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 .
DETAILED ACTION
The text of those sections of Title 35, U.S. Code not included in this action can be found
in a prior Office action.
This action is in response to the papers filed on July 17, 2025. Pursuant to amendment filed on July 17, 2025, claims 1, 3, 4, 9, and 11 have been amended. Claims 14 and 15 are newly added. Claims 2, 12-13 have been canceled.
Therefore, claims 1, 3-11, and 14-15 are currently under examination.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/JP2020/003259, filed January 29, 2020, which claims priority to Japanese Application No. JP2019-014820, filed on January 30, 2019 is acknowledged.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on January 30, 2019. Filing on July 28, 2021 of certified untranslated copy of the Japanese publication JP2019-014820 is also acknowledged. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CPR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
At present, applicant has failed to provide a certified translation. Thus, the present possible priority for the instant application is January 29, 2020.
Withdrawn Claim Objections
In view of Applicants’ amendment to claim 3
New Claim Objections
Claim 3 is objected to and should recite “non-cell-adhesive part is in a range of 80 μm to 880 μm”.
Claim 4 is objected to and should recite “cell-adhesive part along a straight line is in a range of 30 μm”.
Claim 14 is objected to under 37 CPR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.0l(m). In arguments, pg. 12, section VI. New Claims, applicant states new claim 14 is dependent from claim 1. In this case, claim 14 is objected to under 37 CFR 1.75 as being in improper form because a dependent claim should refer to a precedent claim. See MPEP § 608.01(n).
Withdrawn- Claim Rejections- 35 USC§ 112(b)
In view of Applicants’ amendment to claim 1, no longer reciting “each of the one or more discontinued portions has a length of 1/6 or less of the complete periphery of the second non-cell-adhesive part, and” the rejection of claim 1 under U.S.C. 112(b) has been withdrawn.
In view of Applicants’ amendment to claim 3, clarifying the structural measurements, the
rejection under 35 U.S.C. 112(b) has been withdrawn.
In view of Applicants’ amendment to claim 4, deleting the recitation of satisfies, the
rejections under 35 U.S.C. 112(b) have been withdrawn.
In view of Applicants’ amendment to the instant application’s claim set, the rejections to claims 5-11 under 35 U.S.C. 112(b) have been withdrawn.
Withdrawn- Provisional Double Patenting
In view of Applicants’ cancelation of claims 27-33 of '380 application, the provisional rejection of claims 1-13 over claims 27-33 of copending Application No. 17 /426,380 has been withdrawn.
Withdrawn Claim Rejection- 35 USC§ 102
In view of Applicants’ amendments to the instant claims, clarifying the structurally recited dimensions, the rejection of claims 3-4 under U.S.C.102 as being anticipated by Sumaru et al. (US 2018/0104940 A1) and Saito et al. (US 7,883,865 B2) has been withdrawn.
Claim Interpretation
As presently recited, claims 3 and 4 recite distances infinitely greater (>) than 80 μm and 30 μm, respectively. Consistent with the instant specification, these claims are interpreted as distances within the range of 80 μm and 880 μm and 30 μm to 400 μm, respectively, see instant specification [0015-0019]; [0090-0091]; [0094-0095]; [0213].
According to the broadest reasonable interpretation of the ordinary artisan, and consistent with the specification, independent claim 1 is interpreted as encompassing any cell culture substrate having a surface with regions of relatively lower cell adhesion and a localized region within that area that includes a second non-adhesive region bordered, fully or partially, by a region of relatively higher adhesion. Applicant defines the term “cell-adhesive part” as a portion to which cells (preferably stem cells or cancer cells) to be actually cultured adhere when seeded on a cell culture substrate, and the non-cell-adhesive part is a region of a surface having the property that makes cells difficult to adhere (non-cell adhesiveness) and determined by whether or not cell adhesion or spreading is likely to occur (instant speciation, [0041-0044]). Hence, the “non-cell-adhesive and “cell-adhesive” parts are interpreted as defined, relatively, not absolutely.
The “cell adhesive part extending along the periphery” is interpreted to include any adhesive region disposed at or near the boundary of the second non-adhesive region, without requiring a continuous or closed ring, including partial, segmented, or irregular boundary arrangements. The term “surrounds” is interpreted broadly to mean generally disposed around or adjacent to the boundary, not necessarily completely enclosing it, where the cell-adhesive part extends so as to surround the non-cell-adhesive central part, whereby cells that attach and grow on this cell-adhesive part become dense and are more likely to induce a sac-shaped cell construct.
Modified and Maintained Claim Rejections - 35 USC§ 102
Claims 1, 5-11 remain, and claim 14 is newly, rejected under 35 U.S.C. 102 as being anticipated by Sumaru et al. (US 2018/0104940 A1, published April 19, 2018).
Regarding claim 1, Sumaru discloses micro-device for a cellular tissue body culture, including a cell holding chamber for holding cells and culture fluid, and a region exhibiting cell adhesiveness and a second region surrounding the first region and exhibiting non-cell adhesiveness; expressly disclosing that the adhesive region surrounds the non-adhesive region ([0012]; [0113]; [0119]).
Sumaru specifically discloses the claimed apparatus design, presenting the state of the art, stating:
“… tissue body-forming region includes one first region exhibiting cell adhesiveness and a second region surrounding the first region and exhibiting lower cell adhesiveness than that of the first region” ([0002]).
Then Samaru goes on to discloses embodiments and methods of producing a product where “…in a planar view, the adhesive region of the substrate is closed to surround the periphery of the non-adhesive region of the substrate...” ([0012]; [0113]; [0119]).
Regarding claims 5-8, dependent on claim 1, Sumaru discloses the application of a polymer appropriate solvent applied onto the substrate by dipping, spraying, spin, coating, or the like ([0048]). The non-cell adhesivable portion is made of a crosslinked polymer sheet adhered on the substrate ([0013]) with a strong cell adhesion inhibitory property, so that cell adhesion is strongly inhibited ([0136]). More specifically, Sumaru discloses specific examples of the material for the substrate include glass and resin, include a polymer containing polyethylene glycol ([0043] and [0047]) known in the art to be species of hydrophilic polymers.
Regarding claims 9-11, dependent on claim 1, Sumaru discloses the cell culture substrate, media, and coating agents/processes for the substrate ([0048], [0082], [0173], and [0178]). Further, Sumaru discloses a production and cell seeding method with respect to a substrate having a large number of pocket-like structures composed of crosslinked polymer formed in Example 2 on the surface thereof, cells were introduced into the pocket structure by repeatedly pouring the cell dispersion of MDCK cells, a cell line derived from canine renal tubule epithelial cells, or HepG2 cells, a cell line derived from human liver cancer, dispersed in a medium from the inlet direction of the pocket ([0171]). These cells, including the species of human induce pluripotent stem cells, are seeded on the resulting structure ([0178]). Sumaru further discloses the structure where the adhesive region of the substrate is closed to surround the periphery of the non-adhesive region of the substrate and at least one through-hole exists in the non-adhesive region of the crosslinked polymer sheet. As a result, the structure composed of crosslinked polymer of the present embodiment forms a pocketlike structure (bag-like structure) ([0119]). The pocket-like or bag-like structure equals the sac-shaped construct.
***
Claims 1, 5-11 remain, and claim 14 is newly, rejected under 35 U.S.C. 102 as being anticipated by Saito et al. (US 7,883,865 B2, patented February 8, 2011).
Regarding claims 1, 5-11 and 14, Saito discloses a cell culture substrate comprising a support substrate with a surface pattern of cell-adhesive and non-cell-adhesive regions. Specifically, Saito describes a hydrophilic region that serves as a cell-adhesive part, surrounded by a water-repellent (non-cell adhesive) region, which prevents cell adhesion (claims 1 and 8). Particularly, Fig. 8 through 19 and their corresponding descriptions disclose a cell culture substrate comprising a support substrate with a patterned arrangement of non-cell-adhesive and cell-adhesive regions. Figures 8 and 9 illustrate substrates where a circular non-cell-adhesive regions is surrounded by a continuous cell-adhesive part, aligning with the continuous configuration. Figures 13-19 present additional variations in geometric patterns of non-cell adhesive and cell-adhesive regions, demonstrating the substrate design can be adjusted to achieve specific cell adhesion properties including intermittent or discontinued portions (column 15, para. 3).
Saito discloses a method for producing a cell culture product in a desired pattern, by preparing a substrate for culturing cells having a hydrophilic surface formed in a desired pattern and a water-repellent surface formed in a portion other than the pattern, used as a cell-adhesive and non-cell-adhesive region (example 1 and 2). The culture medium is selectively disposed on the hydrophilic surface and cultured in the disposed culture medium (claims 1-15). Moreover, Saito discloses that the cell culture product provided is formed in a three-dimensional pattern (column 2, lines 26-31), for culturing cells including cancer and stem cells (column 11, lines 3-13).
Saito explicitly describes the ability to control the length and arrangement of the discontinued portions in intermittent configurations (column 6, para. 1). Saito emphasizes that the proportion and placement of adhesive and non-adhesive regions are adjustable parameters that influence cell behavior, suggesting that the claimed configuration is inherently achievable based on the disclosed teachings (column 3; para.4; column 4-5, bridging para.; column 10, last para.).
Regarding the coating material and substrate, Saito discloses typical methods for manufacturing a cell culture plate, a substrate having a hydrophilic surface, for example a substrate of which surface is coated with a hydrophilic substance (column 2, lines 61-64). Saito further discloses a material constituting the substrate can be used glass, silicon, ceramics, metal and high-molecular weight materials. A general cell culture plate made of silica glass (for example, Petri dishes) can be favorably utilized. A ceramics substrate made of, for example, silica, alumina or apatite, can also be used as a preferable material. Further, a high-molecular weight substrate made of, for example, polyacetal resin, polyamide, polycarbonate, ABS resin, polyimide, fluorine-based resin, polyethylene, polypropylene, polystyrene, or derivatives of these materials (column 8, lines 1-12). This corresponds to the "pre-coating treatment" of the present application.
Saito discloses the pattern formed by lithography can be of any shape and has no specific limitation. Specifically, the pattern may be of a planar or three-dimensional structure, and may be of an organized or random structure. The planar structure includes patterns composed of lines and spaces, polka-dots, lattice, lines or grooves imitating a complex branching structure of blood vessels, or the like. The three-dimensional structure can be tubular (including a branching structure), depressed (particularly, line grooves having a semicircle cross-section), bulged (particularly hemispherical), or constructed to form patterns of various living tissues (or organs) or the like. Alternatively, according to the plate provided by the present invention, since the culture medium and cells disposed on the surface; and the water-repellent surface of the plate may strongly repel each other, the medium or adherent cells can be disposed in a three-dimensional pattern (typically, as protruding droplets) on the hydrophilic surface. Therefore, a cell culture product can be three dimensionally formed (produced) in the medium disposed in such a three-dimensional pattern (column 10, lines 42-61). The underlined shapes are all considered to be a "sac-shaped" cell construct.
Additionally, regarding the cells, Saito discloses cells to be cultured are not specifically limited and desired culturable cells (typically, eukaryotic cells such as mammalian cells) can be utilized with no specific limitation. Particularly, adherent cells found in various living tissues, such as epithelial cells, fibroblasts, vascular endothelium cells, hepatocytes or cancerous cells, can be cultured as aligned in a prescribed pattern or molded into a prescribed pattern. In addition, various floating cells, such as embryonic stem cells (ES cell) or bone marrow stem cells can also be cultured efficiently in droplets of culture medium disposed on a prescribed pattern ( column 11, lines 3-13).
New Claim Rejections - 35 USC§ 103
Claims 1, 3-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yokoyama (US 2013/0210068 A1, published August 15, 2013), in view of Sumaru et al. (US 2018/0104940 A1), Saito et al. (US 7,883,865 B2).
Regarding claims 1 and 14, Yokoyama teaches a substrate used for cell culture comprising a base material comprising a conductive region and an insulating region provided thereon and cell adhesive regions and non-cell-adhesive regions, where the cell-adhesive part extends intermittently (Abstract, Claims 1-3 and Fig. 3c). Yokoyama teaches a plurality of line-shaped conductive regions may be combined to form an arbitrary configuration, such as a dendroid, netlike, or lattice configuration, deemed equivalent to sac-like ([0127]).
While Yokoyama teaches “conducting”, “insulating”, and “adjacent” positioning, as opposed to surrounding regions (Abstract; claims 1-2), the ordinary artisan would have recognized the structural relationships of these descriptors, further in view of the teachings of Sumaru and Saito.
Sumaru discloses micro-device for a cellular tissue body culture, including a cell holding chamber for holding cells and culture fluid, and a region exhibiting cell adhesiveness and a second region surrounding the first region and exhibiting non-cell adhesiveness; expressly disclosing that the adhesive region surrounds the non-adhesive region ([0002]; [0012]; [0113]; [0119]). Saito discloses a cell culture substrate comprising a support substrate with a surface pattern of cell-adhesive and non-cell-adhesive regions. Specifically, Saito describes a hydrophilic region that serves as a cell-adhesive part, surrounded by a water-repellent (non-cell adhesive) region, which prevents cell adhesion (claims 1 and 8).
The ordinary artisan would have recognized that arranging cell-adhesive and non-cell-adhesive regions in different spatial configurations, including adjacent, and surrounding relationships were routine, conventional, and established design parameters for patterned cell culture substrates, as taught by the combined teachings of Yokoyama, Sumaru, and Saito. Thus, the person of ordinary skill in the art would have found it obvious to modify the arrangement taught by Yokoyama with the surrounding configuration as taught by Samaru and Saito in order to define a boundary for controlling cell placement, yielding the claimed structure with a reasonable expectation of success. See MPEP 2144.0 V. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claims 3-4 and 15, the combined teachings of Yokoyama, Sumaru, and Saito render claim 1 obvious. Yokoyama additionally teaches the cell culture substrate where distances and widths correspond to a cell-adhesive part region of 0.1 μm to 500 μm (claim 7), intervals between 10 μm and 1,000 μm (claim 8), 1 μm to 500 μm and 0.1 μm to 10 μm (claim 13).
Sumaru teaches the area of 100 to 1x 106 μm2 ([0002], [0012]). Specifically, regarding size, Sumaru further discloses the area of the non-adhesive region of the substrate may be, for example 10 to 100,000,000 μm2, for example 50 to 10,000,000 μm2, or for example, 100 to 1,000,000 μm2 ([0131]). Additionally, the area per island-like portion may be, for example 200 to 100,000,000 μm2, for example 1,000 to 200,000 μm2, or for example 5,000 to 50,000 μm2 ([0149]). Saito further teaches culturing vascular endothelium cells such as HUVEC or the like on the substrate, produces a tubular vascular endothelium cell culture product of a desired size, preferably a diameter of approximately 200 μm or smaller (for example 20 μm to 30 μm) (column 20, lines 27-34). Saito additionally disclose, the size of the pattern (for example, the width of a groove pattern, the diameter of a dot pattern) has no specific limitation and can be chosen as desired. For example, in the case of a (line) groove pattern, a fine pattern of a width of 10 mm or less, preferably 3 mm or less, more preferably 1 mm or less, still more preferably 500 μm or less, still more preferably 100 μm or less, and particularly preferably 50 μm or less, can be formed by employing a lithography technique (column 10, lines 62- column 11, lines 1-2).
Regarding the specific numerical ratios and relative distances, the courts have found that “where 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. See MPEP 2144.0 V. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955).
Regarding claim 5, the combined teachings of Yokoyama, Sumaru, and Saito render claim 1 obvious. Yokoyama additionally teaches a non-cell-adhesive region composed of a polymeric hydrophilic membrane comprising an organic compound containing a carbon-oxygen bond ([0067], [0073- 0078], and claims 4, 12)
Regarding claim 6-7, the combined teachings of Yokoyama, Sumaru, and Saito render claim 1 and 5 obvious. Yokoyama additionally teaches examples of water-soluble polymeric materials include polyalkylene glycol and a derivative thereof and a zwitterionic polymer. A molecular configuration can be, for example, line-shaped, branched, or dendrimeric; more specific examples include, but are not limited to, polyethylene glycol ([0074]).
Regarding claim 8, the combined teachings of Yokoyama, Sumaru, and Saito render claim 1 obvious. Yokoyama additionally teaches surface of the cell culture support, such as a glass petri dish, plastic petri dish, glass slide, glass cover ([0103] and [0062]).
Regarding claim 9-11, the combined teachings of Yokoyama, Sumaru, and Saito render claim 1 obvious. Yokoyama additionally teaches the cell culture substrate, media, and coating agents/processes for the substrate ([0003], [0065], [0077-0079], and [0103]). Yokoyama further discloses the configuration of the line-shaped conductive region may be straight or curved. In addition, a plurality of line shaped conductive regions may be combined to form an arbitrary configuration, such as a dendroid, netlike, or lattice configuration (corresponding to sac-shaped) ([0127]), and examples of cells for culture include cancer cells and stem cells ([0101]).
Response to Applicants’ arguments as they apply to the rejection of Claims 1 and 5-11 are rejected under 35 U.S.C. 102 as being anticipated by Sumaru et al. (US 2018/0104940 A1) and Saito et al. (US 7,883,865 B2)
Applicant's arguments filed July 17, 2025, have been fully considered but they are not persuasive.
At pages 8-11 of the remarks filed on July 17, 2025, Applicants essentially argue
the following:
Applicant argues Samuru teaches the inverse, not the invention.
This argument is not persuasive because independent claims 1 and 14 are broad, and there is no clear distinction structures encompassed, considering the breath of the claims language.
Instant claim 1 states the cell-adhesive part can alternatively be continuous or intermittent and:
“a cell-adhesive part that extends along the periphery of the second non-cell adhesive part and surrounds the second non-cell-adhesive part…”
Thus, the claim stipulates the cell-adhesive part extends and surrounds the second non-cell-adhesive part.
Likewise, Samuru states:
“…in a planar view, the adhesive region of the substrate is closed to surround the periphery of the non-adhesive region of the substrate...” ([0012]; [0113])
Moreover, Samuru’s disclosure first presents the state-of-the-art pertaining to the cell substrate apparatus before going on to disclose the method of making the product, where in the Background Art section, Samuru directly states:
“…the tissue body-forming region includes one first region exhibiting cell adhesiveness and a second region surrounding the first region and exhibiting lower cell adhesiveness than that of the first region”
Samuru goes on to state:
“In the structure composed of crosslinked polymer of the present embodiment, in a planar view, the adhesive region of the substrate is closed to surround the periphery of the non-adhesive region of the substrate. In addition, at least one through-hole exists in the non-adhesive region of the crosslinked polymer sheet. As a result, the structure composed of crosslinked polymer of the present embodiment forms a pocket-like structure (bag-like structure).” ([0119])
The Examiner respectfully submits that patents are relevant as prior art for all they contain. "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). With that, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, even nonpreferred embodiments. See MPEP § 2123: Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989); Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). Here, Samuru discloses where a cell-adhesive part that extends and surrounds the second non-cell-adhesive part, in order to form the same sac or bag shaped construct as claimed in claim 9 and 11.
Applicant argues when stem cells are cultured on a cell culture substrate according to the amended claims, constructs can be detached faster and collection rates are higher compared to other techniques for producing sac-shaped cell constructs.
As an initial matter, as already communicated in the last office action, arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.
In response to applicant's argument that the product produces faster detachment and collection rates, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., intended use or utility including faster detachment, higher collection rates) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Concerning Saito, applicant argues a cell culture substrate of the amended claims can be used to improve yield and decrease culture times.
This argument is not persuasive because applicants’ arguments of unexpected results are not commensurate with the scope of the claims and are not over the closest prior art constructs but ‘Comparative Example’ cell substrates with a plurality of round cell-adhesive parts. The alleged unexpected benefit is not unexpected but relies upon the arrangements of the non-cell-adhesive and cell-adhesive parts of the cell culture substrate for generating the sac shaped cell construct. This was disclosed in the prior art, as demonstrated above, since the art taught the same cell substrate structure which yielded the evidence relied upon. Applicant’s evidence cited as unexpected are not over the closest prior art, but Applicant’s own particular ‘Comparative Examples’. For instance, the benefits cited against Comparative Example 1, where the cell substrate is structured according to a plurality of round cell-adhesive parts of 1500 μm in diameter, were derived from the sac-shaped construct obtained from arc shaped cell-adhesive parts, which was already taught in the prior art for the same purposes ([0185]). There is a lack of sufficiently detailed description of the experimental conditions and results, commensurate with the scope of the claims. The specification recites broad ranges and simply states:
“When the distance X falls within the above range, a cell construct having a sac-shaped structure can be cultured at high yields in a relatively short time.” ([0090])
“When the width W falls within the above range, a cell construct can be cultured at high yields in a relatively short time.” ([0091]; [0095])
“When the ratio X/W falls within the above range, a cell construct can be cultured at high yields in a relatively short time.” ([0092]; [0096])
“When the distance X' falls within the above range, a cell construct having a sac-shaped structure can be cultured at high yields in a relatively short time”. ([0094])
Applicants then more specifically state:
“The proportion of the collected tissues having a sac-shaped structure to the number of annular cell-adhesive parts on the cell culture substrate (hereinafter, also referred to as "tissue collection rate") was 80% or more and was thus high yields.” ([0184])
“These results show that the culture of iPS cells in a substrate having a plurality of cell-adhesive parts made of an annular pattern, as in Example 1, can yield tissues having a sacs-shaped structure in a short culture period, and offers a markedly high tissue collection rate.” ([0194])
Applicants’ comparative examples are not commensurate with the scope with the claims of the claims across all ranges ([0185-0186]), and are not relative to the closest prior art, which disclosed structures of the same arrangement producing sac-shaped cellular structures. In this case, the prior art already taught the sac-shaped structure for culturing the same cell types, so there is no sufficient evidence of unexpected results over the prior art. Thus, the alleged “unexpected” benefits are not sufficiently substantiated and are in fact predictable in light of the prior art, since they fail to show a significant departure from known results and known structures, see MPEP § 2145.
Concerning Saito, Applicant argues none of the variations taught by Saito teach or suggest an arrangement claimed.
This argument is not persuasive because Saito discloses multiple planar and 3D perspectives, the formation of a variety of shapes, structures, and patterning of hydrophilic and hydrophobic parts (column 10, lines 42-64; column 15, para. 3).
Conclusion
Claims 1, 3-11, 14, and 15 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner be reached 8:00 am to 5:00 pm, Monday through Friday.
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/J.D.L./ Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/ Supervisory Patent Examiner, Art Unit 1699