DETAILED ACTION
The present office action represents a nonfinal action on the merits.
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 .
Priority
This application claims the priority date of provisional application 63/332,879 dated April 20, 2022.
Election/Restrictions
Applicant's election with traverse of claims 1-10 and 18-21 in the reply filed on 4/14/2026 is acknowledged. The traversal is on the ground(s) that “a search for publications relating to claims 1-10 and 18-21 would reveal publications relating to claims 11-17, and thus, would not impose a serious burden on the Examiner.” (Remarks, page 9). Applicant’s traversal arguments are persuasive and Examiner agrees that no search burden exits. Accordingly, the restriction requirement is withdrawn.
Status of Claims
Claims 1-21 are pending.
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.
Claim 16 is 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 16 recites the limitations, “the label printer.” There is insufficient antecedent basis for this limitation in the claim because claim 16 is dependent on claim 11 and the term is not referenced in claim 11. Examiner is interpreting “the label printer” as “a label printer.” Appropriate correction is requested.
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.
Claims 1-21 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.
Claims 1-10 are drawn to a method, which is within the four statutory categories (i.e., process). Claims 11-17 are drawn to a device, which is within the four statutory categories (i.e., machine). Claims 18-21 are drawn to a device, which is within the four statutory categories (i.e., machine).
Claims 1-10 recite a method comprising:
linking, by a computing device, a pair of identification numbers with one another within a specimen test order for a subject in an electronic medical record system in advance of the pair of identification numbers being printed on a double sided container label;
wherein a first one of the pair of identification numbers is represented by a first machine readable identifier on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container;
receiving, by the computing device via a scanner device, the first machine readable identifier on the first side of the container label before a specimen is collected in the specimen container;
transmitting, by the computing device, the first identification number represented by the scanned first machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the first identification number is associated with the specimen test order for the subject;
receiving, by the computing device via a scanner device, the second machine readable identifier on the second side of the container label after the specimen is collected in the specimen container;
transmitting, by the computing device, the second identification number represented by the scanned second machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the second identification number is associated with the specimen test order for the subject and/or the first machine readable identifier; and
authorizing, by the computing device, the specimen to be tested by the specimen testing facility after verifying that the second identification number is associated with the specimen test order and/or the first machine readable identifier for the subject.
Claims 11-17 recite a system comprising:
a computing device having a processor and memory storage, wherein the memory storage stores executable-instructions, that when executed by the processor, causes the computing device to perform various operations, the various operations including:
linking a pair of identification numbers with one another within a specimen test order for a patient in an electronic medical record system in advance of the pair of identification numbers being printed on a double sided container label;
wherein a first one of the pair of identification numbers is represented by a first machine readable identifier on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container;
receiving, via a scanner device, the first machine readable identifier on the first side of the container label before a specimen is collected in the specimen container;
transmitting the first identification number represented by the scanned first machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the first identification number is associated with the specimen test order for the patient;
receiving, via a scanner device at a specimen testing facility, the second machine readable identifier on the second side of the container label after the specimen is collected in the specimen container;
transmitting the second identification number represented by the scanned second machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the second identification number is associated with the specimen test order for the patient; and
authorizing the specimen to be tested by the specimen testing facility after verifying that the second identification number is associated with the specimen test order for the patient.
Claims 18-21 recite a computer readable storage medium having instructions stored thereon that in response to execution by a computing device, cause the computing device to perform operations comprising:
linking a pair of identification numbers with one another within a specimen test order for a patient in an electronic medical record system in advance of the pair of identification numbers being printed on a double sided container label;
issuing a print command to a label printer for printing the double sided container label, wherein a first one of the pair of identification numbers is represented by a first machine readable identifier on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container;
receiving, via a scanner device, the first machine readable identifier on the first side of the container label before a specimen is collected in the specimen container;
transmitting the first identification number represented by the scanned first machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the first identification number is associated with the specimen test order for the patient;
receiving, via a scanner device at a specimen testing facility, the second machine readable identifier on the second side of the container label after the specimen is collected in the specimen container;
transmitting the second identification number represented by the scanned second machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the second identification number is associated with the specimen test order for the patient; and
authorizing the specimen to be tested by the specimen testing facility after verifying that the second identification number is associated with the specimen test order for the patient.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components. The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2-10, 12-17, and 19-21 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
The dependent claims include additional limitations but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 11, and 18.
The additional elements from claims 1 and 11 include:
a computing device (apply it, MPEP 2106.05(f)).
The additional elements from claims 1, 11, and 18 include:
an electronic medical record system (apply it, MPEP 2106.05(f)).
a scanner device (apply it, MPEP 2106.05(f)).
The additional elements from claim 11 include:
a system (apply it, MPEP 2106.05(f)).
a processor (apply it, MPEP 2106.05(f)).
memory storage (apply it, MPEP 2106.05(f)).
the memory storage stores executable-instructions, that when executed by the processor, causes the computing device to perform various operations (apply it, MPEP 2106.05(f)).
The additional elements from claim 18 include:
a computer readable storage medium having instructions stored thereon that in response to execution by a computing device, cause the computing device to perform operations comprising (apply it, MPEP 2106.05(f)).
a label printer (apply it, MPEP 2106.05(f)).
The dependent claims include additional elements detailed in the independent claims.
Claims 1-21 are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “a computing device”, “a scanner device”, “a system”, “a processor”, “memory storage”, “executable-instructions, that when executed by the processor, causes the computing device to perform various operations”, “a computer readable storage medium having instructions stored thereon that in response to execution by a computing device, cause the computing device to perform operations”, and “a label printer”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g. see Specification Paragraphs [0012], [0017], and 0021]-[0024] (see MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., Paragraphs [0012], [0017], and 0021]-[0024] of the Specification discloses that the additional elements (i.e., a computing device, an electronic medical record system, a scanner device, a system, a processor, memory storage, the memory storage stores executable-instructions, that when executed by the processor, causes the computing device to perform various operations, a computer readable storage medium having instructions stored thereon that in response to execution by a computing device, and a label printer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives patient medical data and specimen data.
Dependent claims 2-10, 12-17, and 19-21 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the coordinated control of therapeutic treatment effects.
Therefore, whether taken individually or as an ordered combination, claims 1-21 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
Examiner acknowledges the limitations in claims 3 and 5:
wherein the first machine readable identifier on the first side of the double sided label is scanned after the first side of the double sided label is adhered to an exterior side of the specimen container such that the first side of the double sided label faces an interior of the specimen container; and
wherein the first machine readable identifier on the first side of the double sided label is scanned through the specimen container after the first side of the double sided label is adhered to an exterior side of the specimen container such that the first side of the double sided label faces an interior of the specimen container.
are free from prior art when considered in combination with the other limitations, and are not subject to any prior art rejections under 103. The closest prior art is:
Kershner (U.S. Pub. No. 2022/0084634 A1) and Koltchine (U.S. Pub. No. 2016/0232820 A1) Kershner Paragraphs [0039]-[0040] discuss the PSCT kit may print one or more labels corresponding to the particular test that is being performed and include information such as the name of the patient, and an identifier of the test being performed, a barcode, or other computer-readable code, that may identify the associated patient account, after the labels are printed, the PSCT kit may instruct the user to affix the labels to a specimen collection container. Koltchine Paragraphs [0068]-[0071] discuss labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading, after the label is adhered, it is in a planar form to facilitate reading by a scanner.
It would not be obvious to combine both references, accordingly, the claims are not subject to any prior art rejections under 103.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1, 4, 6-11, 13-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kershner (U.S. Pub. No. 2022/0084634 A1) in view of Koltchine (U.S. Pub. No. 2016/0232820 A1).
Regarding claim 1, Kershner discloses a method comprising:
linking, by a computing device, a pair of identification numbers with one another within a specimen test order for a subject in an electronic medical record system in advance of the pair of identification numbers being printed on a container label (Paragraphs [0002] and [0064]-[0065] discuss once patient demographic details and answers to triage questions are captured, labels are printed on an included wireless portable label printer and affixed to the specimen container(s), label may include a barcode that links the label to the patient account. The label may include additional information such as the name of the patient, an identifier of the particular test that is being performed, a current date and time, and the location of the patient. The label may be affixable to a specimen collection container.);
wherein a first one of the pair of identification numbers is represented by a first machine readable identifier on a side of the container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a side of the container label (Examiner notes that the prior art does not explicitly state “first” or “second”, however, the identification numbers detailed in the Specification as “first” and “second” are included in the prior art.) (Paragraph [0039] discusses the labels may include information such as the name of the patient, and an identifier of the test being performed. Each label may also include a barcode, or other computer-readable code, that may identify the associated patient account.);
receiving, by the computing device via a scanner device, the first machine readable identifier on the side of the container label before a specimen is collected in the specimen container (Paragraphs [0032]-[0044] discuss the user may use a scanner of the data entry component to scan a barcode or other code on the identification, the PSCT kit may print one or more labels corresponding to the particular test that is being performed and include information such as the name of the patient, and an identifier of the test being performed, a barcode, or other computer-readable code, that may identify the associated patient account and affixed to the container.);
transmitting, by the computing device, the first identification number represented by the scanned first machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the first identification number is associated with the specimen test order for the subject (Paragraphs [0002], [0035]-[0037] discuss order information is transmitted electronically to the testing laboratory information system and the PSCT kit may use the patient identifier to determine a patient account that corresponds to the patient identifier, the PSCT kit may determine the patient account by comparing the patient identifier with stored patient accounts or one or more patient accounts that are scheduled for testing, the PSCT kit may provide the patient identifier to an account engine of the laboratory server, and the account engine may provide a matching patient account to the PSCT kit, collected information may then be transmitted from the PSCT kit to the account engine and may be used to create a patient account for the patient .);
receiving, by the computing device via a scanner device, the second machine readable identifier on the side of the container label after the specimen is collected in the specimen container (Paragraphs [0044] discuss the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit. The barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.);
transmitting, by the computing device, the second identification number represented by the scanned second machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the second identification number is associated with the specimen test order for the subject and/or the first machine readable identifier (Paragraphs [0027]-[0039] and [0044] discuss the tablet computer associated with the PSCT kit may display an instruction to the user to verify the identity of the patient scheduled for testing and the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit. The barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.); and
authorizing, by the computing device, the specimen to be tested by the specimen testing facility after verifying that the second identification number is associated with the specimen test order and/or the first machine readable identifier for the subject (Paragraphs [0043]-[0044] and [0058] discuss the testing facility may be selected by the laboratory server and an electronic record of the test and associated patient account may be provided to the testing facility so that the testing facility may begin processing the specimen as soon as it is received the testing facility may receive the labeled collection container and may scan the label to determine the patient account associated with the test.).
Kershner does not explicitly disclose:
pair of identification numbers being printed on a double sided container label;
on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container;
on the first side of the container label before a specimen is collected in the specimen container; and
on the second side of the container label after the specimen is collected in the specimen container.
Koltchine teaches:
pair of identification numbers being printed on a double sided container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.);
on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container (Paragraphs [0068]-[0069] discuss labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading and the back side has an adhesive on a portion thereof opposite the first indicia.);
on the first side of the container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.); and
on the second side of the container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Kershner to include, pair of identification numbers being printed on a double sided container label; on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container; on the first side of the container label; and on the second side of the container label, as taught by Koltchine, in order to provide a labeling system that is fast and accurate. (Koltchine Paragraph [0011]).
Regarding claims 4 and 13, Kershner does not explicitly disclose wherein the specimen container is transparent.
Koltchine teaches:
wherein the specimen container is transparent (FIG. 6B discuss a label adhered to a translucent container.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Kershner to include, wherein the specimen container is transparent, as taught by Koltchine, in order to provide a labeling system that is fast and accurate. (Koltchine Paragraph [0011]).
Regarding claim 6, Kershner discloses further comprising reading, by the computing device via the scanning device, a subject identifier (Paragraph [0022] discusses data entry component may be a scanner or camera that may be used by an operator of the PSCT kit to scan or capture data that may be used to identify a patient.); and
transmitting, by the computing device, the subject identifier to the electronic medical record system, wherein the electronic medical record system verifies that the subject identifier is associated with the scanned first identification number (Paragraphs [0022], [0033], and [0044] discuss scans may be used to authenticate the patient, to determine a patient account associated with the patient, and to automatically extract information about the patient, the user may use a scanner of the data entry component to scan a barcode or other code on the identification. The scanner may retrieve a patient identifier from the barcode and may provide the patient identifier to the tablet computer and a record generated.).
Regarding claim 7, Kershner discloses further comprising reading, by the computing device via the scanning device, a specimen test order identifier (Paragraphs [0039] and [0044] discuss the PSCT kit may print one or more labels corresponding to the particular test that is being performed. The labels may include information such as the name of the patient, and an identifier of the test being performed. Each label may also include a barcode, or other computer-readable code, that may identify the associated patient account and the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit, the barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.); and
transmitting, by the computing device, the specimen test order identifier to the electronic medical record system, wherein the electronic medical record system verifies that the specimen test order identifier is associated with the scanned first identification number (Paragraph [0035]-[0039] discusses a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit, the barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.).
Regarding claim 8, Kershner discloses further comprising posting, by the computing device, specimen testing results to the electronic medical record system (Paragraph [0003] discusses the results of the test may be electronically transmitted, recorded, and subsequently forwarded to relevant government agencies or private testing facility.).
Regarding claim 9, Kershner discloses wherein the subject is a mammal (Examiner notes that the prior art does not explicitly state “mammal”, the prior art clearly references a patient of human descent.) (Paragraphs [0001]-[0002] discuss patient interview and specimen collection.).
Regarding claim 10, Kershner discloses wherein the mammal is a human (Paragraphs [0001]-[0002] discuss patient interview and specimen collection.).
Claim 11, discloses the same limitations as claim 1 with the exclusion of the method and computing device and including Kershner discloses system comprising (Paragraph [0078] discloses a system.):
a computing device having a processor and memory storage, wherein the memory storage stores executable-instructions, that when executed by the processor, causes the computing device to perform various operations, the various operations including (Paragraphs [0078]-[0079] discuss computing devices include multiprocessor systems, computer-executable instructions, such as program modules, being executed by a computer may be used.).
Regarding claims 14 and 20, Kershner discloses wherein the operations further comprises reading, via the scanning device, a patient identifier (Paragraph [0022] discusses data entry component may be a scanner or camera that may be used by an operator of the PSCT kit to scan or capture data that may be used to identify a patient.); and
transmitting the patient identifier to the electronic medical record system, wherein the electronic medical record system verifies that the patient identifier is associated with the scanned first identification number (Paragraphs [0022], [0033], and [0044] discuss scans may be used to authenticate the patient, to determine a patient account associated with the patient, and to automatically extract information about the patient, the user may use a scanner of the data entry component to scan a barcode or other code on the identification. The scanner may retrieve a patient identifier from the barcode and may provide the patient identifier to the tablet computer and a record generated.).
Regarding claims 15 and 21, Kershner discloses wherein the operations further comprise reading, via the scanning device, a specimen test order identifier (Paragraphs [0039] and [0044] discuss the PSCT kit may print one or more labels corresponding to the particular test that is being performed. The labels may include information such as the name of the patient, and an identifier of the test being performed. Each label may also include a barcode, or other computer-readable code, that may identify the associated patient account and the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit, the barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.); and
transmitting the specimen test order identifier to the electronic medical record system, wherein the electronic medical record system verifies that the specimen test order identifier is associated with the scanned first identification number (Paragraph [0035]-[0039] discusses a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit, the barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.).
Regarding claim 16, Kershner discloses further comprising a label printer (Paragraph [0002] discusses labels are printed on an included wireless portable label printer and affixed to the specimen container(s).).
Regarding claim 17, Kershner discloses further comprising the scanner device at a specimen collection facility or at a specimen testing facility (Paragraph [0044] discusses when the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit.).
Regarding claim 18, Kershner discloses a computer readable storage medium having instructions stored thereon that in response to execution by a computing device, cause the computing device to perform operations comprising (Paragraphs [0083] and [0085] discuss computer storage media include volatile and non-volatile, and removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data, machine- readable storage medium where, when the program code is loaded into and executed by a machine, such as a computer, the machine becomes an apparatus for practicing the presently disclosed subject matter.):
linking a pair of identification numbers with one another within a specimen test order for a patient in an electronic medical record system in advance of the pair of identification numbers being printed on a container label (Paragraphs [0002] and [0064]-[0065] discuss once patient demographic details and answers to triage questions are captured, labels are printed on an included wireless portable label printer and affixed to the specimen container(s), label may include a barcode that links the label to the patient account. The label may include additional information such as the name of the patient, an identifier of the particular test that is being performed, a current date and time, and the location of the patient. The label may be affixable to a specimen collection container.);
issuing a print command to a label printer for printing the container label, wherein a first one of the pair of identification numbers is represented by a first machine readable identifier on a side of the container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a side of the container label (Paragraphs [0003] and [0039] discuss field operator may use the tablet computer included in the kit to register the patient and produce a specimen label using the included printer, the labels may include information such as the name of the patient, and an identifier of the test being performed. Each label may also include a barcode, or other computer-readable code, that may identify the associated patient account..);
receiving, via a scanner device, the first machine readable identifier on the side of the container label before a specimen is collected in the specimen container (Paragraphs [0032]-[0044] discuss the user may use a scanner of the data entry component to scan a barcode or other code on the identification, the PSCT kit may print one or more labels corresponding to the particular test that is being performed and include information such as the name of the patient, and an identifier of the test being performed, a barcode, or other computer-readable code, that may identify the associated patient account and affixed to the container.);
transmitting the first identification number represented by the scanned first machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the first identification number is associated with the specimen test order for the patient (Paragraphs [0002], [0035]-[0038] discuss order information is transmitted electronically to the testing laboratory information system and the PSCT kit may use the patient identifier to determine a patient account that corresponds to the patient identifier, the PSCT kit may determine the patient account by comparing the patient identifier with stored patient accounts or one or more patient accounts that are scheduled for testing, the PSCT kit may provide the patient identifier to an account engine of the laboratory server, and the account engine may provide a matching patient account to the PSCT kit, collected information may then be transmitted from the PSCT kit to the account engine and may be used to create a patient account for the patient.);
receiving, via a scanner device at a specimen testing facility, the second machine readable identifier on the side of the container label after the specimen is collected in the specimen container (Paragraphs [0044] discuss the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit. The barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.);
transmitting the second identification number represented by the scanned second machine readable identifier to the electronic medical record system, wherein the electronic medical record system verifies that the second identification number is associated with the specimen test order for the patient (Paragraphs [0027]-[0039] and [0044] discuss the tablet computer associated with the PSCT kit may display an instruction to the user to verify the identity of the patient scheduled for testing and the labeled specimen container is received at the testing facility, a technician (or other user) may scan the barcode on the label that was generated by the PSCT kit. The barcode may identify the associated patient account to the testing facility, and a record that the labeled specimen container was received may be generated and provided to the laboratory server.); and
authorizing the specimen to be tested by the specimen testing facility after verifying that the second identification number is associated with the specimen test order for the patient (Paragraphs [0043]-[0044] and [0058] discuss the testing facility may be selected by the laboratory server and an electronic record of the test and associated patient account may be provided to the testing facility so that the testing facility may begin processing the specimen as soon as it is received the testing facility may receive the labeled collection container and may scan the label to determine the patient account associated with the test.).
Kershner does not explicitly disclose:
pair of identification numbers being printed on a double sided container label;
printing the double sided container label, on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container;
on the first side of the container label before a specimen is collected in the specimen container; and
on the second side of the container label after the specimen is collected in the specimen container.
Koltchine teaches:
pair of identification numbers being printed on a double sided container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.);
printing the double sided container label, on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container (Paragraphs [0068]-[0069] discuss labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading and the back side has an adhesive on a portion thereof opposite the first indicia.);
on the first side of the container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.); and
on the second side of the container label (Paragraph [0068] discusses labeling system includes a label having a first side (e.g., front side) and a second side (e.g., back side), the front side defines a first indicia of the object, for example, the second indicia is on a white background for better scanner reading.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Kershner to include, pair of identification numbers being printed on a double sided container label; printing the double sided container label, on a first side of the double sided container label, wherein a second one of the pair of identification numbers is represented by a second machine readable identifier on a second side of the double sided container label, wherein the first side of the double sided container label has an adhesive for attaching to a specimen container; on the first side of the container label; and on the second side of the container label, as taught by Koltchine, in order to provide a labeling system that is fast and accurate. (Koltchine Paragraph [0011]).
Claims 2, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kershner in view of Koltchine and in further view of Penuela (U.S. Pub. No. 2004/0113421 A1).
Regarding claims 2, 12, and 19, Kershner does not explicitly disclose wherein a portion of the first identification number is the same as a corresponding portion of the second identification number and a different portion of the first identification number is different than a corresponding portion of the second identification number.
Penuela teaches:
wherein a portion of the first identification number is the same as a corresponding portion of the second identification number and a different portion of the first identification number is different than a corresponding portion of the second identification number (Paragraph [0032] discusses the labels may be printed with indicia which is identical in each portion, this identical information may include `nonvariable` information (i.e., information which does not change from label-to-label or patient-to-patient) such as the name of the hospital, hospital department (e.g., maternity, oncology, etc.), the identical information may also include `variable` information (i.e., information which is unique to an individual and which changes from label to label) such as the patient's name, blood-type, patient number assigned by the hospital (in numeric or bar code form), etc. Alternatively, the labels may be printed with indicia which differs from portion-to-portion. For example, the first, second and intermediate portions may each be printed with a different set or subset of patient information but with at least one common piece of identifying patient information, for example, the label may contain the patient's name, blood-type and patient identification number in bar code form) while other labels may only contain the bar code corresponding to the patient identification number.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Kershner to include, wherein a portion of the first identification number is the same as a corresponding portion of the second identification number and a different portion of the first identification number is different than a corresponding portion of the second identification number, as taught by Penuela, in order to improve the correlation of patient information to lab results, specimens, prescriptions, etc. (Penuela Paragraph [0003]).
Conclusion
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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