DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
Medication injection device (claim 1)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Device (Medication injection device - claim 1)
coupled with functional language
sed to inject medications to the wearer when the abnormal physical conditions are detected (Medication injection device - claim 1)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
see the 35 USC 112(b) rejection below (Medication injection device - claim 1)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 1-8 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.
Regarding claim 1:
The claim is unclear because of the limitation “medication injection device” in line 2. The limitation has been interpreted to invoke 35 USC 112(f) however the specification fails to provide any corresponding structure for the limitation. For this reason, the limitation is unclear and by extension the claim is unclear. For the sake of examination, the office has interpreted this limitation to refer to a needle or similar structure.
Claims 2-8 are rejected due to their dependence on claim 1.
Regarding claim 5:
The claim recites the limitation "the event" in the final line. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6:
The claim recites the limitation "the fall detection algorithm model" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8:
The claim recites the limitation "the secondary danger" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The claim recites the limitation "the highest danger" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160256106 A1 to Krasnow et al. (Krasnow).
Krasnow discloses:
Regarding claim 1:
An intelligent bracelet (figure 9a) capable of injecting medications, comprising a multi-modal sensor assembly (see ¶0101 which indicates a plurality of sensor including pulse, a blood oxygenation, a galvanic skin response sensors), a main control chip (see the electronics of 1100 in figure 11 which can be part of the device 900 as indicate din ¶0119), a medication injection device (950 which can include the needle 200/300/500/700 as shown in figures 2-7) and a bracelet display interface (992);
wherein the multi-modal sensor assembly (plurality of sensor including pulse, a blood oxygenation, a galvanic skin response sensors), the medication injection device (950) and the bracelet display interface (992) are connected with the main control chip (electronics of 1100) (¶0104 indicates the display is connected to the data collection system and ¶0113 indicates 1110 is connected to the sensors);
the multi-modal sensor assembly (plurality of sensor including pulse, a blood oxygenation, a galvanic skin response sensors) is used to acquire physical data of a wearer (¶0101 indicates sensors measure physiological properties of the wearer);
the main control chip (electronics of 1100) comprises a processor (1150), a memory (memory as indicated in ¶0122 of 1150), a communication interface (1135) and a digital interface (1130; instructions for displaying data as indicated in ¶0126), and the main control chip (electronics of 1100) is used to detect abnormal physical conditions by adopting a machine learning method according to the physical data (would be capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation);
the medication injection device (950) is used to inject medications to the wearer when the abnormal physical conditions are detected (includes the needles 200/300/500/700 as shown in figures 2-7); and
the bracelet display interface (992) is used to display the physical data and corresponding danger levels (¶0103 indicates it can display alerts and measured hemodynamic property of blood).
Regarding claim 7:
The intelligent bracelet capable of injecting medications according to claim 1, wherein a home page of the bracelet display interface (see 992 which would be capable of displaying the following information) displays a current heart rate (¶0123 teaches the system can include heart rate sensors) and a blood oxygen concentration (¶0098 teaches the system can include blood oxygenation sensors) of the wearer, with different colors indicating danger levels of the human body currently; and the danger levels comprise a highest danger, a secondary danger and no danger and are displayed in red, orange and green respectively (display 992 is capable of the function described and since the reference teaches the structure required by the claim it has been interpreted to read on the claim).
Regarding claim 8:
The intelligent bracelet capable of injecting medications according to claim 1, wherein when the wearer is in the secondary danger, the bracelet display interface pops up an "SOS" interface for the wearer to determine whether to report an alarm (see the display interface 992 taught by the reference that is capable of the function described in the claim); when the wearer is in a state of the highest danger, the medication injection device is automatically activated to inject the medications (see the injection device 950 of the reference which is capable of this function).
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) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160256106 A1 to Krasnow et al. (Krasnow) as applied to claim 1 above, and further in view of IT AN20060001 A1 to Bianchelli (see English language machine translation attached to this or a previous office action).
Regarding claim 2:
Krasnow fails to disclose:
The intelligent bracelet capable of injecting medications according to claim 1, wherein the multi-modal sensor assembly further comprises an inertial measurement unit, and the inertial measurement unit is used to identify a fall of a human body, and the physical data comprises a heart rate and oxyhemoglobin saturation.
Bianchelli teaches:
An individual control and safety device (see figure 1) that includes detecting falls with sensors (inertial measurement unit) of a user (see page 5 of the translation) and further detecting a heart rate and oxyhemoglobin saturation (see page 8 of the translation). This allows for an alert to be sent out if the measured information is outside of desired levels (see page 12 of the translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Krasnow to further include an inertial measurement unit for detecting falls and detecting the heart rate and oxyhemoglobin saturation as taught by Bianchelli to alert the user or others about the user’s condition (for safety)( Bianchelli, see page 12 of the translation).
Regarding claim 4:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 2 by Krasnow and Bianchelli:
The intelligent bracelet capable of injecting medications according to claim 1, wherein an early warning measure is activated when the multi-modal sensor assembly detects a heart rate (see the heart rate detection of Bianchelli incorporated into Krasnow) of the wearer below 40 or above 160 (the heart rate detection of Bianchelli is capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation) and the oxyhemoglobin saturation (see the oxyhemoglobin saturation detection of Bianchelli incorporated into Krasnow) below 92% within 30 seconds together (the oxyhemoglobin saturation detection of Bianchelli is capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation) with a fall detected from the wearer (see the fall detection of Bianchelli incorporated into Krasnow).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160256106 A1 to Krasnow et al. (Krasnow) and IT AN20060001 A1 to Bianchelli as applied to claim 2 above, and further in view of EP 2575113 A1 to Balazs et al. (Balazs).
Regarding claim 3:
Krasnow and Bianchelli fails to disclose:
The intelligent bracelet capable of injecting medications according to claim 2, wherein the inertial measurement unit adopts a fall detection algorithm model of long short-term memory (LSTM) for fall identification, and steps comprise sensor data acquiring, data preprocessing, feature extracting, threshold detecting, machine learning classifying, fall judging, posture analyzing, and warning and responding.
Balazs teaches:
A device for fall detection that includes a model for a fall detection algorithm (¶0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Krasnow and Bianchelli to further include a model for a fall detection algorithm as taught by Balazs in order to determine if the user has fallen (¶0006 and ¶0010). The addition of this structure makes the structure in Krasnow capable of perform the function of “sensor data acquiring, data preprocessing, feature extracting, threshold detecting, machine learning classifying, fall judging, posture analyzing, and warning and responding” and since the combination teaches the structure required by the claim it is interpreted to read on this limitation.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160256106 A1 to Krasnow et al. (Krasnow) and IT AN20060001 A1 to Bianchelli as applied to claim 4 above, and further in view of WO 2019070191 A1 to Ruiz et al. (Ruiz).
Regarding claim 5:
Krasnow discloses:
The intelligent bracelet capable of injecting medications according to claim 4, wherein the early warning measure comprises: the bracelet display interface (see the display 992 and auditory component as described in ¶0103) automatically popping up a display of a countdown for 30 seconds and simultaneously giving an alarm (the display 992 and auditory component would be capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation);
Krasnow and Bianchelli fails to disclose:
If the wearer does not cancel the countdown, the medication injection device is activated and the wearer is given an intramuscular injection of adrenaline; and if the wearer cancels the countdown, no medication injection is carried out, and a log of the event is recorded and the bracelet returns to a normal state.
Ruiz teaches:
An auto injector (figure 2) that includes giving an intramuscular injection of adrenaline (column 2, lines 14-16) for patients at risk of anaphylaxis (page 2, lines 16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Krasnow and Bianchelli to further include an intramuscular injection of adrenaline as taught by Ruiz to treat anaphylaxis (Ruiz, page 2, lines 16). In regards to the function of “If the wearer does not cancel the countdown, the medication injection device is activated and the wearer is given an intramuscular injection of adrenaline; and if the wearer cancels the countdown, no medication injection is carried out, and a log of the event is recorded and the bracelet returns to a normal state” the structure of the display interface (in Krasnow) and the intramuscular injection of adrenaline (incorporated into Krasnow from Ruiz) would be capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160256106 A1 to Krasnow et al. (Krasnow) as applied to claim 1 above, and further in view of US 20180342081 A1 to Kim et al. (Kim).
Regarding claim 6:
Krasnow fails to disclose:
The intelligent bracelet capable of injecting medications according to claim 1, wherein the main control chip comprises fall detection software, and the fall detection software adopts a pre- trained deep learning algorithm to optimize the fall detection algorithm model for performance in terms of a correct detection rate and a false alarm rate; and a method of the pre-trained deep learning algorithm comprises principal component analysis (PCA), linear discriminant analysis (LDA), over-sampling, transfer learning, online learning, model compression technology, cost function or decision threshold adjustment, dataset fine adjustment, sensor sampling rate optimization, data processing and feature extraction pipeline.
Kim teaches:
A device/system for detecting dangerous situations including a fall detection device (1000) including using a deep learning algorithm (see ¶0103).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Krasnow to further include a deep learning algorithm as taught by Kim to detect a fall or dangerous situation (Kim, abstract). In regards to the “fall detection algorithm model for performance in terms of a correct detection rate and a false alarm rate; and a method of the pre-trained deep learning algorithm comprises principal component analysis (PCA), linear discriminant analysis (LDA), over-sampling, transfer learning, online learning, model compression technology, cost function or decision threshold adjustment, dataset fine adjustment, sensor sampling rate optimization, data processing and feature extraction pipeline” the system incorporated into Krasnow from Kim would be capable of this function and since the combination teaches the structure required by the claim it is interpreted to read on this limitation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is prior art:
US-20160256095
Krasnow
See bracelet 500 in figure 5a
US-20170172522-A1
Insler
See the bracelet as shown in figure 1
KR-102606243-B1
CHUNG
See the bracelet as shown in figure 3
WO-2015021798-A1
SU
See the bracelet in figure 2
CN-103393411-A
SU
See the bracelet in figure 2
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783