DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Response to Amendment
The preliminary amendment to the claims filed 03 April 2025 has been entered. New claim(s) 2-16 has/have been added. Claim(s) 1-16 is/are pending.
Information Disclosure Statement (IDS)
US patent document citations 1-5 on the IDS filed 27 January 2025 each state "(See references cited in parent)" under a US Patent or US Pre-Grant Publication number. It is unclear to the examiner if citations 1-5 refer only to the US Patent or US Pre-Grant Publication cited, or to any/all additional references cited in the parent application(s). If the latter, said IDS fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner's initials; and (5) a heading that clearly indicates that the list is an IDS. The 27 January 2025 IDS has been placed in the application file, but the information referred to therein and struck through on the annotated copy of said IDS mailed herewith has not been considered unless cited on the attached PTO-892.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation ("BRI") using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The BRI of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) (or pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked.
As explained in MPEP § 2181(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term "means" or "step" or a term used as a substitute for "means" that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term "means" or "step" or the generic placeholder is modified by functional language, typically, but not always linked by the transition word "for" (e.g., "means for") or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term "means" or "step" or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word "means" (or "step") in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word "means" (or "step") in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word "means" (or "step") are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word "means" (or "step") are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1-2, 4-5, 9-10 and 12-13 is/are rejected under pre-AIA 35 U.S.C. 102(e) as anticipated by US 2011/0077484 A1 (Van Slyke).
Regarding claims 1-2 and 9-10, Van Slyke discloses a system of displaying physiological information, the system comprising a hardware processor(s) (microprocessor 48; processor 412; etc.) configured to perform a method, the method comprising:
providing a value of a physiological parameter to a display of a patient monitor (display 20 of monitor 14; output 414 (e.g., ¶ [0077] a medical monitor that displays various physiological parameters, a medical alarm, or any other suitable medical device that either displays physiological parameters or uses the output of processor 412 as an input); etc.), the physiological parameter value reflecting physiological information obtained from a physiological sensor (sensor 12; sensor 418; etc.) coupled to a patient (e.g., Fig. 2) (e.g., ¶ [0045], ¶¶ [0087]-[0088], ¶ [0117], ¶ [0019], etc., calculating a physiological parameter(s), e.g., SpO2 and/or pulse rate, and displaying the parameter(s));
calculating a freshness of the physiological parameter value, wherein freshness is calculated based on determining an amount of time that has elapsed since a valid value for the physiological parameter was obtained (¶¶ [0087]-[0088]; ¶ [0117]; ¶ [0119]; etc., determining if a calculated physiological parameter is fresh (i.e., relies on buffered data inside a freshness threshold time window, or stale (i.e., relies on buffered data outside said freshness threshold time window)); and
adjusting an output associated with the parameter value based at least in part on the calculated freshness (¶¶ [0087]-[0088]; ¶ [0117]; ¶ [0119]; etc., an alarm may be triggered if the physiological parameter measurement(s) become stale).
Regarding claims 4 and 12, Van Slyke discloses the valid value comprises a value for the physiological parameter obtained with a good signal quality (e.g., ¶ [0080] valid measurements are determined from suitable artifact-free regions).
Regarding claims 5 and 13, Van Slyke discloses the physiological parameter is frozen on the display until a new value for the physiological parameter is obtained (e.g., ¶ [0088] previously known, good physiological measurements may be held until a sufficient valid signal segment is received and used to determine an updated physiological measurement).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 3, 6, 11 and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Slyke in view of US 2010/0094096 A1 (Petruzzelli).
Regarding claims 3, 6, 11 and 14, Van Slyke discloses the limitations of claims 1-2 and 9-10, as discussed above. Van Slyke further discloses a value of a physiological parameter is displayed until a new, valid value for the physiological parameter is obtained or an alarm is issued because the most recent valid parameter value is stale (e.g., ¶ [0088]). However, Van Slyke does not disclose the output adjusted based on the calculated freshness comprises the amount of time that has elapsed since a valid value for the physiological parameter was obtained or adjusting the output comprises changing a color of the parameter value displayed on the display.
Petruzzelli discloses/suggests adjusting an output associated with a displayed parameter value based at least in part on a calculated freshness (e.g., ¶ [0009] the processor may be adapted to keep track of the elapsed time since the last patient measurement and to modify the display element in a manner representative of such elapsed time), wherein the output comprises the amount of time that has elapsed since a new value for the physiological parameter was obtained (e.g., ¶ [0044] elapsed time may be displayed below a physiologic parameter) and/or adjusting the output comprises changing a color of the parameter value displayed on the display (e.g., ¶ [0045] fill color of the parameter is changed as a function of elapsed time).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Van Slyke with adjusting the output comprising displaying an amount of time that has elapsed since a valid value for the physiological parameter was obtained and/or changing a color of the parameter value displayed on the display as disclosed and/or suggested by Petruzzelli in order to enable a user (e.g., clinician) to quickly comprehend how current, reliable, etc. the last valid, displayed physiological parameter value(s) are (Petruzzelli, ¶ [0005]).
Claim 7 and 15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Slyke.
Regarding claims 7 and 15, Van Slyke discloses the limitations of claims 1 and 9, as discussed above, and further discloses adjusting an output (e.g., triggering an alarm) in response to a predetermined freshness period elapsing (e.g., ¶ [0117], ¶ [0119] threshold time window for determining whether data is stale or not stale (i.e., fresh)). Van Slyke does not disclose the method further comprises providing a functionality on the display of the patient monitor for a clinician to adjust the predetermined freshness period. However, Van Slyke does disclose/suggest a freshness period may be "user-defined" (e.g., ¶ [0115]), and discloses/suggests providing a functionality on the display of the patient monitor for a clinician to enter/select an input (e.g., ¶ [0055] display 20 may exhibit a list of values which may generally apply to the patient, which the user may select using user inputs 56). Since Van Slyke discloses the predetermined freshness period may be defined by a user, and further discloses providing a functionality on the display of the patient monitor for a clinician to input his/her selections, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Van Slyke with providing a functionality on the display of the patient monitor for a clinician to adjust the predetermined freshness period in order to enable a user to select his/her desired freshness period for identifying stale physiological parameter value(s) (e.g., ¶ [0115], ¶ [0117], ¶ [0119], etc.).
Claim 8 and 16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Van Slyke as applied to claim(s) 7 and 15, and further in view of US 4,714,341 A (Hamaguri).
Regarding claims 8 and 16, Van Slyke as modified discloses/suggests the limitations of claims 7 and 15, and further discloses/suggests adjusting an output (e.g., triggering an alarm) in response to the predetermined freshness period elapsing, as noted above. Van Slyke does not expressly disclose the method comprises stopping display of the parameter value in response to the predetermined freshness period elapsing.
Hamaguri discloses and/or suggests a method comprising stopping display of a calculated parameter value in response to a predetermined freshness period elapsing (col. 20, lines 22-36, display of SaO2 stops/vanishes if inaccurate values are obtained successively for a predetermined threshold period of time, i.e., sufficiently "long time," four seconds, etc.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Van Slyke with adjusting the output further comprising stopping display of a calculated parameter value in response to a predetermined freshness period elapsing as disclosed and/or suggested by Hamaguri in order to avoid any misjudgment using old/stale data (Hamaguri, col. 19, lines 37-51).
Double Patenting
The nonstatutory double patenting ("NSDP") 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 NSDP 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 NSDP rejection 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 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 (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.
Claim(s) 1-2, 5 and 7-10, 13 and 15-16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5 of USPN 8,790,268.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-5 of USPN 8,790,268 recite/anticipate each limitation of claims 1-2, 5 and 7-10, 13 and 15-16 of the present application (i.e., method of claims 1-5 of USPN 8,790,268 and the processor recited therein for performing said method and/or the system claims of the present application perform the method(s) of claims 1-5 of USPN 8,790,268 in its normal and usual operation, see MPEP 2112.02).
Claim(s) 3, 6, 11 and 14 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5 of USPN 8,790,268 in view of Petruzzelli.
Claims 1-5 of USPN 8,790,268 recite/anticipate each limitation of claims 3, 6, 11 and 14 of the present application with the exception of the output comprising the amount of time that has elapsed since a valid value for the physiological parameter was obtained and/or adjusting the output comprises changing a color of the parameter value displayed on the display. As discussed respect to the prior art rejection(s) above, Petruzzelli discloses/suggests such a feature. It would have been obvious to modify the method of claims 1-5 of USPN 8,790,268, and/or the processor performing said method, with the above-noted features in order to enable a user (e.g., clinician) to quickly comprehend how current, reliable, etc. a displayed valid physiological parameter value(s) is/are (Petruzzelli, ¶ [0005]).
Claim(s) 4 and 12 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5 of USPN 8,790,268 in view of Van Slyke.
Claims 1-5 of USPN 8,790,268 recite/anticipate each limitation of claims 4 and 12 of the present application with the exception of the valid value comprising a value for the physiological parameter obtained with a good signal quality. As discussed respect to the prior art rejection(s) above, Van Slyke discloses and/or suggests displaying a calculated valid value of a physiological parameter to a display of a patient monitor until a new, valid value for the physiological parameter is obtained, wherein a valid value comprises a value for the physiological parameter obtained with a good signal quality. It would have been obvious to modify the method of claims 1-5 of USPN 8,790,268, and/or the processor performing said method, with the above-noted features in order to ensure a physiological parameter value(s) provided/displayed to a user are sufficiently reliable and/or accurate, e.g., for monitoring, treatment decisions, etc.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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