FINAL REJECTION
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 § 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable Cruz-Jentoft et al., “Sarcopenia: European consensus on definition of diagnosis: Report of the European Working Group on Sarcopenia in Older People”, Age and Aging, 39: 412-423 (2010) (see IDS dated 5/7/2024) (hereinafter “Cruz”) in view of Fotiades et al., US 8,579,814 B2 (hereinafter “Fotiades”) and Faulkner et al., US 6,740,041 (hereinafter “Faulkner”)
Regarding claim 1: A method comprising:
performing a dual energy x-ray absorptiometry scan of at least a portion of a patient using a dual-energy absorptiometry system to acquire a plurality of dual energy x-ray absorptiometry data (dual energy X-ray absorptiometery (DXA) is used to assess muscle mass, etc., see section titled “Muscle mass”, page 415-416);
receiving a signal corresponding to a functional performance indicator of the patient (muscle strength tests and physical performance tests, see sections titled “Muscle strength” and “Physical performance” page 416-417);
accessing at least one population dataset (implied from determining cut-offs from population references; see section titled “Defining cut-off points”; further see Table 5); and
computer-processing the plurality of dual energy x-ray absorptiometry data and the signal corresponding to the functional performance indicator to obtain a comparison to the at least one population data set (comparing the muscle mass determined from the DXA and muscle strength and physical performance tests against cut-off points as shown in Fig. 2).
Cruz does not teach generating a visual representation of the comparison indexed against the at least one population data set. However, generating visual representation of a comparison indexed against population data is known in the medical field.
For example, Fotiades teaches graphically displaying patient data as a comparison against a reference range (see Fig. 4). It is understood or implied that the reference range was determined from population data defining what is considered low, normal, and high. Therefore, Fotiades can be considered to teach generating a visual representation of a comparison indexed against at least one population dataset.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Cruz by generating a visual representation of the comparison indexed against the at least one population data set, as taught by Fotiades; and ordinarily skilled artisan would have been motivated to make this modification in order to convey the data/comparison in a manner that is easy to consume (i.e., visualization of the data/comparison).
Although Cruz is silent as to whether the population dataset was accessed from a computer database per se, the examiner takes OFFICIAL NOTICE that using a computer database for population datasets (or any large dataset for that matter) is well-understood, routine, and conventional in the art for archival and retrieval purposes. For example, the ordinarily skilled artisan would have realized that datasets stored in a format that is easily retrievable and readable by a computer would allow for improved overall data handling such as greater convenience for analysis thereof because manual data entry (which would otherwise be required in the case of paper records) can be eliminated.
It therefore would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to access the population dataset from a computer database as a matter of well-understood, routine, and conventional practice in the art for the purposes of improving overall data handling such as improved convenience.
Cruz modified in view of Fotiades does not teach that the visual representation includes a curve illustrating the comparison to the at least one population data set.
Faulkner teaches a visual representation including a curve illustrating the comparison of patient data to at least one population data set (see Fig. 3 which illustrates population data as what appears to be a bell curve and the patient data at 48).
A bell curve is intuitive in that it shows the distribution including the center/peak (e.g., median or mode) and generally conveys the spread of the data in a visual manner (e.g., standard deviation).
It would have been obvious to one having ordinary skill in the art to further modify the invention of Cruz such that the visual representation includes a curve illustrating the comparison to the at least one population data set as taught by Faulkner; and the ordinarily skilled artisan would have been motivated to make this modification in order to more intuitively convey population data and where the patient fits therein.
Regarding claim 2: Cruz further teaches comprises computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of the patient’s body composition (“CT and MRI are considered to be very precise imaging systems that can separate fat from other soft tissues of the body… DXA is an attractive alternative method for research and for clinical use to distinguish fat, bone mineral and lean tissues.” Page 415).
Regarding claim 3: Cruz further teaches computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of the patient’s bone mineral density (“DXA is an attractive alternative method for research and for clinical use to distinguish fat, bone mineral and lean tissues.” Page 415).
Regarding claim 4: Cruz teaches computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of the patient’s muscle mass (dual energy X-ray absorptiometery (DXA) is used to assess muscle mass, etc., see section titled “Muscle mass”, page 415-416).
Regarding claim 5: Cruz teaches computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of the patient’s adipose tissue (“CT and MRI are considered to be very precise imaging systems that can separate fat from other soft tissues of the body… DXA is an attractive alternative method for research and for clinical use to distinguish fat, bone mineral and lean tissues.” Page 415).
Regarding claim 6: Cruz teaches the received signal corresponds to a result of a short physical performance battery assessment of the patient (“A wide range of tests of physical performance are available, including the Short Physical Performance Battery (SPPB)” page 416; see Fig. 2).
Regarding claim 7: Cruz teaches the received signal corresponds to a handgrip strength assessment of the patient (see section titled Muscle strength/Handgrip strength, page 416).
Regarding claim 8: Cruz teaches the received signal corresponds to a gait speed assessment of the patient. (see section titled Physical performance/Usual gait speed; see Fig. 2).
Regarding claim 9: Cruz teaches the received signal corresponds to a timed get up and go assessment of the patient (see section titled Physical performance/Timed get-up-and-go-test, pages 416-417).
Regarding claim 10: Cruz teaches the received signal corresponds to a standing balance assessment of the patient (“The SPPB evaluates balance, gait, strength and endurance by examining an individual’s ability to stand with the feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times [58].” Page 416; the ability to stand with feet in such position implies a level of balancing abilities of the patient and therefore reads on a standing balance assessment of the patient).
Regarding claim 11: Cruz teaches the received signal corresponds to a fall proclivity assessment of the patient (the aforementioned assessments mentioned with regards to claims 6-10 can read on a fall proclivity assessment in the sense that such assessments would be recognized as being correlative thereto).
Regarding claim 12: Cruz teaches accessing at least one of an age matched population data set, a gender matched population data set, and an ethnicity matched population data set (e.g., see Fig. 5 which shows population defined cut-off points by gender).
Claim 13: Cruz doesn’t teach generating a printable report of the comparison indexed against the at least one population data set.
Fotiades teaches a report of the comparison indexed against the at least one population data set (e.g., see Figs. 3 and 4). Fotiades further teaches printer 102 for printing a report of the data (see Fig. 1). It is therefore understood that Fotiades implicitly teaches generating a printable report of the comparison indexed against the at least one population data set.
It would have been obvious to one having ordinary skill in the art to further modify the invention of Cruz by generating a printable report of the comparison indexed against the at least one population data set, as taught by Fotiades; and the ordinarily skilled artisan would have been motivated to make this modification in order to create hard copies of reports such as for archival and backup purposes.
Claim 14: See above regarding claim 1 (particularly the discussion regarding the curve as taught by Faulkner. Faulkner further teaches that the curve illustrates standard deviations compared to the at least one population dataset (implied in the sense that a bell curve inherently conveys the standard deviation in a visual manner in the sense that a higher standard deviation is reflected as a larger spread or a visually fatter curve and a smaller standard deviation is reflected as a smaller spread or visually skinnier curve; in this case, the standard deviation is marked on the curve as 52 in Fig. 3).
A bell curve is intuitive in that it shows the distribution including the center/peak (e.g., median or mode) and generally conveys the spread of the data in a visual manner (e.g., standard deviation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Cruz such that the curve illustrates standard deviations compared to the at least one population dataset, as taught by Faulkner; and the ordinarily skilled artisan would have been motivated to make this modification in order to more intuitively convey population data (including the standard deviation) and where the patient fits therein.
Response to Arguments
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Applicant argues by way of amendment that Cruz and Fotiades references do not teach the newly recited limitations of amended claim 1 and new claim 14.
In view of the aforementioned amendments, the examiner presents new grounds of rejection which further rely on Faulkner for teaching said newly recited limitations as discussed in the rejections above.
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 COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
7 March 7, 2026