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 .
Response to Amendment
This is an office action in response to Applicant’s arguments filed on 24 February 2026. Claims 1-18, 20, and 22-23 are currently pending in the application. Claims 19 and 21 have been cancelled. Claims 1-18, 20, and 22-23 are being examined herein.
Status of Objections and Rejections
The objection to the drawings is withdrawn in view of amendments.
The objection to the specification is withdrawn in view of amendments.
The rejection of claims 1-18, 20, and 22-23 under USC § 112(b) are withdrawn in view of amendments.
The rejection of claims 19 and 21 under USC § 112(b) are withdrawn due to cancellation.
The rejection of claims 1, 11, 12, 16, 18, 20, and 22-23 under USC § 102(a)(1) under Williamson, et. al. (US 20100184127 A1) are withdrawn in view of amendments.
The rejection of claims 2-3 under USC § 103 under Williamson, et. al. (US 20100184127 A1) are withdrawn in view of amendments.
The rejection of claims 4, 6, 7, and 17 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of Sievert, et. al. (US 2020103320 A1) are withdrawn in view of amendments.
The rejection of claim 5 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of McCormick (US 20050112034 A1) is withdrawn in view of amendments.
The rejection of claim 8 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of Williamson (US 20210138476 A1) is withdrawn in view of amendments.
The rejection of claims 9-10 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of Whitlach, et. al. (WO 0019897 A1) are withdrawn in view of amendments.
The rejection of claims 13 and 15 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of Webber, et. al. (US 20150087018 A1) are withdrawn in view of amendments.
The rejection of claim 14 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of National Society for Histotechnology (“Tumor Sampling and Large Format Histology- Why Bigger is Better”) is withdrawn in view of amendments.
The rejection of claim 19 under USC § 103 under Williamson, et. al. (US 20100184127 A1) in view of Mano, et. al. ("Natural origin biodegradable systems in tissue engineering and regenerative medicine: present status and some moving trends”) is withdrawn in view of amendments.
Response to Arguments
Applicant’s arguments, see Remarks pages 10-11, filed 24 February 2026, with respect to the rejection(s) of claim(s) 1 under USC § 102(a)(1) under Williamson, et. al. (US 20100184127 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yamamoto, et. al. (US 5061452 A).
Applicant argues the newly amended element in regard to the structural arrangement of the place holders is not taught or fairly disclosed by Williamson (Remarks, pg. 11, par. 09) to which examiner agrees.
Applicant offers no additional arguments for claims 2-18, 20, and 22-23 aside from their dependence on claim 1 (Remarks, pg. 11, par. 09).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 8-12, 17, 20, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto, et. al. (US 5061452 A).
Regarding claim 1, Yamamoto teaches a cassette for examination of a plurality of samples (Abstract). Yamamoto teaches a cassette comprising a lid 2 (a first part) and a container 1 (a second part) connected through hinge 3 so projections 10, 11 on lid 2 releasably engage with sunken parts 6, 7 on container 1 (Fig. 1-4) (that are configured to fit together via a releasable locking mechanism). The container 1 further comprises distinct chambers 4 as defined by round walls (see Fig. 2, 3) (a plurality of place holders) to create a well-like chamber 4 (one or more inserts) where samples are placed (col. 2, lines 62-66). Examiner notes, while Figures 1-4 only depict 5 sample chambers 4, Yamamoto teaches the container 1 has not set limitation, but preferred embodiments have up to nine sample chambers 4 that can be arranged in a three by three set up as seen in Figure 8 (col. 3, lines 35-37) (the second part comprising one or more inserts and a plurality of place holders arranged so as to form a plurality of columns of the place holders and a plurality of rows of the place holders respectively extending in length and width directions of the second part, each place holder of the plurality of place holders being configured to receive one of the one or more inserts) (the arrangement of the place holders within the cassette mimics that of wells in a plate having from 6 to 384 wells).
Yamamoto teaches the samples comprise that of medical samples "such as of a living body tissue" (col. 1, lines 6-15) (each of the one or more inserts comprises at least one natural tissue sample).
Yamamoto teaches lid 2 comprises a plurality of through-holes 9 and container 1 comprises a plurality of through-holes 5 that allow a liquid to move into the sample chamber 4 and interact with the sample (Fig. 1-4; col. 3, lines 51-61) (the first part and the second part comprise a plurality of apertures configured to allow a solution to flow through and around each of the one or more inserts and the at least one bioengineered construct or natural tissue sample).
Regarding claim 8, Yamamoto teaches the lid 2 and container 1 further comprise of frames that define the overall structure of the device including but not limited to the inner and outer surfaces of each part (Fig. 1-4). Yamamoto further teaches lid 2 and container 1 can be made of any chemical-resistant synthetic resin like polyacetal resin which is opaque by nature (col. 3, lines 30-35) (wherein a frame of the first part and a frame of the second part are opaque).
Regarding claim 9, Yamamoto teaches the lid 2 and container 1 further comprise of frames that define the overall structure of the device including but not limited to the inner and outer surfaces of each part (Fig. 1-4). Yamamoto further teaches lid 2 and container 1 can be made of any chemical-resistant synthetic resin like polycarbonate resin which is transparent by nature (col. 3, lines 30-35) (wherein a frame of the first part and a frame of the second part are transparent).
Regarding claim 10, Yamamoto teaches the lid 2 and container 1 further comprise of frames that define the overall structure of the device including but not limited to the inner and outer surfaces of each part (Fig. 1-4). Yamamoto further teaches lid 2 and container 1 can be made of any chemical-resistant synthetic resin like fluorocarbon resins (col. 3, lines 30-35) (wherein a frame of the first part and a frame of the second part are composed of Teflon).
Regarding claim 11, Yamamoto teaches lid 2 and container 1 can be made of any chemical-resistant synthetic resin like a polyester resin (col. 3, lines 30-35) (wherein the first part and the second part are formed from a plastic).
Regarding claim 12, Yamamoto teaches container 1 of which the walls of sample chamber 4 is formed within can be made of any chemical-resistant synthetic resin like fluorocarbon resins (col. 3, lines 30-35) (wherein a frame of the first part and a frame of the second part are composed of Teflon).
Regarding claim 17, Yamamoto teaches the through-holes 5, 9 has no limitation on their shape, but the preferred shape is cylindrical (col. 3, lines 45-47) (wherein each aperture of the plurality of apertures is shaped as a circle).
Regarding claim 20, Yamamoto teaches the samples comprise that of medical samples "such as of a living body tissue" (col. 1, lines 6-15) (wherein the at least one natural tissue sample is obtained from a natural tissue or organ).
With regards to Claim 22 and 23, the reusability or disposability of the cassette is drawn to an intended use of the cassette and is therefore not given patentable weight.
Regarding Claim 22, Yamamoto teaches the cassette can be opened and closed meaning the cassette can simply be used for temporary storage of a sample and therefore can be reused (col. 3, lines 11-19) (wherein the cassette is reusable).
Regarding claim 23, Yamamoto teaches a final processing step of the tissue sample in the cassette are used to create a mold out of paraffin to be sliced (col. 4, line 54 - col. 5, line 10); because the entire cassette is embedded in wax, it cannot be reused for additional samples (wherein the cassette is disposable).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto, et. al. (US 5061452 A).
Regarding claim 2, Yamamoto teaches the lid 2 further comprises of a frame that defines the overall structure of the lid 2 including but not limited to the inner and outer surfaces of each part (Fig. 1-4). Yamamoto teaches the overall height of the cassette (both the lid 2 and container 1) is preferably 5-8 mm (col. 3, lines 39-40). As seen in Figure 3, the lid 2 portion of the cassette is significantly thinner than the container 2 portion of the cassette. Should the total height of the cassette be 5 mm as preferred by Yamamoto, the lid contributes less than half of the height to the 5 mm, suggesting a thickness of less than 2.5 mm.
Yamamoto is silent to the frame having a thickness in the range of from 1 to 2 mm.
However, Yamamoto teaches the overall size of the cassette is a two-fold result-effective variable. Specifically, Yamamoto teaches the thickness of the lid 2 frame must be large enough to be easy to handle by the operator and accommodate the preferred number of sample chambers 4 (col. 3, lines 35-45). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify the frame of the lid 2 to have a thickness in the range of from 1 to 2 mm as suggested by Yamamoto because doing so would allow for the cassette to be just large enough for a user to handle while still maximizing the number of sample containers the cassette can hold with reasonable expectation of success MPEP 2143(I)(G).
Regarding claim 3, Yamamoto teaches the container 1 further comprises a frame that defines the overall structure of the container 2 and sample chambers 4 including but not limited to the inner and outer surfaces of each part (Fig. 1-4). Yamamoto teaches the overall height of the cassette (both the lid 2 and container 1) is preferably 5-8 mm (col. 3, lines 39-40). As seen in Figure 1, the container 1 portion has a thickness not only contributed by the frame but also reinforcing parts 14 used during paraffin embedding (col. 3, line 62 - col. 4, line 4). The thickness of the frame itself contributes significantly less to the overall height of the cassette when considering the contribution of the height by reinforcing parts 14.
Yamamoto is silent to the frame having a thickness in the range of from 1 to 2 mm.
However, Yamamoto teaches the overall size of the cassette is a two-fold result-effective variable. Specifically, Yamamoto teaches the thickness of the container 2 frame must be large enough to be easy to handle by the operator and accommodate the preferred number of sample chambers 4 (col. 3, lines 35-45). Further, Yamamoto teaches the container 2 portion of the cassette is embedded with the tissue sample in paraffin and with the reinforcement from reinforcing parts 14 allows for the thickness of the walls (that make up the frame) to be increasingly made narrower because doing so would increase permeability of solution into the cassette (col. 3, line 62 - col. 4, line 4). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify the frame of the container 2 to have a thickness in the range of from 1 to 2 mm as suggested by Yamamoto because doing so would allow for the cassette to be just large enough for a user to handle, maximize the number of sample containers the cassette can hold, and not interfere in embedding processes with reasonable expectation of success MPEP 2143(I)(G).
Regarding claim 4, Yamamoto teaches the size of the through-holes 5, 9 can vary, but have a preferable range of 0.2 - 0.7 mm (col. 3, lines 50-51).
Yamamoto is silent to wherein each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm
However, Yamamoto teaches the size of the through-holes 5, 9 are a result-effective variable. Specifically, Yamamoto teaches the through holes must be large enough to allow a solution to pass through the cassette efficiently, but not so large as to risk smaller samples from escaping the cassette through the through-holes (col. 3, lines 50-55). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm as suggested by Yamamoto because doing so would allow for fluid to efficiently flow into the cassette through the apertures and prevent tissue samples from falling out of the cassette through apertures the with reasonable expectation of success MPEP 2143(I)(G).
Regarding claim 6, Yamamoto teaches the size of the through-holes 5, 9 can vary, but have a preferable range of 0.2 - 0.7 mm (col. 3, lines 50-51). Turning to Figures 1-4, the through-holes 5, 9 appear to be substantially equivalent in size (the diameter of each aperture of the plurality of apertures is the same on both the first and second parts).
Yamamoto is silent to wherein each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm
However, Yamamoto teaches the size of the through-holes 5, 9 are a result-effective variable. Specifically, Yamamoto teaches the through holes must be large enough to allow a solution to pass through the cassette efficiently, but not so large as to risk smaller samples from escaping the cassette through the through-holes (col. 3, lines 50-55). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm as suggested by Yamamoto because doing so would allow for fluid to efficiently flow into the cassette through the apertures and prevent tissue samples from falling out of the cassette through apertures the with reasonable expectation of success MPEP 2143(I)(G).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto, et. al. (US 5061452 A) in view of McCormick (US 20050112034 A1).
Regarding claim 5, Yamamoto teaches the through-holes 5, 9 must be of sufficient size as to allow a solution to encounter the tissue sample in sample chamber 4 (see claim 4) (col. 3, lines 50-55).
Yamamoto is silent to wherein each aperture of the plurality of apertures is spaced from the nearest adjacent aperture by a distance in the range of from 3 to 15 mm.
McCormick teaches a cassette for preparing tissue samples Abstract). McCormick teaches a layered cassette 11 (Fig. 1) for holding a tissue sample 15 on a mounting card 14 (par. 0034). McCormick teaches a plurality of apertures in the first layer 20 and third layer 24 of the mounting card 14 (Fig. 2, 3; par. 0037-0038, 0042). McCormick teaches the number and spacing of the apertures can vary as long as an ideal void space is reached (par. 0042). McCormick teaches the void space is essential for allowing fluid to move through the cassette so the tissue sample can be further processed (par. 0013).
Further, McCormick teaches wherein the space between the apertures is a result effective variable. Specifically, McCormick teaches the void space created by the apertures is essential for allowing fluid to move through the cassette so the tissue sample can be further processed, and therefore the space between apertures must also be taken into account to ensure enough void space is given. Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify the space between the apertures of Yamamoto to be spaced from the nearest adjacent aperture by a distance in the range of from 3 to 15 mm because doing so would create sufficient void space to allow for proper fluid flow as taught by McCormick with reasonable expectation of success. MPEP 2143(I)(G).
Claims 7, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto, et. al. (US 5061452 A) in view of Williamson, et. al. (US 20100184127 A1).
Regarding claim 7, Yamamoto teaches the size of the through-holes 5, 9 can vary, but have a preferable range of 0.2 - 0.7 mm (col. 3, lines 50-51).
Yamamoto is silent to wherein each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm
However, Yamamoto teaches the size of the through-holes 5, 9 are a result-effective variable. Specifically, Yamamoto teaches the through holes must be large enough to allow a solution to pass through the cassette efficiently, but not so large as to risk smaller samples from escaping the cassette through the through-holes (col. 3, lines 50-55). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to make each aperture of the plurality of apertures has a diameter in the range of from 4 to 6 mm.
Modified Yamamoto is still silent to the diameter of each aperture of the plurality of apertures on the first part is different from the diameter of each aperture of the plurality of apertures on the second part.
Williamson teaches a tissue orientation device to retain tissue samples (Abstract). Williamson teaches assembly 10 that comprises a cassette 12 that has lid 12a (a first part) and body 12b (a second part) that snap open and closed (Fig. 1; par. 0076-0078). The body 12b has internal sidewalls 32 that define troughs 30a-d where tissue samples 40a-d are stored (Fig. 1-2; par. 0078). The cassette 12 further comprises apertures in both the lid 12a (lid apertures best seen in Figure 3) and body 12b (body apertures best seen in Figure 1) that vary in size (the diameter of each aperture of the plurality of apertures on the first part is different from the diameter of each aperture of the plurality of apertures on the second part).
Williamson teaches these perforations allow for thorough embedding of tissue samples with wax and further assist in preventing the chipping of the cassette during microtome cutting (par. 0020-0021).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the through-holes of Yamamoto to be different diameters in the first and second part as taught by Williamson because doing so would improve the embedding and cutting process of the tissue sample within the cassette as suggested by Williamson with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 16, Yamamoto teaches the limitations as applied to claim 1 (see above).
Yamamoto is silent to wherein the at least one bioengineered construct or natural tissue sample is fixed/immobilized on a surface of the one or more inserts.
Williamson teaches cassette lid 12a comprises biasing tabs 18 immobilizes the tissue samples against troughs 30a-d (Fig. 2, par. 0079) (wherein the at least one bioengineered construct or natural tissue sample is fixed/immobilized on a surface of the one or more inserts). Williamson teaches the tabs secure the tissue samples in a preferred orientation within the cassette and this allows for the samples, especially smaller fragile samples prone to movement (like curling, folding, etc.) to be immobilized during all processing steps to create an embedded sample in the most ideal orientation for later analysis (par. 0020, 0022, 0024).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the sample container of Yamamoto to further include a biasing member to immobilize the tissue sample as taught by Williamson because doing so holds the tissue samples in a preferred orientation during all steps of the processing method as taught by Williamson with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 18, Yamamoto teaches the limitations as applied to claim 1 (see above).
Yamamoto is silent to wherein a sidewall of the second part comprises a plurality of apertures, where each aperture of the plurality of apertures on the sidewall of the second part is shaped as a square or rectangle.
Williamson teaches cassette body 12b further comprise external sidewalls 32 with apertures in an elongated, rectangular shape (Fig. 1) (wherein a sidewall of the second part comprises a plurality of apertures, where each aperture of the plurality of apertures on the sidewall of the second part is shaped as a rectangle). Williamson teaches these perforations allow for thorough embedding of tissue samples with wax and further assist in preventing the chipping of the cassette during microtome cutting (par. 0020-0021)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the cassette container of Yamamoto to include sidewalls with rectangular through-holes as taught by Williamson because doing so would improve the embedding and cutting process of the tissue sample within the cassette with reasonable expectation of success. MPEP 2143(I)(G).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto, et. al. (US 5061452 A) in view of Webber, et. al. (US 20150087018 A1).
Regarding claim 13, Yamamoto teaches the cassette can vary in size, with a preferred length of 20-30 mm and a width of 30-40 mm (col. 3, lines 37-39). This however includes portions like recording space 13 and holders 12 that do not make up an interior portion of the cassette (Fig. 1-2).
Yamamoto is silent to wherein the area inside the cassette is in the range of from 89 cm2 to 101 cm2.
Webber teaches a histology processing cassette for holding a tissue sample (Abstract). Webber teaches a large processing cassette 1 with internal recess 5 which is where a sample is stored (Fig. 2, 3; par. 0069-0070). Webber teaches large processing cassette can have an area two to six times larger than a "standard sized" cassette (par. 0030); Webber gives an example a cassette with four times the dimensions being 50 to 55 by 70 to 80 mm (par. 0030, 0032). Webber teaches the size of the cassette is mainly determined by the size/volume of the sample or samples being collected (par. 0008, 0026); therefore, a larger sample or multiple samples that combine to have a larger total volume can be stored in a larger cassette.
Further, Webber teaches wherein the area of the cassette is a result effective variable. Specifically, Webber teaches the size of the cassette is dependent on the size and or number of samples being taken and stored but cannot be so large as to allow the samples to move (par. 0030-0033). Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify the interior area of the cassette of Yamamoto to be in the range of from 89 cm2 to 101 cm2 because doing so would create space to store samples without allowing the samples to move as taught by Webber with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 15, Yamamoto teaches the cassette can vary in size, with a preferred length of 20-30 mm, a width of 30-40 mm, and a height of 5-8 mm (col. 3, lines 37-39). This however includes portions like recording space 13 and holders 12 that do not make up an interior portion of the cassette as well as surface areas that are not capable of holding a volume (Fig. 1-4).
Yamamoto is silent to wherein the volume of an entire interior chamber of the multi-sample cassette is in the range of from 81 cm3 to 98 cm3.
Webber teaches a histology processing cassette for holding a tissue sample (Abstract). Webber teaches a large processing cassette 1 with internal recess 5 which is where a sample is stored (Fig. 2, 3; par. 0069-0070). Webber teaches large processing cassette can have an area two to six times larger than a "standard sized" cassette and a depth of two to three times that of a "standard cassette" (par. 0030); Webber gives an example a cassette with four times the dimensions being 50 to 55 by 70 to 80 mm by 12 to 17 (par. 0030, 0032). Webber teaches the size of the cassette is mainly determined by the size/volume of the sample or samples being collected (par. 0008, 0026); therefore, a larger sample or multiple samples that combine to have a larger total volume can be stored in a larger cassette.
Further, Webber teaches wherein the volume of the cassette is a result effective variable. Specifically, Webber teaches the size of the cassette is dependent on the size and or number of samples being taken and stored but cannot be so large as to allow the samples to move (par. 0030-0033). Since this particular parameter is recognized as result-effective variable, i.e., a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. MPEP § 2144.05(II)(A)-(B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the invention and a matter of routine optimization to modify the volume of the cassette of Yamamoto to be in the range of from 81 cm3 to 98 cm3 because doing so would create space to store samples without allowing the samples to move as taught by Webber with reasonable expectation of success. MPEP 2143(I)(G).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto, et. al. (US 5061452 A) in view of National Society for Histotechnology (“Tumor Sampling and Large Format Histology- Why Bigger is Better;” citations made with respect to copy provided with Office Action dated 27 August 2025).
Regarding claim 14, Yamamoto teaches the limitations as applied to claim 1 (see above).
Yamamoto is silent to wherein the volume of the at least one bioengineered construct or natural tissue sample is in the range of from 1 cm3 to 1.5 cm3.
The National Society for Histotechnology (hereinafter NSH) teaches about large format histology samples (pg. 2, par. 01). NSH teaches that for large specimens typically require large samples, specifically “one centimeter block for each centimeter of tumor diameter” (pg. 2, par. 01); a one centimeter block being 1cm x 1cm x 1cm sample size (the at least one natural tissue sample is in the range of from 1cm3). NSH teaches these larger sample sizes assures there is sufficient sample volume to analyze (pg. 2, par. 01).
It would have been obvious for one skilled in the art before the effective filing date of the invention to make the sample size of the tissue samples of Yamamoto to include the larger 1cm3 sample size taught by the NHS because doing so ensures the collected samples are sufficient in size to perform all tests necessary with reasonable expectation of success. MPEP 2143(I)(G).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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