DETAILED ACTION
Pro Se Application
This application appears to have been filed without the assistance of a registered patent attorney or agent. For example, no power of attorney has been filed. Such applications are often referred to as “pro se” applications. The USPTO website provides resources for pro se patent applicants. See, for example, https://www.uspto.gov/patents/basics/using-legal-services/pro-se-assistance-program.
Manual of Patent Examining Procedure (MPEP)
The Manual of Patent Examining Procedure (MPEP) provides instructions for how patent applications are to be examined. It is available on the USPTO website and is cited extensively below. Applicant (i.e., the person(s) who filed this patent application) is encouraged to review the MPEP when preparing their response to this Office Action. Chapters 700 and 2100 may be of particular interest.
Interview
Applicant may wish to request an interview. An interview is a pre-scheduled discussion, typically held by phone, between a patent applicant and the patent examiner reviewing their application (i.e., Examiner). Applicant may request an interview by, for example, calling Examiner at the phone number listed at the bottom of this Office Action. See MPEP 713.
Information Disclosure Statement
Applicants have a duty to disclose information material to patentability. MPEP 2001. Applicants may disclose information by filing an Information Disclosure Statement (IDS). MPEP 609.
Page 1 of the specification includes a list of references below the abstract. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Patent rules are set forth in Title 37 of the Code of Federal Regulations (CFR). They can be found in Appendix R of the MPEP.
37 CFR 1.75(f) requires that, “If there are several claims, they shall be numbered consecutively in Arabic numerals.” The instant application includes two different claims numbered 1. They are not numbered consecutively because the second claim should be numbered 2, not 1. Both of claims 1 are objected to for failure to comply with the requirements of 37 CFR 1.75(f).
In order to correct this issue, Examiner suggests cancelling both of claims 1 and adding new claims with corresponding subject matter. For example, the amended claims would read:
1. (Cancelled).
[claims 2-6 would appear here]
7. (New) The scaphoid can be characterized geometrically.
8. (New) The golden spiral provides an accurate representation of the mid-sagittal coplanar section of the scaphoid.
Note that this example repeats the original claim text in order to demonstrate how the claims should be renumbered to overcome this specific objection. Applicant may wish to make further amendments to the text of the claims in order to overcome the other objections/rejections made below.
In the remainder of this Office Action, the first claim 1 (i.e., the claim reading “The scaphoid can be characterized geometrically”) will be referred to as claim 1a and the second claim 1 will be referred to as claim 1b.
Claim Rejections - 35 USC § 112
Patent laws are set forth in Title 35 of the United States Code (USC). They can be found in Appendix L of the MPEP.
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 1a-6 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.
Claims 1a-6 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
One issue that is repeated throughout the claims is lack of adequate antecedent basis. MPEP 2173.05(e). For example, claim 1a refers to “The scaphoid”, but no scaphoid is introduced earlier in the claim, so it is unclear what is being referred to as the scaphoid. In another example, claims 1a-3 refer to “The golden spiral”, but no golden spiral is introduced earlier any of these claims, so it is unclear what is being referred to as the golden spiral. In another example, claims 2-4 refer to “the mid-sagittal plane”, but no mid-sagittal plane is introduced earlier in any of these claims, so it is unclear what is being referred to as the mid-sagittal plane. In another example, claim 6 refers to “the morphological contours”, but no morphological contours are introduced earlier in the claim, so it is unclear what is being referred to as the morphological contours. Lack of antecedent basis may be corrected by introducing each element into the claims. For example, claim 4 could be amended to introduce “a mid-sagittal plane”.
Another issue repeated throughout the claims is that it is unclear what structure or process is being claimed as an invention. For example, claim 1a states that “The scaphoid can be characterized geometrically,” but it is unclear what Applicant is claiming as their invention. Is the scaphoid the invention? Is a geometric characterization the invention? Is something else the invention? This ambiguity makes the scope of the claim unclear and renders the claim indefinite under 35 U.S.C. 112(b). I.e., the claim does not “particularly point[] out and distinctly claim[] the subject matter which the inventor or a joint inventor regards as the invention.” 35 U.S.C. 112(b). Another example of this issue is at claim 4, where it is unclear what invention is being claimed. I.e., is the invention a machine that assesses a scaphoid, a process of assessing a scaphoid, a human that assesses a scaphoid, or something else? If it is a machine, then what are the components of the machine? If it is a process, then what are the steps of that process? Another example of this issue is at claim 5. Is the invention the relationship between a displaced fracture or established nonunion and a logarithmic spiral exponent itself, a machine that calculates the logarithmic spiral exponent, a process of attempting golden spiral representation, or something else? Another example of this issue is at claim 6. Is the invention the relationship between golden spiral conformity and scaphoid fracture or deformity itself, a machine that evaluates conformity with a golden spiral, a process of evaluating golden spiral conformity, or something else?
Another way of viewing this issue is that many of the claims are purely functional – i.e., they define the invention by what it does rather than by what it is. Functional limitations are discussed at MPEP 2173.05(g). While functional limitations are permissible in some instances, “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” Id. (Note that “Id.” refers to the previous citation, which is MPEP 2173.05(g) in this instance). For example, claim 4 recites “assess[ing] if a scaphoid has suffered a displaced fracture or has a nonunion deformity when viewed along the mid-sagittal plane,” which only states a problem solved or a result obtained, without reciting the particular structure, materials or steps that accomplish the function or achieve the result. All means or methods of resolving the problem may be encompassed by the claim, so the claim does not set forth well-defined boundaries of the invention. I.e., it is unclear what “assesses” in claim 4. Another example is claim 5, which specifies that “Altered scaphoid morphology secondary to a displaced fracture or an established union results in a smaller logarithmic spiral exponent reflective of a rounder profile disallowing golden spiral representation” (emphasis added). This specifies a result to be obtained, but does not recite the particular structure, materials or steps that achieve this result, so the boundaries of the claim are unclear. I.e., it is unclear what achieves the recited result of a smaller logarithmic spiral exponent.
This issue may be corrected by specifying what structure is performing the functions in the claim and/or what process is performed to achieve the claimed results. For example, claim 4 could be amended to recite a process including steps that are performed in order to make the assessment (e.g., capturing an image of a scaphoid viewed along a mid-sagittal plane; mapping contour points of the scaphoid; fitting a logarithmic spiral to the contour points; determining whether a growth factor of the logarithmic spiral meets a threshold; and determining if the scaphoid has suffered a displaced fracture or has a nonunion deformity in response to the threshold determination).
In view of the issues of indefiniteness noted above, there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of the claims. Under such circumstances, “it would not be proper to reject such a claim on the basis of prior art.” MPEP 2173.06, Subsection II. Therefore, no prior art rejections under 35 U.S.C. 102 or 103 are made in this Office Action. However, Examiner has performed a prior art search and pertinent references have been cited – see the Conclusion section below.
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.
The subject matter eligibility (SME) test for compliance with 35 U.S.C. 101 is described in MPEP 2106. A flowchart is shown in Subsection III. Step 1 is to determine whether a claim is to one of the “statutory categories” of patent-eligible inventions enumerated in 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
Claims 1a-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. I.e., each of the pending claims fails step 1 of the SME test.
Claim 1a recites that “The scaphoid can be characterized geometrically.” This is not a process, machine, manufacture or composition of matter.
Claim 1b recites that “The golden spiral provides an accurate representation of the mid-sagittal coplanar section of the scaphoid.” This is not a process, machine, manufacture or composition of matter.
Claim 2 recites that “The golden spiral can be used to model the standard morphological contours of a scaphoid when viewed along the mid-sagittal plane.” This is not a process, machine, manufacture or composition of matter.
Claim 3 recites that “The golden spiral can be utilized as a diagnostic tool in order to assess scaphoid morphology when viewed in the mid-sagittal plane.” This is not a process, machine, manufacture or composition of matter.
Claim 4 recites that “This invention assesses if a scaphoid has suffered a displaced fracture or has a nonunion deformity when viewed along the mid-sagittal plane.” This is not a process, machine, manufacture or composition of matter.
Claim 5 recites that “Altered scaphoid morphology secondary to a displaced fracture or an established nonunion results in a smaller logarithmic spiral exponent reflective of a rounder profile disallowing golden spiral representation.” This is not a process, machine, manufacture or composition of matter.
Claim 6 recites that “If the morphological contours, when viewed along the sagittal plane, do not conform to the golden spiral then the scaphoid may have a displaced fracture or nonunion deformity.” This is not a process, machine, manufacture or composition of matter.
As explained above, all of the pending claims fail the SME test at step 1 and are therefore ineligible under 35 U.S.C. 101. When feasible, the SME analysis is continued into step 2 even after claims have failed step 1 of the SME test. Specifically, the test is continued for claims that can be amended to fall within a statutory category. MPEP 2106.03, Subsection II. While it may be possible to amend the pending claims so that they fall within a statutory category, such amendments would have to be extensive and any further SME analysis would require considerable speculation about the scope of hypothetical claims. Therefore, Examiner has not continued a formal SME analysis into step 2.
However, in the interest of promoting compact prosecution, Examiner does note that many of the concepts described in the specification appear to be directed to judicial exceptions that would be recognized at step 2A of the SME. Paragraphs [0003]-[0010] of the (as-filed) specification describe a golden spiral that would fall within the mathematical concepts category of abstract idea judicial exceptions. MPEP 2106.04(a)(2), Subsection I. Paragraphs [0011]-[0012] of the specification describe that a healthy scaphoid bone conforms to a golden spiral, while a fractured or deformed scaphoid bone does not, which would fall within the laws of nature and natural phenomena type of judicial exception. MPEP 2106.04(b), Subsection I. Paragraph [0018] describes making a decision based on the value of a growth factor
b
, which would fall within the mathematical concepts (e.g., evaluating an inequality) and/or mental processes (e.g., mentally making a decision) categories of abstract idea judicial exceptions. MPEP 2106.04(a)(2), Subsections I and III.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
‘Ten Berg’ (“Analysis of deformity in scaphoid non-unions using two- and three-dimensional imaging,” 2016)
Describes various parameters used to measure scaphoid deformity in 2D and 3D images
‘Gorelick’ (“New Fractal Theory of Wrist Biomechanics,” 2019)
Presented at: 14th IFSSH Triennial Congress in conjunction with the 11th IFSHT Triennial Congress (IFSSH & IFSHT 2019), June 17–21; Berlin, Germany (2019)
Describes how wrist bones – including scaphoid – exhibit a golden spiral shape – see, e.g., sixth, eighth, eleventh, and twelfth slides
In particular, the third-from-the-left image on the eleventh slide shows a golden spiral fit to a scaphoid
‘Taljanovic’ (“Imaging and Treatment of Scaphoid Fractures and their Complications,” 2012)
Includes several examples of images of scaphoid fractures from a variety of different views – e.g., page 10 et seq.
‘Yang’ (“Scaphoid Fracture Detection by Using Convolutional Neural Network,” 2022)
Uses neural networks to detect scaphoid and classify it as fractured or not
‘Hayduke’ (US 2020/0034979 A1)
Has examples of fitting a golden spiral to anatomical images – e.g., Fig. 7G
‘Griffith’ (US 2020/0129114 A1)
Describes automatic segmentation of wrist bones (including scaphoid) in MRI images – e.g., Fig. 5C
‘Lin’ (US 2021/0275123 A1)
Describes training a neural network to detect a scaphoid fracture
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEOFFREY E SUMMERS whose telephone number is (571)272-9915. The examiner can normally be reached Monday-Friday, 7:00 AM to 3:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chan Park can be reached at (571) 272-7409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEOFFREY E SUMMERS/Examiner, Art Unit 2669