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 Amendment
The amendment filed October 9, 2024 has been entered. Claims 1-18 are pending.
Applicant’s amendments overcome the rejection of claims 6 and 11 under 35 U.S.C. 112(a) as well as the drawing objection related to limitations previously recited in claims 6 and 11.
Double patenting rejections are obviated by the Terminal Disclaimer filed October 9, 2024.
New rejections under 35 U.S.C. 112(b) are presented.
Response to Argument
With respect to Applicant’s argument:
“Regarding claim 1, the claim does not recite the actual step of storing (i.e., "an apparatus and the method steps of using the apparatus") as the Office action contends. Rather, claim 1 is directed toward an apparatus and recites "the sensor comprises a memory configured to store information indicative of a plurality of sites at which the sensor is to be used, and wherein the information is stored in the memory during factory production of the sensor." That is, the act of storing is not claimed; but rather, a temporal limitation on the state of being stored is claimed. The claimed use of "stored" here is a past participle, rather than a verb. Thus the term describes or modifies a noun/pronoun. Because claim 1 is not limited by a specific action of storing, and is instead limited by memory that stores particular information, it is definite.”
In the interpretation that independent claim 1 recites a “temporal limitation,” regarding when information is stored in a sensor, such position argued by Applicant is further support that such claim language requires specific sequential steps (i.e., temporally separated), and thus implies a method step. Thus, the rejection under 35 U.S.C. 112(b) of independent claim 1 for reciting a method step in device claim is maintained. Additionally, the limitation requires a person/outside system to perform the storing “during factory production of the sensor” or in other words the sensor itself does not and cannot perform this recitation.
Alternatively, and in accordance with MPEP 2111.05, limitations regarding specific information stored in the memory may be viewed in an alternative interpretation as non-functional descriptive material. Memories merely serve as an element for containing information, having no functional relation between the information and the associated device; thus, the limitations have no patentable weight. The temporal requirement of when the information is stored in the memory does not add any functional relationship to the claim and has no patentable weight for that reason.
Regarding Applicant’s argument:
“Regarding independent claim 1, the prior art fails to teach or render obvious "memory configured to store information indicative of a plurality of sites at which the sensor is to be used" and that "the information is stored in the memory during factory production of the sensor," as recited by the claim.”
Al-Ali teaches a sensor configured to be attached to a living body to acquire vital sign information (Fig. 1B: sensor 106), and communicable with an information acquisition apparatus (Fig. 1B: sensor 106 communicable with monitor 102), wherein the sensor comprises a memory configured to store information indicative of a plurality of sites at which the sensor is to be used (Fig. 1B: information elements 116 and 134 can both be considered sensor memories since a sensor can be considered the combination of a sensor 106 and cable 104 required to connect the sensor 106 to a monitor; Fig. 7; Col. 11, line 53 — Col. 12, line 23: attachment of sensor to a patient monitor writes a monitor ID into sensor memory, which provides indication of which monitors the sensor may be used by via site licensing; Claims 1-3). The memories of Al-Ali are fully capable of storing the claimed information or data at any time, including “at factory production” as presently claimed. See previous responses to remarks made toward the rejection of the claims under 35 U.S.C. 112(b).
Applicant’s arguments directed to the rejection of claim 10 (and dependent claims thereof) under 35 U.S.C. 103 are persuasive.
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 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 broadest reasonable interpretation 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, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“information writing apparatus” in claim 10.
The limitation of “wherein the first site information and the second site information are written by a user via an information writing apparatus” may be read as “an information writing apparatus for allowing a user to write the first site information and the second site information.” The claim limitation uses the term “apparatus” that is a generic placeholder having no specific structural meaning) for performing the claimed function (i.e., writing first site information and second site information by a user). The generic placeholder is modified by functional language (see above). The term “apparatus” is not modified by sufficient structure, material, or acts for performing the claimed function.
The specification appears to provide corresponding structure for “information writing apparatus” by reciting: “The information acquisition apparatus 3 may be configured to function as the information writing apparatus” (Paragraph 0015). No further corresponding structure is provided for “information writing apparatus.” The term “information writing apparatus” is thus limited to the singular example provided (“information acquisition apparatus”) or equivalents for performing the function thereof (allowing a user to write first and second site information).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1 and 10 and dependent claims thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 1: Claim 1 recites a device claim possessing the limitation: “wherein the information is stored in the memory during manufacturing of the sensor.”
It is unclear which statutory category the claims belong to since the limitation above implies a method step (i.e., indicating when information is stored on the sensor by a human performing the step) recited in a device claim of claim 1. Applicant’s recitation of requiring information stored in the memory during manufacturing of the sensor reads upon court decisions of claims possessing both product and process in the same claim, as per MPEP 2173.05(p):
“A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement … occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Further, requiring the information to be stored during manufacturing is not a capability of the device (i.e., in device claim 1), but rather a process of making a component of the device.
Examiner notes that claim 1 is not directed to product by process claims since the method step of storing data at a particular time (manufacturing) does not define the claimed product (i.e., a sensor comprising a memory configured to store site information) since the memory of the sensor is not described in the specification as having any particular limitation which limits the memory to solely storing information written during manufacturing. Applicant’s specification states that both the first and second memory may be “semiconductor memory and the like” (Paragraph 0014) with no further limiting details of the particular structure of the memory. The skilled artisan would recognize semiconductor memory to typically refer to data stored within metal–oxide–semiconductor (MOS) memory cells on a silicon integrated circuit memory chip, e.g., standard general computer memory, e.g., read-only memory (ROM), random access memory (RAM), content-addressable memory (CAM), and the like. Therefore, the limitation of when the memory is written, such as during manufacturing, does not define the product claim since the memory is configurable to store the information claimed regardless of the timing of when the information is written.
It is further unclear whether the claim is directed to the product and not the process of making the product component, particularly since Applicant argues in the Appeal Brief dated April 24, 2024, pages 8-15, that a primary feature which differentiates the prior art of Al-Ali from the present invention is the particular method by which information is stored in sensor memory.
Re. Claim 10: Claim 10 recites a system claim possessing the limitation: “wherein the first site information and the second site information are written by a user via an information writing apparatus.”
See rejection of claim 1 under 35 U.S.C. 112(b) above. Requiring a user to write information is not a capability of the device, but interpretable as a step of entering information. Such a step does not define the product claim since the memory is configurable to store the information claimed regardless of the timing of when the information is written, whether by a user or other entity. Examiner recommends the claim to be amended to read instead as “wherein the first site information and the second site information are configured to be written by a user via an information writing apparatus.”
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.
Claims 1-3 and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by:
Al-Ali (U.S. 9,949,676 B2) (hereinafter – Al-Ali).
Re. Claim 1: Al-Ali teaches a sensor configured to be attached to a living body to acquire vital sign information (Fig. 1B: sensor 106), and
communicable with an information acquisition apparatus (Fig. 1B: sensor 106 communicable with monitor 102),
wherein the sensor comprises a memory configured to store information indicative of a plurality of sites at which the sensor is to be used (Fig. 1B: information elements 116 and 134 can both be considered sensor memories since a sensor can be considered the combination of a sensor 106 and cable 104 required to connect the sensor 106 to a monitor; Fig. 7; Col. 11, line 53 – Col. 12, line 23: attachment of sensor to a patient monitor writes a monitor ID into sensor memory, which provides indication of which monitors the sensor may be used by via site licensing; Claims 1-3), and
wherein the information is stored in the memory during factory production of the sensor (see rejection of the claims under 35 U.S.C. 112(b); the sensor memory of Al-Ali is “configured” to store information which is stored during factory production of the sensor).
Re. Claim 2: Al-Ali teaches the invention according to claim 1. Al-Ali further teaches the invention further comprising an attachment configured to be attached to the living body (Fig. 1B: sensor 106; Col. 6, lines 14-16: “Many of this discussion utilizes pulse oximeters and oximeter cable and sensor accessories in explaining the disclosure and for ease of understanding;” Col. 1, lines 62-64: “The sensor is generally attached to a measurement site such as a patient’s finger, toe, ear, ankle, or the like”), and
a connector configured to allow communication with the information acquisition apparatus, wherein the memory is disposed in the connector (Figs 1-5: information elements stored on sensor and/or cable; Examiner notes that a sensor may be considered a connector the information acquisition apparatus if it is connected thereto such as by means of a connecting cable).
Re. Claim 3: Al-Ali teaches the invention according to claim 1. Al-Ali further teaches the invention wherein the information acquisition apparatus is installed at one of the plurality of sites (Col. 12; “Each oximeter board 440 has its own monitor ID, but also has a list of monitor IDs of the other monitors the hospital owns or licenses. Once a cable is used with one of the hospital's oximeters, the cable 104 may only be able to work with that hospital's other oximeters;” Examiner notes that the plurality of sites of use is indicated by the sensor’s monitor ID, which is tied to monitors within a location based on site licensing).
Re. Claim 6: Al-Ali teaches the invention according to claim 1. Al-Ali further teaches the invention wherein the sensor includes at least one of an SpO2 probe, electrocardiogram electrodes, brain wave electrodes, or a cuff (Col. 6, lines 14-16: “Many of this discussion utilizes pulse oximeters and oximeter cable and sensor accessories in explaining the disclosure and for ease of understanding”), and
wherein the information acquisition apparatus includes a bedside monitor (Fig. 1B: monitor 102).
Re. Claim 7: Al-Ali teaches the invention according to claim 1. Al-Ali further teaches the invention wherein the memory further stores an usage history information, the usage history information is the usage history of the sensor (Col. 12, lines 39-42: “In some embodiments, accessories may record monitor IDs from all monitors to which they are connected, allowing manufacturers, suppliers, end users and the like to track the monitor's use).
Re. Claim 8: Al-Ali teaches the invention according to claim 1. Al-Ali further teaches the invention wherein the memory further stores a condition information, the condition information includes information indicative of operating conditions of the information acquisition apparatus (Col. 6, line 67 – Col. 7, line 7; information element 134 stores sensor authorization code which enables a particular monitor to monitor patient; Col. 8, lines 47-67: second sensor element 134 stores sensor type designation, patient information, sensor characteristics, software such as scripts or executable code, oximeter or algorithm upgrade information, or many other types of data and also providing alarm to prevent indicate out of date components and aid in preventing use with a monitor; Col. 9, lines 5-19: a monitor accessing second information element 134 but not LEDs of a sensor provide conditional operation of the monitor).
Re. Claim 9: Al-Ali teaches the invention according to claims 8 and 13. Al-Ali further teaches the invention wherein the condition information includes
background information of a patient (“… second sensor information element 134 may advantageously store some or all of a wide variety of information, including… patient information…” (Col. 8, lines 47-50) and
information of characteristics of the sensor (Col. 6, line 62 – Col. 7, line 7: information element 116, i.e., sensor memory, can be read by monitor to determine that the cable is a quality, authorized cable, and further allows monitor to retrieve sensor authorization code to identify if sensor can be enabled by the monitor; Col. 8, lines 47-50: “… second sensor information element 134 may advantageously store some or all of a wide variety of information, including, for example, sensor type designation… sensor characteristics, software such as scripts or executable code, oximeter or algorithm upgrade information, or many other types of data”).
Claims 4, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Al-Ali (U.S. 9,949,676 B2) (hereinafter – Al-Ali) (disclosed by Applicant)
Shen et al. (US 20160275776 A1) (hereinafter – Shen).
Re. Claim 4 and 5: Al-Ali teaches the invention according to claims 1, 3, and 10. Al-Ali teaches that a sensor memory may possess a monitor ID (Col. 11, lines 26-31: monitor ID written to sensor memory upon first connection). A monitor ID is associated to a monitor (Col. 11, line 20) which is commonly used in environments such as wards and surgical environments to provide data to caretakers and doctors (Col. 5, lines 27-33). However, the monitor ID alone merely identifies a group of monitors as part of a site license for a site such as a hospital and does not clearly indicate that the sensor memory possesses information “indicative of a plurality of sites at which the sensor is to be used, wherein at least one of the plurality of sites at which the sensor is to be used is a critical care medicine area, an intensive care unit, a neonatal intensive care unit, an operating room, a laboratory, a hospital ward, or a magnetic resonance imaging (MRI) room.” The monitor ID merely associates the sensor with a monitor, which may have a plurality of usage sites, but does not explicitly recite or indicate such at least one of the specific usage sites claimed.
Shen teaches analogous art in the technology of devices and systems for tracking sensors (Abstract). Shen further teaches that an unassigned sensor (akin to Al-Ali’s sensor prior to connection to a first monitor) may contain a memory element which includes information editable to associate the sensor to a patient, room, or area, and including information such as “patient sensor identifier, unit, ward, room, bed, tag, patient name, patient first name, patient last name, medical record number, patient identifier, date of birth, restricted areas, areas to avoid, pressure ulcer data, turn period, time until next turn, turn alert pause status” (Paragraph 0245).
It would have been obvious to modify the information stored and transferred between monitors and sensors of Al-Ali to further include the location-specific information as taught in Shen’s sensor memory elements as well as the information tracking of Shen, the motivation being that, since Al-Ali is concerned with tracking the location of accessories between locations and maintaining accessories at particular locations, including tracking of monitor ID’s of singular monitors and their particular usage environments (Col. 11, lines 13-52; Col. 5, lines 27-33: usage environments), the information and tracking thereof as taught by Shen improves the system of Al-Ali by further increasing the granularity by which a sensor may be tracked, thus preventing accessory/monitor misuse to the precision of individual rooms, and further allowing a user to quickly visualize information regarding a sensor, including locations of particular rooms and wards (Paragraph 0240).
Examiner notes that Applicant constrains the list of “a critical care medicine area, an intensive care unit, a neonatal intensive care unit, an operating room, a laboratory, a hospital ward, or a magnetic resonance imaging (MRI) room,” as interpretable by one of ordinary skill in the art to be within a medical facility (Paragraph 0004, Appeal Briefs pages 8-15, 18-19). In taking this interpretation, it would be understood that modifying Al-Ali to further include the location information as taught by Shen in sensor memory would result in a sensor memory possessing information indicative of the wards/units/rooms of the environments which Al-Ali discusses a monitor as being used (Col. Col. 5, lines 27-33), i.e., the rooms of a medical facility, and further understood in light of Applicant’s Appeal Brief position as recognizable to the skilled artisan as locations within a hospital. Thus, the combination of Al-Ali and Shen teaches a sensor memory configured to store information indicative of a plurality of sites of use at which the sensor is to be used, the plurality of sites including particular locations within a hospital, understood by one of ordinary skill in the art to include at least a critical care medicine area, an intensive care unit, a neonatal intensive care unit, an operating room, a laboratory, a hospital ward, or a magnetic resonance imaging (MRI) room, as posited by Applicant. Examiner further notes that a memory configured to store information of a particular room/unit/ward of a hospital is also configured to store information of any other particular room/unit/ward of a hospital since writing a particular type of location to sensor memory does not appear to require differing programming or protocol to do so (e.g., modifying a memory element from “MRI room” to “laboratory” teaches a memory element configured to store information indicative of either of these sites).
Re. Claim 17: Al-Ali teaches the invention according to claim 1. Claim 17 requires a particular subset of the list of plurality of sites recited in claims 4, 5 – claim 17 requires specifically that a sensor memory is configured to store information indicative of a plurality of sites of use at which the sensor is to be used, wherein at least one of the plurality of sites is a laboratory or a magnetic resonance imaging (MRI) room.
Again, since Applicant constrains the interpretation of “laboratory” and MRI room to solely as interpretable by one of ordinary skill in the art to mean a location within a medical facility (Briefs, pages 17-18), the combination of Al-Ali and Shen as taught in the rejection of claims 4, 5, and 14, teaching a device capable of recognizing particular rooms and wards of a medical facility, thus encompasses particular rooms required by claims 17 and 18.
Examiner notes that a memory configured to store information of a particular room/unit/ward of a hospital is also configured to store information of any other particular room/unit/ward of a hospital since writing a particular type of location to sensor memory does not appear to require differing programming or protocol to do so (e.g., modifying a memory element from “MRI room” to “laboratory” teaches a memory element configured to store information indicative of either of these sites).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791