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 .
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 depends from Claim 8, a withdrawn claim. Examiner believes this is a typographical error and was intended to depend from Claim 1. Further correction is required and the office action will be treated as such.
Appropriate correction is required.
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 17 and 18 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.
Claim 17, line 3 recites the limitation "the membrane". There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is interpreted as the membrane from Claim 2.
Claim 18, line 2 recites the limitation "a second membrane". It is unclear how there is a second membrane when there is not a first membrane. Further clarification and correction is required. For examination purposes, it is interpreted as the claim depending from Claim 2, where a first membrane is recited.
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 1-3, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Halverson (US20190085282A1).
Regarding Claim 1, Halverson teaches the following:
A thin film culture device (cartridge adapted to house at least one biological sample) with at least two overlapping layers (Fig. 2, below) which can include a spacer 24 which is made of polyethylene foam or any material that is hydrophobic, inert to microorganisms and can be sterilized (para 60)(one layer consisting of highly hydrophobic, inert, and biocompatible material, with a contact angle >90 degrees). Note: Hydrophobic materials have a contact angle of 90 degrees by definition.
The spacer can be coupled via an adhesive to the first substrate 12 (para 60)(one layer of double sided adhesive)
The spacer defines a circular hole (one inner hole); since the adhesive only attaches the spacer to the substrate, the hole would necessarily be in the adhesive layer as well and the hole 26 would remain pervious when said layers overlap one another (see Fig. 2, below)
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The walls of the hole provide a well of predetermined size and shape over the growth region of the culture device and the space is thick enough depending on the size of the sample to be placed on the medium (para 60)(at least one inner hole is closed by the biological sample where loaded in said cartridge)
Regarding Claim 2, Halverson teaches all of the limitations of Claim 1 (see above). Halverson further teaches a permeable membrane 14 which is fixed to and is coextensive with at least a growth region of the upper surface of the first substrate (para 32)(at least one membrane adapted to support said at least one biological sample).
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Regarding Claim 3, Halverson teaches all of the limitations of Claim 1 (see above). Halverson further teaches a water resistant first substrate 12, and a water-resistant second substrate 18 (para 32) and adhesive layers 20 and 20’ (para 59)(also see annotated Fig. 2, reproduced below)(at least four overlapping layers, wherein two hydrophobic layers enclose two layers of double sided adhesive material and said biological sample, where present, is housed between said two layers of double-sided adhesive material).
Regarding Claim 17, Halverson teaches all of the limitations of Claim 1 (see above). The at least one biological sample is not a positively recited limitation. As such, the device of Halverson would be capable of housing a self-supporting biological sample and therefore meets the claim. Further, Halverson teaches an optional air permeable membrane 14 (para 32)(microporous membrane).
Regarding Claim 20, Halverson teaches all of the limitations of Claim 1 (see above). The at least one biological sample is not a positively recited limitation. As such, the device of Halverson would be capable of housing a self-supporting biological sample selected from the group consisting of a viable biological tissue, a decellularized biological tissue, a cellularized three-dimensional scaffold, and a cellularized hydrogel and/or wherein the at least one biological sample is supported on at least one membrane housed between said two inner layers of double-sided adhesive material and therefore meets the claim.
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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Halverson (US20190085282A1) in view of Hagihara et al. (WO2019146732A1).
Regarding Claim 18, Halverson teaches all of the limitations of Claim 3 (see above). Halverson does not teach a second biological sample supported on a second membrane, wherein the first and second biological samples are housed between said two layers of double-sided adhesive material.
Hagihara teaches a cell culture system with multiple membranes (para 9). Hagihara further teaches the cell culture module of the present invention is a cell culture module comprising: a top; a bottom;… and a polymer porous membrane fixed to each of two or more gap spaces selected from the gap space between the top and the adjacent partition, the gap space between the bottom and the adjacent partition.. the polymer porous membrane is a three-layer polymer porous membrane having a surface layer A and a surface layer B having a plurality of pores, and a macrovoid layer sandwiched between the surface layers A and B (para 59).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Halverson to have two porous membranes as taught by Hagihara between the two adhesive layers. One would have been motivated to make this modification as it makes it possible to stably culture a large quantity of cells (Abstract).
Response to Arguments
Applicant's arguments filed 06/18/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments on page 9 that Halverson does not teach each of said overlapping layers has at least one inner hole and the only hole is present in the spacer, Halverson teaches the spacer can be coupled via an adhesive to the first substrate 12 (para 60)(one layer of double sided adhesive) and the spacer defines a circular hole (one inner hole); since the adhesive only attaches the spacer to the substrate, the hole would necessarily be in the adhesive layer as well and the hole 26 would remain pervious when said layers overlap one another (see Fig. 2, above). Further, Halverson is not excluded from having more layers than the ones mentioned above.
Regarding Applicant’s arguments on page 10 that Halverson does not teach the hole is closed by the biological sample, Halverson teaches the walls of the hole provide a well of predetermined size and shape over the growth region of the culture device and the space is thick enough depending on the size of the sample to be placed on the medium (para 60). The way the sample closes the pervious hole is not a claimed limitation and therefore the sample closing the pervious hole by the way Halverson describes meets the claim.
The remainder of applicant’s arguments are directed towards new claims and are addressed above.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 19, Halverson teaches the following:
A thin film culture device (cartridge adapted to house at least one biological sample) with at least two overlapping layers (Fig. 2, below) which can include a spacer 24 which is made of polyethylene foam or any material that is hydrophobic, inert to microorganisms and can be sterilized (para 60)(one hydrophobic layer)
The spacer can be coupled via an adhesive to the first substrate 12 (para 60)(one layer of double sided adhesive)
The spacer defines a circular hole (one inner hole); since the adhesive only attaches the spacer to the substrate, the hole would necessarily be in the adhesive layer as well and the hole 26 would remain pervious when said layers overlap one another (see Fig. 2, below)
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The walls of the hole provide a well of predetermined size and shape over the growth region of the culture device and the space is thick enough depending on the size of the sample to be placed on the medium (at least one inner hole is closed by the biological sample where loaded in said cartridge)
Halverson further teaches a water resistant first substrate 12, and a water-resistant second substrate 18 (para 32) and adhesive layers 20 and 20’ (para 59)(also see annotated Fig. 2, reproduced below)(at least four overlapping layers, wherein two hydrophobic layers enclose two layers of double sided adhesive material and said biological sample, where present, is housed between said two layers of double-sided adhesive material).
Halverson does not teach each of said four overlapping layers has at least one inner hole that is pervious when said layers overlap one another, thereby forming a pervious hole through the cartridge.
Further, examiners search provided no other prior art that would anticipate or be obvious to combine to arrive at the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 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, 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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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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