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
Claims 18-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/17/2026.
Applicant’s election with traverse of Group I (claims 1-17) in the reply filed on 08/17/2026 is acknowledged. The traversal is on the ground(s) that:
there is not a serious search burden as the independent claims include common features with the dependent claims.
This is not found persuasive because:
the different groups require different classifications as they are different types of inventions (methods and a device), and the method of assembling of a test device differs in scope from the test device’s intended uses or manner of operation.
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and,
the inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant’s election with traverse of resin cement (for claim 12) in the reply filed on 08/17/2026 is acknowledged, for similar reasons as given above.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
07/10/2026
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Drawings
The examiner notes that color drawings or color photographs have been granted, see petition decision filed 05/15/2024.
Specification
The use of the term “Transwell”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Please use the term “Transwell®” in the instant specification (paragraphs [0078] and [0088]).
Claim Objections
Claims 1-17 are objected to because of the following informalities:
Regarding claim 1, in line 2, the line starts with a capitalized letter “A”, which should be lowercased to “a”.
Regarding claims 2-17, specifically regarding claims 2-12 and 14-17, the claims start with the word “A”, which should be “The”; or, alternatively, claim 13 should start with the word “A” instead of “The” to conform with the previous claim language.
Regarding claim 4, in line 1, the term “the round window membrane” should be “the mammalian round window membrane”.
Regarding claim 8, in line 1, the term “the device” should be “the test device”.
Regarding claim 13, in line 5, the spacing of the line should not be indented.
Regarding claim 14, in line 1, the phrase “comprising apparatus” should be “comprising an apparatus”.
Regarding claim 14, in line 1, the last word in the line “the” should be “a”.
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.
Claim 9 is 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 9 recites the limitation “the support” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 and 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelso (“Microperforations Significantly Enhance Diffusion Across Round Window Membrane”) (previously cited in the IDS filed 07/10/2026).
Regarding claim 1, Kelso discloses a test device (Fig. 2, pgs. 695-697 “Franz Cell Diffusion”) comprising:
a first compartment (pg. 696, “Donor Chamber”) and a second compartment (pg. 696-697, “Receptor Chamber”), wherein the first compartment is fluidly connected to the second compartment by an aperture between the first compartment and the second compartment (Fig. 4, “round window niche” on pg. 697); and
a membrane selected from a mammalian round window membrane (mRWM) (pg. 696 “Guinea pig RWM”)
wherein the membrane is provided over the aperture such that the membrane isolates the first compartment from the second compartment (Figs. 2-4, pg.697, under “Adaptation of Diffusion Cell Method”, watertight seal on the diffusion cell holding RWM).
Kelso does not disclose:
a mammalian oval window membrane (mOWM) or a combination of a mRWM and a mOWM
Regarding feature 1), the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
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Kelso, Fig. 4 (arrow in Fig. 4B pointing to an embedded RWM)
Regarding claim 8, Kelso discloses wherein the device further comprises a support for the membrane (Fig. 4 and its caption on pg. 697, also same page under “Adaptation of Diffusion Cell Method”, “acrylic adapter”).
Regarding claim 9, Kelso discloses wherein the support is any biocompatible material (Fig. 4 and its caption on pg. 697, also same page under “Adaptation of Diffusion Cell Method”, “acrylic adapter”; for biocompatibility, see same citations and see pg. 696, top-right col. “The acrylic holder was tested for reactivity with RhoB and was inert for more than 48 hours”).
Regarding the limitation “inner ear bone”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 10, Kelso discloses wherein the membrane is secured over the aperture by an adhesive (pg. 696, bottom-left col. and top-right col. “dental composites”, “primer”, and “resin” and Fig. 4, on pg. 697).
Regarding claim 11, Kelso discloses wherein the adhesive is any biocompatible sealant (pg. 696, bottom-left col. and top-right col. “dental composites”, “primer”, and “resin” and Fig. 4, on pg. 697).
Regarding claim 12, Kelso discloses wherein the biocompatible sealant is a resin cement (pg. 696, bottom-left col. and top-right col. “dental composites”, “primer”, and “resin” and Fig. 4, on pg. 697).
Regarding the limitations “zinc phosphate, zinc polycarboxylate, glass ionomer, resin modified glass ionomer, zinc oxide eugenol”, the limitation is phrased in the alternative. Additionally, these limitations are the nonelected species. Because at least one of the elected limitations is rejected above, no further rejections are required at this time.
Regarding claim 13, Kelso discloses wherein the first compartment further comprises a first solution (pg. 696, under “Donor Chamber”, 0.3 ml of 1 mM RhoB in phosphate-buffered saline (PBS)); and the second compartment further comprises a solution (pg. 696, under “Receptor Chamber”, 3 ml of PBS), wherein the solution in the second compartment is the same or different than the solution in the first compartment (pg. 696, same solution of PBS except the addition of RhoB).
Regarding claim 14, Kelso discloses further comprising apparatus (pg. 697, left col., “microscope” for “fluorescent microscopy”) for measuring the concentration of a test compound in the second compartment (pg. 697, left and right cols., under “Quantitative Analysis of Rhodamine B” and “Permeability of RWM to Rhodamine B”).
Regarding the limitation “the first compartment … or both the first and second compartments”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso (“Microperforations Significantly Enhance Diffusion Across Round Window Membrane”) (previously cited in the IDS filed 07/10/2026) as applied to claim 1, in view of Wijesinghe (“Adult porcine (Sus scrofa) derived inner ear cells: Characteristics in-vitro cultures”) (newly cited).
Regarding claim 2, Kelso discloses a membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose a large mammal round window membrane, a large mammal oval window membrane, or a combination of a large mammal round window membrane and a large mammal oval window membrane.
Wijesinghe discloses a large mammal round window membrane (pg. 2121; Fig. 1A-1C and caption, a porcine “round window niche” and “round window”) or a large mammal oval window membrane (pg. 2120, left col., under “2.2 | Tissue harvest, isolation and cell culture”, “via the oval window” and right col. “vestibular epithelium”).
In the analogous art of test devices, it would have been obvious to one skilled in the art before the effective filing date to modify the mammalian round window membrane of Kelso with the large mammal membrane of Wijesinghe as a simple substitution in order to use a porcine animal model that closely parallels human anatomy (Wijesinghe, abstract, Fig. 1’s caption (last sentence), and conclusion (“The similarity of the pig’s inner ear anatomy and cellular composition to that of humans suggest that the domestic pig can be another animal model for human inner ear cellular studies.”), located in pgs. 2119, 2121, and 2131).
Regarding the limitation “or a combination of a large mammal round window membrane and a large mammal oval window membrane”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Regarding claim 3, Kelso discloses a membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose wherein the membrane is a porcine round window membrane (pRWM), a porcine oval window membrane (pOWM), or a combination of a pRWM and a pOWM.
Wijesinghe discloses wherein the membrane is a porcine round window membrane (pRWM) (pg. 2121; Fig. 1A-1C and caption, a porcine “round window niche” and “round window”) or a porcine oval window membrane (pOWM) (pg. 2120, left col., under “2.2 | Tissue harvest, isolation and cell culture”, “via the oval window” and right col. “vestibular epithelium”).
In the analogous art of test devices, it would have been obvious to one skilled in the art before the effective filing date to modify the mammalian round window membrane of Kelso with the porcine membrane of Wijesinghe as a simple substitution in order to use a porcine animal model that closely parallels human anatomy (Wijesinghe, abstract, Fig. 1’s caption (last sentence), and conclusion (“The similarity of the pig’s inner ear anatomy and cellular composition to that of humans suggest that the domestic pig can be another animal model for human inner ear cellular studies.”), located in pgs. 2119, 2121, and 2131).
Regarding the limitation “or a combination of a pRWM and a pOWM”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso (“Microperforations Significantly Enhance Diffusion Across Round Window Membrane”) (previously cited in the IDS filed 07/10/2026) as applied to claim 1, in view of Han (“Characterization of the Sheep Round Window Membrane”) (newly cited), Goycoolea (“Round Window Membrane. Structure Function and Permeability: A Review”) (previously cited in the IDS filed 07/10/2026), and Goycoolea (“Experimental Studies On Round Window Structure: Function And Permeability”) (newly cited).
Regarding claim 4, Kelso discloses a round window membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose wherein the round window membrane has a thickness of at least about 65 µm.
Han discloses wherein the round window membrane has a thickness of at least about 65 µm (pg. 11, RWMs of sheep, the minimum thickness ranges from 55 to 71 μm).
In the analogous art of sheep round window membranes, it would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Kelso to be a sheep’s round window membrane with the claimed range of thickness in order for translational studies of the human cochlea. Its longevity (10–12 years of life) allows modelling of age-related chronic conditions in humans, and the size similarities of sheep organs with those of humans provide a platform for testing novel medical devices easily adaptable for human use (Han, pg. 2, right-upper quarter col.).
If it is deemed that the range of thickness of the round window membrane is not fulfilled by Han above, it would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Han to be within the claimed range in order to allow modelling of human round window membranes, which are on average, 70 μm (Han, pg. 2, bottom-left col., citing Goycoolea (“Round Window Membrane. Structure Function and Permeability: A Review”, see pg. 201, left col. under “Structure”), which cites in turn at pg. 203, right col., Goycoolea (“Experimental Studies On Round Window Structure: Function And Permeability”, see pg. 8, bottom-right col.))).
Alternatively, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Han to be within the claimed for the same reasons above.
Regarding claim 5, Kelso discloses a round window membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose wherein the round window membrane has a thickness of at least about 30 µm.
Han discloses wherein the round window membrane has a thickness of at least about 65 µm (pg. 11, RWMs of sheep, the minimum thickness ranges from 55 to 71 μm).
In the analogous art of sheep round window membranes, it would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Kelso to be a sheep’s round window membrane with the claimed range of thickness in order for translational studies of the human cochlea. Its longevity (10–12 years of life) allows modelling of age-related chronic conditions in humans, and the size similarities of sheep organs with those of humans provide a platform for testing novel medical devices easily adaptable for human use (Han, pg. 2, right-upper quarter col.).
If it is deemed that the range of thickness of the round window membrane is not fulfilled by Han above, it would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Han to be within the claimed range in order to allow modelling of human round window membranes, which are on average, 70 μm (Han, pg. 2, bottom-left col., citing Goycoolea (“Round Window Membrane. Structure Function and Permeability: A Review”, see pg. 201, left col. under “Structure”), which cites in turn at pg. 203, right col., Goycoolea (“Experimental Studies On Round Window Structure: Function And Permeability”, see pg. 8, bottom-right col.))).
Alternatively, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify the round window membrane of Han to be within the claimed range in order to allow modelling of human round window membranes, which are on average, 70 μm (Han, pg. 2, bottom-left col., citing Goycoolea (“Round Window Membrane. Structure Function and Permeability: A Review”, see pg. 201, left col. under “Structure”), which cites in turn at pg. 203, right col., Goycoolea (“Experimental Studies On Round Window Structure: Function And Permeability”, see pg. 8, bottom-right col.))).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso (“Microperforations Significantly Enhance Diffusion Across Round Window Membrane”) (previously cited in the IDS filed 07/10/2026) as applied to claim 1, in view of Sarwar (“Magnetic Injection of Nanoparticles Into Rat Inner Ears at a Human Head Working Distance”) (newly cited).
Regarding claim 6, Kelso discloses wherein a membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose wherein the membrane is an oval window membrane having a thickness of at least 30 µm.
Sarwar discloses wherein the membrane is an oval window membrane having a thickness of at least 30 µm (pg. 441, Fig. 2, caption, last two sentences).
In the analogous art of human ear membranes, it would have been obvious to one skilled in the art before the effective filing date to modify the membrane of Kelso with a human oval window membrane in order to test therapies on human tissue before use in patient studies.
Regarding claim 7, Kelso discloses a membrane (pg. 696 “Guinea pig RWM”).
Kelso does not disclose wherein the membrane is a combination of a round window membrane and an oval window membrane.
Sarwar discloses a round window membrane and an oval window membrane (pg. 441, Fig. 2, caption’s disclosure of these membranes within humans or rats, last two sentences).
In the analogous art of human ear membranes, it would have been obvious to one skilled in the art before the effective filing date to modify the membrane of Kelso with a human or rat round window membrane and oval window membrane in order to test therapies on human tissue or a more accessible model organism (rat) before use in patient studies.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kelso (“Microperforations Significantly Enhance Diffusion Across Round Window Membrane”) (previously cited in the IDS filed 07/10/2026) as applied to claim 1, in view of Hannen (US 20210380912) (newly cited) and ThermoFisher Scientific (“Antibiotic-Antimycotic (100X)”) (newly cited).
Regarding claim 15, Kelso discloses a first solution (pg. 696, under “Donor Chamber”, 0.3 ml of 1 mM RhoB in phosphate-buffered saline (PBS)).
Kelso does not disclose wherein the first solution is a cell culture media comprising serum, supplements, growth factors, anti-mycotic agents, and anti-bacterial agents.
Hannen discloses wherein the first solution is a cell culture media (paragraph [0047]) comprising serum (paragraph [0047] “10% (v/v) foetal bovine serum”), supplements (paragraph [0047] “1% (v/v) glutamine”), growth factors (paragraph [0047] “a culture medium that supports the growth of keratinocytes and/or dermal fibroblasts”), and anti-bacterial agents (paragraph [0047] “1% (v/v) penicillin, 1% (v/v) streptomycin”).
In the analogous art of tissue culture apparatuses, it would have been obvious to one skilled in the art before the effective filing date to modify the first solution of Kelso with the cell culture media of Hannen in order to culture ex vivo tissue with nutrition to extend lifespan of the tissue.
ThermoFisher Scientific discloses anti-mycotic agents (pg. 1).
In the analogous art of cell culture media, it would have been obvious to one skilled in the art before the effective filing date to modify the first solution of modified Kelso with the anti-mycotic agents of ThermoFisher Scientific in order to prevent fungal contamination (ThermoFisher Scientific, pg. 1, under “Description”).
Regarding claim 16, Kelso discloses wherein the first solution contains a test compound
or test composition (pg. 696, under “Donor Chamber”, 0.3 ml of 1 mM RhoB in phosphate-buffered saline (PBS); pg. 697, left and right cols., under “Quantitative Analysis of Rhodamine B” and “Permeability of RWM to Rhodamine B”).
Regarding claim 17, Kelso discloses a first solution (pg. 696, under “Donor Chamber”, 0.3 ml of 1 mM RhoB in phosphate-buffered saline (PBS)), and a second solution wherein the second solution is free of a test compound or test composition (pg. 696, under “Receptor Chamber”, 3 ml of PBS; and, pg. 696, same solution as the first solution of PBS except the absence of RhoB).
Kelso does not disclose wherein the first solution is free of a test compound or test composition.
Modified Kelso teaches the first solution (see rejection to claim 15).
The limitation “wherein the first solution is free of a test compound or test composition” is obvious under duplication of parts. Regarding the limitation, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the first solution of Kelso with the absence of a test compound or test composition in order to provide a negative control to a drug permeability study for safety and efficacy for delivery through a mammalian oval window membrane and/or a mammalian round window membrane, and to see the water permeability of the membrane while keeping the ex vivo membrane alive.
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Lundman (“Round window membrane permeability. An in vitro model”) (previously cited in the IDS filed 07/10/2026) – This non-patent literature is about an in vitro model for the permeability of a RWM.
Sun (“In vitro permeability of round window membrane to transforming dexamethasone with delivery vehicles - a dosage estimation”) (previously cited in the IDS filed 07/10/2026) – This non-patent literature is about the dosing of a RWM.
Witte (“Round Window Membrane Permeability to Transforming Growth Factor-α: An in Vitro Study”) (previously cited in the IDS filed 07/10/2026) – This non-patent literature is about transforming growth factor alpha (TGF-α) and its permeability through a RWM.
Lalwani (US 20190200927) (newly cited) – This invention is a device for detecting penetration of a semi-permeable membrane.
Lalwani (US 20150265824) (newly cited) – This invention cites a Franz cell used in determining transdermal drug delivery.
Sun (CN 201373874) (translation) (newly cited) – This invention is an vitro test device for the permeability of a round window film.
Ciotti (US 20210393554) (newly cited) – This invention’s disclosure includes a Franz testing device and motivation for use with the middle ear.
Meyer (US 20090246255) (newly cited) – This invention discusses permeability of membranes of the ear.
American Dental Association “Materials for Direct Restorations” (newly cited) – This evidentiary reference (last updated in 2024) discusses dental materials for direct restoration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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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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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
