DETAILED ACTION
The United States Patent & Trademark Office appreciates the response filed for the current application that is submitted on 01/07/2026. The United States Patent & Trademark Office reviewed the following documents submitted and has made the following comments below.
Amendment
Applicant submitted amendments on 01/07/2026. The Examiner acknowledges the amendment and has reviewed the claims accordingly. Claims 1, 3, and 13-24 have been afforded the benefit of this filing date.
Priority
Applicant claims the benefit of Foreign Priority from Application No JP2022-131892, filed 08/22/2022. Claims 1-14 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated 08/18/2023 has been considered and placed in the application file.
Overview
Claims 1-14 are pending in this application and have been considered below.
Claim 2 is cancelled.
Claims 1 and 3- 14 are rejected.
Applicant Arguments:
In regards to the argument on Argument 1, Applicant/s state/s “Applicant respectfully submits that the '655 application fails to disclose processing circuitry configured to analyze the pre-resection medical image to identify a composition of a. tissue contained in the determined resection target portion, calculate for each of a plurality of cell types, an amount of cells to be produced. based on the identified composition of the tissue contained in the determined resection target portion, and display the amount of cells calculated for each of the plurality of cell types on a display, as recited in amended Claim 1.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 8, paragraph 5).
In regards to the argument on Argument 2, Applicant/s state/s “Thus, Applicant respectfully submits that the '536 application fails to disclose processing circuitry configured to analyze the pre-resection medical image to identify a composition of a tissue contained in the determined resection target portion, calculate for each of a plurality of cell types, an amount of cells to be produced, based on the identified composition of the tissue contained in the determined resection target portion, and display the amount of cells calculated for each of the plurality of cell types on a display, as recited in amended Claim 1.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 9, paragraph 4).
In regards to the argument on Argument 3, Applicant/s state/s “Thus, no matter how the teachings of the '655 and '536 applications are combined, the combination does not teach or suggest the functionality of the processing circuitry recited in amended Claim 1. Accordingly, Applicant respectfully submits that the rejection of Claim 1 is rendered moot by the present amendment to that claim.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 10, paragraph 3).
In regards to the argument on Argument 4, Applicant/s state/s “Independent Claims 13 and 14 recite limitations analogous to the limitations recited in Claim 1, and are amended in a manner analogous to the amendment to Claim 1. Accordingly, for the reasons stated above, Applicant respectfully submits that the rejections of Claims 13 and 14 are rendered moot by the present amendment to those claims.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 10, paragraph 4).
In regards to the argument on Argument 5, Applicant/s state/s “Regarding the rejection of dependent Claims 3-7 and 10 under 35 U. S.C. § 103, Applicant respectfully submits that the '781 and '608 applications fail to remedy the deficiencies of the '655 and '536 applications, as discussed above. Accordingly, Applicant respectfully submits that the rejections of the above-noted dependent claims are rendered moot by the present amendment to Claim 1.” therefore, the rejection of 35 U.S.C. 103 should be withdrawn (See Remarks, page 10, paragraph 5).
In regards to the argument on Argument 6, Applicant/s state/s “Applicant respectfully submits that the rejection of Claim l under 35 U.S.C. § 101 is rendered moot by the present amendment to that claim, or is otherwise traversed.” therefore, the rejection of 35 U.S.C. 101 should be withdrawn (See Remarks, page 10, paragraph 5).
Examiner’s Responses:
In response to Argument 1, Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Rigotti et al. (US Patent Publication US 2013/0131655 A1 hereafter referred to as Rigotti) in view of Hendrick et al. (US Patent Publication US 2012/0308536 A1 hereafter referred to as Hendrick) in further view of Boppart et al (US Patent US 8983580 B2 hereafter referred to as Boppart).
The Examiner finds that Rigotti teaches on the amended claim language “is obtained by scanning a patient using a medical scanner being one of an X-ray diagnostic device” in Claim 1 with the amendment changing the scope of the claim with the limitation “pre-resection medical image”.
Specifically, Rigotti teaches scanning a patient using a medical scanner in ¶0032, ¶0034, and ¶0043 while also disclosing the use of an XRAY, MRI or IR device in ¶0023. Applicant argues that “ ‘655 application fails to disclose processing circuitry configured to analyze the pre-resection medical image to identify a composition of a. tissue contained in the determined resection target portion, calculate for each of a plurality of cell types, an amount of cells to be produced. based on the identified composition of the tissue contained in the determined resection target portion, and display the amount of cells calculated for each of the plurality of cell types on a display, as recited in amended Claim 1”. However, the Examiner interprets that Rigotti teaches the main concept of an medical image processing device that determines the resection area for surgical treatment, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Boppart in the details of the rejection below. The Examiner will maintain prior art Rigotti and details of the rejection are below.
In response to Argument 2, Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Rigotti et al. (US Patent Publication US 2013/0131655 A1 hereafter referred to as Rigotti) in view of Hendrick et al. (US Patent Publication US 2012/0308536 A1 hereafter referred to as Hendrick) in further view of Boppart et al (US Patent US 8983580 B2 hereafter referred to as Boppart).
The Examiner finds that Hendrick teaches on the amended claim language “the amount of cells calculated” and “an amount of cells to be produced” in Claim 1 with the amendment changing the scope of the claim with the limitation “pre-resection medical image”.
Specifically, Hendrick teaches calculating the amount of cells and disclosing the amount of tissue that is produced and the total yield of cells calculated in ¶0054, Table 1, ¶0112, ¶0169*, and ¶0206. Applicant argues that “ '536 application fails to disclose processing circuitry configured to analyze the pre-resection medical image to identify a composition of a tissue contained in the determined resection target portion, calculate for each of a plurality of cell types, an amount of cells to be produced, based on the identified composition of the tissue contained in the determined resection target portion, and display the amount of cells calculated for each of the plurality of cell types on a display, as recited in amended Claim 1”. However, the Examiner interprets that Rigotti and Hendrick teaches the main concept of a processor or CPU performing a method including calculating the amount of cells to be produced, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Boppart in the details of the rejection below. The Examiner will maintain prior art Rigotti and Hendrick and details of the rejection are below.
In response to Argument 3, Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 1 and its dependent claims under 35 U.S.C. 103 in view of Rigotti et al. (US Patent Publication US 2013/0131655 A1 hereafter referred to as Rigotti) in view of Hendrick et al. (US Patent Publication US 2012/0308536 A1 hereafter referred to as Hendrick) in further view of Boppart et al (US Patent US 8983580 B2 hereafter referred to as Boppart).
The Examiner finds that Rigotti and Hendrick teaches on the amended claim language in Claim 1 with the amendment changing the scope of the claim with the limitation “pre-resection medical image”.
Specifically, Rigotti teaches scanning a patient using a medical scanner in ¶0032, ¶0034, and ¶0043 while also disclosing the use of an XRAY, MRI or IR device in ¶0023. Hendrick teaches calculating the amount of cells and disclosing the amount of tissue that is produced and the total yield of cells calculated in ¶0054, Table 1, ¶0112, ¶0169*, and ¶0206. Applicant argues that “ Thus, no matter how the teachings of the '655 and '536 applications are combined, the combination does not teach or suggest the functionality of the processing circuitry recited in amended Claim 1.”. However, the Examiner interprets that Rigotti and Hendrick teaches the main concept of a processor or CPU performing a method including calculating the amount of cells to be produced, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Boppart in the details of the rejection below. The Examiner will maintain prior art Rigotti and Hendrick and details of the rejection are below.
In response to Argument 4, Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claims 13 and 14 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 13 and 14 and its dependent claims under 35 U.S.C. 103 in view of Rigotti et al. (US Patent Publication US 2013/0131655 A1 hereafter referred to as Rigotti) in view of Hendrick et al. (US Patent Publication US 2012/0308536 A1 hereafter referred to as Hendrick) in further view of Boppart et al (US Patent US 8983580 B2 hereafter referred to as Boppart).
The Examiner finds that Rigotti and Hendrick teaches on the amended claim language in Claims 13 and 14 with the amendment changing the scope of the claim with the limitation “pre-resection medical image”.
Specifically, Rigotti teaches scanning a patient using a medical scanner in ¶0032, ¶0034, and ¶0043 while also disclosing the use of an XRAY, MRI or IR device in ¶0023. Hendrick teaches calculating the amount of cells and disclosing the amount of tissue that is produced and the total yield of cells calculated in ¶0054, Table 1, ¶0112, ¶0169, and ¶0206. Applicant argues that “ Thus, no matter how the teachings of the '655 and '536 applications are combined, the combination does not teach or suggest the functionality of the processing circuitry recited in amended Claim 1.”. However, the Examiner interprets that Rigotti and Hendrick teaches the main concept of a processor or CPU performing a method including calculating the amount of cells to be produced, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Boppart in the details of the rejection below. The Examiner will maintain prior art Rigotti and Hendrick and details of the rejection are below.
In response to Argument 5, Applicant’s arguments, see Remarks, filed 01/07/2026, with respect to the rejection(s) of claims 3-7 and 10 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment. However, upon further consideration, a new ground(s) of rejection is made for Claim 3-7 and 10 and its dependent claims under 35 U.S.C. 103 in view of Rigotti in view of Hendrick in view of Boppart in further view of Smith et al (US Patent Publication US 2012/0115781 A1 hereafter referred to as Smith) for claims 3-6 and 10 and Rigotti in view of Hendrick in view of Boppart in further view of Xian (US Patent Publication US 2019/0194608 A1 hereafter referred to as Xian) for claim 7.
The Examiner finds that Smith and Xian teaches on the amended claim language in Claims 3-7 and 10 with the amendment changing the scope of the claim 1.
Specifically, Smith teaches the prospected take rate in ¶0055. Xian teaches the use of iPs cells in ¶0503. Applicant argues that “ '781 and '608 applications fail to remedy the deficiencies of the '655 and '536 applications, as discussed above. Accordingly, Applicant respectfully submits that the rejections of the above-noted dependent claims are rendered moot by the present amendment to Claim 1”. However, the Examiner interprets that Rigotti and Hendrick teaches the main concept of a processor or CPU performing a method including calculating the amount of cells to be produced, the additional details of the function and characteristics of the main concepts as stated above by the applicant in the amendments is taught by Boppart in the details of the rejection below. The Examiner will maintain prior art Smith and Xian and details of the rejection are below to teach the limitations of the dependent claims.
In response to Argument 6, Applicant’s arguments, see Remarks, filed 01/08/2026 with respect to the rejection(s) of claim 1-14 under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn due to the amendment.
Claim Interpretation
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.
Under MPEP 2143.03, "All words in a claim must be considered in judging the patentability of that claim against the prior art." In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494, 496 (CCPA 1970). As a general matter, the grammar and ordinary meaning of terms as understood by one having ordinary skill in the art used in a claim will dictate whether, and to what extent, the language limits the claim scope. Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. In addition, when a claim requires selection of an element from a list of alternatives, the prior art teaches the element if one of the alternatives is taught by the prior art. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009).
Claim 1 and 14 recite “being one of ” then listing “an X-ray diagnostic device, an X-ray Computed Tomography (CT) device, a magnetic resonance imaging (MRI) device, an ultrasonic diagnostic device, and a nuclear medicine diagnostic device”. Since “being one of” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 11 recite “or ” then listing “a standing posture or a sitting posture”. Since “or” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim 7 recite “at least on of ” then listing “iPS cells and adipose stem cells”. Since “at least one of” is disjunctive, any one of the elements found in the prior art is sufficient to reject the claim. While citations have been provided for completeness and rapid prosecution, only one element is required. Because, on balance, it appears the disjunctive interpretation enjoys the most specification support and for that reason the disjunctive interpretation (one of A, B OR C) is being adopted for the purposes of this Office Action. Applicant’s comments and/or amendments relating to this issue are invited to clarify the claim language and the prosecution history.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 8- 9, and 11-14 are rejected under 35 U.S.C. 103 as unpatentable over Rigotti et al. (US Patent Publication US 2013/0131655 A1 hereafter referred to as Rigotti) in view of Hendrick et al. (US Patent Publication US 2012/0308536 A1 hereafter referred to as Hendrick) in further view of Boppart et al (US Patent US 8983580 B2 hereafter referred to as Boppart).
Regarding Claim 1, Rigotti teaches a medical information processing (Rigotti ¶0030 discloses the medical information being stored for use later on by the physician) device (Rigotti ¶0023, ¶0028, ¶0031 discloses a type of information processing device) comprising processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor or CPU) configured to:
determine a resection target portion in a medical image (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) depicting a target site of resection by surgical treatment (Rigotti ¶0025, ¶0041 discloses the breast tissue being removed in a mastectomy)
is obtained by scanning a patient using a medical scanner (Rigotti ¶0032, ¶0034, ¶0043 discloses the patients breast being scanned to obtain images) being one of an X-ray diagnostic device (Rigotti ¶0023 discloses the use of X-ray, MRI, or IR deices to take images in real time), a magnetic resonance imaging (MRI) device (Rigotti ¶0023 discloses the use of X-ray, MRI, or IR deices to take images in real time)
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal),
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal).
Rigotti does not explicitly disclose calculate, an amount of cells to be produced, calculated.
Hendrick is in the same field of medical image analysis. Further, Hendrick teaches calculate (Hendrick ¶0054 discloses how the amount of cells are calculated), an amount of cells to be produced (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue), calculated (Hendrick ¶0054 discloses how the amount of cells are calculated).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti by including an a way to calculate the number of cells to be produced for the cell transfer into the patient based on the amount of cells taken and the blood supply to the cells as taught by Hendrick, to make an invention that can automatically calculate the amount of cells needed for a patient specific transfer; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to improve long term survival and retention when preforming the graft type surgeries (Hendrick ¶0008).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Rigotti and Hendrick in combination do not explicitly disclose wherein the pre-resection medical image, an X-ray Computed Tomography (CT) device, an ultrasonic diagnostic device, and a nuclear medicine diagnostic device, analyze the pre-resection medical image, to identify a composition of a tissue, for each of a plurality of cell types, based on the identified composition of the tissue, display for each of a plurality of cell types on a display.
Boppart is in the same field of medical image analysis in cancer treatment. Further, Boppart teaches wherein the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete) an X-ray Computed Tomography (CT) device (Boppart Col 3 Lines 26-34 disclose the use of on CT, MRI, and ultrasound devices for acquiring images) an ultrasonic diagnostic device (Boppart Col 3 Lines 26-34 disclose the use of on CT, MRI, and ultrasound devices for acquiring images), and a nuclear medicine diagnostic device (Examiner finds since being one of is disjunctive, all alternative limitations have been found which is sufficient for rejection, see claim interpretation)
analyze the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete) to identify a composition of a tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) based on the identified composition of the tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure) for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) on a display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick by including the analysis of the pre and post resection imaging with respect to multiple different cells types in the tissue composition and displaying said composition as taught by Boppart, to make an invention that can automatically determine exactly the type of tissue in the image and its impact on the resection area; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to better localize the potential sites where more tissue needs to be removed as well as determining the amount of tissue needed to be removed. (Boppart Col 13 Lines 56-59).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 8 Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the processing circuitry is further configured to (Rigotti ¶0038 discloses processing of information being done by a processor)
determine a resection portion based on a post-resection medical image obtained (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) after the resection by surgical treatment (Rigotti ¶0025, ¶0041 discloses the breast tissue being removed in a mastectomy), and
analyze the post-resection medical image (Boppart Col Lines 20-25, Col 4 Lines 55-60, Col 15 Lines 40-45, Col 39 Lines 65-67 disclose post-surgery analysis of the image) to identify a composition (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue) contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal),
recalculate, for each of the plurality of cell types, the amount of cells to be produced (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue) based on the identified composition of the tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue) contained in the determined resection portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal)
display, on the display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure), the amount of cells calculated (Hendrick ¶0054 discloses how the amount of cells are calculated), for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) based on the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete) and the amount of cells recalculated (Hendrick ¶0054 discloses how the amount of cells are calculated), for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) based on the post-resection medical image (Boppart Col Lines 20-25, Col 4 Lines 55-60, Col 15 Lines 40-45, Col 39 Lines 65-67 disclose post-surgery analysis of the image). See Claim 1 for rationale, its parent claim.
Regarding Claim 9 Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to:
prospect morphological changes over time of a target site after reconstruction (Rigotti ¶0053 discloses studies of morphology in tissue one month after insertion) in which cultured cells are introduced into the target site of resection (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) by surgical treatment (Hendrick ¶0069 and Fig 4 discloses the surgical treatment performed by a surgeon in which the cells are introduced back into the patient), and
calculate an amount of cells to be additionally (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue) produced based on a form of the target site (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) after the prospected morphological changes (Rigotti ¶0053 discloses studies of morphology in tissue one month after insertion). See Claim 1 for rationale, its parent claim.
Regarding Claim 11 Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the target site of resection (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) by surgical treatment is at least part of a breast (Rigotti ¶0025, ¶0032, ¶0041 discloses the breast tissue being removed in a mastectomy and the medical images being taken for a breast), and the medical image is an image obtained (Rigotti ¶0032 discloses the medical image being obtained of the breast) in a standing posture or a sitting posture (Rigotti Fig 6 and Fig7 discloses the image being taken in standing posture). See Claim 1 for rationale, it’s parent claim.
Regarding Claim 12 Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to:
determine when the resection by surgical treatment is a partial resection (Hendrick ¶0057 discloses how to determine if the portion is partial or full), the resection target portion in a size (Rigotti ¶0042 discloses determining the size of the reconstruction and the amount of adipose tissue needed to address the entire margin of the reconstruction) obtained by adding a predetermined margin to a size of a resection target by the surgical treatment (Rigotti ¶0042 discloses the cc varying from 325cc to 400cc which is a predetermined range and amount of adipose tissue that is needed), and
calculate the amount of cells (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue) to be produced for the resection target portion having the size including the added margin (Rigotti ¶0042 discloses the cc varying from 325cc to 400cc which is a predetermined range and amount of adipose tissue that is needed). See Claim 1 for rationale, its parent claim.
Regarding Claim 13, Rigotti teaches a medical information processing (Rigotti ¶0030 discloses the medical information being stored for use later on by the physician method (Rigotti ¶0029, ¶0040 discloses a method) comprising:
determining a resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) depicting a target site of resection by surgical treatment (Rigotti ¶0025, ¶0041 discloses the breast tissue being removed in a mastectomy),
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal),
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal)
initiating a culture of cells (Rigotti ¶0009, ¶0039 discloses expanding the cells from the biopsy in culture).
Rigotti does not explicitly disclose calculating, an amount of cells to be produced, the amount of cells calculated, based on the calculated amount of cells to be produced.
Hendrick is in the same field of medical image analysis. Further, Hendrick teaches calculating (Hendrick ¶0054 discloses how the amount of cells are calculated),
an amount of cells to be produced (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue)
calculated (Hendrick ¶0054 discloses how the amount of cells are calculated) based on the calculated amount of cells to be produced (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti by including an a way to calculate the number of cells to be produced for the cell transfer into the patient based on the amount of cells taken and the blood supply to the cells as taught by Hendrick, to make an invention that can automatically calculate the amount of cells needed for a patient specific transfer; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to improve long term survival and retention when preforming the graft type surgeries (Hendrick ¶0008).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Rigotti and Hendrick in combination do not explicitly disclose in a pre-resection medical image analyze the pre-resection medical image to identify a composition of a tissue, for each of a plurality of cell types, based on the identified composition of the tissue display for each of a plurality of cell types on a display for each of the plurality of cell types.
Boppart is in the same field of medical image analysis in cancer treatment. Further, Boppart teaches determining a resection target portion in a pre-resection (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete)
analyze the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete) to identify a composition of a tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images),
based on the identified composition of the tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure) for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) on a display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure)
for each of the plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick by including the analysis of the pre and post resection imaging with respect to multiple different cells types in the tissue composition and displaying said composition as taught by Boppart, to make an invention that can automatically determine exactly the type of tissue in the image and its impact on the resection area; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to better localize the potential sites where more tissue needs to be removed as well as determining the amount of tissue needed to be removed. (Boppart Col 13 Lines 56-59).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 14, Rigotti teaches a non-transitory computer readable medium (Rigotti ¶0044 and ¶0038 discloses a computer memory and a computerized model with a processor or CPU) comprising instructions that cause a computer to execute (Rigotti Fig 2 and ¶0016 discloses a computer software with a memory and programs that are run):
determining a resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal) medical image depicting a target site of resection by surgical treatment (Rigotti ¶0025, ¶0041 discloses the breast tissue being removed in a mastectomy),
is obtained by scanning a patient using a medical scanner (Rigotti ¶0032, ¶0034, ¶0043 discloses the patients breast being scanned to obtain images) being one of an X-ray diagnostic device (Rigotti ¶0023 discloses the use of X-ray, MRI, or IR deices to take images in real time), a magnetic resonance imaging (MRI) device (Rigotti ¶0023 discloses the use of X-ray, MRI, or IR deices to take images in real time), and a nuclear medicine diagnostic device (Examiner finds since being one of is disjunctive, all alternative limitations have been found which is sufficient for rejection, see claim interpretation)
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal),
contained in the determined resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal).
Rigotti does not explicitly disclose calculating, an amount of cells to be produced, the amount of cells calculated.
Hendrick is in the same field of medical image analysis. Further, Hendrick teaches calculating (Hendrick ¶0054 discloses how the amount of cells are calculated), an amount of cells to be produced (Hendrick Table 1, ¶0112, ¶0169, ¶0206 discloses the amount of tissue obtained and the total cell yield calculated from that tissue) the amount of cells calculated (Hendrick ¶0054 discloses how the amount of cells are calculated)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti by including an a way to calculate the number of cells to be produced for the cell transfer into the patient based on the amount of cells taken and the blood supply to the cells as taught by Hendrick, to make an invention that can automatically calculate the amount of cells needed for a patient specific transfer; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to improve long term survival and retention when preforming the graft type surgeries (Hendrick ¶0008).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Rigotti and Hendrick in combination do not explicitly disclose in a pre-resection medical image wherein the pre-resection medical image an X-ray Computed Tomography (CT) device an ultrasonic diagnostic device
analyze the pre-resection medical image to identify a composition of a tissue for each of a plurality of cell types, based on the identified composition of the tissue,
display for each of a plurality of cell types on a display.
Boppart is in the same field of medical image analysis in cancer treatment. Further, Boppart teaches in a pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete)
wherein the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete)
an X-ray Computed Tomography (CT) device (Boppart Col 3 Lines 26-34 disclose the use of on CT, MRI, and ultrasound devices for acquiring images)
an ultrasonic diagnostic device (Boppart Col 3 Lines 26-34 disclose the use of on CT, MRI, and ultrasound devices for acquiring images)
analyze the pre-resection medical image (Boppart Col 6 Lines 28-35 and Col 11 Lines 11-17, Col 15 Lines 63-67 discloses preforming analysis on the tissue image before the surgery is complete) to identify a composition of a tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
for each of a plurality of cell types, (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images),
based on the identified composition of the tissue (Boppart Col 2 Lines 20-25, Col 14 Lines 10-15, Col 16 Lines 5-10, Col 18 Lines 51-60 disclose the image differentiating and classifying different types of tissue)
Display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure) for each of a plurality of cell types (Boppart Fig 7A and 7B show a microvasculature, adipose cells, and their nuclei can be seen from the OCT images) on a display (Boppart Fig 5A and 5B discloses data display in 150 and in Col 2 Lines 19-21 discloses displaying the image to differentiate between the tissue microstructure).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick by including the analysis of the pre and post resection imaging with respect to multiple different cells types in the tissue composition and displaying said composition as taught by Boppart, to make an invention that can automatically determine exactly the type of tissue in the image and its impact on the resection area; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to better localize the potential sites where more tissue needs to be removed as well as determining the amount of tissue needed to be removed. (Boppart Col 13 Lines 56-59).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claims 3-6, and 10 are rejected under 35 U.S.C. 103 as unpatentable over Rigotti in view of Hendrick in view of Boppart in further view of Smith et al (US Patent Publication US 2012/0115781 A1 hereafter referred to as Smith).
Regarding Claim 3, Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the processing circuitry is further configured to (Rigotti ¶0038 discloses processing of information being done by a processor) to be introduced into the target site (Hendrick ¶0069 and Fig 4 discloses the surgical treatment performed by a surgeon in which the cells are introduced back into the patient), and calculate the amount of cells to be produced (Hendrick , ¶0169, ¶0206 discloses the amount of cells to be deposited and the total cell yield calculated from that tissue).
Rigotti in view of Hendrick in view of Boppart does not explicitly disclose prospect a take rate of cultured cells, further based on the prospected take rate.
Smith is in the same field of medical treatment for cancer. Further, Smith teaches prospects a take rate of cultured cells (Smith ¶0055 discloses the take rate of the cells based on how the tissue was stored) further based on the prospected take rate (Smith ¶0055 discloses the take rate of the cells based on how the tissue was stored).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick in view of Boppart by including a prediction of the take rate of cells and the option of a skin flap method as taught by Smith, to make an invention that can automatically predict the likelihood of the cells success and add an additional technique to increase the cells success rate once implanted; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to develop improved methods for evaluating treatment modalities (Smith ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 4, Rigotti in view of Hendrick in view of Boppart in further view of Smith teaches the medical information processing device according to claim 3, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to prospect the take rate based (Smith ¶0055 discloses the take rate of the cells based on how the tissue was stored) on a size and blood vessel run (Hendrick ¶0040, ¶0042-0043 discloses developing the blood vessels to support the tissue survival) of the resection target portion (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal). See claim rationale for Claim 3, its parent claim.
Regarding Claim 5, Rigotti in view of Hendrick in view of Boppart in further view of Smith teaches the medical information processing device according to claim 4, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to increase the amount of cells to be produced (Hendrick ¶0111 discloses increasing the regenerative cells) as the prospected take rate (Smith ¶0055 discloses the take rate of the cells based on how the tissue was stored) is lower (Hendrick ¶0138 discloses adding growth factors to increase cell production). See claim rationale for Claim 3, its parent claim.
Regarding Claim 6, Rigotti in view of Hendrick in view of Boppart in further view of Smith teaches the medical information processing device according to claim 4, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to add vascular endothelial cells to a cell strain to be produced (Rigotti ¶0053 discloses regeneration of vascular cells and using endothelia cells), when the prospected take rate (Smith ¶0055 discloses the take rate of the cells based on how the tissue was stored) is less than a predetermined threshold (Rigotti 0042 discloses a rage that is needed for the implantation of tissue being 325 t0 400cc). See claim rationale for Claim 3, its parent claim.
Regarding Claim 10, Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein when the introduction of the cultured cells (Hendrick ¶0069 and Fig 4 discloses the surgical treatment performed by a surgeon in which the cells are introduced back into the patient) into the target site of resection by surgical treatment (Rigotti ¶0041-¶0044 discloses using a medical image to provide a reference area for the implant or site for removal)
the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to reduce the amount of cells to be produced by a tissue migration quantity (Hendrick ¶0044 discloses migration and how growth factors effect cell generation).
Rigotti in view of Hendrick in view of Boppart does not explicitly disclose is combined with a skin flap method, by the skin flap method.
Smith is in the same field of medical treatment for cancer. Further, Smith teaches is combined with a skin flap method (Smith ¶0051 discloses a skin flap method), by the skin flap method (Smith ¶0051 discloses a skin flap method).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick in view of Boppart by including a prediction of the take rate of cells and the option of a skin flap method as taught by Smith, to make an invention that can automatically predict the likelihood of the cells success and add an additional technique to increase the cells success rate once implanted; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to develop improved methods for evaluating treatment modalities (Smith ¶0004).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claim 7 is rejected under 35 U.S.C. 103 as unpatentable over Rigotti in view of Hendrick in view of Boppart in further view of Xian (US Patent Publication US 2019/0194608 A1 hereafter referred to as Xian).
Regarding Claim 7, Rigotti in view of Hendrick in view of Boppart teaches the medical information processing device according to claim 1, wherein the processing circuitry (Rigotti ¶0038 discloses processing of information being done by a processor) is further configured to calculate a time required to culture the cells to be produced (Hendrick ¶0178 discloses culturing the cells for 5 days) based on a stock amount (Hendrick Table 1 discloses the stock amounts taken from humans) and adipose stem cells (Hendrick ¶0194 discloses adipose derived stem cells).
Rigotti in view of Hendrick in view of Boppart does not explicitly disclose of at least one of iPS cells.
Xian is in the same field of stem cell manipulation. Further, Xian teaches of at least one of iPS cells (Xian 0503 discloses the role of Ips cells in targeted insertion techniques).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Rigotti in view of Hendrick in view of Boppart by including the use of Ips cells as taught by Smith, to make an invention that can use two different types of cells to cover a wider range of application options; thus one of ordinary skilled in the art would be motivated to combine the references since there is a need to improve methods to harvest stem cells easily without harm to the patient (Xian ¶0013).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
54. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
56. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL ROBERTS whose telephone number is (571)272-6413. The examiner can normally be reached Monday- Friday 7:30am- 5:00pm.
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/RACHEL L ROBERTS/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674