DETAILED CORRESPONDENCE
Application Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
Claims 1-14 are canceled.
Claim 15 is pending and examined on the merits.
Applicant’s remarks filed on 2/13/2026 in response to the Final Rejection mailed on 1/13/2026 have been fully considered and are deemed not persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Rejections
The rejection of claims 8-11 under 35 U.S.C. 103 as being unpatentable over Zanderberg et al (2012, Journal of Biological Chemistry, cited on PTO-892 dated 3/19/2025) {herein Zanderberg} in view of Fike et al (US 2008/0261308 A1, Date Published: Oct. 23, 2008, cited on PTO-892 dated 3/19/2025) {herein Fike} and evidenced by Lonza (2011, Dulnecco’s modified eagle medium (DMEM), cited on PTO-892 dated 3/19/2025) {herein Lonza} and Fisher Scientific (2025, https://www.fishersci.com/shop/products/gibco-ham-s-f-12-nutrient-mix-8/11765062, cited on PTO-892 dated 3/19/2025) {herein Fisher Scientific} is withdrawn in view of Applicant’s cancellation of claims 8-11.
New Claim Rejections - 35 USC § 112(b)
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 15 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.
Regarding claim 15, the phrase "non-" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. It is not clear if the items/phrases followed by this phrase are to be considered as claim limitations. Appropriate correction is suggested. See MPEP § 2173.05(d). Appropriate correction is suggested.
Maintained 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 rejection of claim 15 under 35 U.S.C. 103 as being unpatentable over Zanderberg et al (2012, Journal of Biological Chemistry, cited on PTO-892 dated 3/19/2025) {herein Zanderberg} in view of Fike et al (US 2008/0261308 A1, Date Published: Oct. 23, 2008, cited on PTO-892 dated 3/19/2025) {herein Fike} and evidenced by Lonza (2011, Dulnecco’s modified eagle medium (DMEM), cited on PTO-892 dated 3/19/2025) {herein Lonza} is maintained. The rejection has been modified in view of Applicant’s canceling of claims 8-11 and amendment of claim 15 to recite ‘consisting of.’
As amended, claim 15 is drawn to a dry powder cell culture medium consisting of a chemically defined cell culture medium, and (a) 5-Thio-L-fucose, (b) a 5-Thio-L-fucose derivative selected from partially or fully acetylated 5-Thio-L-fucose, non-, partially or fully acetylated forms of 2-F-5-Thio-L-fucose, 5-Alkynyl-5-thio-L-fucose, 6, 6, 6-Trifluoro- 5-thio-L-fucose and 5-Thio-L-fucose phosphonate, or a combination of (a) and (b).
With respect to claim 15, Zanderberg teaches a cell culture medium comprised of 5-Thio-L-fucose in liquid media (page 40022, column 2, para 4). The cell culture media comprises DMEM supplemented with 20% FBS and DMEM: Ham’s F12 containing 10% FBS (page 40022, column 2, para 3). Evidentiary reference of Lonza is cited to demonstrate that DMEM contains amino acids, vitamins, glucose, sodium pyruvate and uses a sodium bicarbonate system (page 1). It would be obvious to one of ordinary skill in the art to try the culture medium without FBS as Zanderberg would have a reasonable expectation of success that the culture medium without FBS would have similar results of reducing cellular adhesiveness due to the addition of 5T-Fuc (page 40027, column 1, para 1) and arrive at a chemically defined synthetic culture medium and 5-thio-L-fucose. Especially since it is known by those of ordinary skill in the art that FBS in culture medium promotes cell attachment, stimulates cell growth and proliferation and inclusion of 5T-Fuc would prevent the cell attachment and let the cells remain suspended in the medium. As such, it would be obvious for Zanderberg to try the culture medium without FBS, especially since Zanderberg’s invention encompasses the ability of 5T-Fuc to decrease/reduce cell adhesion (abstract), of which is known by those of ordinary skill in the art that FBS promotes. MPEP 2143.I.E. states “The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.”
However, Zanderberg does not teach a dry powder cell culture medium (claim 15).
With respect to claim 15, Fike teaches a dry powder nutritive cell culture medium comprised of necessary nutritive factors that facilitate the in vitro cultivation of cells (para 0003).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the teachings of Zanderberg of a cell culture medium comprised 5-Thio-L-fucose in liquid media (page 40022, column 2, para 4) or combine the teachings of Fike because Fike teaches a dry powder nutritive cell culture medium comprised of necessary nutritive factors that facilitate the in vitro cultivation of cells (para 0003).
One of ordinary skill in the art would be motivated to combine the teachings of Zanderberg but without the use of FBS and Fike because Fike provides the motivation for one of ordinary skill in the art to use a dry powder cell culture medium as said medium is especially advantages such as said formulation allows for particular ionic and pH conditions upon rehydration, e.g., without the need for adjustment of such conditions prior to use (para 0003). Furthermore, media in dry powder form serves as a convenient alternative to making media from scratch, i.e., adding each nutrient individually, and also avoids some of the stability problems associated with liquid media (para 0010). In addition, dry powder media formulation may increase the shelf-life of the media (para 0013). One of ordinary skill in the art knowing the benefit of 5-Thio-L-fucose for inhibiting cell adhesion of eukaryotic cells in culture (Zanderberg: page 40021, column 1, para 1) and the desire to maintain its activity and concentration within media over an extended period of time based on the teachings of Zanderberg and Fike would have a reasonable expectation of success to substitute the liquid culture medium containing 5-Thio-L-fucose with the dry powder nutritive medium formulations and 5-Thio-L-fucose because one of ordinary skill in the art would expect that utilizing a dry powder nutritive medium formulation with 5-Thio-L-fucose added would extend the shelf -life of the 5-Thio-L-fucose containing media and easily allow for the adjustment of medium components.
One of skill in the art would have a reasonable expectation of success to make and use the claimed dry powder medium consisting of 5-Thio-L-fucose because Zanderberg provides the teaching of 5-Thio-L-fucose and its uses and methods of making. Fike provides the teaching of a dry culture medium the contains all of the supportive factors for the growth of cells in culture. Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 3 of Applicant’s remarks, Applicant’s in summary contend that Zanderberg neither teaches nor suggests the claimed invention as Zanderberg teaches a liquid culture medium with serum.
This argument is found to be not persuasive. Examiner contends that Zanderberg teaches a cell culture medium comprised of 0-100 micromolar of 5-Thio-L-fucose in liquid media (page 40022, column 2, para 4). Although the culture medium taught by Zanderberg contains serum, it is the Examiner’s position that it would be obvious to one of ordinary skill in the art to try the culture medium without FBS as Zanderberg would a reasonable expectation of success that the culture medium without FBS would have similar results of reducing cellular adhesiveness due to the addition of 5T-Fuc (page 40027, column 1, para 1) and let the cells remain in suspension. Especially since it is known by those of ordinary skill in the art that FBS in culture medium promotes cell attachment, stimulates cell growth and proliferation. As such, it would be obvious for Zanderberg to try the culture medium without FBS, especially since Zanderberg invention encompasses the ability of 5T-Fuc to decrease/reduce cell adhesion (abstract). MPEP 2143.I.E. states “The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art.”
Regarding the substitution of a liquid culture medium (taught by Zanderberg) with a dry powder medium (instant application), it remains the Examiner’s position that Fike provides the motivation for one of ordinary skill in the art to use a dry powder cell culture medium as said medium is especially advantageous in incorporation of useable quantities of lipid or other components that are only sparsely soluble in water (para 0005). Additionally, said formulation allows for particular ionic and pH conditions upon rehydration, e.g., without the need for adjustment of such conditions prior to use (para 0003). Furthermore, media in dry powder form serves as a convenient alternative to making media from scratch, i.e., adding each nutrient individually, and also avoids some of the stability problems associated with liquid media (para 0010). In addition, dry powder media formulation may increase the shelf-life of the media (para 0013).
Conclusion
Status of Claims
Claims 1-14 are cancelled.
Claim 15 is pending.
Claim 15 is rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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