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/Restriction
Applicant’s election without traverse of Group I and the species (i) a liquid secondary subsystem, (ii) a positive coefficient of thermal expansion (a), (iii) a magnitude of thermal expansion that is greater than that of water, and (iv) a mass-impermeable barrier being present, in the reply filed on February 6, 2026, is acknowledged. Claims 1-31 are pending of which claims 20-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claims and claims 1-8 and 10-12 are withdrawn as being directed to non-elected species. Pending claims 9 and 13-19 have been examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on 9/23/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy of the IDS has been placed in the instant Application file.
Please note, however, the information disclosure statements (of 9/23/2023, as marked up) fails to fully comply with 37 CFR 1.98(b)(5), which requires that each publication listed in an information disclosure statement must be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). In the present case, examiner has considered all references filed by the applicant to expedite the prosecution. However, the applicant is informed that the references filed in an improper and/or incomplete format (lined through) should be resubmitted in a proper format to be printed in the patent. MPEP 1302.12.
Claim Rejections - 35 USC § 102/103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 9 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Powell-Palm et al (WO 2021/146122 A1; IDS).
The instant claims are drawn to a process of excess-pressure-reducing in an isochoric systems comprising:
(a) providing a rigid and sealable master container;
(b,c) placing a biological matter-comprising primary subsystem and water-immiscible liquid secondary subsystem into the master container;
wherein water has a negative coefficient of thermal expansion at sub-0 degrees C; and
wherein the secondary subsystem has a positive coefficient of thermal expansion that is greater in absolute magnitude than the coefficient of thermal expansion of water;
(d,e,f) removing bulk gas phase from, sealing, and cooling below-0 degrees C, the master container;
(g) maintaining the master container at the desired storage temperature for a desired storage period;
(h) warming the master container to a temperature that is greater than the equilibrium melting point of the primary subsystem; and
(i,j) unsealing and removing the biological matter from the master container.
Powell-Palm WO ‘122, however, anticipates the claims by teaching an isochoric system (constant-volume; see fig. 8 and claims 2) comprising a master container capable of receiving and retrieving therefrom a biological material and a liquid, the container being rigid, (un)sealable, configured to remove a bulk gas phase, and temperature controlled (cooled, held/maintained, and heated)(see WO ’122 at figure 8)(see instant claims 1 and the parts and functions of (a-j), claim 9, 17).
The reference teaches that the system may be provided with aqueous solution ([0275]; broadly, comprising pure water, as required of claim 14). The container may be provided with additional elements, including sheaths, sleeves, etc ([014-016], broadly, mechanical elements as required of claim 15), or a plurality thereof (instant claims 17-19; [090-098]).
Although WO ‘122 does not expressly recite providing a “higher than” grade 5 titanium (see instant claim 16), the reference teaches [0266] that Titanium Grade V” and “any rigid material, including metallic materials such as but not limited to Aluminum 7075, Titanium Grade 5, 316 Stainless Steel, composites such as but not limited to carbon- or glass-fiber reinforced polymers, ceramics, hard plastics, etc.” may be used and further that [0267] “may additionally be treated or coated in any manner in order to achieve a variety of improving effects”, such that the genus of materials embraced, combined with the temperature and pressure effects required of the use thereof [0268] would teach to one of skill the providing of such materials, and further the instant claims and disclosure do not limit or define what materials are intended as included or excluded thereby (and as such remain inclusive of the broad and reasonable interpretation applied herein).
WO ‘122 is relied upon for the reasons discussed above. If not expressly taught therein, based upon the overall beneficial teaching provided by this reference with respect to providing an isochoric system for preserving biological materials and the benefit and conditions thereof upon reducing nucleation, and in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable material or multiplicity thereof and the ranges of conditions in which to perform such an isochoric system operation), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, 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 effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claim Objections
Claim 13 is objected to because the claim depends from an objected base claim. Appropriate correction is required.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
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