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 .
Response to Amendment
The response filed on 3/20/2026 is not in conformance with the Office’s rules and regulations regarding claim amendments. In particular, some of the deletions of one or two characters were done with a strikethrough, for example, the semicolon in claim 1, line 19, the “a” in claim 4, line 2, the “a” in claim 5, line 2, the semicolon in claim 6, line 2, the “a” in claim 6, line 3, the “a” in claim 6, line 4, the “a” in claim 6, line 17, the “3” in claim 7, line 1, and the “1” in claim 8, line 1. The Applicant should be mindful that such deletions are very difficult to see. The Applicant should use double brackets to delete characters of five characters or less. Also, some words have both strike-through indicating deletions and underlines indicating additions, which is improper. For example, “” in claim 6, line 12 and “” in claim 9 line 2. The words will be treated as existing in the claim language. In an effort to continue prosecution, the amendments have been entered, but the Applicant should be mindful of the proper format for making amendments.
Specification
The abstract of the disclosure is objected to because of improper grammar. In particular the recitation “A method and apparatus that non-invasively measures and monitors intraorbital pressure waves and intracranial pressure waves in humans.” in lines 1-3 is not a complete sentence because it lacks a predicate. The expression should read “A method and apparatus [[that]] non-invasively measures and monitors intraorbital pressure waves and intracranial pressure waves in humans”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
the sealing component in claim 1; and
the control unit in claim 1 and/or claim 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
For example, structure of the sealing structure in claim 1 is disclosed in paragraph 0038 of the specification. Also, the structure of the control unit of claim 1 and/or claim 6 is a display (paragraph 0008 of the specification).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 6, 8, 10-17 are objected to because of the following informalities:
in claim 1, line 13: “the” should be inserted before “intraorbital pressure waves”;
in claim 1, line 16: “the” should be inserted before “pressure wave measurement signals”;
in claim 6, line 13: “the” should be inserted before “intraorbital pressure waves”;
in claim 6, line 14: “the” should be inserted before “pressure wave measurement signals”;
in claim 6, line 15: “the” should be inserted before “pressure wave measurement data “;
in claim 8, line 1: the comma after “wherein” should be deleted;
in claim 10, line 1: the comma after “wherein” should be deleted;
in claim 11, line 1: the comma after “wherein” should be deleted;
in claim 12, line 1: the comma after “wherein” should be deleted;
in claim 13, line 1: the comma after “wherein” should be deleted;
in claim 14, line 1: the comma after “wherein” should be deleted;
in claim 15, line 1: the comma after “wherein” should be deleted;
in claim 16, line 1: the comma after “wherein” should be deleted; and
in claim 17, line 1: the comma after “wherein” should be deleted.
Appropriate correction is required.
Claim Rejections - 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.
Claims 1-19 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 1 recites “a pressure meter” in line 14, but it is not clear if this recitation is the same as, related to, or different from “a pressure meter” of claim 1, line 6. If they are the same, “a pressure meter” in line 14 should be “the pressure meter”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 1 recites “the control unit being configured to record and store the pressure wave measurement data received from the pressure meter” in lines 18-19, but paragraph 0008 of the specification discloses that the control includes a display and no other structure. It is not clear how the control unit can perform the functions of recording and storing when it only comprises a display.
Claims 2-19 are rejected by virtue of their dependence from claim 1.
Claim 5 depends from claim 43, which does not exist. A claim that depends from a non-existent claim is indefinite since metes and bounds of such a claim cannot be determined. For the purposes of examination, claim 5 will be interpreted so as to depend from claim 1.
Claim 5 recites “the intracranial pressure (ICP) brain wave of the patient” in lines 1-2 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “the non-compressible media volume in the bladder” in lines 6-7 and “the non-compressible media volume in the bladder” in line 9, but it is not clear if these recitations are the same as, related to, or different from “a volume of the media to the bladder” of claim 1, line 9. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the non-compressible media volume in the bladder” in claim 6.
Claim 6 recites “the non-compressible media pressure in the bladder” in line 81, but it is not clear if this recitation is the same as, related to, or different from “pressure of media to the bladder” of claim 1, lines 10-11. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Also, if they are different, there is insufficient antecedent basis for “the non-compressible media pressure in the bladder” in claim 6.
Claim 6 recites “the air” in line 9 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites “bladderpressure waves in the bladder” in line 12, but it is not clear if this recitation is the same as, related to, or different from “pressure waves in the bladder” in claim 1, line 12. If they are the same, “bladderpressure waves in the bladder” in line 12 should be “the pressure waves in the bladder”. If they are different, their relationship should be made clear.
Claim 6 recites “recording and storing the pressure wave measurement data in the control unit” in line 16, but paragraph 0008 of the specification discloses that the control includes a display and no other structure. It is not clear how the control unit can perform the functions of recording and storing when it only comprises a display.
Claim 6 recites “pressure wave changes” in line 17, but it is not clear if this recitation is the same as, related to, or different from “the pressure wave measurement data” of claim 1, line 20. The relationship among these recitations should be made clear.
Claims 7-14 and 18-19 are rejected by virtue of their dependence from claim 6.
Claim 11 recites “a pulse wave” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “intraorbital pressure waves” of claim 1, line 2, “pressure waves in the bladder” in claim 1, line 12, and/or “bladderpressure waves in the bladder” of claim 6, line 12. If it is different from these recitations, it is not clear where this pulse wave comes from. Clarification is required.
Claim 12 recites “the waves displayed by the control unit” in line 1, but it is not clear if this recitation is the same as, related to, or different from “the pressure wave measurement data” of claim 1, line 20 and/or “pressure wave changes” of claim 6, line 17. The relationship among these recitations should be made clear. If they are different, there is insufficient antecedent basis for “the waves displayed by the control unit” in claim 12.
Claim 13 recites “the waves displayed by the control unit” in line 1, but it is not clear if this recitation is the same as, related to, or different from “the pressure wave measurement data” of claim 1, line 20 and/or “pressure wave changes” of claim 6, line 17. The relationship among these recitations should be made clear. If they are different, there is insufficient antecedent basis for “the waves displayed by the control unit” in claim 13.
Claim 13 recites “the intracranial pressure [waves] of the patient” in lines 1-2, which is indefinite. First, the meaning of the brackets around “waves” is not clear. Is the word “waves” intended to be part of the expression or not? In either case, there is insufficient antecedent basis for “the intracranial pressure…of the patient” or “the intracranial pressure waves of the patient” in the claim.
Claim 17 recites “a pulse wave” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “intraorbital pressure waves” of claim 1, line 2 and/or “pressure waves in the bladder” in claim 1, line 12. If it is different from these recitation, it is not clear where this pulse wave comes from. Clarification is required.
Claim 18 recites “there non-compressible media pressure in the bladder is not modified by the pump” in lines 1-2, which is so grammatically awkward that its meaning is not clear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 depends from claim 43, which does not exist. Dependence from a non-existent clam is improper.
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.
Claims 1-9, 12-13, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0279877 (Berdahl)(previously cited), in view of U.S. Patent Application Publication No. 2009/0287084 (Ragauskas)(previously cited), further in view of U.S. Patent No. 4,628,938 (Lee)(previously cited), and further in view of U.S. Patent Application Publication No. 2003/0078486 (Klein)(previously cited).
Berdahl teaches an apparatus for non-invasive measurement and monitoring of intraorbital pressure waves of a patient comprising:
a pressure applicator (the goggle enclosure 210 of FIGS. 3-4 of Berdahl);
a pressure sensor (the cavity pressure sensors 5081 of Berdahl);
a sealing component (the seal material 214 of Berdahl) extending and connected to the pressure applicator configured to hermetically seal the pressure applicator around the patient’s eye (paragraph 0065 of Berdahl);
a pump (the pump 220 of Berdahl); and
a display (the user interface of Berdahl) connected to the control unit (the control circuitry 230 of Berdahl) configured to display the pressure measurement data.
Berdahl teaches the use of a cavity 212 within the goggle enclosure 210 to which positive pressure is applied to the eye (paragraphs 0055, 0066, 0075-0076, 0078, 0143-0144, and 0177 of Berdahl). Ragauskas teaches the use of an inner flexible member 32 that conforms to the shape of the eye (paragraphs 0025-0026 of Ragauskas). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include an inner flexible member 32 that conforms to the shape of the eye at the interface between the enclosure of Berdahl and the patient since it provides a level of comfort or protection to the patient’s ocular regions during the application of positive pressure.
Lee teaches the use of water as a suitable medium when inflating a bladder for the application of pressure to the subject’s ocular regions (col. 5, lines 40-60 of Lee). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use water as the pressurizing medium of the combination since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it provides more stable readings since the volume of a fluid does not change with increased pressure.
Berdahl teaches a pressure sensor (the cavity pressure sensors 5081 of Berdahl). Klein teaches that such pressure sensors are placed inside the chamber to which pressure is measured (paragraph 0119 and FIG. 8 of Klein). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the cavity pressure sensor of Berdahl in the bladder of the combination since a placement of the pressure sensor is required and Klein teaches one such placement.
Berdahl teaches the depiction of waveforms in FIG. 1B of Berdahl and the use of a user interface for a display (paragraph 0086 of Berdahl). Ragauskas teaches that determined pressures, such as ICP, are displayed so as to monitor the values of the parameter (paragraphs 0031 and 0034 of Ragauskas). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to display the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl since it permits medical professionals and patients to monitor the values of these parameters.
With respect to claim 1, the combination teaches or suggests an apparatus for non-invasive measurement and monitoring of intraorbital pressure waves of a patient comprising:
a pressure applicator (the goggle enclosure 210 of FIGS. 3-4 of Berdahl) with a bladder (the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas); the bladder comprising an elastic, film (the inner flexible member 32 of Ragauskas) filled with a non-compressible media (the water of Lee), positioned on an exterior of the pressure applicator;
a pressure sensor (the cavity pressure sensors 5081 of Berdahl) inside the bladder (the placement suggested by Klein) connected to a pressure meter (the data interface of Berdahl; paragraphs 0009, 0086, 0089, 0094, 0116, 0194, 0212-0214, and 0226 of Berdahl);
a sealing component (the seal material 214 of Berdahl) extending and connected to the pressure applicator configured to hermetically seal the pressure applicator around the patient’s eye (paragraph 0065 of Berdahl);
a pump (the pump 220 of Berdahl) connected to the bladder (the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas) to control and adjust a volume of the media to the bladder; the pump also being connected to a control unit (the CPU and user interface of the control circuit of Berdahl) for controlling the volume and pressure of media to the bladder (paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl); the pressure sensor being configured to measure pressure waves in the bladder, the pressure waves in the bladder being generated by intraorbital pressure waves of the patient, and to send pressure wave measurement signals to a pressure meter (paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl; FIG. 1B of Berdahl suggests the waveform nature of the pressure readings);
the pressure meter (the data interface of Berdahl) being connected the control unit (the CPU and user interface of the control circuit of Berdahl) and being configured to receive pressure wave measurement signals from the pressure sensor and transmit pressure wave measurement data to the control unit (paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl);
the control unit being configured to record and store the pressure wave measurement data received from the pressure meter (paragraphs 0123, 0129, and 0187 of Berdahl) and to display the pressure wave measurement data (paragraphs 0047, 0086 and 0123 of Berdahl; FIG. 1B of Berdahl; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 2, the combination teaches or suggests that the media is water (the water of Lee) and the pump is a water pump (the pump 220 of Berdahl used with water).
With respect to claim 3, the combination teaches or suggests that the pressure wave measurement data is displayed in wave form (the IOC and ICP measurements over time are in wave form; paragraph 0047 and FIG. 1B of Berdahl; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 4, the combination teaches or suggests that the wave form displayed is an extracranial orbital pressure wave of the patient (the orbital pressures over time; paragraphs 0047, 0057, 0100, 0107, 0120-0121, 0214, and 0248 and FIG. 1B of Berdahl; the display of the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 5, the combination teaches or suggests that the wave form displayed is the intracranial pressure (ICP) brain wave of the patient (the ICP measurements over time; paragraphs 0047, 0057, 0100, 0107, 0120-0121, 0214, and 0248 and FIG. 1B of Berdahl and FIG. 1B of Berdahl; the display of the ICP pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 6, the combination teaches or suggests a method for non-invasive measurement and monitoring of intraorbital pressure waves of a patient using the apparatus of claim 1 (see the rejection of claim 1) comprising:
applying the pressure applicator to a closed eyelid of the patient (the device is applied to a closed eyelid in FIGS. 3-4 of Berdahl);
sealing the bladder of the pressure applicator to an orbital area of the patient (using the seal material 214 of Berdahl; paragraph 0065 of Berdahl);
pumping the non-compressible media into the bladder to increase the non-compressible media volume in the bladder (using the pump 220 of Berdahl to inflate the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas; paragraphs 0009, 0088, 0117, 0146-0150, 0206-0208, 0212, and 0246 of Berdahl);
measuring the non-compressible media pressure in the bladder (using the cavity pressure sensors 5081 of Berdahl over periods of time; paragraphs 0009, 0076-0082, 0084, 0086, 0089, 0094, 0116, 0135, 0194, 0212-0214, and 0226 of Berdahl);
increasing the non-compressible media volume in the bladder until all the air is forced out from beneath the seal (using the pump 220 of Berdahl to inflate the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas until the membrane impacts the eyelid completely as suggested by FIG. 2 of Ragauskas) and the pressure applicator is hermetically sealed to the orbital area of the patient (the sealing of Berdahl; paragraph 0065 of Berdahl);
measuring bladderpressure waves in the bladder, the pressure waves in the bladder being generated by intraorbital pressure waves of the patient (using the cavity pressure sensors 5081 of Berdahl; paragraphs 0009, 0086, 0089, 0094, 0116, 0194, 0212-0214, and 0226 of Berdahl; FIG. 1B of Berdahl suggests the waveform nature of the pressure readings);
transmitting pressure wave measurement signals from the sensor to the pressure meter (transmitting the pressure data from the cavity pressure sensors to the data interface of Berdahl; paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl);
transmitting pressure wave measurement data from the pressure meter to the control unit (transmitting the pressure data from the data interface of Berdahl to the CPU and user interface of the control circuit of Berdahl; paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl);
recording and storing the pressure wave measurement data in the control unit (paragraphs 0047, 0086, 0123, 0129, and 0187 of Berdahl);
recording and displaying pressure wave changes in wave form with the control unit connected to the pressure sensor (the storage by the CPU and the display of the waveforms by the user interface; paragraphs 0009, 0047, 0086, 0090, 0116, 0118-0123, 0129, 0133, 0149, and 0187; FIG. 1B of Berdahl suggests the recording and display of how the pressure wave changes in time; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 7, the combination teaches or suggests that the non-compressible media is water (the water of Lee).
With respect to claim 8, the combination teaches or suggests that the pressure measurement data is recorded for at least 20 seconds (paragraph 0079 of Berdahl).
With respect to claim 9, the combination teaches or suggests that a second pressure applicator is applied to a second orbital area of the patient (FIG. 2 of Berdahl teaches two pressure applicators).
With respect to claim 12, the combination teaches or suggests that the waves displayed by the control unit are the intraorbital pressure waves of the patient (the display of the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 13, the combination teaches or suggests that the waves displayed by the control unit are the intracranial pressure [waves] of the patient (the display of the ICP pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas).
With respect to claim 15, the combination teaches or suggests that the media is a liquid or a gel (the water of Lee).
With respect to claim 19, the combination teaches or suggests that the media is a liquid or a gel (the water of Lee).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl, in view of Ragauskas, further in view of Lee, and further in view of Klein, and further in view of U.S. Patent Application Publication No. 2005/0197571 (McVeigh).
The combination teaches or suggests a pressure sensor (the cavity pressure sensors 5081 of Berdahl) and a control unit configured to record and store the pressure wave measurement data received from the pressure meter (paragraphs 0123, 0129, and 0187 of Berdahl) and to display the pressure wave measurement data (paragraphs 0047, 0086 and 0123 of Berdahl; FIG. 1B of Berdahl; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas). McVeigh teaches that to record intraocular pressure, a resolution of 0.01 mmHg is good for pressure readings (paragraph 0046 of McVeigh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the 0.01 mmHg pressure resolution for the pressure resolution of the readings of the combination since (1) a resolution is required and McVeigh teaches such a resolution and/or (2) it provides a high level of preciseness in the pressure readings.
With respect to claim 10, the combination suggests that the pressure sensor has a pressure resolution of less than 0.01 mmHg (the 0.01 mmHg resolution of McVeigh; MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”).
With respect to claim 16, the combination suggests that the pressure sensor has a pressure resolution of less than 0.01mm Hg (the 0.01 mmHg resolution of McVeigh; MPEP 2144.05: “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”).
Claims 10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl, in view of Ragauskas, further in view of Lee, and further in view of Klein, and further in view of U.S. Patent Application Publication No. 2005/0197571 (McVeigh) and U.S. Patent Application Publication No. 2009/0299216 (Chen).
The combination teaches or suggests a pressure sensor (the cavity pressure sensors 5081 of Berdahl) and a control unit configured to record and store the pressure wave measurement data received from the pressure meter (paragraphs 0123, 0129, and 0187 of Berdahl) and to display the pressure wave measurement data (paragraphs 0047, 0086 and 0123 of Berdahl; FIG. 1B of Berdahl; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas). McVeigh teaches that to record intraocular pressure, a resolution of 0.01 mmHg is good for pressure readings (paragraph 0046 of McVeigh). Also, Chen suggests that resolution can be optimized for IOP measurements since measurements can have a 1 mmHg resolution or better (paragraph 0011 of Chen). The pressure resolution would depend upon the factors of accuracy, computational speed and storage, and preciseness. As such, the pressure resolution is a results-effective variable that would have been optimized through routine experimentation based on the factors of accuracy, computational speed and storage, and preciseness. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the pressure resolution, using the 0.01 mmHG resolution of McVeigh as a starting point, so as to obtain the desired pressure resolution. Thus, the features of “wherein, the pressure sensor has a pressure resolution of less than 0.01 mmHg” of claim 10 and “wherein, the pressure sensor has a pressure resolution of less than 0.01mm Hg” of claim 16 would have been obvious.
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl, in view of Ragauskas, further in view of Lee, and further in view of Klein, and further in view of U.S. Patent Application Publication No. 2007/0276264 (Eide).
The combination teaches or suggests a pressure sensor (the cavity pressure sensors 5081 of Berdahl) and a control unit configured to record and store the pressure wave measurement data received from the pressure meter (paragraphs 0123, 0129, and 0187 of Berdahl) and to display the pressure wave measurement data (paragraphs 0047, 0086 and 0123 of Berdahl; FIG. 1B of Berdahl; the display of the ICP, the IOP, the orbital, and the intraorbital pressures of Berdahl on the user interface of Berdahl as suggested by Ragauskas). Eide teaches that for intracranial pressure, the amplitude is between 1.0 and 35.0 mmHg (paragraph 0063 of Eide). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the pressure sensor and the control unit be configured to measure pressures spanning at least between 1 to 35 mmHg since Berdahl teaches that ICP is determined and Eide what operational range this pressure resides.
With respect to claim 11, the combination teaches or suggests that the pressure sensor is configured to measure a pulse wave having an amplitude in the range of 1.0-2.0 mmHg (the operational range for ICP suggested by Eide).
With respect to claim 17, the combination teaches or suggests that the pressure sensor is configured to measure a pulse wave having an amplitude in the range of 1.0-2.0 mmHg (the operational range for ICP suggested by Eide).
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Berdahl, in view of Ragauskas, further in view of Lee, and further in view of Klein, and further in view of U.S. Patent No. 5,165,409 (Coan).
The combination teaches or suggests a bladder (the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas); the bladder comprising an elastic, film (the inner flexible member 32 of Ragauskas) filled with a non-compressible media (the water of Lee), positioned on an exterior of the pressure applicator and a pump (the pump 220 of Berdahl) connected to the bladder (the cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas) to control and adjust a volume of the media to the bladder; the pump also being connected to a control unit (the CPU and user interface of the control circuit of Berdahl) for controlling the volume and pressure of media to the bladder (paragraphs 0009, 0086, 0088-0090, 0116-0117, 0146-0150, 0194, 0202, 0206-0208, 0212-0214, 0226, and 0246 of Berdahl).
Coan teaches that low pressures such as 1, 2, 3, 4, 5 or any interval in between are suitable pressures applied to the ocular region (col. 15, lines 45-65 of Coan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the 1 mmHg pressure for the bladder pressure since (1) a pressure is required and Coan teaches one such pressure and/or (2) it is a simple substitution of one known element for another to obtain predictable results. Thus, the features of “the pumping of the non-compressible media into the bladder is stopped before the non-compressible media pressure in the bladder reaches 2 mmHg” of claim 14 would have been obvious.
Alternatively or additionally, Coan teaches that the pressure application is subject to change. The pressure application would depend upon the factors of patient comfort and measurement accuracy. As such, the pressure application is a results-effective variable that would have been optimized through routine experimentation based on the factors of patient comfort and measurement accuracy. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the pressure application, using the values of Coan as a starting point, so as to obtain the desired patient comfort and measurement accuracy. Thus, the features of “the pumping of the non-compressible media into the bladder is stopped before the non-compressible media pressure in the bladder reaches 2 mmHg” of claim 14 would have been obvious.
With respect to claim 18, Berdahl teaches that the pressure should be maintained in the cavity during the procedure (paragraphs 0065-0066, 0071, 0076-0077, 0079, and 0096 of Berdahl). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to not modify the non-compressible media pressure in the bladder until after the pressure waves in the bladder have been measured since it will reduce inconsistency and errors. Thus, the combination teaches or suggests that the non-compressible media pressure in the bladder is not modified by the pump until after the pressure waves in the bladder have been measured (the maintenance of pressure during measurements suggested by Berdahl).
Response to Arguments
The Applicant’s arguments filed on 3/20/2026 have been fully considered.
Specification
The Applicant’s amendment to the abstract created a grammatical issue, as articulated above. Thus, there is a new objection to the abstract that was necessitated by the claim amendments filed on 3/20/2026.
Claim objections
There are new grounds of claim objections that were necessitated by the claim amendments filed on 3/20/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 3/20/2026.
Also, the Applicant did not explicitly address, by amendment or argument, the indefiniteness issues with respect to:
“a pressure meter” in claim 1, line 14,
“the control unit being configured to record and store the pressure wave measurement data received from the pressure meter” in claim 1, lines 18-19, and
“the intracranial pressure (ICP) brain wave of the patient” in claim 5, lines 1-2;
“the air” in claim 6, line 9; and
“recording and storing the pressure wave measurement data in the control unit” in claim 6, lines 17-18.
The Examiner cannot find a reason to withdraw the rejections.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph
There are new grounds of claim rejection under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, that were necessitated by the claim amendments filed on 3/20/2026.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1-9 over the prior art have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejections that were necessitated by the claim amendments filed on 3/20/2026.
To the extent that the Applicant’s arguments are pertinent to the current rejections, these arguments are addressed below.
The Applicant asserts:
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This argument is not persuasive. First, the claim does not recite “an elastic film bladder”, but rather recites “a bladder; the bladder comprising an elastic, film filled with a non-compressible media”. Thus, the Applicant’s argument is not commensurate with the claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, the bladder of claim 1 is taught by the combination of Berdahl and Ragauskas. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Berdahl teaches the use of a cavity 212 within the goggle enclosure 210 to which positive pressure is applied to the eye (paragraphs 0055, 0066, 0075-0076, 0078, 0143-0144, and 0177 of Berdahl). Ragauskas teaches the use of an inner flexible member 32 that conforms to the shape of the eye (paragraphs 0025-0026 of Ragauskas). The cavity 212 of Berdahl covered with the inner flexible member 32 of Ragauskas is considered to be the bladder of claim 1.
The Applicant asserts that there would have been no motivation or reasons to combine Berdahl, Ragauskas, Lee, and Klein in the way suggested by the combination, In particular, the Applicant asserts:
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These arguments are not persuasive. First, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Berdahl does not have to teach the film since Ragauskas does. Second, the placement of the film provides a level of comfort or protection to the patient’s ocular regions during the application of positive pressure since it is a barrier that prevent direct impact of the fluid flow on the eye and the patient would instinctually close the eye because of the presence of the film. This motivation is from general knowledge.
Third, Berdahl teaches or suggests that the apparatus can touch the eye. For example, paragraph 0050 of Berdahl says, “In an example, an instrument can be placed in contact with the eye 100, such as an anterior potion [sic] of the eye 100, and the instrument pressed against the eye 100, such as to increase the IOP of the eye 100.” Paragraphs 0095-0097 of Berdahl teaches the use of non-contact and contact tonometers. Paragraph 0098 of Berdahl teaches the use of a device that can be in substantial contact with the eye. Also, though Berdahl suggests embodiments where the device does not contact the eye, some of these teachings are couched in optional terms. For example, paragraph 0065 of Berdahl says, “The goggle enclosure 210 can be sized and shaped to surround the patient eye 100, such as to be seated on an eye socket of the eye 100, and be spaced from the eye 100 without contacting the eye 100”. Paragraph 0066 of Berdahl says, “A fluid pressure within the cavity 212 can act on the front surface of the eye 100, such as to apply a positive or negative force to the anterior portion of the eye 100, without physically contacting the eye 100 with any non-gaseous fluid body or device, such as to influence TOP in a patient eye 100, such as to decouple TOP from ICP”. Paragraph 0069 of Berdahl says, “The base 424 can be sized and shaped to surround the eye 100 and be spaced from the eye 100 without contacting the eye 100”. In view of the above, no contact with the eye is clearly not a “core design principle”, but simply an optional aspect among the embodiments. As such, having the film of Ragauskas is not incompatible with the teachings of Berdahl.
Fourth, Berdahl is not relied upon to teach the film. Rather, Ragauskas teaches the use of an inner flexible member 32 that conforms to the shape of the eye (paragraphs 0025-0026 of Ragauskas). One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The Applicant asserts:
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These arguments are not persuasive. First, as previously mentioned, Berdahl teaches or suggests that the apparatus can touch the eye (see paragraphs 0050 and 0095-0098 of Berdahl). Also, though Berdahl suggests embodiments where the device does not contact the eye, some of these teachings are couched in optional terms (see paragraphs 0065-0066 and 0069 of Berdahl). In view of the above, no contact with the eye is clearly not “the entire operating principle of Berdahl of a contactless device”, but simply an optional aspect among the embodiments. As such, having the film of Ragauskas is not incompatible with the teachings of Berdahl.
Second, the claim does not recite “an exterior thin elastic film bladder filled with (degasified) water”. The claim recites “a bladder; the bladder comprising an elastic, film filled with a non-compressible media”. Thus, the Applicant’s argument is not commensurate with the claim language. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Third, there is an improvement since the placement of the film provides a level of comfort or protection to the patient’s ocular regions during the application of positive pressure since it is a barrier that prevent direct impact of the fluid flow on the eye and the patient would instinctually close the eye because of the presence of the film.
The Applicant asserts:
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These arguments are not persuasive. With respect to the assertion that the teaching of Ragauskas and the Applicant’s disclosure are materially different, this argument is not persuasive since the combination of Berdahl, Ragauskas, Lee, and Klein results in the structure of claim 1 even if the reasons for the combination are not the same as the Applicant’s. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Also, the arguments directly solely at Ragauskas do not address the combination as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Furthermore, Ragauskas teaches the use of an inner flexible member 32 that conforms to the shape of the eye (paragraphs 0025-0026 of Ragauskas). Ragauskas explicitly teaches that “Chamber 28 is approximately annular in shape so as to enable an ultrasonic transducer 30 to be mounted against an inner flexible membrane 32 and enable a pressurization of the chamber by a pump 34” (paragraph 0025 of Ragauskas). Thus, the assertion that there is no teaching that the flexible membrane of Ragauskas is a fluid-containing bladder wall is incorrect.
The Applicant asserts:
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This argument is not persuasive. In particular, Ragauskas explicitly teaches that “Chamber 28 is approximately annular in shape so as to enable an ultrasonic transducer 30 to be mounted against an inner flexible membrane 32 and enable a pressurization of the chamber by a pump 34” (paragraph 0025 of Ragauskas). Thus, Ragauskas teaches that the membrane 32 contains the air within the chamber of the bladder, which would purge air (see FIG. 2 of Ragauskas) and create a low-compliance interface (again see FIG. 2 of Ragauskas). That is, the membrane 32 of Ragauskas is more than a liner.
The Applicant asserts:
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These arguments are not persuasive. First, as previously mentioned, Berdahl teaches or suggests that the apparatus can touch the eye (see paragraphs 0050 and 0095-0098 of Berdahl). Also, though Berdahl suggests embodiments where the device does not contact the eye, some of these teachings are couched in optional terms (see paragraphs 0065-0066 and 0069 of Berdahl). In view of the above, no contact with the eye is clearly not paramount in the teachings of Berdahl, but simply an optional aspect among the embodiments. Also, Berdahl teaches the use of a cavity 212 within the goggle enclosure 210 to which positive pressure is applied to the eye (paragraphs 0055, 0066, 0075-0076, 0078, 0143-0144, and 0177 of Berdahl) and Ragauskas teaches the use of an inner flexible member 32 that conforms to the shape of the eye (paragraphs 0025-0026 of Ragauskas) such that it would have been obvious include an inner flexible member 32 that conforms to the shape of the eye at the interface between the enclosure of Berdahl and the patient. Lee teaches the use of water as a suitable medium when inflating a bladder for the application of pressure to the subject’s ocular regions (col. 5, lines 40-60 of Lee). Thus, there is a reason to combine the use of water to the bladder of the combination.
The Applicant asserts:
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This argument is not persuasive since the Applicant is arguing a combination of Berdahl, Ragauskas, and Lee that is not commensurate with the rejection itself. Also, the teaching of Lee is applicable since it discusses the inflation of a cavity covered by the flexible membrane in the ocular region of the patient. This is the same context as the combination of Berdahl and Ragauskas. Also, Lee is relied upon for a type of inflation fluid in the context of a cavity covered by the flexible membrane in the ocular region of the patient. Finally, claim 1 does not require that all the air in the bladder be removed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant asserts:
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This argument is not persuasive since it is not commensurate with the rejection. The rejection is based on the combination of Berdahl, Ragauskas, Lee, and Klein. For example, Ragauskas teaches the flexible membrane and Lee teaches the media. This argument leaves out these two teachings such that the argument is not even applicable to the rejection. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
For the above reasons, the rejection of claim 1 is proper. The rejection of claim 6 that depends from claim 1 is properly rejected for the same reasons. It is noted that claim 6 also does not require that all the air in the bladder be removed (only that the air between the bladder and eyelid is forced out from beneath the seal, which is not the same thing, and FIG. 2 of Ragauskas suggests this). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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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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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Claim 14 also recites “the non-compressible media pressure in the bladder” in line 2 and claim 18 recites “non-compressible media pressure in the bladder” in lines 1-2.
Prosecution Insights