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 with traverse of Group I, claims 1-9, in the reply filed on 1/9/2026 is acknowledged.
The traversal is on the ground(s) that the search and examination of all the claims can be made without serious burden and that they should be examined on the merits, even though they include claims to independent or distinct groups. This is not found persuasive because the restriction was evaluated under Unity of Invention, and the lack of Unity of Invention was determined because a device for supporting growth of a three dimensional tubular organ as recited in claim 1 of the instant application is known in the art and does not make a contribution over the prior art. Furthermore, the Applicant did not specify how the prior art, Nuber et al., fails to teach the technical feature of a device for supporting growth of a three dimensional tubular organ as recited in claim 1 to overcome the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because “Disclosed is” is a phrase which can be implied and should therefore be deleted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the terms AutoCAD (para. 0062); Matrigel (para. 0063); mTESR medium (para. 0063); ReLeSR (para. 0063); Aggrewell (para. 0064); SYBR Green real-time PCR master mix (para. 0072); Duolink (para. 0075), which are a trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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.
Claim Objections
Claim 3 is objected to because of the following informalities: it is recommended that "comprise at least one of holes, pores, slots, mesh, and semi-permeable membranes" should read "comprise at least one of holes, pores, slots, mesh, or semi-permeable membranes". Appropriate correction is required.
Claim 4 is objected to because of the following informalities: it is recommended that "a size of about 250 . Appropriate correction is required.
Claim 7 is objected to because of the following informalities: it is recommended that "the . 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 4-5 and 7 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 4 recites the limitation "the plurality of openings have a size" in lines . It is unclear what dimension “size” is referring to (diameter, radius, circumference, etc.).
Claim 5 recites the limitation "the " in lines . It is unclear what dimension “size” is referring to (height, width, etc.).
Claim 7 recites the limitations "the fluid" in line 4 and "the permeable features" in line . There is insufficient antecedent basis for these limitations in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation "about 1 micron to about 1 cm", and the claim also recites "about 250 micron" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation "about 0.5 microns to about 2 millimeters", and the claim also recites "about 1 micron to about 500 microns" which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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)(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 1-3, 6, and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gojo et al. (US 2021/0032585 A1).
Regarding claim 1, Gojo et al. teaches a device for supporting growth of a three dimensional tubular organoid (abstract “support device for cultivating a tubular cell structure”), the device comprising: a support structure (Fig. 2 rod-shaped member) having a wall and a lumen extending from a first end to a second end (abstract “openings at both ends of the tubular cell structure maintaining support device”), wherein the wall comprises a plurality of openings extending therethrough (para. 0020 “small through-holes for oxygen penetration may be drilled between the conduit 2a of the rod-shaped member 2”); an enclosure configured to extend at least partially around the support structure (Fig. 2 cell structure 5; abstract “outer diameter insertable into the hollow portion of the cell structure”) and support a plurality of cells disposed between the enclosure and the support structure (para. 0002 “lump of a plurality of cells formed by combining and cultivating single cells”); and a first reservoir fluidly coupled to at least one of the ends of the support structure (Fig. 1 culture chamber 3).
Regarding claim 2, Gojo et al. teaches a device wherein the enclosure is configured to be removed from extending at least partially around the support structure (abstract “outer diameter insertable into the hollow portion of the cell structure”).
Regarding claim 3, Gojo et al. teaches a device wherein the plurality of openings comprise at least one of holes, pores, slots, mesh, and semi-permeable membranes (para. 0020 “small through-holes for oxygen penetration may be drilled between the conduit 2a of the rod-shaped member 2”).
Regarding claim 6, Gojo et al. teaches a device wherein the support structure is formed from an additive manufacturing process, or wherein the support structure is composed of a biocompatible polymer (para. 0020 “fluoropolymer material… dimethylpolysiloxane (PDMS)”; claims 7-8).
Regarding claim 9, Gojo et al. teaches a device wherein the plurality of cells comprise a group selected from a cell mass, an embryonic body, a tissue fragment, and a cell culture (para. 0002 “a cell aggregate refers to a lump of a plurality of cells formed by combining and cultivating single cells”).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gojo et al. (US 2021/0032585 A1) in view of Breuer et al. (US 2011/0281358A1).
Regarding claim 4, Gojo et al. teaches a device comprising a plurality of openings (para. 0020 “small through-holes for oxygen penetration may be drilled between the conduit 2a of the rod-shaped member 2”), but is silent to the openings have a size from about 1 micron to about 1 cm; and optionally, wherein the plurality of openings have a size of about 250 microns. However, Breuer et al. discloses a porous scaffold with 0.4 cm sized perforations (Fig. 2) which are a suitable size to allow cells to adhere and grow/differentiate (para. 0079).
It would have been obvious to a person of ordinary skill in the art to use the Breuer et al. configuration of 0.4 cm sized perforations in Gojo et al.’s device with a reasonable expectation that it would be a suitable size to allow cells to adhere and grow/differentiate. This method for improving Gojo et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Breuer et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gojo et al. and Breuer et al. to obtain the invention as specified in claim 4.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Gojo et al. (US 2021/0032585 A1) in view of Nuber et al. (US 2011/0281358 A1).
Regarding claim 5, Gojo et al. teaches a device comprising a wall and a lumen extending from a first end to a second end (abstract “openings at both ends of the tubular cell structure maintaining support device”), but is silent to the wall having a size from about 0.5 microns to about 2 millimeters; and optionally, wherein the wall has a size of about 1 micron to about 500 microns. However, Nuber et al. discloses a chamber extending from several hundred micrometers to one millimeter (para. 0008) which influences growth, maturation, and maintenance of cells (para. 0008).
It would have been obvious to a person of ordinary skill in the art to use the Nuber et al. configuration of a chamber extending from several hundred micrometers to one millimeter in Gojo et al.’s device with a reasonable expectation that it would influence growth, maturation, and maintenance of cells. This method for improving Gojo et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Nuber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gojo et al. and Nuber et al. to obtain the invention as specified in claim 5.
Regarding claim 7, Gojo et al. teaches a device comprising a first reservoir fluidly coupled to at least one of the ends of the support structure (Fig. 1 culture chamber 3) comprising culture solution (Fig. 1 culture solution 3a), but does not teach a second reservoir, wherein the first reservoir is fluidly coupled to the first end of the support structure and the second reservoir is fluidly coupled to the second end of the support structure. However, Nuber et al. discloses a chamber comprising at least two fluid reservoirs (abstract; para. 0074 “the fluidic device 10 further comprises four fluid reservoirs 16”) arranged at opposite sides of the chamber (Fig. 1 fluid reservoirs 16) so different fluid media can flow through each fluid reservoir (para. 0010).
It would have been obvious to a person of ordinary skill in the art to use the Nuber et al. configuration of four fluid reservoirs in Gojo et al.’s device with a reasonable expectation that it would allow different fluid media to flow through each fluid reservoir. This method for improving Gojo et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Nuber et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gojo et al. and Nuber et al. to obtain the invention as specified in claim 7.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gojo et al. (US 2021/0032585 A1) in view of Allbritton et al. (US 2021/0087515 A1).
Regarding claim 8, Gojo et al. teaches a device for supporting growth of a three dimensional tubular organoid (abstract “support device for cultivating a tubular cell structure”), but is silent to the system being configured to be positioned within a standard well plate. However, Allbritton et al. discloses cell support structures for culturing cells or tissues (abstract) arranged in an array in a microtiter plate (para. 0044; Fig. 1C) which supports a plurality of cell support structures at a time (para. 0182).
It would have been obvious to a person of ordinary skill in the art to use the Allbritton et al. configuration of cell support structures arranged in an array in a microtiter plate in Gojo et al.’s device with a reasonable expectation that it would supports a plurality of cell support structures at a time. This method for improving Gojo et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Allbritton et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gojo et al. and Allbritton et al. to obtain the invention as specified in claim 8.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Akers et al. (US 2004/0203140 A1) discloses a bioreactor for culturing cells and tissues comprising a tubular housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799