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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“measurement feature” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, in claim 1, the specification fails to provide the structure of a measurement feature that monitors the concentration of the cryopreservation agent , therapeutic agent, restoration agent, or a combination thereof. The specification states “one or more measurement features that monitors parameters selected from temperature, concentration, tension, compression, and/or biological material dimensions during use of the system” (para. [0005]), but is unclear regarding the specific structure for achieving the function of monitoring concentration. Dependent claims 2-8 are included in the rejection since they depend on the independent claim 1 and fail to cure the deficiencies of the rejection.
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 limitation “measurement feature” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. As seen above, the specification states “one or more measurement features that monitors parameters selected from temperature, concentration, tension, compression, and/or biological material dimensions during use of the system” (para. [0005]), but is unclear regarding the specific structure for achieving the function of monitoring concentration. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes, the measurement feature will be interpreted as any element (such as a sensor) for tracking the cryopreservation agent’s (CPA) concentration in the enclosure.
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.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Soltz (US 8551025 B2) (referenced in prior office action) in view of Fang and Gong (CN 101381577 A – referenced in prior office action) and Kilbride et al. (US 20200229427 A1) (referenced in 892).
Regarding claim 1, Soltz teaches a loading apparatus (See annotated Figure 4A below – device 100) comprising:
a loading mechanism (pusher, element 116) for applying tension and compression to a biological material that becomes associated with the loading apparatus during use (Figure 7, element 132 – “compress tissue to desired gap”). Soltz specifically teaches that the pusher (element 116) may be a piston or similar structure (this is interpreted to include a pneumatic piston) (p. 22, Col 9, 4th paragraph). Soltz also teaches that the pusher may be manually operable (p. 22, Col 9, 4th paragraph).
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Soltz fails to teach following limitations:
An enclosure constructed with inert materials that contains the loading apparatus and that has a volume to accept a solution comprising a cryopreservation agent, therapeutic agent, restoration agent, or a combination thereof.
A measurement feature that monitors concentration of the cryopreservation agent within the biological material that becomes associated with the loading apparatus during use. Note: 112(f) was invoked for this claim element.
Regarding limitation I, Fan and Gong teaches a tissue engineering reactor with torsion and tension/compression functions for tissue cultures (para. [0002]). Fan and Gong specifically teaches a culture chamber (See Annotated Figure 1 below - element 103) (interpreted as enclosure) that contains the loading apparatus (holding devices, elements 108 & tissue culture, element 109). Fan and Gong also teaches that during the tissue culture procedure, the enclosure (culture chamber 103) is completely filled with liquid while the enclosure is made of a material (glass, plastic (inert materials)) to provide a sterile closed environment for the tissue (element 109) to be cultured (para. [0050] of MT). Furthermore, the enclosure would be structurally capable of accepting a solution comprising a cryopreservation agent, therapeutic agent, restoration agent, or a combination thereof, as filling the culture chamber would allow this claim limitation to be met.
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It would have been obvious of one of ordinary skill in the art to use Fan and Gong’s teaching of an enclosure constructed with inert materials that has a volume to accept a solution in Soltz’s loading device because an inert enclosure that can be filled with a solution would allow the tissue to be cultured. This method of improving Soltz’s device was within the ability of one of ordinary skill in the art based on the teachings of Fan and Gong. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Fan and Gong and Soltz’s to obtain the invention specified in claim 1.
Regarding limitation II, Kilbride et al. teaches an apparatus for the cryopreservation of biological samples using a cryopreservation agent (CPA) (abstract). Specifically, Kilbride et al. the usage of a plurality of sensors located in the cavity or container, which allows an automated liquidus tracking vitrification to be performed with CPA concentration being modulated in response to readings from a sensor or sensors in the cavity or container (para. [0053]). This further allows a programmed amount of additional cryopreservation agent or cryopreservation medium to be introduced in response to readings obtained from a sensor or a plurality of sensors located in the cavity or sample container (para. [0053]).
It would have been obvious of one of ordinary skill in the art to use Kilbride et al.’s teaching of sensors located in the cavity or sample container for monitoring CPA concentrations in Soltz’s loading device because the sensors enable a programmed amount of additional cryopreservation agent or cryopreservation medium to be introduced in response to readings obtained from the sensor. This method of improving Soltz’s loading device was within the ability of one of ordinary skill in the art based on the teachings of Kilbride et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kilbride et al. and Soltz to obtain the invention specified in claim 1.
Regarding claim 2, modified Soltz teaches the loading apparatus of claim 1. Soltz also teaches that the loading mechanism comprises an attachment feature secures the biological material in a fixed position (“the device 100 has a clamp bar 114 to clamp on the tissue” (p. 22, Col. 9, 3rd Paragraph). Soltz also teaches a compression mechanism (piston – interpreted as including pneumatic piston in claim 1 - 103 rejection above) that compresses the biological material.
Regarding claim 3, modified Soltz teaches the loading apparatus of claim 2. Soltz also teaches “Thereafter, the load cell assembly 106 has the movable platen 120 moving toward the stationary plate 122 to compress the tissue T (as shown in FIG. 6) to apply a predetermined load on the tissue” (p. 22, Col 10, 2nd paragraph). Structurally, when the device is applying a predetermined load, the device is maintaining a compression pressure applied to the biological material. Furthermore, the piston of claim 2 encompasses a pneumatic piston system of claim 3. Therefore, the claim is prima facie obvious.
Regarding claim 4, modified Soltz teaches the loading apparatus of claim 1. Soltz also teaches the pusher (element 116) may be a piston or similar structure (this is interpreted to include pneumatic pistons) (p. 22, Col 9, 4th paragraph).
Regarding claim 6, modified Stolz teaches the device of claim 1. Stolz also teaches that the loading apparatus features measurement features (specifically a load sensor). “The shaft assembly 104 also has a load cell assembly 106. The load cell assembly 106 includes a transducer which converts a force into a measurable electrical output” (p. 21, Col. 8, 7th paragraph). Thus, the claim is prima facie obvious.
Regarding claim 7, modified Stolz teaches the device of claim 1. Fan and Gong also teaches seal plugs (element 106) that act as ports that can be fluidly coupled to one or more tubes (inlet pipe (element 107) and outlet pipe (element 115) and liquid pump (liquid driving device – element 102) (para. [0048] of MT). The ports, tubes, and liquid pumps would be structurally capable to facilitate introducing the cryopreservation agent, therapeutic agent, restoration agent, or the combination thereof into and/or out of the enclosure.
Regarding claim 8, modified Stolz teaches the loading apparatus of claim 1. Fang and Gong teaches an enclosure (culture chamber 103) made of a material (glass, plastic (inert materials)) to provide a sterile closed environment for the tissue (element 109) to be cultured (para. [0050] of MT, Fang and Gong). The inert materials of glass or plastic are also non-ferromagnetic materials, and would therefore be structurally capable of avoiding generating artifacts during imaging. Thus, the combination of references of claim 1 would encompass a structure of an enclosure constructed of inert materials.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Soltz (already referenced), Fang and Gong (already referenced), and Kilbride et al. (already referenced) as applied to claim 1 above, and further in view of Ally (US 20180292051 A1) (referenced in 892).
Regarding claim 5, modified Soltz teaches the loading apparatus of claim 1. Modified Soltz (Fan and Gong) teaches an enclosure as a bioreactor, specifically as a tissue engineering reactor for tissue cultures (para. [0002] of MT). Modified Soltz fails to teach a cryopreservation storage unit comprising a cryogenic unit that maintains biological material at a temperature ranging from -80 °C to -196 °C. Ally teaches a cryogenic storage system for biological samples (para. [0001]) including tissue samples (para. [0040]), wherein the storage system also includes a cryogenic storage container that holds a storage space therein at a desired temperature within a range of about −190° C. to about −120° C (para. [0014] and [0040]). Ally further teachers that the storage system enables samples on the storage rack can be returned to a cryogenic environment quickly to avoid thermal-inducted degradation of samples (para. [0012]).
It would have been obvious of one of ordinary skill in the art to use Ally’s teaching of a cryogenic storage system in Soltz’s loading device because a cryogenic storage device enables samples to be returned to a cryogenic environment quickly to avoid thermal-inducted degradation. This method of improving Soltz’s loading device was within the ability of one of ordinary skill in the art based on the teachings of Ally. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ally and Soltz to obtain the invention specified in claim 5.
Furthermore, it has been established that in the case where claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP § 2144.05 I). The claimed range of -80 °C to -196 °C overlaps or lies inside the range disclose by the prior art (−190° C. to about −120° C). It would have been prima facie obvious to one of ordinary skill in the art to use the claimed range because tissue samples require continuous storage at cryogenic temperatures of −120° C. or less (Ally, para. [0040]). Thus, the claimed range is prima facie obvious.
Response to Arguments
Applicant’s arguments, see p. 7, filed on 07/02/2026, with respect to the claim rejection under 35 U.S.C 112 (a) and 35 U.S.C 112 (b) have been fully considered and are persuasive. The claim rejections of claims 3 and 5 have been withdrawn.
Applicant’s arguments, see p. 8-9, filed 07/02/2026, with respect to the rejections of claims 1-8 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Soltz (US 8551025 B2), Fan and Gong (CN 101381677) and Kilbride et al. (US 20200229427 A1).
Conclusion
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.
/J.F.Y./ Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
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