DETAILED ACTION
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, presently claims 1 and 13-16, in the reply filed on 6/26/2026 is acknowledged.
Claims 2-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/26/2026.
Claims 1 and 13-16 are under consideration on the merits.
Claim Rejections - 35 USC § 102 and 103
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.
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 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Grieger et al. (Molecular Therapy (2016), 24(2), 287-297; provided in the IDS dated 9/22/2025) as evidenced by Rabinowitz et al. (Journal of Virology (2002), 76(2), 791-801; Reference U).
Grieger teaches a HEK293 cell strain adapted/selected to grow in suspension and in serum-free media (page 295, the 1st paragraph under Materials and Methods), anticipating or reading on claim 1. Grieger teaches making the suspension- and serum-free adapted HEK293 cell strain by culturing an adherent HEK293 cell strain previously selected for high transfection efficiency and rAAV production in successively reduced serum concentrations from 10% to 2.5% and then zero serum, and then growing the cells in serum-free media in shaker flasks (page 295, 1st paragraph under Materials and Methods; the paragraph spanning both columns on page 288), anticipating or reading on claim 1.
Grieger teaches a method preparing a viral vector, the method comprising i) performing suspension culture on the suspension- and serum-free adapted HEK293cell strain; ii) introducing a recombinant adeno-associated viral (rAAV) vector expression system into the cell strain by transfection; iii) culturing the cell strain under a condition favorable for the production of the viral vector in WAVE bioreactors; and iv) collecting/harvesting the viral vector (page 295, the 1st-3rd and 5th paragraphs under Materials and Methods; Table 1), anticipating or reading on claims 13 and 15. Grieger teaches tittering the rAAV by dot blot (page 296, the paragraph spanning both columns; the paragraph spanning pages 292-293), anticipating or reading on claim 14. Grieger teaches wherein the viral vector expression system includes a heterologous nucleic acid-containing pXX680:pXR2:TR plasmid wherein TR is the carrier plasmid, and pXX680 and pXR2 are helper plasmids (page 295, the 2nd paragraph under Materials and Methods, citing ref. 36 to Rabinowitz), and wherein pXR inherently contains AAV replication (rep) and capsid (cap) domains (Rabinowitz at Fig. 1 and subheading “Plasmids” on page 792), anticipating or reading on claim 16.
Regarding claims 1 and 13-16, Grieger does not teach HEK293 cell strain deposited at the China General Microbiological Culture Collection Center with a deposit number of CGMCC NO.: 23020. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same or similar as that of the claim but does not explicitly disclose the function or property. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 102 rejection by showing the prior art product lacks the claimed function/property, and to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the HEK293 cell strain of claims 1 and 13 is disclosed as being adapted to grow in suspension and in serum-free media from commercially-available but unspecified HEK293 cell lines, and are made by selecting a HEK293 cell line for rAAV production under adherent conditions, adapting the adherent HEK293 cell line to growth in serum-free media, and then adapting the HEK293 cell line to suspension culture in shaker flasks (Example 1). Grieger’s HEK293 cell line must be held as substantially identical to the claimed HEK293 cell line because both cell lines are adapted for suspension culture in serum-free media, and are made by substantially identical methods of selecting an HEK293 cell line for rAAV production, growing the HEK293 cell line adherently, and then growing the HEK293 cell line under suspension conditions and in serum-free medium. Therefore, the burden is reasonably shifted back to Applicant to show that the claimed HEK293 cell line is both novel and nonobvious over the HEK293 cell line of Grieger.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bauler et al. (Molecular Therapy (June 2020), 17, 58-68 plus appended Supplemental Information; Reference V).
Bauler teaches a HEK293T cell strain adapted/selected to grow in suspension and in serum-free media (the paragraph spanning both columns on page 59; i.e. SJ293TS cells), anticipating or reading on claim 1. Bauler teaches making the suspension- and serum-free adapted HEK293 cell strain by culturing an adherent HEK293T cells in successively reduced serum concentrations to zero serum, and then growing the cells in serum-free media in a shaking incubator (the paragraph spanning both columns on page 59), anticipating or reading on claim 1.
Bauler teaches a method preparing a viral vector, the method comprising i) performing suspension culture on the suspension- and serum-free adapted HEK293T cell strain (i.e. SJ293TS cells); ii) introducing a recombinant lentiviral (LV) vector expression system into the cell strain by transfection; iii) culturing the cell strain under a condition favorable for the production of the viral vector; and iv) collecting/harvesting the viral vector (page 59, the paragraph starting “We assessed vector production…” through paragraph ending …”SJ293TS cells (Table 1).”), anticipating or reading on claim 13. Bauler teaches tittering the LV (page 59, the paragraph starting “We assessed vector production…” through paragraph ending …”SJ293TS cells (Table 1).”), anticipating or reading on claim 14.
Regarding claims 1, 13, and 14, Bauler does not teach HEK293 cell strain deposited at the China General Microbiological Culture Collection Center with a deposit number of CGMCC NO.: 23020. However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same or similar as that of the claim but does not explicitly disclose the function or property. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 102 rejection by showing the prior art product lacks the claimed function/property, and to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the HEK293 cell strain of claims 1 and 13 is disclosed as being adapted to grow in suspension and in serum-free media from commercially-available but unspecified HEK293 cell lines, and are made by selecting a HEK293 cell line for rAAV production under adherent conditions, adapting the adherent HEK293 cell line to growth in serum-free media, and then adapting the HEK293 cell line to suspension culture in shaker flasks (Example 1). Bauler’s HEK293T cell line must be held as substantially identical to the claimed HEK293 cell line because both cell lines are adapted for suspension culture in serum-free media, and are made by substantially identical methods of selecting an HEK293T cell line for viral vector production, growing the HEK293 cell line adherently, and then growing the HEK293 cell line under suspension conditions and in serum-free medium. Therefore, the burden is reasonably shifted back to Applicant to show that the claimed HEK293 cell line is both novel and nonobvious over the HEK293T cell line of Bauler.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 1 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hildinger et al. (Biotechnol Lett (2007), 29, 1713-1721; Reference W).
Hildinger teaches a HEK293E cell strain adapted/selected to grow in suspension and in serum-free media (page 1714, subheading “Expansion”), anticipating or reading on claim 1.
Hildinger teaches a method preparing a viral vector, the method comprising i) performing suspension culture on the suspension- and serum-free adapted HEK293E cells, ii) introducing a recombinant adeno-associated virus (rAAV) vector expression system into the cell strain by transfection; iii) culturing the cell strain under a condition favorable for the production of the viral vector; and iv) collecting/harvesting the viral vector (Abstract and subheadings “Standard Protocol”, “Expansion”, and “Transfection” on pages 1714-1715), anticipating or reading on claims 13 and 15.. Hildinger teaches tittering the rAAV (page 1715, subheading “Functional titer”), anticipating or reading on claim 14. Hildinger teaches wherein the viral vector expression system includes a heterologous nucleic acid-containing pAAV eGFP (the carrier/transfer plasmid), pRepCap2, and pHelper (subheading “Transfection” on pages 1714-1715), anticipating or reading on claim 16.
Regarding claims 1 and 13-16, Hildinger does not teach HEK293 cell strain deposited at the China General Microbiological Culture Collection Center with a deposit number of CGMCC NO.: 23020. However, where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." Also, alternate rejections under both 102 and 103 are appropriate when Applicant claims a composition in terms of a function or property and the composition of the prior art is the same or similar as that of the claim but does not explicitly disclose the function or property. See M.P.E.P. § 2112; once a substantially identical product/composition has cited and a rationale tending to show inherency is set forth, the burden shifts to Applicant to overcome the 102 rejection by showing the prior art product lacks the claimed function/property, and to overcome the 103 rejection by further showing that any different in the claimed function/property is non-obvious.
In this case, the HEK293 cell strain of claims 1 and 13 is disclosed as being adapted to grow in suspension and in serum-free media from commercially-available but unspecified HEK293 cell lines (Example 1). Hildinger’s HEK293E cell line must be held as substantially identical to the claimed HEK293 cell line because both cell lines are adapted for suspension culture in serum-free media. Therefore, the burden is reasonably shifted back to Applicant to show that the claimed HEK293E cell line is both novel and nonobvious over the HEK293E cell line of Hildinger.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Graham et al. (J. gen. Virol. (1977), 36, 56-72; Reference X), in so much that HEK293 cells are human embryonic kidney cells transformed with adenovirus type 5 DNA (Abstract) and so are not reasonably a product of nature under 35 U.S.C. § 101 (see M.P.E.P. § 2106.04(c)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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