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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/28/2026 has been entered.
In view of the amendments, the 103 reference is withdrawn.
However, upon further review of the amended claims and corresponding support from the specification/figures, the following rejections are set forth below.
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.
Claims 1-11, 14, 16-19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 includes the language “a plurality of scaffolds stacked in a modular configuration”. Upon reviewing the specification and the figures, it is not clear where the disclosure provides support for “stacked” configuration.
“[0029] In some embodiments, phantom 1 comprises one or more anisotropic diffusion modules of a well-defined filament material that approximates the size and scale of the myelinated axons of white matter. In some embodiments, phantom 1 comprises one or more isotropic diffusion modules. In some embodiments, phantom 1 comprises one or more fiber networks, with each network representing a different health state of organized tissue. In some embodiments, phantom 1 comprises one or more modular scaffolds that support a plurality of arrangements of fiber bundle networks such that network terminus and bifurcation/intersection locations are in desired locations and orientations. In some embodiments, additional isotropic diffusion modules composed of isolated domains containing a solution with predictable ADC properties are co-located on this inner-housing system of phantom 1. In some embodiments, the inner housing elements of phantom 1 are immersed with a suitable matrix fluid producing biologically relevant T1 and T2 values.”
It is not clear from the above paragraph and figure 3, the “stacked” configuration as claimed. It is suggested claim language be amended to language that has proper support from the specification and/or the figures.
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 1-11, 14, 16-19 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 includes the language “a plurality of scaffolds stacked in a modular configuration”. As set forth previously, the specification/figures do not provide adequate support this “stacked” configuration and therefore it is not clear how the scaffolds are arranged in the three-dimensional space within the DTI phantom. Is the configuration such that the plurality of scaffolds are arranged in a pile or a space that is filled up or “stacked”? There is lack of clarity with respect to this language in view of the specification. According to the specification, “phantom 1 comprises one or more modular scaffolds that support a plurality of arrangements of fiber bundle networks such that network terminus and bifurcation/intersection locations are in desired locations and orientations” [0029]. It is suggested that the “stacked” configuration be modified to language representative of the configuration, as supported by the specification/figures.
The dependent claims stand rejected as not providing additional clarity.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “stacked” configuration of the plurality of scaffolds in a modular configuration must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because figures 3-5 are not clear with respect to the what is being shown in terms of the differences between the phantom images as the quality of the proton density weighted images of the DTI phantom is very blurry, difficult to follow, and fails to show any specific details. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 19 is rejected under 35 U.S.C. 101 because the claim language is directed to a “computer-readable memory having… instructions…” Signals, being transitory can also store instructions and therefore it is suggested that the claim language be modified to “non-transitory computer-readable memory having computer-executable instruction”.
Other relevant prior art:
Yao et al. (2022/0018779):
Directed to a method and system 3D molecular diffusion tensors that can be applied to determine diffusion tensors for wide range of biological molecules and probe [0065]. Figure 3 shows that and results demonstrating direction-dependent changes in 3D diffusion due to structural manipulations in tissue engineering scaffolds. Reference directed to “methods applying such systems to determine three-dimensional (3D) diffusion tensors, and simultaneously, to perform 3D structure imaging. Example data acquisition systems can include computing systems in communication with modified light sheet microscopes that are configured for high-speed volumetric imaging to record 3D diffusion processes and high-resolution 3D structural imaging” (abstract).
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797
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