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 .
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.
Status of Claims
Claims 1 and 4-15 are pending and under consideration for patentability; claims 2 and 3 were cancelled and claims 1, 4, 5, 8-10, and 12-15 were amended via a Preliminary Amendment dated 06 October 2023.
Information Disclosure Statement
The Information Disclosure Statement submitted on 06 October 2023 has been acknowledged and considered by the Examiner.
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.
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 1, 4-7, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nigg et al. (Nigg BM, Liu W. The effect of muscle stiffness and damping on simulated impact force peaks during running. J Biomech. 1999 Aug;32(8):849-56) in view of Inan et al. (US 2017/0238847 A1).
Regarding claims 1, 14, and 15, Nigg describes an apparatus, a computer implemented method, and a computer program product for predicting a ballistic force on a subject (p. 850: “examine the influence of changes in mechanical properties of spring and damper elements of a simplified lumped mass-spring-damper model of the human body”), the apparatus comprising
a memory comprising instruction data representing a set of instructions (p. 851, memory being an inherent component of the “multi-body dynamic simulation software” as described)
a processor configured to communicate with the memory and to execute the set of instructions, wherein the set of instructions, when executed by the processor (p. 851, a processor and instructions being inherent components of the “multi-body dynamic simulation software” as described), cause the processor to
model the body of the subject as a mechanical system comprising a plurality of masses joined by springs and dampers (p 850: “a simplified lumped mass-spring-damper model of the human body”), wherein
each of the masses represents a different region of the body of the subject (p. 850: “The upper body and the swing leg were represented by a combination of a rigid mass (M3) and a non-rigid (wobbling) mass (M4). The shank, leg and foot of the supporting leg were represented by a combination of a rigid mass (M1) and a non-rigid (wobbling) mass (M2).”)
the sum of the masses is set proportional to the subject's mass (p. 850: “a total body mass of 75 kg was used”)
physical characteristics of the subject are used to distribute the subject's mass between the plurality of masses in the mechanical system (p. 850: “The values for the four masses were adapted from Cole (1995), who determined body segment masses and their distribution to skeletal (bone) and soft tissues using data and formulas from Clauser et al. (1969) and Clarys et al. (1986). A total body mass of 75 kg was used. The upper rigid mass was 6 kg, the upper wobbling mass 50.3 kg, the lower rigid mass 6.1 kg, the lower wobbling mass 12.6 kg.”)
predict the ballistic force on the subject, based on oscillations of the mechanical system (p. 852, Results)
Regarding claim 1, Nigg does not explicitly disclose wherein the predicted ballistic force is a predicted ballistocardiogram measurement due to a heart-beat of the subject. However, Inan also describes an apparatus for monitoring ballistic force on a subject ([0021]), including the use of a mass-spring-damper system ([0129]), and wherein a predicted ballistic force is a predicted ballistocardiogram measurement due to a heart-beat of the subject ([0133] - [0134]). As Inan is also directed towards monitoring ballistic forces on a subject and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use an apparatus similar to that described by Nigg in order to assist in evaluating a ballistocardiogram of a user, similar to that described by Inan, as doing so advantageously allows the resulting apparatus to account for the distribution of the subject’s mass in the various extremities or body regions when determining the ballistocardiogram.
Regarding claim 4, Nigg describes wherein spring characteristics associated with the springs of the mechanical system and/or damping characteristics associated with the dampers of the mechanical system are set based on the physical characteristics of the subject (p. 850: “The values for the four masses were adapted from Cole (1995), who determined body segment masses and their distribution to skeletal (bone) and soft tissues using data and formulas from Clauser et al. (1969) and Clarys et al. (1986). A total body mass of 75 kg was used. The upper rigid mass was 6 kg, the upper wobbling mass 50.3 kg, the lower rigid mass 6.1 kg, the lower wobbling mass 12.6 kg.”).
Regarding claim 5, Nigg describes wherein the physical characteristics comprise weight (p. 850: “a total body mass of 75 kg was used”).
Regarding claim 6, Nigg describes wherein a first one of the plurality of masses represents the upper torso of the subject and wherein the processor being caused to predict a ballistic force on the subject comprises the processor being caused to apply an oscillating force to the first mass corresponding to the upper torso (p. 850: “the upper body and the swing leg were represented by a combination of a rigid mass (M3) and a non-rigid (wobbling) mass (M4)”). Inan describes using the model to simulate a ballistocardiographic effect of a heart-beat of the subject on the mechanical system ([0046]).
Regarding claim 7, Nigg describes wherein the predicted ballistic force measurement is predicted for a second region of the body, based on an acceleration of a respective second mass of the plurality of masses due to the applied oscillating force, and wherein the second mass represents the second region of the body in the mechanical system (p. 850).
Regarding claim 13, Nigg describes a patient monitor comprising the apparatus of claim 1 (p. 850).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nigg in view of Inan, further in view of Suriani et al. (Investigation of a Ballistocardiogram-Based Technique for Unobtrusive Monitoring of Fluid Accumulation in the Body. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul:2020:5146-5149).
Regarding claim 10, Nigg in view of Inan suggests the apparatus as in claim 1, but neither Nigg nor Inan explicitly disclose wherein the apparatus is for determining fluid accumulation in the body of the subject, and wherein the processor is further configured to obtain a ballistocardiogram measurement of the subject and determine whether there is fluid accumulation based on a comparison of the ballistocardiogram measurement to the predicted ballistocardiogram measurement. However, Suriani also describes an apparatus for monitoring ballistic force on a subject (Abstract), including wherein the apparatus is for determining fluid accumulation in the body of the subject (Abstract: “we introduce a novel monitoring solution for fluid accumulation in the human body), and wherein the processor is further configured to obtain a ballistocardiogram measurement of the subject (p. 5146, Data Collection) and determine whether there is fluid accumulation based on a comparison of the ballistocardiogram measurement to the predicted ballistocardiogram measurement (p. 5146: “fluid accumulation is thought to cause additional damping to the vibrating system, thereby reducing the energy of oscillation…we investigate whether this effect is observable in the form of a decrease in BCG signal energy as compared to its baseline value”). As Suriani is also directed towards monitoring ballistic forces on a subject and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the apparatus described by Nigg and Inan to monitor for fluid accumulation, as described by Suriani, as doing so advantageously allows the resulting apparatus to screen for a large number of serious pathological conditions, as described by Suriani (p. 5146, Introduction).
Regarding claim 11, Suriani describes wherein the processor being caused to determine whether there is fluid accumulation comprises the processor being caused to determine that fluid accumulation has occurred if the ballistocardiogram measurement is different to the predicted ballistocardiogram measurement (p. 5146).
Allowable Subject Matter
Claims 8, 9, and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 8, the prior art of record does not disclose or suggest wherein the processor is configured to determine an eigenfrequency of the mechanical system and use the eigenfrequency to set a frequency range within which to predict the ballistic force measurement from oscillations of the mechanical system.
Regarding claim 9, Nigg in view of Inan suggests the apparatus as in claim 1. Suriani describes that the ballistocardiogram can be used to determine fluid accumulation in the body (p. 1546: “use of BCG is, for the first time, investigated as a monitoring technique for the onset of fluid accumulation in the body”), thereby suggesting wherein the predicted ballistic force measurement is predicted for the subject in the presence of fluid accumulation in the body. However, the prior art of record does not disclose or suggest redistributing mass corresponding to the fluid accumulation to a mass representing the lower torso, whilst keeping the total mass in the mechanical system proportional to the weight of the subject.
Regarding claim 12, although Suriani describes wherein the fluid accumulation is due to internal bleeding (Abstract), claim 12 depends on claim 9 and contains at least the same allowable subject matter as claim 9.
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796