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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 October 2025 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first end and second end of each cut-out extending beyond two adjacent intermediate channels must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. At this time it is unclear which embodiment or figure is relied upon for the invention as claimed, but none show ends of a cut-out (elements 212, 312, 412, 512, 612) extending beyond or being remotely near more than one intermediate channel (elements 142) in any of figures 3-7.
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 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-4 and 6-16 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. Claim 1 calls for the first end and second end of each cut-out to extend “beyond two adjacent intermediate channels”. As noted above, the disclosure and drawings of the instant invention do not describe or show a cut-out with ends extending beyond two channels – rather, all of the embodiments show a cut-out with ends extending beyond a single channel. The only two elements beyond which any cut-out extends are adhesive segments which define the channels – see, for example, annotated figures 5 and 6:
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No part of the disclosure describes any other embodiment where a cut-out might extend beyond more than one channel, such that the disclosure does not reasonably convey possession of a device with the first end and second end of each cut-out of a second adhesive member to extend “beyond two adjacent intermediate channels” of a first adhesive member at the time the invention was filed.
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 1-4 and 6-16 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 defines that “the plurality of cut-outs” are “disposed entirely between the plurality of intermediate channels”; the term “between” is generally used to describe a position relative to two objects, such that if more than two channels are present in the plurality of channels, it is unclear how these cut-outs might be distributed. Further, the claim continues by calling for the cut-outs to then “extend beyond two adjacent intermediate channels”. It is entirely unclear how the cut-outs are disposed entirely between the channels but also extend beyond them. Further, it is unclear if “adjacent” defines the relationship of the cut-out to the channels, or the channels to each other. Still further, it is unclear if these “two adjacent intermediate channels” includes the ”one intermediate channel” which is in communication with the second end of each cut-out or if that is an additional channel among the plurality of channels. Clarification is required.
Claim 4 recites that “the four intermediate channels are equally spaced between the four cut-outs”; claim 1 recites that the cut-outs are between the channels. In addition to the issues with “between” describing four points of reference, it is entirely unclear how the cutouts can be between the channels when the channels are between the cutouts. Clarification is required.
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.
Claim(s) 1-4, 6-8, 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0058380) in view of Thomas (US 2021/0161437).
Regarding claim 1, Lee discloses a medical device, comprising:
a base supporting an insertable member configured to be inserted in an anatomy (paragraph [0156]), the base having a perimeter (element 236; paragraphs [0176], [0188]);
a coupling system to couple the base to the anatomy, the coupling system includes a first adhesive member (element 278, adhesive pad) coupled to a second adhesive member (element 276), where the first adhesive member couples to the base and the second adhesive member is configured to adhere directly to the anatomy (paragraph [0187]);
where the first adhesive member defines a “main channel” within the perimeter of the base (paragraph [0258], these channels may “extend from a center portion of the electronics units housing 4420 in a straight line outwards to its edge in a spoke-like pattern” or “extend in a straight line, in a substantially straight line, or in a curve”, any one of these may be considered the “main channel”), and a plurality of intermediate channels between adjacent ones of a plurality of sections of adhesive material and in communication with the main channel (figure 44A, see the unlabeled element which corresponds to element 278 and which has a plurality of cutouts; paragraph [0258], the remainder of channels); and
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where the second adhesive member extends beyond the perimeter of the base (see figures 6, 44A). Lee also teaches an adhesive pad (i.e. “second adhesive member” herein) which includes at least one cut-out (paragraphs [0253], [0254]), where each cut-out includes a first end and a second end (figure 33, each of elements 552 includes multiple ends),
where the first end of each cut-out extends beyond the perimeter of the base to direct the moisture to the ambient environment (figure 33, elements 552 extend to the edge of the adhesive pad which as per figures 6 and 44A would be beyond the edge of the base). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have included at least one cut-out with first and second ends in the second adhesive member of Lee in order to enable moisture to be removed without needing to remove the adhesive pad from the host (paragraph [0252]).
Lee does not explicitly disclose that the second end of each second cut-out is in communication with the “main channel” and an “intermediate channel”, though as Lee does disclose a number of shapes and configurations for each layer which extend over each layer between a center point and the edge of each layer (paragraphs [0253], [0258]) there is likely to be overlap between channels and cut-outs. Thomas teaches a medical device which includes various cut-outs, grooves, and channels used to transport fluid from a subject’s body to the ambient environment, where the grooves and channels of adjacent elements are aligned and in communication (paragraph [0470]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Lee with the second cutouts’ first portions each in communication with the main channel, as taught by Thomas, in order to ensure that moisture reaches the outer perimeter of the device.
Lee and Thomas do not disclose the first and second ends of each cut-out extending beyond two adjacent intermediate channels, with each second cut-out having a first width defined along an axis and its respective intermediate channel having a second width defined along the same axis that is greater than the first width; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have had the ends of the cut-outs extending beyond corresponding intermediate channels, with the intermediate channels being of greater width across some axis than their cut-outs, since Applicant has not disclosed use of these particular shapes as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the channels in Lee and Thomas. Moreover, it appears that any combination of layers of channels would perform equally well to allow fluid transport, particularly as "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Lee and Thomas with each cut-out having a first width defined along an axis and its respective intermediate channel having a second width defined along the same axis that is greater than the first width, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Lee and Thomas.
Regarding claim 2, Lee further discloses that the plurality of cut-outs comprises four cut-outs (figure 33, see elements 552).
Regarding claim 3, Lee further discloses that the plurality of intermediate channels comprises four intermediate channels (figure 44A).
Regarding claim 4, Lee, as modified, does not specify that the four intermediate channels are equally spaced between the four cut-outs ; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have spaced the intermediate channels equally between the cut-outs, since Applicant has not disclosed use of this particular configuration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of Lee and Thomas. Moreover, it appears that any spacing of the channels and cut-outs so long as they remain in communication would perform equally well to allow transport of fluid. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Lee and Thomas with the four intermediate channels equally spaced between the four cut-outs, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Lee and Thomas.
Regarding claim 6, Lee further discloses that the plurality of cut-outs are equally radially spaced from a center axis of the second adhesive member (figure 34).
Regarding claim 7, Lee further discloses that each of the plurality of intermediate channels extends radially outward from the main channel (paragraph [0258]).
Regarding claim 8, Lee further discloses that the first adhesive member includes a central hub portion that defines a central bore to receive the insertable member (element 286, see figures 6 and 44A) and where the main channel is defined “between” the central hub portion and the plurality of sections (paragraph [0258]).
Regarding claim 10, Lee further discloses that the plurality of sections are located within the perimeter of the base (figures 6, 44A – as the plurality of sections are part of the first adhesive member 278 which is the same size as the base 236, the sections are inherently located within the perimeter of the base).
Regarding claim 11, Lee further discloses that the plurality of sections are located along the perimeter of the base (paragraph [0258], where the channels defining the sections extend to the base such that the sections between these channels are also inherently “along” the perimeter of the base).
Regarding claim 12, Lee further discloses that the second adhesive member includes a skin adhesive layer configured to adhere to the anatomy (element 556) and a backing layer located between the skin adhesive layer and the first adhesive member (element 554), and where the plurality of cut-outs are defined through both the backing layer and the skin adhesive layer (figure 34, the cut-outs extend through both layers).
Regarding claim 13, Lee further discloses that the first adhesive member is stacked on top of the second adhesive member (see figures 6, 44A). The Examiner notes that “on top of” is a relative term dependent upon a user’s orientation; these elements are in contact and, when viewed from above, the first member is “on top of” the second.
Regarding claim 14, Lee further disclose that the first adhesive member is located between the base and the second adhesive member (see figures 6, 44A).
Regarding claim 15, Lee further discloses that the insertable member is a sensor configured to sense a characteristic of an anatomy (paragraph [0125], [0156]).
Regarding claim 16, Lee further discloses that the sensor is a glucose sensor (paragraph [0126]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee, as modified and applied above, and further in view of Sass (US 2008/0249383).
Regarding claim 9, Lee, as modified above, does not explicitly disclose the “main channel” fully surrounding the central hub portion. Sass teaches a medical device with an adhesive member configured in the shape of a main channel surrounding a central hub portion, the main channel being in communication with a plurality of intermediate channels defining a plurality of sections (figure 3A; paragraph [0035]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Lee, as modified above, with the “main channel” fully surrounding the central hub portion, in order to ensure the area directly adjacent the central hub portion is securely adhered and prevent fluid from inadvertently being directed into the central hub portion.
Response to Arguments
Applicant's arguments filed 15 September 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant asserts that the previous rejections have been overcome by the amendments. The Examiner notes that the amendments have raised numerous new issues; the Examiner also notes that the amendments differ in language than the proposed amendments discussed during the interview of 5 September 2025.
Regarding the art rejections, Applicant argues that the relative locations and widths of the cut-outs and channels would require more than design choice in having ends extending and differing sizes, asserting that the Examiner has not presented “a convincing line of reasoning” despite having “review[ed] the Specification and ascertain[ed] if the limitation in question is disclosed as serving any advantage or particular purpose, or whether it solves a stated problem. The Examiner also should explain the reasoning used to determine that the prior art would have performed equally as well as the claimed invention.” These have been presented above. Applicant’s assertion that these relative widths and communication between cut-outs and channels would provide “a greater surface area” for transport of fluids is an inherent relationship in the art of fluid transport, where a greater dimension allows higher transport, and would not provide any particular purpose than the fluid transport also taking place in the cut-outs and channels of Lee and Thomas; further, one of ordinary skill in the art would also be concerned with optimizing the fluid flow such that adjusting the sizes and shapes of these components would be obvious as part of such optimization, particularly in light of inherent fluid transport mechanics. Applicant has not presented any arguments as to why the line of reasoning is not convincing beyond asserting that it is not, such that this is unpersuasive.
Applicant further argues that the relative sizes and locations of cut-outs and channels would require the use of improper hindsight. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Lee and Thomas both use adhesive patches to hold sensors to the body, where those adhesive patches are explicitly disclosed as including channels to enhance transport of sweat and other moisture away from the sensor – see Lee paragraphs [0257]-[0258], discussing sweat being advantageously transported away, and Thomas paragraph [0470] discussing fluid communication between the grooves to properly direct moisture away, such that inclusion of these cut-outs and channels and optimizing their relative sizes and locations to enhance transport would not require any impermissible hindsight from one of ordinary skill in the art also concerned with transport of fluid via channels/grooves/cut-outs in adhesive patches. The Examiner notes that Applicant also includes Sass in this discussion; as Sass is not relied upon to teach the limitation in question it will not be addressed further here. The Examiner notes that Applicant has not presented any remarks regarding the limitations which Sass is relied upon to teach.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791