sdDETAILED ACTION
Status of Claims
This action is in reply to the Request for Continued Examination filed on 04/13/2026.
Claims 1 and 6-7 have been amended.
Claims 1-8 are currently pending and have been examined.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/13/2026 has been entered.
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.
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
Claims 1, 4 and 6-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,706,887 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 recites a “neural” system and device, instead of a “medical” system and device. According to specification, the “neural” systems, “medical” systems and devices don’t’ have any special definitions, having different names, but the same functions, and the name does not affect the scope of the claim.
This is a nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Furthermore, there is no apparent reason why applicant was prevented from presenting claims corresponding to those of the instant application during prosecution of the application which matured into a patent. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968). See also MPEP § 804.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Soykan (US 2020/0352441 A1) in view of Doerr (US 2009/0028185 A1).
Claim 1:
Soykan discloses A medical device system for use with a subject, the medical device system (See Figs. 8A-B, Abstract, P0098 implantable medical device 40 to detect, treat and manage other conditions or events, such as syncope, stroke, or myocardial infarction.) comprising:
a medical device configured to sense data from the subject, the medical device comprising:
a plurality of electronics modules (Besides Fig. 5, P0050, P0053 include other sensors 49, the sense amplifier module 42, compression/filter/algorithm module 47, Galvanic communication module 53, see Fig. 9, P0073-P0074, P0084 connectivity module 92, audio output module 94, visual output module 95, Surface ECG Measurement Module 97 and Long-range telemetry module 88.), comprising an electrode amplifier, an analog front-end, an analog-to- digital converter, a digital signal processor, and a transceiver (See Fig. 3, Fig. 5, P0045 a sense amplifier module 42 sense amplifiers, analog front-end 18 in [P0039] decoder 12 convert the received waveforms into digital data, and transceiver controller 15, which can either send the received data 26 to a processor for further processing.); and
an external device communicably coupled to the medical device, the external device configured to at least one of receive or communicate data to the medical device (See Fig. 3, P0041-P0042 exemplary Galvanic communication link for External device 80 to communicate with implantable medical device.);
a storage medium communicably coupled to the external device, the storage medium comprising data configured to be retrieved by the external device (Besides [P0027] a galvanic communications link between the implantable device and the external device, where the body tissue of the patient between the devices serves as the conductive medium over which the communications signals travel or are conducted and transmission medium in P0034, see memory buffer 19 in Fig. 3, P0039.).
Although Soykan discloses the medical device system with encryption transmission features mentioned in P0108-P0110, Soykan does not explicitly teach an encryption protocol between electronics modules via a communications interface. Doerr taches:
a communications interface between two of the plurality of electronics modules, the communications interface comprising an encryption protocol (See Figs. 1-4, data transmission interface in P0023-P0025 for verifying communication including encryption module or protocol and encryption modules in P0054.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical device communications before the effective filing date of the claimed invention to modify the system of Soykan to include an encryption protocol between electronics modules via a communications interface as taught by Doerr for securing the privacy and confidentiality of the patient’s data, and avoiding manipulation of medical implant settings mentioned in Doerr’s P0005.
Regarding claim 2, Soykan discloses the medical device system of claim 1, wherein the medical device comprises an implantable medical device (See Fig. 4A-B, implantable medical device external to patient’s body in P0027, P0042.).
Regarding claim 3, Soykan discloses the medical device system of claim 1, wherein the medical device comprises a non- implantable device (See P0068 where the patch sends ECG signals.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical device communications before the effective filing date of the claimed invention to modify the system of Soykan to include a patch to do both the “medical device” functions and the “external device” functions as taught by Soykan on an explicit basis, because the patch can be disposably worn above the skin’s surface, unlike a cardiac implant placed under surface skin’s surface.
Regarding claim 4, Soykan discloses the medical device system of claim 1, wherein the external device comprises a tablet, a smartphone, a laptop, a desktop, a secure server, a smartwatch, a head-mounted virtual reality device, a head-mounted augmented reality device, or a smart inductive charger device (See smartphone and a wearable smart device in P0047, a tablet computing device, a laptop computing device in P0083 and cloud based servers in P0056.).
Regarding claim 5, Soykan discloses the medical device system of claim 1, wherein the medical device comprises a pacemaker, an insulin pump, a cardioverter-defibrillator, a left ventricular assist device, a glucose monitor, an infusion pump, or a neurostimulator (See cardiac pacemaker, cardioverter-defibrillator, neurostimulator, left ventricular assist device, artificial heart valve, coronary stent, insulin pump and devices in P0028.).
Regarding claim 6, Soykan and Doerr teach the medical device system of claim 1 mentioned above, and Doerr further teaches wherein the communications interface is one of a plurality of communications interfaces between the plurality of electronics modules, and wherein each of the plurality of communications interfaces are encrypted (See Figs. 1-4, data transmission interface in P0023-P0025 for verifying communication including encryption module or protocol and encryption modules in P0054.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical device communications before the effective filing date of the claimed invention to modify the system of Soykan to include an encryption protocol between electronics modules via a communications interface as taught by Doerr for securing the privacy and confidentiality of the patient’s data, and avoiding manipulation of medical implant settings mentioned in Doerr’s P0005.
Regarding claim 7, Soykan and Doerr teach the medical device system of claim 1 mentioned above, and Doerr further teaches wherein communications interface is one of a plurality of communications interfaces between the plurality of electronics modules, and wherein a subset of the plurality of communications interfaces are encrypted (See interface for implant transmission set-up in P0057, parameter set operating implant in P0059, Figs. 1-4, data transmission interface, compression data settings in P0023-P0025 for verifying communication including encryption module or protocol and encryption modules in P0054.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical device communications before the effective filing date of the claimed invention to modify the system of Soykan to include an encryption protocol between electronics modules via a communications interface when a subset of the communications interfaces are encrypted as taught by Doerr for securing the privacy and confidentiality of the patient’s data, and avoiding manipulation of medical implant settings mentioned in Doerr’s P0005.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Soykan (US 2020/0352441 A1) in view of Doerr (US 2009/0028185 A1) further in view of Nin (US 2021/0085988 A1).
Regarding claim 8, although Soykan and Doerr teach the medical device system of claim 1 with a encryption protocol mentioned above, Soykan and Doerr do not explicitly teach when the encryption protocol comprises Advanced Encryption Standard. Nin teaches wherein the encryption protocol comprises at least one of Advanced Encryption Standard, Data Encryption Standard or variations thereof (e.g., Triple DES), Rivest-Shamir—Adleman (RSA), Blowfish, or Twofish (See the Advanced Encryption Standard (AES) block cipher in P0078.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical device communications before the effective filing date of the claimed invention to modify the system of Soykan and Doerr to include the encryption protocol comprising the Advanced Encryption Standard as taught by Nin in order to avoid posing risks to a patient’s privacy and health during long-range communications mentioned in Nin’s P0002.
Response to Arguments
Regarding the double patenting rejection, the amendment entered 04/13/2026 does not place the claims in better form for an allowance. Therefore, the double patenting rejection is maintained.
Regarding the prior art rejection, Applicant’s arguments have been fully considered and are now moot in view of the new grounds of rejection. The Examiner has entered a new rejection under 35 USC § 103 and applied new art and art already of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA S WILLIAMS whose telephone number is (571)270-5509. The examiner can normally be reached Mon-Fri, 8:30 am -6:30 pm.
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/T.S.W./Examiner, Art Unit 3687
08/19/2026
/Anita Y Coupe/Supervisory Patent Examiner, Art Unit 3619
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