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 Objections
Claims 12-13 are objected to because of the following informalities:
In claim 12, “a vital signs sensor output” in lines 12 should read “the vital signs sensor output” to be in proper antecedent form.
Similarly, in claim 13, “a soother sensor signal” in line 2 should read “the soother sensor signal” to be in proper antecedent form.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-14 are directed either to a method/process or to a system/machine. Claim 15 is separately rejected below as being software per se, but is included in this analysis since it is likely that Applicant will amend the claim to be in a tangible system form.
Step 2A, Prong One: The claims recite a mental process including steps such as “interpret the vital signs sensor output taking account of the soothers sensor signal, to obtain a vital signs measurement” which could be performed by the human mind and/or by a human with a physical aid such as pen and paper. Essentially, the claims recite a mental process of analyzing two signals together to obtain a result.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the steps of sensing the sensor signals (e.g. soother sensor signal, vital signs sensor output) using various known generic sensors is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process. Furthermore, merely carrying out mental steps using generic computing technology such as “a processor” is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection/sensing components. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Claim 15 is also rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 15 is directed to a computer program/software per se. See MPEP 2106.03(I): “Non-limiting examples of claims that are not directed to any of the statutory categories include: Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations …”
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 1-2 and 5-15 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2014/0296661 A1 to Zwartkruis-Pelgrim et al. (hereinafter “Zwartkruis”).
Regarding Claims 1, 10 and 15, Zwartkruis teaches an infant monitoring system, comprising:
an infant soother system (30 in FIG. 3 and/or 40 in FIG. 4), comprising:
a soother portion (31 in FIG. 3 and/or 41 in FIG. 4); and
a soother sensor (32 in FIG. 3 and/or 42 in FIG. 4) providing a soother sensor signal for identifying a position or movement of the soother portion (see e.g. Paras. 59-60);
a vital signs sensor for providing a vital signs sensor output (see e.g. “[0041] In a particularly preferred embodiment according to the invention it is provided that the system further comprises at least one device selected from the group consisting of: [0042] actigraph [0043] polysomnograph [0044] temperature sensor [0045] infrared video camera system [0046] night vision based video camera system, and/or [0047] pressure pads or accelerometers for sleep position sensing.”); and
a processor (see e.g. “computer” in Para. 48 and 61), configured to:
interpret the vital signs sensor output taking account of the soother sensor signal, to obtain a vital signs measurement (see e.g. Para. 63; as noted in the incoming written opinion, a copy of which can be found in this application’s file wrapper filed on 07/18/2023, this limitation is met since Zwartkruis takes into account both the vital sign sensor output and the soother sensor signal).
Regarding Claims 2, 9 and 11, again see e.g. Para. 63 (in addition to the portions cited above for claim 1).
Regarding Claims 5-6 and 12, see e.g. Paras. 41-47, which are quoted in full in the rejection of claim 1 above.
Regarding Claims 7 and 13, see e.g. Paras. 59-60.
Regarding Claims 8 and 14, see e.g. Para. 49.
Claim Rejections - 35 USC § 103
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 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zwartkruis in view of US 2016/0206247 A1 to Morland et al. (hereinafter “Morland”).
Regarding Claims 1-4, 9-11 and 15, Zwartkruis teaches an infant monitoring system, comprising:
an infant soother system (30 in FIG. 3 and/or 40 in FIG. 4), comprising:
a soother portion (31 in FIG. 3 and/or 41 in FIG. 4); and
a soother sensor (32 in FIG. 3 and/or 42 in FIG. 4) providing a soother sensor signal for identifying a position or movement of the soother portion (see e.g. Paras. 59-60);
a vital signs sensor for providing a vital signs sensor output (see e.g. “[0041] In a particularly preferred embodiment according to the invention it is provided that the system further comprises at least one device selected from the group consisting of: [0042] actigraph [0043] polysomnograph [0044] temperature sensor [0045] infrared video camera system [0046] night vision based video camera system, and/or [0047] pressure pads or accelerometers for sleep position sensing.”); and
a processor (see e.g. “computer” in Para. 48 and 61), configured to:
interpret the vital signs sensor output taking account of the soother sensor signal, to obtain a vital signs measurement (see e.g. Para. 63; as noted in the incoming written opinion, a copy of which can be found in this application’s file wrapper filed on 07/18/2023, this limitation is met since Zwartkruis takes into account both the vital sign sensor output and the soother sensor signal identifying the frequency of sucking motion).
Concerning the final “interpret …” limitation, this is met by Zwartkruis as discussed above. However, further concerning this limitation, and also especially in reference the additional limitations found in claims 3-4, it is noted that Zwartkruis fails to specifically teach that the vital sign sensor output is interpreted by filtering out contribution of the sucking motion frequency, and/or using adaptive noise cancellation with a motion reference signal. Concerning those deficiencies, attention is further directed to Morland which teaches that a vital sign sensor output of interest (in this case PPG) can be interpreted by using an adaptive filter to filter out undesired motion frequencies by using a motion reference signal (see e.g. the abstract and claim 1; see terms “adaptive filter” and “reference signal” throughout Morland). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Zwartkruis to use the measured sucking frequency as a noise reference signal to be used in an adaptive filter on the vital sign data, akin to that seen in Morland, because it would predictably enhance the detection of desired signals (e.g. breathing or heart signals) by removing or reducing contribution of the sucking motion.
Regarding Claims 5-6 and 12, see e.g. Paras. 41-47 of Zwartkruis, which are quoted in full in the rejection of claim 1 above.
Regarding Claims 7 and 13, see e.g. Paras. 59-60 of Zwartkruis.
Regarding Claims 8 and 14, see e.g. Para. 49 of Zwartkruis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792