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 .
This Office Action is responsive to the Reply to Office Action filed May 21, 2025. The Examiner acknowledges the amendments to claims 1-3 & 5-14. Claims 1-14 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed , with respect to the previous objections made to claims 1 & 13 have been fully considered and are persuasive. The previous objections made to claims 1 & 13 have been withdrawn.
Regarding the previous rejection of claims 1-14 under 35 USC 112(b), though Applicant’s amendments have overcome some of the previous rejection of the claims under 35 USC 112(b), indefiniteness issues remain within the claims. Regarding claim 6, it is unclear as to which tab of the at least two tabs (since there are at least two parts of the peelable cover) the claim is referring, or if there is an additional tab not previously claimed that the claim is referring to. Regarding claim 7, it is unclear whether the "a longitudinal direction of the patch" recited in claim 7 is the same as or different than the "a longitudinal direction of the patch" as recited in claim 5. Regarding claim 8, it is unclear as to whether “the longitudinal direction” referenced in claim 8 is the “a longitudinal direction of the patch” as recited in claim 5 or the “a longitudinal direction of the patch” as recited in claim 7, as claims 5 & 7 are the base claims for claim 8. As such, claims 6-8 & 14 are rejected under 35 USC 112(b). See 35 USC 112(b) rejections.
Regarding the previous rejection of the claims under 35 USC 103, Applicant argues that the primary reference “McRae” fails to teach the peelable cover has at least two separate parts, wherein the at least two separate parts are adjacent to each other and in contact, and as such McRae fails to disclose the claimed parts are in contact to properly cover the opening and the microneedles of the capsule, as fig. 5 of McRae discloses a slit 122 (see McRae, fig. 5, par 0095). The Examiner respectfully disagrees with this argument, because as shown in fig. 5 of McRae, the at least two separate parts are adjacent to each other and in contact (see McRae, fig. 5). Furthermore, as demonstrated in McRae, the slit 122 does not preclude the opening and the microneedles of the capsule from sufficiently being covered, and instead the purpose of the slit 122 is so that the second release liner can be easily grasped and removed without using too much force (see McRae, fig. 5, par 0095). Therefore, Applicant’s argument is unpersuasive and the claims are still rejected under 35 USC 103 over McRae in view of Deck. See 35 USC 103 rejections.
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 6-8 & 14 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 6 recites “wherein a tab is fixedly mounted at one end of the peelable cover”. Claim 6 is dependent upon claim 4 which recites “each part of the peelable cover comprises a tab adapted to be gripped by a user” [emphasis added]. Therefore, it is unclear as to which tab of the at least two tabs (since there are at least two parts of the peelable cover), the claim is referring, or if there is an additional tab not previously claimed that the claim is referring to. For examination purposes, it will be interpreted that each of the at least two tabs are fixedly mounted at ends of the peelable cover.
Claim 7 recites “wherein at least one tab extends along a main axis having a non-zero component along a longitudinal direction of the patch” [emphasis added]. Claim 5, which claim 7 depends upon, recites "wherein at least one of the tabs is linked to one end of the peelable cover relative to a longitudinal direction of the patch" of “a longitudinal direction of the patch” in claim 7 is referring to the same one as in claim 5.
Claim 8 recites “wherein the absolute value of an angle formed between the longitudinal direction and the main axis is comprised between 30 degrees and 60 degrees”. There is insufficient antecedent basis for "the longitudinal direction" in the claim, as claims 5 & 7 recite “a longitudinal direction of the patch”. Therefore, it is unclear as to whether “the longitudinal direction” referenced in claim 8 is the “a longitudinal direction of the patch” as recited in claim 5 or the “a longitudinal direction of the patch” as recited in claim 7, as claims 5 & 7 are the base claims for claim 8. For examination purposes, it will be interpreted that the recitation of “the longitudinal direction” in claim 8 is referring to the “a longitudinal direction of the patch” as recited in claim 7.
Dependent claims are similarly rejected as their base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 11-12 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20150190074 --as cited by applicant-- hereinafter referenced as "McRae" in view of US Patent Application Publication 20130131468 --as previously cited--, hereinafter referenced as "Deck".
With respect to claim 1, McRae teaches a body monitoring system, comprising:
- a capsule 70 (i.e., a filament array 70 comprising filaments 72) (see McRae, par 0060, 0064, 0071-0073), the capsule comprising a first face capable of being brought into contact with the skin of a user, and microneedles fixedly mounted on the first face (i.e., filament array 70 comprises a plurality of filaments 72 that interface with the skin of a user to create micropores) (see McRae, par 0060-0061, 0064, 0071-0073, figs. 6-7 & 10-13),
- a patch 100 (see McRae, figs. 22 & 23, par 0093-0095) comprising a main body 40 (i.e., a substrate) (see McRae, par 0064-0066, 0073, , the main body comprising a second face 102 (i.e., a backing layer) capable of being brought into contact with the skin of a user (i.e., the patch comprises a backing layer 102 that contains an adhesive that permits the patch to stick to a body tissue of a user such that the filament array interfaces with the skin of a user) (see McRae, 0093-0095, figs. 22 & 23), the patch comprising a first layer of adhesive 103 covering at least partly the second face (see McRae, par 0093-0094), and a peelable cover 120 (i.e., a second release liner) (see McRae, par 0094-0095, fig. 20) covering the layer of adhesive (see McRae, par 0094-0095, fig. 20), wherein:
- the peelable cover 120 comprises at least two separate parts, the at least two separate parts being adjacent to each other and in contact (i.e., the second release liner comprises a slit 122 that separates the second release liner into two adjacent parts that are in contact with one another (see McRae, fig. 5) so that the second release liner can be easily grasped and removed without using too much force) (see McRae, par 0095, fig. 5),
- the main body 40 (i.e., the substrate) and the first layer of adhesive 103 comprise a central part in which an opening capable of receiving the capsule is formed (i.e., the substrate and layer of adhesive of the patch form an opening that comprises the filament array) (see McRae, figs. 21-23),
- the peelable cover entirely covers the opening (see McRae, fig. 21),
- the capsule is removably received in the opening (i.e., the filament array is mounted to substrate 40, thus it can be removed from substrate 40 and out of the opening) (see McRae, fig. 21 where the filament array ), and
- the peelable cover covers the microneedles (see McRae, fig. 21).
McRae fails to teach that the capsule of the system is for measuring a body analyte, and further that the opening has a maximum diameter greater than 2 mm.
Deck teaches a medical device comprising a multipart housing wherein the medical device is configured to carry out measuring or medication administering functions, such as measuring a glucose concentration and/or administering insulin (see Deck, par 0011, 0036, 0044, 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of McRae such that the capsule of the system is for measuring a body analyte, because that would permit the continuous and/or long-term measurement of analytes in a body tissue and/or body fluid, such as for the long-term monitoring of a glucose concentration (see Deck, par 0053).
McRae as modified by Deck fails to teach that the opening capable of receiving the capsule has a maximum diameter greater than 2 mm. Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body monitoring system of McRae as modified by Deck such that the opening has a maximum diameter greater than 2 mm because McRae as modified by Deck teaches the filament array comes in many different sizes, such as in a 1 square centimeter array size (see McRae, par 0132), and as such, the opening would be accordingly sized to fit the filament array. Therefore, it would merely be a matter of routine optimization to arrive at a determined maximum diameter greater than 2 mm of the opening, since it has been held that "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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 2, McRae as modified by Deck teaches the system according to claim 1. McRae further teaches the patch extends along a longitudinal direction (see McRae, fig. 21) and wherein the at least two separate parts are arranged on either side of an axis parallel to the longitudinal direction (i.e., the slit that forms the two parts of the second release liner are formed parallel to the longitudinal direction, as the second release liner also extends in the longitudinal direction) (see McRae, fig. 21).
With respect to claim 3, McRae as modified by Deck teaches the system according to claim 1. McRae as modified by Deck fails to teach the patch has an oblong shape along a longitudinal direction of the patch. Nonetheless, it would be an obvious design choice to a person of ordinary skill in the art to modify the shape of the patch such that it has an oblong shape along a longitudinal direction of the patch because McRae discloses that the shape of the patch as disclosed in McRae is merely representative and not limiting. Therefore, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the shape of the patch of the cited prior art because both provide the same or similar results, e.g., adhering to the skin of a user such that the skin of the user can be penetrated. See MPEP 2144.04 IV. B. Changes in Shape.
With respect to claim 4, McRae as modified by Deck teaches the system according to claim 1. McRae fails to teach each part of the peelable cover comprises a tab adapted to be gripped by a user.
Deck teaches a wearable medical device comprising a multipart housing wherein the medical device is configured to carry out measuring or medication administering functions, such as measuring a glucose concentration or administering insulin, wherein the device is configured to have two pull-off tabs 178 that when pulled, expose a self-adhesive surface that can then be affixed to a skin surface 148 (see Deck, par 0058, fig. 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of McRae such that each part of the peelable cover comprises a tab adapted to be gripped by a user because that enables a user to easily remove the peelable covering of the body monitoring system and affix the body monitoring system to themself (see Deck, par 0058, fig. 3A).
With respect to claim 5, McRae as modified by Deck teaches the system according to claim 4. McRae as modified by Deck further teaches at least one of the tabs is linked to one end of the peelable cover relative to a longitudinal direction of the patch (i.e., the tabs are connected to a liner 174 and extend from the liner in a longitudinal direction) (see Deck, par 0058, fig. 3A).
With respect to claim 6, McRae as modified by Deck teaches the system according to claim 4. McRae as modified by Deck further teaches a tab is fixedly mounted at one end of the peelable cover (i.e., the pull-off tabs are connected to ends of the liner 174) (see Deck, par 0058, fig. 3A).
With respect to claim 7, McRae as modified by Deck teaches the system according to claim 5. McRae as modified by Deck further teaches at least one tab extends along a main axis having a non-zero component along a longitudinal direction of the patch (i.e., the pull-off tabs stick out from an axis along the longitudinal direction of the liner 174) (see Deck, fig. 3A).
With respect to claim 8, McRae as modified by Deck teaches the system according to claim 7. McRae as modified by Deck fails to teach the absolute value of an angle formed between the longitudinal direction and the main axis is comprised between 30 degrees and 60 degrees.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body monitoring system of McRae as modified by Deck such that the absolute value of an angle formed between the longitudinal direction and the main axis is comprised between 30 degrees and 60 degrees because McRae as modified by Deck teaches the tabs 178 are angled away from the longitudinal axis of the liner 174 (see Deck, fig. 3A). Therefore, it would merely be a matter of routine optimization to arrive at a determined absolute value of an angle formed between the longitudinal direction and the main axis of 30 degrees to 60 degrees, since it has been held that "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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 9, McRae as modified by Deck teaches the system according to claim 1.
McRae as modified by Deck teaches the main body 40 is thicker than the layer of adhesive 103 (see McRae, fig. 21) but fails to teach the main body has a thickness greater than 50 microns.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the body monitoring system of McRae as modified by Deck such that the main body has a greater thickness than a thickness of the layer of adhesive that is a thickness greater than 50 microns because McRae as modified by Deck teaches the main body 40 is thicker than the layer of adhesive 103 (see McRae, fig. 21). Therefore, it would merely be a matter of routine optimization to determine the main body has a greater thickness than a thickness of the layer of adhesive that is a thickness greater than 50 microns, since it has been held that "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." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
With respect to claim 11, McRae as modified by Deck teaches the system of claim 1. McRae further teaches the peelable cover comprises at least one external layer disposed opposite the main body relative to the rest of the peelable cover (i.e., the second release liner is disposed opposite the substrate) (see McRae, fig. 21, par 0094-0095),
the external layer covering the microneedles (see McRae, fig. 21), the peelable cover also comprising at least one spacer arranged at least partly around the opening (i.e., between the second release liner and the liner is a de-blocking member 146 that acts as a spacer by separating the adhesive layer from a first release liner) (see McRae, fig. 21, par 0111),
a thickness of the at least one spacer being configured to raise a part of the at least one external layer covering the opening relative to the rest of the at least one external layer so as to form a space between the external layer and a top of each microneedle (i.e., between the second release liner and the liner is a de-blocking member that acts as a spacer by separating the adhesive layer from a first release liner, thereby spacing the filament array from the second release liner) (see McRae, fig. 21, par 0111).
With respect to claim 12, McRae as modified by Deck teaches the system of claim 11. McRae as modified by Deck fails to teach that the system comprises two spacers arranged on either side of the opening along a direction transverse to a longitudinal direction of the patch, each spacer extending mainly along the longitudinal direction.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify system of McRae as modified by Deck such that the system comprises two spacers arranged on either side of the opening along a direction transverse to a longitudinal direction of the patch, each spacer extending mainly along the longitudinal direction because that would merely be the duplication of parts (i.e., having spacer in the system of McRae as modified by Deck other than the one as disclosed above). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI. Reversal, Duplication, or Rearrangement of Parts B. Duplication of Parts.
With respect to claim 14, McRae as modified by Deck teaches the system according to claim 6. McRae as modified by Deck further teaches at least one tab extends along a main axis having a non-zero component along a longitudinal direction of the patch (i.e., the pull-off tabs stick out from an axis along the longitudinal direction of the liner 174) (see Deck, fig. 3A).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over McRae in view of Deck as applied to claim 1 above, and further in view of US Patent Application Publication 20050240138 --as previously cited--, hereinafter referenced as "Mori".
With respect to claim 10, McRae as modified by Deck teaches the system according to claim 1. McRae as modified by Deck fails to teach the patch has a contour, and wherein parts of the contour arranged on either side of the opening along a direction transverse to a longitudinal direction of the patch form sawteeth.
Mori teaches a liner for a patch, wherein the liner of the patch has a sawtooth portion that facilitates peeling of the liner off of the patch (see Mori, par 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of McRae as modified by Deck such that the patch has a contour, and wherein parts of the contour arranged on either side of the opening along a direction transverse to a longitudinal direction of the patch form sawteeth because sawteeth facilitate easier peeling (see Mori, par 0004), therefore the patch would be more easily removed from a user after use with such a contour.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McRae as modified by Deck as applied to claim 1 above, and further in view of US Patent Application Publication 20180242890 --as previously cited--, hereinafter referenced as "Chickering".
With respect to claim 13, McRae as modified by Deck teaches a device intended to be attached to a limb, comprising a system in accordance with claim 1 (see rejection of claim 1 above).
McRae further teaches that the device intended to be attached to a limb comprises a microprocessor and a battery (see McRae, par 0061, 0141 & 0143-0144, fig. 28 & 29).
McRae fails to teach the device intended to be attached to a limb comprises a casing able to be removably fixed with the capsule and a strap configured to hold the casing in place on the limb.
Deck teaches a removable protective component 160 (i.e., a casing) of the multipart housing of the medical device that houses a battery and other functional modules of the device (see Deck, fig. 3A, par 0036, 0058-0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device intended to be attached to a limb of McRae such that it comprises a casing able to be removably fixed with the capsule, and further that houses components of the device such as the battery and the processor, because that permits the protection of interior components of the device (see Deck, fig. 3A, par 0036, 0058-0059).
McRae as modified by Deck fails to teach the device intended to be attached to a limb comprises a strap configured to hold the casing in place on the limb.
Chickering teaches a sampling device interface wherein the sampling device is held to the skin of a user by a strap that holds the device in place against the skin of a user (see Chickering, par 0144).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of McRae as modified by Deck such that the device intended to be attached to a limb comprises a strap configured to hold the casing in place on the limb because that mechanically attaches the device to the limb of a user ensuring that the device will stay affixed to the user (see Chickering, par 0144).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791