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 .
Amendment Entered
In response to the amendment filed on 12/18/2025 , amended claim 1 is entered. Claims 1 – 21 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification and drawings have been fully considered and overcome each and every objection and rejection previously set forth in the Non-Final Office Action mailed 06/18/2025.
The objections and rejections under 35 U.S.C. 112(b) regarding claim1 2 and 14 are withdrawn in view of amendments to claim 1 (see pg. 19 of remarks).
The objections and rejections under 35 U.S.C. 112(b) regarding claims 2 and 14 are withdrawn in view of applicants arguments regarding “and/or” (see pg. 19 of remarks).
Additionally, Examiner acknowledges applicant’s note regarding interpretation of limitations in claims 1-3, 7, 9, and 12 under 35 USC 112(f) previously set forth in the Non-Final Office Action mailed 06/18/2025 (see pg. 11 of remarks).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/18/2025 have been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, and all claims dependent thereon, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a decryption unit, configured to de-identify the pressure-related digital data for sensitive information, resulting in de-identified pressure-related digital data” in lines 13-14. Applicant has not pointed out where this claim limitation is supported, nor does there appear to be a written description of the claim limitation “a decryption unit, configured to de-identify the pressure-related digital data for sensitive information, resulting in de-identified pressure-related digital data ” in the application as filed. No support is provided in the description or figures of the disclosure regarding what is decrypting the sensitive information of the pressure-related signal data is de-identified, or structural and functional equivalents of such methods. What structural component of the invention is de-identifying the pressure-related digital data? The lack of written description leads Examiner to interpret the claim limitation of “a decryption unit, configured to de-identify the pressure-related digital data for sensitive information, resulting in de-identified pressure-related digital data” as any structure capable of identifying pressure related data and identifying sensitive information.
Claim 2 recites “an identifier unit configured to receive the de-identified pressure-related digital data” in lines 3-4.Applicant has not pointed out where these claim limitation are supported, nor does there appear to be a written description of the above recited claim limitations in the application as filed. No support is provided in the description or figures of the disclosure regarding what structure is receiving de-identified pressure signals and identifying single pressure waves related to cardiac beat induced waves, or structural and functional equivalents of such methods. The lack of written description leads Examiner to interpret the claim limitation of “an identifier unit configured to receive the de-identified pressure-related digital data from the second transfer unit and identify single pressure waves related to cardiac beat-induced pressure waves from the de-identified pressure-related digital data”, as any structure capable of receiving digital data, and identifying data.
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.
Claims 1-3, 7, and 9 recite limitations invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structures, materials, or acts for performing the entire claimed functions and to clearly link the structures, materials, or acts to the functions.
Claim 1 recites “a decryption unit, configured to de-identify the pressure-related digital data for sensitive information, resulting in de-identified pressure-related digital data” in lines 13-14. The disclosure fails to disclose any structure that performs the claimed function of de-identifying the pressure-related digital data for sensitive information, rendering the scope of the claim unclear.
Claim 1 further recites “an analyzer unit configured to analyze the de-identified pressure-related digital data” in lines 19-20. The disclosure fails to disclose sufficient structure for performing the claimed function of analyzing the de-identified pressure-related digital data. The specification discloses a pressure analyzer unit having an outlet and an information providing device (see [0443]). However, it is unclear how the disclosed structure performs the function of analyzing the de-identified pressure-related digital data.
Claim 2 recites “an identifier unit configured to receive the de-identified pressure-related digital data from the second transfer unit and identify single pressure waves related to cardiac beat-induced pressure waves from the de-identified pressure-related digital data” in lines 3-5. The disclosure fails to disclose any structure that performs the claimed function of receiving de-identified pressure-related digital data and identifying single pressure waves related to cardiac beat-induced pressure waves from the de-identified pressure related data, rendering the scope of the claim unclear.
Claim 2 further recites “a computing device…configured to compute one or more of delta single pressure wave (dSW.x)-related parameters…” in lines 9-10. The structure disclosed in the specification for performing the claimed function, as identified above (computer system), does not appear to be linked to the claimed function of computing delta single pressure wave related parameters. This renders the scope of the claim unclear, as there is ambiguity regarding what structure is performing these computations.
Claim 2 further recites “wherein a calculation unit…configured to calculate pressure stability levels (SW.x.PSL)…” in lines 14-15. The structure disclosed in the specification for performing the claimed function, as identified above (computer system), does not appear to be linked to the claimed function of calculating pressure stability levels. This renders the scope of the claim unclear, as there is ambiguity regarding what structure is performing these calculations.
Claim 2 further recites “wherein a determination unit…configured to determine pressure differences (SW.x.PSL.PD) between different pressure stability levels (n-i;n) (SW.x.PSL)” in lines 22-24. The structure disclosed in the specification for performing the claimed function, as identified above (computer system), does not appear to be linked to the claimed function of determining pressure differences between different pressure stability levels, rendering the scope of the claim unclear.
Claim 3 recites “wherein a correction unit…configured to correct mean pressure (SW.meanP) levels related to the baseline pressure instability as a function of the pressure differences between different pressure stability levels (SW.x.PSL.PD…” in lines 1-4. The structure disclosed in the specification for performing the claimed function, as identified above (computer system), does not appear to be linked to the claimed function of correcting mean pressure levels using a function of pressure differences, rendering the scope of the claim unclear. Furthermore, regarding the limitation “…wherein the correction unit is configured to present the corrected mean pressure” recited in line 6, the specification fails to disclose that the identified structure (computer system) performs the claimed function of presenting the corrected mean pressure, rendering the scope of the claim unclear.
Claim 7 recites “wherein the third transfer unit is configured to route the analysis output from the analyzer unit to a database unit, and to a correction unit, before transmitting the analysis output to the output unit” in lines 1-3. The structure disclosed in the specification for performing the claimed function, as identified above (wireless communication), does not appear to be linked to the claimed function of routing the analysis output from the analyzer unit to a database unit and a correction unit before transmitting the analysis output to the output unit. This renders the scope of the claim unclear, as there is ambiguity regarding how the identified structure (i.e., wireless communication) can perform both routing and transmission.
Claim 9 recites “wherein the analyzer unit…configured to perform a simultaneous analysis of multiple continuous pressure signals from a plurality of pressure sensors and pressure transducer systems…” in lines 1-3. The structure disclosed in the specification for performing the claimed function, as identified above (computer system), does not appear to be linked to the claimed function of performing simultaneous analysis of multiple pressure signals from a plurality of pressure sensors and transducer systems, rendering the scope of the claim unclear.
Therefore, the identified claims (1-3, 7, and 9) are indefinite and are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-2, 13-14, and all claims dependent thereon, 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.
Claims 1 and 13 recite, inter alia, “a decryption unit, configured to de-identify the pressure-related digital data for sensitive information, resulting in de-identified pressure-related digital data” in lines 13-14 and 9-10 respectively. The content of the claims has not made it clear what “sensitive information” is referring to within the scope of the claims. There appears to be a disconnect between “decryption” and “de-identification”, as it relates to “sensitive information”
It would appear, according to the specification ([0637]) that “sensitive information” includes information related to patient identification, or information regarding data of a pressure recording, or time of a pressure recording. However, it is unclear how a de-identification of sensitive information is occurring, when an identification of sensitive information has not occurred.
Response to Arguments
Applicant's arguments filed 12/18/2025 with respect to the rejection of claims 1-2 under 35 U.S.C §112(a) have been fully considered but they are not persuasive.
Applicant argues that the “decryption unit”, as recited in claim 1, is recited in the specification as part of remote processing unit 2415, further citing portions of the disclosure providing exemplary processing implementations (see pg. 12-13 of remarks).
Examiner respectfully disagrees with this line of argument. While Examiner acknowledges that a decryption unit is recited in the specification as filed, as recited in claim 1, it is unclear whether the “decryption unit” is part of the remote processing unit as applicant argues (see pg. 12 of remarks), or it’s own structural entity. Applicant has not explicitly stated that the features recited in claim 1 are separate physical entities, or merely parts of a processing system. No support is provided in the description or figures of the disclosure regarding what physical structure is decrypting the sensitive information of the pressure-related signal data is de-identified, or structural and functional equivalents of such methods. Therefore, the rejection of claim 1 under 35 U.S.C. 112(a) is maintained.
Applicant argues that the “identification unit”, as recited in claim 2, is recited in the specification as part of remote processing unit 2415, further citing portions of the disclosure providing exemplary processing implementations (see pg. 13-14 of remarks).
Examiner respectfully disagrees with this line of argument. While Examiner acknowledges that an identification unit is recited in the specification as filed, as recited in claim 2, it is unclear whether the “identification unit” is part of the remote processing unit as applicant argues (see pg. 14 of remarks), or its own structural entity. Applicant has not explicitly stated that the features recited in claim 2 are separate physical entities, or merely parts of a processing system. No support is provided in the description or figures of the disclosure regarding what structure is receiving de-identified pressure signals and identifying single pressure waves related to cardiac beat induced waves, or structural and functional equivalents of such methods. Therefore, the rejection of claim 2 under 35 U.S.C. 112(a) is maintained.
Applicant's arguments filed 12/18/2025 with respect to the rejection of claims 1-3, 7, 9, 13, and 14 under 35 U.S.C §112(b) have been fully considered but they are not persuasive.
Regarding the rejection of claims 1-3, 7, and 9 for insufficient structure under 35 U.S.C. 112(f) interpretation (see pg. 14-17 of remarks), applicant argues that cited figures and associated portions of text provide additional details of various aspects of the identified limitations being interpreted under 35 U.S.C. 112(f). This argument is not considered persuasive, because the disclosure fails to disclose structures that perform the entire claimed functions of the identified limitations (see pg. 14-17 of remarks),rendering the scopes of the claims unclear. Therefore, the rejection of claims 1-3, 7, and 9 under 35 U.S.C. 112(b) is maintained.
Regarding the rejection of claims 1 and 13, reciting decryption and de-identification of sensitive information, applicant argues that “sensitive information”, “decryption” and “de-identification” are clear to one of ordinary skill in the art (see pg. 19 of remarks). In particular, applicant argues that Examiner’s interpretation involves the breadth of claim terms rather than indefiniteness (see pg. 18 of remarks), further citing portions of the specification.
Examiner respectfully disagrees with this line of argument. Examiner acknowledges applicant’s description of “sensitive information” as provided in [0328] of the specification (see pg. 18 of remarks). However, it is still unclear how a decryption unit is de-identifying sensitive information, if the identification of sensitive information has not been positively recited in the claims. This renders the scope of the claims unclear, as there is ambiguity regarding how applicant intends to de-identify sensitive information that has not been identified. Therefore, the rejection of claims 1 and 13 under 35 U.S.C. 112(b) is maintained.
Applicant’s arguments, filed 12/18/2025, with respect to the rejection of claims 1-21 under 35 U.S.C §103 (see pg. 19-27 of remarks) have been fully considered and are persuasive. The rejection of claims 1-21 under 35 U.S.C. 103 as being unpatentable over US 2007/0276263 A1 to Eide in view of US 2022/0257136 A1 to Hu et al. (“Hu”) has been withdrawn.
Allowable Subject Matter
Claims 1 and 13 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 2-12 and 14-21 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA P NOVAK whose telephone number is (703)756-1947. The examiner can normally be reached M-F: 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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