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
No IDS has been filed.
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. 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) 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.
“engaging means” read on guides, rails, slots, threaded members and all other functionally equivalent devices (see paragraph [0006] of the printed publication)
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.
Claim 6 is 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 6 is written as being dependent on the “apparatus of claim r”. It is believed that claim 6 should be dependent on claim 1.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 and 8 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Isenberg (US 20220340848).
With respect to claim 1, Isenberg discloses an apparatus comprising a first component (Figure 2:210) having a sample holder (Figure 2:250). A second component (Figure 1:105) is coupled to the first component. The second component has an actuator, such as a pump (see paragraphs [0038]-[0056], “the cells on the membrane are also subjected to controlled fluid shear stress by moving fluid across the face of the membrane (e.g., via an integrated pumping mechanism or an externally connected pumping system, etc.”), a stretching means (see paragraph [0057] and Figs. 4 and 8A-8D), and/or a pin actuator (see paragraphs [0058]-[0063] and Figs. 6 and 6). An engaging means (Figure 3C:315) is used to couple the first component with the second component to register the actuator with the sample holder.
With respect to claim 2, Isenberg discloses the apparatus as described above. Isenberg shows that an opening is provided at the top of the first component. Another opening (Figure 3A:320) is provided in the second component. Both openings may be used to introduce therapies to the biological sample.
With respect to claim 8, Isenberg discloses the apparatus as described above. Isenberg shows in Figs. 1-4 that a cross section of the sample holder is circular.
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.
Claims 3-7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Isenberg (US 20220340848) as applied to claim 1, and further in view of Moraes (US 20090088342).
With respect to claim 3, Isenberg discloses the apparatus as described above, however Isenberg does not appear to teach that the actuator includes a hollow portion having a flexible membrane that is deflected to apply force to the sample.
Moraes discloses an apparatus comprising a first component (generally, Fig. 9:142) having a sample holder (Figure 9:144) and a second component (generally, Fig. 9:122) having an actuator configured to apply a force to a biological sample (Figure 9:222) on the sample holder. The actuator includes a hollow portion (Figure 9:126) and a flexible membrane (Figure 9:130), such that an introduction of fluid or gas to the hollow portion causes deflection of the membrane towards the biological sample. This is described in paragraphs [0063] and [0064].
Before the effective filing date of the claimed invention, it would have been obvious to provide the Isenberg second component with an actuator comprising a hollow portion having a flexible membrane, especially given that this is similar to the operation already described by Isenberg in the Figs. 1-3C embodiment. Moraes teaches that the hollow portion is controllably filled with a fluid to precisely move a flexible membrane into contact with a biological sample, thereby regulating exactly how much force is applied to the sample. Moraes describes how it is especially important to subject tissue samples to a variety of environmental forces to better simulate in vivo conditions (“The cells can be mechanically stimulated by actuating the deformable membrane to which they are attached by any of the methods described herein. In addition to membrane deformation, the cells on the membrane are also subjected to controlled fluid shear stress by moving fluid across the face of the membrane (e.g., via an integrated pumping mechanism or an externally connected pumping system, etc.))”, and that this can be accomplished using an actuator having a flexible membrane deflected in response to applied pressure changes to a hollow portion.
With respect to claims 4-6, Isenberg and Moraes disclose the combination as described above. Isenberg states in paragraph [0056] that the engaging means may include essentially any kind of connector (“a connector, such as a threaded connector, a press-fit connector, a friction fit connector, or a Luer-lock connector, among others”). Accordingly, it would have been obvious to consider engaging means that include guides, rails, slots and/or male and female threaded members, as these are generally identified by Isenberg and are considered to be well known in the art.
With respect to claims 7 and 10, Isenberg and Moraes disclose the combination as described above. Isenberg and Moraes each show embodiments in which a plurality of devices are disposed in the wells of a multiwell plate. For example, Figs. 8A-8D show first and second components disposed within a well of a well plate. Isenberg and Moraes describe other embodiments in which a plurality of sample holders are provided with a corresponding number of actuators. See, for example, Figs. 3C and 5-6B of Isenberg and Figs. 6 and 16 of Moraes.
With respect to claim 9, Isenberg and Moraes disclose the combination as described above. Moraes states that the actuator may include a loading post (Figure 9:160), and paragraph [0073] indicates that the loading post may be configured as a variety of different shapes (“Variations in shape of the loading post can create different strain fields in the culture membrane”). Accordingly, it would have been obvious to consider a loading post in the shape of a truncated cone.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Sticker (US 20190184394) and Tuan (US 20160201037) references disclose the state of the art regarding devices for applying a force to a biological sample.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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