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 .
Status of the Claims
Claims 1-30 are pending.
Claims 13-30 are withdrawn.
Applicant's election with traverse of Group I, claims 1-12 in the reply filed on 4/17/2026 is acknowledged. The traversal is on the ground(s) that the described groups do share a technical feature that is disclosed in the prior art, because Mogs fails to disclose a chip capable of moving relative to the carrier. Applicant was persuasive regarding the Mogs reference, however, the device of claim 1 (which is the shared technical feature of the described groups) is anticipated (as currently claimed) by a different reference, Sun (US9723831B2), as described below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-12 are examined.
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 1- 12 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.
Indefinite claims are listed below along with broadest reasonable interpretations of the claims as they appear.
“oil-phase thawing fluid”
Claim 1 recites the term “oil-phase thawing fluid”. The term “oil-phase thawing fluid” is not defined in the specification. No examples of an oil-phase thawing fluid are recited. In one instance the specification recites that “ In other embodiments, a non-oil-phase thawing fluid, i.e., a general thawing solution, can also be used for thawing-rewarming”. That is, an oil-phase thawing fluid is not a general thawing solution. (Specification [0048]). However, a “general thawing solution” is also not defined.
A search of the prior art did not provide a clear answer to the intended meaning of this limitation of the claim. It isn’t clear if this thawing solution must be some kind of oil, is only oil or a mixture, or if the solution just has to have certain undefined oil-like qualities.
For purposes of examination, any thawing solution comprising any amount of any kind of oil will be considered to be an “oil-phase thawing solution”.
“Front end”
Claim 1 recites the term “a carrier with a recess located near a front end of the carrier”. The term “near a front end” is a relative term which renders the claim indefinite.
The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “a front end” is also not defined by the claim, the specification does not provide a standard for ascertaining which end of a device would be a front end or some other end, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Additionally, the term “a front end” implies that there is more than one front end, which invites more confusion to what part of the claimed carrier is being described.
For the purposes of examination, “a recess near a front end” will be considered to be any recess of any dimension located in any part of the carrier.
“Basic solution”
Claim 1 recites the term “a basic solution”. No definition of “basic solution” is given in the specification. No examples are given for what a “basic solution” might be. The specification does not discuss pH, so the term “basic” can’t be construed as basic in the sense of a pH level. It appears that the most likely intended meaning of a “basic” solution would be a conventional or typical solution used for thawing of biological material. In other words, “a basic solution” appears to include virtually any solution used at any point in the process of thawing cryopreserved biological materials.
For purposes of examination, “a basic solution” must be construed to include virtually any solution.
“a chip encapsulating a chemical including a cryoprotectant and/or a basic solution”
Claim 1 recites the phrase “a chemical including a cryoprotectant and/or a basic solution”. The meaning of this phrase is unclear. Does this mean a chip encapsulating a single solution comprising a cryoprotectant and/or a basic solution? How does a chemical contain another chemical? It also appears in later claims that this chip may comprise a “chemical” that “includes” several different solutions that are used separately in different phases of the thawing process, which suggests that “a chemical” does not necessarily have to be a single composition.
For purposes of examination “a chemical” must be construed to mean any composition, including a series of separate compositions used in different stages of the thawing process.
“non-permeable cryoprotectant” Claim 2 recites a limitation for a “non-permeable cryoprotectant”. No definition is given. No examples of a non-permeable hydrogel are given. What does non-permeable refer to in this instance? The cryoprotectant is non-permeable to what? Or does this mean that the cryoprotectant does not permeate other compositions? The specification recites that, in an example, the non-permeable cryoprotectant has different concentrations when a part of different hydrogels namely 0.5-1.5M, “a concentration lower than the concentration of the TS gel” or 0.1M-0.75M. (Spec. [0038])
For purposes of examination, a non-permeable cryoprotectant will be considered to read on any conventional cryoprotectant.
“the [hydrogels] move sequentially to an upper side of the recess”
The term “upper side of the recess” in claim 9 is a relative term which renders the claim indefinite. The term “upper side” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite direction, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what would differentiate an upper or lower side of the recess. It is unclear what is meant by an “upper side” in relation to what other part of the apparatus?
For purposes of examination, an “upper side” will be considered to by any part of the recess.
Claim 9 recites “The second dilution solution contains…a plurality of sections for embedding a second dilution hydrogel”.
Here it appears that “the chemical” is also claimed to comprise multiple different solutions, but that the “solutions” are in the form of hydrogels. How does a solution have different “sections” for embedding of a hydrogel?
It is also not clear how a solution comprises a section for the insertion of anything? This phrase is so indefinite that it effectively can’t have patentable weight since it is impossible to discern the meaning.
“interstice distance”
Claim 11 recites the term “interstice distance”. Interstice typically means a space that intervenes between things, or a gap or break in something generally continuous. It is not clear if this is meant to be a limitation directed to the size of the gap, or dimensions of the gap, or that there simply just is a gap between these components of any dimension.
Thus, in this case “interstice distance” is a relative term which renders the claim indefinite. The term “interstice distance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
For purposes of examination, any gap that exists for any period of time will read on an “interstice distance”.
Claims 2-12 are rejected for being dependent on indefinite claims.
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.
(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.
Sun
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Sun (US9723831B2)
Regarding claim 1 and 7, Sun teaches automated methods for cryopreserving and thawing biological material. (Sun, column 7, lines 25-50).
Regarding the “carrier” limitation, Sun’s device comprises a frozen straw containing cryopreserved embryos and cryoprotectant. This straw (carrier) contains an opening at one end (recess at the front end) in which the embryo frozen in vitrification solution (material to be thawed and a cryoprotectant) is loaded. (Sun, column 12-14, Fig. 2 and 3, 303). Sun teaches a carrier with a recess located near the front end of the carrier, in which a biological material to be thawed and a cryoprotectant are loaded.
Regarding the “container for loading” limitation, when Sun’s device is configured to thaw the cryopreserved embryos, Sun’s device comprises a multi-well dish comprising a pre-warmed thawing solution, a dilution solution, and a washing solution. In operation, the vitrification straw is plunged into the pre-warmed thawing solution, covering the opening of the straw and causing the thawing solution to contact the cell and cryoprotectant inside the vitrification straw. (Sun, column 14, Step 0, FIG 3.). Thus, Sun teaches a container (one of the wells in the the multi-well plate) for loading a thawing fluid, which is used to cover the recess of the carrier immersed therein (immersion of the opening of the vitrification straw) to thaw and rewarm the biological material. Regarding an oil phase thawing fluid, the container is configured to deliver effectively any thawing fluid, including oil-phase fluids or other fluids.
Regarding the “chip” limitation, Sun’s device comprises a multi-well dish comprising a pre-warmed thawing solution, a dilution solution, and a washing solution. In operation, the vitrification straw is plunged into the pre-warmed thawing solution, covering the opening of the straw and causing the thawing solution to contact the cell and cryoprotectant inside the vitrification straw. (Sun, column 14, Step 0, FIG 3.). The embryos are then released from the straw, and after thawing in the thawing solution (TS) they are aspirated into a micropipette and then introduced into a second solution, a dilution solution (DS) (i.e. a “basic solution”). The dilution solution/basic solution is contained in another well of the multi-well plate. That is, a separate well of the multi-well plate encapsulates dilution solution (basic solution) reads on the “chip” limitation. The micropipette also reads on a “carrier” with a recess (the opening of the micropipette). The micropipette moves to the well containing the basic solution. So, technically the carrier and the chip are moving “relative to” each other when the pipette is inserted into the dilution solution well / chip encapsulating basic solution. The pipette tip (recess) is completely inserted into the dilution solution, i.e. contacting the dilution solution (Chemical) in a “full-covering manner”, which removes the cryoprotectant in the recess (washes the cryoprotectant away from the embryo in the pipette). (Sun, column 14, Step 1, FIG 3.).
Sun anticipates claim 1.
Regarding claim 2 and 8, Sun’s multi-well plate contains a cryoprotectant, when the cryoprotectant (Sun refers to this as VS or vitrification solution) surrounding the embryo in the vitrification straw is deposited into the thawing solution well along with the embryo. “The straw is plunged into TS. The straw is gently shaken to let embryos fall off from the straw tip.” (Sun, column 14, Step 0(d), FIG 3.). Thus, the chemical solution contained in the “chip” comprises some amount of cryoprotectant. As explained in the 112(b) rejection above, for purposes of examination, a “non-permeable cryoprotectant” will be considered to read on any conventional cryoprotectant.
Claim Objections
Claim 9 is objected to because of the following informalities: typos. Claim 9 recites “…in the first dilution solutiona the comprises a plurality…”. It appears that the most likely interpretation is “…in the first dilution solution, which comprises a plurality…” Appropriate correction is required.
Allowable subject matter
Zhang, Chaocan et al. “Hydrogel Cryopreservation System: An Effective Method for Cell Storage.” International journal of molecular sciences vol. 19,11 3330. 25 Oct. 2018
Wang, Shanshan, et al. "A compact, high-throughput semi-automated embryo vitrification system based on hydrogel." Reproductive BioMedicine Online 48.5 (2024): 103769.
Roy, Tammie K., et al. "Embryo vitrification using a novel semi-automated closed system yields in vitro outcomes equivalent to the manual Cryotop method." Human Reproduction 29.11 (2014): 2431-2438.
Claims 3-6 and 8-12 are free of the art.
Regarding claim 3, 5-6, and 8-12 Sun’s chip comprises what they describe as a thawing solution (TS), a dilution solution (DS) and a washing solution (WS). (Sun, Fig. 3). However, Sun does not teach that these solutions are in hydrogel form, instead Sun teaches that these solutions are in liquid form. It does not appear that Sun’s method/apparatus would function with hydrogel substitutes since they seem to rely on allowing the embryo to rest in the liquid media for their method.
Hydrogels were known in the art to be useful for cryopreservation (Zhang, Abstract). And even in Zhang’s paper, the method seems to rely on encapsulation of cell aggregates in hydrogel, not necessarily using them interchangeably to replace conventional thawing solutions.
The use of hydrogels in a device for the delivery of thawing solution, dilution solution, and washing solution specifically for the thawing of biological materials appears to be novel. A paper published much later than the priorioty date of the application seems to share this opinion. (Wang, Conclusion).
Regarding claim 4, Sun’s chip comprises what they describe as a thawing solution (TS), a dilution solution (DS) and a washing solution (WS) which are in the form of liquid solutions. (Sun, Fig. 3). However, the wells appear to just be exposed to the air, and a covering or membrane is not mentioned by Sun or essentially elsewhere in the prior art.
There is another vitrification system that employs “seals” over a container comprising embryos to be vitrified. (Roy, Abstract) However, this seal is meant to prevent embryo or solution contact with liquid nitrogen. This seal ro even a membrane does not appear in the thawing steps. This membrane covering of the thawing cells appears to be a novel concept as well.
Conclusion
Claims 1-12 are rejected.
Claim 9 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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/THOMAS R. AMICK/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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