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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 12, 2024 have been considered and made of record.
Regarding the information disclosure statement filed on March 12, 2024, there is no requirement that applicants explain the materiality of English language references, however, is should be noted that it is desirable to avoid long lists of documents. If a long list is submitted, it is suggested to highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. In the case of lengthy documents, concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability. For further reference, see MPEP 609.04(a) III and MPEP 2004 (13).
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 18-19 and 23 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.
Claims 18 and 19 recite the limitation "a retention tab." However, it is unclear if the retention tab is referring to one of the retention tabs recited earlier in the claims or is an additional element. The rejection can be overcome by amending the claims to recite --- a retention tab of the plurality of retention tabs ---.
Claim 23 recites the limitation "about 0.04 in to about 0.5" in line 2. However, the language of the claim is such that one of ordinary skill in the art could not interpret the meets and bounds of the claim. In particular, it is not clear as to what range is covered by the limitations "about 0.04 in to about 0.5" The rejection can be overcome by deleting the term “about”.
Appropriate correction is required.
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 1-6, 10-11 and 26-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miwa et al. (already of record, US 2018/0201888).
Regarding claim 1, Miwa discloses a cell culture vessel, comprising: a vessel body comprising a bottom wall and a plurality of side walls that define a cell culture chamber (FIG. 9: vessel (70) having sidewalls (11) and bottom wall (12); [0030], [0058]), the bottom wall comprising a cell culture surface ([0058]); a baffle configured to be disposed parallel to the cell culture surface within the vessel
body, the baffle comprising: a first baffle crossbar extending across a length of the cell culture surface (see annotated FIG. 9, reproduced below; partition (75) in a lattice shape; [0058]-[0059]);
PNG
media_image1.png
388
698
media_image1.png
Greyscale
a second baffle crossbar intersecting the first baffle crossbar (FIG. 9: partition (75) in a lattice shape; [0058]-[0059]); and a third crossbar disposed at an end of the first baffle crossbar (FIG. 9: partition (75) in a lattice shape, wherein at least one partition is coupled to an end portion of another partition; [0058]-[0059]).
Regarding claim 2, Miwa further discloses wherein the second baffle crossbar is disposed perpendicular to the first baffle crossbar (see FIGS. 9-10).
Regarding claim 3, Miwa further discloses wherein the second baffle crossbar extends across a width of the cell culture surface (see FIGS. 9-10).
Regarding claim 4, Miwa further discloses wherein the third crossbar is disposed perpendicular to the first baffle crossbar (see FIGS. 9-10).
Regarding claim 5, Miwa further discloses wherein the third baffle crossbar extends
across a portion of a width of the cell culture surface (see FIGS. 9-10).
Regarding claim 6, the third baffle crossbar of Miwa is structurally the same as the instant third baffle crossbar and thus considered to function as a flow diverter.
Regarding claim 10, Miwa further discloses wherein the cell culture surface comprises a plurality of microcavities (culture surface 3; see, e.g., FIGS. 2 and 10; [0058]-[0059]).
Regarding claim 11, Miwa further discloses wherein , wherein the cell culture vessel further comprises a port disposed at one side wall of the plurality of side walls (FIGS. 2 and 9: opening at an upper end of the culture vessel; [0030]), wherein the port is configured for aspiration and media exchange (opening of the culture vessel of Miwa can be used for spiration and media exchange). Furthermore, it is noted that the recitation of functional language "e.g., or aspiration and media exchange” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed cell culture vessel and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 26, Miwa further discloses wherein the vessel body is configured to receive a liquid culture medium within the cell culture chamber ([0010]), wherein the baffle is configured to inhibit movement of the liquid culture medium across the cell culture surface (baffle of Miwa is structurally the same as the instant baffle and thus fully capable “to inhibit movement of the liquid culture medium across the cell culture surface”).
Regarding claim 27, Miwa further discloses wherein the baffle is removable (claim 9).
Therefore, Miwa meets and anticipates the limitations set forth in claims 1-6, 10-11 and 26-27.
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.
Claims 1, 5-6, 11-13, 15 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (already of record, CN 2012261785; with English machine translation) in view of Barlow et al (US 6,039,972; hereinafter “Barlow”).
Regarding claim 1, Zhu discloses a cell culture vessel, comprising: a vessel body comprising a bottom wall and a side wall that define a cell culture chamber (see FIGS. 5-6; [0032]-[0033]), the bottom wall comprising a cell culture surface (FIGS. 5-6; [0019]); a baffle configured to be disposed parallel to the cell culture surface within the vessel body (FIGS. 5-6), the baffle comprising: a first baffle crossbar extending across a length of the cell culture surface (FIGS. 5-6: partition (2)); and a third crossbar disposed at an end of the first baffle crossbar (FIGS. 5-6: partition (10)). Zhu does not explicitly disclose a second baffle crossbar intersecting the first baffle crossbar. However, Zhu does disclose in another embodiment that more than two baffles can be used within the cell culture vessel (see FIGS. 1-2). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicated the baffles of Zhu such that the cell culture baffles includes an additional baffle intersecting the first baffle as claimed, since it has been held that a mere duplication of working parts of a device involves only routine skill in the art (see MPEP § 2144.04 VI. B.). One would have been motivated to duplicate the baffle of Zhu for the purpose of providing a plurality of partitions to facilitate culturing a plurality of cell cultures separately. Zhu does not explicitly disclose wherein the vessel body comprises a plurality of side walls. Barlow discloses a cell culture vessel comprising a vessel body comprising a bottom wall and a plurality of side walls that define a cell culture chamber (see FIG. 4). In view of Barlow, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the vessel body of Zhu with the vessel body having a plurality of sidewalls of Barlow to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known cell culture vessel for another for the predictable result of culturing cells.
Regarding claim 5, modified Zhu further discloses wherein the third baffle crossbar extends
across a portion of a width of the cell culture surface (see FIGS. 5-6).
Regarding claim 6, modified Zhu further discloses wherein the third baffle crossbar is a flow diverter (see FIGS. 5-6).
Regarding claim 11, modified Zhu further discloses wherein the cell culture vessel further comprises a port disposed at one side wall of the plurality of side walls (FIG. 5: opening (6); [0032]), wherein the port is configured for aspiration and media exchange (opening of the culture vessel of modified Zhu can be used for spiration and media exchange). Furthermore, it is noted that the recitation of functional language "e.g., or aspiration and media exchange” is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed cell culture vessel and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 12, modified Zhu further discloses wherein the third baffle crossbar is arranged proximal to the port and perpendicular to fluid flow from the port (see FIGS. 5-6 of Zhu).
Regarding claim 13, modified Zhu further discloses wherein the cell culture vessel further comprises a cap or lid removable to provide access to the port (sealing plug (7); see FIGS. 5-6 and [0032] of Zhu).
Regarding claim 15, modified Zhu further discloses wherein the vessel body further comprises a top wall (see FIGS. 5-6 of Zhu), but does not explicitly disclose wherein the cell culture vessel further comprises a lid configured to releasably attach to a top portion of the sidewalls to enclose the cell culture chamber. Barlow further discloses wherein the vessel body further comprises a top wall (FIG. 4) and wherein the cell culture vessel further comprises a lid configured to releasably attach to a top portion of the sidewalls to enclose the cell culture chamber (FIG. 4: access port (13)) and a further access port through neck (6). In view of Barlow, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated an additional access port, as disclosed by Barlow, into at a top portion of the vessel body of modified Zhu to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have resulted in a vessel body having the added advantage of removing content within the vessel body separate from the inlet port, as disclosed by Barlow.
Regarding claim 26, modified Zhu further discloses wherein the vessel body is configured to receive a liquid culture medium within the cell culture chamber ([0010]), wherein the baffle is configured to inhibit movement of the liquid culture medium across the cell culture surface (baffle of modified Zhu is structurally the same as the instant baffle and thus fully capable “to inhibit movement of the liquid culture medium across the cell culture surface”).
Regarding claim 27, modified Zhu further discloses wherein the baffle is removable (baffle of modified Zhu is structurally the same as the instant third baffle crossbar and thus considered to be removable).
Claims 1-4, 6-8, 23-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Morozov (US 5,952,191).
Regarding claim 1, Morozov discloses a cell culture vessel, comprising: a vessel body comprising a bottom wall and a plurality of side walls that define a cell culture chamber, the bottom wall comprising a cell culture surface (see, e.g., FIG. 9: plate 4); a baffle configured to be disposed parallel to the cell culture surface within the vessel body, the baffle comprising: a first baffle crossbar extending across a length of the cell culture surface (FIG. 9: a plurality of dividers (6) within the cell culture vessel); and a second baffle crossbar intersecting the first baffle crossbar (FIG. 9: culture vessel include four intersecting dividers (6)); and a third crossbar (see FIG. 9: a plurality of dividers (6)). Morozov does not explicitly disclose wherein the third crossbar (one of the four intersecting dividers (6)) is disposed at an end of the first baffle crossbar. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged a crossbar of the plurality of baffle crossbars (dividers (6)) of Morozov such that the crossbar is disposed at an end of the one of the baffle crossbars, since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (see MPEP § 2144.04 VI. C.). One would have been motivated to have made said modification so as to achieve desired number of compartments at desired locations within the culture vessel.
Regarding claim 2, modified Morozov further discloses wherein the second baffle crossbar is disposed perpendicular to the first baffle crossbar (FIG. 9: intersecting dividers (6)).
Regarding claim 3, modified Morozov further discloses wherein the second baffle crossbar extends across a width of the cell culture surface (FIG. 9: intersecting dividers (6)).
Regarding claim 4, modified Morozov further discloses wherein the third crossbar is disposed perpendicular to the first baffle crossbar (FIG. 9: intersecting dividers (6)).
Regarding claim 6, the third baffle crossbar of modified Morozov is structurally the same as the instant third baffle crossbar and thus considered to function as a flow diverter.
Regarding claim 7, modified Morozov further discloses wherein the third baffle crossbar comprises shoulders on a top of the third baffle crossbar at either end of the third baffle crossbar (FIG. 9), but does not explicitly disclose wherein the shoulders are round shoulders. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shoulders of baffles of modified Morozov to comprise rounded edges to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been a matter of an engineering design choice which a person of ordinary skill in the art would have found obvious since the claimed baffle would not perform differently than the prior art device of modified Morozov.
Regarding claim 8, modified Morozov further discloses wherein the third baffle crossbar comprises feet in contact with the cell culture surface to provide a gap where the horizontal portion of the third baffle crossbar is raised away from the cell culture surface (see FIG. 9).
Regarding claim 23, modified Morozov further discloses wherein a bottom of the baffle is raised from the cell culture surface (FIG. 9 of Morozov), but does not explicitly disclose wherein the bottom of the baffle is raised about 0.04 in to about 0.5 from the cell culture surface. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the spacing between the bottom of the baffle and cell culture surface of the cell culture vessel of modified Morozov to comprise the claimed spacing to arrive at the claimed invention. One of ordinary skill in the art would have made said modification so as to achieve desired fluid communication between the compartments. Furthermore, 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. See MPEP 2144.04(IV)(A).
Regarding claim 24, modified Morozov does not explicitly disclose wherein an end of the first baffle crossbar is angled to correspond to a draft angle of a corresponding side wall of the cell culture vessel. However, modified Morozov does disclose in another embodiment that ends of the baffle correspond to an angle of a corresponding side wall of the cell culture vessel (FIGS. 8A-8B of Morozov). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the baffle of modified Morozov such that the ends of the baffle correspond to an angle of a corresponding side wall of the cell culture vessel (FIGS. 8A-8B of Morozov). One of ordinary skill in the art would have made said modification so that the ends of the baffles are flush with the walls of the culture vessel and thereby maintain desired isolation between compartments.
Regarding claim 27, modified Morozov further discloses wherein the baffle is removable (abstract).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Morozov as applied to claim 1 above, and further in view of Rainey (US 4,494,878).
Regarding claims 16-17, modified Morozov discloses the cell culture vessel according to claim 1. Modified Morozov does not explicitly disclose wherein a plurality of baffle retention areas are disposed at a top portion of side walls of the vessel, and wherein the baffle further comprises a plurality of retention tabs configured for insertion into corresponding baffle retention areas.
Rainey discloses a reaction vessel comprising a vessel body (FIG. 1: vessel (14)), baffles (11a-d) arranged within the vessel body, and a plurality of baffle retention areas are disposed at a top portion of side walls of the vessel (FIG. 1). The plurality of baffles further comprises a plurality of retention tabs configured for insertion into corresponding baffle retention areas. In view of Rainey, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vessel of modified Morozov with the vessel of Rainey to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have resulted in a culture vessel having the added advantage of ease of removal of the baffles from the cell culture vessel.
Allowable Subject Matter
Claims 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
Prosecution Insights