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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-6) in the reply filed on November 6, 2025 is acknowledged. The traversal is on the ground(s) that Group I and Group II are related by a single general inventive concept and should therefore be examined together. Specifically, Group I is a product and Group II is production/use of that product, sharing the special technical feature of “self-positioning front surface matched to a non-spherical outer surface of the medium”. This is not found persuasive because “self-positioning front surface matched to a non-spherical outer surface of the medium” is not considered to be a special technical feature, because concave shaped lens are well-known in the art and substantially match to the surface of the skull (i.e. the non-spherical outer surface of the medium). For example, the transducer with plano-concave lens 12 as shown in Figures 1, 3 of US 3958559 to Glenn. Another example is shown in US 20180192990 to Tanter in Figure 1 where the lens substantially conforms to the shape of the skull (i.e. no air gap is present). Further, the production method of claim 7 does not include any production steps to make any lens, so it is not considered a production of a product category of invention. It is only related to modeling and calculations. For sake of argument, even if claim 7 is considered a production method, the modeling and calculations are not required by the lens of claim 1, so it follows that any lens made by the modeling and calculations of claim 7 is different than the lens of claim 1.
The requirement is still deemed proper and is therefore made FINAL.
Examiner withdraws claims 7, 9-13, 15-22 as being directed towards a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a) and under 35 U.S.C. 365(c) is acknowledged.
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 1-6 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.
Regarding Claim 1, the term “self-positioning acoustic lens” appears to contradict its plain meaning. While the claim requires “the front surface is constrained and is adapted to match the outer surface of the medium in order to be self-positioned on the outer surface of the medium”, there is nothing to cause positioning, e.g. actuator. Rather, the lens would be positioned on the outer surface of the medium by hand. The claim seems to be implying that “self-positioning” is caused by the geometrical match between the outer surface of the medium and the front surface of the lens. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “self-positioning” in claim 1 is used by the claim to mean “matching to a surface,” while the accepted meaning is “automatically positioning.” The term is indefinite because the specification does not clearly redefine the term. During examination, “self-positioning” will be interpreted as meaning “matching to a surface” as described in the claim limitation as “the front surface is constrained and is adapted to match the outer surface of the medium in order to be self-positioned on the outer surface of the medium”.
In Claim 4, the last line seems to end prematurely with “the predetermined”. Should this be “the predetermined objective ultrasonic wave field” from claim 1?
Regarding Claim 6, it is unclear how the claim further limits the characteristics required by claim 1. In particular, claim 1 requires “wherein the front surface is constrained and is adapted to match the outer surface of the medium”. It is not understood how being “in a complementary way” further limits the matching requirement, as surfaces geometrically matching together seem to already be “complementary” to each other. During examination, it is assumed that “in a complementary way” is the same as “adapted to match”.
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.
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180192990 to Tanter.
Regarding Claim 1, Tanter teaches a self-positioning acoustic lens comprising a front surface and back surface (lens 9, Figure 1), said back surface being opposed to the front surface, said self-positioning acoustic lens being adapted for transmitting an ultrasound wave into a medium comprising at least one aberrating barrier (skull 8, Figure 1) and a substantially homogeneous internal part masked by said aberrating barrier (brain 7, Figure 1), said ultrasound wave being generated by an ultrasound probe located outside of the medium and said back surface facing the emission surface of the ultrasound probe (ultrasound probe 2, Figure 1),
wherein the self-positioning acoustic lens being configured to, when the self-positioning acoustic lens is interposed between the ultrasound probe and the aberrating barrier and when the ultrasound probe transmits a predetermined ultrasonic wave, generate a predetermined objective ultrasonic wave field in at least one predetermined area belonging to said internal part despite the presence of the aberrating barrier (as shown by the predetermined ultrasound wave 13a, which produces the predetermined wavefront 13c as modified by the lens 9 and aberrating layer 8 and focused at the predetermined area F in the brain 7, Figure 4, while the lens 9 is positioned between the aberrating barrier/skull 7 and the ultrasound probe 2; par. 0120-0121),
and wherein the front surface is constrained and is adapted to match the outer surface of the medium in order to be self-positioned on the outer surface of the medium (the lens 9 is constrained within the helmet 4 and constrained against the skull 8, par. 0120, Figure 1; the lens approximately matches to the surface of the skull as seen in Figure 1, as there is good transmission of ultrasound waves, i.e. minimal air gap, par. 0069), said outer surface of the medium not being perfectly spherical (the skull 8 is not perfectly spherical), and wherein the back surface being spaced from the front surface according to a specific self-positioning acoustic lens thickness in order to create the said predetermined objective ultrasonic wave field (the specific thickness of the lens, at each point of the lens, is designed to account for aberrations caused by the skull, par. 0105; for example, as shown by S4 in Figure 3, the thicknesses e extending across the lens in the y direction).
Examiner notes that the claim does not require precise fitting of the front surface to the skull to account for the aberration correction. The variability of the thickness of the lens (S4, Figure 3) and general conformity to the skull (as shown in Figure 1), as in Tanter, is sufficient to read on the claim.
Regarding Claim 2, Tanter further teaches wherein the surface of contact between the front surface of the self-positioning acoustic lens and the outer surface of the medium is limited to a restricted and specific area on the outer surface of the medium (the lens 9 is constrained within the helmet 4 and constrained against the skull 8 in a specific area, par. 0120, Figure 1).
Regarding Claim 3, Tanter further teaches wherein the aberrating barrier is a skull (skull 8, Figure 1) and the outer surface is the skin surrounding the skull (as shown in Figure 1), and the restricted and specific area corresponds to a part of the outer surface in contact with the front surface of the self-positioning acoustic lens (the lens 9 is constrained within the helmet 4 and constrained against the skull 8 in a specific area, par. 0120, Figure 1).
Regarding Claim 6, Tanter further teaches wherein the front surface is constrained and is adapted to match the outer surface of the medium in a complementary way (the lens 9 is constrained within the helmet 4 and constrained against the skull 8, par. 0120, Figure 1; the lens approximately matches to the surface of the skull as seen in Figure 1, as there is good transmission of ultrasound waves, i.e. minimal air gap, par. 0069).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180192990 to Tanter.
Regarding Claim 4, Tanter further teaches the formula (formula 3, par. 0028; variables explained in par. 0025-0030):
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of which is used to calculate the thickness of the self-positioning acoustic lens from each point of the front surface of the self-positioning acoustic lens (to calculate what is shown in S4, Figure 3 which is the thicknesses e extending across the lens in the y direction). Tanter’s formula is identical to what is claimed except that it does not utilize all three dimensions. Instead, it utilizes two dimensions (x, y). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it routine to extend the formula into three dimensions (x, y, z) as claimed because the object thickness being calculated is of a three-dimensional object in a three-dimensional system to produce a three-dimensional wavefield. Where the figure of Tanter (Figure 4) is drawn in two dimensions for simplicity, one of ordinary skill in the art should have no problems extending it into three dimensions.
Regarding Claim 5, Tanter further teaches the formula (formula 3, par. 0028; variables explained in par. 0025-0030):
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of which is used to calculate the thickness of the self-positioning acoustic lens from each point of the front surface of the self-positioning acoustic lens (to calculate what is shown in S4, Figure 3 which is the thicknesses e extending across the lens in the y direction). Tanter’s formula is identical to what is claimed except that it is in Cartesian coordinates instead of polar coordinates. Transforming between Cartesian and polar coordinates in a mathematical system is considered routine for one of ordinary skill in the art and only predictable results would occur.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20250041630 to Hosoya teaches a conformal holder and lens portion (elements 3, 4, 5 in Figure 2).
US 20190308036, US 20230293911, US 11596812, US 12329991 to Ebbini teaches a lens that precisely conforms to the skull/scalp geometry to account for aberrations (par. 0065; lens 170, scalp/skull 150 in Figure 3) and reads on the claimed invention.
US 20190022424 to Kim teaches a lens that conforms to the skull/scalp geometry to account for aberrations (lens 200, Figure 5) and reads on the claimed invention.
US 11141130 to Tanter teaches the claimed invention for the same reasons as used in the rejection above.
US 3958559 to Glenn teaches a plano-concave shaped lens that generally conforms to the skull/scalp geometry (lens 12, Figure 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANGELA MARIE HOFFA whose telephone number is (571)270-7408. The examiner can normally be reached Monday - Friday 9:30 am - 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (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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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799