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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 299-306) in the reply filed on Feb. 17, 2026 is acknowledged.
Claims 307-315 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 299-306 (independent claim 299 and dependent claims 300-306) are examined on their merits below.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US22/19161, filed March 7, 2022. Applicant’s claim for the benefit of a prior-filed parent provisional application 63/157554 filed on March 5, 2021 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority date is March 5, 2021.
Information Disclosure Statement
The information disclosure statement filed June 26, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
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 300-302 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.
Claim 301 recites “…at a concentration of about 400-600 µg/mL, for example about 50 µg/mL.” First, it is assumed that the 50 is intended to be 500 (such that it would be within the recited 400-600 range). However, even with 500 being recited, this limitation is problematic, as it is unclear if the recitation of a range, followed by a specific “for example” is intended to further limit the claim to only the recited specific value or if the claim limitation encompasses the entire range. oever
Claim 300 also recite the term “for example” (e.g. “…at a concentration of about 50-600 µg/mL, for example about 100 µg/mL, and is rendered indefinite for the reason described above.
For the purposes of examination, the claims are interpreted as only reciting the broad ranges of the antibiotics.
Claim 302 recites “wherein the antibiotic component comprises a combination of antibiotics comprising about 50 µg/mL gentamicin and about 400-600 µg/mL clindamycin, wherein optionally the antibiotic component comprises a combination of antibiotics comprising about 50 µg/mL gentamicin and about 50-600 µg/mL vancomycin. This claim is indefinite because it is unclear if the “optionally” recited item is intended to be recited in the alternative (as both options recite 50 µg/mL gentamicin) or as an addition to the non-optional item. For the purposes of examination, the claim is interpreted as including either about 50 µg/mL gentamicin and about 400-600 µg/mL clindamycin or 50 µg/mL gentamicin and about 50-600 µg/mL vancomycin.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 299-302 and 306 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Louart et al. (PLoS One, 2019, cited in IDS filed on June 26, 2024).
The claims are directed to a composition for hypothermic storage of a tumor sample that includes a serum-free, animal component-free cryopreservation medium and an antibiotic component that includes gentamicin and vancomycin; gentamicin and clindamycin; gentamicin and amphotericin B or vancomycin. It is noted (as explained below) that “composition for hypothermic storage of a tumor sample” does not require that the composition actually be used for hypothermic storage of a tumor sample; rather, it requires that the composition taught by the prior art is capable of being used for this purpose. The limitation that “ii. an antibiotic component comprising either: 1) a combination of antibiotics…or vancomycin” is not limited to only the specified combination or vancomycin because the use of comprising (“antibiotic component comprising”) would include prior art that teaches additional antibiotics.
With respect to the independent claim, Loart et al. teaches a cryopreservation solution that includes SCOT30™ (serum-free, animal component free), 10% DMSO, and an antibiotic mixture, which includes cefamandole, clindamycin, colistine, vancomycin, amphotericin B, and gentamicin. (2- Skin grafts)
With respect to claim 300, Loart et al. teach vancomycin is present at 100 µg/mL (2- Skin grafts).
With respect to claim 301, Loart et al. teach clindomycin is present at 128 µg/mL (2- Skin grafts).
With respect to claim 302, Loart et al. teach gentamicin is present at 320 µg/mL and vancomycin is present at 100 µg/mL (2- Skin grafts).
With respect to claim 306, Loart et al. teach DMSO is present at 10%. (2- Skin grafts).
The limitation that the composition is "for hypothermic storage of a tumor sample" is intended use. The prior art structure taught by Loart et al. is capable of performing the recited intended use and, therefore, this limitation is met. See e.g. In re Schreiber, 128 F.3d 1473, 1477; 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP 2114 (Apparatus Claims Must Be Structurally Distinguishable From the Prior Art).
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.
Claim(s) 303-305 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Louart et al. (PLoS One, 2019, cited in IDS filed on June 26, 2024), as applied to claims 299-302 and 306 above, and further in view of Veerapathran et al (WO 2020/061429 A1, cited in IDS filed on June 26, 2024).
With respect to claim 303, Loart et al. teach gentamicin is present at 320 µg/mL and amphotericin B is present at 50 µg/mL (2- Skin grafts).
Loart et al. does not teach the specific concentrations of antibiotics of claim 303, that the cryopreservation medium contains electrolytes, buffers, simple sugars, impermeant anion, substrates effect for ATP regeneration or EDTA or vitamin E.
Veerapathran et al. teach preparation medium for fresh tumors that include Hypothermasol™ (bovine free, animal component-free) and gentimicin-amphotericin. (Ex. 8, paras [917]-[921]). Veerapahtran et al. teach that wash solutions include HBSS (claimed buffer and electrolytes), and cell culture media including glutamine. (paras. [0748]-[0750], Tables 21-22).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the cryopreservation media taught by Loart et al. to incorporate additional components (as taught by Veerapathran et al.) that were included in previous solutions/media the cells were treated with prior to cryopreservation because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Making this modification would have led to predictable results with a reasonable expectation of success because Loart et al. teaches that solutions that are used for steps prior to cryopreservation can be used in cryopreservation through the addition of a cryopreservative. Therefore, it would have been obvious to have added components and to have adjusted their concentrations based on what is known to be used in solutions used for extraction/purification of cells prior to cryopreservation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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