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 .
Claim Objections
Claims 1 – 2, 4 – 8 and 10 – 15 are objected to because of the following informalities:
The Applicant are advised to remove all numbers (with parenthesis) in the claimed limitations.
Claim 7 has a typo “wherein the image sensor (5) is an scanning electron or bright field microscope creating microscopy images as digital images (6)” (emphasis added).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim limitation “means for” in claim 6 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “means” coupled with functional language “input” and “instructions” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 6 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
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: the Specification discloses the physical structure of user interface 9 for above means.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 – 15 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 (similar as to claim 6) recites the limitation: “
creating digital microscopy images (6) of the small particles (10) used for the drug formulation by an image sensor (5) and providing the images to a computer (2) performing a measurement software (8)” (emphasis added).
There is insufficient antecedent basis for this limitation in the claim.
Claim 1 (similar as to claim 6) further recites the limitation: “
wherein the software (8) samples different candidate parameter sets, applies them automatically for the segmentation and/or calculation process and shows the results via a display (4) to a user (1)” (emphasis added).
There is insufficient antecedent basis for this limitation in the claim.
Claim 1 (similar as to claim 6) still further recites the limitation: “
wherein the user (1) picks the candidate parameter set with the best results, the software (8) establishes and trains an internal machine learning model (7) with this user feedback and applies the trained model (7) to reiterate the automatic segmentation and/or calculation and user feedback obtaining process until an optimal parameter set has been approved by the user (1).” (emphasis added).
There is insufficient antecedent basis for this limitation in the claim.
Regarding to claims 2 – 5 and 7 – 15, they are depended on claim 1 and 6, respectively, thus, they are rejected accordingly.
Claim Rejections - 35 USC § 103
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, 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.
Claim(s) 1, 4 – 8 and 10 – 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Patent Application Publication 2020/0134831, IDS), hereinafter referred as Chen, in view of Jacob et al. (US Patent Application Publication 2021/0264589, IDS), hereinafter referred as Jacob, and in further view of Brittain et al. (“Physical Characterization of Pharmaceutical Solids”, IDS), hereinafter referred as Brittain.
Regarding claim 6, Chen discloses a system to perform a computer-based small particle measurement (Fig. 1 and 9) comprising:
a computer (2) performing a measurement software (8) (Fig. 9, [0055]),
a display (4) to show information to a user (1) ([0055], “a display usable to present visual information to a user”),
means for the user (1) to input data and/or instructions to the software (8) ([0055], “one or more touchscreen …”), and
an image sensor (5) ([0055], “ an image sensor”),
wherein the system (11) is arranged to create digital microscopy images (6) of the small particles (10) via the image sensor (5), to segmentate the small particles (10) in the digital microscopy images (6) ([0017 – 0022, 0029]) and calculate properties of the small particles (10) via the software (8) ([0029], thresholding) according to specific parameter sets (Fig. 1, #130, specific segmentation algorithms), and
wherein the software (8) shows the results via the display (4) to the user (1) (Fig. 2, display segmentation result; [0055], “a display usable to present visual information to a user”), and
wherein the user (1) picks the candidate parameter set with the best results ([0018], “using human input to generate 3D ground truth images for training a deep-learning system of neural networks”; [0020]), the software (8) establishes and trains an internal machine learning model (7) with this user feedback and applies the trained model (7) to reiterate the automatic segmentation and/or calculation and user feedback obtaining process until an optimal parameter set has been approved by the user (1) ([0018 – 0022], “iterative deep learning workflows complement each other—the classic image segmentation workflow can generate sufficiently accurate segmentations for a wide range of cellular structures for analysis purposes”; [0038], human intervention).
However, Chen fails to explicitly disclose the system further comprising samples different candidate parameter sets, applies them automatically for the segmentation and/or calculation process.
However, in a similar field of endeavor Jacob discloses a system for generating a segmentation mask of an anatomical structure (abstract). In addition, Jacob discloses the system comprising samples different candidate parameter sets, applies them automatically for the segmentation and/or calculation process ([0015, 0020 - 0024]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and samples different candidate parameter sets, applies them automatically for the segmentation and/or calculation process. The motivation for doing this is to overcome the limitations of manual parameter tuning, which is both time-consuming and prone to human.
However, Chen fails to explicitly disclose the system is used for the drug formulation.
However, in a similar field of endeavor Brittain discloses a method for the physical characterization of pharmaceutical solids (abstract). In addition, Brittain discloses the method is used for the drug formulation (Introduction, page 969, col. 1, para. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and the system is used for the drug formulation. The motivation for doing this is to maximize therapeutic efficacy, ensure predictable bioavailability, and improve patient compliance.
Regarding claim 7 (depends on claim 6), Chen fails to explicitly disclose the system wherein the image sensor (5) is an scanning electron or bright field microscope creating microscopy images as digital images (6).
However, in a similar field of endeavor Brittain discloses a method for the physical characterization of pharmaceutical solids (abstract). In addition, Brittain discloses the method using a scanning electron microscope creating microscopy images as digital images (page 966 - 968, SEM for computer analysis).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and using a scanning electron microscope creating microscopy images as digital images. The motivation for doing this is that the imaging and analysis can be more powerful.
Regarding claim 8 (depends on claim 6), Chen discloses the system wherein the software (8) comprise of either two connected software components, one component responsible for the particle segmentation ([0029], “pre-processed 3D image stack and generates a preliminary segmentation”) and the other one for the property calculation ([0029], thresholding), or of one software component performing both tasks ([0029]).
Regarding claim 1, it is corresponding to claim 6, thus, it is interpreted and rejected for the same reason set forth for claim 6.
Regarding claim 4 (depends on claim 1), Chen discloses the method wherein the small particles (10) comprise of highly variable particle shapes and sizes ([0016], “These segmentations permitted initial analyses of basic morphometric features of these structures including size, number, shape, and location within the cell and form the basis for more complicated feature parameterizations”).
Regarding claim 5 (depends on claim 1), Chen fails to explicitly disclose the method wherein the digital microscopy images (6) are created under variable lighting conditions.
However, in a similar field of endeavor Brittain discloses a method for the physical characterization of pharmaceutical solids (abstract). In addition, Brittain discloses wherein the digital microscopy images (6) are created under variable lighting conditions (page 968, col. 2, light scattering, X-rays).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and the digital microscopy images (6) are created under variable lighting conditions. The motivation for doing this is that particles can be well detected.
Regarding claim 10 (depends on claim 2), Chen discloses the method wherein the small particles (10) comprise of highly variable particle shapes and sizes ([0016], “These segmentations permitted initial analyses of basic morphometric features of these structures including size, number, shape, and location within the cell and form the basis for more complicated feature parameterizations”).
Regarding claims 11, 13 and 14, they are corresponding to claim 5, thus, they are interpreted and rejected for the same reason set forth for claim 5.
Regarding claim 12 (depends on claim 3), Chen discloses the method wherein the small particles (10) comprise of highly variable particle shapes and sizes ([0016], “These segmentations permitted initial analyses of basic morphometric features of these structures including size, number, shape, and location within the cell and form the basis for more complicated feature parameterizations”).
Regarding claim 15 (depends on claim 7), Chen discloses the system wherein the software (8) comprise of either two connected software components, one component responsible for the particle segmentation ([0029], “pre-processed 3D image stack and generates a preliminary segmentation”) and the other one for the property calculation ([0029], thresholding), or of one software component performing both tasks ([0029]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Jacob, in further view of Brittain and Sei et al. (US Patent Application Publication 2022/0218616), hereinafter referred as Sei,
Regarding claim 2 (depends on claim 1), Chen fails to explicitly disclose the method wherein Active Pharmaceutical Ingredient particles (API) (10) are used as small particles (10).
However, in a similar field of endeavor Sei discloses a method for the physical characterization of pharmaceutical solids (abstract). In addition, Sei discloses the method wherein Active Pharmaceutical Ingredient particles (API) (10) are used as small particles ([0082, 0085]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and Active Pharmaceutical Ingredient particles (API) (10) are used as small particles. The motivation for doing this is that the application of Chen can be broadened.
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Jacob, in further view of Brittain, Sei and Yao et al. (Chinese Patent Application Publication CN 113776469), hereinafter referred as Yao,
Regarding claim 3 (depends on claim 1), Chen fails to explicitly disclose the method wherein the measured properties comprise of the structure and fractality of the small API particle surface to determine the surface smoothness of small API particles and of the particle size distributions.
However, in a similar field of endeavor Sei discloses a method for the physical characterization of pharmaceutical solids (abstract). In addition, Sei discloses the method wherein Active Pharmaceutical Ingredient particles (API) (10) are used as small particles ([0082, 0085]).
In a similar field of endeavor Yao discloses a system for detecting the surface roughness of powder particles (abstract). In addition, Yao discloses the system wherein measured properties comprise of the structure and fractality of the small particle surface to determine the surface smoothness of small particles and of the particle size distributions ([n0004, n0009, n0026 – n0028], “comprehensively and quantitatively describe the surface roughness of particles, calculate the fractal dimension at different scales to characterize the surface roughness of particles,).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Chen, and measured properties comprise of the structure and fractality of the small API particle surface to determine the surface smoothness of small API particles and of the particle size distributions. The motivation for doing this is that the particle characterization can be better analyzed.
Regarding claim 9, it is corresponding to claim 3, thus, it is interpreted and rejected for the same reason set forth for claim 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIAN YANG whose telephone number is (571)270-7239. The examiner can normally be reached on Monday-Thursday 8am-6pm.
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/QIAN YANG/
Primary Examiner, Art Unit 2677
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