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 Arguments
Applicant’s arguments with respect to claims 47-48, 51-55, 58-62, 65-67 have been considered but moot in view of new grounds of rejection.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: means selected from…. a pull tab and a snap-fit tab” in claim 47.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 47-48, 54-55, 61-62 rejected under 35 U.S.C. 103 as being unpatentable over Lewis [US 20130144193 A1] in view of Wohlgemuth [US 5642825 A]
As per claim 47, Lewis teaches an ultrasound coupling device (Lewis Fig 7) comprising
an ultrasound coupling adapter for coupling an ultrasound transducer to an ultrasound coupling medium housed in the ultrasound coupling adapter (Lewis Fig 7, ¶0070 “These containment seals are effective to keep the gel, gel-like material, or hydrogel contained within the coupling compartment ”), said ultrasound coupling adapter comprising:
an interface support region for operably interfacing the ultrasound transducer to the ultrasound coupling medium (Lewis ¶0070 “Transducer Gel Cup Holder”); and
an integrated portion for rendering the ultrasound coupling adapter inoperable upon manipulation by dislodging the ultrasound transducer from the ultrasound coupling adaptor, thereby rendering the ultrasound coupling device inoperable (Lewis ¶0070 “removal of the transducer from the holder can be accomplished by actually breaking the gel cup holder by pulling the pull tab 21 (e.g., a plastic tab) on the side (e.g., similar to a tab on a milk container before you open it), which will break the gel cup holder (see break apart area 26) and allow for easy removal of the ultrasound transducer from the coupling device”, ¶0073 “a pull tab in order to break away the … while also destroying the bandage/gel cup holder to make it only one time use.” i.e., similar to a milk jar the gel cup holder is inoperable for its intended purpose of showing that is not a new bottle, if the seal is broken, and cannot be returned to a sealed position. Further, the claims encompass a human dislodging the transducer by manipulation. It is possible, and common for humans /users to use hands or tools in dislodging components, using excessive force, and hence breaking them, and rendering it inoperable),
wherein the integrated portion functions to permanently alter the interface support region , thereby rendering the interface support region inoperable for performing its mechanical function of maintaining the ultrasound coupling medium therein (Lewis ¶0073 “a pull tab in order to break away the … while also destroying the bandage/gel cup holder to make it only one time use.”, gel cup holds gel),
wherein the integrated portion consists essentially of
said integrated portion being configured to facilitate permanently altering a portion of the interface support region (Lewis ¶0073 “a pull tab in order to break away the … while also destroying the bandage/gel cup holder to make it only one time use.”, gel cup holds gel), and
wherein the
Lewis does not expressly recite that the area 26 is perforated or thinned.
Wohlgemuth, in the field of caps for use with containers, teaches the area is perforated or thinned (Wohlgemuth Fig 1 tab 121 and annular tear groove 112).
Lewis refers to tabs and area as that similar to that as used in a milk container. Wohlgemuth evidences that, such structure for a pull tab with perforations were known in the art of containers (including that for milk). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Lewis by including grooves as shown in Wohlgemuth. As per MPEP 2143.I.F, known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. In this case, the variations are predictable since Lewis provides direction towards a milk container for implementing the tab and break apart area. One design incentive is to provide tamper-indicating cap which is equally convenient to both the left-handed and the right-handed user while being easy for that user to remove (Wohlgemuth Col 2 lines 59-62).
As per claim 48, 55, Lewis in view of Wohlgemuth further teaches wherein the pull tab serves as a lever capable of rendering the ultrasound coupling device inoperable (Wohlgemuth Col 4 lines 41- Col 5 line 10 “Each pull-tab includes an easily graspable pinch end 121 which allows a user to firmly grasp the tab for pulling. …Removal of the frangible ring further provides tamper-indication by alerting the user that the cap has likely been removed since initial assembly.”).
As per claim 54, Lewis in view of Wohlgemuth further teaches an ultrasound coupling system comprising: an ultrasound coupling device according to claim 47; and an ultrasound transducer configured for operable attachment to the ultrasound coupling device (Lewis Fig 6A, item 9, ¶0069).
As per claims 61-62, they are directed to method of using claims 47-48 and are rejected for same reasons as above.
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 51-53, 58-60, 65-67 rejected under 35 U.S.C. 103 as being unpatentable over Lewis in view of Wohlgemuth as applied to claims 47, 54, 61 above and further in view of Baril [US 20060163111 A1].
As per claims 51-53, 58-60, 65-67, Lewis in view of Wohlgemuth teaches 47, 54, 61 as discussed above. Lewis in view of Wohlgemuth does not expressly teach an adhesive fabric for interfacing the ultrasound coupling device with a subject, wherein the fabric has adhesive properties that substantially diminish after first use by the subject, an adhesive fabric for interfacing the ultrasound coupling device with a subject, wherein the fabric has adhesive properties that diminish by 50% or greater using the ASTM D903 standard.
Baril teaches an adhesive fabric for interfacing the ultrasound coupling device with a subject (Baril Fig 1B items 20, 22), wherein the fabric has adhesive properties that substantially diminish after first use by the subject., an adhesive fabric for interfacing the ultrasound coupling device with a subject, wherein the fabric has adhesive properties that diminish by 50% or greater using the ASTM D903 standard (As per ¶0113, applicant refers to adhesives made of “acrylics, silicones, or the like”. Baril ¶0022 “In alternate embodiments, the adhesive is acrylic”. ¶0025 “he release liner 22 is any substrate coated with silicone” The claim limitations are directed to properties of the adhesive fabric. Since Baril uses similar materials properties is also the same).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in , Lewis in view of Wohlgemuth by integrating liner and adhesive as in Baril. The motivation would be to maintain the ultrasound device and ultrasound gel pad 38 in the desired location on the patient's skin (Baril ¶0033).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797