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 .
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: “interface unit”; “patient monitoring unit”; “display unit” in claims 1-17.
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.
Pages 4 and 5, teaches that the “interface unit”; “patient monitoring unit”; and “display unit” are hardware structures.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 and 12-20 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by U. S. Patent no. 6,379,304 to Gilbert et al.
Regarding Claim 1, 16, and 17-20, Gilbert teaches an ultrasound interface unit, communicatively coupleable in use with both: an ultrasound sensing apparatus and a patient monitoring unit, said ultrasound interface unit configured in use to: receive from the ultrasound sensing apparatus acquired ultrasound data representative of a subject, and perform processing of said data to derive at least one physiological or anatomical parameter related to the subject (fig. 3-5 and col. 5 lines 1 through col. 6 line 50); generate a data output representative of said derived parameter and communicate said data output to the patient monitoring unit, and perform a configuration function comprising communicating with the ultrasound sensing apparatus to cause adjustment of one or more image-related operating parameters of the ultrasound sensing apparatus for configuring the ultrasound sensing apparatus to acquire ultrasound data suitable for monitoring said physiological or anatomical parameter over time (fig. 2-8, 11, 12, 15, 16, and col. 5 lines 1 through col. 6 line 50 and claim 8; Gilbert further teaches changing different Modes, B-mode, M-mode, doppler, color doppler etc, which are different imaging parameters, for monitoring anatomic/physical parameters (doppler and color doppler is used for blood flow, which is blood vessel imaging, the anatomical feature being blood vessel).
Regarding Claim 2, Gilbert teaches that the ultrasound interface unit is configured in use to supply power to the ultrasound sensing apparatus for driving ultrasound transmission by ultrasound transducers of the ultrasound sensing apparatus (col. 6 lines 37-48 teaches an interface unit to power the probe).
Regarding Claim 3, Gilbert teaches that the ultrasound sensing apparatus is an ultrasound transducer unit comprising one or more ultrasound transducers (col. 4 lines 30-40).
Regarding Claim 4, Gilbert teaches that the interface unit is configured to generate drive signals for driving ultrasound transmission by the ultrasound transducers of the ultrasound transducer unit, wherein the configuration function comprises configuring parameters of said drive signals (col. 6 lines 37-48 teaches an interface unit to dive the ultrasonic transducers in the probe).
Regarding Claims 5-7, Gilbert teaches that the ultrasound sensing apparatus includes local drive means for generating drive signals for driving ultrasound transmission by transducers comprised by an ultrasound transducer unit of the ultrasound sensing apparatus, and wherein the configuration function comprises communicating with the ultrasound sensing apparatus to cause the ultrasound sensing apparatus to adjust parameters of said locally generated drive signals (figs. 3-5; col. 6 lines 37-48 teaches an interface unit to dive the ultrasonic transducers in the probe).
Regarding Claims 8-10, Gilbert teaches that the ultrasound sensing apparatus comprises a display unit, and the ultrasound interface unit is configured to communicate with the ultrasound sensing apparatus to cause display on said display unit of the at least one physiological or anatomical parameter derived by the interface unit (figs. 3-5 and col.6 lines 22-55).
Regarding Claims 12 and 13, Gilbert teaches an ultrasound interface unit communicatively coupled with the ultrasound sensing apparatus (fig. 3 teaches ultrasound interface unit communicatively coupled with the ultrasound sensing apparatus).
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.
Claim(s) 11, 14, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U. S. Patent no. 6,379,304 to Gilbert et al. in view of U. S. Publication No. 2017/0112472 to Song et al.
Regarding Claims 11, 14, and 15, Gilbert teaches all of the above claimed limitations but does not expressly teach one or more medical sensors for receiving medical sensor data, and an ultrasound interface unit communicatively coupled with the patient monitoring unit.
Song teaches one or more medical sensors for receiving medical sensor data, and an ultrasound interface unit communicatively coupled with the patient monitoring unit (para 066 and 0131 teaches multiple sensors).
It would be obvious to one of ordinary skill in the art at the time of filing to modify Gilbert with one or more medical sensors for patient monitoring as taught by Song, since such a setup would result in coordinated images with patient phyiologic data, resulting in more medical data in the images.
Response to Arguments
Applicant's arguments filed 10/20/25 have been fully considered but they are not persuasive.
Applicant argues that Gilbert reference does not teach the limitations of the independent claim.
Examiner would like to point out that the Claims are very broad and the limitations are interpreted using the broadest reasonable interpretation.
Claim 1 requires “receive ultrasound data to acquire physiological/ anatomical parameter related to the subject”. This limitations under broadest reasonable interpretation, merely requires receiving ultrasound signals from the subject. The physiological parameters are not defined.
The limitation “generating data output representative of derived parameter and communicate said data output to the patient monitoring unit”. This limitations under broadest reasonable interpretation, merely requires displaying the acquired ultrasonic data.
Claim 1 further requires “perform a configuration function comprising communicating with the ultrasound sensing apparatus to cause adjustment of one or more image-related operating parameters of the ultrasound sensing apparatus for configuring the ultrasound sensing apparatus to acquire ultrasound data suitable for monitoring said physiological or anatomical parameter over time.
The “configuration function” the “parameters” etc. are not defined, as such any change in ultrasonic mode, or change in any parameters meets the claim limitation.
The Gilbert reference teaches acquiring ultrasonic data from the subject and displaying the data, which includes the receiving and generating step (figs. 2, 3, 8, 16). Gilbert further teaches changing different Modes, B-mode, M-mode, doppler, color doppler etc, which are different imaging parameters, for monitoring anatomic/physical parameters (doppler and color doppler is used for blood flow, which is blood vessel imaging, the anatomical feature being blood vessel), as such meets the claim limitations and the rejection is maintained and is made FINAL.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANJAY CATTUNGAL whose telephone number is (571)272-1306. The examiner can normally be reached M-F 9-5 EST.
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/SANJAY CATTUNGAL/Primary Examiner, Art Unit 3798