DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 28, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following claim interpretation(s) are being made given the guidance provided in MPEP § 2111.04 (II).
The broadest reasonable interpretation (BRI) of a method claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required because the condition(s) precedent are not met. Contrastingly, a BRI of a system (or apparatus) claiming a structure that performs a function which only needs to occur if a condition is met requires the structure for performing the function should the condition occur.
In the instant case, method claim 21 recites (in the last limitation): “wherein when the acclimated specimen sample comprises a live cell […]” and “when the specimen freezing rate regulator device is placed […]” (emphasis added), which are considered contingent limitations. The use of the word “when” implies a condition without there being an explicit recitation of placing a live cell as the specimen sample or the regulator device in a freezer. As such, the last limitation of the claim does not appear to be required under a broadest reasonable interpretation of the claim, and will therefore be omitted from examination against the prior art. Applicant is suggested to amend said method claim to positively recite the limitations at issue to avoid this interpretation.
Claim Objections
The following claims are objected to because of informalities, wherein appropriate correction is required:
In claim 24: a period should be added at the end of the claim. See MPEP § 608.01(m), first paragraph.
In claim 28: the recitation of “are is”, in line 2 of page 7, should be amended to –are—, for grammatical purposes.
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 pre-AIA 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.
Claims 21-25 and 27 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kaplan (US 20070012066 A1).
As per claim 21, Kaplan discloses a method for regulating freezing of a specimen sample (using the system shown in fig. 1), said method comprising:
acclimating to a first temperature a specimen freezing rate regulator device (e.g., ¶ 3), comprising:
a container (2) comprising:
a base (34) formed of a first insulating material (evident from its discrete structure in fig. 1); and
an upper portion (32) coupled to the base (34) and comprising four lateral walls formed of a second insulating material (evident from its discrete structure in fig. 1), the four lateral walls and the base defining a central cavity (space for 4);
a first layer of thermoconductive material (e.g., 37 or 20) configured to be positioned within the central cavity and in contact with the base (34; see figs. 1, 2 and 5);
a specimen tube rack (6) configured to be placed within the central cavity such that a bottom surface of the specimen tube rack (6) is in contact with the first layer of thermoconductive material (37 or 20; see at least figs. 1, 2 and 5);
a second layer of thermoconductive material (7) configured to be positioned within the central cavity and in proximity to a top surface of the specimen tube rack (6); and
a cover (50) configured to close and seal the central cavity (see fig. 1 and ¶ 40), wherein the cover (50) is formed of a third layer insulating material (i.e., evidenced by its discrete structure);
acclimating to the first temperature (e.g., room temperature) a specimen sample (e.g., represented by 150 in fig. 11);
assembling the acclimated specimen freezing rate regulator device (see at least figs. 1, 2, 5 and 11) by:
inserting the acclimated specimen sample (150) into the specimen tube rack (6) of the acclimated specimen freezing rate regulator device (evident from at least fig. 11); and
securing the cover (50) to the container (2) thereby enclosing the acclimated first layer of thermoconductive material (of 34), the acclimated second layer of thermoconductive material (of 32), the acclimated specimen tube rack (6), and the acclimated specimen sample (150) therein (see at least figs. 1 and 11); and
placing the acclimated assembled specimen freezing rate regulator device (2) into an environment (e.g., a refrigerator or freezer; see at least ¶ 82) having a second temperature (i.e., a refrigerated temperature) that is less than the first temperature (i.e., room temperature).1
As per claim 22, Kaplan discloses wherein the cover (50) is coupled to a top surface (21 or 33) of the second layer of thermoconductive material (of 32; see at least fig. 5).
As per claim 23, Kaplan discloses an apparatus (see fig. 1) for providing2 a temperature reduction profile of a live cell suspension configured for enhanced cell survival following cryogenic storage of the live cell suspension (e.g., represented by 150 in fig. 11), the apparatus comprising:
a container (2), comprising:
a base (34) formed of a first insulating material (evident from the structure of 34; see fig. 1); and
an upper portion (32) coupled to the base (34) and comprising four lateral walls formed of a second insulating material (evident from the structure of 32), the four lateral walls and the base (34) defining a central cavity (as shown in at least fig. 1);
a first layer of thermoconductive material (e.g., 37 or 20) configured to be positioned within the central cavity and in contact with the base (34; see figs. 1, 2 and 5);
a specimen tube rack (6) configured to be placed within the central cavity such that a bottom surface of the specimen tube rack (6) is in contact with the first layer of thermoconductive material (37 or 20; see at least figs. 1, 2 and 5);
a second layer (7) of thermoconductive material configured to be positioned within the central cavity and in proximity to a top surface (see at least fig. 1) of the specimen tube rack (6); and
a cover (50) configured to close and seal the central cavity (see at least figs. 1 and 6), wherein the cover (50) is formed of a third layer of insulating material (evident from the structure of 50).
As per claim 24, Kaplan discloses wherein the cover (50) is coupled to a top surface (21 or 33) of the second layer of thermoconductive material (7).
As per claim 25, Kaplan discloses wherein the cover (50) is configured to lie on top of the four lateral walls (of 32) and suspend the second layer of thermoconductive material (7) above the specimen tube rack (6; see at least ¶ 69 and figs. 1 and 5).
As per claim 27, Kaplan discloses wherein the specimen tube rack (5) comprises a plurality of receptacles (10; evident from fig. 1), wherein an exact geometric equivalent position of each of the plurality of receptacles relative to the first (37 or 22) and second (7) thermoconductive layers provides an identical temperature reduction profile for a specimen sample (e.g., 150) inserted therein (e.g., evident from the symmetry of 6).
Allowable Subject Matter
Claim 26 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 28-33 are allowed.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The prior art, when taken as a whole, does not appear to reasonably anticipate nor render prima facie obvious the claimed invention as recited in at least claims 26 and 28. Namely, there appear to be no prior art references of record that would otherwise suggest modifying the structure(s) to have the specific temperature reduction profile characteristics claimed therein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIGUEL A DIAZ whose telephone number is (313)446-6587. The examiner can normally be reached Monday - Friday: 9:00 AM - 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jianying C. Atkisson can be reached at (571) 270-7740. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MIGUEL A DIAZ/Primary Examiner, Art Unit 3763
1 The last limitation of claim 21 has been omitted from examination against the prior art given MPEP § 2111.04 (II).
2 The preamble does not appear to explicitly require or limit the structure of the apparatus, but rather appears to recite an intended use thereof. See MPEP § 2111.02