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
Claim 1 is objected to because of the following informalities:
“accepting data about a procdure…” should read “accepting data about a procedure…”
“calculating the probability that a surgicial instrument will be used” should read “calculating the probability that a surgical instrument will be used”
“familiarizing operating room staff with the instruments” should read “familiarizing operating room staff with the surgical instrument”
“inspecting and packaing the instruction” should read “inspecting and packaging the instructions”
Semicolons should be placed at the end of each distinct function.
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 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional elements crossed out):
A surgical supply and reprocessing method comprising:
accepting data about a procdure, patient, the surgical team or other relevant information from at least one source;
calculating the probability that a surgicial instrument will be used;
optimizing the surgical instrument configuration based on an algorithm;
calculating the cost of the configuration
choosing a minimal cost option;
displaying a candidate configuration to a qualified person;
personalizing the option presented;
developing package instructions;
inspecting and packaging the instruction
sterilizing the surgical instruments
familiarizing operating room staff with the instruments; and
transporting the surgical instruments post operation
The above limitations as drafted, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people. That is, nothing in the claim precludes the steps as being described as managing personal behavior or relationships or interactions between people. For example, the limitations describe (as best can be determined) a method for accepting data about a proc[e]dure, patient, surgical team, or other information from a source, calculating the probability that a surgical instrument will be used, optimizing a surgical instrument configuration, calculating the cost of the configuration, choosing a minimal cost option, displaying a candidate configuration, personalizing the option presented, developing package instructions, inspecting and packa[g]ing the instruction[s], sterilizing the surgical instruments, familiarizing operating room staff with the instruments, and transporting the surgical instruments post operation. The limitations describe the management of personal behavior. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claim fails to recite any additional elements.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the claim fails to recite any additional elements. This is not sufficient to amount to significantly more than the judicial exception. The claim is therefore still directed to an abstract idea.
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.
Claim 1 is 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 1 recites the limitation "the surgical team". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "calculating the probability that a surgicial instrument will be used". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "calculating the cost of the configuration". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "personalizing the option presented". There is insufficient antecedent basis for this limitation in the claim.
The term “relevant information” in claim 1 is a relative term which renders the claim indefinite. The term “relevant information” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 1, the limitation “inspecting and packaing the instruction” is indefinite. The limitation features multiple typos which render the limitation unclear. For sake of examination, the Examiner shall interpret the limitation as “inspecting the package instructions” (as it was interpreted in the ISR).
Regarding claim 1, the limitation “optimizing the surgical instrument configuration based on an algorithm” is indefinite. It is unclear if the “surgical instrument configuration” is related to the settings of a particular surgical instrument (ex., a power setting of a tool), or if it is related to the particular surgical instruments included in a set/kit (ex., a set consisting of a scalpel, forceps, etc.). For sake of examination, the Examiner shall assume the latter.
Regarding claim 1, the limitation “choosing a minimal cost option” is indefinite. The limitation is preceded by “calculating the cost of the configuration”. This indicates that only one cost has been determined. Since there is only one calculated cost, it is unclear as to how a minimal cost option may be chosen. In other words, there is only one calculated cost to choose from.
Regarding claim 1, the limitations “sterilizing the surgical instruments”, “familiarizing operating room staff with the instruments”, and “transporting the surgical instruments post operation” are indefinite. The limitations refer to multiple instruments. However, the term “surgical instruments” has insufficient antecedent basis as the limitations are preceded by “calculating the probability that a surgical instrument will be used”, which indicates a singular instrument. It is unclear as to what multiple instruments are referred to in the limitations since multiple instruments were never introduced.
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uthegenannt (2012/0303004) in view of Hanajima (US 2020/0043605) and Gloger (US 2013/0091679).
Regarding claim 1, Uthegenannt discloses a surgical supply and reprocessing method comprising:
accepting data about a procdure, patient, the surgical team or other relevant information from at least one source; (See at least Para. [0006] – “The method includes preparing a pre-operative surgical plan for a patient and selecting a set of surgical instruments based on the pre-operative surgical plan.”)
calculating the probability that a surgicial instrument will be used; (See at least Para. [0006] – “The surgeon-specific instrument is selected based on a surgeon preference and is a different instrument than the selected general instrument, first size-specific instrument, and patient-specific instrument. The method further includes preparing a surgeon instrument kit containing the set of surgical instruments in sterilized form.”
optimizing the surgical instrument configuration based on an algorithm; (See at least Para. [0039] – “Accordingly, one or more patient-specific instruments can be selected based on, for example, the image information for the patient's anatomy obtained at 112, the model of the joint created at 114, and/or the implant and alignment guide designs selected at 122, 124.”)
Uthegenannt does not explicitly disclose calculating the cost of the configuration See Hanajima Para. [0155] – “The second processor 202 may be configured or programmed to calculate the work cost for a surgical instrument set in a predetermined period Z1, based on the work information of the users and the work unit prices of the users for the surgical instrument set. This makes it possible to calculate the work cost (which corresponds to a labor cost) for one surgical instrument set.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Uthegenannt to utilize the teachings of Hanajima since the cost of the surgical instrument set may factor in to selection of the particular instruments of Uthegenannt.
Uthegenannt does disclose choosing a minimal cost option; (See Para. [0049] – “By using patient-specific instruments, the number of size-specific instruments can be limited and the surgeon instrument kit can be prepared to include a reduced number of overall instruments than other conventional kits.”)
Uthegenannt also discloses displaying a candidate configuration to a qualified person; (See at least Para. [0038] – “At 126, 128, 130, instruments for performing the orthopedic procedure are selected. The instruments can be selected based on various aspects of the pre-operative surgical plan. An initial selection can be made by one or more medical professionals, including the surgeon. Modification and/or approval of the initial selection can be made at 132, discussed in more detail below, where the pre-operative surgical plan is approved. The instruments can be selected from groups including patient-specific instruments, size-specific instruments, and general surgical instruments.”
personalizing the option presented; (See Para. [0049] - By using patient-specific instruments, the number of size-specific instruments can be limited and the surgeon instrument kit can be prepared to include a reduced number of overall instruments than other conventional kits.”
Uthegenannt does not explicitly disclose developing package instructions; (See Gloger Para. [0004] – “In practice, this is accomplished by virtue of there being a specific packing list for each instrument tray. This packing list contains not only the information about which instruments belong to the respective set of instruments but also information concerning the manner in which the instruments are packed in the instrument tray.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Uthegenannt to utilize the teachings of Gloger since it would ensure that the proper instruments are included for surgical procedures.
Uthegenannt does not disclose inspecting and packaing the instruction (Also see Gloger Para. [0004])
Uthegenannt does disclose sterilizing the surgical instruments (See Para. [0049] – “At 180, a surgeon instrument kit can be prepared by sterilizing and packaging the various surgical instruments obtained at 140, 160, 170 in a container that holds the instruments in sterilize form until opened.”
familiarizing operating room staff with the instruments; (See Para. [0052] – “label or other indicia identifying each of the replacement instruments can be affixed to the containers” and
In light of the 112 rejection, Uthegenannt discloses transporting the surgical instruments post operation (See Para. [0050] – “At 190, the surgeon instrument kit can be delivered to a medical facility where the orthopedic procedure is to be performed. The surgeon instrument kit can be delivered just in-time, or in other words, just prior to a time when the orthopedic procedure is scheduled to be performed.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
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