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
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on 04/10/2026 is acknowledged.
Claims 16-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/10/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “joining complementary bodies comprising hemispherical volumes” whereas each of claims 3, 4, and 5, which depend on claim 2, recite “the two complementary bodies”. Explicit antecedent basis for two complementary bodies is not present, although this is understood to be necessarily encompassed by hemispherical volumes that are joined to form a sphere. It is recommended to amend claim 2 to recite “joining two complementary bodies comprising hemispherical volumes” to match the style of claims 3, 4, and 5.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
elements for flowing material into and out of the inner volume of the tissue culture vessel in claim 8;
elements for flowing culture medium through the conduit in claim 9; and
mechanical components configured to rotate such that the tissue culture vessel inner volume experiences a state of reduced gravity or weightlessness in claim 14.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 11-13 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 11 recites “wherein the conduit is functionalized with bioactive molecules”. Claim 11 depends on claim 9, which recites “a conduit traversing the inner volume of the vessel”, and claim 9 further depends on claim 1, which recites “a conduit.”. Therefore, claim 11 is ambiguous at it could be referring back to either the “conduit traversing” of claim 9 or the “conduit” of claim 1; it is not immediately clear that the conduits discussed in each of claims 1 and 9 are the same element. Therefore, there is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the central conduit" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 13 depends, recites a conduit but does not provide antecedent basis support for a “central” conduit. For the purpose of examination on the merits, the Examiner will interpret claim 13 as referring to the conduit set forth in claim 1.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
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, 7-9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al. (US Patent 6,642,019) (already of record).
Regarding claim 1, Anderson et al. discloses a tissue culture system (Abstract), comprising:
a spherical tissue culture vessel (Abstract, col. 5 lines 65-67), comprising:
an inner volume having “substantially spherical” geometry lacking corners, edges, flat planes, and protrusions (Abstract, col. 2 lines 24-44, col. 8 lines 1-5) (Fig. 6, sheet 4 of 16); and
two or more ports accessing the inner volume (col. 8 lines 19-38) (Fig. 6, sheet 4 of 16), wherein the two or more ports comprises a first port and a second port (col. 8 lines 19-38) (Fig. 6, sheet 4 of 16), and wherein the first port and the second port are configured to receive opposing ends of a conduit (filter 36 reads on such a conduit as it comprises opposing ends received in each of first and second ports 18, see col. 6 lines 18-21 and Fig. 6, sheet 4 of 16; specifically, fluid is configured to enter the filter from one opposing end and flow out through another opposing end, see col. 2 lines 8-23, col. 3 lines 53-57, col. 4 lines 35-40, and Fig. 6, sheet 4 of 16; thus it reads on a conduit).
Regarding claim 7, Anderson et al. discloses wherein the tissue culture vessel comprises one or more ancillary ports (16) accessing the inner volume therein (col. 9 lines 38-44) (Fig. 6, sheet 4 of 16).
Regarding claim 8, Anderson et al. discloses wherein the one or more ancillary ports accessing the inner volume of the tissue culture vessel comprise at least one input port and at least one output port in connection with valves for flowing material into and out of the inner volume (reads on the claimed elements for flowing material into and out of the inner volume of the tissue culture vessel, consistent with Applicant’s specification at para. 56) (col. 9 lines 38-44) (Fig. 6, sheet 4 of 16).
Regarding claim 9, Anderson et al. discloses the tissue culture system further comprises:
a conduit traversing the inner volume of the vessel (filter 36 reads on a conduit, as set forth above, and traverses the inner volume, see Fig. 6, sheet 4 of 16);
wherein the conduit comprises a tubular body (Fig. 6, sheet 4 of 16) comprising a biocompatible material (the filter is fabricated from cloth, metal or plastic, see col. 9 lines 15-17, and the material is clearly biocompatible as cells or tissue are grown therein, see Abstract);
wherein the conduit further comprises an inner lumen (Abstract) (Fig. 6, sheet 4 of 16); and
wherein ends of the conduit are in connection with a source of liquid medium and elements including a pump and valve for flowing culture medium through the conduit (reads on the claimed elements for flowing culture medium through the conduit, consistent with Applicant’s specification at para. 56) (col. 2 lines 8-23, col. 3 lines 53-60, col. 4 lines 35-40, col. 8 lines 39-62).
Regarding claim 13, the entirety of the claim is understood to be directed to a further limitation of the conduit of claim 1. However, claim 13 and claim 1 from which it depends do not positively recite that the system comprises the conduit. Therefore, claim 13 is directed to an intended use of the claimed system. The system disclosed by Anderson et al. would be fully capable of achieving the intended use of wherein the conduit comprises a cellular scaffold (e.g., the conduit disclosed by Anderson et al., which is disclosed to fabricated from cloth, metal or plastic, see col. 9 lines 15-17, would be fully capable of serving as a scaffold for adherent cells).
Claims 1-2, 4-5, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Poo et al. (US Patent Application Publication 2006/0121437).
Regarding claim 1, Poo et al. discloses a tissue preservation system (Abstract), comprising:
a spherical tissue preservation vessel (para. 10, 43) (Figs. 12-15, sheets 8-9 of 12), comprising:
an inner volume having “substantially spherical” geometry (para. 10, 43) lacking corners, edges, flat planes, and protrusions (Figs. 14-15, sheet 9 of 12); and
two or more ports (136, 138) accessing the inner volume (para. 42), wherein the two or more ports comprise a first port and a second port (para. 42), and wherein the first port and the second port are configured to receive opposing ends of a conduit (note: this is a recitation of intended use and has therefore been given appropriate patentable weight; each of the ports 136 and 138 is disclosed to be capable of fitting to a conduit, see para. 36 and 42, and would be fully capable of attaching to and receiving opposing end of a same conduit of sufficient length).
Poo et al. does not expressly teach that the vessel and system are for tissue culture. However, the limitation of the system being a culture system is a recitation of intended use and has therefore been given appropriate patentable weight. The tissue vessel disclosed by Poo et al. is configured to receive therein a tissue comprising cells and deliver a preservation solution thereto (para. 1-6) and thus the vessel is fully capable of being used as a culture vessel (e.g., a user could culture cells by delivering nutrient medium to cells in the vessel), and therefore the noted limitation does not introduce a patentable distinction over the prior art.
Regarding claim 2, Poo et al. discloses wherein the spherical inner volume of the vessel is formed by joining complementary bodies (124, 128) comprising hemispherical volumes (para. 42) (Figs. 12-15, sheets 8-9 of 12).
Regarding claim 4, Poo et al. discloses wherein each of the two complementary bodies forming the spherical inner volume of the tissue culture vessel comprise a hemispherical demiorb (see Fig. 14, each body has the form of a hollow half-orb shell).
Regarding claim 5, Poo et al. discloses two complementary bodies comprising hemispherical volumes forming the spherical inner volume of the tissue culture vessel, as set forth in the rejection of claim 2, above. As to the limitation of wherein each of the two bodies is mounted in a support block, this is a recitation of intended use of the bodies as the claim does not positively recite that the tissue culture system comprises a support block. The two complementary bodies disclosed by Poo et al. would be structurally capable of being mounted in a support block and therefore fulfill the claim limitation.
Regarding claim 13, the entirety of the claim is understood to be directed to a further limitation of the conduit of claim 1. However, claim 13 and claim 1 from which it depends do not positively recite that the system comprises the conduit. Therefore, claim 13 is directed to an intended use of the claimed system. The system disclosed by Poo et al. would be fully capable of receiving a conduit as set forth in the rejection of claim 1, above, and would be structurally capable of receiving a central conduit comprising a cellular scaffold, as the vessel disclosed by Poo et al. is appropriately dimensioned to do so.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Poo et al. (US Patent Application Publication 2006/0121437) in view of Lichtenberg et al. (US Patent Application Publication 2021/0245945).
Regarding claim 3, Poo et al. discloses two complementary bodies comprising hemispherical volumes forming the spherical inner volume of the tissue culture vessel, as set forth in the rejection of claim 2, above.
Poo et al. is silent as to wherein each of the two complementary bodies comprises a block of material having a hemispherical depression therein; rather Poo et al. discloses wherein each complementary body is in the form of a hemispherical shell (e.g., see Fig. 14, sheet 9 of 12).
Lichtenberg et al. discloses a tissue culture system (Abstract, para. 101-106) comprising a vessel including a spherical inner volume (Abstract, para. 42, 85) (Fig. 3A, sheet 5 of 10), wherein the spherical inner volume is formed by joining two complementary bodies comprising hemispherical volumes (11A, 11B) (Fig. 3A, sheet 5 of 10), each complementary body comprising a block of material having a hemispherical depression therein (para. 17, 22) (Figs. 2A and 3A, sheets 2 and 5 of 10).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the two complementary bodies disclosed by Poo et al. such that each comprises a block of material having a hemispherical depression therein, as such a modification represents simple substitution of one known element for another, in this case, substitution of a block body for a shell body in order to arrive at two complementary bodies comprising hemispherical portions configured to join so as to form a spherical inner volume.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent 66,42,019) in view of Woodard et al. (US Patent Application Publication 2016/0113269).
Regarding claim 6, Anderson et al. discloses the tissue culture vessel, as set forth above.
Anderson et al. is silent as to the vessel comprising a transparent material.
Woodard et al. discloses that it was known in the art to form a tissue vessel from a transparent material to allow a user to observe a tissue without the need to remove it from the vessel to maintain sterility (para. 73, 90).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the vessel disclosed by Anderson et al. to comprise a transparent material, based on the teachings of Woodard et al., to allow a user to observe a tissue without compromising sterility.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Poo et al. (US Patent Application Publication 2006/0121437) in view of Woodard et al. (US Patent Application Publication 2016/0113269).
Regarding claim 6, Poo et al. discloses the tissue culture vessel, as set forth above.
Poo et al. is silent as to the vessel comprising a transparent material.
Woodard et al. discloses that it was known in the art to form a tissue vessel from a transparent material to allow a user to observe a tissue without the need to remove it from the vessel to maintain sterility (para. 73, 90).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the vessel disclosed by Poo et al. to comprise a transparent material, based on the teachings of Woodard et al., to allow a user to observe a tissue without compromising sterility.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Poo et al. (US Patent Application Publication 2006/0121437).
Regarding claim 7, Poo et al. discloses wherein the vessel comprises ports accessing the inner volume thereof (mapped to the claimed two or more ports in the rejection of claim 1, above). Poo et al. further discloses wherein the ports comprise at least one input port and one output port in connection with fittings for flowing material into and out of the inner volume (para. 36, 42).
Poo et al. is silent as to one or more ancillary ports accessing the inner volume, in addition to the ports discussed above.
Nonetheless, it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04). Modifying the vessel disclosed by Poo et al. to comprise one or more ancillary ports accessing the inner volume of the vessel would require mere duplication of the ports already disclosed by Poo et al., e.g., providing multiple of each of the input port and one output port in connection with fittings for flowing material into and out of the inner volume, which would yield the predictable and advantageous outcome of allowing additional fluid to be flowed through the vessel.
Regarding claim 8, Poo et al. teaches the one or more ancillary ports, wherein the one or more ancillary ports comprise at least one input port and one output port in connection with fittings for flowing material into and out of the inner volume of the vessel (reads on the claimed elements for flowing material into and out of the inner volume of the tissue culture vessel), as set forth in the rejection of claim 7, above.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent 66,42,019) in view of Reid et al. (US Patent Application Publication 2004/0152149).
Regarding claim 10, Anderson et al. discloses wherein the conduit comprises a cloth (reads on a textile), as set forth in the rejection of claim 9, above.
Anderson et al. does not expressly teach a medical textile.
Reid et al. discloses that it was known in the art to use a medical textile as a material when culturing cells to study tissue-specific behavior owing to the high biocompatibility of this material (Abstract, para. 25-28).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the textile disclosed by Anderson et al. to comprise a medical textile, based on the teachings of Reid et al., in order to use a highly biocompatible material to ensure continued tissue growth.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent 66,42,019) in view of Teoh et al. (US Patent Application Publication 2021/0277348) and in further view of Zhang et al. (Dual-delivery of VEGF and PDGF by double-layered electrospun membranes for blood vessel regeneration).
Regarding claim 11, Anderson et al. discloses the tissue culture system comprising a conduit traversing the inner volume of the vessel, as set forth in the rejection of claim 9, above. Anderson et al. further discloses wherein the conduit (called filter) is configured to retain tissue within the vessel wherein the vessel rotates (Abstract).
Anderson et al. is silent as to wherein the conduit is functionalized with biomolecules.
Teoh et al. discloses a tissue culture system (Abstract) comprising a spherical vessel configured to rotate (para. 56-57), the vessel comprising hollow tube scaffold (reads on a tubular body conduit) traversing the inner volume thereof (para. 42) (Fig. 2, sheet 2 of 12), wherein the scaffold is configured to retain cells for formation of tissue (para. 2, 42). The scaffold provides added functionality such as nutrient distribution and the possibility of applying tissue stimulus (para. 2, 6).
Zhang et al. discloses that it was known in the art to generate engineered tissue on a scaffold functionalized with bioactive substances to guide tissue formation (p. 2202 col. 1 para. 1-col. 2 para. 1). Zhang et al. further discloses that vascular grafts have wide application in clinical procedures (p. 2202 col. 2 para. 2) and to this end, Zhang et al. discloses use of a tubular scaffold functionalized with vascular endothelial growth factor (VEGF) for improved vascular tissue formation (Abstract, p. 2203 col. 2 para. 1-p. 2204 col. 1 para. 3).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the conduit disclosed by Anderson et al. to comprise a scaffold, based on the teachings of Teoh et al., in order to achieve the goal of retaining tissue while the vessel rotates while allowing for nutrient distribution and the possibility of applying tissue, and further, it would have been obvious to use a scaffold functionalized with VEGF (reads on bioactive molecules), based on the teachings of Zhang et al., in order to provide a structure configured to improve formation of clinically valuable vascular grafts.
Regarding claim 12, Anderson et al. in view of Teoh et al. and in further view of Zhang et al. teaches wherein the bioactive molecules comprise VEGF (reads on angiogenic agents, consistent with Applicant’s specification at para. 47).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent 66,42,019) in view of Navran (US Patent Application Publication 2011/0136226).
Regarding claim 14, Anderson et al. discloses wherein the system further comprises means for rotating the tissue culture vessel such as a drive motor or the like (col. 8 lines 29-38) wherein the rotational rate is controlled to “balance the gravitational forces” within the inner volume (col. 12 lines 49-66). Anderson et al. further discloses wherein it is desirable to prevent shear damage to cells (col. 2 lines 24-44).
Anderson et al. does not expressly teach mechanical components configured to rotate such that the tissue culture vessel inner volume experiences a state of reduced gravity or weightlessness.
Navran discloses a culture system comprising a rotating culture chamber (Abstract), the system further comprising a clinostat configured to rotate such that the culture chamber inner volume experiences a state of microgravity (reads on reduced gravity) wherein cells are maintained “at very low shear stress (0.8 dynes/cm2) with high diffusion rates of oxygen, nutrients and waste” (para. 37).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the system disclosed by Anderson et al. to comprise a clinostat configured to rotate such that the tissue culture vessel inner volume experiences a state of reduced gravity (reads on the claimed mechanical components configured to rotate such that the tissue culture vessel inner volume experiences a state of reduced gravity or weightlessness, consistent with Applicant’s specification at para. 76), based on the teachings of Navran, as the skilled artisan would have been motivated to provide a rotation means recognized in the art to minimize shear damage.
Regarding claim 15, Anderson et al. in view of Navran teaches wherein the mechanical components comprise a clinostat, as set forth above.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yazdan et al. (US Patent Application Publication 2021/0261897) is directed to rotating culture vessel with a spherical inner volume.
Funamoto et al. (WO 2009130845 A1) (machine translation) is directed to a culture system comprising a rotating means for rotating a culture vessel such that the inner volume thereof experiences microgravity, wherein the vessel can include therein a tubular scaffold for blood vessels.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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