DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 12 November 2025. Claims 3 and 7 have been amended. Claim 4 has been cancelled. Claim 5 remains withdrawn. Claims 10-12 are newly added. Claims 3, 6-8, and 10-12 are currently pending and under examination.
This Application is a national phase application under 35 U.S.C. §371 of International Application No. PCT/JP2020/038938, filed 15 October 2020, which claims priority to Japanese patent document No. JP2020-010229, filed 24 January 2020, and JP 2019-189611, filed 16 October 2019.
Withdrawal of Rejections:
The rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
Maintenance/Modification/New Rejections Necessitated by Amendment:
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 11 and 12 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.
The term “substantially perpendicular” in claim 11 is a relative term which renders the claim indefinite. The term “substantially perpendicular” 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 metes and bounds of this claim are unclear, because it is unclear what degree of variation from perpendicular (i.e. from a 90° angle) is intended to be included in, or excluded from, “substantially” perpendicular.
Further regarding claim 11, the limitation that “the holding member has a surface that is substantially perpendicular to the cylindrical placement portion and comes into contact with the surface” (emphasis added) is indefinite, because it is unclear how a surface of the holding member is intended to come into contact with itself. Additionally, as the ring member is also indicated as having “a surface,” it is further unclear which surface is referred to by “the surface.”
Claim 12 includes a projection that is formed “on the surface of the holding member or the ring member.” This limitation is indefinite, because no surface of either the holding member or the ring member is previously recited in claim 3. As such, it is unclear what surface (e.g. top, bottom, inner, outer) of either component is being referred to by “the surface.”
Further regarding claim 12, the limitation of “a locking projection that stops movement of the projection on the surface of the surface of the holding member or the ring member” (emphasis added) is indefinite, because it is unclear what that surface of the surface is referring to.
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 3, 6-8, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Annala et al. (IDS; US 2008/0076170, Published 2008).
PNG
media_image1.png
110
302
media_image1.png
Greyscale
PNG
media_image2.png
607
394
media_image2.png
Greyscale
With regard to claim 3, Annala et al. teach, referring to Figs. 2 and 5 reproduced below, a cell sheet production device comprising a container (5) configured to contain a culture medium for culturing cells; and a support unit (4) configured to be removably held in the container (5). The support unit (4) including: a mesh sheet (1) that is a substrate to which the cells are caused to adhere and on which the cells are cultured; a holding member (3), which holds the mesh sheet (1) such that the mesh sheet (1) floats from a bottom surface of the container (5); and a ring member (2) detachable provided to the holding member (3). The support unit (4) being held in the container (5) such that the support unit (4) is at a fixed position in vertical and horizontal direction in the culture medium (see Fig. 2, bottom). The holding member (3) detachably holding the mesh sheet (1), and including a cylindrical placement portion (see Fig. 5, bottom of the holding member (3)) on which the mesh sheet (1) is placed. The ring member (2) having a shape surrounding an outer periphery of the cylindrical placement portion of the holding member (3) (see Fig. 5). The mesh sheet (1) having a peripheral edge sandwiched between the cylindrical placement portion of the holding member (3) and the ring member (2) (see Fig. 1 (4); Fig. 5).
The ring member (2) includes a locking portion which locks the ring member (2) and the holding member (3) to keep them from separating (Abs.; see also Fig. 5 – the inner surface of the ring member (2) functions as a locking portion to secure the bottom (cylindrical placement portion) of the holding member, thus “locking” the components together to prevent separation). Both the ring member (1) and the holding member (3) have a through hole (see Fig. 5 – the open center of each component is a “through hole”), which necessarily provides for the use of a pushing pin for pushing together and apart the ring member (1) and the holding member (3), being able to cause locking and unlocking when the device is being used. It is noted that no “pushing pin” is recited as being required to be present as a component in the device, and is only recited for use of the device.
With regard to claim 6, Annala et al. teach that the support unit (4), which includes the holding member (3), is made of moldable materials including polystyrene (Para. 42). It is noted that Applicant indicates polystyrene is a preferred material for the holding member (see Spec., p. 15, line 23-25), and thus the holding member (4) of Annala et al. has a larger specific gravity than the culture medium.
With regard to claim 7, Annala et al. teach that the support unit (4) includes the holding member (3), which is a covering body having an injection port (through hole) capable of being used for injecting a suspension containing cells between the mesh sheet and the covering body, wherein there is a set distance (through hole) between the mesh sheet (1) and covering body (see Figs. 2, 5). It is noted that the limitation that the distance is set “so that the suspension is injected between the mesh sheet and the covering body while the suspension comes in contact with both of the mesh sheet and the covering body” is an intended use of the device as claimed. The device as taught by Annala et al., which has the structural components as claimed, would necessarily be capable of performing this use, which would depend on other factors including the amount of suspension injected between the mesh sheet and the covering body.
[AltContent: rect]
PNG
media_image1.png
110
302
media_image1.png
Greyscale
With regard to claims 8 and 10, Annala et al. teach, referring to the mesh sheet (1) in Fig. 5 reproduced here, the mesh sheet (1) includes an opening having an elongated shape in one direction, the shape being a rectangle, where a ratio of the short side to the long side is 1:2 (see for example rectangular portion in the mesh sheet indicated by inserted arrow).
With regard to claim 11, it is noted that this claim is indefinite, as discussed previously. Annala et al. teach, referring to Figs. 2 and 5, the ring member (2) has a surface (flat rim as seen in Fig. 5) that is perpendicular to the axis of the ring member (dotted midline in Fig. 2, top), and can be contacted by the mesh sheet (1). The holding member (3) has a surface (e.g. side) that is perpendicular to the cylindrical placement portion (see Fig. 5, bottom of the holding member (3)) that comes into contact with a surface of the ring member (2) (see Fig. 2, top and bottom). Both the ring member (1) and the holding member (3) have a through hole (see Fig. 5 – the open center of each component is a “through hole”) that passes toward a surface of the other component.
With regard to claim 12, it is noted that is claim is indefinite, as discussed previously. Annala et al. teach, referring to Figs. 2 and 5, that the holding member (3) has a top/side projection (flange that protrudes from the top side) and has a bottom projection (lip that protrudes above the cylindrical placement portion), and the ring member (2) has a projection (flange that protrudes from the side). The bottom projection (lip that protrudes above the cylindrical placement portion) of the holding member (3) is a locking projection, as it has a surface and stops movement of a surface of the ring member (2) and its attached projections.
Response to Arguments
Applicant urges that as amended, claim 3 expressly recites that at least one of the holding member and ring member includes both a locking portion that locks the components together and a through hole through which a pushing pin passes to release the lock, as illustrated in Figure 21 and paragraphs [124] and [128] of the specification. Annala’s Fig. 5 and para. 35 do not teach or suggest any through hole, mechanical pushing-pin release structure, or unlocking mechanism. Unlike the device of Annala, the claimed device permits the mesh to be released easily, even while submerged in the culture medium, allowing one-handed aseptic operation, and reducing contamination risk, while inserting a pin into the opening of Annala would damage the membrane and disturb cell culture.
Applicant’s arguments have been fully considered, but have not been found persuasive.
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., at least one of the holding member and ring member includes both a locking portion that locks the components together and a through hole through which a pushing pin passes to release the lock, as illustrated in Figure 21 and paragraphs [124] and [128] of the specification) are not recited in the rejected claim(s). 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). Fig. 21 and the cited paragraphs illustrate and discuss embodiments with components not recited in claim 3 as amended.
With regard to the limitations now presented in claim 3, as discussed in the rejection above, Annala et al. teach that the ring member (2) includes a locking portion which locks the ring member (2) and the holding member (3) to keep them from separating (Abs.; see also Fig. 5 – the inner surface of the ring member (2) functions as a locking portion to secure the bottom (cylindrical placement portion) of the holding member, thus “locking” the components together to prevent separation). Both the ring member (1) and the holding member (3) have a through hole (see Fig. 5 – the open center of each component is a “through hole”), which necessarily provides for the use of a pushing pin for pushing together and apart the ring member (1) and the holding member (3), being able to cause locking and unlocking when the device is being used. It is noted that no “pushing pin” is recited as being required to be present as a component in the device, and is only recited for use of the device.
As Annala et al. teach the device as claimed, including the structural components as claimed, the device of Annala et al. would necessarily be capable of performing the functions discussed by Applicant, absent unclaimed features.
Regarding dependent claim 7, Applicant urges that Annala does not teach or suggest the limitations of claim 7 as amended. Annala's paragraph [0015] merely describes insertion of a pipette between sidewalls of a culture insert and a well, which is fundamentally different from the claimed structure. As described in paragraphs [0100]-[0103] and shown in Figures 3-5 and Example 5 of the specification, the present invention sets the spacing so that surface tension holds the cell suspension on the mesh, preventing it from falling through even with large-area meshes. Additionally, Annala fails to teach or suggest a mesh sheet that floats from the bottom surface of the container while being fixed in both vertical and horizontal directions, nor any structure that can be reversed in the culture medium to permit observation of both surfaces of the cell sheet as taught in paragraphs [0056 and 0060].
Applicant’s arguments have been fully considered, but have not been found persuasive.
With regard to Applicant’s argument about dependent claim 7, as discussed in the rejection above, the limitation that the distance is set “so that the suspension is injected between the mesh sheet and the covering body while the suspension comes in contact with both of the mesh sheet and the covering body” is an intended use of the device as claimed. The device as taught by Annala et al., which has the structural components as claimed, would necessarily be capable of performing this use, which would depend on other factors including the amount of suspension injected between the mesh sheet and the covering body.
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., the present invention sets the spacing so that surface tension holds the cell suspension on the mesh, preventing it from falling through even with large-area meshes as described in paragraphs [0100]-[0103], Figs. 3-5, and Example 5 of the specification; and the mesh sheet floats from the bottom surface of the container while being fixed in both vertical and horizontal directions, and the structure that can be reversed in the culture medium to permit observation of both surfaces of the cell sheet as taught in paragraphs [0056 and 0060] of the specification) are not recited in the rejected claim(s). 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). The noted features are not present as structural elements required in the claimed device.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653