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 .
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 1-16 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.
On line 3 of claim 1, the phrase “movably coupled to the frame” is indefinite since it is not clear whether this means that the retaining assembly is physically attached to the frame (i.e. with a hinge or other structure) and movable relative to the frame while being physically attached, or whether this means that the retaining assembly is a separate and distinct component of the cassette from the frame that can be moved to become attached to the frame. On line 5 of claim 1, the phrase “wherein the biasing member is configured to urge the tissue sample towards the base” is indefinite since a tissue sample has not been positively recited as being present in any of the components of the cassette. On lines 5-6 of claim 1, the phrase “towards the base to holding the tissue sample” does not make proper sense. On lines 6-7 of claim 1, the phrase “and the base is movable along with the retaining assembly relative to the frame” is indefinite since it is not clear whether this means that the base and the retaining assembly are attached to one another as they move relative to the frame.
On lines 2-3 of claim 3, the phrase “coupled to the coupling member through the biasing member” is indefinite since it is not clear how the biasing member serves to couple the abutment member to the coupling member. The physical structure of the retaining assembly as comprising each of the biasing member, the coupling member and the abutment member is not clear from claim 3. Is the biasing member physically attached to or a part of the coupling member, and is the abutment member a separate component of the retaining assembly that is physically attached to the coupling member containing the biasing member so that the biasing member urges the abutment member towards the bottom of the base to hold a tissue sample between the abutment member and the base? On line 3 of claim 3, the phrase “the coupling member is movably coupled to the frame” is indefinite since it is not clear whether this means that the coupling member is physically attached to the frame (i.e. with a hinge or other structure) and movable relative to the frame while being physically attached, or whether this means that the coupling member is a separate and distinct component of the cassette from the frame that can be moved to become attached to the frame. On line 4 of claim 3, the phrase “the tissue sample” is indefinite since a tissue sample has not been positively recited as being present in any of the components of the cassette.
On line 2 of claim 4, the phrase “intermediate member movably coupled to the frame” is indefinite since it is not clear whether this means that the intermediate member is physically attached to the frame (i.e. with a hinge or other structure) and movable relative to the frame while being physically attached, or whether this means that the intermediate member is a separate and distinct component of the cassette from the frame that can be moved to become attached to the frame. On lines 2-3 of claim 4, the phrase “the coupling member is coupled to the intermediate member” is indefinite since it is not clear what “coupled” in this phrase means. Claim 4 is also indefinite since it is not clear where the intermediate member of the retaining assembly is located relative to the coupling member and the abutment member.
On line 3 of claim 11, the phrase “the surface of the flange facing the base” lacks antecedent basis and should be changed to –a surface of the flange facing the base--.
On line 3 of claim 12, the phrase “the surface of the flange facing away from the base” lacks antecedent basis and should be changed to –a surface of the flange facing away from the base--.
On line 2 of claim 13, the phrase “the side wall of the base” lacks antecedent basis. On line 3 of claim 13, the phrase “the outer side wall of the intermediate member” lacks antecedent basis.
On line 3 of claim 15, the phrase “a receiving groove in a surface of the intermediate away from the base” should be changed to -- a receiving groove in a surface of the intermediate member away from the base—so as to make proper sense.
On line 1 of claim 16, the phrase “stopping portion” should be changed to –a stopping portion— so as to positively recite this component of the intermediate member.
Inventorship
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williamson, IV (US 2021/0138476, submitted in the IDS filed on December 14, 2023).
With regards to claim 1, Williamson, IV teach of a cassette 10 for holding and orienting a tissue sample (see the abstract of Williamson, IV where it states “A histologic tissue sample support device includes a tissue cassette…”) comprising a frame 14 defining an accommodating chamber, wherein the accommodating chamber is provided by the space inside the four walls 14a, 14b, 14c and 14d of the frame 14 (see Figure 1A and paragraph 0054 in Williamson, IV), a retaining assembly 18 movably coupled to the frame 14 and having biasing members 42 thereon, wherein the biasing members 42 are configured to urge a tissue sample 44 towards a base 12 to hold the tissue sample between the base 12 and the retaining assembly 18 (see Figure 1A and paragraph 0066 in Williamson, IV where it states “…a resilient structure carried on an underside of the lid 18. The resilient structure is in the form of curved, resilient fingers 42 for purposes of allowing flexible engagement between distal ends 42a of the resilient fingers 42 and the one or more tissue samples 44 in the cassette 12. Resilient fingers 42 form a compliant structure that holds the tissue 44 in the desired orientation and position without creating an artifact impression on the tissue sample 44 during processing”), and a base 12 detachably coupled to the retaining assembly 18 (see Figure 1A and paragraph 0054 in Williamson, IV). Williamson, IV teaches that the base 12 is movable along with the retaining assembly 18 relative to the frame 14 between a first position where the base 12 is received in the accommodating chamber of the frame 14, as depicted in figures 3B, 3C and 4B of Williamson, IV, and a second position where the base 12 is protruded from the accommodating chamber of the frame 14 , as depicted in Figures 3D and 4C of Williamson, IV. See paragraph 0054 in Williamson, IV where it states “The frame 14 generally includes an interior defined between surrounding outer walls 14a, 14b, 14c, 14d and a bottom edge 14e, and the cassette/base 12 is sized and configured to move within the interior between at least first and second positions….The first position is shown in Figs. 3B and 3C, while the second “staged” position is shown in Fig. 3D. In the second position, the lower portion of the cassette/base 12 is exposed below the bottom edge 14e of the frame 14 for allowing cassette/base 12 and an embedded tissue sample 44 to be sectioned in a microtome while the frame 14 is held in the microtome chuck”. Also, see paragraphs 0063-0064 which state:
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Also, see paragraphs 0069 and 0071 in Williamson, IV where it states:
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With regards to claim 2, Williamson, IV teaches that the base 12 of the cassette 10 comprises a bottom wall 12b and a side wall 12a extending from an edge of the bottom wall 12b, and the bottom wall 12b defines a plurality of holes. See Figure 1A in Williamson, IV.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/570,294 in view of Williamson, IV (US 2021/0138476, submitted in the IDS filed on December 14, 2023). For a teaching of Williamson, IV, see previous paragraphs in this Office action.
Claim 1 of copending Application No. 18/570,294 recites a cassette for holding and orienting a tissue sample comprising a frame defining an accommodating chamber, a retaining assembly movably coupled to the frame, and a base detachably coupled to the retaining assembly, wherein the base is movable along with the retaining assembly relative the frame between a first position where the base is received in the accommodating chamber and a second position where the base is protruded out of the accommodating chamber.
Claim 1 of copending Application No. 18/570,294 fails to recite that the retaining assembly of the cassette comprises a biasing member that is configured to urge a tissue sample towards the base for holding the tissue sample between the base and the retaining assembly. However, based upon a combination of claim 1 of copending Application No. 18/570,294 and Williamson, IV, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a biasing member on the retaining assembly of the cassette recited in claim 1 of copending Application No. 18/570,294 since Williamson, IV teaches that such a biasing member comprising bendable fingers 42 on a retaining member 18 of a cassette for holding a tissue sample is advantageous since the biasing member forms a “compliant structure that holds a tissue in a desired orientation and position without creating an artifact impression on the tissue sample during processing”. See paragraph 0066 in Williamson, IV.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 3-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims since the closest prior art to Williamson, IV fails to teach or fairly suggest that the retaining assembly 18 of the cassette 10 further comprises an intermediate member, a coupling member, and an abutment member coupled to the coupling member, wherein the biasing member 42 urges the abutment member towards the bottom of the base 12 to hold a tissue sample 44 between the abutment member and the base, and wherein the coupling member is also coupled to the intermediate member and the base 12 is detachably coupled to the intermediate member. In addition, Williamson, IV fails to teach or fairly suggest the specific types of connecting structures located on the intermediate member, the frame and the base, as recited in claims 3-16, for positioning the base 12 and the retaining assembly 18 relative to the frame 14 between the first and second positions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Wu et al (US 2024/0286133 and US 2024/0280448) who teach of cassettes for holding and orienting a tissue sample; Knorr et al (US 2014/0271407) who teach of a tissue cassette with a biasing element; and Williamson, IV (US 2023/0041994) who teach of a method and a cassette for preparing biopsy tissue samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 June 30, 2026
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