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 .
Claim Status
Claims 1-20 are pending.
Claims 13-20 are withdrawn.
Claims 1-12 are under examination.
It is noted that the Examiner of record has changed.
Election/Restrictions
Applicant’s election with traverse of the following invention
Invention
Invention I , claims 1-12 drawn to a method of biomanufacturing organoids by disposing a cellular starting material in a bioreactor and continuously exposing the cellular starting material to mechanical stress,
in the reply filed on 12th, August, 2026 is acknowledged.
Applicant’s traversal is on the grounds that “the Office Action has not shown that a serious burden would be required to examine all of the claims.”
In response, the Examiner asserts that the claims are still properly restricted for the reasons below.
First, Inventions I-II encompass different classifications as set forth in the previous Restriction requirement, and therefore would require different search queries.
Additionally, serious search and examination burden applies to all aspects of examination. Applicant is directed MPEP 803 (II) which states that for purposes of the initial requirement, a serious search burden on the examiner may be prima facie shown by appropriate explanation of separate classification, or separate status in the art, or a different field of search as defined in MPEP § 808.02. Similarly, a serious examination burden, for example, may be prima facie shown by appropriate explanation of non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) relevant to one invention that are not relevant to the other invention. In the instant case, the method of Invention I requires consideration under 35 U.S.C. 112(a) for non-prior art issues that are not relevant to the product of Invention II and the product of Inventions II requires consideration under 35 U.S.C. 101 for non-prior-art issues that are not relevant to the method of Invention I.
Therefore, the Inventions pose a serious search and examination burden as defined in MPEP § 808 under proper 35 U.S.C. 121 restriction practice
The requirement is still deemed proper and is therefore made FINAL.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Objections to Drawings
Color photographs and color drawings
Color drawings have been noted in this Application, with no granted petition under 37 CFR 1.84(a)(2).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-5, 7 and 11 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 2 and 4 each recites “critical size,” with no corresponding definition of “critical size.”
Similarly, claims 3 and 5 each recite the phrase “critical threshold size” with no corresponding definition.
Therefore the scope of the claims 2-5 is unclear. A claim may be rendered indefinite by reference to subjective phrase (see MPEP 2173.05(b), IV). Specifically, the phrases are subjective phrases which renders the claim indefinite. The phrases "critical size” and “critical threshold size” are not defined by the claim, the specification does not provide a standard for some standard for measuring the scope of the phrase, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention
Claims 3 and 5 also are indefinite because they each recite “critical threshold size” together with “critical size” and it is unclear whether the recited limitation of “the spheroid critical size is from about 100 μm to about 600 μm” is intended to refer back to the previously recited “critical threshold size” or the previously recited “critical size.”
Claim 7 recites “mechanical mixing” which appears to attempt to refer back to claim 1, upon which claim 7 depends. However, while claim 1 recites “mechanical stress,” it does not previously recite “mechanical mixing” and therefore the metes and bounds of scope of this phrase is unclear as it is unclear how “mechanical mixing” is incorporated into the method of claim 1 or the method of claim 7, and there is improper antecedent basis for the phrase.
Claim 11 recites the relative term “healthy.” A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). In the instant case the term “healthy” is dependent on what is unhealthy which is not sufficiently defined (see MPEP 2173.05(b)).
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 7-8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Schulz et al. (US-20190093076-A1; henceforth “Schulz”).
Regarding claim 1, Schulz discloses a method of biomanufacturing organoids comprising:
a) disposing a cellular starting material (hES or hESC “dissociates human ES cells to single cells then creates aggregates by rotational culture at shear rates optimized for improve control of aggregate diameter and cell survival” para. [0120]; Examples 17-18); see in a bioreactor (para. [0070, 0086, 0089, 0091, 0187, 0274, 0325, 0333, 0347]; see in particular para. [0191, 0349]); and
b) continuously exposing the cellular starting material to mechanical stress (“rotational culture at shear rates” para. [0120]; see in particular Examples 17-18 and Table 6).
Regarding the preamble of claim 1, the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). In the instant case, because Schulz discloses the active method steps of structurally complete invention in the claim body, Schulz anticipates instant claims. Furthermore, a disclosed embodiment includes further differentiation of the ES aggregates (“directly differentiates the ES cell aggregates to definitive endoderm then foregut endoderm, then pre-pancreatic foregut endoderm, then pancreatic endoderm and finally pancreatic endocrine cells” para. [0120]; see also Example 18 “Differentiate to Endoderm-Lineage Type Cells”). The clusters of differentiated cells disclosed as an embodiment of the method fall under the broadest reasonable interpretation of “organoid” of instant claims and therefore because the method comprises forming organoids, it also falls under the broadest reasonable interpretation of “a method of biomanufacturing organoids” as claimed.
Regarding claim 7, further to the discussion of claim 1 above, Schulz discloses the mechanical stress, which includes mechanical mixing, comprises shear stress and agitation, wherein the shear stress is 0.158 or 0.116 Pascals (disclosed as 1.58 or 1.16 dynes/cm2 with 1 Pascal is equivalent to 10 dyne/cm2; Table 6), and wherein a rate of agitation in the bioreactor is 120 rpm (see specific embodiments of Rotation rate (rpm) disclosed in Table 6 for Example 17) (see in particular Example 17; Table 6; para. [0259-0267]; see also Example 18).
Regarding claim 8, further to the discussion of claim 1 above, Schulz discloses the starting material comprises (hES or hESC) or is derived from (cells derived from hESCs) human stem cells (para. [0007, 0015, 0038-0039, 0041-0042, 0044-0046, 0063, 0076, 0103, 0108, 0115-0117, 0119, 0136, 0147, 0180, 0189-0190, 0337]; Table 1; Examples 5, 15-18, 20, 25 27).
Accordingly, Schulz anticipates instant claims.
Claims 1-5, 8-9 and 11-12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lippman et al. (US-20220364061-A1; henceforth “Lippman”).
Regarding claim 1, Lippman discloses a method of biomanufacturing organoids (“Brain organoids”; para. [0003, 0092, 0095-0097, 0099) comprising:
disposing a cellular starting material (neuroectoderm; Figure 18A), in a bioreactor (“bioreactor system” or “Spin Ω”; abstract; Figure 18A; para. [0004-0009, 0013, 0015, 0022, 0025, 0032-0036, 0042, 0044, 0051-0053, 0058-0059, 0061-0062, 0065-0066, 0068, 0070, 0082-0083, 0087, 0092-0093, 0098-0100]; claims 1-13 and 17-19); and
b) continuously exposing the cellular starting material to mechanical stress (“Organoid growth under continuous agitation” Figure 18A).
Regarding claim 2, further to the discussion of claim 1 above, Lippman discloses the cellular starting material is precursor cells (neuroectoderm; Figure 18A), and the method further includes inducing spheroid formation from precursor cells until a critical size (“organoid growth under continuous agitation”; Figure 18A).
Regarding claim 3, further to the discussion of claims 1-2 above, Lippman disclose the spheroid size at day 10 (see Figure 18B Day 10) is about 500 µm, grows to about 1000 µm by day 14 (Figure 18B Day 14) and therefore the method includes inducing spheroid formation from precursor cells until a critical size of between about 500 µm and about 600 µm because this inherently occurs between days 10 and 14 as disclosed by Lippman, Lippman’s disclosed method meets instant claims. Note that the transitional phrase of “includes” is interpreted as open-ended and therefore culturing after the spheroid has reached a critical size in the range is not excluded by instant claims.
Regarding claim 3, concerning the wherein clause that “wherein the spheroid reaches critical threshold size when the spheroid exhibits self-differentiation” this recites a contingent limitation and does not recite an active method step. Applicant is directed to MPEP 2111.05 (II) which states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. Therefore, in the instant case, because reaching the critical threshold size need not occur, the requirements of claim 3 are met by Lippman for the reasons set forth above.
Regarding claims 4-5, further to the discussion of claim 1 above, Lippman discloses the starting material is spheroids which are about 500 µm at day 10 (see Figures 18A-18B) which falls under the broadest reasonable interpretation of a critical size.
Regarding claim 5, concerning the wherein clause that “wherein the spheroid reaches critical threshold size when the spheroid exhibits self-differentiation” this recites a contingent limitation and does not recite an active method step. Applicant is directed to MPEP 2111.05 (II) which states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. Therefore, in the instant case, because reaching the critical threshold size need not occur, the requirements of claim 5 are met by Lippman for the reasons set forth above.
Regarding claim 8, further to the discussion of claim 1 above, Lippman discloses the starting material (neuroectoderm) is derived from embryoid bodies (Figure 18A) which are stem cells and Lippman discloses they can be human (para. [0003, 0032, 0094, 0098]).
Regarding claim 9, further to the discussion of claim 1 above, Lippman discloses the cellular starting material comprises neural progenitor cells (neuroectoderm; Figure 18A).
Regarding claim 11, further to the discussion of claim 1 above, the organoids disclosed by Lippman are made from cells that are not diseased and can be used to model development (“tool to model development” para. [0003]) and therefore these organoids fall under the broadest reasonable interpretation of the claimed “healthy neural organoids.”
Regarding claim 12, further to the discussion of claim 1 above, Lippman discloses the organoids are about 1 mm ( Figure 18A day 14) or about 1.5 mm (see Figure 18B day 28) (see also Figures 19C, 20A-C, 21A-C, 22A-B and 23A-B which disclose organoids and scalebars for size).
Accordingly, Lippman anticipates instant claims.
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Massai et al. (PLoS One. 2016 May 4;11(5):e0154610. eCollection 2016.; henceforth “Massai”).
Regarding claim 1, Massai discloses a method of biomanufacturing organoids (“Calu-3 cells forming the spheroids”; “in vitro culture outcome” Materials and Methods pg. 9-10; see also spheroids in Figure 5) comprising:
a) disposing a cellular starting material (Non-Small Cell Lung Cancer (NSCLC) cell line Calu-3; “In vitro cell culture” Materials and Methods pg. 5-6) in a bioreactor (“dynamic suspension bioreactor” Materials and Methods pg. 3-4); and
b) continuously exposing the cellular starting material to mechanical stress (“tunable shear
stress conditions” abstract; see also (“dynamic suspension bioreactor” Materials and Methods pg. 3-4).
Regarding claims 8-9, further to the discussion of claim 1 above, Massai discloses the cellular starting material is Calu-3 cells (Non-Small Cell Lung Cancer (NSCLC) cell line Calu-3; “In vitro cell culture” Materials and Methods pg. 5-6), which are human lung cancer cell line. The claimed limitation of “is derived from” is product by process language with respect to the human stem cells. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113). Therefore, because the Calu-3 cells of Massai are capable of being derived from human stem cells (instant claim 8), or cancer stem cells (instant claim 9) they meet the structural requirements of instant claims.
Accordingly, Massai anticipates instant claims.
Claims 1, 4-5 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barisam et al. (Micromachines (Basel). 2018 Feb 25;9(3):94.; see IDS filed 22nd, January, 2025; henceforth “Barisam”).
Regarding claim 1, Barisam discloses a method of biomanufacturing organoids (“(3D) multicellular spheroid” abstract) comprising:
a) disposing a cellular starting material(“3D cell aggregates”) in a bioreactor (“Microbioreactors” abstract); and
b) continuously exposing the cellular starting material to mechanical stress (flow rate and sheer stress; abstract).
Regarding the preamble of claim 1, preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). In the instant case, because Barisam discloses the active method steps of structurally complete invention in the claim body, Barisam anticipates instant claims. Furthermore, Barisam discloses formation of (3D) multicellular spheroids (abstract) or tumor aggregates (Figure 3) which fall under the broadest reasonable interpretation of an “organoid” and therefore because the method comprises forming organoids, it also falls under the broadest reasonable interpretation of “a method of biomanufacturing organoids” as claimed.
Regarding claim 4, further to the discussion of claim 1 above, Barisam discloses the starting material is 3D cell aggregates (abstract), which have a size which falls under the broadest reasonable interpretation of a “critical size”.
Regarding claim 5, further to the discussion of claims 1 and 4 above, Barisam discloses the spheroid size (diameter) is 200, 300, 400, or 500 µm (Figure 4).
Regarding claim 5, concerning the wherein clause that “wherein the spheroid reaches critical threshold size when the spheroid exhibits self-differentiation” this recites a contingent limitation and does not recite an active method step. Applicant is directed to MPEP 2111.05 (II) which states that the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. Therefore, in the instant case, because reaching the critical threshold size need not occur, the requirements of claim 5 are anticipated by Barisam for the reasons set forth above.
Regarding claim 12, further to the discussion of claim 1 above, Barisam discloses the organoids (spheroids or tumor aggregates) have a diameter of 500 µm (abstract and Figure 4).
Accordingly, Barisam anticipates instant claims.
Claims 1, 4 and 8-11 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Kim et al. (US-20150368619-A1; henceforth “Kim”).
Regarding claim 1, Kim discloses a method comprising:
a) disposing a cellular starting material (Tumor Spheroids) in a bioreactor; and
b) continuously exposing the cellular starting material to mechanical stress (“region of defined shear stress” see in particular Figure 3).
Regarding the preamble of claim 1, Kim discloses the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). In the instant case, because Kim discloses the active method steps of structurally complete invention in the claim body, Kim anticipates instant claims. Furthermore, an embodiment of Kim includes organoid formation (see Sphere Formation; Figure 1), and therefore because the method comprises forming organoids, that specific disclosed embodiment also falls under the broadest reasonable interpretation of “a method of biomanufacturing organoids” as claimed.
Regarding claim 4, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above) Kim discloses the starting material is Tumor Spheroids (see also “spheres” and “aggregate spheres” Figures 1 and 3; para. [0006-0008, 0012, 0017, 0020, 0022, 0024, 0029-0036, 0038-0039, 0041, 0044, 0046, 0050]; claims 1 and 18). The spheroids of Kim have a size which falls under the broadest reasonable interpretation of a critical size because they are “grown to a critical sphere diameter” (para. [0005])
Regarding claims 8-9, further to the discussion of claim 1 above, Kim discloses the cellular starting material is derived from human stem cells (instant claim 8; see “Removal of brain tumor”; Figure 1) or cancer stem cells including human cancer stem cells (malignant CSCs; “both therapeutic stem cells and malignant CSCs (collectively referred to henceforth as “stem cells”)” para. [0005]) (instant claim 9).
Regarding claims 10-11, further to the discussion of claims 1 and 9 above, Kim discloses the cellular starting material is derived from glioblastoma stem cells (U87 (glioblastoma) Figure 9 which is derived from a brain tumor and made into an organoid) (instant claim 10), and therefore the organoids would comprise glioblastoma organoids (instant claim 11).
Accordingly, Kim anticipates instant claims.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Schulz et al. (US-20190093076-A1; henceforth “Schulz”).
The teachings of Schulz above are incorporated herein in their entirety.
Regarding claim 6, further to the discussion of claim 1 above, while Schulz teaches Reynolds number (para. [0072-0073]), Schulz does not disclose the specific Reynolds number for the disclosed condition
Nevertheless, regarding claim 6, Schulz teaches the disclosed the rotations speeds are under laminar flow conditions (para. [0261]), and Schulz teaches that laminar flow dominates when Reynold’s number (Re) is less than 2300 (para. [0072]). Schulz teaches that Reynold’s number the Reynold's numbers related to fluid velocity and thus the degree to which fluid flow is laminar or turbulent is directly proportional to the shear rate and shear stress experienced by cells in suspension (para. [0072]) Schulz further teaches high shear stress can cause cell lysis (para. [0072]) or death (para. [0091]), and can have a negative effect on the scale-up of cell culture-based manufacturing systems (para. [0072]). Schultz teaches means of creating fluid movement in a manner that is non-turbulent, yet generates sufficient low shear force to promote cell collision and allow the cells to adhere to each other and form the cell aggregate (para. [0084]; see also para. [0088]). Schulz teaches optimizing shear rates to improve control of aggregate diameter and cell survival (para. [0119]).
Therefore, regarding claim 6, because the disclosed rotation speeds of Schulz are under laminar flow conditions (para. [0261]), it would be obvious and expected for the disclosed conditions to have a Reynold’s number (Re) of less than 2300 (para. [0072]), which overlaps with the instantly claimed range of “about 600 to about 2200,” and thereby makes it obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See M.P.E.P. §2144.05.
Finally, regarding claim 6, applicant is reminded that generally, differences in amounts will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such amount is critical (MPEP 2144.05 II). Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been motivated by routine practice to optimize the shear force to improve control of aggregate diameter and cell survival (para. [0119]) as taught by Schulz to reduce sufficient low shear force to promote cell collision and allow the cells to adhere to each other and form the cell aggregate (para. [0084]), which would also optimize the Reynold’s number, with a reasonable expectation of success (see Examples 17-18).
Hence, the claimed invention as a whole was prima facie obvious.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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