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 .
Claim Status
The amendment of 12/15/2025 has been entered. Claims 15-18 and 20-28 are pending in this US patent application. Claims 25-26 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2025.
Claims 15-18, 20-24, and 27-28 are currently under examination and were examined on their merits.
Withdrawn Objections/Rejections
The objection to claim 23 for failing to end in a period as set forth in the previous Office action is withdrawn in light of the amendment of 12/15/2025, which added a period to the end of claim 23.
All rejections of claim 19 set forth in the previous Office action are withdrawn in light of the amendment of 12/15/2025, which canceled claim 19.
Claim Interpretation
Claims 15 and 27-28 contain preambles in which the inventions are described as processes “for” particular purposes comprising particular steps. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02 (II). A clause in a method claim does not receive weight when it simply expresses the intended result of a process step positively recited. See MPEP § 2111.04. In the instant case, the bodies of claims 15 and 27-28 fully and intrinsically set forth all of the limitations of the claimed invention, and the preambles merely state the intended outcome of performing the instantly recited steps. As such, any prior art that reads on the steps recited in instant claims 15 and 27-28 will read on the entireties of claims 15 and 27-28, regardless of whether the prior art specifically recites the intended use limitations from the preambles of the claims.
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 15-18, 20-23, and 27-28 remain rejected under 35 U.S.C. 103 as being unpatentable over international patent application WO 2008/141207 filed by Morris et al., published 11/20/2008 (cited on the IDS filed 02/17/2023).
Morris teaches feed media for cell culture (see entire document, including page 2, lines 7-10). The pH of the feed medium can be from about 5.8 to about 7.4 (page 3, line 3; cf. claims 15, 17, and 27-28; in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists; see MPEP § 2144.05 (I)). The invention provides for increasing production of a recombinant protein produced by cultured mammalian cells, which may be CHO cells, comprising feeding the cultured cells with a feed medium of the invention one or more times during the culture (page 4, lines 1-11; cf. claims 15-16, 21, and 27-28; the Examiner notes that any phase in which protein is produced by cells may be interpreted as a “production phase” as recited in claims 15 and 27-28 and that any feed medium may be interpreted as a “main feed medium” as recited in instant claim 16 in the absence of any further definition of these terms). The culture may be a fed batch culture (page 8, lines 18-23; cf. claim 18). Cysteine and tyrosine may be omitted from the feed medium (page 11, lines 24-25; cf. claims 15 and 27-28). The media and methods of the invention may be used to produce antibodies, including human antibodies, chimeric antibodies, and humanized antibodies (page 16, lines 24-26; cf. claims 22-23). Table 1 of Morris recites a number of exemplary components of a feed medium, including tryptophan, and states that not all of the components need be present in the medium (page 12, lines 9-10, and Table 1; cf. claim 20).
However, Morris does not explicitly teach that the pH of the medium has values within the ranges listed in Morris that fall within the instantly recited ranges or the omission of cysteine, tyrosine, and tryptophan from the medium.
While Morris does not explicitly teach that the pH of the medium has values from the ranges listed in Morris that fall within the instantly recited pH ranges, it would have been obvious to one of ordinary skill in the art to do so because Morris suggests pH values that overlap with the all of the instantly recited ranges. One of ordinary skill in the art would have a reasonable expectation that using any of the pH values taught by Morris, including those that fall within the ranges recited in the instant claims, in a feed medium that is used for the production of recombinant antibodies from CHO cells would successfully result in the production of recombinant antibodies from the cells.
While Morris does not explicitly teach the omission of cysteine, tyrosine, and tryptophan from the feed medium, it would have been obvious to one of ordinary skill in the art to do so because Morris explicitly teaches that cysteine and tyrosine can be left out of the feed medium and includes tryptophan in a list of ingredients that may be included or may be omitted from the culture medium depending on the needs of the cells. One of ordinary skill in the art would have a reasonable expectation that omitting cysteine, tyrosine, and tryptophan from the feed medium in the method of culturing CHO cells in a fed-batch process taught by Morris would successfully result in the production of recombinant proteins by the cells.
Therefore, claims 15-18, 20-23, and 27-28 are rendered obvious by Morris and are rejected under 35 U.S.C. 103.
Claims 15-18, 20-24, and 27-28 remain rejected under 35 U.S.C. 103 as being unpatentable over international patent application WO 2008/141207 filed by Morris et al., published 11/20/2008 (cited on the IDS filed 02/17/2023), in view of Girish et al., Cancer Chemother. Pharmacol. 69: 1229-1240 (2012).
As discussed above, claims 15-18, 20-23, and 27-28 are rendered obvious by Morris. In addition, Morris teaches that the methods of the invention can be used to produce conjugates including an antibody and a cytotoxic substance, including maytansine derivatives such as DM1 (page 16, lines 24-33). However, Morris does not explicitly teach that the antibody produced by the CHO cells is an IgG antibody as recited in instant claim 24.
Girish teaches that trastuzumab emtansine is an antibody-drug conjugate containing trastuzumab, a humanized IgG1 monoclonal antibody, and DM1 (see entire document, including page 1230, left column, paragraphs 2-4; cf. claim 24).
While Morris does not explicitly teach that the antibody produced by the CHO cells is an IgG antibody as recited in instant claim 24, it would have been obvious to one of ordinary skill in the art to do so because Morris teaches that the methods of the invention can be used to produce conjugates including an antibody and a cytotoxic substance, including maytansine derivatives such as DM1, and because Girish teaches that trastuzumab emtansine is an antibody-drug conjugate containing trastuzumab, a humanized IgG1 monoclonal antibody, and DM1. One of ordinary skill in the art would have a reasonable expectation that producing the trastuzumab emtansine of Girish as the antibody-drug conjugate containing DM1 produced in the method of Morris would successfully result in the production of trastuzumab emtansine.
Therefore, claims 15-18, 20-24, and 27-28 are rendered obvious by Morris in view of Girish and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has traversed the above rejection of the claims under 35 U.S.C. 103 as being unpatentable over Morris. Applicant states that Morris teaches methods for stabilizing feed media with approximately neutral pH and that the specific pH values of the medium feeds of Morris are mentioned only in Examples 4 and 5, which do not go below pH 6.01. Applicant states that Morris teaches away from lower pH because only neutral pH values were assessed. Applicant states that, in contrast, the present invention is related to main feeds that do not comprise cysteine and tyrosine, which Applicant states leads to main feeds that do not unexpectedly precipitate (remarks, pages 6-7). These arguments have been fully considered but have not been found persuasive.
The Examiner notes that Morris explicitly states that the pH of the feed medium may be 5.8 to 7.4, as discussed above and in the previous Office action. This pH range taught by Morris overlaps with every pH range recited in the instant claims. As such, Morris renders the recited pH ranges obvious and cannot be interpreted to teach away from using these pH ranges, which Morris directly suggests for use in the feed medium. In response to Applicant's argument that Morris has different reasons for leaving cysteine/tyrosine out of the feed medium than Applicant does, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, the Examiner has maintained the rejections presented above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 04/02/2026