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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-4, 6-8, 11, 14 and 18, drawn to a continuous transfection system.
Group II, claim(s) 21-23, 25-26 and 28-32, drawn to a method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of at least a first input line and a second input line, a mixing chamber, a delivery line, and a component configured to control flow rate of liquid, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Maguire (US 2020/0216862), as discussed in the rejection below.
During a telephone conversation with Applicant’s representative, Matthew Hierholzer, on June 17, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-4, 6-8, 11, 14 and 18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-4, 6-8, 11, 14 and 18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 limitation(s) is/are: “a component” recited in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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.
Claim 11 is 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 the limitation "a maximum culture volume greater than about 0.5 liters (L)" 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 "greater than about." The rejection can be overcome by deleting the term “about.” Moreover, it is unclear as to the maximum volume the cell culture vessel can comprise to meet said limitation.
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 1-4, 6-8, 14 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maguire (US 2020/0216862).
Regarding claim 1, Maguire discloses a continuous transfection system comprising: a) at least a first input line and a second input line (FIGS. 7-8: inlets (211); [0050]), wherein the first input line and the second input line are configured for sterile, fluid connection to a first reagent housing and a second reagent housing, respectively (FIG. 8: inlets (211) connected to reservoirs (301,302,303,304); [0005], [0050], [0067]-[0068], [0070], [0074]); b) a mixing chamber that is fluidly connected to the at least first and second input lines (FIGS. 7-8: mixing channel (210); [0050]); c) a delivery line fluidly connected to the mixing chamber, wherein the delivery line is configured for sterile, fluid connection to a cell culture vessel (FIGS. 7-8: channel connecting mixing channel (210) to reactor chamber (220); [0050], [0058]); and d) a component configured to control flow rate of liquid into the at least first and second input lines, throughout the mixing chamber, and into the cell culture vessel (FIG. 8: pumps (350); [0063]), [0075]).
Regarding claim 2, Maguire discloses wherein the continuous transfection system of claim 1, further comprising the first reagent housing and the second reagent housing in sterile, fluid connection with the first input line and the second input line (FIG. 8: reservoirs (301,302,303,304); [0005], [0050], [0067]-[0068], [0070], [0074].
Regarding claim 3, Maguire discloses wherein the continuous transfection system of claim 1, further comprising the culture vessel, wherein the culture vessel is in sterile, fluid connection with the delivery line (reactor chamber (220); [0050], [0050], [0058]).
Regarding claim 4, Maguire further discloses a temperature sensor ([0059]-[0060]).
Regarding claim 6, Maguire further discloses processor, wherein the processor controls one or more conditions selected from the group consisting of: flow rate of liquid into the first input line and/ or the second input line, temperature of any contents in the first reagent housing and/or the second reagent housing, any contents in the culture vessel, one or more sensors, and any combination thereof (FIG. 8: controller (340) adapted to control temperature controller (330), heater (320) and pumps (350); [0063], [0075]).
Furthermore, it is noted that while the invention contains a cell culture vessel, the cell culture vessel is not positively recited in the instant claim.
Regarding claim 7, Maguire further discloses wherein the system is partially or fully automated [0063], [0075]).
Regarding claim 8, Maguire discloses wherein the cell culture vessel is a bioreactor (reactor chamber (220); [0050], [0050], [0058]).
Regarding claim 14, Maguire further discloses wherein the system comprises at least two pumps (FIG. 8: pumps (350); [0063]), [0075]).
Regarding claim 18, Maguire further discloses wherein the system is a closed, sterile system ([0067], [0076]).
Therefore, Maguire meets and anticipates the limitations set forth in claims 1-4, 6-8, 14 and 18.
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire as applied to claim 1 above.
Regarding claim 11, Maguire discloses the continuous transfection system of claim 1 as set forth above. Maguire discloses wherein the cell culture vessel comprises a culture volume (FIGS. 7-8), but does not explicitly disclose wherein the cell culture vessel comprises a maximum culture volume greater than about 0.5 liters (L). 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 culture volume of the cell culture vessel of Maguire to have any volume including the claimed volume, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04 IV. A.). Further, it’s noted that the courts have held 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 (In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777). See MPEP 2144.04 (IV) (A). Furthermore, it is noted that while the invention contains a cell culture vessel, the cell culture vessel is not positively recited in the instant claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Benali et al (US 2009/0142845) disclose a system comprising a plurality of input lines, mixing chamber and a vessel. Morita et al (US 2005/0161326) disclose a system comprising a plurality of input lines, mixing chamber and a vessel.
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.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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