DETAILED ACTION
Notice of AIA Status
1. 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 § 101
2. 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.
Regarding claims 1-20 under the broadest reasonable interpretation, the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skilled in the art. See MPEP 2111.
The claimed invention locates features in an image of an implant in a patient so as to extract medical information based upon the features.
The claims are directed mental process and do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
The claims do not have any limitations that are indicative of integration of the judicial exception into a practical application such as improvements to functioning of a computer or a technical field, using any particular machine, effect a transformation of a particular article to a different state or thing, or apply the judicial exception in any meaningful way beyond generally linking the use to a particular technological environment. Therefore, the claims as a whole do not amount to significantly more than the judicial exception.
A patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof," 35 U.S.C. § 101, but “laws of nature, natural phenomena, and abstract ideas are not patentable.”
Step 1
Claims 1 is directed to one of the four statutory categories of eligible subject matter (process): thus, the claim pass Step 1 of the Subject Matter Eligibility Test.
Step 2A, prong 1 analysis
Claims 1-20 direct to a judicial exception in terms of mental processes which can be performed by human being with aids of simple tools like pen, ruler and paper or a computer. A trained physician looking at a medical image of an implant can locate a serial number on the implant and look up a database to obtain patient or manufactural information associated with the features. The features may be carved/embossed/molded on the implant.
Step 2A, prong 2 analysis
Other than retrieving information, defining information, or displaying information, the claims do not have any limitations that are indicative of integration of the judicial exception into a practical application such as improvements to functioning of a computer or a technical field, using any particular machine, effect a transformation of a particular article to a different state or thing, or apply the judicial exception in any meaningful way beyond generally linking the use to a particular technological environment.
Step 2B
Further, the claims do not include other additional elements that are beyond what is well-understood, routine, conventional activities in the field and sufficient to amount to significantly more than the judicial exception.
Conclusion:
The claims do not include additional elements amount to significantly more in terms of improving functionalities of a computer/device itself, improving another technology or technical field, effecting a transformation or reduction of a particular article to a different state or thing, adding unconventional steps that confine claim to a particular useful application or by use of a particular machine that is unconventional. In conclusion, the claims 1-20 do not comply with the current standards for patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 102
3. The following is a quotation of 35 U.S.C. 102 which forms the basis for all obviousness rejections set forth in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
4. Claims 1, 4, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies (WO Pub: 2016/185180).
Regard claim 1, Davies teaches: A method of identifying medical information comprising the steps of: imaging an implant implanted in a patient to generate an image of the implant, the implant having an identification feature, locating the identification feature in the image, and identifying the medical information based upon the identification feature [abstract, page 10: p08; page 11: p01].
Regarding claim 4, Davies further teaches: The method of identifying medical information of claim 1, wherein the identification feature is a barcode or a QR code on a surface of the implant [page 11: p03, p05].
Regarding claim 8, Davies further teaches: The method of identifying medical information of claim 1, wherein the medical information is a batch number of the implant [page 13: p02].
Regarding claim 9, Davies further teaches: The method of identifying medical information of claim 1, wherein the medical information is a file of the patient [page 14: p05, page 15: p05].
Regarding claim 10, Davies further teaches: The method of identifying medical information of claim 1, wherein the implant is substantially metallic [page 21: p06].
Claim Rejections - 35 USC § 103
5. 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 of this title, 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.
61066.. Claims 2, 3, 5-7, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (WO Pub: 2016/185180) and in further view of Black (US Pub: 2023/0025033).
Regarding claim 2, Davies further teaches: The method of identifying medical information of claim 1. wherein the identification feature is text on a surface of the implant [page 11: p01 (serial number)]. For a redundant teaching in the same field of endeavor, Black also teaches text on a surface of an implant as identification feature [p0031, p0033]. Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of the two to include text as identification per design choice.
Regarding claim 3, the rationale applied to the rejection of claim 2 has been incorporated herein. Black further teaches: The method of identifying medical information of claim 2. wherein the text is a protrusion or a recession on the surface of the implant [p0028].
Regarding claim 5, the rationale applied to the rejection of claim 4 has been incorporated herein. Davies does not specify a protrusion or a recession on the surface of the implant. In the same field of endeavor, Black teaches: The method of identifying medical information of claim 4, wherein the identification feature is a protrusion or a recession on the surface of the implant [p0028, p0031]. Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of the two to have identification engraved or etched on the surface of an implant per design choice.
Regarding claim 6, the rationale applied to the rejection of claim 5 has been incorporated herein. Davies further teaches: The method of identifying medical information of claim 5, further comprising the step of scanning the barcode or QR code to identify the medical information [page 11: p03, p05].
Regarding claim 7, the rationale applied to the rejection of claim 6 has been incorporated herein. Davies further teaches: The method of identifying medical information of claim 6, further comprising the steps of: scanning the barcode or QR code with an image sensor; analyzing the barcode or QR code with a programmed processor; retrieving medical information from a database; displaying the medical information on a display screen; and identifying the medical information [page 11: p05; page 12: p08, p09; page 13: p02, page 14: p04].
Claims 14-19 have been analyzed and rejected with regard to claims 7, 5, 8, 9, 7, and 10 respectively.
71066.. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (WO Pub: 2016/185180) and in further view of Miller et al (US Pub: 2021/0038396).
Regarding claim 11, Davies does not emphasize polymeric implant. In the same field of endeavor, Miller et al teaches: The method of identifying medical information of claim 1, wherein the implant is substantially polymeric [p0024]. Therefore, given Keith et al’s prescription on printing implant with photopolymer resin, it would have been obvious for a skilled in the art before the effective filing date of the claimed invention to combine the teaching of the two to apply various material such as polymer for implant for the benefit of complex shape design and easy surface control.
Regarding claim 12, Davies further teaches: The method of identifying medical information of claim 11, wherein the identification feature is radiopaque [page 11: p01, p04].
Regarding claim 13, Davies further teaches: The method of identifying medical information of claim 12, wherein the identification feature is metallic [page 22: p03].
81066.. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davies (WO Pub: 2016/185180) and Black (US Pub: 2023/0025033); and in further view of Miller et al (US Pub: 2021/0038396).
Regarding claim 20, the rationale applied to the rejection of claim 14 has been incorporated herein. Claim 20 has been analyzed and rejected with regard to claim 12.
Contact
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FAN ZHANG whose telephone number is (571)270-3751. The examiner can normally be reached on Mon-Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benny Tieu can be reached on 571-272-7490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Fan Zhang/
Patent Examiner, Art Unit 2682