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 .
Specification
Examiner suggests applicant to update the status of parent U.S. Patent Application Serial No. 18/103,458 as follows:
Under “RELATED APPLICATIONS” in page 1,
-Line 2: After “2023, “, insert “now U.S. Patent No. 12,026,271, “.
Claim Objections
Claims 36 and 45 are objected to because of the following informalities:
-Claim 36, Line 13: “predetermining” should be corrected to “predetermined”.
-Claim 36, Line 13: After “internal memory”, “location” should be added.
-Claim 45, Line 2: After “memory”, “location” should be added.
Appropriate correction is required.
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.
Claim 36 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Recitation of “the downloaded files” in line 12 lacks a positive antecedent basis.
For examination purpose, “the downloaded files” is interpreted as “received files”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 36, 38, 40, 44-52 and 57 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2013/0104120 A1 (Arrizza et al.).
Regarding claim 36, Arrizza et al. teach a method to protect a medical system having a medical device that uses a processor from malicious software (see paragraph [0068]: The encryption mechanism will also insure that if an update filter is intercepted, it cannot be modified and then replayed to the medical device as a valid update. If attempted, the device will reject the update as an invalid file”), the method comprising: providing at least one control software module that controls the operation of the medical device and is executable on the processor (see paragraph [0035]: FIG. 1…an application subsystem 18 controls the operation of the medical device 10”), a remote access application i.e. a data management module that manages data flow to and from the at least one control software module from and exterior sources (see paragraph [0035]: FIG. 1… A communication subsystem 16 facilitates communications between the medical device 10 and the server 12”), and an agent module having access to only predetermined memory locations in the medical device (see FIG. 1: Communication subsystem 16 can only write to storage 20); enabling a communications link from the medical device to a remote server;
activating the remote access application e.g., the agent module to transmit a request to the remote server via the enabled communications link (see paragraph [0089]: FIG. 14… software user activates a drug delivery for one or more infusion pumps. In response, the server 112 generates and sends an update message for the medical device), receive files from the remote server, and store the received files from the remote server in the predetermined memory locations accessible by the remote access application e.g., the agent module (see paragraph [0013]: FIG. 7 is a timing diagram showing a process where two new updates are downloaded prior to installation” Only storage 20 is accessible); validating the received files, with a remote access application i.e. a data management module, prior to transferring the received files stored within the predetermined memory locations into an internal memory location accessible by the at least one control software module (see paragraph [0045]:…will calculate a checksum over the first chunk 30, which will be used later by the respective device 12 to verify that the translator of the chunk 30 was completed without corruption); reading the received files into the data management module if the received files are validated by the data management module for storage within the internal memory location (see paragraph [0063]: FIG. 8 is a diagram and flow chart illustrating the state of a medical device before and after an update); deleting all received files in the predetermined memory locations if any part of validation fails (see paragraph [0039]: …if the downloaded update files cannot be verified, the process proceeds back to steps 2-16, where the updates are downloaded again.”. It is implicit, that a second download overwrites a failed download, thereby deleting the files); and disabling the communications link before when a therapy using the medical device is started, and enabling the communications link after the therapy has ended (“claim 9….update files are downloaded while the medication administering device is being used to administer medication. Arrizza et al. describe the possibility to have both at the same time as something new and inventive. Therefore, the method of Arrizza et al. cannot do both simultaneously. Only therapy or update is possible, one after the other). Regarding claim 38, Arrizza et al. teach the remote access application comprises an agent module (see FIG. 1: Communication subsystem 16 can only write to storage 20; the agent module to transmit a request to the remote server via the enabled communications link (see paragraph [0089]: FIG. 14) that communicates over a wireless connection to the remote server wherein the communication link is a wireless router (see FIG. 5; paragraph [0051]). Regarding claim 40, Arrizza et al. teach validating the downloaded files comprises comparing a plurality of directory names corresponding to a directory structure of the received files against a list of acceptable directory names (see paragraph [0105]: The update message contains a manifest or list of the files and their locations on the server). Regarding claim 44, Arrizza et al. teach the received files contain prescription data and the method further comprises a user confirming and accepting a prescription as indicated by the prescription data. Arrizza et al. is all is all about prescription data, see " paragraph [0002]: Intravenous infusion therapy is prescribed where it is desirable to administer medications and other fluids directly into the circulatory system of a patient. " See also paragraph [0040]: After the updates files are downloaded, verified, and stored... the process determines whether the user accepts the update or rejects the update." Regarding claim 45, Arrizza et al. teach validating the received files by the remote access application e.g., the data management module before reading the received files for storage within the internal memory location (see paragraph [0040]: After the updates files are downloaded, verified, and stored", it is clear that the storage comes after the validation). Regarding claim 46, Arrizza et al. teach creating an update request file at a specified memory location accessible by the remote access application e.g., the agent module (see FIG.6: GET UPDATE BASED ON MANIFEST by Communication subsystem 16 that writes only to storage 20 in FIG. 1). Regarding claim 47, Arrizza et al. teach communicating the update request file to the remote server (see Fig. 6 “UPDATE MESSAGE” and “STATUS MESSAGE” to the remote server). Regarding claims 48-51, Arrizza et al. teach that the communication link is a wireless link, a wired link, an Ethernet connection and/or a WiFi connection (see FIG. 3-5; paragraph [0051]). Regarding claim 52, Arrizza et al. disclose a system for protecting a medical device having a processor from malicious software (see paragraph [0068]: The encryption mechanism will also insure that if an update filter is intercepted, it cannot be modified and then replayed to the medical device as a valid update. If attempted, the device will reject the update as an invalid file”) comprising: a control software module executable on the processor and configured to control operation of the medical device (see paragraph [0035]: FIG. 1…an application subsystem 18 controls the operation of the medical device 10”); a remote access application comprising a data management module configured to manage data flow between an exterior source and the control software module (see paragraph [0035]: FIG. 1… A communication subsystem 16 facilitates communications between the medical device 10 and the server 12”); and an agent module having access only to predetermined memory locations in the medical device (see FIG. 1: Communication subsystem 16 can only write to storage 20); the control software module configured to request a communications link from the medical system to a remote server, to activate remote access application e.g., the agent module to transmit a request to the remote server via the enabled communications link (see paragraph [0089]: FIG. 14… software user activates a drug delivery for one or more infusion pumps. In response, the server 112 generates and sends an update message for the medical device), to receive files from the remote server, and to store the received files from the remote server in the predetermined memory locations accessible by remote access application e.g., the agent module (see paragraph [0013]: FIG. 7 is a timing diagram showing a process where two new updates are downloaded prior to installation” Only storage 20 is accessible); the remote access application e.g., the data management module configured to perform a validation of the received files stored within the predetermined memory locations (see paragraph [0045]:…will calculate a checksum over the first chunk 30, which will be used later by the respective device 12 to verify that the translator of the chunk 30 was completed without corruption), and to transfer the received files into an internal memory location accessible by the control software module if the validation succeeds (see paragraph [0063]: FIG. 8 is a diagram and flow chart illustrating the state of a medical device before and after an update), or to delete all received files in the predetermined memory locations if the validation fails (see paragraph [0039]: …if the downloaded update files cannot be verified, the process proceeds back to steps 2-16, where the updates are downloaded again.”. It is implicit, that a second download overwrites a failed download, thereby deleting the files); wherein the control software module is configured to only receive files when a therapy is not running on the medical device (or disable the communications link when a therapy using the medical device is started, and to enable the communications link after the therapy has ended (“claim 9….update files are downloaded while the medication administering device is being used to administer medication. Arrizza et al. describe the possibility to have both at the same time as something new and inventive. Therefore, the method of Arrizza et al. cannot do both simultaneously. Only therapy or update is possible, one after the other). Regarding claim 57, Arrizza et al. teach that the received files contain prescription data and wherein validation of the prescription data comprises displaying for user confirmation a prescription indicated by the prescription data. Arrizza et al. is all is all about prescription data, see " paragraph [0002]: Intravenous infusion therapy is prescribed where it is desirable to administer medications and other fluids directly into the circulatory system of a patient. " See also paragraph [0040]: After the updates files are downloaded, verified, and stored... the process determines whether the user accepts the update or rejects the update."
Claim Rejections - 35 USC § 103
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 37, 39 and 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0104120 A1 (Arrizza et al.).
Arrizza et al. disclose the method and the system for protecting a medical device having a processor from malicious software as disclosed above.
Claim 37, 39 and 53-55 differ from the method and the system of Arrizza et al. in reciting that the remote access application or the agent module or the processor is assigned a predetermined usage limit of the processor, a predetermined amount of storage space, a predetermined amount of memory usage or a predetermined memory location.
It is well-known in the art that general predetermined usage limits, a predetermined amount of storage space predetermined amount of memory usage or a predetermined memory location in computers are always present by the hardware available and would have been obvious to a person of ordinary skill in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 36-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 12-13 and 15 of U.S. Patent No. 12,026,271. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 12,026,271 that anticipate the instant application claims are set forth below and any necessary comparison.
Claims of
Application No. 18/676934
Claims of
U.S. Patent No. 12,026,271
Comparison
36
1
Narrow claim 1 anticipates broad instant claim 36 and contains all the limitations of claim 36.
37
2/1
Narrow claim 2/1 anticipates broad instant claim 37 and contains all the limitations of claim 37.
38
7/1
Narrow claim 7/1 anticipates broad instant claim 38 and contains all the limitations of claim 38.
39
2/1
Narrow claim 2/1 anticipates broad instant claim 39 and contains all the limitations of claim 39.
40
3/1
Narrow claim 3/1 anticipates broad instant claim 40 and contains all the limitations of claim 40.
41
4/1
Narrow claim 4/1 anticipates broad instant claim 41 and contains all the limitations of claim 41.
42
4/1
Narrow claim 4/1 anticipates broad instant claim 42 and contains all the limitations of claim 42.
43
4/1
Narrow claim 4/1 anticipates broad instant claim 43 and contains all the limitations of claim 43.
44
5/1
Narrow claim 5/1 anticipates broad instant claim 44 and contains all the limitations of claim 44.
45
6/1
Narrow claim 6/1 anticipates broad instant claim 45 and contains all the limitations of claim 45.
46
6/1
Narrow claim 6/1 anticipates broad instant claim 46 and contains all the limitations of claim 46.
47
6/1
Narrow claim 6/1 anticipates broad instant claim 47 and contains all the limitations of claim 47.
48
7/1
Narrow claim 7/1 anticipates broad instant claim 48 and contains all the limitations of claim 48.
49
7/1
Narrow claim 7/1 anticipates broad instant claim 49 and contains all the limitations of claim 49.
50
7/1
Narrow claim 7/1 anticipates broad instant claim 50 and contains all the limitations of claim 50.
51
7/1
Narrow claim 7/1 anticipates broad instant claim 51 and contains all the limitations of claim 51.
52
12
Narrow claim 12 anticipates broad instant claim 52 and contains all the limitations of claim 52.
53
13/12
Narrow claim 13/12 anticipates broad instant claim 53 and contains all the limitations of claim 53.
54
13/12
Narrow claim 13/12 anticipates broad instant claim 54 and contains all the limitations of claim 54.
55
13/12
Narrow claim 13/12 anticipates broad instant claim 55 and contains all the limitations of claim 55.
56
15/12
Narrow claim 15/12 anticipates broad instant claim 56 and contains all the limitations of claim 56.
57
15/12
Narrow claim 15/12 anticipates broad instant claim 57 and contains all the limitations of claim 57.
Claims 36-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-13, 18-21 and 23 of U.S. Patent No. 11,568,043. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The claim comparison table discusses claims and relevant differences below.
The corresponding claims of U.S. Patent No. 11,568,043 that anticipate the instant application claims are set forth below and any necessary comparison.
Claims of
Application No. 18/676934
Claims of
U.S. Patent No. 11,568,043
Comparison
36
1
Narrow claim 1 anticipates broad instant claim 36 and contains all the limitations of claim 36.
37
2/1
Narrow claim 2/1 anticipates broad instant claim 37 and contains all the limitations of claim 37.
38
10/1
Narrow claim 10/1 anticipates broad instant claim 38 and contains all the limitations of claim 38.
39
3/1
Narrow claim 3/1 anticipates broad instant claim 39 and contains all the limitations of claim 39.
40
5/1
Narrow claim 51 anticipates broad instant claim 40 and contains all the limitations of claim 40.
41
1
Narrow claim 1 anticipates broad instant claim 41 and contains all the limitations of claim 41.
42
1
Narrow claim 1 anticipates broad instant claim 42 and contains all the limitations of claim 42.
43
1
Narrow claim 1 anticipates broad instant claim 43 and contains all the limitations of claim 43.
44
6/1
Narrow claim 6/1 anticipates broad instant claim 44 and contains all the limitations of claim 44.
45
7/1
Narrow claim 7/1 anticipates broad instant claim 45 and contains all the limitations of claim 45.
46
8/1
Narrow claim 8/1 anticipates broad instant claim 46 and contains all the limitations of claim 46.
47
9/1
Narrow claim 9/1 anticipates broad instant claim 47 and contains all the limitations of claim 47.
48
10/1
Narrow claim 10/1 anticipates broad instant claim 48 and contains all the limitations of claim 48.
49
11/1
Narrow claim 11/1 anticipates broad instant claim 49 and contains all the limitations of claim 49.
50
12/1
Narrow claim 12/1 anticipates broad instant claim 50 and contains all the limitations of claim 50.
51
13/1
Narrow claim 13/1 anticipates broad instant claim 51 and contains all the limitations of claim 51.
52
18
Narrow claim 18 anticipates broad instant claim 52 and contains all the limitations of claim 52.
53
19/1
Narrow claim 19/1 anticipates broad instant claim 53 and contains all the limitations of claim 53.
54
20/1
Narrow claim 20/1 anticipates broad instant claim 54 and contains all the limitations of claim 54.
55
21/1
Narrow claim 21/1 anticipates broad instant claim 55 and contains all the limitations of claim 55.
56
18
Narrow claim 18 anticipates broad instant claim 56 and contains all the limitations of claim 56.
57
23/18
Narrow claim 23/18 anticipates broad instant claim 57 and contains all the limitations of claim 57.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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, INSUK BULLOCK can be reached on 571-272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/John Kim/Primary Examiner, Art Unit 1772
JK
8/13/26
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