DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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 3 and 17-18 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 3 recites the limitation "the number of apertures" in line 3. There is insufficient antecedent basis for this limitation in the claim.
NOTE: Claim 2 recites “a number of apertures”. For the purposes of prior art, the examiner considers claim 3 to depend from claim 2.
Regarding claim 17, the phrase "especially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
NOTE: For the purposes of prior art, the examiner does not consider the limitation cited after “especially” (“wherein the adhesive layer has a multiple layer structure comprising a carrier layer attached by an adhesive sublayer to the baseplate and a contact layer that serves as a skin adhesive during intended use”) to be included as part of the claimed invention. Examiner recommends removing “especially” to resolve the indefiniteness.
Claim 18 recites the limitation "the respective aperture" in line 3. 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 1-7, 9, 11-14 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mazza et al. (US 20120022346 A1).
As to claim 1, Mazza et al. discloses a retaining device (Abstract) for retaining a wearable monitoring device comprising a holding frame (transmitter mount, depicted as 520 in Figures 5A-5C) having a baseplate (depicted in Figure 5C, as well as Figures 5A-5B) and retaining means (a plurality of hooks (or barbs), depicted as 521A and 521B in Figures 5A and 5C; [0038]) for reversibly retaining the monitoring device (insertion mechanism, depicted as 550 in Figure 5B, which includes a sensor, depicted as 510 in Figure 5A-5C) onto the baseplate ([0038-0039]; “Referring to FIGS. 5A-5C, transmitter mount 520 is provided with a plurality of hooks (or barbs) 521A, 521B, each of which are configured to mate with a corresponding one of a plurality of open segments 511A, 511B on the sensor 510”[0038]), wherein an area covered by the baseplate is reduced (Figures 5A-5C; the lower portion of the transmitter mount includes cut outs and thus has a reduced area) with respect to an area covered by the monitoring device (Figure 5B) for ventilation of the skin during wearing the monitoring device (Figure 5B).
Additionally, as to claim 1, the functional language and introductory statement of intended use of claim 1 has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Mazza et al. utilizes a baseplate with cutouts (see Figure 5A-5B) for reduced area as claimed by the Applicant, Mazza et al. is therefore capable of being used for ventilation of the skin during wearing the monitoring device. In addition nothing prevents Mazza et al. from being used to ventilate the skin during wearing of the monitoring device. Therefore, the reduced area baseplate of Mazza et al. is capable of being used for ventilation of the skin during wearing the monitoring device.
As to claim 2, Mazza et al. discloses the holding frame has a number of apertures penetrating the baseplate (Figures 5A-5C).
As to claim 3, as best understood in light of the rejection under 35 U.S.C. 112 above, Mazza et al. discloses the baseplate has a skeleton-like or meshed structure of interconnected bars outlining the number of apertures (Figure 5C as well as Figure 5A-5B).
As to claim 4, Mazza et al. discloses the baseplate comprises means for ventilation of at least some of the number of apertures that are located at an upper side of the baseplate facing the monitoring device during intended use (Figure 5A-5C; [0039]; Adhesive is disposed on the lower side of the baseplate and thus the apertures are located on the upper side of the baseplate facing the monitoring device; Figures 5A-5B).
As to claim 5, Mazza et al. discloses the means for ventilation comprise at least one ventilation channel embossed into the upper side of the baseplate (Figure 5C; disposed along the inner periphery) and connecting one of the number of apertures with a rim of the baseplate (Figure 5C).
As to claim 6, Mazza et al. discloses the means for ventilation comprise at least one protrusion (the upright portion of the transmitter mount, depicted as 520 in Figure 5A-5C, protrudes upwards as seen on the righthand side in Figure 5C) serving as a spacer between the surface of the upper side (Figures 5C) and the surface of the monitoring device ([0038-0039]; “Referring to FIGS. 5A-5C, transmitter mount 520 is provided with a plurality of hooks (or barbs) 521A, 521B, each of which are configured to mate with a corresponding one of a plurality of open segments 511A, 511B on the sensor 510”[0038]) being directed to the baseplate during intended use (Figures 5A-5C).
As to claim 7, Mazza et al. discloses the baseplate has a beam-like structure connecting the retaining means leaving a number of recesses open to a border defined by the area covered by the monitoring device (Figures 5A-5C).
As to claim 9, Mazza et al. discloses the retaining means comprise a snap-on hook ([0038-0039]; “Referring to FIGS. 5A-5C, transmitter mount 520 is provided with a plurality of hooks (or barbs) 521A, 521B, each of which are configured to mate with a corresponding one of a plurality of open segments 511A, 511B on the sensor 510”[0038]; since the open segments engage with the hook or barbs, the examiner considers the retaining means to be a “snap-on hook” that snaps on to the open segments).
As to claim 11, Mazza et al. discloses the retaining means comprise an overhanging structure (plurality of hooks (or barbs), depicted as 521A and 521B in Figure 5A; [0038-0039]) into the clearing of which the monitoring device is inserted during intended use (Figure 5A; [0038-0039]).
As to claim 12, Mazza et al. discloses the overhanging structure (plurality of hooks (or barbs), depicted as 521A and 521B in Figure 5A; [0038-0039]) is positioned in a region of the baseplate facing upwards during intended use (Figure 5A and 5C).
As to claim 13, Mazza et al. discloses the snap-on hook is provided at a rim (Figure 5C) confining a heel part of the baseplate being tapered with respect to a remaining main part of the baseplate (Figures 5A and 5C).
As to claim 14, Mazza et al. discloses “the plurality of hooks/barbs 521A, 521B on the transmitter mount 520 are provided as molded plastic protrusions on the transmitter mount 520. Upon engaging with the respective open segments 511A, 511B on the sensor 510, it can be seen that the sensor 510 is retained substantially in a fixed position relative to the transmitter mount 520 (which is in turn, fixedly positioned on the patient's skin by the adhesive layer 530), so that proper alignment and coupling with the respective electrical contact pins on the transmitter unit 102 may be achieved”([0039]). As such, the examiner considers the open segments, depicted as 511A and 511B in Figures 5A and 5C to be the “means for preventing an unintended allocation of the monitoring device to the holding frame” since they are configured to be dimensioned for “proper alignment and coupling”.
As to claim 17, as best understood in light of the rejection under 35 U.S.C. 112 above, Mazza et al. discloses an adhesive layer (depicted as 530 in Figure 5A-5C; [0039]) attached at least to a part of the baseplate for fixation of the holding frame onto the skin of the person ([0039]; Figure 5A-5C).
As to claim 18, as best understood in light of the rejection under 35 U.S.C. 112 above, Mazza et al. discloses the adhesive layer has a number of through-holes (Figure 6A depicts the adhesive layer 610 with a number of through-holes that align with the transmitter mount; Figure 6A) corresponding to the respective aperture of the baseplate (Figure 6A and 6B).
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.
Claims 8, 10 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Mazza et al. (US 20120022346 A1).
As to claim 8, Mazza et al. discloses the invention substantially as claimed with a ventilated area which is not covered by the baseplate, but does not explicitly disclose “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 portion, 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). Furthermore, such a modification would provide the predictable results of optimizing performance and patient comfort during use to meet specific patient needs and requirements.
As to claim 10, Mazza et al. discloses the invention substantially as claimed with retaining means, but does not explicitly disclose the retaining means comprise a holding magnet. Employing magnets as a means to connect two components is extremely well known. It is particularly well known for engaging and anchoring components of medical devices. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the retainment means of Mazza et al. to incorporate a magnet in order to provide the predictable results of employing well known mechanisms to ensuring sufficient connection and coupling between the components.
As to claim 15, Mazza et al. discloses the invention substantially as claimed but does not explicitly disclose “a 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”. It would have been obvious to one having ordinary skill in the art to modify the construction of the monitoring device and the baseplate to have corresponding geometry, such as contours or curves, in order to provide the predictable results of ensure sufficient engagement and connection between the components. Furthermore, modifying the profile of components to optimize engagement and connection would provide the predictable results of ensuring sufficient operation, function and attachment between the monitoring device and the retaining means of the medical device.
As to claim 16, Mazza et al. disclose the invention substantially as claimed with a snap-on hook, but does not explicitly disclose “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”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify hook length in order to provide the predictable results of optimizing material costs and construction without sacrificing function or engagement capabilities.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mazza et al. (US 20120022346 A1) in view of Rau (US 4685466 A). Mazza et al. discloses the invention substantially as claimed with wearable monitoring system that includes a retaining means to mount a monitoring device but does not explicitly disclose the wearable monitoring device is for gathering a bio-electrical signal. Rau discloses a sensor for monitoring biomedical signals, including electro-physiological qualities (Abstract) with the electrode resembling a needle point (Figures 1a-1c). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensor and sensing means of Mazza et al. to include a sensor for monitoring biomedical signals, including electro-physiological qualities as disclosed by Rau in order to provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
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