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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 27, 2024 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:
“clamping mechanism” in claim 1;
“compression mechanism” in claim 5; and
“clamping force adjustment mechanism” in claim 5
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).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “set of one or more pins” that “direct the variable clamping force along an axis perpendicular to a primary plane of the fluidic chip” recited in claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The only reference to a “pin” in the figures is element 32 illustrated ion Figure 6. However, it is unclear how element 32 directs a variable clamping force along an axis perpendicular to a primary plane of the fluidic chip as recited in claim 8. As indicated above, the figures cannot merely identify a claimed element. It must show “every feature of the invention specified in the claims”, in this case, one or more pins that “direct the variable clamping force along an axis perpendicular to a primary plane of the fluidic chip”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 8 is objected to because of the following informalities:
In claim 8, the limitation “a set of one or more” should be changed to “one or more” or “a set of”. A set conveys multiple elements.
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 3, 7 and 8 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 3 recites “the clamping face”. There is no antecedent basis for the limitation.
Claim 7 recites “the base plate”. There is no antecedent basis for the limitation.
Claim 8 is indefinite because the relationship between the clamping mechanism and the set of one or more alignment pins is unclear. According to claim 1, the clamping mechanism applies a clamping force to the fluidic chip. Yet, claim 8 recites that the one or more pins direct said clamping force. Further clarification regarding how the clamping force is applied/directed to the chip is requested. As discussed above, the specification is devoid of disclosure directed to how the one or more alignment pins direct the clamping force.
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, 2, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Joris et al. (“Joris”) (US 2022/0291246 A1).
With respect to claim 1, Joris discloses a clamping and aligning device for securely attaching a fluidic chip 6 to a tissue sample 36, the device comprising (see Figs. 3c and 5):
a base member 24;
a chip holder 40/10, configured to receive (i.e. support) the fluidic chip 6 and to allow the fluidic chip 6 to contact a tissue sample of interest 36 (see [0059] and Fig. 5);
a tissue aligner 11 configured to align a substrate 34 to which the tissue sample of interest 36 is attached along at least one alignment axis (see Fig. 3c);
a clamping mechanism 15 (which comprises actuator 18 and lid 9) configured to apply a variable amount of clamping force to the fluidic chip 6 to clamp the fluidic chip 6 to the tissue sample of interest 36 when the fluidic chip 6 and the tissue sample of interest 36 are mounted in the clamping and aligning device (see [0059]), wherein:
the clamping and aligning device defines a light-transmitting path from a first side (bottom) of the clamping and aligning device to a second side (top) of the clamping and aligning device (see [0044] disclosing a light source beneath the sample, and see Fig. 5 illustrating a microscope above the sample; naturally an optical path exists from the first side to the second side); and
the light-transmitting path passes through a first opening in the base member 24 (see Fig. 3c; element 24 is not numerically identified in Fig. 3c, but it is numerically identified in Fig. 3a), a second opening 19 in element 9 of the clamping mechanism (see Fig. 3c), and the tissue sample of interest 36, when the tissue sample of interest is mounted in the clamping and aligning device (see Fig. 3c).
With respect to claim 2, a distal edge (bottom edge) of the tissue sample of interest 36 and an exterior surface (top surface) of the base member 24 are separated by substrate 34 (see Fig. 5). Because the thickness of the substrate 34 is about 1 mm (see [0044]), a distance, along the light-transmitting path, between the distal edge of the tissue sample of interest 36 and the exterior surface of the base member 24, when the fluidic chip and the tissue sample of interest are mounted in the clamping and aligning device, is no greater than 4mm.
With respect to claim 7, element 9 of the clamping mechanism 15 is rotatably attached to a base plate (unnumbered plate supporting unit 7 in Fig. 3a) via an attachment member 13 configured to allow element 9 of the clamping mechanism to rotate at least partially around an axis that is perpendicular to the light-transmitting path (see Figs. 3a and 3b).
With respect to claim 8, the device further comprises a set of one or more alignment pins 13 configured to:
direct the variable clamping force along an axis perpendicular to a primary plane of the fluidic chip, when the fluidic chip and the tissue sample of interest are mounted in the clamping and aligning device (by rotating and allowing the element 9 to clamp down on the chip 6, the clamping force is directed along the claimed axis), and
position the fluidic chip 6 parallel to the substrate 34, when the fluidic chip and the tissue sample of interest are mounted in the clamping and aligning device (element 9 is identified as “chip holder”; naturally it properly positions the chip 6 with respect to substrate 34 in the mounted configuration illustrated in Fig. 3b).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Joris.
With respect to claim 3, Joris does not disclose the clamping pressure applied by the clamping mechanism. However, given the broad range recited in the claim, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the clamping mechanism 15 to apply a clamping force that falls within the claimed range. The claimed range is deemed to encompass pressure suitable for achieving the result disclosed by Joris, which is to establish a hermetic seal between the chip 6 and the substrate 34 (see [0059]).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Joris in view of Szita et al. (“Szita”) (US 2011/0306081 A1) .
With respect to claim 4, Joris discloses a clamping mechanism in the form of a piston (see [0059]), not a screw. Nevertheless, the piston-based mechanism is merely exemplary (see [0059] disclosing “may comprise” and “for instance”). That said, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used other forms of clamping mechanisms, for example a screw-based mechanism comprising a screw at the top of the device, as taught by Szita (see [0102] and Figs. 1A and 3). The modification would constitute substitution of one element (piston) for an equivalent (screw) for the same purpose (clamping), which is considered obvious.
With respect to claim 5, if the modification is made, then the clamping mechanism would include:
a compression mechanism 9 configured to contact the fluidic chip 4, and to apply the clamping force to the fluidic chip; and
a clamping force adjustment mechanism (screw) configured to change the variable amount of clamping force by displacing the compression mechanism 9 along an axis parallel to the light-transmitting path.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but it would be allowable if it is 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 discussed above, Joris discloses a clamping and aligning device for attaching a fluidic chip to a tissue sample. The chip holder of the device further comprises a gasket 10 (see Fig. 5). However, the chip holder does not comprise a clasp/snap, as recited in claim 6. Moreover, based on how the disclosure of Joris is mapped to the claims, there is no motivation to modify the structure corresponding to the claimed chip holder such that it comprises a clasp/snap.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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