DETAILED ACTION
This is a Final Office Action is response to claims on 08/19/2025. Claims 1-14, 16, and 19-22 are pending. The effective filing date is 06/29/2020.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2022 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-14, 16, and 19-22 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. Specifically independent claims 1, 21 and 22 contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
“performing research and developing vaccines against at least one of the IVPPs” is a complex scientific process, and the Specification [037-039] merely recites similar language that research and development occurs. The broadest reasonable interpretation of the terms research and development are so wide, that it would cover so many actions, that it is unclear what can be covered, therefore a person seeking to understand the patent claims would be unable to determine what steps to take to perform he process.
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 1-14, 16, and 19-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1-Claims 1-14, 16, and 19-22 are directed to a method, a method is synonymous to a process, an enumerated category of subject matter. Claims 1-14, 16, and 19-22 pass step 1.
Step 2A, Prong 1-The independent claim 1, and similarly claim 21 and 22, recites:
selectively providing access to an inventory of pre-pandemic vaccines (providing access to inventory is a certain method of organizing human activity, where social activities include controlling and limiting the information being sent to a specific person, see MPEP 2106.04(a)(2)(II)(C) Another example of a claim reciting social activities is Interval Licensing LLC, v. AOL, Inc., 896 F.3d 1335, 127 USPQ2d 1553 (Fed. Cir. 2018). The social activity at issue was the social activity of "’providing information to a person without interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 USPQ2d 1553 (citing Interval Licensing LLC v. AOL, Inc., 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention manager for acquiring content from an information source, controlling the timing of the display of acquired content, displaying the content, and acquiring an updated version of the previously-acquired content when the information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at 1555. The Federal Circuit concluded that "[s]tanding alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is an abstract idea," observing that the district court "pointed to the nontechnical human activity of passing a note to a person who is in the middle of a meeting or conversation as further illustrating the basic, longstanding practice that is the focus of the [patent ineligible] claimed invention." 896 F.3d at 1344-45, 127 USPQ2d at 1559.) comprising:
identifying at least two Influenza Viruses of Pandemic Potential (IVPP) with reference to an Influenza Risk Assessment Tool to provide available vaccines (identification of a specific vaccine is the act of making a decision about vaccines from a list, the identification can be seen as following rules, since the identification is based on specific factors, under MPEP 2106.04(a)(2)(II)(C) An example of a claim reciting following rules or instructions is In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). The patentee claimed a method of playing a dice game including placing wagers on whether certain die faces will appear face up. 911 F.3d at 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims were directed to the abstract idea of "rules for playing games", which the court characterized as a certain method of organizing human activity. 911 F.3d at 1160-61; 129 USPQ2d at 1011; additionally the act of making a decision is a mental process under MPEP 2106.04(a)(2)(III));
performing research and developing vaccines against at least one of the IVPPs (performing research is something done by a person, and therefore, it can be both a mental process of analyzing information under MPEP 2106.04(a)(2)(III) As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’));
obtaining regulatory approval for the developed vaccines (obtaining approval from a regulatory agency is a method of following rules and instructions, which is a certain method of organizing human activity under MPEP 2106.04(a)(2)(II)(C) An example of a claim reciting following rules or instructions is In re Marco Guldenaar Holding B.V., 911 F.3d 1157, 1161, 129 USPQ2d 1008, 1011 (Fed. Cir. 2018). The patentee claimed a method of playing a dice game including placing wagers on whether certain die faces will appear face up. 911 F.3d at 1160; 129 USPQ2d at 1011. The Federal Circuit determined that the claims were directed to the abstract idea of "rules for playing games", which the court characterized as a certain method of organizing human activity. 911 F.3d at 1160-61; 129 USPQ2d at 1011.);
determining a stockpile requirement for vaccines against selected IVPPs among the at least two IVPPs (making a determination is a mental process, because the analyzing of information under MPEP 2106.04(a)(2)(III)(a) a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016););
obtaining finished vaccines against each of the selected IVPPs (receiving either actual vaccines for comparison, or receiving information about finished vaccines are both abstract concepts; the act of controlling finished vaccines within a warehouse is the act of controlling inventory, and controlling inventory is typically associated with the relationship between two entities since one person has the vaccine, and another needs the vaccine, and an exchange occurs, and therefore can be seen as a commercial interaction under MPEP 2106.04(a)(2)(B) An example of a claim reciting business relations is found in Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The business relation at issue in Credit Acceptance is the relationship between a customer and dealer when processing a credit application to purchase a vehicle. The patentee claimed a "system for maintaining a database of information about the items in a dealer’s inventory, obtaining financial information about a customer from a user, combining these two sources of information to create a financing package for each of the inventoried items, and presenting the financing packages to the user." 859 F.3d at 1054, 123 USPQ2d at 1108.; additionally the act of obtaining information is a mental process under MPEP 2106.04(a)(2)(III));
storing an inventory of the finished vaccines against each of the selected IVPPs (storing actual inventory, or storing information about inventory is the act of tracking inventory, which is monitoring sales activities, see MPEP 2106.04(a)(2)(II)(B) and also the process of storing information can be accomplished within the human mind, see MPEP 2106.04(a)(2)(III)(A));
preparing delivery logistics of the finished vaccines against at least one of the selected IVPPs in response to an access request (creating a plan for delivery vaccine is a matter of business relations, because it is the management of goods between two parties, see MPEP 2106.04(a)(2)(II)(C)); and
periodically obtaining further finished vaccines against one or more of the selected IVPPs and adding the further finished vaccines to the inventory of finished vaccines, such that the stored inventory of finished vaccines has a sufficient number of finished vaccines that have not reached their expiration date to meet the stockpile requirement (the act of obtaining information is a mental process under MPEP 2106.04(a)(2)(III) and obtaining physical stock act of controlling inventory, and controlling inventory is typically associated with the relationship between two entities since one person has the vaccine, and another needs the vaccine, and an exchange occurs, and therefore can be seen as a commercial interaction under MPEP 2106.04(a)(2)(B) An example of a claim reciting business relations is found in Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 123 USPQ2d 1100 (Fed. Cir. 2017). The business relation at issue in Credit Acceptance is the relationship between a customer and dealer when processing a credit application to purchase a vehicle. The patentee claimed a "system for maintaining a database of information about the items in a dealer’s inventory, obtaining financial information about a customer from a user, combining these two sources of information to create a financing package for each of the inventoried items, and presenting the financing packages to the user." 859 F.3d at 1054, 123 USPQ2d at 1108).
Step 2A, Prong 2- The additional elements in claim 1, and similarly claims 21 and 22, are vaccines and an Influenza Risk Assessment Tool. This judicial exception is not integrated into a practical application because the management of vaccines is the abstract concept of controlling inventory as part of the business, and including the vaccines are distinguishing a field of use, which does not indicate more than the judicial exception under MPEP 2106.05(h) vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)). Additionally, the Influenza Risk Assessment Tool is described as a tool to perform the abstract idea of identification, and without additional description of the tool, it is recited by name only as a tool to perform the abstract idea under MPEP 2106.05(f).
Step 2B- Claim 1, and similarly claims 21 and 22, does not include additional elements that are sufficient to amount to significantly more than the judicial exception because linking inventory management to a specific field of art, such as vaccines, does not provide more than general linking the judicial exception to a particular environment under MPEP 2106.05(h), and using tools to perform the abstract idea under MPEP 2106.05(f).
Dependent Claims
Claims 2-3, 6, 12-14, 16, 19 add details about the finished vaccines. The act of controlling finished vaccines within a warehouse is the act of controlling inventory, and controlling inventory is typically associated with the relationship between two entities since one person has the vaccine, and another needs the vaccine, and an exchange occurs, and therefore can be seen as a commercial interaction under MPEP 2106.04(a)(2)(B). The claims link the judicial exception to vaccines, which is not more than the abstract idea under MPEEP 2106.05(h).
Claim 4- add details to the schedule to create vaccines. Scheduling vaccine manufacturing is another form of controlling vaccines, and is a commercial interaction under MPEP 2106.04(a)(2)(B) in a particular field, which is not more than the judicial exception under MPEP 2106.05(h).
Claim 5, 8-9, 11 adds details to the inventory requirements. Management of vaccine inventory is another form of controlling vaccines, and is a commercial interaction under MPEP 2106.04(a)(2)(B) in a particular field, which is not more than the judicial exception under MPEP 2106.05(h).
Claim 7 adds details about payment for vaccines. The payment for vaccines is the commercial part of a transaction, and therefore is a commercial interaction under MPEP 2106.04(a)(2)(B) in a particular field, which is not more than the judicial exception under MPEP 2106.05(h).
Claim 10 adds procedure to request vaccines. Requesting a specific item is a method of requesting and receiving vaccines is a transaction, since it is the exchange of vaccines between two parties, and is a commercial transaction under MPEP 2106.04(a)(2)(B) in a particular field, which is not more than the judicial exception under MPEP 2106.05(h).
Claim 20 adds producing a panel based on facts and analyzing and selecting information based on the production. The exchange and presentment of information is a mental process under MPEP 2106.04(a)(2)(III) and relating it to a specific field of vaccines does not provide more than the abstract idea, see MPEP 2106.05(h).
Claim Limitations not found in Prior Art
The following is a statement of reasons for the indication of allowable subject matter in claims 1, 21 and 22:
Influenza Viruses of Pandemic Potential (IVPP) with reference to an Influenza Risk Assessment Tool.
wherein the finished vaccines have a shelf life of at least 1 year
wherein the further finished vaccines are manufactured in the time available between northern hemisphere vaccine production and southern hemisphere vaccine production.
Available Prior Art teaches:
US 2018/0357389 A9 Warren teaches planning a supply chain (Warren Abstract, planning supply chain of pharmaceuticals).
US 2014/0234356 A1 Bonnet et al. teaches vaccine analysis vaccines (Bonnet Abstract, influenza vaccines).
US 2020/0317445 A1 Schultz et al. teaches storing products (Schultz Abstract, monitoring and controlling storage).
US 2020/0334635 A1 Busey teaches subscription services (Busey Abstract, subscription for goods).
However, the claims remain rejected under 101, as maintains a 112(a) rejection for enablement, and therefore are not in proper form for allowability.
Response to Arguments
Applicant's arguments filed 08/19/2025 have been fully considered but they are not persuasive.
Regarding 101, USPTO Example 28 continues to make eligible claims to an actual vaccine because the judicial exception being applied was a natural element. However, the claims recite inventory management of obtained vaccines. The vaccine is the inventory item, not the invention, and therefore, the idea of obtaining an inventory item is in the abstract idea category, and there needs to show integration into a practical application around a specific technology. The broad idea of performing researching and going through a regulation process is not a natural element as described in Example 28, but is a mental process, that needs to be evaluated as an abstract idea.
Regarding 103, the independent claims have included the previously identified elements that are not found in the prior art, and therefore the dependent claims now include elements that are not found in prior art. However, the claims remain rejected under 101 as containing abstract ideas.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2020/0360507 A1 Hanon et al. teaches vaccine formulation (Abstract).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JESSICA E SULLIVAN/ Examiner, Art Unit 3627
/FAHD A OBEID/ Supervisory Patent Examiner, Art Unit 3627
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