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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/13/2026 has been entered.
Claims 1, 4-7, 9-12, 16, 18-19 and 21 remain pending in this application.
The 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection of the claims has been withdrawn in light of the amendments.
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, 4-7, 9-12, 16, 18-19 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1, 4-7, 9-12, 16, 18 and 21 are drawn to a system which is within the four statutory categories (i.e. machine). Claim 19 is drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
Claim 1 has been amended to recite:
“…receive information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with the public health crisis;
store the information in a database;
process the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis;
determine a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack; and
generate instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof”,
Claim 12 has been amended to recite:
“…receive information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with the public health crisis;
process the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis;
determine a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack; and
generate instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof”, and
Claim 19 has been amended to recite:
“…receiving, via a wireless network, information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with public health crisis;
storing the information to a database;
processing the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis; and
determining a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack; and
generating instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof”.
The steps of “…receive information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with the public health crisis; …; … process the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis” and “determine a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack” correspond to “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processor and generic network devices does not take the claims out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 4, 7, 9-11, 16, 18 and 21 are ultimately dependent from claims 1, 12 and include all the limitations of claims 1, 12. Therefore, claims 4, 7, 9-11, 16, 18 and 21 recite the same abstract idea. Claims 4, 7, 9-11, 16, 18 and 21 describe a further limitation regarding determine a quantity of the therapeutically effective item to account for the one or more trends. These are all just further describing the abstract idea recited in claims 1, 12, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “at least one processor”, “a memory”, using at least one processor to perform “receiving, storing information, process the information to determining one or more trends and determine the quantity of therapeutically effective item to account, and generating the instructions that control the therapeutic procedural pack manufacturing process…” functions.
These additional elements are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as receiving/storing data from/to a database, communicating data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these 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. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform processing data and generating instructions steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
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.
Claims 1, 4, 7, 9-12, 16, 18, 19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Essig et al. (hereinafter Essig) (WO 2007/005021 A1).
Claim 1 has been amended to recite a system comprising:
at least one processor (Essig discloses “…at least one electronic computer system…” on page 11, lines 10-35); and
a memory including instructions (Essig discloses “…at least one electronic computer system…” on page 11, lines 10-35) that, when executed by the at least one processor, cause the at least one processor to:
receive information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with the public health crisis (Essig discloses “…said software is operable for tracking the environmental conditions experienced by a dose of vaccine after production.” on page 11, lines 8-10, page 77, lines 3-29);
store the information in a database (Essig discloses “…at least one electronic database configured to receive and store vaccine reservation information” on page 34, lines 24-25);
process the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis (Essig discloses “providing a substantially automated system and/or method for pre-authorizing (and for optionally pre-paying) the possible future production of one or more vaccines (which optionally are substantially undetermined at the time of pre-authorization by the prospective vaccine consumer), such as would be appropriate for a currently unknown, unexpected, and/or possibly emerging pathogenic threat (e.g., a highly virulent strain of avian influenza virus that might mutate to become highly infectious and lethal to humans, a biological warfare agent, etc.), whereby the production of one or more such pre-authorized vaccines can commence as soon as practicable once the pathogenic threat is identified, thereby rendering the vaccine available to the consumer as soon as practicable…collecting and evaluating pathogenic threat information (such as by means described herein above) that can be used to determine if a threat has exceed some predetermined level, which, if exceeded, would trigger the start of production of the pre-authorized vaccine…” on page 77, lines 3-29, page 18, lines 11-28);
determine a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack (Essig discloses “automated system and/or method for pre-authorizing the possible future production of one or more vaccines…collecting and evaluating pathogenic threat information that can be used to determine if a threat has exceed some predetermined level, which if exceeded, would trigger the start of production of the pre-authorized vaccine” on page 77, lines 3-29); and
generate instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof (Essig discloses “…automated system and/or method operable for accurately matching seasonal vaccine supply (i.e. production quantities) with seasonal consumer demand…” on page 88, lines 3-7, “…establishing production quantities based significantly (or at least partially) on such total quantities of reserved vaccine, but generally increasing production quantities to account for loss and/or breakage, arid optionally further increasing production quantities to provide some vaccine for consumers who have not reserved a vaccine on a pre-production basis, whereby the production quantities so established provide a far more accurate balance between seasonal vaccine supply and seasonal demand)…” on page 88, line 28 to page 89, line 4).
Claim 4 recites the system of Claim 1, wherein the public health crisis comprises at least one of a mutating virus, a biochemical threat, a biological attack, and a combination thereof (Essig; page 77, lines 3-29).
Claim 7 recites the system of Claim 1, wherein the therapeutically effective item comprises at least one of a medication, a vaccine, and a combination thereof (Essig; page 75, line 32 to page 76, line 23).
Claim 9 recites the system of Claim 1, wherein the at least one processor is further configured to receive informational updates from a computer storing data pertaining to the public health crisis, the database, and a combination thereof (Essig; page 77, lines 3-29).
Claim 10 recites the system of Claim 1, wherein the at least one processor is further configured to transmit data pertaining to the information to a computer coupled to a research system.
Claim 11 recites the system of Claim 1, wherein the information comprises data received from sensors in real time or near real time.
Claim 12 has been amended to recite a computer system for controlling a manufacturing process comprising:
a database to store information (Essig discloses “…at least one electronic database configured to receive and store vaccine reservation information” on page 34, lines 24-25);
at least one processor (Essig discloses “…at least one electronic computer system…” on page 11, lines 10-35); and
a memory including instructions (Essig discloses “…at least one electronic computer system…” on page 11, lines 10-35) that, when executed by the at least one processor, cause the at least one processor to:
receive information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with the public health crisis (Essig discloses “…said software is operable for tracking the environmental conditions experienced by a dose of vaccine after production.” on page 11, lines 8-10, page 77, lines 3-29);
process the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis (Essig discloses “providing a substantially automated system and/or method for pre-authorizing (and for optionally pre-paying) the possible future production of one or more vaccines (which optionally are substantially undetermined at the time of pre-authorization by the prospective vaccine consumer), such as would be appropriate for a currently unknown, unexpected, and/or possibly emerging pathogenic threat (e.g., a highly virulent strain of avian influenza virus that might mutate to become highly infectious and lethal to humans, a biological warfare agent, etc.), whereby the production of one or more such pre-authorized vaccines can commence as soon as practicable once the pathogenic threat is identified, thereby rendering the vaccine available to the consumer as soon as practicable…collecting and evaluating pathogenic threat information (such as by means described herein above) that can be used to determine if a threat has exceed some predetermined level, which, if exceeded, would trigger the start of production of the pre-authorized vaccine…” on page 77, lines 3-29, page 18, lines 11-28);
determine a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack (Essig discloses “automated system and/or method for pre-authorizing the possible future production of one or more vaccines…collecting and evaluating pathogenic threat information that can be used to determine if a threat has exceed some predetermined level, which if exceeded, would trigger the start of production of the pre-authorized vaccine” on page 77, lines 3-29); and
generate instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof (Essig discloses “…automated system and/or method operable for accurately matching seasonal vaccine supply (i.e. production quantities) with seasonal consumer demand…” on page 88, lines 3-7, “…establishing production quantities based significantly (or at least partially) on such total quantities of reserved vaccine, but generally increasing production quantities to account for loss and/or breakage, arid optionally further increasing production quantities to provide some vaccine for consumers who have not reserved a vaccine on a pre-production basis, whereby the production quantities so established provide a far more accurate balance between seasonal vaccine supply and seasonal demand)…” on page 88, line 28 to page 89, line 4).
Claim 16 recites the computer system of Claim 12, wherein the therapeutically effective item comprises at least one of a medication, a vaccine, and a combination thereof (Essig; page 75, line 32 to page 76, line 23).
Claim 18 recites the computer system of Claim 12, wherein the at least one processor is further configured to receive informational updates from a computer storing data pertaining to the public health threat, wherein the public health threat comprises at least one of a mutating virus, a biochemical threat, a biological attack, and a combination thereof (Essig; page 77, lines 3-29).
Claim 19 has been amended to recite a method for controlling a manufacturing process comprising the steps of:
receiving, via a wireless network, information pertaining to one or more deployment locations of a therapeutic procedural pack during a public health crisis, wherein the therapeutic procedural pack comprises a therapeutically effective item for a therapeutic procedure associated with public health crisis (Essig discloses “vaccine reservation system…comprises one or more electronic computer databases for receiving, storing, processing and/or outputting seasonal vaccine reservation in electronic format…” on page 47, line 7 to page 48, line 3, “…wireless network” on page 51, line 22 to page 52, line 3);
storing the information to a database (Essig discloses “…at least one electronic database configured to receive and store vaccine reservation information” on page 34, lines 24-25);
processing the information to determine one or more trends of movement of the therapeutic procedural pack during the public health crisis (Essig discloses “providing a substantially automated system and/or method for pre-authorizing (and for optionally pre-paying) the possible future production of one or more vaccines (which optionally are substantially undetermined at the time of pre-authorization by the prospective vaccine consumer), such as would be appropriate for a currently unknown, unexpected, and/or possibly emerging pathogenic threat (e.g., a highly virulent strain of avian influenza virus that might mutate to become highly infectious and lethal to humans, a biological warfare agent, etc.), whereby the production of one or more such pre-authorized vaccines can commence as soon as practicable once the pathogenic threat is identified, thereby rendering the vaccine available to the consumer as soon as practicable…collecting and evaluating pathogenic threat information (such as by means described herein above) that can be used to determine if a threat has exceed some predetermined level, which, if exceeded, would trigger the start of production of the pre-authorized vaccine…” on page 77, lines 3-29, page 18, lines 11-28);
determining a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack (Essig discloses “automated system and/or method for pre-authorizing the possible future production of one or more vaccines…collecting and evaluating pathogenic threat information that can be used to determine if a threat has exceed some predetermined level, which if exceeded, would trigger the start of production of the pre-authorized vaccine” on page 77, lines 3-29); and
generating instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof (Essig discloses “…automated system and/or method operable for accurately matching seasonal vaccine supply (i.e. production quantities) with seasonal consumer demand…” on page 88, lines 3-7, “…establishing production quantities based significantly (or at least partially) on such total quantities of reserved vaccine, but generally increasing production quantities to account for loss and/or breakage, arid optionally further increasing production quantities to provide some vaccine for consumers who have not reserved a vaccine on a pre-production basis, whereby the production quantities so established provide a far more accurate balance between seasonal vaccine supply and seasonal demand)…” on page 88, line 28 to page 89, line 4).
Claim 21 recites the system of Claim 1, wherein the instructions further cause the therapeutic procedural pack manufacturing machine to modify a step in an injection molding therapeutic procedural pack manufacturing process to produce the therapeutic procedural pack Essig; page 75, line 32 to page 76, line 23).
Response to Arguments
Applicant's arguments filed 07/13/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Applicant argues that Essig does not teach the newly added features. I response, Examiner submits that Essig discloses “determining a quantity of the therapeutically effective item to account for the one or more trends of movement of the therapeutic procedural pack on page 77, lines 3-29 (“automated system and/or method for pre-authorizing the possible future production of one or more vaccines…collecting and evaluating pathogenic threat information that can be used to determine if a threat has exceed some predetermined level, which if exceeded, would trigger the start of production of the pre-authorized vaccine”); and generating instructions that, when executed by a therapeutic procedural pack manufacturing process, control the therapeutic procedural pack manufacturing process to modify at least one or a production rate of the therapeutic procedural pack, a volume of the therapeutically effective item, a type of the therapeutically effective item, or a combination thereof on page 88, lines 3-7 (“…automated system and/or method operable for accurately matching seasonal vaccine supply (i.e. production quantities) with seasonal consumer demand…”, and on page 88, line 28 to page 89, line 4 “…establishing production quantities based significantly (or at least partially) on such total quantities of reserved vaccine, but generally increasing production quantities to account for loss and/or breakage, arid optionally further increasing production quantities to provide some vaccine for consumers who have not reserved a vaccine on a pre-production basis, whereby the production quantities so established provide a far more accurate balance between seasonal vaccine supply and seasonal demand)…”).
Conclusion
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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