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 .
Specification
The disclosure is objected to because of the following informalities:
The specification refers to both a “Hella code” and a “HELAC code.” The corresponding Chinese application translates the same structure to a “Haila code.” It is interpreted that at least one, if not all, of these unrecognized terms are a translation error.
Appropriate correction is required.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
The claims make reference to a “Hella code.” Hella code is not an art recognized term. Additionally, the specification refers to both a “Hella code” and a “HELAC code.” The corresponding Chinese application translates the same structure to a “Haila code.” It is interpreted that at least one, if not all, of these unrecognized terms are a translation error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
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 1-10 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) Regarding claim 1 the factors weigh as follows:
The breadth of the claim is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification.
The nature of the invention is in some way locating a position and tracking the position of a tumor. The method is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification.
The state of the prior art is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification.
The level of one of ordinary skill would be unable to determine the structure of a “Hella code” because it is not an art recognized term and is not defined in the specification.
The level of predictability in the art is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification
The inventor fails to define a “Hella code.”
The existence of working examples is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification
The quantity of experimentation is unable to be determined as the key structure of the claims are a “Hella code” which is not an art recognized term and is not defined by the specification.
For these reasons, claim 1 fails to comply with the enablement requirement. Claims 2-10 are dependent on claim 1 and are rejected for the same reason.
Claims 1-10 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.
Regarding claim 1, the claim limitation “Hella code” is indefinite insofar as the examiner is unclear about the structure of “Hella Code” and it is impossible to determine the intending scope of the structure of “Hella Code” in claim 1. Hella code is not an art recognized term. Additionally, the specification refers to both a “Hella code” and a “HELAC code.” The corresponding Chinese application translates the same structure to a “Haila code.” It is interpreted that at least one, if not all, of these unrecognized terms are a translation error and it is impossible to determine the structure of the “Hella code”
Also, dependent Claims 2-10 are rejected by virtue of its dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ferte teaches a method for feature extraction and evaluation for monitoring and identifying tumors (abstract, pg. 10-11), comprising: dividing a image into a plurality of voxels, extract a variety of features from said image, encoding said features into a scoring code, comparing said cade with a reference value, and deriving the presence, density, or evolution of a tumor (pg. 10-11).
Yan teaches a self-recognizing method of image segmentation in medical imaging (abstract, pg. 2).
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/RICHARD O TOOHEY/Examiner, Art Unit 2884
/EDWIN C GUNBERG/Primary Examiner, Art Unit 2884