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 .
Response to Amendments
Applicant's amendments filed 9/8/2025 to claim 9 has been entered. Claims 1-13 and 17-19 remain pending, of which claims 9-13 and 17-19 are being considered on their merits. Claims 1-8 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and applicant’s comments.
Election/Restrictions
Applicant’s election of Group II, and the species of polypeptide being “CBE3”, corresponding to the SEQ ID NO: 11, in the reply filed on 12/27/2022, stands. Claim 9 has been amended to recite SEQ ID NO: 12, which is generic to the elected species of SEQ ID NO: 11. Regarding dependent claims 12-13, the claimed SEQ ID NO: 12 is generic to the claimed SEQ ID NO: 1.
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 19 is 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.
Dependent claim 19 recites the limitation “wherein the cell mass is in a form of cell sheet“. However, independent claim 9 recites the limitation “wherein the cell mass or the cell structure is not a cell sheet”. It is unclear how the cell mass can both be in the form of a sheet, and not be a cell sheet. As such, the metes and bounds of the claim are unclear. Clarification within the claim is required.
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 18-19 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.
Dependent claim 18 recites the limitation “wherein the cell is in a form of cell mass or cell structure“. However, independent claim 9 limits to the cells being a “cell mass or the cell structure”. Therefore claim 19 fails to further limit the subject matter of the claim upon which it depends.
Dependent claim 19 recites the limitation “wherein the cell mass is in a form of cell sheet“. However, independent claim 9 recites the limitation “wherein the cell mass or the cell structure is not a cell sheet”. Therefore claim 19 fails to include all the limitations of the claim upon which it depends.
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.
Response to Arguments
Applicant's arguments filed 9/8/2025 have been fully considered as they apply to these new grounds for rejection, but they are not persuasive.
Applicant’s arguments together with the claim amendment limiting Condition X to being broadly based on "an area of maximum molecular weight peak" (emphasis added), overcome the prior reasons for indefiniteness.
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.
Claims 9-13 and 17-19 remain rejected under 35 U.S.C. 103 as being unpatentable over Yamashita et al (U.S. PGPUB 2016/0121025) in view of Iwazawa et al (U.S. PGPUB 2013/0071441) and Ohyabu et al (2014, J. Biosci. Bioeng. 118(1) 112-115).
Regarding claim 9, Yamashitais drawn to cell constructs for cell transplantation (see abstract and paragraph [0049]). Regarding claims 9 and 17-18, Yamashita teaches a method of preparing the cell constructs comprising stacking sheet-like cell aggregates with a diameter of over 100 μm said method comprising adding said sheet-like cell aggregates to a phosphate buffer solution (PBS) with gelatin hydrogel, said gelatin being either dissolved or alternatively in the form of dispersed gelation hydrogel particles (dispersed gelation hydrogel particles reads on blocks disposed in gaps between a plurality of cells), and alternating layers of the gelatin solution with the sheet-like cell aggregates (see paragraphs [0061] and [0108]-[0109], and Figure 2); Yamashitais’ “sheet-like cell aggregates” reads on the broadest reasonable interpretation of “not a cell sheet” as Yamashitais defines it as “sheet-like”. Regarding claims 9 and 17-19, Yamashita teaches adding the PBS solution containing gelatin hydrogel onto cell aggregate surface and allowing them to stand at 37 C for 10 or more minutes wherein the hydrogel undergo swelling in the solution (see paragraph [0108]). Therefore, regarding claim 9 step (i), Yamashita teaches a solution of gelatin (reads on polypeptide), layered with cell structures such that said gelatin solution is added between each of the cell structure and the combination is then held at 37 C (see paragraphs [0108]-[0109]), and this teaching reads on “immersing” the cell structure in gelatin (reads on polypeptide) solution, so that it is “embedded in a dispersed state” as the cell structure have said gelatin solution underneath and above them.
Regarding claims 9 and 17-19, Yamashita teaches that room temperature (which is considered to be 25 C or higher) is a returning temperature for obtaining a cultured cell construct which has been prepared and subjected to a different temperature treatment (see paragraph [0119]); reads on returning the polypeptide to a solution at 25 C or higher. Additionally, Yamashita teaches that the cells are grown and maintained at 37 C (see paragraphs [0046], [0089], [0108] and [0119]); which also reads on returning the polypeptide to a solution at 25 C or higher. and there Therefore, regarding claim 9 step (iv), Yamashita teaches that the product of the cell construct is at a temperature of 25 C or higher for its use. Regarding claim 9, Yamashita teaches the cell construct with gelatin hydrogel is useful for cell transplantation therapeutics (see paragraph [0007] and [0002]); reads on transporting). Regarding claim 19, Yamashita teaches it is useful for the cell construct to be in the form of a cell sheet (see abstract).
Yamashita does not teach the gelatin polypeptide sequence or properties (claims 9-13). Yamashita does not teach that the composition of cells immersed in the gelatin peptide solution are gelled to embed the cells for a transfer step (claim 9 steps (ii) - (iii)), Yamashita does not teach all of the different temperatures recited in claim 17.
Regarding claim 9, like Yamashita, Iwazawa is also drawn to cell constructs that are in the form of cell aggregates for cell transplantation (see title and abstract). Regarding claims 9-13, Iwazawa teaches a modified gelatin, termed CBE3, that is useful for said cell constructs in the form of cell sheets or aggregates with diameters over 100 μm, and specifically for beneficially dispersing gelatin blocks with/between said cell constructs, and Iwazawa teaches this polypeptide has the same sequence as instant SEQ ID NO: 1 (See Iwazawa SEQ ID NO: 1 and paragraphs [0083]-[0084], [0134]-[0135], [0160], [0168] – [0171] and Example 1). Regarding claim 9, Iwazawa teaches that this is a preferred polypeptide for biocompatibility that is a modified gelatin also having characteristics of collagen (see paragraphs [0087] and [0109]-[0117]). Regarding claim 9, Iwazawa, SEQ ID NO: 12 is generic to SEQ ID NO: 1, so Iwazawa’s SEQ ID NO: 1 also anticipates SEQ ID NO: 12 12 which reads on “Formula (1)”. Furthermore, Iwazawa also teaches a generic sequence in paragraph [0032] and reads on “Formula (1)”. Regarding claim 11, Iwazawa teaches the molecular weight is between10 KDa to 90 KDa (see paragraph [0102]).
Regarding claim 9, Ohyabu teaches that there is a need to safely transport cell constructs to clinical sites for transplantation, and that dispersing and embedding said cell constructs in gelatin is a useful means to protect said cells during transportation (see page 112). Regarding claim 9, Ohyabu teaches gelatin solution at 37 C is fluid, and that rapid gelation occurs by decreasing temperature, and rapid melting of gels occurs by increasing temperature to 37 C, and that this property is essential for a cell transportation carrier (see page 114). Regarding claim 9, Ohyabu further teaches that the first stage of cell transportation is allowing cell culture solution containing gelatin to reach a temperature of 37 C, and then, the solution containing cells and fluidity of gelation solution can be placed in a refrigerator (which temperature is considered to be 4 C or lower). Regarding claim 9 steps (ii) and (iii), Ohyabu teaches this stage of the cell transportation allows encapsulating (reads on embedding) of the cells in a rigid gelatin hydrogel (reads on gelling) which offers an advantage to eliminate shear stresses generated by turbulence of the containers during said cell transportation (see page 114). Therefore, regarding claim 9 steps (ii) and (iii), Ohyabu teaches that for transportation of cells, embedding the cells in a gelled rigid gelatin hydrogel offers an advantage to eliminate shear stresses generated by turbulence of the containers during said cell transportation.
It would have been obvious to combine Yamashita and Iwazawa to use Iwazawa’s modified gelatin in Yamashita’s method to prepare cell constructs in the form of aggregates for transplantation. A person of ordinary skill in the art would have had a reasonable expectation of success in using Iwazawa’s modified gelatin with cell constructs in the form of cell aggregates in Yamashita’s method because Iwazawa teaches it is compatible with cell constructs, including sheets and aggregates, for transplantation. The skilled artisan would have been motivated to use Iwazawa’s modified gelatin with cell constructs in the form of cell aggregates in Yamashita’s method because Iwazawa specifically teaches cell constructs in the form of cell aggregates with Iwazawa’s modified gelatin are useful for transplantation, and Iwazawa teaches that this is a preferred polypeptide for biocompatibility that is a modified gelatin also having characteristics of collagen.
It would have been obvious to combine Yamashita and Ohyabu to lower the temperature to below 4C for gelling during the transport before rewarming to Yamashita’s working temperature. A person of ordinary skill in the art would have had a reasonable expectation of success in lowering the temperature to below 4C for gelling during the transport before rewarming to Yamashita’s working temperature because Ohyabu teaches it is useful to refrigerate samples like Yamashita’s. The skilled artisan would have been motivated to lower the temperature to below 4C for gelling of the gelatin to embed the cells therein during the transport before rewarming to Yamashita’s working temperature because Ohyabu teaches it can protect the samples during transport, and Yamashita specifically teaches that the cells can be used for transplantation, which requires transportation to the patient, and that they can be cultured, in which case transportation to other laboratories or laboratory locations is also useful.
Regarding the properties of the polypeptide in claim 9, Iwazawa teaches a modified gelatin termed CBE3, with a sequence identical to the claimed modified gelatin termed CBE3, and therefore Iwazawa’s modified gelatin termed CBE3 appears to possess the inherent property of the CBE3 if an area of the maximum molecular weight peak in molecular weight distribution measurement by gel permeation chromatography is 80% or more of the total area of all of the molecular weight peaks in the CBE3. Alternatively, it would be obvious to modify Iwazawa’s CBE3 because Iwazawa also teaches that a generic sequence identical to claimed SEQ ID NO: 12 can be used in Iwazawa’s method. A person of ordinary skill in the art would have had a reasonable expectation of success in modifying Iwazawa’s CBE3 because Iwazawa teaches a generic sequence that can be modified. The skilled artisan would have been motivated to modify Iwazawa’s CBE3 because Iwazawa specifically teaches a generic sequence that can be modified.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Response to Arguments
Applicant's arguments filed 9/8/2025 have been fully considered but they are not persuasive.
Applicant highlights that in Yamashita, the gelatin hydrogel particles are placed as particles between the cell sheet layers, whereas the claims limit to the cell mass or cell structure not being a sheet. As an initial matter, as stated above, Yamashitais’ “sheet-like cell aggregates” reads on the broadest reasonable interpretation of the claimed cell mass or cell structure that not a cell sheet as Yamashitais specifically defines it as “sheet-like cell aggregate”. Additionally, as stated above, Iwazawa specifically teaches cell constructs in the form of cell aggregates with gelatin are useful for as cell constructs for transplantation, and therefore it is also obvious to combine Yamashita and Iwazawa to use cell constructs in the form of cell aggregates for transplantation.
Applicant highlights that claim 9 limits to the cell mass or cell structure being embedded in a dispersed state, and alleges that this feature is not taught by Yamashita. Applicant further alleges that Iwazawa does not teach a polypeptide solution where the cell is immersed is gelled to obtain a gel product in which the cell is embedded, and concludes that Iwazawa does not cure the deficiencies of Yamashita. However, as stated above, Yamashita teaches the solution of gelatin and the cell structures are layered such that said gelatin solution is added between each of the cell structures, and this teaching reads on embedding in a dispersed state as the cell structures have said gelatin both underneath and above them. While Yamashita does not specifically teach lowering the temperature to gel the gelatin, as stated above, this feature is obvious over the Ohyabu reference. Specifically, Ohyabu teaches that there is a need to safely transport cell constructs to clinical sites for transplantation, and that dispersing and embedding said cell constructs in gelatin is a useful means to protect said cells during transportation. Ohyabu further specifically teaches that this can be accomplished by lowering to temperature to gel the gelatin such that the cell construct is encapsulated (embedded) in the gelled gelatin. Therefore, this limitation is obvious over the combination of Yamashita in view of Ohyabu, and this argument is not persuasive.
Applicant summarizes the teachings of Ohyabu, noting that Ohyabu teaches the solution containing gelatin is fluid when it is combined with the cells. The examiner does not disagree. It is noted that just as taught by both Yamashita and Ohyabu, the claimed method also limits to combining the cell construct with a gelatin solution, and a solution is fluid.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 9-13 and 17-19 remain rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-12 of U.S. Patent No. 9,211,266,
claims 1-3 and 16 of U.S. Patent No. 10471180,
claims 1-6 of U.S. Patent No. 11027044, or
claims 1 and 11-13 of U.S. Patent No. 12018282 (previously copending Application No. 16870388),
when any are taken in view of Yamashita et al (U.S. PGPUB 2016/0121025) and Ohyabu et al (2014, J. Biosci. Bioeng. 118(1) 112-115).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claims 1-12 of ‘266 are drawn a cell construct for cell transplantation, which comprises polymer blocks of biodegradable material wherein the polymer block is a recombinant peptide and cells, wherein the plural polymer blocks are arranged in spaces between the plural cells, wherein the recombinant an amino acid sequence of SEQ ID NO:1 that has 100% sequence identity to instant SEQ ID NO:1. The combination of cells with the gelatin also renders obvious the immersing step.
Claims 1-3 and 16 of ‘180 claim a method of cell transplantation comprising transplanting the cell structure into a subject site, wherein the cell structure comprises
biocompatible macromolecular block and at least one kind of cell and has voids and in which a plurality of the biocompatible macromolecular blocks are arranged in gaps between a plurality of the cells, wherein the biocompatible macromolecular block is a recombinant gelatin peptide that has the amino acid sequence of SEQ ID NO:1 that has 100% sequence identity to instant SEQ ID NO:1. The combination of cells with the gelatin also renders obvious the immersing step.
Claims 1-6 of ‘044 claims a method for producing a sheet-like cell structure, comprising: adding a biocompatible macromolecular block, a cell, and a liquid medium and immersing the biocompatible macromolecular block which is recombinant gelatin and cell wherein the gelatin has the amino acid sequence of SEQ ID NO:1 that has 100% sequence identity to instant SEQ ID NO:1, and wherein the SEQ ID NO:1 reads on instant Formula 1 set forth in instant claim 1. The combination of cells with the gelatin also renders obvious the immersing step.
Claims 1 and 11-13 of ‘282 claim a method of producing an insulin producing cell comprising biocompatible macromolecular block and plurality of mesenchymal stem cell wherein biocompatible macromolecular block is a recombinant peptide are arranged in a gap between the cells. Said recombinant peptide has formula: A-[(Gly-X-Y)n]m-B wherein X and Y is independently amino acid, n is 3 to 100, m is 2 to 10, and said peptide has the amino acid sequence of SEQ ID NO:1 that has 100% sequence identity to instant SEQ ID NO:1, which is the common subject matter of the instant claims 1 and 3-5. The combination of cells with the gelatin also renders obvious the immersing step.
The conflicting claims do not recite that the cells with the polypeptide in solution, and transported in a gel then returned to a solution. The conflicting claims do not recite all of the different temperatures recited in claim 17.
Yamashita teaches a method of stacking cell sheets (layered cell sheets) comprising adding to cell sheets a phosphate buffer solution (PBS) in which gelatin hydrogel can be either dissolved or alternatively gelation hydrogel can be dispersed, wherein the gelatin hydrogel is dissolved in the solution, and alternating layers of the gelatin solution with the cell sheets. Yamashita also teaches adding the PBS solution containing gelatin hydrogel onto cell sheet surface and allowing them to stand at 37 C for 10 or more minutes wherein the hydrogel undergo swelling in the solution. Therefore, regarding claim 9 step (i), Yamashita teaches a solution of gelatin (reads on polypeptide), layered with cell sheets such that said gelatin solution is added between teach of the layered cell sheets and the combination is then held at 37 C, and this teaching reads on “immersing” the cell sheet in gelatin (reads on polypeptide) solution as the cell sheets have said solution underneath and above. Yamashita teaches that the cells are grown and maintained at 37 C (see paragraphs [0046], [0089], [0108] and [0119]); which reads on returning the polypeptide to a solution at 25 C or higher. and there Therefore, regarding claim 9 step (iii), Yamashita teaches that the product of the cell sheet is at a temperature of 25 C or higher for its use. Regarding claim 9, Yamashita teaches the cell sheet with gelatin hydrogel is useful for cell transplantation therapeutics (see paragraph [0007] and [0002]); reads on transporting).
Ohyabu teaches gelatin solution at 37 C is fluid, and that rapid gelation occurs by decreasing temperature, and rapid melting of gels occurs by increasing temperature to 37 C, and that this property is essential for a cell transportation carrier (see page 114Ohyabu further teaches that the first stage of cell transportation is allowing cell culture solution containing gelatin to reach a temperature of 37 C, and then, the solution containing cells and fluidity of gelation solution can be placed in a refrigerator (which temperature is considered to be 4 C or lower). Ohyabu teaches this stage of the cell transportation allows encapsulating (reads on embedding) of the cells in a rigid gelatin hydrogel (reads on gelling) which offers an advantage to eliminate shear stresses generated by turbulence of the containers during said cell transportation (see page 114). Therefore, Ohyabu teaches that for transportation of cells, embedding the cells in a gelled rigid gelatin hydrogel offers an advantage to eliminate shear stresses generated by turbulence of the containers during said cell transportation.
It would have been obvious to combine any of the patents with Yamashita and Ohyabu to form and use the cell sheets in gelatin solution, and to lower the temperature to below 4C to gel the gelatin solution and embed the cells during transport. A person of ordinary skill in the art would have had a reasonable expectation of success in forming and use the cell sheets in gelatin solution, and lowering the temperature to below 4C to gel the gelatin solution and embed the cells during transport because Yamashita teaches gelatin in solution is useful for making cell sheets while Ohyabu teaches it is useful to refrigerate samples like Yamashita’s. The skilled artisan would have been motivated to form and use the cell sheets in gelatin solution, and lower the temperature to below 4C to gel the gelatin solution and embed the cells during transport because Yamashita teaches gelatin in solution is useful for making cell sheets while Ohyabu teaches it can protect the samples.
Response to Arguments
Applicant's arguments filed 9/8/2025 have been fully considered but they are not persuasive.
Applicant alleges that these rejections should be withdrawn based on their arguments above. However, as applicant’s arguments above were not persuasive, this argument is not persuasive.
Conclusion
No claims are free of the art. No claims are 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 Stephanie McNeil whose telephone number is (571)270-5250. The examiner can normally be reached Monday - Friday 9:30am - 5:30pm.
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/S.A.M/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653