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 with traverse of Group II (claims 10-21) in the reply filed on 01/05/2026 is acknowledged. The traversal is on the ground(s) that the Applicant does not acquiesce to or agree with the Examiner’s characterization of the applicability of Zhao to the pending claims.
This is not found persuasive because the groups are restricted under lack of unity of invention restriction practice and the common technical features of the Groups has been determined to not include a special technical feature. The common technical features of the two Groups are a reactor configured to accommodate a tissue sample to be processed with reagents and a carrier material, with inlets and outlets for processing reagents, containers to accommodate the carrier material and the reagents, configurations for temperature and pressure control, a condenser and liquid containers for condensed liquid from the condenser. These common technical features are all disclosed and rendered obvious by Sears et al (WO 2019/036760) (which better describes the common features between the restricted Groups) as described below in the obviousness rejection.
The expression “special technical feature” refers to those features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. Thus, a feature found and rendered obvious in the prior art cannot be considered to be a special technical feature.
The requirement is still deemed proper and is therefore made FINAL.
No claims have been amended. Claims 1-9 have been newly canceled and claims 22-25 have been newly added. Newly added claims 22-25 depend from and are drawn to the elected method of claim 10 and have been included in the claims for examination.
Claims 10-25 are currently pending and have been examined on their merits.
Claim Objections
Claim 13 is objected to because of the following informalities:
In line 4 of the claim there is a typo regarding the pressure value of -50 kPa. The letter O has been used instead of the number 0.
Appropriate correction is required.
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.
Claim(s) 10-14 and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over Sears et al (WO 2019/036760).
Regarding claim 10, Sears disclose a method for tissue processing comprising providing a tissue sample to be processed in a reactor, fixing the tissue with a fixing reagent (formalin)(page 21 para 87), dehydrating the fixed tissue with a dehydrating reagent (alcohol) (page 23 para 90-91), clearing the dehydrated tissue and the reactor with a clearing reagent to remove the dehydrating reagent (isopropanol) (page 23 para 90-91), providing a carrier material (paraffin) to the reactor from a container which will infiltrate the cleared tissue sample and also comprise the clearing reagent which has not yet been removed (page 23-25 para 92-94, pages 26-27 para 98, para 101), controlling the reactor to be a temperature that the vapor of the clearing reagent is generated from the carrier material (page 25 para 93-94), controlling the reactor to have a pressure that the vapor generated is drawn out of the reactor (page 25 para 94-95) and using a condenser to convert the vapor that has been condensed by the condenser coil into a liquid that can be removed as waste (page 22 para 89).
The specific combination of features claimed is disclosed within the broad genera of processing steps, reagents, containers, temperatures, pressures and time ranges taught by Sears, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any specific teaching to select this specific combination of variables, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have selected various combinations of processing steps, reagents, containers, temperatures, pressures and time ranges from within the disclosure of Sears to arrive at methods and compositions “yielding no more than one would expect from such an arrangement”.
The motivation and reasonable expectation of success in making these combinations comes from the fact that Sears suggests that all these cited variables are suitable for inclusion in their method/composition.
Regarding claims 11 and 22, Sears disclose wherein the infiltrating material, such as paraffin, is from a carrier material container (infiltrating baths) to the retorts (reactor chamber) by the use of valves (para 92). The filling of the retort (reactor chamber) is preferably performed for 10 seconds (para 138) and cycling the bioreactor through various settings is suggested as an option (pare 95). While Sears do not specifically disclose controlling the carrier material in cycles of opening and closing times, this would have been a matter of routine experimentation and optimization with the person of ordinary skill in the art motivated to provide a final processed tissue that is stable and purified in an efficient manner.
Regarding claims 12, 20 and 23, Sears disclose the use of a temperature sensor mounted directly to the retort (bioreactor chamber) and a sensor that is mounted to a heating mat and these are used to provide more rapid heating (para 75). Sears disclose using temperatures of 54˚C, raising the temperature to 65˚C and holding at the elevated temperature until required (para 92). Sears disclose that if isopropanol is used a boiling temperature of 82˚C is used to remove the isopropanol (para 93). While Sears do not disclose the rate of heating or the specific time period that the elevated temperature is kept at, these are deemed to be a matter of routine experimentation and optimization with the person of ordinary skill in the art motivated to provide a final processed tissue that is stable and purified in an efficient manner.
Regarding claims 13 and 24, Sears disclose wherein the pressure of the bioreactor is typically kept at -20 to -80 kPa gauge, but a wide variety of pressures may be used and are user programmable via the controller (para 93). Cycling through pressure ranges is specifically disclosed (para 95). While Sears do not disclose the specific time periods for keeping the pressure or the rate of decreasing the pressure, these are deemed to be a matter of routine experimentation and optimization with the person of ordinary skill in the art motivated to provide a final processed tissue that is stable and purified in an efficient manner.
Regarding claims 14, 17-19, and 25, Sears disclose controlling the reactor to have a pressure that the vapor generated is drawn out of the reactor (page 25 para 94-95) and using a condenser to convert the vapor that has been condensed by the condenser coil into a liquid that can be removed as waste (page 22 para 89). While Sears do not specifically disclose a second condenser to be used prior to providing a carrier material to the reactor from the carrier material container, the addition of a second condenser to further assist in the removal of prior reagents prior to addition of the carrier material would have been an obvious modification as the duplication of parts that aid in the purifying of a product is a well known and routine form of optimization (MPEP 2144.04 VI and VII). The cycling times and values would have been a matter of routine optimization and experimentation with the person of ordinary skill in the art motivated to provide a final processed tissue that is stable and purified in an efficient manner.
Regarding claim 21, Sears disclose wherein the retort (bioreactor chamber) is heated by heater pads and one or more sensors (para 87) which suggests that including an additional heating pad is an option. The addition of a second heater would have been motivated by the ability to provide additional control of the heating process. One of ordinary skill in the art would have had a reasonable expectation of success because Sears suggests using more than one pad.
Therefore, the teaching of Sears et al renders obvious Applicant’s invention as claimed.
Claim(s) 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Sears et al (WO 2019/036760) as applied to claims 1-14 and 17-25 above, and further in view of Ulbrich et al (US 2010/0323395-from IDS filed 02/08/2023).
Regarding claims 15-16, Sears renders obvious the claimed invention as described above, but does not disclose providing a carrier protective reagent to the reactor to remove the clearing reagent in the cleaned tissue sample and the reactor prior to providing a carrier material.
Ulbrich disclose methods of tissue processing and include the use of a carrier protective reagent (CARPRO) prior to providing a carrier material so that no residues of the intermedium can get into the carrier material and via the carrier material into the finished tissue sample (page 2 para 18-19).
One of ordinary skill in the art would have been motivated to include a carrier protective reagent (CARPRO, clearing reagent substitute) prior to providing a carrier material in the method of Sears because Ulbrich teach and suggest that this provides the benefit of no residues of the intermedium getting into the carrier material and via the carrier material into the finished tissue sample (page 2 para 18-19). One of ordinary skill in the art would have had a reasonable expectation of success because Sears and Ulbrich are both processing tissue with reagents and carrier materials designed to provide a final tissue product that is fixed, dehydrated and purified.
Therefore, the teaching combined teachings of Sears et al and Ulbrich et al render obvious Applicant’s invention as claimed.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wolf, Dee, “Tissue Processing”, Bancroft’s Theory and Practice of Histological Techniques, Eighth Edition, 2019, Chapter 6, pp. 1-25.
Wolf disclose the various parameters of heat, vacuum, pressure, and the processing of solvents and contamination during various stages of tissue processing methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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