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 1-19 are pending.
Applicant’s election without traverse of Group I, claims 1-10, corresponding to the method, in the reply filed on 07/23/2026 is acknowledged.
Claim 11-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/23/2026.
Claims 1-10 have been examined on their merits.
Claim Rejections - 35 USC § 112(b)
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 1-10 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 1 in its entirety is “A cell culture method for attaching a masking sheet having an opening portion to a culture surface and forming cells or cell aggregates a portion of the culture surface, which is exposed in the opening portion, wherein the masking sheet includes an adhesive layer that is adhered to the culture surface, and a support layer that is laminated on the adhesive layer to support the adhesive layer.”
The claim recites no active method steps for the use the masking sheet (a composition). The claim does not require steps of attaching a masking sheet or forming cells or cell aggregates. Rather, the claims only suggests that these are properties that could happen if unrecited method steps were performed.
In regards to unrecited method steps, while the specification may provide specific methods, and although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
Therefore, in regards to method claims that do not recite steps, according to 2173.05(q), attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).
Therefore, claim 1 is indefinite because it only describes a use of a composition without reciting steps for practicing the invention.
Claims 2-9 likewise do not recite specific method steps, but rather only describe further properties of the composition.
In regards to claim 9, while the claim describes that “the opening portion [of the masking sheet] is formed by laser processing”, this is a non-limiting product-by-process step in regards to the structure of the composition (see MPEP 2133), not an active method step of either performing the cell culture method of claim 1 or of manufacturing the composition.
Claim 2-10 are also rejected under 35 USC 112(b) for their dependence on claim 1.
In regards to claim 10, while the claim is indefinite because it depends on claim 1, the claim recites active method steps (e.g., “a step of applying”, etc.). Therefore, incorporating claim 10 into claim 1 could be ameliorative for the purposes of overcoming the rejection under 35 USC 112(b).
Appropriate clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon (an abstract idea) without significantly more.
Specifically, claims 1-9 are rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
As discussed above, claim 1 provides for the use (for attaching) of a composition (a masking sheet), but does not recite any particular method steps.
Claims 2-9 likewise do not recite specific method steps, but rather only describe properties of the composition to be used.
As above, while the claim suggests properties that can happen if unrecited method steps are performed, in regards to unrecited method steps, while the specification may provide specific methods and although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
As discussed above, since the claim does not set forth any steps involved in the method, it is unclear what method Applicant is intending to encompass. As above, claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Additionally, as discussed in MPEP 2173.05(q), it is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 112(b) and 35 U.S.C. 101 if the facts support both rejections.
In regards to the analysis under 35 U.S.C. 101, Applicant is directed to the subject matter eligibility test for products processes (MPEP 2106; specifically, MPEP 2106(III) flowchart).
Briefly summarized here, the guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
In regards to Step 1, the claimed invention is directed to (a method) which is a statutory class of invention (Step 1: YES).
In regards to Step 2A, prong one, independent claim 1 is drawn to “A cell culture method for attaching a masking sheet having an opening portion to a culture surface and forming cells or cell aggregates a portion of the culture surface, which is exposed in the opening portion, wherein the masking sheet includes an adhesive layer that is adhered to the culture surface, and a support layer that is laminated on the adhesive layer to support the adhesive layer.”
As discussed above, while the claim suggests properties that can happen if unrecited method steps are performed, in regards to unrecited method steps, while the specification may provide specific methods and although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.
As above, dependent claims 2-9 likewise to no recite method steps, but only further describe properties of the composition.
Therefore, the claim is drawn to an abstract idea (a culture method “for” attaching a masking sheet, but without carrying out any method steps).
Accordingly, the claim is directed to a judicial exception (Step 2A, prong one: YES).
In regard to Step 2A, prong two, the instant claim is directed to “A cell culture method for attaching a masking sheet having an opening portion to a culture surface and forming cells or cell aggregates a portion of the culture surface, which is exposed in the opening portion, wherein the masking sheet includes an adhesive layer that is adhered to the culture surface, and a support layer that is laminated on the adhesive layer to support the adhesive layer.”
With respect to Step 2A, prong two, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, prong two, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regards to Step 2A, prong 2, the instant claim does not recite additional elements or a combination of elements in the claims other than the abstract idea itself (i.e., the claim only describes a method “for” using the composition but does not carry out any method steps), and therefore, does not integrate the judicial exception into a practical application (therefore, Step 2A, prong one: NO).
In regards to Step 2B, the instant claim does not recite additional elements or a combination of elements in the claims other than the abstract idea itself (i.e., the claim only describes a method “for” using the composition but does not carry out any method steps). Thus, the claim does not additional elements or a combination of elements in the claims other than the natural product itself. Therefore, the claim does not the claim recite additional elements that amount to significantly more than the judicial exception (therefore, Step 2B: NO).
Thus, instant claims do not amount to significantly more than the judicial exception itself and do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
In regards to claim 10, it is noted that this claim is NOT rejected because it recites embodiments with active method steps. Therefore, if incorporated into claim 1, the claim would no longer be directed to a natural phenomenon (an abstract idea), Step 2A would be “NO” and the claim would qualify as eligible subject matter under 35 U.S.C. § 101.
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.
(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 1-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(1) as being anticipated by Khademhosseini et al. (US20080220169A1 on IDS 01/07/2025) as evidenced by Klotzsch et al. (PNAS, 2009).
In regards to claim 1, Khademhosseini discloses methods for using a cell culture stencil (masking sheet) for culturing cells on a substrate complex (culture surface) (Abstract; claim 20; paragraph [0033]; Fig. 1, Fig. 8). In embodiments, Khademhosseini discloses that the stencil may comprise a cell adhesive agent (an adhesive layer) over a substrate (e.g., fibronectin or collagen over parylene, etc., paragraphs [0033, 0207]; Fig. 13A) (a support layer). Since this attaches to the substrate (culture surface) (see Figs. 1 and 8), this results in an adhesive layer (the cell adhesive agent) on a support later (the parylene layer), as claimed. Khademhosseini discloses that the support layer can comprise multiple layers itself (paragraph [0036]) and is therefore laminated.
In regards to claims 2-5, Khademhosseini discloses that the support later (parylene) can be mechanically stiff and have a Young's Modulus of 1.0 GPa or greater (paragraphs [0019, 0070, 0072]), which overlaps with the claimed range. While Khademhosseini is silent as to the stiffness of the adhesive layer, it is noted that both fibronectin and collagen are well-known compliant (not stiff) substances. Additionally, as evidenced by Klotzsch, fibronectin at least as an elastic modulus of 1-15 MPa (Introduction, p18267). Therefore, it is determined that the Young’s modulus of the adhesive layer of Khademhosseini overlaps with the claimed range, absent evidence to the contrary.
Therefore, the arrangement of the masking sheet of Khademhosseini still results in a support layer that has a higher rigidity (a higher Young’s modulus, which is a measure of stiffness) compared to the adhesive layer.
In regards to claim 6, Khademhosseini discloses that the support later (parylene) can have a thickness of at least 10 µm (paragraphs [0149, 0246], which overlaps with the claimed range.
In regards to claim 8, Khademhosseini discloses that the masking sheet has a plurality of openings with the same size and are arranged as in claim 8 (Figs. 1 and 3).
In regards to claim 9, in regards to “wherein the opening portion is formed by laser processing”, since the opening portion (of the masking sheet) “is formed” by laser processing, Applicant should note that this is a product-by-process step, not an active method step (claim) per se.
In regards to product-by-process claims, according to MPEP 2113, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.)
Additionally, while the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
However, in the instant case, the laser processing is only provided to create an opening, and therefore, is determined not to impart distinctive structural characteristics to the final product (the opening of the masking sheet).
Thus, since Khademhosseini discloses openings in the masking sheet, as claimed, because it is identical to the openings as claimed it anticipates this product-by-process step.
In regards to claim 10, as above, Khademhosseini discloses methods for using a cell culture stencil (masking sheet) for culturing cells on a substrate complex (culture surface) (Abstract; claim 20; paragraph [0033]; Fig. 1, Fig. 8). Khademhosseini discloses that the method comprises “applying a multilayer microfabrication stencil to a substrate to form a first complex” (claim 20). Following this, Khademhosseini discloses “incubating a first protein . . . over the first complex”, which may be an adhesive (paragraphs [0089, 0111]; Fig. 8). Following this (thus, after the adhesive is added), Khademhosseini discloses seeding cells to the culture surface (Claim 20; Fig. 8). Khademhosseini also discloses that the masking sheet is removed (Fig. 8).
Therefore, Khademhosseini anticipates the invention as claimed.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Khademhosseini et al. (US20080220169A1 on IDS 01/07/2025) in view of Tang et al. (Adv Mater, 2004).
In regards to claim 7, Khademhosseini is silent as to the thickness of the adhesive layer. However, a person of ordinary skill in the art could have arrived at a thickness of 1 µm to 100 µm by routine optimization, and the disclosure does not point to a criticality in this amount (see MPEP 2144.05(II)(A), generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
In the instant case, because Tang teaches that 100 µm ultrathin collagen gels with patterned cavities for culturing cells can be made (see last paragraph, p1345; Fig. 1, p1346) and indeed, in a cell scaffold that acts as an adhesive layer covered with a relatively stiffer layer (PDMS) that sits on a cell culture surface (see Fig. 2, p1345), a person of ordinary skill in the art could have arrived at the claimed thickness by routine optimization with predicable results and a reasonable expectation of success.
Therefore, the combined teachings of Khademhosseini and Tang render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
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