NON-FINAL REJECTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-9, 11, and 12) in the reply filed on 5/7/2026 is acknowledged. The traversal is on the ground(s) that examination of all claims together allegedly “places no undue burden on the Examiner”. This is not found to be persuasive because:
This application is the result of an international application which has entered national stage under 35 USC §371 (often referred to informally as a “371 application”). This is not a national application filed under 35 USC 111(a) (often referred to informally as a “111(a) application”).
MPEP 823, titled “Unity of Invention Under the Patent Cooperation Treaty”, recites:
The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). See MPEP Chapter 1800, in particular MPEP § 1850, § 1875, and § 1893.03(d), for a detailed discussion of unity of invention under the Patent Cooperation Treaty (PCT). However, the guidance set forth in this chapter with regard to other substantive and procedural matters (e.g., double patenting rejections (MPEP § 804), election and reply by applicant (MPEP § 818), and rejoinder of nonelected inventions (MPEP § 821.04) generally applies to national stage applications submitted under 35 U.S.C. 371.
MPEP 1896, titled “The Differences Between a National Application Filed Under 35 U.S.C. 111(a) and a National Stage Application Submitted Under 35 U.S.C. 371”, recites in part:
III. UNITY OF INVENTION
U.S. national applications filed under 35 U.S.C. 111(a) are subject to restriction practice in accordance with 37 CFR 1.141 -1.146. See MPEP § 803. U.S. national stage applications are subject to unity of invention practice in accordance with 37 CFR 1.475 and 1.499. See MPEP § 1893.03(d).
MPEP 1893.03(d), titled “Unity of Invention”, recites in part:
Examiners are reminded that unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371. Restriction practice in accordance with 37 CFR 1.141 -1.146 continues to apply to U.S. national applications filed under 35 U.S.C. 111(a), even if the application filed under 35 U.S.C. 111(a) claims benefit under 35 U.S.C. 120 and 365(c) to an earlier international application designating the United States or to an earlier U.S. national stage application submitted under 35 U.S.C. 371.
A careful comparing and contrasting of US restriction practice for 111(a) applications (37 CFR 1.141-1.146 as described in MPEP chapter 800) and Unity of Invention analysis for 371 applications (37 CFR 1.499 as described in MPEP 1893.03(d)) reveals that search and/or examination burden –while part of US restriction practice– is not part of Unity of Invention analysis.
Since this application is a 371 application (see filing receipt dated 1/2/2026), Applicant’s argument that “examination of all claims together places no undue burden on the Examiner” is irrelevant. Even if, for argument’s sake, search and/or examination burden was relevant, Applicant’s argument appears to be merely a conclusory statement lacking any evidenced reasoning in support thereof (i.e., Applicant does not state why/how they came to such conclusion). Applicant’s argument is therefore not found to be persuasive.
Otherwise, the traversal itself (irrespective of the aforementioned argument) appears to be moot since the Applicant, by their own actions, has withdrawn the unelected claims from consideration/examination (see claim amendment dated 5/7/2026 which has changed the status identifiers of claims 10, 13-33, 49, and 50 to “Withdrawn”).
The restriction/election requirement is still deemed proper and is therefore made FINAL.
Specification
The amendment to the Specification filed 3/21/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
“This application is a National Stage Entry of International Application No. PCT/EP2023/076102, filed September 21, 2023, which claims priority to United Kingdom Patent Application No. 2213953.9, filed September 23, 2022. The disclosures of the priority applications are hereby incorporated in their entirety by reference.”
(emphasis added)
This statement is being interpreted as incorporating by reference the aforementioned UK application. This statement is considered new matter for the following reason(s) below:
MPEP 608.01(p), I. B. recites in part:
As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211 et seq. where domestic benefit is claimed. See MPEP §§ 213 - 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).
As stated above in the MPEP, for the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)).
The incorporation by reference statement was filed as an amendment dated 3/21/2025. So, what is the filing date of the application? Was the amendment filed on the on the filing date or was it filed after the filing date? In order words, was the Application filed before 3/21/2025 or not?
MPEP 1893.03(b) recites in part:
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
National stage applications are ordinarily taken up for action based on the date of entry into the national phase. See MPEP § 1893.01 regarding entry into the national stage. Because the date of entry is dependent upon receipt of certain items required under 35 U.S.C. 371(c), this date is also referred to as the "371(c) date." The 371(c) date, not the international filing date, is the date that appears in the "Filing or 371(c) Date" box on the filing receipt and the application data sections of the Patent Data Portal and private PAIR.
In other words, the filing date of a national stage application submitted under 35 USC 371 (often informally called “371 application”) is the international filing date, not the 371(c) date.
In this case, the instant application (19/114,363) is a 371 application. The filing date of the 371 application is the international filing date (in this case, 9/21/2023); i.e., the filing date of the instant application is 9/21/2023 (not 3/21/2025).
The amendment to the Specification (which includes an incorporation by reference statement) was filed after the filing date – because 3/21/2025 is after 9/21/2023. Since the amendment to the Specification –which includes an incorporation by reference statement– was filed after the filing date, the amendment to the Specification is considered to contain new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Note: In retrospect, what the Applicant should have done was include the incorporation-by-reference statement of the UK application in the application as originally filed on 9/21/2023 (i.e., at the time the international application was filed) instead of waiting until the national stage thereof to file such an amendment.
Note: Moving forward for this application, it is noted that any portion of the Specification/Drawings of the UK application (GB 2213953.9) that may have been inadvertently omitted from the instant application may be amended into the instant application provided the amendment is done so in accordance with 37 CFR 1.57(b) (see MPEP 217) and any other applicable regulation/law governing amendments (e.g., 37 CFR 1.121, etc.).
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duval et al., US 2021/0236192 A1 (hereinafter “Duval”).
Duval discloses an apparatus for sensing a condition or type of biological tissue, the apparatus comprising:
a control circuit (collectively 101 and 102 which includes processor 104, diagnostic sensing logic 107, and therapy process logic 108, Fig. 1), wherein the control circuit comprises an electrical connection for delivering electrical signals to the biological tissue (implied from the functions below), and wherein the control circuit is adapted to:
deliver an electrical signal to the biological tissue for an active time period (see steps 210, 212, and 214, Fig. 4; ¶ [0057]-[0060])
obtain a charge measurement of an amount of charge stored in the biological tissue in response to the electrical signal during a sampling period after the active time period (see steps 214, 204, 206, Fig. 4; ¶ [0059]-[0062]; further, Duval considers measuring electric charge, ¶ [0043]).
Allowable Subject Matter
Claims 2-9, 11, and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2: Within the context of the invention of claim 1, the prior art of record does not teach or reasonably suggest to the ordinarily skilled artisan that the control circuit comprises a switching unit adapted to switch the control circuit between a plurality of operation modes, the plurality of operation modes comprising:
an active mode, wherein the electrical connection is connected to an electrical signal source during the active time period; and
a floating mode, wherein the electrical connection is connected to a sensing ground during the sampling period, thereby obtaining the charge measurement.
For example, Duval teaches the invention of claim 1 as discussed above (see rejection under §102 above) but does not teach switching between the active and floating modes as specifically recited in claim 2.
Other Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Collins et al., US 2009/0082765 A1
Conclusion
This application is not in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
28 May 2026
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