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 .
Subject Matter Free of Prior Art
Claim(s) 31, 33-36 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the dependent claims. Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in claims 31, 33-36, claims 31, 33-36 are hereby deemed to be allowable over prior art.
However, the claims are still rejected under 101.
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:
“a receiving unit” in claim 38; and
“a processing unit” in claim 38.
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 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.
Claim(s) 38-39 is/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 38 recites “A dose event processing device…comprising: a receiving unit… a processing unit.” 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. Under broadest reasonable interpretation, the aforementioned claim limitations could be implemented as software (i.e., program code, algorithms) or hardware. The specification only mentions: “The dose event processing device may be or may form part of a mobile device, e.g. a smartphone, a tablet or a portable computer. Alternatively, the dose event processing device may be or may form part of a stationary processing device, e.g. a stationary computer or a server” (page 17). Furthermore, the specification does not further describe the structure of the aforementioned units and only further describes the functions of the aforementioned claim limitations. However, this does not clearly link the structure, material, or acts to the function of the aforementioned claim limitations. Therefore, the disclosure's lack of a description that clearly links the structure to the function of the aforementioned claim limitations evidences that the Applicant did not have possession of the invention at the time of filing. Because no additional information is given, the disclosure fails to sufficiently describe the aforementioned claim limitations of claim 38.
Claim(s) 39 is/are rejected as being dependent on claim 38.
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.
Claim(s) 38-39 is/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 limitations “A dose event processing device…comprising: a receiving unit… a processing unit” (claim 38) 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. It is unclear if the aforementioned claim limitations are implemented as software (i.e., program code, algorithms) or hardware because Under broadest reasonable interpretation, the aforementioned claim limitations could be implemented as software (i.e., program code, algorithms) or hardware. The specification only mentions: “The dose event processing device may be or may form part of a mobile device, e.g. a smartphone, a tablet or a portable computer. Alternatively, the dose event processing device may be or may form part of a stationary processing device, e.g. a stationary computer or a server” (page 17). Furthermore, the specification does not further describe the structure of the aforementioned units and only further describes the functions of the aforementioned claim limitations. However, this does not clearly link the structure, material, or acts to the function of the aforementioned claim limitations. Furthermore, it is unclear how the aforementioned claim limitations are structurally related to each other and the overall “system,” as they are not positively recited as being tied to any known hardware components (i.e., processor, memory). Under 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 aforementioned claim limitations can be implemented as software and/or hardware. 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.
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.
Claim(s) 39 is/are rejected as being dependent on claim 38.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 21 is drawn to a method which is within the four statutory categories (i.e., method). Claim 38 is drawn to a device which is within the four statutory categories (i.e., machine). Claim 40 is drawn to one or more non-transitory computer-readable storage media storing instructions which is within the four statutory categories (i.e., manufacture).
Independent claim 21 (which is representative of independent claims 38, 40) recites… determining an absolute time or standard time of one or more dose events performed with a medical device, wherein the one or more dose events are recorded in a dose event record…, wherein at least one part of the dose event record is received by or receivable…, and wherein the method comprises determining an absolute time or standard time TDose(e) of a particular dose event e based on (i) at least one time information…, and(ii) at least one time information...
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output (i.e., dosage time) accordingly in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., a recording unit; a receiving unit). Claim 38 recites additional elements (i.e., A dose event processing device comprising: a receiving unit; a processing unit; and one or more storage devices storing instructions; a recording unit). Claim 40 recites additional elements (i.e., One or more non-transitory computer-readable storage media storing instructions; a processing unit; a recording unit; a receiving unit). Looking to the specifications, a computing device having computing units, one or more storage devices storing instructions, one or more non-transitory computer-readable storage media storing instructions is described at a high level of generality (pages 17-18), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computing device having computing units, one or more storage devices storing instructions, one or more non-transitory computer-readable storage media storing instructions) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 22-37, 39 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 22-36 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 37 further recites the additional elements of “transmitting the at least one part of the dose event record from the recording unit to the receiving unit,” which only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. See: MPEP § 2106.05(g). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application. Reevaluated under step 2B, the limitation is determined to constitute well-understood, routine, and conventional elements/functions; receiving or transmitting data over a network has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not provide “significantly more.”
Claim 39 further recites the additional elements of “a user interface operatively connected to the receiving unit,” which is described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 21-30, 37-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. US 2009/0163793 A1 (hereinafter referred to as "Koehler").
Regarding (new) claim 21, Koehler teaches a method of determining an absolute time or standard time of one or more dose events performed with a medical device (Koehler: abstract),
wherein the one or more dose events are recorded in a dose event record by a recording unit (Koehler: ¶ 0047, i.e., “A first dosing is performed by the user using the dosing device at instant T1 and a corresponding data set is stored, which comprises the delivered dose quantity and the associated time count”),
wherein at least one part of the dose event record is received by or receivable by a receiving unit (Koehler: ¶ 0047, i.e., “a transmission of the data set to the data processing apparatus is performed at instant T2”), and
wherein the method comprises determining an absolute time or standard time TDose(e) of a particular dose event e based on (i) at least one time information from the recording unit, and (ii) at least one time information from the receiving unit (Koehler: ¶ 0048-0049).
Regarding (new) claim 22, Koehler teaches the method of claim 21,
wherein the time information from the recording unit comprises at least one of:
a dose event related time information, Tstamp (e), of the recording unit, the dose event related time information being indicative of the time at which the particular dose event e was recorded in the dose event record, and
a transmission related time information, TRTCtrans, of the recording unit, the transmission related time information being indicative of the time at which the at least one part of the dose event record is transmitted to the receiving unit, and/or
wherein the time information from the receiving unit comprises a time, Tclient, of the receiving unit that is indicative of the time at which the at least one part of the dose event record is received by the receiving unit (Koehler: ¶ 0048, i.e., “the current time value of the time counter (at the time of transmission) of the dosing device”).
Regarding (new) claim 23, Koehler teaches the method of claim 21, wherein the at least one part of the dose event record for each dose event comprises information relating to at least one of a unique dose event identifier, a dose quantity, or a dose event related time information Tstamp (e) of the recording unit (Koehler: ¶ 0047, i.e., “Together with the dose value and the associated time value, the current time value of the time counter (i.e., the time value at data transmission) is also transmitted to the data processing apparatus by the dosing device”).
Regarding (new) claim 24, Koehler teaches the method of claim 21, wherein the recording unit comprises a timer configured to provide time information for the recording unit, the time information being TRTC (Koehler: ¶ 0047, i.e., “When the time counter is contacted by an operating voltage, it begins to run at a constant and known in advance pulse rate. A first dosing is performed by the user using the dosing device at instant T1 and a corresponding data set is stored, which comprises the delivered dose quantity and the associated time count”).
Regarding (new) claim 25, Koehler teaches the method of claim 22, further comprising defining a determination period in the at least one part of the dose event record, wherein the determination period comprises one or more dose events, denoted as (e to ek) for which TDose(e) is to be determined, wherein k > i >1 (Koehler: ¶ 0061), and wherein the absolute time or standard time TDose(e)of a particular dose event e of the one or more dose events (e to ek) within the determination period is determined using a determination function (Koehler: ¶ 0048-0049; ¶ 0063).
Regarding (new) claim 26, Koehler teaches the method of claim 25, wherein the determination period is selectable or selected by a user (Koehler: ¶ 0033, i.e., “The user of the dosing device may also set the time counter”; ¶ 0034, i.e., “The user may be given the ability via operating buttons of performing reprogramming of the conversion unit or, in other words, setting the clock”; ¶ 0060, i.e., “the time reference point is predefined by the user”).
Regarding (new) claim 27, Koehler teaches the method of claim 25, wherein the determination function, denoted as f, is a function of the time information from the recording unit and the time information from the receiving unit, such that:
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(Koehler: ¶ 0027-0031; ¶ 0048)
Regarding (new) claim 28, Koehler teaches the method of claim 21, further comprising evaluating the at least one part of the dose event record with respect to an occurrence of an irregularity in a time information contained in the at least one part of the dose event record (Koehler: ¶ 0048, i.e., “A time difference or correction value is calculated from the time value of the clock or time standard at a specific instant and the time value of the time counter at the same instant”; ¶ 0053).
Regarding (new) claim 29, Koehler teaches the method of claim 28, wherein the evaluation is based on at least one of the information stored in the dose event record, the time information from the recording unit, or the time information from the receiving unit (Koehler: ¶ 0047; ¶ 0048, i.e., “Upon a subsequent analysis of the history of data stored in the dosing device”).
Regarding (new) claim 30, Koehler teaches the method of claim 28, wherein the irregularity is a reset event of the recording unit at which a timer of the recording unit is reset, resulting in a change of TRTC to a default value of TRTC (Koehler: ¶ 0017, i.e., “The clock times in the infusion pump and the computer are compared, and if a deviation occurs, the user is requested to reset the time in the clock”; ¶ 0049, i.e., “the time counter in the dosing device may be reset or the status of the time counter and the associated time of the time standard is stored therein such that this data pair may be used as a new calculation basis for converting time values into absolute times”).
Regarding (new) claim 37, Koehler teaches the method of claim 21, wherein prior to the determination of TDOSe(e), the method comprises transmitting the at least one part of the dose event record from the recording unit to the receiving unit (Koehler: ¶ 0047, i.e., “a transmission of the data set to the data processing apparatus is performed at instant T2. Together with the dose value and the associated time value, the current time value of the time counter (i.e., the time value at data transmission) is also transmitted to the data processing apparatus by the dosing device”).
Regarding (new) claim 38, Koehler teaches a dose event processing device for determining an absolute time or standard time of one or more recorded dose events performed with a medical device (Koehler: abstract), the dose event processing device comprising:
a receiving unit configured to receive at least a part of a dose event record (Koehler: ¶ 0047, i.e., “a transmission of the data set to the data processing apparatus is performed at instant T2”);
a processing unit (Koehler: ¶ 0038); and
one or more storage devices storing instructions that, when executed by the processing unit, cause the processing unit to perform operations (Koehler: ¶ 0038) comprising:
determining an absolute time or standard time TDOSe(e)of a particular dose event e based on (i) at least one time information from a recording unit that recorded the particular dose event in the dose event record, and (ii) at least one time information from the receiving unit (Koehler: ¶ 0047-0049).
Regarding (new) claim 39, Koehler teaches the dose event processing device of claim 38, further comprising a user interface operatively connected to the receiving unit (Koehler: ¶ 0038).
Regarding (new) claim 40, Koehler teaches one or more non-transitory computer-readable storage media storing instructions which, when executed by at least one processing unit, causes the at least one processing unit to perform operations (Koehler: ¶ 0038) for determining an absolute time or standard time of one or more recorded dose events performed with a medical device (Koehler: abstract),
wherein the one or more dose events are recorded in a dose event record by a recording unit (Koehler: ¶ 0047, i.e., “A first dosing is performed by the user using the dosing device at instant T1 and a corresponding data set is stored, which comprises the delivered dose quantity and the associated time count”),
wherein at least one part of the dose event record is received by or receivable by a receiving unit (Koehler: ¶ 0047, i.e., “a transmission of the data set to the data processing apparatus is performed at instant T2”), and
wherein the operations comprise determining an absolute time or standard time TDOSe(e) of a particular dose event e based on (i) at least one time information from the recording unit, and (ii) at least one time information from the receiving unit (Koehler: ¶ 0048-0049).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2009/0163793 A1 (hereinafter referred to as "Koehler") in view of U.S. Patent App. Pub. No. US 2016/0267251 A1 (hereinafter referred to as "KANADA").
Regarding (new) claim 32, Koehler teaches the method of claim 28.
Yet, Koehler does not explicitly teach, but KANADA teaches, in the same field of endeavor, wherein the determination function for the particular dose event (e) is selectable or selected from a plurality of different determination functions depending on the occurrence of the irregularity in the time information of the at least one part of the dose event record during the determination period (KANADA: ¶ 0139-0140).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the determination function for the particular dose event (e) is selectable or selected from a plurality of different determination functions depending on the occurrence of the irregularity in the time information of the at least one part of the dose event record during the determination period, as taught by KANADA, within the system of Koehler, with the motivation to “determine the presence or absence of a change in the symptoms…easily and appropriately” (KANADA: ¶ 0139).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2019/0307957 A1 teaches identifying and correcting the difference between timestamps associated with a therapy delivery device based on the universal concept of time.
WO 2009/002621 A2 teaches altering therapy timings to account for time zone changes.
“Timing errors and temporal uncertainty in clinical databases—A narrative review” teaches converting and formatting timestamps to reconcile differences.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY HUYNH/Primary Examiner, Art Unit 3683
