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 claims 1-10 in the reply filed on July 6, 2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on August 8, 2023, January 14, 2025, March 18, 2025 and December 3, 2025 are being considered by the examiner.
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 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. he 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitations use generic placeholders that are coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholders are not preceded by a structural modifier.
Such claim limitations are: “tissue collector” in claim 1.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If Applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f), Applicant may:
(1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or
(2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, the limitation “a slide” should be changed to “the slide”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 1-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is indefinite because the scope of the limitation “tissue collector” is indefinite. As indicated above, the limitation is subject to interpretation under 35 U.S.C. 112(f). However, the specification fails to disclose identifiable features corresponding to the claimed “tissue collector” such that the limitation can be properly interpreted under 35 U.S.C. 112(f). Figures 1 and 2 merely illustrate a rectangular prism and the text of the specification is devoid of disclosure directed to the features of the tissue collector responsible for collecting tissue. Consequently, the scope of the limitation “tissue collector” is indefinite.
Claims 2-4 and 6-9 positively recite method steps, yet the subject matter of the steps appear to be directed to an alternative subject matter (e.g. applying heat in claim 2; using the adhesive strip in claims 6-9). It is unclear whether the claims intend to limit the claimed method to the corresponding alternative embodiment (e.g. claim 2 requires heat to be used and the method comprises the step of heating the tissue section to the claimed temperature), or whether the claims are conditional subject matter that only limits the corresponding alternative embodiment (e.g. claim 2 still encompasses use of physical force or heat, but if heat is used, the tissue section is heated to the claimed temperature). Because the method steps are positively recited, it will be presumed that the claims intend to convey the former interpretation. The claims should be amended to clearly reflect this intent (e.g. in claim 6, recite “wherein the tissue section is collected with the adhesive strip, the method further comprising positioning the adhesive strip…”).
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ott et al. (“Ott”) (US 2015/0260619 A1).
With respect to claim 1, Ott teaches a method for transferring a tissue section onto a slide, the method comprising:
collecting a tissue section with a tissue collector 32 comprising an adhesive strip 33 (see Fig. 3 and [0036]);
moving the tissue collector 32 to bring at least a portion of the tissue section in contact with a slide (see [0036] and arrow 25 in Fig. 1); and
applying physical force to the tissue section at a contact site of the tissue section with the slide (see [0036] and arrow 25 in Fig. 1).
With respect to claim 6, the adhesive strip 33 is positioned on a collecting end (bottom) of the tissue collector 32 (see Fig. 3).
With respect to claim 7, as discussed above (see rejection of claim 1), the method comprises collecting the tissue section by adhering the tissue section to the adhesive strip 33.
With respect to claim 8, the adhesive strip 33 is provided on a first reel (left reel in Fig. 1), and the adhesive strip extends from the first reel, across the collecting end, to a second reel (right reel in Fig. 1).
With respect to claim 9, the method further comprises advancing the adhesive strip across the collecting end after a first section of the adhesive strip is used to transfer a tissue section to the slide, whereby a second section of the adhesive strip is positioned on the collecting end (see [0036]-[0037]; see also arrow in Fig. 3 indicating the direction in which the adhesive strip advances).
With respect to claim 10, because the adhesive strip has the ability to adhere to the tissue section and subsequently release the tissue section onto a slide by application of pressure (see [0036]), it is deemed to comprise “low-tack” pressure-sensitive adhesives.
Claims 1, 4 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim et al. (“Lim”) (US 2019/0195748 A1).
With respect to claim 1, Lim teaches a method for transferring a tissue section onto a slide (see abstract), the method comprising (see Fig. 1):
collecting a tissue section with an adhesive strip 106 (see [0026]);
moving the adhesive strip 106 to bring at least a portion of the tissue section in contact with a slide 104 (see [0026] and Fig. 1); and
applying heat (the slide 104 is in a warm bath 110 and hence has heat, see [0022]) and physical force (i.e. physical contact) to the tissue section at a contact site of the tissue section with the slide 104 (see [0026]-[0027] and Fig. 1).
With respect to claim 4, based on the manner in which the tissue section is transferred to the slide (see [0026] disclosing that the tissue section floats on the surface of bath 110 during the transfer and the transfer is facilitated by heat provided by filament 112), it appears that physical force of about 275kPA or less is applied to the tissue section at the contact site.
With respect to claim 5, the contact site is 25% or less of the tissue section (see [0023]).
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 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lim.
With respect to claim 2, Lim does not explicitly disclose the temperature to which the contact site is heated to facilitate the transfer to the slide. However, Lim discloses that for tissues embedded in paraffin, this process typically occurs at a temperature of 40 degrees Celsius or higher (see [0022]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have heated the embedded tissue section at the contact site to a temperature that falls within the claimed range.
With respect to claim 3, the tissue section comprises an embedding medium in the form of paraffin (see [0021]). Naturally, the heat (see rejection of claim 2 above), would be sufficient to at least partially melt the embedding medium.
Claim 4 is alternatively rejected under 35 U.S.C. 103. While Lim does not disclose whether physical force of about 275kPA or less is applied to the tissue section at the contact site, given that the transfer of the tissue section from the adhesive strip 106 to the slide 104 is achieved using heat, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have applied physical force of less than about 275kPA to the tissue section at the contact site when making the transfer. The modification would preserve the integrity of the tissue section.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/ Primary Examiner, Art Unit 1796
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