DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 were previously pending in the instant application.
Applicant submitted an amended claim set on 17 December, 2025 with no claims directed to the composition previously examined in the non-final rejection mailed 18 August, 2025. This response necessitated the restriction requirement mailed on 15 April, 2026 to which Applicant has now responded.
Applicant’s election of the invention of group II drawn to a method of preserving a biomaterial (claims 9-11) in the reply filed on 12 June, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Receipt is acknowledged of the amendments to the claims submitted on 12 June, 2026. Claims 13-14 are amended to correct dependency. Claims 15-20 are newly added.
Claims 1-8, and 12-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The terminal disclaimer filed on 12/17/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of U.S. Patent Application No. 17/601861 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Thus, claims 9-11, and 15-20 are pending and under examination in the present Official Action. Since every ground of rejection presented herein is necessitated by Applicant’s amendments to the claims which removed claims drawn to the composition previously examined, this action is final.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/JP2021/006281, filed 19 February, 2021, which claims priority to Japan Application No. JP2020-028227, filed 21 February, 2020. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified untranslated copies of papers required by 37 CFR 1.55 have been filed in this application on 19 August, 2022.
The earliest possible priority for the instant application is 21 February, 2020.
Drawings
The drawings submitted on 19 August, 2022 are accepted by the Examiner.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 17 December, 2025, and 21 May, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Withdrawn Rejections/Objections in view of Applicant’s Amendments to the claims
Claim Objections
The objection to claim 7 is withdrawn because claim 7 is no longer under examination. Applicant has amended claim 7 to read on a non-elected invention, rendering this objection moot.
Claim Rejections - 35 USC § 102
The rejection of claims 1-8 under 35 U.S.C. 102(a)(1) as being anticipated by US 2003/0104347 A1 (Published: 5 June, 2003) (hereinafter “Mori”) (of record) is withdrawn in view of Applicant’s amendments to the claims. Applicant has withdrawn claims 1-8 reading on a non-elected invention in response to the supplemental restriction send on 4/15/2026, rendering this rejection moot.
Double Patenting
The provisional rejection of claims 1-8 on the ground of nonstatutory double patenting as being unpatentable over claims 11-22 of copending Application No. 18027892 (reference application) is withdrawn in view of Applicant’s amendments to the claims. Claims 11-22 of the reference application have been cancelled and claims 23-30, and 33-37 are drawn to distinct methods of modifying a cell population comprising a 3D culture step whereas the instantly pending claims are drawn to a preserving system, a method of preserving, and a method of transporting. Therefore, this rejection has been rendered moot by Applicant’s amendments to the claims.
The provisional rejection of claims 1-8 on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 17601861 (reference application) is withdrawn in view of Applicant’s filing of a terminal disclaimer over the reference application.
New Rejections
As mentioned at the beginning of this Official Action, Applicant has amended the claims such that no claims read on the previously examined invention. Applicant has presented and elected the invention of claims 9-11, and 15-20 to which the following grounds of rejection are applicable. All rejections presented herein are, consequently, necessitated by amendment.
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 15-17 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 15 recites the limitation "the gel phase" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Neither claim 15 nor claim 9 from which it depends recites a gel phase. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
Claim 15 also recites the limitation "maintaining" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 from which claim 15 depends does not recite a step of maintaining. Rather, claim 9 recites a step of preserving. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
Claim 16 recites the limitation "maintaining" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 9 from which claim 16 depends does not recite a step of maintaining. Rather, claim 9 recites a step of preserving. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
Claim 17 recites the limitation "the maintaining" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim. Neither claim 17 nor claim 9 from which it depends recites a step of maintaining. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
The term “substantially” in claims 16-17 is a relative term which renders the claim indefinite. The term “substantially” 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 metes and bounds of the term “substantially” cannot be determined and a person having ordinary skill in the art would not know how much proliferation must be reduced to be considered “not substantially proliferate”. Therefore, a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 15, 16, and 17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 15-17 all depend on claim 9 which requires “a constant or variable temperature ranging from 4°C to 30°C”. Claims 15-17 do not further limit the temperature of 4°C to 30°C. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
Claims 9-11, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2003/0104347 A1 (Published: 5 June, 2003) (hereinafter “Mori”) (of record) as evidenced by Rieder et al. Cell cycle 1.3 (2002): 168-174, hereinafter “Rieder”.
Regarding claim 9, Mori discloses a thermoreversible (“heat-reversible”) polymer for the preservation of biological tissues (Mori, Abstract). The broadest reasonable interpretation of “biomaterial” encompasses the biological tissues of Mori. The polymer of Mori is a hydrogel that undergoes a solution (sol) to gel (gel) transition with changes in temperature and Mori discloses that the gel is thermos-reversible (Mori, Abstract, [0018], Fig. 1). Mori also discloses a method of preserving biological tissues comprising applying the composition in the solution (sol) state (10 degrees C) to a living organism tissue, then raising (varying) the temperature to convert the composition to a gel state (a temperature higher than the sol-gel transition temperature) and coat the tissue (Mori, FIG. 1; [0021]-[0024]). Mori also discloses that the sol-gel transition of their compositions are 10, 20, or 35 degrees C (Mori, [0207]) and that the temperature at which the tissue is preserved is not more than 20 degrees C (Mori, [0189]). Mori also discloses preservation for 2 to 7 days (Mori, [0168]-[0171]). Mori discloses that the tissue can be skin (Mori, [0161]). The proliferation rate of skin at not more than 20 degrees C is necessarily lower than 1/5th of the proliferation rate of skin at 37 degrees C as evidenced by Rieder who teaches that the mitotic index of most mammalian cell cultures shifted to 19 degrees C from 37 degrees C falls to near-zero (Rieder, page 169, fourth paragraph; Figure 2). Therefore, Mori anticipates the invention of instant claim 9.
Regarding claims 10 and 11, Mori discloses that the tissue can be gullet, stomach, small intestine, colon, pancreas, liver, skin, blood vessel, bone, cornea, red blood cells, white blood corpuscle, blood platelet, T cells, dendritic cells, embryo cells, embryonic stem cells, or fertilized ovum (Mori, [0161]-[0165]).
Regarding claims 15-17, Mori discloses a variety of mammalian tissues and a preservation temperature not more than 20 degrees C and these mammalian tissues necessarily have a near-zero proliferation rate as evidenced by Rieder who teaches that the mitotic index of most mammalian cell cultures shifted to 19 degrees C from 37 degrees C falls to near-zero (Rieder, page 169, fourth paragraph; Figure 2). The broadest reasonable interpretation of both a 1/10 and a 1/20 proliferation rate encompasses a near-zero proliferation rate.
Therefore, Mori anticipates the invention claimed in instant claims 9-11, and 15-17.
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.
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.
Claims 9 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0104347 A1 (Published: 5 June, 2003) (hereinafter “Mori”) (of record) as evidenced by Rieder et al. Cell cycle 1.3 (2002): 168-174, hereinafter “Rieder” in view of Michel et al. Heart, lung and vessels 7.3 (2015): 246, hereinafter “Michel”, and Ekerdt et al. Advanced healthcare materials 7.12 (2018): 1800225, hereinafter “Ekerdt”.
Mori discloses a thermoreversible (“heat-reversible”) polymer for the preservation of biological tissues (Mori, Abstract). The broadest reasonable interpretation of “biomaterial” encompasses the biological tissues of Mori. The polymer of Mori is a hydrogel that undergoes a solution (sol) to gel (gel) transition with changes in temperature and Mori discloses that the gel is thermos-reversible (Mori, Abstract, [0018], Fig. 1). Mori also discloses a method of preserving biological tissues comprising applying the composition in the solution (sol) state (10 degrees C) to a living organism tissue, then raising (varying) the temperature to convert the composition to a gel state (a temperature higher than the sol-gel transition temperature) and coat the tissue (Mori, FIG. 1; [0021]-[0024]). Mori also discloses that the sol-gel transition of their compositions are 10, 20, or 35 degrees C (Mori, [0207]) and that the temperature at which the tissue is preserved is not more than 20 degrees C (Mori, [0189]). Mori also discloses preservation for 2 to 7 days (Mori, [0168]-[0171]). Mori discloses that the tissue can be skin (Mori, [0161]). The proliferation rate of skin at not more than 20 degrees C is necessarily lower than 1/5th of the proliferation rate of skin at 37 degrees C as evidenced by Rieder who teaches that the mitotic index of most mammalian cell cultures shifted to 19 degrees C from 37 degrees C falls to near-zero (Rieder, page 169, fourth paragraph; Figure 2).
Regarding claim 18, Mori does not disclose transporting the biomaterial in a first container including the thermoreversible gelation polymer and a temperature control element.
Mori does teach that the method of preservation is particularly preferred to allow for the carrying or transporting of the preserved tissue (Mori, [0066]). Michel teaches a device for the transportation of living tissues (Michel, Title; Abstract). The device of Michel includes a container and a temperature control element (cooling mechanism to provide “safe, consistent method for cold ischemic storage and transport of donor organs”)(Michel, Figure 1, Figure 2; page 248, third paragraph). Michel teaches that the device consistently keeps the temperature of tissue within at 4 to 8 degrees C across variable exterior temperatures to prevent cold injury of the tissue within (Michel, Abstract).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used the device of Michel to transport the tissue preserved in a thermoreversible polymer of Mori and to have arrived at the invention claimed in instant claim 18 with a reasonable expectation of success because they would have been motivated to do so to keep the tissue at a consistent temperature during transport to reduce cold injury of the tissue as taught by Michel. There would have been a reasonable expectation of success in doing so insofar as Mori teaches to transport the preserved tissue and Michel teaches an optimal device for the transport of preserved tissues.
Regarding claim 19, Mori teaches to filter the thermoreversible gelation polymer to produce a low-molecular weight fraction and a high-molecular weight fraction with a molecular weight cutoff of 30,000 (Mori, [0199]).
Mori does not teach to use a molecular weight cutoff of 100,000 in the filtration step.
However, Mori does teach to use poly(N-isopropyl polyacrylamide) and teaches to use an open-ended list of hydrophilic blocks (Mori, [0118], [0132]). Ekerdt teaches thermoreversible poly(N-isopropyl polyacrylamide)-hyaluronic acid (HA-PNIPAAm) hydrogel solutions and teaches to filter them through a 100,000 molecular weight cutoff (MWCO) filter prior to use (Ekerdt, page 10, fourth paragraph). Ekerdt teaches that the filtration was done to remove unreacted reaction components and teaches that the HA-PNIPAAm hydrogels with higher molecular weights had a lower critical solution temperature (LCST) which prevented significant hydrogel loss over time (Ekerdt, page 4, second paragraph; page 9, third paragraph). Ekerdt also teaches that the HA-PNIPAAm hydrogels can be used to expand cells, incorporate biochemical cues, and then inject directly into the body for transplantation applications via a tunable system (Ekerdt, page 9, “Conclusions”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used HA-PNIPAAm filtered with a 100,000 MWCO filter as taught by Ekerdt as the thermoreversible polymer in the method of Mori and Michel and to have arrived at the invention claimed in instant claim 19 with a reasonable expectation of success because they would have been motivated to do so to leverage a tunable hydrogel system that can be used to expand cells, incorporate biochemical cues, and then inject directly into the body for transplantation applications. Further, they would have been motivated to use the 100,000 MWCO filter to remove unreacted reaction components, prevent significant hydrogel loss over time. There would have been a reasonable expectation of success in combining Ekerdt, Mori, and Michel insofar as Mori teaches to use poly(N-isopropyl polyacrylamide) with a hydrophilic block while Ekerdt teaches poly(N-isopropyl polyacrylamide) with a hyaluronic acid block which benefits from filtration with a 100,000 MWCO to remove unreacted components and prevent significant hydrogel loss over time.
Regarding claim 20, the device of Michel places a tissue in a second container within a first container in which there is a temperature control element, Ekerdt teaches HA-PNIPAAm filtered with a 100,000 MWCO filter, and Mori teaches that the tissue can be cells. With regard to the functional property of “the proliferation of the cell tissue after transport in the thermoreversible gelation polymer is significantly higher than the proliferation of the cell tissue after transport in a phosphate-buffered saline (PBS)”, it is noted that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus, for the purpose of applying prior art, a disclosure of an identical or substantially identical product is presumed to inherently possess the claimed properties. See MPEP 2112.01. Here, all structural limitations of claim 20 are rendered prima facie obvious by Mori, Michel, and Ekerdt. Thus, the method of Mori, Michel, and Ekerdt is presumed to inherently possess the claimed property of “the proliferation of the cell tissue after transport in the thermoreversible gelation polymer is significantly higher than the proliferation of the cell tissue after transport in a phosphate-buffered saline (PBS)”.
Conclusion
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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