Prosecution Insights
Last updated: April 19, 2026
Application No. 18/896,569

APPARATUS AND METHOD TO MONITOR INTRACRANIAL ALTERATIONS IN PATIENTS

Non-Final OA §112
Filed
Sep 25, 2024
Examiner
MCDONALD, JAMES F
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Valley Children'S Healthcare
OA Round
1 (Non-Final)
55%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 55% of resolved cases
55%
Career Allow Rate
42 granted / 76 resolved
-14.7% vs TC avg
Strong +44% interview lift
Without
With
+44.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
33 currently pending
Career history
109
Total Applications
across all art units

Statute-Specific Performance

§101
5.1%
-34.9% vs TC avg
§103
41.5%
+1.5% vs TC avg
§102
19.4%
-20.6% vs TC avg
§112
32.1%
-7.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 76 resolved cases

Office Action

§112
DETAILED ACTION 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 II (claims 10, 12-13 and 15 as amended) in the reply filed on 11/4/2025 is acknowledged. The traversal is on the ground(s) that there is no undue search burden as elements of elected Group II are common to Groups I and III. This is not found persuasive because the independent claims 1, 10 and 16 are pointed to divergent subject matter. As provided in the requirement for restriction/election filed 9/4/2025: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. The requirement is still deemed proper and is therefore made FINAL. Applicants request for rejoinder of non-elected claims upon allowance of elected claims is acknowledged. As previously noted, the examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Drawings The drawings are objected to because figure 4 uses the reference “R1” to represent resistors with different values 2Ω and 8Ω. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Additionally, the drawings are objected to because, according to MPEP 608.02 and 67 CFR 1.84, "India ink, or its equivalent that secures solid black lines, must be used for drawings". Drawings should be presented as India ink drawings unless the illustration is not capable of being accurately or adequately depicted by India ink drawings. Figures 1 and 7A-8B are objected to for this rationale. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim(s) 10, 12-13 and 15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim(s) 12-13 and 15 are rejected at least by virtue of dependency upon a rejected base claim. Claim 10 recites the limitation "a system comprising: at least one of a monitor and an alarm device; and a controller communicatively connected to the transmitter transducer and the receiver transducer and at least one of the monitor and the alarm device […] automatically predicting with an appropriately programmed processor having instructions to perform the steps of:", which renders the claim indefinite. First, it is unclear if the ‘controller’ and the ‘processor’ are the same device, separate devices, if the ‘processor’ is comprised within the ‘controller’, etc. Furthermore, the ‘system’ merely requires one of either a ‘monitor’ or the ‘alarm device’; in the interpretation that the ‘system’ only comprises the ‘monitor’, it is not clear how the ‘alarm’ is provided by the system. It is suggested to amend the claim to indicate the relationship between the ‘system’, ‘controller’ and ‘processor’ (e.g., the system comprises a processor, the controller comprising a processor, etc.) and to remove the ‘at least one of’ language to definitively claim the ‘monitor’ and ‘alarm device’ structures as part of the ‘system’. It is also suggested to clarify what type of ‘monitor’ is being claimed to distinguish from the ‘patient being monitored’ language – in distinct interpretations the ‘monitor’ may be either a display screen for presenting information to a user, or the ‘monitor’ may be a patient monitoring device configured to collect and interpret medical data from a patient. For the purposes of examination the broadest reasonable interpretation of the claim language – including those discussed above – is applied to the limitations. Claim 10 further recites the limitations “comparing the measured intracranial blood velocity with a reference lookup table correlating intracranial blood velocity with intraocular pressure recorded from a matched patient having intraocular pressure within the normal range associated with […]”, which renders the claim indefinite. There is insufficient antecedent basis for these limitations in the claim. In particular, it is not clear what ‘the measured intracranial blood velocity’ or ‘the normal range’ are specifically referring to, as there has neither been a ‘measurement’ method step by which intracranial blood velocity is derived nor a recitation/definition of a ‘normal range’ for intraocular pressure. It is suggested to amend the claim to include the required method steps and recitations or to particularly point out what the ‘the measured intracranial blood velocity’ or ‘the normal range’ are specifically referring to. For the purposes of examination the broadest reasonable interpretation of the claim language is applied to the limitations. Claim 12 recites the limitation “wherein the transducer array comprises a transmitter transducer for transmitting an ultrasound beam and a receiver transducer for receiving an echo signal” which renders the claim indefinite. There is insufficient antecedent basis for these limitations in the claim. In particular, it is not clear what the “transmitter transducer” and “receiver transducer” are specifically referring to. In an interpretation the “transmitter transducer” and “receiver transducer” may refer to the ‘transducers’ introduced in claim 10, and in another interpretation they may be new distinct ‘transducers’ separate from what has already been claimed. It is suggested to amend the claim to clarify what the “transmitter transducer” and “receiver transducer” are specifically pointing to, or to cancel the instant claim 12. For the purposes of examination the broadest reasonable interpretation of the claim language – including those discussed above – is applied to the limitations. Allowable Subject Matter Claim(s) 10, 12-13 and 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. Claims 13 and 15 are allowable at least by virtue of dependency upon an allowed base claim. As noted in the election/restriction requirement, the non-elected apparatus’ claimed in inventive Groups I and III are directed to divergent subject matter from the elected method of Group II. To be considered for rejoinder the Groups I and III must be amended in line with the allowable subject matter provided in the Group II. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to James F. McDonald III whose telephone number is (571)272-7296. The examiner can normally be reached M-F; 8AM-6PM EST. 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, Chris Koharski can be reached at 5712727230. 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. JAMES FRANKLIN MCDONALD III Examiner Art Unit 3797 /JOEL LAMPRECHT/ Primary Examiner, Art Unit 3798
Read full office action

Prosecution Timeline

Sep 25, 2024
Application Filed
Nov 04, 2025
Response after Non-Final Action
Jan 07, 2026
Non-Final Rejection — §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
55%
Grant Probability
99%
With Interview (+44.3%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 76 resolved cases by this examiner. Grant probability derived from career allow rate.

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