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 statement (IDS) submitted on 07/11/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. Specifically, the current title is “MIDSCALE MODEL FOR ORGANIC GROWTH AND PHASING”; however, the claims are directed to a system for buffer distribution, and make no mention of a midscale model for organic growth and phasing.
This application contains numerous trade names or marks used in commerce (e.g., “BOTOX” and others in [0123], “HUMIRA” in [0124], and others). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 36 is objected to because of the following informalities:
It is believed claim 36 should read “The system of claim 33…”.
Appropriate correction is required.
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 26-27 and 29-32 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 26 recites the limitation "the buffer mixture output from the first buffer dilution device" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the input (i) of any buffer dilution device downstream of the first buffer dilution device" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
The term “about” in claim 27 is a relative term which renders the claim indefinite. The term “about” 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. Specifically, the specification does not provide any guidance as to which value ranges would meet the limitation of “about the same concentration.”
Claim 29 recites the limitation "the buffer mixture distribution manifold" in line 1. There is insufficient antecedent basis for this limitation in the claim. Specifically, claim 25, from which claim 29 depends, contains multiple recitations of a buffer mixture distribution manifold (“a buffer mixture distribution manifold” in line 6 and “at least one buffer mixture distribution manifold” in line 7) and it is unclear which one claim 29 is referring to.
Claim 30 recites the limitation "the buffer mixture distribution manifold" and is rejected for the same rationale applied to claim 29, above.
Claim 31 recites the limitation "the buffer mixture distribution manifold" and is rejected for the same rationale applied to claim 29, above.
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 25-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayme et al. (Continuous, high capacity reconstitution of nutrient media from concentrated intermediates).
Regarding claim 25, Jayme et al. discloses a system for buffer distribution (Abstract, p. 260 col. 2) comprising:
at least one buffer dilution device (called “concentrate formulation”) which accepts at least two inputs (i) and (ii) (p. 257 col. 2) (Fig. 2, p. 256),
wherein (i) is a buffer concentrate source stream and (ii) is a sterile water for injection source stream (p. 257 col. 2) (Fig. 2, p. 256); and
at least one buffer dilution device (called concentrate mixing skid) (p. 258 col. 1) (Fig. 1, p. 256; Fig. 7, p. 259).
As to the limitation of which delivers a buffer mixture comprising (i) and (ii) to a buffer mixture distribution manifold, this is a recitation of intended use of the claimed system, as the claim does not positively recite that the system comprises a buffer mixture distribution manifold wherein the at least one buffer dilution device delivers a buffer mixture comprising (i) and (ii) to the buffer mixture distribution manifold. Nonetheless, Jayme et al. discloses wherein at least one buffer dilution device (called concentrate mixing skid) delivers a buffer mixture comprising the first input and the second input to a buffer distribution manifold (p. 258 col. 1) (Fig. 1, p. 256; Fig. 7, p. 259).
As to the limitation of wherein at least one buffer mixture distribution manifold may be used to control parameters of the buffer mixture delivered to each of a plurality of destinations independently, the parameters including at least one of the following: flow rate or concentration, this limitation does not introduce a patentable distinction over the prior art, because the “at least one buffer mixture distribution manifold” is not a positively recited structural element of the claimed system, and because the ”may be used” phrasing is interpreted as meaning that the limitation is optional.
As to the limitation of wherein the buffer mixture is not stored before delivery to any of the plurality of destinations, this is a recitation of intended use of the claimed system. The system disclosed by Jayme et al. is fully capable of operating such that a buffer mixture is immediately delivered to a plurality of destinations (i.e., not stored before delivery) (see Figs. 1 and 7).
Regarding claim 26, Jayme et al. discloses wherein the system comprises:
a first buffer dilution device (called “concentrate formulation”) (p. 257 col. 2) (Fig. 2, p. 256).
As to the limitation wherein the buffer mixture output from the first buffer dilution device is delivered to at least one downstream buffer dilution device as input (i), this is a recitation of intended use of the claimed first buffer dilution device, as the claim does not positively recite that the system comprises “at least one downstream buffer dilution device”. Nonetheless, Jayme et al. discloses wherein a buffer mixture output from the first buffer dilution device is delivered to at least one downstream buffer dilution device (called concentrate mixing skid) (p. 258 col. 1) as input (i) (a buffer concentrate source stream) (Fig. 1, p. 256).
As to the limitation wherein the input (i) of any buffer dilution device downstream of the first buffer dilution device may be partially diverted to another buffer dilution device or to at least one buffer mixture distribution manifold, this limitation does not introduce a patentable distinction over the prior art, as the claim does not positively recite that the system comprises any buffer dilution device downstream of the first buffer dilution device, and the “may be” phrasing in interpreted as meaning that the function is optional.
As to the limitation wherein at least two buffer mixture distribution manifolds distribute buffer of a different concentration, this limitation does not introduce a patentable distinction over the prior art, as the claim does not positively recite that the system comprises at least two buffer mixture distribution manifolds.
Regarding claim 27, the limitation wherein at least two buffer dilution devices deliver buffer of about the same concentration to at least one buffer mixture distribution manifold does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises at least two buffer dilution devices that deliver buffer of about the same concentration to at least one buffer mixture distribution manifold. Nonetheless, Jayme et al. discloses two buffer dilution devices, as set forth in the rejection of claim 25, above, and the two buffer dilution devices would be fully capable of delivering buffer of about the same concentration to at least one buffer mixture distribution manifold (Fig. 1, p. 256; Fig. 7, p. 259).
Regarding claim 28, the limitation wherein at least one buffer destination comprises a media preparation subsystem, a cell culture subsystem, a bioreactor subsystem, a harvest subsystem, and/or a purification subsystem does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises at least one buffer destination comprising a media preparation subsystem, a cell culture subsystem, a bioreactor subsystem, a harvest subsystem, and/or a purification subsystem. Nonetheless, Jayme et al. discloses wherein the at least one buffer destination comprises a bioreactor subsystem (Abstract).
Regarding claim 29, the limitation wherein the buffer mixture distribution manifold controls the flow rate of the buffer mixture does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises a buffer mixture distribution manifold, as discussed in the rejection of claim 25, above.
Regarding claim 30, the limitation wherein the buffer mixture distribution manifold controls the concentration of the buffer mixture does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises a buffer mixture distribution manifold, as discussed in the rejection of claim 25, above.
Regarding claim 31, the limitation wherein the buffer mixture distribution manifold comprises a sensor responsive to a target parameter does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises a buffer mixture distribution manifold, as discussed in the rejection of claim 25, above.
Regarding claim 32, the limitation wherein the target parameter comprises pH, temperature, or cell density does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises the sensor responsive to a target parameter, as discussed in the rejection of claim 31, above.
Regarding claim 33, it is noted that any claim limitation directed to a composition of the buffer mixture represents a recitation of intended use of the claimed system, as the buffer mixture is not a positively recited structural element of the claimed system. Nonetheless, Jayme et al. discloses wherein the buffer mixture comprises media (Abstract, p. 260 col. 2).
Regarding claim 34, it is noted that any claim limitation directed to a composition of the media represents a recitation of intended use of the claimed system, as the media is not a positively recited structural element of the claimed system. Nonetheless, Jayme et al. discloses wherein the media is defined (p. 259 col. 2).
Regarding claim 35, it is noted that any claim limitation directed to a composition of the media represents a recitation of intended use of the claimed system, as the media is not a positively recited structural element of the claimed system. Nonetheless, Jayme et al. discloses wherein the media is comprises glutamine (reads on at least one non-essential amino acid) (p. 259 col. 2).
Regarding claim 36, it is noted that any claim limitation directed to a composition of the media represents a recitation of intended use of the claimed system, as the media is not a positively recited structural element of the claimed system. Jayme et al. discloses wherein the system is configured to deliver a buffer mixture comprising media comprising various ingredients (Abstract, p. 256 col. 2-p. 258 col. 2) and therefore the system would be fully capable of delivering a buffer mixture comprising media comprising at least one of the minerals listed in claim 36.
Regarding claim 37, the limitation wherein the buffer mixture distribution manifold is located centrally does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises a buffer mixture distribution manifold, as discussed in the rejection of claim 25, above. Nonetheless, Jayme et al. discloses wherein a buffer mixture distribution manifold is located centrally between a filtration skid and medium containers (see Figs. 1 and 6-7).
Regarding claim 38, the limitation wherein the buffer mixture distribution manifold is automated to be responsive to at least pH of the plurality of destinations does not introduce a patentable distinction over the prior art because the claim does not positively recite that the system comprises a buffer mixture distribution manifold, as discussed in the rejection of claim 25, above.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Brandt (US Patent Application Publication 20160243512 ) is directed to a system for in-line buffer dilution.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
