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 Group I, claims 1-10 and 12-13 in the reply filed on 03/19/26 is acknowledged. Claims 11 and 14-15 are withdrawn from consideration as being drawn to a nonelected Group.
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 1-10 and 12-13 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 1, the claim recites “wherein the shape and/or cross sectional area of the structure as measured from a height direction…varies with the height of the structure relative to the base section” followed by the limitation “for measuring the height of the tissue on the pillar”. Due to placement of the phrases, it raises grammatical ambiguity as it is unclear if the limitation is intended use or further limiting the structure. Examiners recommend reorder the limitation for clarification such as:
“a structure protruding from the base section for measuring the height of the tissue on the pillars”.
Regarding claim 3, the claim recites a staircase like structure comprising at least two discrete and calibrated height references in the form of steps. It is unclear what the references are calibrated with respect to. For the purpose of examination. Claim two discrete and calibrated height references are being interpreted requiring at least two steps arranged in a stair like manner.
Claims 2-10 and 12-13 are also rejected for being 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)(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, 6, 9-10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiao (Plasmonic micropillars for precision cell force measurement across a large field-of-view, 2018; cited in IDS).
Regarding claim 1, Xiao discloses a device comprising:
a base section (Figure 1, rectangular base with “PDMS” label);
two pillars each with a proximal end and a distal end for growing tissue between and around the two pillars such that (Figure 1, the tilting/deflecting pillars holding cell colored in red), when the tissue contracts, the two pillars deflect (Figure 1b),
a structure protruding from the base section (Figure 1a), the two standing free pillars on either end of the device), wherein the shape and/or the cross sectional area of the structure as measured from a height direction, perpendicular to the base section (Page 4, left col., Lines 6-8, The pillar in Fig. 2(c) does not look perfectly cylindrical due to its 508 nm high conically shaped tip), varies with the height of the structure relative to the base section for measuring the height of the tissue on the pillar (In Figure 1 and 2, the free pillars height is known and do not participate in the traction study. The height of the free pillar is suitable as reference point).
PNG
media_image1.png
385
800
media_image1.png
Greyscale
Regarding claim 2, Xiao discloses the claimed invention as discussed above in claim 1. Xiao discloses the two pillars protrude from the base section (Fig. 1).
Regarding claim 6, Xiao discloses the claimed invention as discussed above in claim 1. Xiao discloses the structure has a conical shape such that the circumference of the structure varies in the height direction (The pillar in Fig. 2(c) does not look perfectly cylindrical due to its 508 nm high conically shaped tip. Page 4, left column, first paragraph).
Regarding claim 9, Xiao discloses the claimed invention as discussed above in claim 1. Xiao discloses the device comprises a silicone rubber (PDMS).
Regarding claim 10, Xiao discloses the claimed invention as discussed above in claim 1. Xiao discloses the structure further comprises at least one height mark (First, each micropillar has a single gold nanosphere embedded in its tip to serve as a strong light scattering center, page 1, right column, para. 1; nanosphere embedded in the tip is interpreted as a mark).
Regarding claim 12, Xiao discloses the claimed invention as discussed above in claim 1. Xiao discloses the device is obtainable by injection molding; injection compression; transfer molding; or embossing (The fabrication of a plasmonic micropillar platform starts from a hard silicon mold…Uncured PDMS was then poured onto the PDMS mold and cured. Page 2, left column, para. 2).
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(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao in view of Ikefuji (US 20190010438 A1) cited in IDS filed on 05/11/23.
Regarding to claim 3, Xiao discloses the claimed invention as discussed above in claim 1. Xiao does not disclose the structure protruding from the base section is a staircase like structure comprising at least two steps in the form of steps.
Analogous art Ikefuji (US 20190010438 A1) discloses a well-plate with a staircase structure (portion 140, Fig. 5) protruding from the base of a well of a well plate (Fig. 5) wherein the staircase is used for determining height of the fluid (para. [0065]).
Even though Ikefuji’s staircase like structure is used for measuring height of fluid level in a well of a plurality of wells in a well-plate, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Xiao by further incorporating a staircase structure protruding from the base of the device of Xiao for being a serving as height marker for the pillars and measuring the height of the tissues depositing on top of the pillars.
Regarding claims 4-5, Modified Xiao discloses the claimed invention as discussed above in claim 3. Ikefuji does not explicitly discloses the steps are separated by at least 10 microns or at most 200 microns. Xiao discloses the height of the pillar is at least 10 microns (page 3, left column). It would have been obvious to one of ordinary skill in the art to have modified the step height of Ikefuji to the claimed ranges in claims 4-5 in order to match the height of pillars for measurement of tissues height.
Claim(s) 7-8 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao in view of Dostanic (A Minaturized EHT Platform for accurate measurements of tissue contractile properties, 2020) as cited in IDS filed on 05/11/2023.
Regarding claims 7-8, Xiao discloses the claimed invention as discussed above in claim 1. Xiao does not explicitly disclose the device further comprising a wall section with an inner wall surface surrounding the structure or pillars and a second wall surface at least partially surrounding the structure.
In an analogous art, Dostanic discloses PDMS-based platform for measurement of contractile properties of engineered heart tissues (EHTs) (Fig. 1) comprising
a base section (See Fig. 1);
two pillars each with proximal and a distal end (See Fig. 1) for growing tissue between and around the two pillars such that, when the tissue contracts, the two pillars deflect (Fig. 2);
a structure protruding from the base (Elliptical sub-well, See Fig. 1); and
a wall section (transparent ring of a well of a well-plate, Fig. 1) with an inner wall surface surrounding the structure/pillars (inner surface of the transparent ring) and a second wall surface at least partially surrounding the structure (outer surface of the transparent ring).
PNG
media_image2.png
400
648
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of Xiao by incorporating a microwell/wall section as taught by Dostanic to the device of Xiao to derive the claimed invention. Doing so improves cell seeding (After fabrication, the devices were characterized by nanoindentation to assess the mechanical properties of the pillars and transferred to 96-well plates for cell seeding. Abstract).
Regarding claim 13, Xiao discloses the claimed invention as discussed above in claim 1. Xiao does not explicitly disclose a system comprising a microwell plate with a plurality of wells; and
a plurality of the devices of claim 1 each positioned in a respective one of the wells of the microplate.
Dostanic discloses system for measurement of contractile properties of engineered heart tissues (EHTs) (Fig. 1) comprising
a base section (See Fig. 1);
two pillars each with proximal and a distal end (See Fig. 1) for growing tissue between and around the two pillars such that, when the tissue contracts, the two pillars deflect (Fig. 2);
a structure protruding from the base (Elliptical sub-well, See Fig. 1);
a microwell plate with a plurality of wells (96-well plates, Abstract); and
a plurality of the devices each positioned in a respective one of the wells of the microwell plate (Fig. 1; After fabrication, the devices were characterized by nanoindentation to assess the mechanical properties of the pillars and transferred to 96-well plates for cell seeding).
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of Xiao by incorporating a microwell plate as taught by Dostanic to a plurality of devices of Xiao, wherein each device is positioned in a respective one of the wells of the microwell plates, to derive the claimed invention. Doing so improves cell seeding (After fabrication, the devices were characterized by nanoindentation to assess the mechanical properties of the pillars and transferred to 96-well plates for cell seeding. Abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9394514 B2 discloses a nano/micropillars array in a cell culture substrate/plate, wherein one embodiment has the pillars arranged in a staircase like manner (Fig. 11A and 11B).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.H./Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
Prosecution Insights