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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-3,16,22, and 77, drawn to a method involving contacting a cell culture in a first medium with one or more recombinant nucleic acids; incubating the cell culture for 4-8 hours under conditions sufficient for the nucleic acid transfection, and contacting the cell culture with a second medium, classified in C12N 15/63.
II. Claims 34,41,46-47,76, drawn to incubating one or more recombinant nucleic acids and one or more transfection reagents in a vessel in a first medium under conditions sufficient for complex formation, and contacting a cell culture with a volume of the first medium using pressure, wherein the volume is at least 25L, and wherein the pressure is greater than one atmosphere (atm) , classified in C12N 2521/00.
III. Claims 78-79, drawn to a method comprising incubating one or more recombinant nucleic acids and one or more transfection reagents in a first medium under conditions sufficient for complex formation; contacting a cell culture with a volume of the first medium, wherein the volume is at least 25 L, and incubating the cell culture for 4-8 hours under conditions sufficient for nucleic acid transfection; and contacting the cell culture of c with a second medium, classified in C12N 2511/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related methods of transfection and cell culture. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are distinct. Invention I requires an incubation period of 4-8 hours to facilitate transfection. The incubation time period of Invention I is not required by Invention II. Invention II can be further distinguished from Invention I because Invention II requires a transfection process that involves a large volume of 25 liters or more, and the transfection is facilitated using pressure greater than 1 atm. These limitations recited in Invention II are not required in Invention I. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions I and III are directed to related methods of transfection and cell culture. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are distinct. Invention III requires a large scale operation (25 liters)/large scale process which would involve special machinery/distinct methods steps to carryout out an operation involving a large volume of cells. Invention III also requires a step of incubating one or more recombinant nucleic acids and one or more transfection reagents to form a complex which is then exposed to a cell culture; Invention I does not recite such limitations. The process of Invention I can occur in small volumes, requiring minimal equipment. Invention I does not require a transfection reagent or complex formation. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II and III are directed to related methods of transfection and cell culture. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are distinct. Invention II’s transfection process relies on using pressure to assist with transfection which is not required in Invention III; instead, Invention III requires a transfection incubation period of 4-8 hours and two types of medium. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Searching all 3 groups would be a burden for examiner. The searches would not be coextensive. For example, large scale operation processes require different types of equipment and method steps in order to carry out larger scale operations. Furthermore, transfection that relies on incubation has a different mode of operation than transfection that relies on pressure exposure. Because of all of these differences, each group would require a search in the CPC that is not coextensive.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Anne Weeks on July 23, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-3,16,22, and 77 . Affirmation of this election must be made by applicant in replying to this Office action. Claims 34,41,46-47,76,78-79 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 1-3,22, and 77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clement (US 20200224173)
Clement discloses a. contacting a cell culture in a first medium with one or more recombinant nucleic acids (Abstract); b. incubating the cell culture for 4-8 hours under conditions sufficient for nucleic transfection (Paragraph 9 and 84); and c. contacting the cell culture of b. with a second medium (Paragraphs 9 and 85-86) as in instant Claim 1. Clement discloses wherein one of the one or more recombinant nucleic acids encode recombinant AAV (rAAV) genome (Abstract and Paragraphs 4-5) as in instant Clam 2. Clement discloses wherein the rAAV genome comprises a gene of interest flanked by interested inverted terminal repeats (ITRs) (Paragraphs 16-17,36 of Clement) as in instant Claim 3. Clement discloses the cell culture produces adeno-associated virus (AAV) particles (Abstract) as in instant Claim 22. Clement discloses isolating rAAV from the cell culture after step (b) or step (c) (Paragraph 23,62,68) as in instant Claim 77.
The reference anticipates the claim limitations.
Claims 1-3, 22, and 77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (AU 2020315477).
Wang teaches a method of contacting cells in a first culture medium with one or more recombinant nucleic acids; incubating the cell culture for 4-8 hours under conditions sufficient for nucleic acid transfection; and contacting the cell culture with a second medium (Abstract, Paragraphs 2 of Wang; the medium is changed through the administration of additional ions, Paragraph 22 of Wang; Figure 10, Paragraph 52; Paragraph 93 of wang) as in instant Claim 1. Wang discloses wherein one of the one or more recombinant nucleic acid encodes a recombinant AAV (r AVV) genome (Abstract) as in instant Claim 2. Wang discloses wherein the rAAV genome comprises a gene of interest flanked by interested inverted terminal repeats (ITRs) (Paragraph 6 of Wang) as in instant Claim 3. Wang discloses where the cell culture produces adeno-associated virus (AAV) particles (Abstract) as in instant Claim 22. Wang discloses isolating r AAV from the cell culture after step (b) or step (c) (Paragraph 22 of Wang) as in instant Claim 77.
The reference anticipates the claim limitations.
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 1-3,16, 22, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Clement (US 20200224173) in view of Alam (WO 2022245675)
Clement applies as above to teach 1-3,22, and 77. Clement does not teach further culturing in a third medium. Clement does not teach the addition of a third culture medium 24 hours after exposure to the first culture medium. Clement’s cell culture is suspension culture; Alam teaches that suspension culture can last for 24 hours after which the cells can be placed in additional medium (Paragraph 188 of Alam) It would have been obvious to an artisan of ordinary skill at the time of effective filing to have cultured in cells in a third medium 24 hours after the initiation of culture in the first medium. An artisan would have been motivated to have cultured the cells in a third medium because Alam teaches that cells cultured in suspension can be placed in a third medium and cultured under adherent conditions at least 24 hours after the initiation of culture in a first medium (Paragraphs 16-17, and 188 of Alam). Alam further teaches that the time of harvest or isolation of the viral vector with the recombinant nucleic acid produced by the cell culture is between about 24 hours to 120 hours post transfection which includes a period of time where the cells are cultured in adherence (Paragraph 240 of Alam). An artisan would have been motivated to have placed the suspension culture cells of Clement into the third culture medium of Alam in order to make the cells adherent so that they can then be harvested and the RAAV particles easily obtained by lysing (Paragraph 114). An artisan would have been motivated to have combined the two culture processes taught by Clement and Alam because they produce numerous copies of gene therapy vectors such as adeno-associated vectors (Paragraph 3 of Alam) as in instant Claim 16.
Clement teaches a method for creating copies of gene therapy vectors such as adeno-associated vectors by transfecting cells in cell culture. Clement focuses on suspension expansion culture production methods of such vectors. Alam teaches methods of converting suspension cultures into adherent cultures allowing for successfully harvesting of gene therapy vectors. The adherent cultures can be used to further expand particles with nucleic acid particles and facilitate easy harvesting of such nucleic acid particles. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicant’s invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Col. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.Ds. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature. These people will have practical knowledge in recombinant nucleic acid technology. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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