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 .
Specification
The amended specification was received on 04/29/2025. The amended specification is acceptable.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Regarding claim 1, ll. 5-6 recite “axis is straight line“. Applicant may amend the claim by adding the article “a” to read “axis is a straight line”. Appropriate correction is required.
Regarding claim 11, l. 2 recites “said single processing reagent is selected from” and proceeds to list different mixtures to choose from. The claim lacks an “or” transition term in the grouping and therefore leaves the claim ambiguous as to where one option ends and another begins. Applicant may amend the claim by adding “or” after “limonene;” in line 6.
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, l. 2 recites the limitation “said container”. There is insufficient antecedent basis for this limitation in the claim. The container limitation is not present in claim 1 from which claim 3 depends, but is rather first introduced in claim 2. Applicant may amend claim 3 to depend from claim 2.
Regarding claim 4, l. 2 recites the limitation “said vessels”. There is insufficient antecedent basis for this limitation in the claim. The “vessels” limitation is not present in claim 1 from which claim 4 depends, but rather a singular “vessel” is first introduced in claim 3. Applicant may amend claim 4 to depend from claim 3. Applicant may also amend claim 4 to read “vessel” instead of “vessels,” or alternatively amend claims 3 and 4 to recite “at least one vessel”.
Regarding claim 4, l. 3 recites the limitation “said container”. There is insufficient antecedent basis for this limitation in the claim. The container limitation is not present in claim 1 from which claim 4 depends, but is rather first introduced in claim 2 and is also present in claim 3. Applicant may amend claim 4 to depend from claim 3.
Regarding claim 10, l. 3 recites the limitation “said treatments are carried out simultaneously,” while depending from claim 9 which recites that the processing comprises the treatments of “fixation and/or dehydration and/or clarification and/or paraffin infiltration”. Because the use of “and/or” in claim 9 permits the selection of one or more of the recited treatments, it is unclear whether “said treatments” in claim 10 requires all of the treatments recited in claim 9 to be performed simultaneously or at least two of the selected treatments. If the latter interpretation is intended, which two? Accordingly, the scope of the claim cannot be determined with reasonable clarity. Paragraph [0074] of the instant specification (US 20250237584 A1) states the sample is previously fixed with formalin and that only dehydration, clarification and paraffin infiltration are performed simultaneously using a single reagent. Also, the single processing reagent of the instant specification used to perform this simultaneous processing does not include a fixative reagent (See para. [0050] and claim 11). Therefore, under broadest reasonable interpretation, the Examiner interprets the plural term “treatments” to require at least two treatments to be performed simultaneously chosen from dehydration, clarification and paraffin infiltration.
Claim 11 is rejected based on dependency of all of the limitations of claim 10.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such claim limitations are:
“means (3) suitable for the purpose” in ll. 3-4 of claim 3. The Examiner interprets the corresponding structure to be a rod or equivalents thereof and the purpose to be rotating the container containing the biological sample around its own axis (See [0038] of the instant specification US 20250237584 A1).
“means for moving said container around its own axis” in l. 3 of claim 4. The Examiner interprets the corresponding structure to be a rod or equivalents thereof (See [0038] of the instant specification US 20250237584 A1).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6, 9, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hollander (US 20100009349 A1), in view of Massai et al. (WO 2020250121 A1, see attached English translation).
Regarding claim 1, Hollander teaches a process for processing a biological sample to be subjected to an anatomo-pathological analysis (method of stabilizing a biological sample should make possible both a histological analysis of the stabilized biological sample and an analysis of the biomolecules present in the biological sample; [0021]),
said process comprising rotating said biological sample immersed in a processing reagent around its own axis (“the immersion aid 3, which is provided with a sample receptacle, can also be designed in such a way that…oblique side panels act as guide vanes 4 when the immersion aid is rotated about the axis L,” wherein “immersion aid (.beta.3)…[is] for fully immersing, into the liquid, a sample”; [0126];[0071]; Figs. 4,4a,4b)(The fluid is also described as the composition which can include additives such as fixatives; See Abstract, [0032],[0040])(See rotational axis L extending through the center of the axis of sample 5 in Fig. 4),
wherein said axis is straight line passing through the center of mass of the sample in any direction (See rotation axis L extending vertically through sample 5 in Fig. 4 and arrow showing the direction)(pin arranged above, below or at the level of the immersion aid, the length of which pin corresponds approximately to the diameter of the vessel (.beta.1) and whose center is connected to the center of the lid via a connection. When the lid (.beta.2) is screwed shut, the movement of the pin in the inside of the vessel (.beta.1) leads to mixing of the fluid; [0077]).
Hollander fails to teach said rotating step is carried out at a speed from 100 to 1000 rotations per minute.
Massai teaches a rotating step is carried out at a speed from 100 to 1000 rotations per minute (for a rotation speed imposed on the magnetic stirrer equal to 150 revolutions per minute; p. 10, ll. 9-10).
Massai is considered to be analogous to the claimed invention because it is in the same field of endeavor for processing biological samples through sample container rotation. Hollander evaluates the mixing performance of the device by measuring the time needed for potassium permanganate dye solution to reach a homogenous distribution within the vessel during rotation, while expressing a preference for progressively shorter mixing times (from 60 secs. to 10 secs.) at 10 rotations per minutes ([0076]). 60 seconds and 10 seconds are separated by about a magnitude of 10, and therefore it can be expected that increasing the rotation speed by the same scale factor or more would allow for sample homogenization at a fraction of the time. Massai teaches that stirring a sample mixture at 150 revolutions per minute induces a pressure drop, allows the solution speed to increase, and exposes the samples to a convective flow that facilitates the transport of the solution through the samples (p. 10, ll. 10-16). Similar to Massai, Hollander aims to apply the rotation step to an actual tissue sample which would require more reagent penetration as compared to the evaluation run using 1 gram of potassium permanganate dye in 1 liter of water. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander to incorporate the teachings of Massai by increasing the sample mixture rotation speed to within a range of 100 to 1000 rotations per minute which includes 150 rev/min because it would accommodate for penetration of the reagent through the tissue sample while reducing the processing time, and this involves routine optimization of a result-effective variable to achieve a desired result (See MPEP 2144.05(II)(A)).
Regarding claim 2, Modified Hollander teaches the process according to claim 1, wherein said biological sample is placed inside a container, for housing biological samples (the immersion aid 3 comprises a sample receptacle; Hollander, [0126]; See sample 5 in immersion aid 3 in Figs. 4, 4a, 4b of Hollander).
Regarding claim 3, Modified Hollander teaches the process according to claim 1, wherein said container containing the biological sample is rotated around its own axis (the immersion aid 3, which is provided with a sample receptacle, can also be designed in such a way that…oblique side panels act as guide vanes 4 when the immersion aid is rotated about the axis L; Hollander, [0126]; Figs. 4,4a,4b) inside a vessel (2) containing the processing reagent (The vessel 1 is filled up to the filling level h with a composition, preferably a liquid composition, preferably with the composition comprising the at least one polyol and, if appropriate, the at least one additive; Hollander, [0125]; Figs. 4,4a,4b), by means (3) suitable for the purpose (pin arranged above, below or at the level of the immersion aid, the length of which pin corresponds approximately to the diameter of the vessel (.beta.1) and whose center is connected to the center of the lid via a connection. When the lid (.beta.2) is screwed shut, the movement of the pin in the inside of the vessel (.beta.1) leads to mixing of the fluid; Hollander, [0077])(The examiner interprets the corresponding structure or “means” to be a rod or equivalents thereof. See 112(f) claim interpretation above).
Regarding claim 6, Modified Hollander teaches the process according to claim 1, wherein said rotating step is carried out in any way or direction (See rotation direction arrow around axis L which extends through the length of the sample 5 in Fig. 4 of Hollander)(The Examiner understands that any rotation is naturally carried out in a way or direction and would satisfy this claim limitation).
Regarding claim 9, Modified Hollander teaches the process according to claim 1, wherein said processing comprises the treatments of fixation (“bringing the biological sample into contact with a composition, comprising…at least one additive,” wherein “The additive (.alpha.2) which was optionally present in the composition may take the form of…fixatives; Hollander, Abstract, [0040]) and/or dehydration and/or clarification and/or paraffin infiltration, which are carried out separately, sequentially or simultaneously (The claim provides the option to select one or more, and since the Examiner has selected only fixation, whether the treatments are performed separately, sequentially or simultaneously is not limiting).
Regarding claim 12, Modified Hollander teaches the process according to claim 1, wherein said biological sample is a cytological, histological or autopsical sample to be subjected to an anatomo-pathological analysis (histological analysis of the biological sample brought into contact with the composition; Hollander, [0051]).
Regarding claim 13, Modified Hollander teaches the process according to claim 2.
Modified Hollander fails to teach said container is a cassette (1).
Modified Hollander, however, does teach a sample receptacle comprised within the immersion aid ([0127]; Fig. 4).
Massai teaches a cassette (cassettes for histological inclusion, biological samples; Abstract).
Massai is considered to be analogous to the claimed invention because it is in the same field of endeavor for processing biological samples through sample container rotation. Hollander uses a sample receptacle within the immersion aid to contain the sample while being immersed in the reagent. Similarly, Massai utilizes a cassette to encase the sample during immersion (p. 3, ll. 8-11) which prevents the sample from incurring damage from high shear forces and trapping that can occur when the sample is directly immersed in the solution under random suspension during rotation (p. 2, ll. 5-10). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander in view of Massai to further incorporate the teachings of Massai by substituting the sample receptacle with a cassette because it can protect the sample during agitation, and this involves the simple substitution of one known element for another to obtain predictable results (See MPEP 2143(I)(B).
Regarding claim 14, Modified Hollander teaches the process according to claim 6, wherein said direction is longitudinal (See rotation direction arrow around axis L which extends through the length of the sample 5 in Fig. 4 of Hollander), transverse, diagonal or sagittal.
Claims 4-5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hollander (US 20100009349 A1), in view of Massai et al. (WO 2020250121 A1, see attached English translation), as applied to claim 1 above, and in further view of Angros (US 20140287456 A).
Regarding claim 4, Modified Hollander teaches the process according to claim 1.
Modified Hollander fails to teach said vessels containing the processing reagent are housed in a device provided with means for moving said container around its own axis.
Modified Hollander, however, does explain there to be a first device comprising a plurality of vessels and immersion aids (Hollander, [0059]).
Angros teaches vessels containing the processing reagent are housed in a device provided with means for moving said container around its own axis (“FIG. 5 is a perspective view of the staining apparatus of FIG. 3A shown as having three slide support elements ejected from the inner space of the staining apparatus,” wherein “The slide support element is rotated”; [0018]; Abstract; Figs. 3A, 5).
Angros is considered to be analogous to the claimed invention because it is in the same field of endeavor for processing biological samples through sample container rotation. Both Hollander and Angros teach rotating multiple vessels containing sample reagents but Hollander is silent as to how each vessel is arranged. Angros teaches an apparatus shown to house each slide which is a well-known arrangement for processing multiple samples in a laboratory. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander in view of Massai to incorporate the teachings of Angros by integrating each sample vessel within one housing because it would organize laboratory space so that multiple samples can be monitored at once, and this involves combining prior art elements according to known methods to yield predictable results. (See MPEP 2143(I)(A)).
Regarding claim 5, Modified Hollander teaches the process according to claim 1.
Modified Hollander is silent to teaching said biological sample is processed separately from other biological samples.
Modified Hollander, however, does explain there to be a first device comprising a plurality of vessels and immersion aids (Hollander, [0059]).
Angros teaches a biological sample processed separately from other biological samples (“each microscope slide is separated and treated with its own reagent in a separate reaction compartment or on a separate slide support element,” wherein each slide contains a biological specimen; [0108]).
Angros is considered to be analogous to the claimed invention because it is in the same field of endeavor for processing biological samples through sample container rotation. Angros teaches that providing a separate compartment for each individual sample is important because “cross contamination from reagents or biological specimens on adjacent or nearby microscope slides is eliminated because each microscope slide is separated and treated with its own reagent in a separate reaction compartment or on a separate slide support element” ([0108]). Another advantage is that “each microscope slide can be treated…at pressures and for varying amounts of treatment times which are the same or different from any other microscope slide loaded into the apparatus” (Angros, [0108]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander in view of Massai to incorporate the teachings of Angros by placing each individual sample within a separate vessel for processing because it would eliminate cross contamination while allowing each sample to follow a unique sample preparation method, and this involves the use of known techniques to improve similar methods in the same way (See MPEP 2143(I)(C)).
Regarding claim 7, Modified Hollander teaches the process according to claim 1.
Modified Hollander fails to teach said rotating step is carried out at a speed from 200 rotations per minutes to 500 rotations per minute.
Modified Hollander instead teaches a rotating step is carried out at a speed of 150 revolutions per minute (Massai, p. 10, ll. 9-10).
Angros teaches a rotating step is carried out at a speed from 200 rotations per minutes to 500 rotations per minute (“the reagent contacting the biological specimen on the microscope slide present on the slide support element can be mixed…the microscope slide can be rotated completely,” wherein “revolution(s) per minute (rpm) of the spinning, rotating, and/or turning of the present inventions slide support element(s)…are: 500 rpm”; [0221]).
Angros is considered to be analogous to the claimed invention because it is in the same field of endeavor for processing biological samples through sample container rotation. Angros explains that the process for evenly distributing the reagent across the tissue specimen is dependent upon the thickness of the tissue specimen which can exist within a range of values ([0189]-[0190]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander in view of Massai to incorporate the teachings of Angros by increasing the sample mixture rotation speed to within a range of 200-500 rot/min which includes 500 rot/min because it would accommodate for sample thickness to ensure optimal penetration of the reagent through the tissue sample while reducing the processing time, and this involves routine optimization of a result-effective variable to achieve a desired result (See MPEP 2144.05(II)(A)).
Regarding claim 8, Modified Hollander teaches the process according to claim 7, wherein said speed is modulated during the sample processing (Rotation can be…variable speed according to a predefined sequence of accelerations, decelerations and time intervals at constant speed; Massai, p. 8, ll. 7-10).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hollander (US 20100009349 A1), in view of Massai et al. (WO 2020250121 A1, see attached English translation), as applied to claim 9 above, and in further view of Visinoni (US 6042874 A).
Regarding claim 10, Modified Hollander teaches the process according to claim 9.
Modified Hollander fails to teach said treatments are carried out simultaneously, by using a single processing reagent.
Modified Hollander, however, does teach the conventional histological sample laboratory protocols of fixation, dehydration, clarification and paraffin infiltration are carried out sequentially (“rat liver and muscle tissue is treated with the final composition,” which is composed of “paraformaldehyde”; [0131],[0130])(tissue pieces…following conventional protocols, incubated in an ascending ethanol series and in xylene, and embedded in paraffin; [0128]).
Visinoni teaches said treatments are carried out simultaneously, by using a single processing reagent (the steps of dehydrating and clearing are carried out simultaneously by applying a mixture of a dehydration agent and an essentially lipophilic agent simultaneously to the sample; Abstract)(The Examiner interprets the plural term “treatments” to require at least two treatments to be performed simultaneously chosen from dehydration, clarification and paraffin infiltration. See 112(b) rejection above).
Visinoni is considered to be analogous to the claimed invention because it is in the same field of endeavor for histological processing of tissue samples. Both Hollander and Visinoni teach the same four processing steps for tissue samples, however, Visinoni combines the dehydrating and clarifying steps using one reagent to simplify the process. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sample processing method taught by Hollander in view of Massai to incorporate the teachings of Visinoni by using a single processing reagent for carrying out the dehydration and clarification steps because it would shorten the processing time for each sample, reduce the volume of dehydrating agent and the clearing agent expended, and lower the cost of the procedure (See col. 1, ll. 43-54 of Visinoni), and this involves the use of known techniques to improve similar methods in the same way (See MPEP 2143(I)(C)).
Regarding claim 11, Modified Hollander teaches the process according to claim 10, characterized in that wherein said single processing reagent is selected from
a mixture of paraffin, at least one alcohol selected from ethyl and isopropyl alcohol and at least one hydrocarbon selected from naphtha and octane (“combination of isopropanol with one or more of…n-hexane…n-octane,” wherein “n-hexane” is a paraffin; Visinoni, col. 3, ll. 40-42);
a mixture of paraffin, at least one alcohol selected from ethyl and isopropyl alcohol and at least one hydrocarbon selected from isoparaffin and limonene;
a mixture of paraffin, ethyl alcohol and isoparaffin.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Duymelinck et al., 2008 (instant PTO-892), teaches “simultaneous fixation, dehydration and initial clearing of the sample using a fixation-dehydration-clearing, FDC, solution” ([0013]).
Lisowski, 2019 (instant PTO-892) teaches the conventional processing protocol for histological tissue sample processing and the delicate balance of processing time, sequence, and repetition of steps. The reference also teaches motivation to replace xylene for limonene as a clearing agent.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE SIMMONS whose telephone number is (703)756-1361. The examiner can normally be reached M-F 7:30-4:00.
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/V.S./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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