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 .
Response to Arguments
Applicant’s arguments with respect to claims 1, 3 and 5-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 21 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “a ventilated area which is not covered by the baseplate has at least a portion of 25 percent with respect to the area covered by the monitoring device and a maximum portion of 85 percent”, and the claim also recites “especially a portion between 40 and 75 percent” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, claim 21 recites the limitation " the adhesive layer" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 5-7, 9, 11-16, 19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tang et al. (US 20200029834 A1).
As to claim 1, Tang et al. discloses a retaining device (bottom portion of housing, depicted as 70 in Figure 4) for retaining a wearable monitoring device (optical system, depicted as 60 in Figure 4) for gathering a bio-electrical signal from a body region of a person (optical system 60 is part of the optical sensor 36 in Figure 4; [0061]) comprising a holding frame (depicted as 70 in Figure 4) having a baseplate (bottom portion which has cut-out portions 86 in Figure 4) and retaining means (snaps, depicted as 84 and 85 in Figure 4) for reversibly retaining the monitoring device onto the baseplate (snaps 84, 85 anchor the bottom portion of the housing 70 to the top portion of the housing 53 and thus retain the monitoring device 60 onto the baseplate; [0062]; Figure 3B), wherein an area covered by the baseplate is reduced (see cut-out portions, depicted as 86 in Figure 4) with respect to an area covered by the monitoring device (Figure 4) for ventilation of the skin during wearing the monitoring device (the cut-outs, depicted as 86 in Figure 4, create open spaces in the baseplate that would create portions capable of ventilating the skin during wearing of the monitoring device); wherein the holding frame has a number of apertures (cut-out portions, depicted as 86 in Figure 4) penetrating the baseplate (Figure 4); and wherein the baseplate comprises means for ventilation of at least some of the number of apertures (the baseplate, depicted as 70 in Figure 4, includes two cylindrical protrusions located on the upper side of the baseplate facing the monitoring device at the base of the snap depicted as 84 in Figure 4. The fiberglass circuit board, depicted as 80, would be situated on top of the cylindrical protrusions and thus be elevated from the baseplate. Such elevation would provide ventilation between the monitoring device and the apertures within the baseplate. Therefore, the examiner considers the protrusion on the baseplate to be the “means for ventilation” of at least some of the number of apertures), said means for ventilation located at an upper side of the baseplate (Figure 4), the upper side of the baseplate facing the monitoring device during intended use (Figure 4).
As to claim 3, the examiner considers the baseplate (depicted as 70 in Figure 4) to have a skeleton-like structure of interconnected bars outlining the number of apertures (Figure 4).
As to claim 5, in addition to the protrusions depicted in Figure 4, Tang et al. further depicts channels disposed on either side of the snap (snaps depicted as 84 and 85). The two channels, or grooves are formed into the upper side of the baseplate (Figure 4) and connect one of the number of apertures with a rim of the baseplate (Figure 4). Therefore, the examiner considers Tang et al. to disclose “means for ventilation comprise at least one ventilation channel embossed into the upper side of the baseplate and connecting one of the number of apertures with a rim of the baseplate” (Figure 4).
As to claim 6, as stated above, the examiner considers the two cylindrical protrusions to be the means for ventilation (see section # above). Therefore, Tang et al. discloses the means for ventilation comprise at least one protrusion (Figure 4) serving as a spacer between the surface of the upper side and the surface of the monitoring device being directed to the baseplate during intended use.
As to claim 7, Tang et al. discloses the baseplate has a beam-like structure connecting the retaining (Figure 4; snaps 84, 85 are located at the distal end of a beam-like structure as seen in Figure 4) means leaving a number of recesses open to a border defined by the area covered by the monitoring device (Figure 4).
As to claim 9, Tang et al. discloses the retaining means comprise a snap-on hook (see 84 and 85 in Figure 4).
As to claim 11, Tang et al. discloses the retaining means comprise an overhanging structure into the clearing of which the monitoring device is inserted during intended use (see 84 and 85 in Figure 4).
As to claim 12, Tang et al. discloses the overhanging structure is positioned in a region of the baseplate facing upwards during intended use (see 84 and 85 in Figure 4).
As to claim 13, Tang et al. discloses the snap-on hook (84, 85 in Figure 4) is provided at a rim confining a heel part of the baseplate being tapered with respect to a remaining main part of the baseplate (Figure 4).
As to claims 14-15, the Applicant discloses “According to a further expedient embodiment the retaining device additionally comprises means for preventing an unintended allocation of the monitoring device to the holding frame. In other words, there is a fool proof attaching mechanism with the retaining device. Said means for preventing an unintended allocation of the monitoring device preferably comprise the baseplate having a curvature. Especially, such curvature is a convex bulge of the baseplate towards the monitoring device. Preferably, such curvature is adapted to a curvature of the monitoring device. In that case, a wrong allocation of the monitoring device would prevent the snap-on hook and/or the overhanging structure from getting a hold on the monitoring device” ([0038-00039]). As such, since Tang et al discloses the baseplate having a curvature (Figure 4), especially the curvature being adapted to a curvature of the monitoring device (Figure 4), the examiner considers Tang et al. to disclose a “means for preventing an unintended allocation of the monitoring device to the holding frame” wherein the “means for preventing an unintended allocation of the monitoring device comprise the baseplate having a curvature, especially the curvature being adapted to a curvature of the monitoring device”.
As to claim 16, Tang et al. discloses the means for preventing an unintended allocation of the monitoring device comprise the snap-on hook having a length shorter than the thickness of the monitoring device and different to half of the thickness of the monitoring device (see Figure 4).
As to claim 19, Tang et al. discloses a wearable monitoring device for gathering a bio-electrical signal and a retaining device according to claim 1 (optical system 60 is part of the optical sensor 36 in Figure 4; [0061]).
As to claim 20, Tang et al. discloses two channels, one on each side of the snap(s) (depicted as 84 and 85 in Figure 4). The examiner considers each of the channels (disposed on the left and right side of each snap) to be considered the means for ventilation located in the upper side of the baseplate. Furthermore, each of the channels, depicted in Figure 4, has a bottom that is recessed relative to a surface of the baseplate (Figure 4) and configured to contact the monitoring device during intended use (Figure 3B and 4) and that extends from one of the number of apertures to a perimeter of the baseplate (Figure 4). As such, since Tang et al. discloses the channels as a means for ventilation, Tang et al. thus is capable providing “ventilation of the one of the number of apertures”.
As to claim 22, Tang et al. discloses a retaining device (bottom portion of housing, depicted as 70 in Figure 4) for retaining a wearable monitoring device (optical system, depicted as 60 in Figure 4) for gathering a bio-electrical signal from a body region of a person (optical system 60 is part of the optical sensor 36 in Figure 4; [0061]) comprising a holding frame (depicted as 70 in Figure 4) having a baseplate (bottom portion which has cut-out portions 86 in Figure 4) and retaining means (snaps, depicted as 84 and 85 in Figure 4) for reversibly retaining the monitoring device onto the baseplate (snaps 84, 85 anchor the bottom portion of the housing 70 to the top portion of the housing 53 and thus retain the monitoring device 60 onto the baseplate; [0062]; Figure 3B), wherein an area covered by the baseplate is reduced (see cut-out portions, depicted as 86 in Figure 4) with respect to an area covered by the monitoring device (Figure 4) for ventilation of the skin during wearing the monitoring device (the cut-outs, depicted as 86 in Figure 4, create open spaces in the baseplate that would create portions capable of ventilating the skin during wearing of the monitoring device); wherein the holding frame has a number of apertures (cut-out portions, depicted as 86 in Figure 4) penetrating the baseplate (Figure 4); and wherein the baseplate comprises channels (Tang et al. discloses two channels, one on each side of the snap(s) depicted as 84 and 85 in Figure 4) on an upper side of the baseplate facing the monitoring device during intended use (Figure 4), each of said channels recessed relative to a surface of the baseplate that is configured to contact the monitoring device during intended use (Figures 3B and 4), each of said channels extending from one of the number of apertures to a perimeter of the baseplate (Figure 4). As such, since Tang et al. discloses the channels as a means for ventilation, Tang et al. thus is capable providing “ventilation of the one of the number of apertures”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8, 10 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (US 20200029834 A1).
As to claim 8, Tang et al. discloses the invention substantially as claimed with a ventilated area (Figure 4) but does not explicitly discloses “the ventilated area which is not covered by the baseplate has at least a portion of 25 percent with respect to the area covered by the monitoring device and a maximum portion of 85 percent, especially a portion between 40 and 75 percent”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ventilated area to between 40 and 75 percent since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the percentage of ventilated area to optimize the ventilation to enhance patient comfort and improve device performance.
As to claim 10, Tang et al. discloses the device substantially as claimed with a retaining means to retain the device, but does not explicitly disclose the retaining means comprise a holding magnet. Magnets and magnetic closures and connections are extremely well known in mechanical and medical device arts (Tang et al., [0008]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the retaining means, the snap of Tang et al., with a magnet for a magnetic connection in order to provide the predictable results of ensuring there is sufficient engagement and alignment between the components without the possibility of mechanical fatigue or fracture from the snap mechanism.
As to claim 17, Tang et al. discloses the employment of adhesives for engagement of the device to the patient ([0053, 0062, 0090]) but does not explicitly disclose the retaining device includes an adhesive layer attached to at least a part of the baseplate. As taught by Tang et al., implementing adhesives and adhesive layers on medical devices that engage with the human tissue is well known in the medical device art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the adhesive layer to the be attached to the baseplate in order to provide the predictable results of ensuring sufficient connection and engagement with the patient. Furthermore, it has been held that that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (see MPEP 2144.04).
As to claim 18, the modified Tang et al., as applied to claim 17 above, would thus have an adhesive layer attached to the baseplate with a number of through-holes corresponding to a respective one of the number of apertures in the baseplate in order to enable the cut out portions (depicted as 86 in Figure 4) to pass optical radiation ([0062]) and maintain the function of Tang et al. while ensuring sufficient adhesive connection with the patient.
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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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