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
Claims 17-21, 23 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
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 6, 8-10, and 13 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.
The term “strong promoter” in claim 6 is a relative term which renders the claim indefinite. The term “strong promoter” 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. It is unclear what specific physical, chemical and biological criteria must be met for a promoter to be considered “strong.”
Regarding claims 8-10 and 13, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US Pat. 7,863,020 [IDS Reference]) and Kim, et al (US Pat. 12,188,036. Hamilton teaches cells that are engineered to express sialyltransferase, galactosyltransferase, and CMP-sialic acid transporter, wherein preferred embodiments can include α-2,6-sialyltransferase, β-1,4-galactosyltransferase, and CMP-sialic acid transporter. See column 1, lines 23-32; column 9, lines 55-58; column 10, lines 8-10; column 12, lines 5-25. Although Hamilton does not explicitly teach the insertion of these genes into mammalian cells, it is explicitly stated that the cells can be eukaryotic host cells, including animal cells. See column 1, lines 24-30. Hamilton further states that some of the inserted genes have successfully been inserted into Chinese Hamster Ovary (CHO) cells. See column 39, lines 32-40. This would suggest to the ordinary artisan that the genes discussed in Hamilton can be predictably and successfully inserted into a mammalian cell, like CHO cells.
Kim notes that CHO cells are widely used to produce recombinant products, suggesting that the ordinary artisan would find it obvious to use a widely used cell-type for recombinant methods. See column 1, lines 26-32. Kim also, generally, indicates that all of the claimed genes can be successfully and predictably inserted into CHO cells. See column 3, lines 50-67; continuing to column 4, lines 1-53.
With respect to claim 1, Hamilton provides for preferred embodiments that include cells that have been modified to provide for all of the claimed expressions. Hamilton generally suggests that animal cells, like CHO cells, can be used, while Kim explicitly indicates that the mammalian CHO cell is a widely used option for providing cells with the increased expression of certain proteins.
With respect to claim 2, Hamilton provides for embodiments that show the insertion of exogenous nucleic acids that are consistent with those claimed. See Table 6.
With respect to claim 3, although providing expression cassettes and promoters is routine when creating an engineering cell, and thusly obvious to the ordinary artisan, Hamilton teaches these. See column 84, lines 1-24.
With respect to claim 4, Hamilton’s cells are explicitly created for the heterologous expression of non-natural proteins. This, by definition, would be increased expression.
With respect to claim 5, although providing expression cassettes and promoters is routine when creating an engineering cell, and thusly obvious to the ordinary artisan, Hamilton teaches these. See column 84, lines 1-24.
With respect to claim 6, see the 35 USC 112(b) rejection above. It appears as though the promoters of Hamilton are consistent with those claimed, but it is unclear what defines a “strong promoter.”
With respect to claims 7 and 8, Kim teaches the same promoters. See columns 8-10.
With respect to claim 9, Hamilton teaches α-2,6-sialyltransferase, β-1,4-galactosyltransferase, and CMP-sialic acid transporter, wherein they can be derived from any organism that naturally possesses them, including human. See Table 6.
With respect to claim 10, Hamilton generally indicates that animal cells, like CHO cells could be used; however, Kim explicitly indicates that CHO cells are widely used for the purpose of creating engineered cells that produce heterologous compounds.
With respect to claim 11, Hamilton indicates that the cells are engineered for recombinant expression of glycosylated polypeptides. See column 1, lines 22-32.
With respect to claim 12, although Hamilton does not show the production of the claimed glycosylated peptides, as claimed, Hamilton provides for generalized methods that could be predictably applied to one of the preferred embodiments. See column 89 and 90, Example 15.
With respect to claim 13, neither reference provides motivation for any temperature shift. Furthermore, there is implicit motivation to provide consistent temperature, because inconsistent temperature would be expected to lead to unpredictable results.
With respect to claim 14, although not stated in either reference, the ordinary artisan would be implicitly motivated to provide engineered cells in an ideal temperature. For example, Kim teaches CHO cells, which are stated as being widely used. The ordinary artisan is well aware that cells used to produce recombinant products should be provided an ideal temperature. Since CHO cells are widely used in the biological arts, and specifically in methods that involve engineered cells, it would be obvious to place them in the claimed temperature.
With respect to claim 15, Hamilton is explicitly concerned with “therapeutic agents” that can include glycoproteins. See column 1, line 28; column 4, lines 42-64. Since it would be clear to the ordinary artisan that Hamilton’s product is used for therapeutic methods, it would be obvious to provide the compound as a pharmaceutical formulation.
With respect to claim 16, Hamilton shows reduced immunogenicity. See column 35, lines 20-23. Hamilton describes the claimed antibodies. See column 72, lines 21-25.
With respect to claim 22, Hamilton and Kim describe the claimed method. See the rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651