description Issue #4
Claim 16 features the following limitation:
the SDP translating device comprises a power circuit configured to receive power from the multi-function medical device and distribute a portion of the received power to the NSDP sensor device.
The applicant did not provide any description of such a power circuit. Paragraph 92 references a “power controller” but provides no description of any circuit related to the “power controller”.
Written Description Issue #5
Claim 17 features the following limitation:
an isolation barrier that electrically isolates the first region from the second region.
Claim 19 features the following limitation:
the power circuit is located in the second region and is configured to distribute a further portion of the received power across the isolation barrier to the processing circuit.
The applicant references an “isolation barrier” in paragraphs 93 and 128 but provides no description of what a “isolation barrier” is or how it performs isolation electrically.
Written Description Issue #6
Claim 18 features the following limitation:
the SDP translating device comprises a processing circuit configured to generate the SDP data based on the NSDP sensor data and the NSDP-to-SDP conversion algorithm, wherein the processor circuit is located in the first region.
Claim 23 features the following limitations
at least one processor configured to generate SDP data by applying an NSDP-to-SDP conversion algorithm to the NSDP sensor data, and further configured to enrich the SDP data with additional information,
The applicant did not disclose any specific circuitry for generating the SDP data. The applicant’s disclosure relies on “any suitable processing device” (paragraphs 57, 63, 64, 73, and 89), and not a specific processor or processing circuit that is “configured” for the purpose of generating SDP data. If the applicant is attempting to claim a conventional computer that stores software in memory that is executed by a convention processor, the applicant needs to claim the invention as such and not as a special purpose processor or circuit.
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.
Claim(s) 1-3, 5-7, 14, 15, 18, and 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication Number 2003/0105389 by Noonan et al.
As to claim 1, Noonan teaches a communication protocol translation system, comprising: a non-self-describing protocol (NSDP) sensor device (Figure 1, data router 106) configured to receive electrical signals (signals 114, 115, or 116) corresponding to at least one physiological condition of a patient from at least one sensor (Figure 1, medical devices 102, 103, or 104 described in paragraph 27), generate NSDP sensor data according to a NSDP based on the received electrical signals; a multi-function medical device (Figure 1, information systems 110, 111, or 112) configured to receive and process self-describing protocol (SDP) data formatted according to an SDP; and an SDP translating device (Figure 1, server 108) interposed between and in communication with the NSDP sensor device and the multi-function medical device (See Figure 1), wherein the SDP translating device is configured to receive the NSDP sensor data corresponding to at least one physiological condition of a patient (step 802 in Figure 8), generate the SDP data based on the NSDP sensor data and an NSDP-to-SDP conversion algorithm by translating the NSDP sensor data into SDP data (paragraphs 72 and 73, steps 805 and 806, the different decoders are “NSDP-to-SDP” conversion algorithms, a concept that the applicant’s disclosure did not describe with any technical detail), enrich the SDP data with additional information (step 807), and transmit the at least one translated physiological condition with the SDP data as enriched SDP data to the multi-function medical device (step 808).
As to claim 2, see steps 805 and 806.
As to claim 3, see paragraph 72.
As to claim 5, see paragraphs 27 and 74.
As to claim 6, the information provided in step 808 is shown on the monitor described in paragraph 6.
As to claim 7, this information displayed on the monitor is considered a “settings”.
As to claim 14, see paragraph 74.
As to claim 15, see paragraphs 72-73.
As to claim 18, see Figure 3.
As to claim 20, see paragraph 27.
As to claim 21, see paragraph 4 and 5.
As to claims 22 and 23 they are rejected according to the mapping of server 108 in the rejection of claim 1.
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) 4 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication Number 2003/0105389 by Noonan et al. in view of U.S. Patent Application Publication Number 2017/0043089 by Handler.
As to claim 4, Noonan teaches the system of claim 2 however Noonan does not explicitly teach testing at least one clinically-relevant quantity of the sensor data against a limit and signaling information on a condition outside a clinically-relevant quantity.
Handler teaches a medical translation device that, while translating, tests a clinically relevant quantity of sensor data against a limit and generates additional information when the quantity is outside the limit (Paragraphs 5, 33, and 66, for example).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding adding information about which data exceeds limits because such information would be clearly helpful to medical staff (paragraph 41 of Handler).
As to claim 8, Noonan teaches the system of claim 2 however Noonan does not explicitly teach calculating a value of the sensor data wherein the calculated value replaces or augments sensor data.
Handler teaches calculating a value of the sensor data wherein the calculated value replaces or augments sensor data (paragraphs 5, 34, and 36).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding calculating values to augment medical data because such information would be clearly helpful to medical staff (paragraph 41 of Handler).
As to claim 9, Noonan teaches the system of claim 2 however Noonan does not explicitly teach receiving and using additional data to calculate a value.
Handler teaches receiving and using additional data to calculate a value (see paragraph 65 and 66).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding receiving data from a multi-function device because it allows a medical professional to make better decisions (see paragraph 65 and 66 of Handler).
As to claim 10, Noonan teaches the system of claim 2 however Noonan does not explicitly teach converting a unit of measure to another unit of measure.
Handler teaches converting a unit of measure to another unit of measure (paragraph 5).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding converting a unit of measure to another unit of measure because such information can show relationships between types of data (paragraph 5 of Handler).
As to claim 11, Noonan teaches the system of claim 2 however Noonan does not explicitly teach generating descriptive text strings that characterize a quantity.
Handler teaches generating descriptive text strings that characterize a quantity (paragraph 119).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding generating descriptive text because such text provides a medical person information about the patient.
As to claim 12, Noonan teaches the system of claim 2 however Noonan does not explicitly teach generating settings that permit the device to change how the device processes quantities.
Handler teaches generating settings that permit the device to change how the device processes quantities (paragraph 65 and 66, the medical staff uses feedback from the devices to adjust how the devices operate).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding settings to change processing of data because such information allows the user to run the device more efficiently (see paragraph 65 and 66 of Handler).
As to claim 13, Noonan teaches the system of claim 2 however Noonan does not explicitly teach making a temporal change to a clinically relevant quantity of data.
Handler teaches making a temporal change to a clinically relevant quantity of data (see paragraph 6, the data is temporally adjusted).
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Handler regarding making a temporal change to a clinically relevant quantity of data because such information would be clearly helpful for better therapy (see paragraph 6 of Handler).
Claim(s) 16, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication Number 2003/0105389 by Noonan et al. in view of U.S. Patent Number 11,309,665 to Jukic.
As to claims 16, 17, and 19, Noonan teaches the system of claims 1 and 18 however Noonan does not explicitly teach controlling power with the translating device.
Jukic shows how a translating device can receive power from a monitor and provide it to a translating device in the manner claimed in claims 16, 17, and 19 (see Figure 6 and col. 4, lines 31-51 and col. 5, lines 47-62). The Dongle is the isolation barrier.
It would have been obvious to one of ordinary skill in the medical device monitoring art at the time of the applicant’s filing to combine the teachings of Noonan regarding translating information from medical devices with the teachings of Jukic regarding using the translation device to supply power to the sensor device because the network in Noonan could use power over ethernet or USB connections as suggested by Jukic (col. 2, lines 18-42) as a way to supply power to portable sensors such as those taught by Noonan.
Conclusion
THIS ACTION IS MADE FINAL. 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 DOUGLAS B BLAIR whose telephone number is (571)272-3893. The examiner can normally be reached Monday-Friday 9am-5pm.
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/DOUGLAS B BLAIR/Primary Examiner, Art Unit 2442