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 .
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.
Election/Restrictions
Applicant’s election without traverse of group I, claims 102-106, 108-110, 118-120 in the reply filed on 6/30/26 is acknowledged.
Claims 102-106, 108-110, 113-116, 118-120 are currently pending.
Claims 113-116 are withdrawn as directed to non-elected inventions.
Claims 102-106, 108-110, 118-120 are elected and examined on the merits.
Claim Objections
Claims 102-103,118-119 objected to because of the following informalities. Appropriate correction is required.
Claim 102 appears to be missing several commas and should read “a metal, and glass” and “3D printing, for spatially separating”.
Claim 103 appears to contain multiple typographical errors and should read “any one of or a combination of, a cell separation structure”, “shape, and having one or more of”, “50 µm, or a cross sectional area”.
Claim 108 appears to contain multiple typographical errors and should read “into, or over, the”.
Claim 118 appears to contain a typographical error and should read “50%, or an average”.
Claim 119 appears to contain a typographical error and should read “ pulleys, and pistons”.
Claim Interpretation
With respect to claim 1, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. The limitation “formed by one or more of etching, micromolding, milling, and 3D printing” does not appear to confer any specific structural limitations on the claimed cell separation structure. Therefore, this limitation is not considered in the patentability analysis.
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 108-110, 119 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.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
The term “substantially” in claim 108 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “substantially” is utilized to describe both a planar support body and a tubular support body. It is not clear to what degree a support member must be either planar or tubular to satisfy the requirements of the claim.
Claim 110 contains the limitation “wherein the cells are mesenchymal progenitor cells comprising one or more of a… mature adipocyte”. It is unclear how a fully differentiated somatic cell may also be a mesenchymal progenitor cell.
Claim 119 recites the limitation "the plurality of punch heads" in limitation (i). There is insufficient antecedent basis for this limitation in the claim.
Claim 119 contains the limitations “one or more punch heads” and “the plurality of punch heads”. It is unclear if the claim encompasses embodiments with only one punch head, or if there must be a plurality.
Claim 120 contains a listing of additional elements present in the system. However, the claim does not indicate how, or if, the elements interact or physically connect. For example, as currently written, the reservoir layer must merely be “above” the cell support and base layer. Therefore, it is unclear what this claim is intending to encompass.
Claim Rejections - 35 USC § 112(a)/1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claim 108-110 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish if). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G. D. Searie & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). See MPEP § 2163.
Claim 108 contains the limitations “configured for insertion into or over the cell separation structure”. The specification as originally filed contains no limitations as to what the term “over” may encompass. The specification seems to indicate that support body is in physically contact with an upper surface of the cell separation structure (See e.g., [0005],[0007], [0063], [0066]). The specification does not appear to contain any embodiments in which there is not physical contact between the cell separation structure and the support body (e.g., the support body is suspended “over” the cell separation structure). Therefore, it is not clear that applicants possessed the invention as presently claimed at the time of filing.
Claim 120 contains the limitation “positioned over the cell separation structure”. The specification as originally filed contains no limitations as to what the term “over” may encompass. The specification seems to indicate that support body is in physically contact with an upper surface of the cell separation structure (See e.g., [0005],[0007], [0063], [0066]). The specification does not appear to contain any embodiments in which there is not physical contact between the cell separation structure and the support body (e.g., the support body is suspended “over” the cell separation structure). Therefore, it is not clear that applicants possessed the invention as presently claimed at the time of filing.
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 102-103 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CorningTM ElplasiaTM 12K Open Well Plate. Datasheet [online]. Corning, 2026 [retrieved 2026-08-017] Retrieved from the Internet: <https://www.fishersci.com/shop/products/elplasia-12k-open-well-plate/01670690#?keyword=> (hereinafter Elplasia).
Regarding claim 102, Elplasia discloses a 12,000-well polystyrene microwell plate (Description). Elplasia discloses that the plate contains 152 microcavities per cm2 with a rounded microcavity geometry (Description)
Regarding claim 103, Elplasia discloses that the microcavities comprise an ultra-low attachment surface (Description).
Therefore, every limitation of claims 102-103 is present in Elplasia and the subject matter is anticipated.
Claim(s) 102, 104, 108-110 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Futrega et al., (2015) The microwell-mesh: A novel device and protocol for the high throughput manufacturing of cartilage microtissues. Biomaterials, 62:1-12 (hereinafter Futrega).
Regarding claims 102, 104, Futrega discloses a microwell platform for single cell culture (Abstract). Futrega discloses methods of producing PDMS microwells having a pyramidal shape, with a diameter of 2 mm and a depth of 0.8 mm (2.2, Fig. 1). The microwells are spaced approximately 0.5mm apart (Fig. 1).
Regarding claim 108, Futrega discloses that the microwells are covered with a nylon mesh with 36 µm pores (2.2, 2.9, Fig. 1).
Regarding claims 109-110, Futrega discloses isolating bone marrow-derived mesenchymal stem cells and seeding in the microwells (2.5, 2.9). Futrega explains that the single cells may pass through the micromesh, but aggregates are retained within the wells (2.9). Futrega explains that the disclosed system is ideal for high-throughput analyses (Conclusions).
Therefore every limitation of claims 102, 104, 108-110 is present and the subject matter is anticipated.
Claim(s) 102, 104, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevens et al., (2018) VyCAP’s puncher technology for single cell identification, isolation, and analysis. Cytometry Part A, 93(12):1255-1259 (hereinafter Stevens).
Regarding claims 102, 104, Stevens discloses systems for the isolation of single cells (Abstract). Stevens discloses utilizing a microwell chip containing 6,400 wells in an 8 x 8 mm chip (Microwell chip). The bottom of each well is an optically clear silicon nitride membrane (Microwell chip).
Regarding claim 118-119, Stevens discloses that the microwells have a single pore having a diameter small enough that the cells are not able to pass through (Microwell chip). In some embodiments, the diameter of the pore is 5 µm (Microwell chip). Stevens discloses coupling the microwell plated with an automated puncher system comprising needles capable of isolating cells of interest from the microwells (Puncher technology, Fig. 1). Stevens discloses that Eppendorf tubes, PCR well plates, or culture plates may be positioned directly beneath the microwell plate such that punched cells drop into the underlying container (Isolation of the cells, Fig. 1). Stevens explains that disclose system allows for easy identification and isolation of cells (Isolation by punching, Conclusion).
Therefore, every limitation of claims 102, 104, 118-119 is present in Stevens and the subject matter is anticipated.
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) 102-104-106 is/are rejected under 35 U.S.C. 103 as being unpatentable over ViewPlate-1536 Collagen Coated, Black, Optically Clear Bottom, Tissue Culture, Sterile, 1536-Well with Lid, Case of 10. Data Sheet [online]. Revvity, 2026 [retrieved 2026-08-017] Retrieved from the Internet: <https://www.revvity.com/product/col-coated-viewplate-1536-10x1b-6004810?_gl=1*1yv4kxh*_up*MQ..*_ga*MTcyNTcyMjY2Ni4xNzg2OTc3NzM0*_ga_0PJ9SJEC34*czE3ODY5Nzc3MzQkbzEkZzAkdDE3ODY5Nzc3MzQkajYwJGwwJGgxMzg5NjE1NDI1#product-overview> (hereinafter ViewPlate).
Regarding claims 102, 104, ViewPlate discloses a 1536 collagen-coated, polystyrene, microwell plate (Overview). ViewPlate discloses that the microplate comprises 1536 wells, with a well-to-well spacing of 2.25 mm (Overview).
Regarding claims 105-106, ViewPlate discloses that the microwells are collagen coated (Specifications).
ViewPlate does not disclose that the spacing between adjacent cells (i.e., well-to-well spacing) is between 5 and 500 µm. However, as per MPEP § 2144.04 both changes in size/proportion and rearrangement of parts are considered routine expedients requiring no more than ordinary skill in the art. Therefore, in the absence of evidence to the contrary, reducing the spacing between wells is considered obvious in view of ViewPlate.
Claim(s) 118 is/are rejected under 35 U.S.C. 103 as being unpatentable over Futrega as applied to claims above.
Regarding claim 118, Futrega discloses that the micromesh is composed of nylon (a polyamide) disk fitted to cover each of the microwells (2.2, Fig. 1).
Futrega does not disclose that the micromesh has an average pore size of 1 to 5 µm. However, Futrega discloses that the size and shape of the microwells may be varied depending on the particular application (Discussion; “a range of microwell dimensions [are] readily achievable”). Further as per MPEP § 2144.04 changes in shape and size are considered routine expedients requiring no more than ordinary skill in the art. Therefore, it would be obvious to one of ordinary skill in the art that the average pore size may be altered.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bae et al., Double-sided microwells with a stepped through-hole membrane for high-throughput microbial assays. Analytical Chemistry, 92(14) 9501-9510 (hereinafter Bae).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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