DETAILED ACTION
Status of Claims
This action is in reply to the amendment filed on 09/16/2025.
Claim 1 has 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 .
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.
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Claims 1, 4 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of copending Application No. 18491425 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claim 1 of the copending application recites all the limitations of claim 1 of the instant application; however, claim 1 of the copending application differs since it further recites additional claim limitations including: 1)“ a neural device configured to sense data associated with the subject or receive control input, the neural device,” 2) “an external device communicably coupled to the neural device, the external device configured to at least one of receive or communicate data to the neural device,” and 3) “one or more communications interfaces between the neural device, the external device, and the storage medium or components thereof, wherein the one or more communications interfaces comprise an encryption protocol.”
However, it would have been obvious to a person of ordinary skill in the art to modify claim 1 of the copending application by removing the additional limitations (1-3), resulting generally in the claims of the present application, since the claims of the present application and the claim recited in the Patent Document actually perform a similar function. It is well settled that the omission of an element and its function is an obvious expedient if the remaining elements perform the same function as before.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jha (US 10,135,849 B2).
Claim 1:
Jha discloses A medical device system for use with a subject, the medical device system (See Fig. 3, column 1, lines 38-53 implantable and wearable medical devices (IWMDs) to perform cardiac pacing, defibrillation, insulin delivery and glucose monitoring, deep brain stimulation, intrathecal drug infusion, and many other diagnostic, monitoring, and therapeutic functions and personal healthcare system (PHS) in column 12, line 62 to column 13, line 15.) comprising:
a medical device configured to sense data associated with the subject or receive control input, the medical device comprising one or more electronics modules (Besides the personal healthcare system with sensors for physiological data collection in column 1, lines 45-58, see tamper proof software and Trusted Platform Module (TPM) in column 10, line 64 to column 11, line 8 and column 11, line59-64.), the one or more electronics modules comprising one or more of an electrode amplifier, an analog front-end, an analog-to- digital converter, a digital signal processor, or a transceiver (See communication interface include a processor in column 12, lines 47-54, receiver between medical devices in column 2, lines 45-51, exemplary RF signal down-converted to the baseband and then sampled at 64 MS/s, intercepted and down-converted wireless signal in column 18, lines 32-55, signal amplification levels in column 22, lines 46-54.);
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 exemplary smartphone 130 as an external device mentioned in column 12, line 62 to column 13, line 15.);
a storage medium communicably coupled to the external device, the storage medium comprising data configured to be retrieved by the external device (See Fig. 3 Health Server 140 as receiver mentioned in column 12, line 62 to column 13, line 15. Also, see column 24, lines 28-43 a computer program, software, or firmware incorporated in a computer-readable (non-transitory) storage medium.); and
one or more communications interfaces between at least two of the one or more electronics modules, wherein the one or more communications interfaces comprise an encryption protocol (See column 9, line 64 to column 10, line 14 exemplary protocol as encrypted IWMD messages and commands.).
Regarding claim 2, Jha discloses the medical device system of claim 1, wherein the medical device comprises an implantable medical device (See Fig. 3, column 1, lines 38-53, implantable and wearable medical devices (IWMDs).).
Regarding claim 3, Jha discloses the medical device system of claim 1, wherein the medical device comprises a non- implantable device (See Fig. 3, column 1, lines 38-53 where wearable medical devices are not implanted. Also, see wearable fall detector in column 7, lines 34-40.).
Regarding claim 4, Jha 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 Fig. 3 exemplary smartphone 130 as an external device mentioned in column 12, line 62 to column 13, line 15.).
Regarding claim 5, Jha 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 implantable and wearable medical devices (IWMDs) to perform cardiac pacing, defibrillation, insulin delivery and glucose monitoring, deep brain stimulation, intrathecal drug infusion, and many other diagnostic, monitoring, and therapeutic functions and personal healthcare system (PHS) in column 1, lines 38-53 and column 12, line 62 to column 13, line 15.).
Regarding claim 6, Jha discloses the medical device system of claim 1, wherein all of the one or more communications interfaces are encrypted (See exemplary shield as communications interfaces for encrypted messages and commands in column 9, line 64 to column 10, line 14.).
Regarding claim 7, Jha discloses the medical device system of claim 1, wherein a subset of the one or more communications interfaces are encrypted (Besides exemplary encrypted messages and commands in column 9, line 64 to column 10, line 14, see trusted computing with a set of standards in column 11, line 48 to column 12, line 2.).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jha (US 10,135,849 B2) in view of Nin (US 2021/0085988 A1).
Regarding claim 8, although Jha discloses the medical device system of claim 1 with a encryption protocol mentioned above, Jha does 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 Jha 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 09/16/2025 does not deem to place the claims in better form for an allowance. Therefore, the double patenting rejection is maintained.
Applicant’s arguments, with respect to the 101 rejection have been fully considered and are persuasive. Implementing an encryption protocol using communications components and electronics modules of the medical device system is not a certain method of organizing human activities. The 101 rejection of claims 1-8 has been withdrawn.
Applicant's arguments filed 09/16/2025 have been fully considered but they are not persuasive. The revised amendments recited with “the medical device comprising one or more electronics modules, the one or more electronics modules comprising one or more of an electrode amplifier, an analog front-end, an analog-to- digital converter, a digital signal processor, or a transceiver" do not sufficiently overcome the art rejection. See Jha’s exemplary processor in column 12, lines 47-54, receiver between medical devices in column 2, lines 45-51, RF signal down-converted to the baseband and then sampled at 64 MS/s, intercepted and down-converted wireless signal in column 18, lines 32-55, and signal amplification levels in column 22, lines 46-54.
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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/T.S.W./Examiner, Art Unit 3687 12/30/2025
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687
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