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 Preliminary Amendment
The Preliminary Amendment filed on 05/30/2025 has been entered.
Response to Preliminary Remarks
Applicant's Preliminary Remarks filed 05/30/2025 concerning the Preliminary Amendment have been considered and the amendments have been entered.
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.
Claims 2-21 have been interpreted under 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) to invoke 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) claim interpretation as follows.
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:
“the controller configured to” in claim 2;
“the controller being further configured to” in claim 2;
“the controller is further configured to” in claim 3;
“the controller is configured to” in claims 5-8;
“the first medical device and the second medical device are configured to” in claim 17;
“the output module is configured to” in claims 19 and 20; and
“an input module is configured to” in claim 20.
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 18/347,453; 17/888,278; 16/891,921; and 15/126,971; and 61/955,046, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 2 claims:
“detecting the coincident data entries that are anomalous and/or
detecting anomalies in the time stamp recorded for each data entry of the respective data sets compared to a time range or a geographical separation between the first medical device and the second medical device, wherein the geographical separation of the first medical device and the second medical device is determined by tracking the first medical device and the second medical device using a tracking technology and determining a relative distance between the first medical device and the second medical device, and setting the time range automatically based on said relative distance.” (emphasis added).
The parent applications do not convey claim 2, refer to paragraph [0096] of US Patent Application Nos. 18/347,453; 17/888,278; 16/891,921; and 15/126,971 and refer to US Patent Application No. 61/955,046 which lacks any text corresponding to paragraph [0096].
Due to alternatively claimed “time range or a geographical separation” a correlation between “time range” and “geographic separation” and “setting the time range automatically based on said relative distance” is lacking in the claimed algorithm to have the claimed result of “and setting the time range automatically based on said relative distance.” which is not conveyed by these applications and additionally the conjunctively and alternatively claimed “detecting the coincident data entries that are anomalous” and “detecting anomalies in the time stamp … and setting the time range automatically based on said relative distance” is not conveyed by these applications.
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 2-21 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 2 claims:
“detecting the coincident data entries that are anomalous and/or
detecting anomalies in the time stamp recorded for each data entry of the respective data sets compared to a time range or a geographical separation between the first medical device and the second medical device, wherein the geographical separation of the first medical device and the second medical device is determined by tracking the first medical device and the second medical device using a tracking technology and determining a relative distance between the first medical device and the second medical device, and setting the time range automatically based on said relative distance.” (emphasis added).
Due to alternatively claimed “time range or a geographical separation” a correlation between “time range” and “geographic separation” and “setting the time range automatically based on said relative distance”is lacking in the claimed algorithm to have the claimed result of “and setting the time range automatically based on said relative distance.”. Thus, the metes and bounds of the claimed algorithm is unclear.
The dependent claims inherit and do not correct this indefinite issue.
Claim limitation “the controller being further configured to identify desynchronization between a first clock in the first medical device and a second clock in a second medical device by at least one of:” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Claim 2 claims:
“the controller being further configured to identify desynchronization between a first clock in the first medical device and a second clock in a second medical device by at least one of:
detecting the coincident data entries that are anomalous and/or
detecting anomalies in the time stamp recorded for each data entry of the respective data sets compared to a time range or a geographical separation between the first medical device and the second medical device, wherein the geographical separation of the first medical device and the second medical device is determined by tracking the first medical device and the second medical device using a tracking technology and determining a relative distance between the first medical device and the second medical device, and setting the time range automatically based on said relative distance.” (emphasis added).
This application does not convey claim 2, refer to paragraph [0096] of this US Patent Application.
Due to alternatively claimed “time range or a geographical separation” a correlation between “time range” and “geographic separation” and “setting the time range automatically based on said relative distance” is lacking in the claimed algorithm to have the claimed result of “and setting the time range automatically based on said relative distance.” which is not conveyed by this application and additionally the conjunctively and alternatively claimed “detecting the coincident data entries that are anomalous” and “detecting anomalies in the time stamp … and setting the time range automatically based on said relative distance” is not conveyed by this application.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The dependent claims inherit and do not correct this indefinite issue.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 2-21 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.
Claim 2 claims:
“the controller being further configured to identify desynchronization between a first clock in the first medical device and a second clock in a second medical device by at least one of:
detecting the coincident data entries that are anomalous and/or
detecting anomalies in the time stamp recorded for each data entry of the respective data sets compared to a time range or a geographical separation between the first medical device and the second medical device, wherein the geographical separation of the first medical device and the second medical device is determined by tracking the first medical device and the second medical device using a tracking technology and determining a relative distance between the first medical device and the second medical device, and setting the time range automatically based on said relative distance.” (emphasis added).
This application does not convey claim 2, refer to paragraph [0096] of this US Patent Application.
Due to alternatively claimed “time range or a geographical separation” a correlation between “time range” and “geographic separation” and “setting the time range automatically based on said relative distance” is lacking in the claimed algorithm to have the claimed result of “and setting the time range automatically based on said relative distance.” which is not conveyed by this application and additionally the conjunctively and alternatively claimed “detecting the coincident data entries that are anomalous” and “detecting anomalies in the time stamp … and setting the time range automatically based on said relative distance” is not conveyed by this application.
The dependent claims inherit and do not correct this written description issue.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dal Moline et al., US Patent Application Publication No. 2012/0263218, describes determine an offset between the clocks of two independent medical devices in wireless communications, so as to implement any appropriate remedial actions tracking medical devices, refer to abstract and paragraphs [0019], [0038], [0101]-[0103].
Semen et al., US Patent Application Publication No. 2014/0032231, describes tracking medical device usage indicating the time and date of usage, refer to paragraphs [0002], [0003], [0024] “In accordance with one embodiment, a patient uses a medical device 101 in connection with a medical therapy. As the patient uses the device, medical device 101 may collect usage data indicating the time and date of usage.”, and [0030] discussing compliance criteria.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFERY A BRIER whose telephone number is (571)272-7656. The examiner can normally be reached on Mon-Fri from 8:30am-3:00pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao M Wu, can be reached at telephone number 571-272-7761. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JEFFERY A. BRIER
Primary Examiner
Art Unit 2613
/JEFFERY A BRIER/Primary Examiner, Art Unit 2613
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