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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1-3, 5-7, 9, 10, 12-18, 20, 22, and 24 are pending.
Claims 4, 8, 11, 19, 21, 23, and 25-73 were previously cancelled.
Claims 1, 5, 12, and 13 have been amended.
Comment regarding Amendments filed on October 20, 2025
Although Applicant discusses and argues in support of amendments to the specification in the response filed on October 20, 2025, Applicant does not appear to have properly submitted amendments to the specification. The amendments only appear in the Remarks. However, pursuant to MPEP § 714, II.A: “Each section of an amendment document (e.g., Specification Amendments, Claim Amendments, Drawing Amendments, and Remarks) must begin on a separate sheet to facilitate separate indexing and electronic scanning of each section of an amendment document for placement in a file wrapper.” (emphasis added).
Nevertheless, with the goal of a compact prosecution, Examiner has examined the amendments as if they were properly filed. After considering the objection to the specification and rejections for new matter (both discussed below), Examiner requests that the next response include amendments to the specification that are properly submitted. To avoid any confusion with respect to the October 20, 2025 response, Examiner strongly suggests filing a substitute specification that includes all of the amendments.
Specification
The amendments to the disclosure filed October 21, 2025 are objected to under 35 U.S.C. 132(a) because they introduce new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention.
“If new subject matter is added to the disclosure, whether it be in the abstract, the specification, or the drawings, the examiner should object to the introduction of new matter under 35 U.S.C. 132 or 251 as appropriate, and require applicant to cancel the new matter.” (MPEP 2163.06, I).
PNG
media_image1.png
200
400
media_image1.png
Greyscale
The added material which is not supported by the original disclosure include the amendments to paragraphs [0017] and [0257] and Figure 56. The amendments to the paragraphs are shown below as well as a comparison of the relevant portion of Figure 56 prior to and after the amendment.
[AltContent: textbox (Transducer face)][AltContent: textbox (Transducer face)]
PNG
media_image6.png
200
400
media_image6.png
Greyscale
The entire disclosure, including the claims, drawings, and description, when read by one having ordinary skill in the art do not support the amendments to the specification. These amendments do not merely rephrase the previously disclosed subject matter (see 2163.07, I), nor correct obvious errors (see 2163.07, II), nor describe features that are necessarily inherent. (see 2163.07(a)). These amendments introduce subject matter that was not disclosed at the time of filing. In other words, the amendments include new matter.
First, with respect to paragraph [0017], the amendments are not supported by the rest of the disclosure. The amendments tie the description in [0017] to Figure 56, yet there is no direct or exclusive connection between paragraph [0017] and Figure 56 nor any reason why one would believe that paragraph [0017] is directed to or applicable to Figure 56. Paragraph [0017] is within the “Summary” portion of the description. The Summary refers to various embodiments that include a coupling pad and a handheld device. These embodiments are shown throughout the application. For example, Figures 1A-1C, 2A-2C, 3A-3D, 4A, 4B illustrate coupling pads (also called acoustic couplers) attached to handheld devices (which can have ultrasound energy sources, device bodies, and energy delivery elements). The Summary extends between paragraphs [0010] and [0057] all of which do not refer to any particular drawing or reference number. There is no reason why a person skilled in the art would understand that paragraph [0017] was describing the embodiment shown in Figure 56.
Moreover, there is no reason why a person skilled in the art would understand that a certain particular portion of the coupling pad in Figure 56 was a “first area 5601” while another portion was a “second area 5603,” especially when the rest of the original disclosure does not identify any other similar areas or parts as such.
Second, with respect to paragraph [0297], the amendments are not supported by the rest of the disclosure. In particular, the disclosure does not support changing the general description of “the attachment between the coupling pad 5602 and the ultrasound device 5610” to the more specific description of “the attachment (snap fit) between a first area 5601 and a second area 5603 of the second part 5606 of the coupling pad 5602 and the ultrasound device 5610.” Prior to the amendments (text and drawings), the disclosure generally referred to two elements being attached. After the amendments, the disclosure is attempting to specify that two elements are snap-fit and one element is secured between two opposing surfaces of another element. While the application refers to the possibility of snap-fit connections, the application refers to many different types of attachment. (see, e.g., [0120], [0127], [0128], [0129], [0228], [0235], [0237], [0238], and [0257] describing various attachment mechanisms). The embodiment shown in Figure 56 might be consistent with a coupling pad that can be snap-fit, but it is also consistent with other attachment means, including threaded connections, slots, and protruding tabs (Id.).
Accordingly, the amendments to paragraphs [0017] and [0297] and Figure 56 introduce new matter. Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-3, 5-7, 9, 10, 12-18, 20, 22, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
“While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure.” (MPEP 2163 I, B). “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention as now claimed.” (Id.)
With respect to claim 1, the claim limitations that Applicant now seeks to add were not adequately supported in the disclosure as originally-filed. As discussed above with respect to the specification, the amendments to paragraphs [0017] and [0297] and Figure 56, which include subject matter now recited in claim 1, were not supported by the disclosure as originally filed. Likewise, these claim limitations are not supported by the disclosure as originally-filed. (See MPEP 2163.01: “While the test or analysis of description requirement and new matter issues is the same, the examining procedure and statutory basis for addressing these issues differ.”).
Applicant amended claim 1 to recite “[a] coupling pad for a handheld device for vulvovaginal rejuvenation, the coupling pad comprising a first portion; and a second portion…wherein the second portion is shaped for coupling onto an ultrasound energy source of the handheld device; wherein a snap fit is formed via coupling a first area of the second portion of the coupling pad to the ultrasound energy source before coupling a second area of the second portion of the coupling pad to the ultrasound energy source….” (emphasis added).
With respect to the claim limitations specifically, the originally-filed disclosure does not adequately support a snap fit in which a first area of the second portion of the coupling pad is coupled to the ultrasound energy source before coupling a second area of the second portion of the coupling pad to the ultrasound energy source. Note that the ultrasound energy source is equivalent to the transducer. (see [0122] of Applicant’s disclosure). As best understood by the Examiner, Figure 56 demonstrates that the alleged first area 5601 directly engages/contacts the body (not enumerated) of the device 5610 prior to the alleged second area 5603 directly engaging/contacting the body of the device. The ultrasound energy source (i.e., the transducer 5608) does not appear to directly engage/contact either of the areas 5601, 5603. If either of the areas 5601, 5603 “couple to” (i.e., connect to) the transducer 5608, it appears to occur simultaneously when the alleged snap-fit occurs.
With respect to “wherein the snap fit has a greater force between the first area and the ultrasound energy source than between the second area and the ultrasound energy source,” as noted above, the first and second areas do not directly engage the ultrasound energy source. Instead, the first and second area directly engage the body of the device.
Accordingly, the disclosure does not convey with reasonable clarity to those skilled in the art that, as of the filing date, that the inventors were in possession of the invention now recited in claim 1.
With respect to claim 12, the claim limitations that Applicant now seeks to add were not adequately supported in the disclosure as originally-filed. Claim 12 depends from claim 1 and recites “wherein the snap fit of the coupling pad and the handheld device comprises a first area configured to couple to a contour of the handheld device and a second area configured to couple to an edge of the handheld device, wherein the snap fit between the coupling pad and the handheld device is configured to engage the coupling pad and the handheld device with greater force in the first area than in the second area.”
As noted above, claim 12 depends from claim 1 which recites that the first and second areas couple to the ultrasound energy source at different times. It is not clear (see indefiniteness rejection below) if “a first area” and “a second area” in claim 12 are different from the first and second areas of claim 1. Regardless, the alleged first area 5601 (not second area 5603) couples to the edge (not enumerated) in Figure 56 and the alleged second area 5603 (not first area 5601) couples to the contour of the handheld device.
Moreover, there is no support for “the snap fit between the coupling pad and the handheld device [being] configured to engage the coupling pad and the handheld device with greater force in the first area than in the second area.” Applicant refers to paragraph [0285], but this paragraph is referring to Figures 52A-52E, which illustrate an assembly for manufacturing the coupling pad 5100. Paragraph [0285] is not clearly tied to the embodiment of Figure 56. In addition, paragraph [0285] refers to parts of the coupling pad and portions of the coupling pad. Reference to the second part appear to be a reference to the “second part 5104.” However, references to “portion” appear to refer to that portion of the coupling pad that directly engages the transducer face. Neither of the alleged first area 5601 or the alleged second area 5603 directly engage the transducer face.
Accordingly, the disclosure does not convey with reasonable clarity to those skilled in the art that, as of the filing date, that the inventors were in possession of the invention now recited in claim 12.
Because all dependent claims either depend directly or indirectly from claim 1, all claims are rejected for lacking support in the written description.
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.
Claims 1-3, 5-7, 9, 10, 12-18, 20, 22, and 24 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 1 recites a “coupling pad for a handheld device for vulvovaginal rejuvenation, the coupling pad comprising a first portion; and a second portion…wherein the second portion is shaped for coupling onto an ultrasound energy source of the handheld device; wherein a snap fit is formed via coupling a first area of the second portion of the coupling pad to the ultrasound energy source before coupling a second area of the second portion of the coupling pad to the ultrasound energy source….” (emphasis added).
It is not clear if claim 1 only requires a coupling pad or if claim 1 requires both a coupling pad and a handheld device. “The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent.” (MPEP 2173). Claim 1 was amended to overcome the prior art by reciting that a snap-fit exists between the coupling pad and the ultrasound energy source. First, this does not appear to be mere intended-use language as the recitation requires a particular structural/spatial relationship, specifically, that the first area couples to the energy source before the second area couples to the energy source. Second, and more importantly, Applicant is relying upon a structural relationship (i.e., the recited “snap fit”) to overcome the rejections based on KRONE and LINDEKUGEL. A snap-fit only exists if both elements are designed with respect to one another. For example, a “snap” occurs only if the elements have complementary shapes and at least one of the elements is capable of being temporarily displaced or otherwise deformed and then returning or “snapping” back toward the original shape. To be clear, if the claim requires a “snap fit” between two elements and Applicant is relying upon that snap-fit to overcome the prior art, then the claim requires both elements.
However, claim 1 recites “a coupling pad for a handheld device.” Claim 1 does not positively recite the handheld device or a component of the handheld device. Thus, it is not clear if claim 1 requires both the coupling pad and the ultrasound energy source.
Claim 12 recites “wherein the snap fit of the coupling pad and the handheld device comprises a first area configured to couple to a contour of the handheld device and a second area configured to couple to an edge of the handheld device, wherein the snap fit between the coupling pad and the handheld device is configured to engage the coupling pad and the handheld device with greater force in the first area than in the second area.”
First, claim 12 is indefinite because it is not clear if “a first area” and “a second area” refer to the first area and the second area recited in claim 1 or different areas.
Second, similar to claim 1 above, claim 12 was amended to positively recite that the “snap fit…comprises a first area configured to couple to a contour of the handheld device and a second area configured to couple to an edge of the handheld device…” First, this does not appear to be mere intended-use language as the recitation requires that the snap fit have a first area and a second area. Moreover, the claim requires that the snap fit is configured to engage with greater force in one area over another. Second, Applicant is relying upon this structural relationship (i.e., the recited “snap fit”) to overcome the rejections based on KRONE and LINDEKUGEL. A snap-fit only exists if both elements are designed with respect to one another. Again, if the claim requires a “snap fit” between two elements and Applicant is relying upon that snap-fit to overcome the prior art, then the claim requires both elements.
However, claim 12 does not positively recite the handheld device or a component of the handheld device. Thus, it is not clear if claim 12 requires both the coupling pad and the ultrasound energy source.
NOTE: To overcome this Section 112(b) rejections, Examiner suggests either positively reciting the ultrasound energy source and/or handheld device (e.g., claim 1 recites “an assembly comprising a coupling pad and a handheld device having an ultrasound energy source….”) or amending the claims so that it is clear that the coupling pad must only be capable of forming a snap fit with another element.
In the interest of a compact prosecution, Examiner is interpreting claim 1 (and consequently claim 12) to positively recite a handheld device having an ultrasound transducer. Examiner is also interpreting claim 12 to recite “[[a]]the first area” and “[[a]]the second area.”
Based on the disclosure (e.g., Figure 56) Examiner is also interpreting the last limitation in claim 1 as follows: “wherein the snap fit has a greater force between the first area and the handheld device than between the second area and the handheld device.”
Because all dependent claims either depend directly or indirectly from claim 1, all claims are rejected for being indefinite.
RESPONSE TO APPLICANT’S ARGUMENTS
In favor of the amendments to claim 12 (which are similar to those recited in claim 1) filed on October 20, 2026, Applicant argues that the amendments are “supported by replacement Figure 56.” However, as discussed above, the changes to Figure 56 and amendments to paragraphs [0017] and [0297] constitute new matter.
Also, in favor of the “greater force” limitation in claim 12 (which is also recited in claim 1), Applicant relies upon paragraph [0285]. However, as discussed above, paragraph [0285] refers to Figures 52A-52E, which illustrate an assembly for manufacturing the coupling pad 5100. Paragraph [0285] is not clearly tied to the embodiment of Figure 56. Even if it were, however, paragraph [0285] does not support the amendments to claims 1 and 12. Paragraph [0285] refers to parts of the coupling pad and portions of the coupling pad. Reference to the second part appear to be a reference to the “second part 5104.” However, references to “portion” appear to refer to that portion of the coupling pad that directly contacts the transducer face (e.g., see “gradual contact” discussion immediately below). Neither of the alleged first area 5601 or the alleged second area 5603 directly contact the transducer face.
In support of the claim amendments, Applicant emphasizes the last sentence in [0285]: “In some embodiments, this effect may be enhanced by forming the snap feature (or other interference fit feature) to be tighter at a portion of the coupling pad, causing the looser portion of the snap feature to be connected first, thereby forcing a user to first contact only a portion of the coupling pad to the transducer face.” However, the term “this effect” refers to gradual contact between the transducer face and the coupling pad material. Specifically, the gradual contact chases “any air bubbles out from between the coupling pad and the transducer.” (Id).
But claims 1 and 12 are not claiming this feature in which the transducer face and the coupling pad gradually contact each other to chase away bubbles between them. As shown in the annotated Figure 56 above, the first and second areas 5601, 5603 do not directly contact the transducer face where the unwanted bubbles would appear. Thus, [0285] does not support the amendments to claims 1 and 12.
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 1-3, 7, 9, 10, 12-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2019/0060675 A1 to Krone et al. (hereinafter referred to as “KRONE”) and U.S. Patent Appl. Publ. No. 2013/0338503 A1 to Cohen et al. (hereinafter referred to as “COHEN”).
With respect to claim 1 (and in light of the Section 112 rejection), KRONE teaches a coupling pad for a handheld device for vulvovaginal rejuvenation. “A handheld ultrasound device and corresponding methods used for rejuvenating the vulvovaginal area of the user.” (Abstract). KRONE teaches several examples of “coupling pads” or “acoustic couplers” of the handheld device. (see, e.g., [0082]: “The energy delivery element 112 may include an acoustic coupler 114 or coupling pad….”). The coupling pad includes a first portion and a second portion. “FIG. 43 illustrates an embodiment of a coupling pad component 4300 comprising a support ring 4304 and a coupling pad 4302. In this embodiment, the coupling pad comprises two different materials, as described above. A first portion 4306 of the coupling pad comprises a first material, and a second portion 4308 of the coupling pad comprises a second material, different from the first.” ([0215]). NOTE: The first portion 4306 is being interpreted as at least part of the claimed “second portion” and the second portion 4308 is being interpreted as at least part of the claimed “first portion.” KRONE also teaches a support ring 4304 that is also considered a part of the second portion. Notably, KRONE teaches that the support rings may be molded with the first portion of the coupling pad. (see, e.g., [0171] et seq. and accompanying Figures). “The coupling pad can be molded onto a support ring configured to provide structure to the coupling pad component. The support ring and coupling pad can together form the disposable component of the handheld device.” ([0171]).
KRONE teaches the handheld device throughout the reference. (see, e.g., the devices 100 having respective bodies 110 in Figures 1A-1C, 2A-2C, and 3A-3C).
KRONE also teaches wherein the second portion has a higher durometer than the first portion. “For example, the first portion 4306 [i.e., at least part of the claimed second portion] can comprise 2% agarose; and the second portion [i.e., claimed first portion] can comprise 0.5% agarose.” The portion having a higher concentration of agarose will inherently have a higher durometer. (see, e.g., Normand, Valéry, et al. “New insight into agarose gel mechanical properties.” Biomacromolecules 1.4 (2000): 730-738).
KRONE also teaches wherein the second portion is shaped for coupling onto an ultrasound energy source of the handheld device. The second portion in KRONE is shaped for coupling onto an ultrasound energy source using the support ring 4304.
KRONE does not explicitly teach wherein a snap fit is formed via coupling a first area of the second portion of the coupling pad to the ultrasound energy source before coupling a second area of the second portion of the coupling pad to the ultrasound energy source and wherein the snap fit has a greater force between the first area and the ultrasound energy source than between the second area and the ultrasound energy source. Nevertheless, KRONE teaches that various attachment mechanisms may be used. (see, e.g., [0120], [0127], [0128], [0129], [0228], [0235], [0237], [0238], and [0257]) and even suggests that snap-fits may be used. (see, e.g., [0024]: “The method can comprise alerting the user to sufficient contact between the coupling pad and the energy source via feature locks that provide snap sounds.”; and [0093]: “These feedback mechanisms include simple feature locks that may provide “snap” sounds to inform the user the part is seated;….”; and [0094]: “This adjustment can be achieved
PNG
media_image7.png
800
517
media_image7.png
Greyscale
[AltContent: textbox (“first area” engaging contour of device)][AltContent: textbox (“second area” engaging edge of device)]by spring-loaded features, magnetic or mechanical snap fits,….”).
In the same field of endeavor, COHEN teaches an ultrasound imaging device that has the ability to determine when a removable probe cap is attached to a portion of an ultrasound probe. (Abstract). “Such a cap can include a spacer component to provide a standoff for the probe head, which enables relatively shallow subcutaneous structures of the patient's body to be suitably imaged. The spacer component of the probe cap is implemented in one embodiment as an acoustically transparent hydrogel insert that enables the cap to slide easily over the skin of a patient during ultrasound imaging procedures.” ([0002]).
Fig. 5 of COHEN is a cross sectional side view of a portion of an ultrasound probe and attachable cap. ([0011]). In particular, “Fig. 5 depicts the positional relationship between the probe head surface 44A and the hydrogel insert 54 when the cap 50 is attached to the probe 40.” ([0039]). Notably, the cap 50 is secured to the probe “via a snap-fit arrangement….” ([0038]). Moreover, the annotated Figure 5 shown here demonstrates that COHEN teaches a snap fit that is formed via coupling a first area to the ultrasound energy source before coupling a second area to the ultrasound energy source. More specifically, the first area includes a portion of the cap that resiles (or “bounces back”) into the depressed contour, thereby causing a snap, prior to the second area coupling to the device and/or ultrasound energy source.
Furthermore, the annotated Figure 5 also demonstrates that COHEN teaches that the snap fit has a greater force between the first area and the device and/or the ultrasound energy source than between the second area and the device and/or the ultrasound energy source. More specifically, the first area snaps such that a portion of the cap 50 presses into the surface that defines the depressed contour. On the other hand, the second area has a tiny gap between the surface of the device and an interior surface of the cap.
NOTE: “During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification.” (MPEP 2111). Applicant describes embodiments that include two-part coupling pads (see, e.g., [0297] and Figure 56). The embodiment of Figure 56 includes a first part and a second part. “The first part may comprise a lower durometer material and may be configured to engaging with a user's anatomy. The second part 5606 may comprise a higher durometer than the first part and may be configured to attach to the ultrasound device 5610.” ([0297]).
COHEN also teaches a two-part coupling pad having a hydrogel insert 54 and a cap 50. Similarly, KRONE teaches a two-part coupling pad (e.g., 3304) that includes a support ring (e.g., 3308) molded with a medium for the coupling pad. (see, e.g., [0185] and Figure 33; see also [0179] and Figure 30 showing a cross-section of a similar two-part design).
It would have been obvious to one having ordinary skill in the art at the time of filing to use COHEN’s cap design and integrate it with a mold of the coupling pad as taught in KRONE. One would be motivated to mold the support ring and the coupling pad material together in order to provide structure to the coupling pad (see, e.g., [0171] of KRONE) and also make the design simpler to use and ship. (see, e.g., [0181]). One would be motivated to use the cap design in COHEN because the snap-fit arrangement provides a simple and effective way to quickly attach the coupling pad to the device body. There would have been a reasonable expectation of success as COHEN and KRONE teach that support rings/caps can be molded with the coupling pad and can be used to quickly attach the coupling pad to the device.
With respect to claim 2, KRONE teaches wherein the first portion and the second portion comprise a gel. “For example, the first portion 4306 [i.e., at least part of the claimed second portion] can comprise 2% agarose; and the second portion [i.e., claimed first portion] can comprise 0.5% agarose.” (emphasis added) ([0215]). Agarose is a hydrogel or gel. See also [0085] describing various forms of the acoustic coupler including “preformed gel,” “acoustic conducting gel,” and “gel.”
With respect to claim 3, KRONE teaches wherein the first portion comprises a rounded shape and is configured to engage tissue at or near the vulva and introitus. See, e.g., the rounded shape in Figure 43. A rounded shape is also described throughout KRONE as a desirable shape. “All volunteers found the Oval Nub and Dome to be more comfortable than the Round Nub and Ridge.” ([0136] and Figure 11; see also Figure 12 illustrating the “short dome 1202” which was “reported to be the most comfortable contour.” ([0140]).
With respect to claim 7, KRONE teaches wherein the first and second portions comprise agarose. The two portions 4306, 4308 in the embodiment of Figure 43 comprise different concentrations of agarose. ([0215]).
With respect to claim 9 (depending from claim 7), KRONE teaches the subject matter of claims 1 and 7 as discussed above. KRONE does not explicitly teach the second portion comprises about 4-6% agarose.
However, KRONE teaches agarose concentrations up to 5% can be used and still accomplish performance goals, such as minimizing ultrasound attenuation and having a high shear strength (durability). (see, e.g., [0121] and [0123]). It is known that higher concentrations of agarose will inherently have a higher durometer. (see, e.g., Normand, Valéry, et al. “New insight into agarose gel mechanical properties.” Biomacromolecules 1.4 (2000): 730-738) (see also Table 1 of KRONE acknowledging that agarose is “[f]airly deformable depending on agarose concentration.”).
Moreover, KRONE teaches that a coupling pad may have combination of agarose layers/portions having different concentrations. ([0215]). In the embodiment shown in Figure 43, a top portion 4308 of the coupling pad (i.e., the portion that contacts the user’s tissue) is 0.5% agarose while a base portion 4306 that supports the top portion has 2% agarose.
It would have been obvious to modify the base portion of the coupling pad such that agarose concentration was 4-5%. KRONE teaches that an agarose concentration of up to 5% achieves the desired performance goals of minimizing attenuation and having sufficient strength or durability. One would have been motivated to increase the agarose concentration of the base portion because higher agarose concentrations correspond to greater durability. The base portion does not contact the user but supports the top portion having greater deformability. As such, there would not be a significant loss to the deformability of the coupling pad. There would be a reasonable expectation of success because KRONE teaches that different portions of the coupling pad can have different agarose concentrations. See MPEP 2144.05(II).
With respect to claim 10 (depending from claim 7), wherein the first portion comprises about 1-2% agarose. In the embodiment of Figure 43, KRONE provides one example of material that may be used for the claimed first portion: “For example,…the second portion [i.e., claimed first portion] can comprise 0.5% agarose.” (emphasis added) ([0215]).
However, KRONE teaches elsewhere that various concentrations between 0.5% and 5.0% can be used. (see, e.g., [0123]). In fact, when discussing a process to select the best material, KRONE taught that “[l]ubricity can be key to maximizing energy delivery, as it decreases the acoustical impedance at the tissue interface by minimizing air gaps between the ultrasound device and the user’s tissue.” ([0118]). KRONE examined agarose concentrations between 0.5% and 5.0% and found that “2% agarose optimized the performance goals.” (emphasis added) ([0123]). Moreover, KRONE teaches testing coupling pad prototypes having different contours. The prototypes were made “from both Shore 10A silicone and 2% agarose.” The preferred shape is similar to the embodiment of Figure 43. “As shown in Table 4 below, the short dome 1202 was reported to be the most comfortable contour.” ([0140]).
It would have been obvious to one skilled in the art to modify the embodiment of Figure 43 such that the first portion of the coupling pad included 1-2% agarose. The coupling pad 4302 includes first and second portions that each comprise agarose of differing concentrations. Based on KRONE’s teachings in which the preferred composition of the coupling pad included 2% agarose for a similarly shaped coupling pad, one would have been motivated to modify the coupling pad so that the first portion (the portion that contacts the user) has a concentration of 1-2% agarose. There would have been a reasonable expectation of success because, as taught in KRONE, the coupling pad can comprise layers/portions having different concentrations. See
PNG
media_image7.png
800
517
media_image7.png
Greyscale
[AltContent: textbox (“first area” engaging contour of device)][AltContent: textbox (“second area” engaging edge of device)]MPEP 2144.05(I)(II).
With respect to claim 12 (and in light of the Section 112 rejection), KRONE does not teach wherein the snap fit of the coupling pad and the handheld device comprises a first area configured to couple to a contour of the handheld device and a second area configured to couple to an edge of the handheld device, wherein the snap fit between the coupling pad and the handheld device is configured to engage the coupling pad and the handheld device with greater force in the first area than in the second area.
As discussed above with respect to claim 1, COHEN teaches an ultrasound imaging device that has the ability to determine when a removable probe cap is attached to a portion of an ultrasound probe. (Abstract). “Such a cap can include a spacer component to provide a standoff for the probe head, which enables relatively shallow subcutaneous structures of the patient's body to be suitably imaged. The spacer component of the probe cap is implemented in one embodiment as an acoustically transparent hydrogel insert that enables the cap to slide easily over the skin of a patient during ultrasound imaging procedures.” ([0002]).
Fig. 5 of COHEN is a cross sectional side view of a portion of an ultrasound probe and attachable cap. ([0011]). In particular, “Fig. 5 depicts the positional relationship between the probe head surface 44A and the hydrogel insert 54 when the cap 50 is attached to the probe 40.” ([0039]). Notably, the cap 50 is secured to the probe “via a snap-fit arrangement….” ([0038]). Moreover, the annotated Figure 5 shown here demonstrates that COHEN teaches a snap fit that is formed via coupling a first area to the ultrasound energy source before coupling a second area to the ultrasound energy source. More specifically, the first area includes a portion of the cap that resiles (or “bounces back”) into the depressed contour, thereby causing a snap, prior to the second area coupling to the device and/or ultrasound energy source.
Furthermore, the annotated Figure 5 also demonstrates that COHEN teaches that the snap fit has a greater force between the first area and the device and/or the ultrasound energy source than between the second area and the device and/or the ultrasound energy source. More specifically, the first area snaps such that a portion of the cap 50 presses into the surface that defines the depressed contour. On the other hand, the second area has a tiny gap between the surface of the device and an interior surface of the cap.
NOTE: “During patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification.” (MPEP 2111). Applicant describes embodiments that include two-part coupling pads (see, e.g., [0297] and Figure 56). The embodiment of Figure 56 includes a first part and a second part. “The first part may comprise a lower durometer material and may be configured to engaging with a user's anatomy. The second part 5606 may comprise a higher durometer than the first part and may be configured to attach to the ultrasound device 5610.” ([0297]).
COHEN also teaches a two-part coupling pad having a hydrogel insert 54 and a cap 50. Similarly, KRONE teaches a two-part coupling pad (e.g., 3304) that includes a support ring (e.g., 3308) molded with a medium for the coupling pad. (see, e.g., [0185] and Figure 33; see also [0179] and Figure 30 showing a cross-section of a similar two-part design).
It would have been obvious to one having ordinary skill in the art at the time of filing to use COHEN’s cap design and integrate it with a mold of the coupling pad as taught in KRONE. One would be motivated to mold the support ring and the coupling pad material together in order to provide structure to the coupling pad (see, e.g., [0171] of KRONE) and also make the design simpler to use and ship. (see, e.g., [0181]). One would be motivated to use the cap design in COHEN because the snap-fit arrangement provides a simple and effective way to quickly attach the coupling pad to the device body. There would have been a reasonable expectation of success as COHEN and KRONE teach that support rings/caps can be molded with the coupling pad and can be used to quickly attach the coupling pad to the device.
With respect to claim 13, COHEN teaches that the cap 50 forms a second portion that forms a lip around an edge of the first portion of the coupling pad. See Figure 5 of COHEN in which an edge of the first portion (i.e., hydrogel insert 54) is sandwiched between a lip of the second portion (i.e., cap 50) and the body of the probe head 40.
With respect to claim 14, COHEN teaches that the cap 50 (i.e., lip) forms a depression that is shaped to receive a transducer face of the handheld device. See Figure 5 of COHEN in which the cap 50 forms a cavity (i.e., depression) that receives a portion of the probe head 40.
With respect to claim 15, COHEN teaches that the cap 50 and hydrogel insert 54 form a bottom surface of the depression that is flat.
With respect to claim 17, KRONE teaches wherein attachment between the second portion and the ultrasound energy source of the handheld device is configured to hold a surface of the coupling pad against a transducer face of the handheld device. “The relative orientation of the ultrasound energy source 102 and the energy delivery element 112 may be achieved using couplers 118 that mate between the ultrasound energy source 102 and the attachment mechanism 116 (see FIG. 3B).” The very purpose of each embodiment with a removable coupling pad in KRONE is to hold a surface of the coupling pad against a transducer face of the handheld device so that the ultrasound energy may be directed onto the patient’s tissue. (see also [0025] and [0093]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2019/0060675 A1 to Krone et al. (hereinafter referred to as “KRONE”) and U.S. Patent Appl. Publ. No. 2013/0338503 A1 to Cohen et al. (hereinafter referred to as “COHEN”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0223837 A1 to Petrossian et al. (hereinafter referred to as “PETROSSIAN”).
With respect to claims 5 and 6, KRONE does not explicitly teach a single embodiment that, in addition to the second portion snap-fitting with an ultrasound source, the second portion is also configured for coupling to other structures via magnetic attachments, as recited in claim 5, or that the second portion comprises one or more metal components configured for magnetic attachment to the handheld device, as recited in claim 6. However, in the “Summary of the Disclosure,” KRONE teaches a coupling assembly for coupling the energy delivery element to the handheld device in which “the coupling assembly comprises magnets arranged and configured for magnetically coupling to corresponding magnets on a portion of the energy delivery element.” (emphasis added) ([0012]). Claim 1 of KRONE recites that “the coupling pad [is] detachably connected to the energy delivery element via magnets and comprising a dome shaped contour….” (emphasis added) (see also [0016] disclosing an “attachment means” having “magnets.”). Also within the “Summary of the Disclosure,” KRONE teaches “[r]emovably attaching the energy delivery element to the handheld device can comprise engaging magnets positioned on the energy delivery element with magnets positioned on the handheld device.” (emphasis added) ([0023]). In addition to magnets being described generally for multiple embodiments in KRONE, Figures 36A-36D show a coupling pad portion 3600 that is similar to the coupling pad component 4300. “FIG. 36B shows a bottom surface 3606 of the support ring. The bottom surface 3606 comprises attachment means, such as magnets 3608, configured to engage with corresponding attachment means on a head portion of the main device.” ([0206]). NOTE: Examiner is interpreting the “second portion” as including the support ring 4304 and the first portion 4306.
In the same field of endeavor, PETROSSIAN teaches a disposable probe that is configured to be removably attached to a base. (Abstract). “In some arrangements, the base 102 and/or the disposable probe 101 include magnets and in some examples, metal disks to further aid in installation and alignment of the disposable probe 101 with respect to the base 102. As shown, the base 102 includes magnets 116, while the disposable probe 101 includes metal contacts 118 configured to align with the magnets 116 (or vice versa) via magnetic attraction or coupling. That is, the magnets 116 are configured to be magnetically attracted to the metal contacts 118 due to magnetism.” ([0052]). The metal contacts 118 are embedded within a
PNG
media_image9.png
659
515
media_image9.png
Greyscale
housing of the probe 101.
Moreover, the magnetic connection may be one of multiple mechanisms used to connect the base 102 and the disposable probe 101. “In other words, the disposable probe 101 includes a connection interface 150 configured to removably attach to a connection interface 155 of the base 102. The connection interface 150 includes one or more of the pins 112, the metal contacts 118, and other suitable connection mechanisms…The connection interface 155 includes one or more of the recessed contacts 114, the magnets 116, and other suitable connection mechanisms.” ([0054]). Other suitable mechanisms include “press fitting, compression fitting, snap fitting, friction fitting….” ([0052]).
It would have been obvious to one skilled in the art to add one or more metal components to the second portion and magnets to the handheld device (or vice versa) so that the magnetic attraction between the two would facilitate aligning and snap-fitting the coupling pad to the handheld device. One would have been motivated to provide an additional mechanism for coupling by adding the metal components or magnets because magnetic attraction is a simple and proven way to align the components prior to or during the snap-fitting process. There would have been a reasonable expectation of success because, as taught in KRONE and PETROSSIAN, magnets can be used to connect components.
Claims 16 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2019/0060675 A1 to Krone et al. (hereinafter referred to as “KRONE”) and U.S. Patent Appl. Publ. No. 2013/0338503 A1 to Cohen et al. (hereinafter referred to as “COHEN”) as applied to claims 14 and 1, respectively, above, and further in view of U.S. Patent Appl. Publ. No. 2014/0180116 A1 to Lindekugel et al. (hereinafter referred to as “LINDEKUGEL”).
With respect to claim 16, neither KRONE nor COHEN teach that the coupling pad has a bottom surface of the depression is convex.
In the same field of endeavor, LINDEKUGEL teaches that the spacer component 118 (coupling pad) has a bottom surface of the depression is convex. More specifically, Figure 20 of LINDEKUGEL teaches a spacer component 118 that is very similar to the spacer component shown in Figure 18B. “FIG. 20 shows that a probe contact surface 136 of the compliant spacer component 118 also defines a convex surface.” ([0080]). The front face of the head of the probe also has a convex shape. (Id., see Figures 19 and 21). When the “convexly shaped probe contact surface 136 of the spacer component 118 deformably engages the convexly shaped acoustic surface 134 of the probe head 32 so as to ensure adequate contact therebetween and to provide a suitable acoustic path through the spacer component.” ([0080]).
It would have been obvious to one skilled in the art at the time of invention to shape the second portion so that the depression has a bottom surface that is convex. One would have been motivated to shape the bottom surface to be convex “to ensure adequate contact…and to provide a suitable acoustic path through” the second portion when engaging a probe having a front surface that is also convex. There would have been a reasonable expectation of success because, as shown in LINDEKUGEL, the second portion can be shaped so that the bottom surface has a convex shape.
With respect to claim 24, neither KRONE nor COHEN teach that the coupling pad comprises a convex device facing surface
In the same field of endeavor, LINDEKUGEL teaches that the spacer component 118 (coupling pad) comprises a convex device facing surface. More specifically, Figure 20 of LINDEKUGEL teaches a spacer component 118 that is very similar to the spacer component shown in Figure 18B. “FIG. 20 shows that a probe contact surface 136 of the compliant spacer component 118 also defines a convex surface.” ([0080]). The front face of the head of the probe also has a convex shape. (Id., see Figures 19 and 21). When the “convexly shaped probe contact surface 136 of the spacer component 118 deformably engages the convexly shaped acoustic surface 134 of the probe head 32 so as to ensure adequate contact therebetween and to provide a suitable acoustic path through the spacer component.” ([0080]).
It would have been obvious to one skilled in the art to shape the second portion so that the second portion has a convex device facing surface. One would have been motivated to shape the surface facing the device to be convex “to ensure adequate contact…and to provide a suitable acoustic path through” the second portion when engaging a probe having a front surface that is also convex, as taught in LINDEKUGEL. ([0080]). There would have been a reasonable expectation of success because, as shown in LINDEKUGEL, the second portion can be shaped so that the surface facing the device is convex.
Claims 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2019/0060675 A1 to Krone et al. (hereinafter referred to as “KRONE”) and U.S. Patent Appl. Publ. No. 2013/0338503 A1 to Cohen et al. (hereinafter referred to as “COHEN”) as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2015/0231415 A1 to Lewis et al. (hereinafter referred to as “LEWIS”).
PNG
media_image10.png
542
567
media_image10.png
Greyscale
With respect to claim 18, KRONE does not teach wherein attachment between the second portion and the ultrasound energy source of the handheld device comprises foil or wire. However, KRONE does teach the desirability of features that can provide feedback to inform the user whether contact between the transducer face and the coupling pad is non-optimal.([0093]).
In the same field of endeavor, LEWIS teaches coupling adapters for coupling a transducer to a coupling medium. (Abstract). The coupling adapter is configured to prevent operation of the ultrasound transducer when not properly coupled with the ultrasound coupling adapter and/or ultrasound coupling medium. (Id).
“FIG. 14 shows an ultrasound coupling adapter 10 with embedded metallic or electrically conductive ring 29. The conductive ring 29 may extend completely or partially around the perimeter of the ultrasound coupling adapter 10. The conductive ring 29 may further be located at any dimension along the height of the ultrasound coupling adapter 10. When the ultrasound transducer 40 is connected to the ultrasound coupling adapter 10, electrical means 72 are used to either activate the treatment, in the form of two or more contacts 21 on the ultrasound transducer 40 electrically connected by the conductive ring 29 on the ultrasound coupling adapter 10.” ([0113]).
It would have been obvious to one skilled in the