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 Objections
Claims 1 and 11 are objected to because of the following informalities: the word “assembles” should be amended to “assemblies” as this appear to be a typographical error. Appropriate correction is required.
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: “forehead assembly comprising one or more settings for headset size adjustment” in claim 1.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 8 and 9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 8 recites in part “the one ring is positioned over an inion of a patient, the one or more rings being positioned over a left and right temporal area of a patient” and claim 9 recites in part “… one or more feet with pads positioned to contact skin of a patient”. Each of these recitations includes a patient within the scope of the claim, for the one or more rings or the one or more feet to be positioned. Because Applicant’s intent is understood, it is suggested to replace the word “positioned” with either the phrase “adapted to” or “configured to” before the word “positioned” in each instance, or amend the recitations in such a way that the patient is not positively recited, to overcome this rejection.
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 8, 12, 16-18 and 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.
Claim 8 recites the limitation "the one or more rings being positioned over a left and right temporal area of a patient" in line 3-4. There is insufficient antecedent basis for this limitation in the claim. As a first matter, “ a patient” lacks proper antecedence basis, as it is unclear whether this recitation refers to the same patient in regards to inion or a distinct patient. Additionally, it is unclear whether recitation of “the one or more rings” refers to the one ring of the one or more rings or different ones of the one or more rings. For examination purposes, it will be presumed that the claim refers to the same patient and the recitation in question above refers to two other ones of the one or more rings.
As to claims 12, 17, 18 and 20, claim 12 recites in part, “wherein the sliding latch toggles connection of the one or more recessed notches with the one or more transducer probe assemblies”, i.e., referencing to the one or more transducers in claim 1, claim 17 recites in part “a probe fiducial coupled to the one or more transducer probe assemblies” also referencing to the one or more transducers in claim 1, and claim 20 recites in part “wherein the back ring assembly is coupled to the one or more transducer probe assemblies” also referencing to the one or more transducers in claim 1. However, the one or more transducer assemblies being referred to are not positively recited, see recitation in claim 1 “… one or more rings for attaching one or more transducer probe assembles”, thus rendering the scope of claims 12, 17 and 20 indefinite as claim 1 does not require one or more transducer probe assemblies. Claim 18 is likewise rejected as it includes all limitations and deficiencies of claim 17.
As to claim 16, the recitation “… wherein the head fiducial comprises a fiducial marker and a fiducial attachment” renders claim 16 indefinite because the head fiducial in not positively recited in claim 15 “… a quick-release attachment for attaching a head fiducial”.
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 (i.e., changing from AIA to pre-AIA ) 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 1-7, 9, 10 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang US 20180304101 A1 in view of Jordan et al., US 20180117364 A1 ("Jordan") .
Regarding claim 1, Yang discloses an adjustable transcranial ultrasound headset (100, e.g., [0044-0045], see reproduced Fig. 1A with added annotations for clarity purposes) comprising an adjustable top strap ;a headband strap comprising a latch assembly for adjustment of the headband strap; and a forehead assembly coupled to the adjustable top strap and the headband strap, the forehead assembly comprising one or more settings for headset size adjustment.
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Yang doses not explicitly disclose an adjustable chin strap and one or more rings (304) for attaching one or more transducer probe assembles, wherein the one or more rings are coupled to the adjustable chin strap and forehead assembly.
Attention is directed to Jordan disclosing an analogous adjustable transcranial ultrasound headset (see e.g., Figs. 1H and 12) comprising an adjustable chin strap (302B) and one or more rings (cradle 304) for attaching one or more transducer probe assembles, the cradle 304 allows for pivoting of a transducer at different angles ([0089], [0140-0141]). In view of these, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the headset of Yang with one or more rings and a chin strap such that the one or more rings is coupled to the chin strap and the forehead assembly, as an art recognized alternative way of fastening a transducer on a patient and for added benefit of pivoting the transducer to target specific regions of the patient head as taught by Jordan in [0143].
Regarding claims 2-3, the headset of Yang in view of Jordan is adjustable and configured to be applied to different users head ([0064]) and is therefore capable of being adjustable to the recited width or length as the recited width and length correspond those of the general population to which the headset of Yang is intended to be used.
Regarding claim 4, the headset of Yang in view of Jordan meets all the structural requirements of claim 1, as such, the forehead assembly would adjust to reposition the one or more rings over one or more temporal regions of a patient, else the claim is incomplete for failing to recite other significant structural features that would distinguish from the headset of Yang in view of Jordan.
Regarding claim 5, the headset of Yang in view of Jordan has built-in adjustment settings as discussed in claim 1 above and would comprise the head size setting recited in the claim, as the recited head sizes correspond with the size in the general population to which the headset of Yang is intended to be used, else the claim is incomplete for failing to recite other significant structural features that would distinguish from the headset of Yang in view of Jordan.
Regarding claims 6-7, Yang in view of Jordan discloses the headset as discussed in claim 1 above, Yang does not explicitly disclose wherein the headband strap comprises a flexible material or wherein the one or more rings are coupled to the headband strap using one or more hooks. However, Jordan teaches the use of flexible material for straps and use or one or more hooks to couple a headband strap to one or more rings (e.g., [0089-0091] use of elastic material that are stretched and held compressively). In view of these, at the time of filing the claimed invention, it would have been obvious to modify the headband strap of Yang with a flexible material and use one or more hold to couple a headband strap to one or more rings, as this configuration would allow for compressively holding the headset over the patients head, thus securely holding a transducer next to the patient’s skin.
Regarding claims 9-10, Yang in view of Jordan discloses the headset as discussed in claim 1 above, as modified, the one or more rings comprise one or more feet with pads that comprise a flexible material (see illustration Figs. 7-9 of Jordan and [0089] “… screws 114 may rotatably extend through housing arms 112 and may include elastomeric cushions 118 that press up against head 90”).
Regarding claim 24, Yang in view of Jordan discloses the headset as discussed in claim 1 above, while Yang does not explicitly disclose that the ultrasound headset further comprises a coupling interface including at least one adhesive tape and conformable interface, Jordan teaches in [0142] attaching a gel pack 306 into cradle 304. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the headset of Yang to include a coupling interface comprising a conformable interface, to eliminate air between the transducer and surface of skin to ensure efficient propagation of ultrasound waves from a transducer assembly to the skin of the patient.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan as applied to claim 1 above, and further in view of Alleman et al., US 20120083717 A1 (“Alleman”).
Regarding claim 8, Yang in view of Jordan as discussed in claim 1 above, in modified Yang, one ring of the one or more rings will be positioned over a left temporal area of a patient during use, while a second one of the one or more rings will be positioned over a right temporal area. Yang in view of Jordan does not explicitly disclose one ring of the one or more rings is positioned over an inion of the patient during use.
Alleman discloses a transcranial ultrasound apparatus with a headset comprising two paired contralateral temporal transducer arrays 105a, 105b and a posterior occipital transducer array 106 ([0104], Figs. 3A, 3B, 4 and 8A), examiner notes that an inion is a part of occipital prominence (OCP). At the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the headset of Yang in view of Jordan to include one ring that is positionable at an occipital prominence during use, because Alleman exemplifies that it was known to provide a combination of one or more rings in the same configuration, to allow providing treatment to a patients head from temporal and posterior occipital regions of the patients head. In modified Yang, the one or more ring positionable at the occipital prominence would be adjustable to be positioned at an inion of the patient and will be coupled with head strap.
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan as applied to claim 1 above, and further in view of Applicant cited Schafer et al., “Design, Development, and Operation of Low-Intensity Focused Ultrasound Pulsation (LIFUP) System for Clinical Use” (Schafer”).
Regarding claims 11-13, Yang in view of Jordan discloses the invention of claim 1 as discussed above, however, the combination does not specifically disclose wherein the one or more rings comprise a retainer ring, the retainer ring comprising one or more recessed notches for securing the one or more transducer probe assembles [claim 11] and wherein the retainer ring comprises a sliding latch for toggling connection of the one or more recessed notches with the one or more transducer probe assemblies, a counterweight, or a probe cover [claim 12] or wherein the retainer ring comprises a debossment for placement of one or more wires within the retainer ring for attachment to the one or more transducer probe assemblies [claim 13].
Schafer in paragraph birding page 57 and 58 and Figs. 4a-4d in page 58, discloses an analogous transducer probe assembly comprising a transducer with a clip mechanism (Fig. 4a) coupled to a ring (Fig. 4B, 4c and 4d), in Fig. 4b, the clip mechanism identical to that used in snap-on, center pinch camera lens covers is coupled to recessed notches/grooves, see Figs. 4b and 4c) a snap-on and a toggle mechanism are known alternative means of fixing two components together, the retainer ring is disclosed as having a debossment/ recessed feature, for routing one or more wires (see Fig. 4c). In view of the teachings of Schafer, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the one or more rings of Yang in view of Jordan to include a retainer ring comprising one or more recessed notches and a snap on or toggle mechanism so as to securely fasten the transducer assembly on the ring or include a recessed feature or debossment on the retainer ring, so as to arrange the cable away from ultrasound waves propagation path into the patient’s skin during treatment and for comfort of the patient when the ring is affixed on the patients skin.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan and Schafer as applied to claim 11 above, and further in view of Edwards et al., US 20170337737 A1 (“Edwards”).
Regarding claim 14, Yang in view of Jordan and Schafer discloses the invention of claim 14 as discussed above discloses, in modified Yang, one ring of the one or more rings will be positioned over a left temporal area of a patient during use, while a second one of the one or more rings will be positioned over a right temporal area for coupling a transducer assembly. However, Yang in view of Jordan and Schafer does not explicitly disclose wherein the one or more rings comprise a counterweight and a second ring is coupled to a transducer. However, the invention of modified Yang encompasses treatment on one side of the head and not the other, in such a configuration, one of the rings would not be coupled to a transducer assembly. Edwards teaches the use of counterweights to counterbalance weight of a headset, to enable effective weight distribution ([0035-0036]). In view of these teachings, at the time of filing the claimed invention, it would have been obvious to on having ordinary skill in the art to have modified the headset of Yang to include a counterweight, to be applied onto one or more rings that is not coupled to a transducer assembly, so as to enable effective weight distribution on the patient’s head during treatment.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan as applied to claim 1 above, and further in view of Lathrop et al., US 20160106508 A1 (“Lathrop”).
Regarding claims 15 and 16, Yang in view of Jordan as discussed in claim 1 above but does not further disclose wherein the forehead assembly comprises a quick-release attachment for attaching a head fiducial comprising a fiducial marker and a fiducial attachment.
Lathrop discloses that it was known in the prior art to attach tracking fiducials to a patient head, to allow a tracking system to identify and follow location of the patients head ([0007]), as depicted in Figs 8-10, a device mount 240 comprising a quick release mechanism is attached on a forehead assembly to hold and facilitate swapping of medical devices ([0072]), such as a rigid body supporting target fiducials. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the forehead assembly of the headset of Yang in view of Jordan to include a quick-release attachment for attaching a head fiducial comprising a fiducial marker and a fiducial attachment, so as to allow a tracking system to identify and follow location of the patient’s head while facilitating swapping of the head fiducial.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan as applied to claim 1 above, and further in view of Kim et al., US 20200000428 A1 (“Kim”).
Regarding claims 17 and 18, Yang in view of Jordan as discussed in claim 1 above but does not further disclose a probe fiducial that includes one or more reflecting balls coupled to one or more ultrasound transducers. Kim discloses a probe fiducial ([0047] , [0061] “second marker 33”) that includes one or more reflecting balls (“330”) coupled to an ultrasound generating device (“31”), to track a focus direction of the ultrasound generating device. In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have modified the headset of Yang in view of Jordan to include a probe fiducial that includes one or more reflecting balls coupled to one or more ultrasound transducers, so as to enable tracking of a focus of the ultrasound transducers, as taught by Kim in [0061].
Claims 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Jordan as applied to claim 1 above, and further in view of Alleman and in view of Pritz US 20170055623 A1.
Regarding claim 19, Yang discloses a back adjustment knob 13 (see Fig. 1), Yang in view of Jordan has been modified by the teachings of Alleman to include one ring that is positionable at an occipital prominence during use (see claim 8 above for obviousness rationale in view of the teachings of Alleman, the citations and discussions in claim 8 are applicable here) as such, Yang in view of Jordan and Alleman discloses a back-ring assembly comprising a ring and an adjustment knob.Yang does not explicltu disclose a latch assembly. However, Pritz in [0028] discloses knobs and latches as art recognized alternative fasteners. Inasmuch as Pritz discloses knobs and latches as art recognized alternatives, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), to arrive at the claimed invention.
Regarding claim 20, the back-ring assembly will be coupled to one or more transducers during use.
Regarding claim 21, as modified by the teachings of Jordan, the headstrap will be coupled to the ring of the back-ring assembly via one or more hooks, see Jordan [0089].
Regarding claim 22, the top strap will be coupled to the back ring assembly via hooks, but does not explicitly disclose a snap-fitted attachment. However, Pritz in [0028] discloses knobs and latches as art recognized alternative fasteners. Inasmuch as Pritz discloses hooks and snaps as art recognized alternatives, at the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), to arrive at the claimed invention.
Regarding claim 23, see discussion in claim 19 above, as modified by Pritz, the latch would comprise a self-locking ramp release pinion to tighten the headband strap as discussed by Pritz in [0044-0045].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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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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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797