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 .
Response and Amendment Filed
Applicant’s response and amendment, filed December 16, 2025, has been entered and made of record. Accordingly, the status of the claims is as follows: Claims 18-23, 26 and 29 are amended; claims 24, 25, 27, 28, 30-32 and 34 remain as originally presented; claims 1-17 and 35-52 are canceled; claim 53 is newly added.
Information Disclosure Statement
The information disclosure statement filed December 16, 2025 has been entered and the references cited therein have been considered by the examiner as the fee required by 37 CFR 1.17(p) has been submitted.
Previously Set Forth Objections and Rejections
The objection to the specification as set forth in the previous Office action has been overcome by amendments to the specification.
The objections to claims 26 and 29 as set forth in the previous Office action have been overcome by amendments to those claims.
The 35 USC 112(a) rejection of claim 52 as set forth in the previous Office action has been rendered moot by the cancellation of claim 52.
The 35 USC 112(b) rejection of claims 18-34 and 52 as set forth in the previous Office action has been overcome with respect to claims 18-22, 24-27 and 32-34 by amendments to claim 18 and the cancellation of claim 52. However, the 35 USC 112(b) rejection of claims 23 and 28-30 is hereby maintained and is reiterated below.
The 35 USC 112(d) rejection of claims 19 and 20 as set forth in the previous Office action has been overcome by amendment to claims 19 and 20.
The 35 USC 103 rejection of claims 18-25, 31-34 and 52 as being unpatentable over Laster et al. (U.S. Patent Application Publication No. 2019/0073632) in view of Godfrey (U.S. Patent Application Publication No. 2019/0223409) is hereby withdrawn.
The following new and reiterated grounds of rejection are set forth:
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 23 and 28-30 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 23 recites “one or more other patient parameters” which is vague and indefinite.
Claim 28 recites the limitation "the other patient parameters" in line 3. There is insufficient antecedent basis for this limitation in the claim as neither claims 26 or 18 recite “other patient parameters.” In addition, the recitation of “other patient parameters” is vague and indefinite.
Claims 29 and 30 recite “and/or” which renders the claims vague and indefinite as the metes and bounds of the claims cannot be determined.
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.
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.
Claim(s) 18-25, 31-34 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laster et al. (U.S. Patent Application Publication No. 2019/0073632) in view of Hopper et al. (PCT Publication No. WO 2019/133232).
In regard to claims 18-20, 31, 32 and 53, Laster et al. teach a system 100 for predictive modeling with a scheduler 110 comprised of one or more computers that executes software modules (see para. 0060). The scheduler 110 communicates with a clinician app 130 that allows physicians and nurses to enter information about patients, a medical facility app 140 that includes a database 141 with electronic medical records and inventory data 143 (see paras. 0062-0064). The scheduler 110 also uses predictive models 112 to predict appropriate sizes and types of implants based on a patient’s height, weight and other characteristics (see paras. 0065-0066). The scheduler 100 then determines the two or three most likely implant sizes (see paras. 0066 and 0084). Laster et al. do not specifically teach a thermal contact pad set. However, Hopper et al. teach a thermal control system 20 that includes a thermal control unit 22 coupled to one or more thermal therapy devices 24 such as a first thermal pad 24 that is wrapped around a patient’s torso and second and third thermal pads 24 that are wrapped around a patient’s right and left legs (see Fig. 1 and paras. 0049 and 0051). The thermal control unit 22 is coupled to thermal pads 24 via a plurality of hoses 26 and the thermal control unit 22 delivers temperature-controlled fluid to the thermal pads 24 via fluid supply hoses 26a (see Fig. 1 and para. 0050). After the fluid has passed through thermal pads 24, thermal control unit 22 receives the temperature-controlled fluid back from thermal pads 24 via return hoses 26b (see Fig. 1 and para. 0050). Laster et al. is directed a recommending any items needed for a medical procedure (see para. 0003) and Hopper et al. teaches a thermal pad set for hot/cold therapy. Thus, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the system of Laster et al. to select thermal therapy pads of Hopper et al. in a particular size/shape according to the patient parameters available through the database 141 with electronic medical records and inventory data 143. Furthermore, the comparison of input data with ranges (tables) is a straightforward and well-known procedure in computer science and in the step of determining the most likely implant sizes and Laster et al. would recognize the comparison of data with ranges. In regard to claims 21-25, Laster et al. teach that inputted patient medical data may include height, weight, age, sex, race, BMI or other characteristics (see para. 0077). In regard to claims 33 and 34, Laster et al. teach that the output of the predictive models 112 includes probability scores (see para. 0087).
Claim(s) 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laster et al. (U.S. Patent Application Publication No. 2019/0073632) in view of Hopper et al. (PCT Publication No. WO 2019/133232) and further in view of Kramb et al. (U.S. Patent No. 12,340,881).
In regard to claims 26-30, Laster et al. do not specifically teach a multi-step or iterative procedure. However, Kramb et al. teach a method of medical implant device data processing 200 that includes a step of presenting queries 124 to the patient and in response, generating a second list of medical implant devices (see col. 3, line 22 to col. 4, line 64). Kramb also teaches repeating the query loop to further refine the device selection (see Fig. 4C and col. 7, line 37 to col. 8, line 12). Kramb et al. thus demonstrate that including, in the method of selecting a medical device, a multi-step or iterative procedure that results in a refined recommendation is well-known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the system of Laster et al. with the ability to perform a multi-step or iterative procedure that results in a refined recommendation. With further respect to claims 29 and 30, see the above rejection for claims 21-25.
Response to Arguments
Regarding the arguments pertaining to the Godfrey et al. reference, applicant’s arguments with respect to claim(s) 18-34 and 53 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the arguments pertaining to the Kramb reference, applicant's arguments filed December 16, 2025 have been fully considered but they are not persuasive.
Applicant argues that the first set of Kramb is defined before and independent of any query data (reading on the values of patient parameters) and the defining second list of Kramb is the first occurrence of defining a lest based on query data (see page 8 of the 12/15/25 response). Applicant is referred to Fig. 4C of Kramb et al. which clearly shows that the query loop is repeated to further refine the device selection (see also col. 7, line 37 to col. 8, line 12).
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794