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 .
Election/Restrictions
Applicant’s election without traverse of group II, claims 9-19 in the reply filed on 19 May 2026 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 May 2026.
References Cited but not Relied Upon
Ogrezeanu et al. US PG-PUB 2006/0195030 A1 discloses a phantom for use with diffusion and appears pertinent to Applicant’s disclosure.
Marmarelis US PG-PUB 2003/0171677 A1 discloses systems and methods for obtaining images of body organs or tissue and appears pertinent to Applicant’s disclosure.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-11 and 16-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 10-13 of Bauer et al. U.S. Patent No. 12,085,490 B2 (hereafter “the 490 patent”). Although the claims at issue are not identical, they are not patentably distinct for the reasons indicated in the following table below.
Differences between the claims are indicated by bold and underlined text with an included explanation of why the claim scopes are considered to be coextensive.
Claims of the instant application (18/779,330)
Claims of US Pat 12,085,490 (i.e. the 490 patent)
9. A method of processing a tissue sample, comprising:
a) obtaining a first look up table comprising a plurality of first processing times for each of a plurality of first tissue samples having different tissue types, sizes, and/or shapes, (claim 11 of the 490 patent recites limitations considered to be coextensive with the instant limitation in the instant claim as well as additionally recited limitations)
wherein each first processing time of the plurality of first processing times comprises a time period sufficient for a predetermined amount of a first processing fluid to diffuse into the first tissue sample of the plurality of first tissue samples having the particular tissue type, size, and/or shape; (these limitations are considered to all be recited in the limitations from claim 11 of the 490 patent previously above)
b) obtaining a second tissue sample; (the claim scopes are considered to be coextensive)
c) selecting one of the first processing times from the plurality of first processing times in the first look up table based on a tissue type, size, and/or shape of the obtained second tissue sample; and (the claim scopes are considered to be coextensive)
d) treating the obtained second tissue sample in the first processing fluid for a processing period derived from the selected one of the first processing times. (the 490 patent limitations on the right hand side of the table indicate that the amount of processing period time is derived from a pre-determined functional relationship and used to determined the amount of processing period for a second tissue sample as later recited in claim 12 of the 490 patent and together the limitations therein are considered to be coextensive with the instant limitation of the instant application)
(from claim 1 of the 490 patent) “A method of processing tissue sample, comprising:”
(from claim 11 of the 490 patent) “wherein the subjecting of the first tissue sample to TOF analysis while the first tissue sample is immersed in the first processing fluid and determining the first processing time sufficient for a predetermined amount of the first processing fluid to diffused into the first tissue sample is performed across a plurality of tissue types, a plurality of tissue sizes, and a plurality of tissue shapes to provide a look up table of first processing times for tissue samples of particular types, size, and/or shapes”
(from claim 12 of the 490 patent) “a. selecting a second tissue sample”
(from claim 12 of the 490 patent) “b. selecting a first processing time for the second tissue sample from the look up table, wherein selecting the first processing time is based on the type, size, and/or shape of the second tissue sample”
(from claim 1 of the 490 patent) “a pre-determined functional relationship between the first processing time and the second processing time, wherein the pre-determined functional relationship is derived from fitting data pairs representing (i) first processing times sufficient for the pre-determined amount of the first processing fluid to diffuse into a tissue having a similar type, a similar shape, and/or a similar size to the first tissue sample, and (ii) second processing times sufficient for the pre-determined amount of the second processing fluid to diffuse into the tissue having the similar type, the similar shape, and/or the similar size of the first tissue sample; and d. immersing the first tissue sample in the second processing fluid for the second processing time”
10. The method of claim 9, wherein each first processing time of the plurality of first processing times is derived from a time-of-flight analysis. (the claim scopes are considered to be coextensive)
(from claim 1 of the 490 patent) “obtaining time of flight data from an acoustic device”
11. The method of claim 9, wherein the selection of the first processing time based on the tissue type, size, and/or shape of the obtained second tissue sample comprises correlating the tissue type, size, and/or shape of the obtained second tissue sample to a tissue type, size, and/or shape to one of the first tissue samples of the plurality of first tissue samples in the first look up table. (the combined limitations of claims 11 and 12 in the 490 patent are considered to be coextensive with the claim scope of the instant limitation of the instant application)
(from claim 12 of the 490 patent) “b. selecting a first processing time for the second tissue sample from the look up table”
(from claim 11 of the 490 patent) “determining the first processing time sufficient for a predetermined amount of the first processing fluid to diffuse into the first tissue sample is performed across a plurality of tissue types, a plurality of tissue sizes, and a plurality of tissue shapes to provide a look up table of first processing times for tissue samples of particular types, size, and/or shapes.”
16. The method of claim 9, wherein the first processing fluid is selected from the group consisting of about 70% ethanol, about 90% ethanol, and about 100% ethanol. (the claim scopes are considered to be coextensive because the 490 patent recites the limitation depicted on the right hand side of the table)
(from claim 3 of the 490 patent) “wherein the first processing fluid comprises about 70% ethanol”
17. The method of claim 9, further comprising processing the obtained second tissue sample in a second processing fluid for a second processing time. (the claim scopes are considered to be coextensive)
(from claim 10 of the 490 patent) “further comprising immersing the second tissue sample in the first processing fluid for the first processing time and in the second processing fluid for the second processing time”
18. The method of claim 16, wherein the second processing fluid is selected from the group consisting of a fluid comprising ethanol, xylene, and paraffin. (the claim scopes are considered to be coextensive)
(from claim 4 of the 490 patent) “wherein the second processing fluid is selected from the group consisting of about 90% ethanol, about 100% ethanol, xylene, and paraffin”
19. The method of claim 17, wherein the second processing time is determined based on the selected first processing time and a predetermined functional relationship for calculating the second processing time from the first processing time, wherein the predetermined functional relationship represents a correlation of a plurality of data pairs, each data pair comprising first data indicating a measured processing time sufficient for the predetermined amount of the first processing fluid to diffuse into a specific type of tissue sample and comprising second data indicating a measured processing time sufficient for the predetermined amount of the second processing fluid to diffuse into the specific type of tissue sample. (the claim scopes are considered to be coextensive as depicted in this side by side comparison)
(from claim 1 of the 490 patent) “c. determining a second processing time sufficient for a predetermined amount of a second processing fluid to diffuse into the first sample, wherein the second processing time is calculated based on (i) the first processing time, and (ii) a pre-determined functional relationship between the first processing time and the second processing time, wherein the pre-determined functional relationship is derived from fitting data pairs representing (i) first processing times sufficient for the pre-determined amount of the first processing fluid to diffuse into a tissue having a similar type, a similar shape, and/or a similar size to the first tissue sample, and (ii) second processing times sufficient for the pre-determined amount of the second processing fluid to diffuse into the tissue having the similar type, the similar shape, and/or the similar size of the first tissue sample”
Allowable Subject Matter
Claims 12-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 12: The prior art of record does not disclose or render obvious to the skilled artisan obtaining a third tissue sample having a similar tissue type, size, and/or shape as compared with the obtained second tissue sample, when considered in combination with the limitations of parent claim 9 and when the term “similar” is interpreted in light of Applicant’s as-filed specification ¶ 250 which notes that “similar sized and shaped samples of tissues exhibiting similar porosities or to contain a mixture of samples having different porosities, but different sizes”.
As to claims 13-15: Each of said claims depends directly from claim 12 and accordingly each is also indicated objected to as containing allowable subject matter at least by virtue of their respective dependencies upon a claim that is itself objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN M ROYSTON whose telephone number is (571)270-7215. The examiner can normally be reached M-F 8-4:30 E.S.T..
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/JOHN M ROYSTON/Examiner, Art Unit 2855
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