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 .
Priority
Acknowledgment is made of Applicant's claim for foreign priority based on an application filed in Europe on 23 January 2023. It is noted, however, that Applicant has not filed a certified copy of the EP23152905.8 application as required by 37 CFR 1.55.
Claim Objections
Claim 11 is objected to because of the following informalities: in line 3, “a position and course” should apparently read --a position and a course--. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an acquiring unit, a processing unit, and a provisioning unit in claim 11. The acquiring unit is taught to be an input interface, such as various imaging devices (US, CT, MRI, PET); the processing unit is taught to be a CPU or computer/tablet, and the provisioning unit is taught to be an output interface, such as a display, VR glasses, or tablet.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 1 recites the limitation “a native trochlea of the first bone” in line 10. It is not clear if this is intended to refer to the native trochlea of the first bone recited in lines 3-4 or to a separate trochlea. If the former is intended, the limitation should read --the native trochlea of the first bone--.
Claim 1 also recites the limitation “the alignment and positioning data” in the last line. It is not clear if this is intended to refer to the alignment and positioning data recited in line 1 or to the alignment and positioning data recited in lines 7-8.
Claims 2-10 each recite the limitation "the endoprosthesis fitting of joints" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims; claim 1 only recites an endoprosthesis fitting of a joint.
Claim 4 recites the limitation “output data” in line 6. It is not clear if this is intended to refer to the output data recited in claim 1 or to separate output data. If the former is intended, the limitation should read --the output data--.
Claim 4 also recites the limitation "the individual best possible kinematics" in the last two lines. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitations "the complete range of motion" in line 2 and “the patella” in the last line. There is insufficient antecedent basis for these limitations in the claim.
Claim 5 also recites the limitation "the trochlea" in the last line. It is not clear which trochlea is being referred to.
Claim 8 recites the limitations "the alignment and orientation [of the implant components]" and “the implant components” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 8 also recites the limitations “input data” and “output data” in the last line. It is not clear if these are intended to refer to the input data and the output data recited in claim 1 or to separate data. If the former is intended, the limitations should read --the input data-- and --the output data--.
Claim 10 recites the limitation “output data” in line 5. It is not clear if this is intended to refer to the output data recited in claim 1 or to separate output data. If the former is intended, the limitation should read --the output data--.
Claim 10 also recites the limitations "the alignment and orientation [of the humeral and antebrachial implant]" in lines 6-7 and “the individual best possible kinematics” in line 7. There is insufficient antecedent basis for these limitations in the claim.
Claims 2-10 are rejected by virtue of their dependence upon at least one rejected base claim.
Claim 11 recites the limitation “a native trochlea of the first bone” in line 10. It is not clear if this is intended to refer to the native trochlea of the first bone recited in lines 3-4 or to a separate trochlea. If the former is intended, the limitation should read --the native trochlea of the first bone--.
Claim 11 also recites the limitation “the alignment and positioning data” in the last two lines. It is not clear if this is intended to refer to the alignment and positioning data recited in line 1 or to the alignment and positioning data recited in line 8.
Claim 14 recites the limitation “output data” in line 4. It is not clear if this is intended to refer to the output data recited in claim 11 or to separate output data. If the former is intended, the limitation should read --the output data--.
Claim 14 also recites the limitation "the individual best possible kinematics" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitations "the complete range of motion" in lines 1-2 and “the patella” in the last line. There is insufficient antecedent basis for these limitations in the claim.
Claim 15 also recites the limitation "the trochlea" in the last line. It is not clear which trochlea is being referred to.
Claim 18 recites the limitations "the alignment and orientation [of the implant components]" and “the implant components” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 18 also recites the limitations “input data” in line 4 and “output data” in the last line. It is not clear if these are intended to refer to the input data and the output data recited in claim 11 or to separate data. If the former is intended, the limitations should read --the input data-- and --the output data--.
Claim 20 recites the limitation “output data” in line 5. It is not clear if this is intended to refer to the output data recited in claim 11 or to separate output data. If the former is intended, the limitation should read --the output data--.
Claim 20 also recites the limitation “the individual best possible kinematics” in the last line. There is insufficient antecedent basis for this limitation in the claim.
Claims 12-20 are rejected by virtue of their dependence upon at least one rejected base claim.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claims 1 and 11 recite steps of acquiring input data, processing the input data to calculate output data, and providing the output data. This series of operations falls under the mathematical calculations grouping, which have consistently been interpreted to be abstract ideas by the courts, as it explicitly requires mathematical calculations. Further, this series of operations falls under the mental processes grouping, which have also consistently been interpreted to be abstract ideas by the courts. The recited steps can be practically performed by the human mind (or via pen and paper).
Neither claim has the judicial exception integrated into a practical application. Claim 1 recites no additional elements, while claim 11 recites generic computer units that amount to no more than mere instructions to apply the abstract idea on a computer and are nothing more than a general link of the abstract idea to the technological environment of a computer. The courts have made it clear that mere physicality or tangibility of additional elements is not a relevant consideration in the eligibility analysis. Mere data gathering/acquiring, processing, and output have consistently been considered to be insignificant extra-solution activity and are basic, typical computer functions. Further, none of the recited steps are proactively used to improve the functioning of a computer or other technology/technical field. They are also not used to effect a particular treatment or prophylaxis. The claims do not apply the results or do anything with the results; they merely provide the output data. There is no provisional of a treatment (e.g., using the alignment and positioning data to perform the endoprosthesis fitting).
For similar reasons, the dependent claims also fail to provide significantly more than the abstract idea. The dependent claims merely further specify the acquired input data or further calculation and output steps; they do not directly use or apply the abstract idea to perform a particular treatment.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) and 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: the prior art teaches similar systems and methods for making measurements of biological features that can be used for modeling/selecting/designing implant components; such features can include joint lines or joint gaps, trochleas, tibias, patellas, femurs, and humeri; while the measurements can include relative locations, angles, distances, and shapes (e.g., U.S. Pub. Nos. 2022/0273450 A1, 2023/0111847 A1, 2021/0192759 A1, and 2015/0265291 A1; U.S. No. 11,278,413 B1). It is also well-known to assist in alignment or positioning of first and second joint partial implants. However, none of the prior art of record teaches or reasonably suggests acquiring and processing input data that includes a position and a course of a native trochlea of a first bone relative to a joint center, to a first joint line of the first bone and to a second joint line of a second bone that forms the joint with the first bone, and to bony axes of the first and second bones, and calculating and providing output data as the alignment and positioning data. In other words, none of the prior art of record teaches using such data that includes the position and the course of the native trochlea in relation to all of the recited elements, even if generally using data regarding the trochlea, joint lines, and bony axes is known in the art, as is mapping the native joint.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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