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 Group I, claims 1-4, 6, 7, 10, 13 and 16 in the reply filed on 20 November 2025 is acknowledged.
Claims 5, 8, 9, 11, 12, 14, 15 and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 November 2025.
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.
Claims 2, 3, 10 and 13 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.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 recites a range of “1-100 µmin width”. It is believed that the term “µmin” should be written as “µm”.
Claim 2 appears to broaden the scope of the independent claim by requiring a width range “1-100 µm” that is greater than the width range “1-50 µm” previously set forth in claim 1. It is therefore unclear what range is contemplated by claim 3.
Regarding claim 3, the phrases "preferably", “more preferable” and “most preferable” render the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 is rejected for being written as dependent on a withdrawn claim (claim 9). Accordingly, the scope of claim 10 is unclear.
Claim 10 recites the limitation "the APC" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 is rejected for being written as dependent on a withdrawn claim (claim 12). Accordingly, the scope of claim 13 is unclear.
Claim 13 recites the limitation "the attached cells" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102/103
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.
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 1-4, 6, 7, 10, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kuwabara (US 20080057578).
With respect to claims 1 and 2, Kuwabara discloses a microtopography system for modulating one or more cell processes on a surface. An array of repeated micropillars (Figure 1:21) is applied to a surface (Figure 1:2) of a product to produce a pattern that acts to modulate one or more cellular processes of a cultured cell (Figure 1:1). Paragraphs [0049]-[0059] describe that the micropillars have a width that is “not particularly limited” and “preferably not less than 10 nm and not more than 10 µm, more preferably not less than 0.2 µm and not more than 5.0 µm”. The height of the micropillars is said to be “ preferably not less than 10 nm and not more than 1 mm, more preferably not less than 0.1 µm and not more than 100 µm”. In the event that these teachings do not anticipate the claimed height and width ranges, it would have nevertheless been obvious to consider experimenting with width values between 1-50 µm and height values between 1-100 µm due to the significant overlap with the teachings of Kuwabara. It is well established that a prima facie case of obviousness exists in cases where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05.
With respect to claim 3, Kuwabara discloses the system as described above. Kuwabara teaches micropillars having diameter and height combinations that produce a mean surface area of below 50 µm2. For example, a micropillar having a radius of 1 micron and a height of 5 microns will have a surface area of approximately 35 µm2.
With respect to claims 4, 6, 7, 10 and 13, Kuwabara discloses the system as described above. The Kuwabara system is fully capable of being used to accommodate immune cells, macrophages and/or dendritic cells, and may be used to prevent or reduce biofilm formation. It is well-established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114. It is additionally noted that the specific cells and cell types are not positively recited. Rather, the cells are passively claimed using recitations that describe an intended use (e.g., “acts to modulate…”, “for preventing or reducing…”).
With respect to claim 16, Kuwabara discloses the system as described above. Kuwabara states in paragraph [0066] that the system is configured as an implantable medical device (“this material may be implanted in the body of patient”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Agrawal (US 20030148401), Miyauchi (US 20050095699), Cousins (US 7374903), Mobini (US 20200054875), Faris (US 20110086427) and Rajasekaran (US 20170269077) references teach the state of the art regarding microtopography systems having an array of repeating micropillars.
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