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 .
Information Disclosure Statement
1. The information disclosure statement (IDS) submitted on 08/21/2023 has been considered by the examiner.
Claim Interpretation
2. 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.
3. 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.
4. 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: “the projection module”, “the preprocessing module”, “the registration module”, “a femoral contour line generating unit”, “a femoral head fitting unit”, “a femoral neck characteristic line selecting unit”, “a femoral coordinate system establishing unit”, “a femoral characteristic circle generating unit”, “a femoral characteristic line selecting unit” and “a femoral characteristic point selecting unit”, “a first femoral characteristic line selecting subunit”, “a second femoral characteristic line selecting subunit”, “a third femoral characteristic line selecting subunit”, “a fourth femoral characteristic line selecting subunit”, “a fifth femoral characteristic line selecting subunit”, “femoral coordinate system overlap unit”, “a femoral characteristic point registration unit”, “ an interested region selecting unit” in claims 1-5.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding “the projection module”, “the preprocessing module”, “the registration module”, “a femoral contour line generating unit”, “a femoral head fitting unit”, “a femoral neck characteristic line selecting unit”, “a femoral coordinate system establishing unit”, “a femoral characteristic circle generating unit”, “a femoral characteristic line selecting unit” and “a femoral characteristic point selecting unit”, “a first femoral characteristic line selecting subunit”, “a second femoral characteristic line selecting subunit”, “a third femoral characteristic line selecting subunit”, “a fourth femoral characteristic line selecting subunit”, “a fifth femoral characteristic line selecting subunit”, “femoral coordinate system overlap unit”, “a femoral characteristic point registration unit”, “ an interested region selecting unit”– the specification does not disclose the structure for these cited modules and units. See rejection under 35 U.S.C 112.
Claim Rejections - 35 USC § 112
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not disclose a written description for the structure for “the projection module”, “the preprocessing module”, “the registration module”, “a femoral contour line generating unit”, “a femoral head fitting unit”, “a femoral neck characteristic line selecting unit”, “a femoral coordinate system establishing unit”, “a femoral characteristic circle generating unit”, “a femoral characteristic line selecting unit” and “a femoral characteristic point selecting unit”, “a first femoral characteristic line selecting subunit”, “a second femoral characteristic line selecting subunit”, “a third femoral characteristic line selecting subunit”, “a fourth femoral characteristic line selecting subunit”, “a fifth femoral characteristic line selecting subunit”, “femoral coordinate system overlap unit”, “a femoral characteristic point registration unit”, “ an interested region selecting unit” as recited in claims 1-5.
7. 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.
8. Claims 1-5 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 pre-AIA the applicant regards as the invention.
In claims 1-5, the various means plus function claim limitations for which it was indicated the specification fails to disclose the corresponding structure material or acts for performing the recited function are rejected as being indefinite for that reason.
Claim Rejections - 35 USC § 102
9. 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.
10. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
11. Claim(s) 1, 6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al., Chinese Patent Publication No. CN112509022A (Publication Date – 03/16/2021).
Regarding claim 1, Liu discloses an image registration system for a femur surgery, comprising:
a projection module, a preprocessing module and a registration module;
the projection module is configured to carry out DRR projections at different angles of a three-dimensional femur CT image, to obtain a plurality of two-dimensional DRR projection images (figure 5 – femur; page 2 – obtaining a series of three-dimensional image by CT…starting from 0 degree, generating N pieces of DRR image according to the three dimensional image provided by CT…obtaining the corresponding pose parameter P; wherein, P = (ø x, ø y, ø z, X, Y, Z); ø x, ø y, ø z represents the rotating direction; X, Y, Z represents the translation amount in each direction under the coordinate system);
the preprocessing module is configured to preprocess femur images in the two- dimensional DRR projection images and two-dimensional X-ray images, to generate femoral coordinate systems and femoral characteristic points (page 1 - Abstract – obtaining the pose coordinate P of each image; page 2 – “obtaining the corresponding pose parameter P; wherein, P = (ø x, ø y, ø z, X, Y, Z); ø x, ø y, ø z represents the rotating direction; X, Y, Z represents the translation amount in each direction under the coordinate system”; page 3 – contour extraction for contour correlation and points for point registration corresponds to the femoral characteristic points); and
the two-dimensional X-ray images include a plurality of X-ray plane images taken from different angles of a femur (page 2 - the X ray machine on the C-shaped arm obtains X-Ray perspective image with different angles); and
the registration module is configured to determine, from the plurality of two-dimensional DRR projection images, a two-dimensional DRR projection image in a same femoral posture as a femoral posture of the two-dimensional X-ray images according to the femoral coordinate systems and the femoral characteristic points of the two-dimensional DRR projection images and the two-dimensional X-ray images, to obtain a plurality of target DRR projection images (page 3 – outputting the image after accurate registration; page 5 – “7) matching the two DRR image and X-Ray image successfully, respectively extracting the shift angle point, as shown in FIG. 5 (c), (d), and performing angular point matching, obtaining the angular point matching matrix.”; Abstract – “in the operation, the X-ray machine obtains two X-Ray perspective images with different angles; 4) generating N DRR images according to the operation requirement; obtaining the pose coordinate P of each image; 5) processing the image data generated by the DRR algorithm; then selecting the interested area without fracture part, extracting the outline; 6) extracting the contour line of the real Xray according to the same method; 7) based on the contour line and characteristic point related property is three-dimensional image before operation and X-Ray perspective image accurate registration, outputting the image after accurate registration”).
Regarding claim 6, claim 6 has been similarly analyzed and rejected as per citations made in the rejection of claim 1.
Regarding claim 9, Liu discloses The image registration method according to claim 6, wherein the determining, from the plurality of two-dimensional DRR projection images, a two-dimensional DRR projection image in the same femoral posture as a femoral posture of a two-dimensional X-ray image according to the femoral coordinate systems and the femoral characteristic points of the two-dimensional DRR projection images and the two-dimensional X-ray images, to obtain a plurality of target DRR projection images specifically comprises: overlapping the femoral coordinate systems of the two-dimensional DRR projection images and the two-dimensional X-ray images; and matching positions of the femoral characteristic points of the two-dimensional DRR projection images and the two-dimensional X-ray images in a one-to-one correspondence (see the citations made in the rejection of claim 1; obtaining corresponding pose coordinates is nothing but obtaining overlapping pose coordinates).
12. Claims 7-8 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior arts of record as cited do not teach the subject matter as recited in claims 2-5, 7-8 and 10.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Manav Seth whose telephone number is (571) 272-7456. The examiner can normally be reached on Monday to Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Sumati Lefkowitz, can be reached on (571) 272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Manav Seth/
Primary Examiner, Art Unit 2672
June 6, 2026
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