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 .
Drawings
The drawings are objected to because “the unlabeled rectangular box(es) shown in the drawings should be provided with descriptive text labels” (see MPEP § 608.02(b)). It should be appreciated that reference numbers in FIGS. 30-32 & 35 do not encompass “descriptive text labels.” Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 19 is recited as being dependent upon Claim 1, like Claim 11; however, this appears to be a typographical error and should depend upon Claim 12.
Claim Objections
Claims 1 & 20 are objected to because of the following informalities: Claim has an erroneous period in line 9, and Claim 20 has an erroneous period in line 6. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-20 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.
In particular, Claim 1 recites “wherein each adjustable part in the plurality of adjustable parts is designed to be removably and interchangeably coupled to the fixed part of the handpiece, one at a time”; however, the claim language recites function rather than structure such that neither the instant specification nor the claims precisely define present structural attributes of interrelated component parts of the claimed assembly. More specifically, the original disclosure fails to provide explicit or inherent structure that distinguishes between removable or non-removable.
For the purposes of compact prosecution, the limitation will be interpreted such that the adjustable piece 161 is removable via routine disassembly. It should be noted that such an interpretation has not been evaluated for compliance with the written description requirement under 35 U.S.C. 112(a).
Claims 12 & 20 recite similar limitations and are rejected under the same rationale as claim 1. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
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:
Claim 1 recites “a plurality of adjustable parts for the handpiece wherein each adjustable part in the plurality of adjustable parts is designed to be removably and interchangeably coupled to the fixed part of the handpiece, one at a time” and “wherein a penetration depth of the handpiece is adjusted by coupling different adjustable parts in the plurality of adjustable parts with the fixed part” which includes the generic placeholder “plurality of adjustable parts” coupled to functional language “designed to be removably and interchangeably coupled to the fixed part of the handpiece” & “a penetration depth of the handpiece is adjusted” without reciting sufficient structure to achieve the function. For the purpose of this Examination, the broadest reasonable interpretation of the claim limitation is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act. In particular, the instant specification fails to provide any details regarding the structure of the adjustable parts beyond element 161 as illustrated in FIG. 20;
Similarly, Claim 2 recites “in the plurality of adjustable parts” associated with the functional language “provides imaging of a treatment surface through any adjustable part in the plurality of adjustable parts” without providing any details regarding the structure of the adjustable parts beyond element 161 as illustrated in FIG. 20;
Claims 12 and 20 recite the same “adjustable parts” nonce term associated with similar functional language without providing any details regarding the structure of the adjustable parts beyond element 161 as illustrated in FIG. 20.
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.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6, 10-16, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zawada et al. (US PGPUB 20190282834; hereinafter "Zawada").
With regards to Claim 1, an acoustic generating system (handheld assembly 36; see Zawada FIG. 36) comprising:
a fixed part of a handpiece wherein the fixed part includes a focused acoustic generating source with a fixed acoustic focal length (transducer head 11 {i.e. fixed part} is threadably fixed to second housing 19, wherein the second housing 19 couples the optical monitoring assembly 56 with the transducer head 11; see Zawada ¶ [0215]; housing 12 of the transducer head 11 establishes a fixed distance between a acoustic generating device 9, that generates focused waves, and the end 51 of housing 12; see Zawada ¶ [0098 & 0099]);
a plurality of adjustable parts for the handpiece (threaded interface 20 allows for translational movement of either the lens holder 21 or image sensor holder 22 along the optical axis in order to adjust the relative distance therebetween; see Zawada ¶ [0210]; it should be appreciated that “or” indicates only translating one of either 21 or 22, thus, the other being fixed) wherein each adjustable part in the plurality of adjustable parts is designed to be removably and interchangeably coupled to the fixed part of the handpiece, one at a time (second housing 19 that couples the optical monitoring assembly 56 with the transducer head 11; see Zawada ¶ [0215]; second housing and first housing are selectively detachable; see Zawada ¶ [0043]; selecting the correct type of imaging sensor 24 and corresponding optical lens 25 for matched FoV; it should be appreciated that the adjustable parts are easily accessible via the detachable second housing 19 and removability & interchangeability are functional limitations not limited by structure, accordingly Zawada adjustable optical focus objective with threaded interface 20 and either lens holder 21 or image sensor holder 22 are capable of being removed and interchanged with correctly selected image sensor 24 and optical lens 25); and
a watertight chamber formed by the fixed part and one of the plurality of adjustable parts when coupled together, wherein the watertight chamber is designed to hold a coupling medium (the optical system 56 is protected from the coupling medium 40 of cavity 52 of the transducer head 11 by a water-tight seal formed by separator 46 or glued borosilicate glass; see Zawada ¶ [0100 & 0205-0206]; it should be appreciated that the when the optical system 56 is coupled to the transducer head 11 the watertight seal is still maintained),
wherein a penetration depth of the handpiece is adjusted by coupling different adjustable parts in the plurality of adjustable parts with the fixed part (as detailed directly above, Zawada is capable of disassembly and selection of different optical components).
With regards to Claim 21, wherein the fixed part of the handpiece further comprises an optical system that provides imaging of a treatment surface through any adjustable part in the plurality of adjustable parts that is coupled to the fixed part (optical system 56 has an adjustable focus depth of the PoT to be imaged; see Zawada ¶ [0210]).
Claim 12 recite similar limitations and are rejected under the same rationale as Claim 2.
With regards to Claim 32, wherein the optical system comprises an objective and an imaging plane and wherein a distance along a longitudinal axis between the objective and the imaging plane is adjustable (threaded interface 20 allows for translational movement of either the lens holder 21 {i.e. objective} or image sensor holder 22 along the optical axis in order to adjust the relative distance therebetween; see Zawada ¶ [0210]; it should be appreciated that “or” indicates only translating one of either 21 or 22, thus, the other being fixed).
Claim 13 recite similar limitations and are rejected under the same rationale as Claim 3.
With regards to Claim 43, wherein the distance is adjusted by mechanically moving the objective along the longitudinal axis towards or away from the imaging plane (threaded interface 20 allows for translational movement of either the lens holder 21 {i.e. objective} or image sensor holder 22 along the optical axis in order to adjust the relative distance therebetween; see Zawada ¶ [0210]; it should be appreciated that “or” indicates only translating one of either 21 or 22, thus, the other being fixed).
Claim 14 recite similar limitations and are rejected under the same rationale as Claim 4.
With regards to Claim 52, wherein an optical principal axis of the optical system is coaxial with a main acoustic axis of the focused acoustic generating source (the optical monitoring system is integrated in the hand piece concentrically with the focused piezoelectric element, i.e. the optical axis of the optical system is aligned with longitudinal axis of the hand piece 36 and/or with the axis of symmetry of the focused transducer that passes through the PoT; see Zawada ¶ [0204]).
Claim 15 recite similar limitations and are rejected under the same rationale as Claim 5.
With regards to Claim 62, wherein the optical system comprises an imaging plane and at least one optical component with an adjustable optical focal length along a longitudinal axis (threaded interface 20 allows for translational movement of either the lens holder 21 {i.e. objective} or image sensor holder 22 {i.e. imaging plane} along the optical axis in order to adjust the relative distance therebetween; see Zawada ¶ [0210]; it should be appreciated that “or” indicates only translating one of either 21 or 22, thus, the other being fixed).
Claim 16 recite similar limitations and are rejected under the same rationale as Claim 6.
With regards to Claim 102, wherein the optical system has an optical main axis that includes a portion that is not coaxial with an acoustic main axis (the optical system is shown along the longitudinal axis in the embodiments above, the optical system may also be off axis; see Zawada FIG. 36 & ¶ [0214]).
With regards to Claim 111, further comprising a fixing collar that couples an acousto-optical window to any adjustable part in the plurality of adjustable parts (acoustic window 200 {i.e. acousto-optical window}, of acoustic coupler 18, is made from a thin acoustically and optically transparent material, acoustic coupler 18 having a circumferential protrusion 53 {i.e. collar} which engages a corresponding groove 54 of housing 12 of head 11; see Zawada ¶ [0099]; it should be appreciated that the claim does not preclude an indirect coupling of said acoustic window 200 to any adjustable part).
Claim 19 recites similar limitations and are rejected under the same rationale as Claim 11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9 & 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zawada.
With regards to Claim 92, while Zawada teaches of focal point of the piezoelectric transducer is about 0.1 mm to about 10 mm (see Zawada ¶ [0035]) and translation [of the objective] along the optical axis allows the surface of the skin above the PoT to be imaged (see Zawada ¶ [0209]) and an exampled focal length of 10 mm (see Zawada ¶ [0215]), i.e. one of ordinary skill in the art would recognize that the desired focal point of the optical system corresponds to the focal point of the piezoelectric transducer; it appears that Zawada may be explicitly silent to wherein the penetration depth is adjustable in a range between at least 0 mm and 5 mm and an optical depth of field of the optical system is equal to or greater than range.
However, based on the above disclosures of Zawada, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawada to provide at least a focal point range of the optical system 56 that corresponds to the 0.1 mm to 10 mm focal range of the piezoelectric transducer. Doing so would amount to combining prior art elements according to known methods to yield predictable results because Zawada already teaches of focusing on the skin just above the PoT.
Claim 18 recites similar limitations and are rejected under the same rationale as Claim 9.
Claims 8 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zawada in further view of Subhash et al. (US PGPUB 20200179713; hereinafter "Subhash").
With regards to Claim 86, while Zawada discloses the optical monitoring system 56 may include other components including additional lenses or other optical components (see Zawada ¶ [0210]), it appears that Zawada may be silent to wherein the adjustable optical focal length is achieved by one of a group consisting of a liquid lens, electrowetting, use of shape-changing polymers and acousto-optical tuning.
However, Subhash teaches of a skin personal care device for including a handheld probe (see Subhash ¶ [0127] & FIG. 5) for transmitting therapeutic electromagnetic radiation to the skin (see Subhash Abstract). More specifically, Subhash teaches of an imaging sensor with electrically tunable lens 103B based on shape-changing elastic polymer material or electrowetting-driven liquid lens technology (see Subhash ¶ [0143] & FIG. 14).
Zawada and Subhash are both considered to be analogous to the claimed invention because they are in the same field of handheld treatment probes with optical imaging. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zawada to incorporate the above teachings of Subhash to provide at least electrowetting-driven liquid lens. Doing so would aid in capturing images with an automatically tuned focus (see Subhash ¶ [0143]).
Claim 17 recites similar limitations and are rejected under the same rationale as Claim 8.
Allowable Subject Matter
Claims 7 & 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regards to Claim 7, while Branson teaches of reducing bubbles (see Branson ¶ [0081]), neither the cited prior art {of Zawada, Subhash, or Khuri-Yakub et al.} nor the searched prior art teaches of the arrangement of Claim 1 along with a bubble trap, let alone a bubble trap with the recited depth of 0.1 mm to 100 mm
With regards to Claim 20, the closest prior art reference Branson et al. (US PGPUB 20150321026) teaches that “the spacer 600 is an acoustic spacer, an offset device, a standoff, a shim, a bladder, a focal depth adjustment device, a mechanical focal depth control device, and/or a focal depth modification device.” However, said space 600 is disposed on the exterior of fluid filled emitter/receiver module 200 as illustrated in FIG. 1A (see also Branson ¶ [0051]). Accordingly, the Branson arrangement cannot anticipate or obviate the claimed adjustable part of Claim 20 which is recites that said adjustable parts pass through the water-tight chamber containing liquid coupling medium. In addition, the searched prior art failed to recite such a limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Khuri-Yakub et al. (US PGPUB 20230414299) – adjustable bladder spacer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798