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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-25 and 39, drawn to a three-dimensional cellular microcompartment comprising at least one external hydrogel layer and inside said external layer at least one layer of cells and/or at least one cellular base layer, characterized in that less than 20% of the total population of cells present in the microcompartment are cells having at least one mutation.
Group II, claims 26-38, drawn to a method for preparing a three dimensional cellular microcompartment by preparing a suspension of cells comprising single cells and/or at least one cluster of cells in an isotonic medium, encapsulating the cellular suspension in a hydrogel layer, culturing the microcompartments in an isotonic solution comprising a apoptosis inhibitor, and rinsing the microcompartment so as to remove the apoptosis inhibitor, and culturing the microcompartments in an isotonic solution for at least two cell division cycles, and recovering the resulting microcompartments.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a three-dimensional cellular microcompartment comprising at least one external hydrogel layer and inside said external layer at least one layer of cells and/or at least one cellular base layer, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Feyeux (US 20190330589). Feyeux teaches a cellular microcompartment comprising at least one external hydrogel layer with at least one layer of cells and/or at least one cellular base layer (Abstract, Paragraphs 7-22 of Feyeux).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with E. Kate Berezutskaya on December 19, 2025 a provisional election was made with traverse to prosecute the invention of Group I, claims 1-25 and 39. Affirmation of this election must be made by applicant in replying to this Office action. Claims 26-38 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicants’ traversal was on the grounds that the method claims of Group II recited how to make the composition recited in Group I. In response, examiner would like to respectfully point out that the technical feature shared between Groups I and II is not special technical feature since Feyeux (US 20190330589) teaches a cellular microcompartment comprising at least one external hydrogel layer with at least one inner layer of cells and/or at least one cellular base layer (Abstract, Paragraphs 7-22 of Feyeux).
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1-25 are objected to because of the following informalities: “characterised” should be –characterized--. Appropriate correction is required.
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 2,8,13, and 20-22 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 2 recites “characterized in that the cells represent more than 50% by volume relative to the volume of the microcompartment, preferably more than 70% by volume relative to the volume of the microcompartment.” It is not clear if the amount of volume of the cells must be greater than 50% or 70% the volume of the microcompartment because the claim states that the preferred value is greater than 70%. It is not clear if the preferred range is required. The claim is indefinite because the metes and bounds are unclear.
Claim 8 recites, “characterized in that the cells having at least one mutation represent between 0 and 10% of the total population of cells present in the microcompartment, preferably between 0 and 5%.” The claim is indefinite because it is unclear if the require range is between 0 and 10% or the preferred range of 0 to 5%. It is not clear if the preferred range is required. Because of the indefiniteness of the claims, the metes and bounds of the claim cannot be determined.
Claim 13 recites that the intermediate layer of isotonic aqueous solution has a Young’s modulus between 0.05 and 3kDa. This limitation is indefinite because kDa is a unit for measuring molecular weight of compounds, not for measuring the Young’s modulus of isotonic aqueous solutions. For measuring the Young’s modulus for isotonic solutions, kPa is the appropriate unit, not kDa. Because the incorrect unit is applied, it is not clear what the actual Young’s modulus unit is. For purposes of examination, the examiner will interpret the limitation to be between 0.05 and 3 kPa, not kDa.
Claim 20 recites, “characterised in that it comprises at least 20 cells, preferentially at least 1000 cells.” Because the term preferentially is used, it is not clear if the cells required are “at least 20” or “at least 1,000.” Therefore, the metes and bounds cannot be adequately determined.
Claim 21 recites, “the microcompartment were obtained after at least two cell division cycles after encapsulation in an external hydrogel layer of at least one cell, preferentially between 1 and 50 cells.” Because the term preferentially is used, it is not clear if the cells required are “at least one” or “between 1 and 50 cells.” Thus, the metes and bounds cannot be adequately determined.
Claim 22, recites, “after at least 5 cell division cycles after the encapsulation in an external hydrogel layer of at least one cell, preferentially between one and fifty cells.” Because the term preferentially is used, it is unclear if the required cells are “at least one cell” or “between one and fifty cells.” Thus, the metes and bounds cannot be adequately determined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(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.
Claims 1,3-12,14-20,23-24, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feyeux (US 20190330589)
Feyeux discloses a three-dimensional cellular microcompartment comprising at least one external hydrogel layer and inside said external layer at least one layer of cells and/or at least one cellular base layer (Abstract, Paragraphs 7-22 of Feyeux). The Feyeux reference does not expressly state that the cells contain mutations. However, the Feyeux reference manufactures the same three-dimensional cellular microcompartment as claimed, uses an apoptosis inhibitor (RHO/ROCK), encapsulates the same cell types as applicants invention, and applies a hydrogel coating (Abstract and Paragraphs 7-22 of Feyeux). The conditions and cells used in the Feyeux reference are the same as disclosed in applicants’ specification, therefore, Feyeux’s cell mutation level would be expected to be the same as the mutation level and mutation type recited in the instant set of claims. Feyeux also teaches that multiple cellular microcompartments may be assembled (Abstract of Feyeux) as in instant Claims 1,3-8,23-24,39. Feyeux teaches that the cells are organized in the form of a tissue/micro-tissue (Paragraphs 77-78; Applications Section of Feyeux) as in instant Claim 9. Feyeux discloses that the cellular microcompartment comprises an internal lumen (Abstract and Paragraphs 7-8,23, 25-26, and Figure 1 of Feyeux) as in instant Claims 10 and 15. Feyeux does teach the presence of an inner cell layer, an extracellular matrix layer, and an outer hydrogel layer (Paragraph 7 of Feyeux). Paragraph 8 of Feyeux further states that cell culture medium is present in between the cells/cell layer and the hydrogel outer layer; the cell culture medium is considered an isotonic solution as in instant claims 11-12, and 15. Feyeux discloses that the cells are human/animal cells (Paragraph 1 of Feyeux) as in instant Claim 14. Feyeux discloses teaches that the cells are human pluripotent cells (Paragraphs 1-4 of Feyeux) as in instant Claim 16. Feyeux teaches that the system is closed (Paragraph 25 of Feyeux) as in instant Claim 17. Feyeux discloses that the outer layer comprises alginate (Paragraph 27 of Feyeux) as in instant Claim 18. Feyeux discloses that the shape may be an ovoid or a tube (Paragraph 40 of Feyeux) as in instant Claim 19. Feyeux teaches that the microcompartment is between 1 and several thousand cells per microcompartment (Paragraph 43 of Feyeux) as in instant Claim 20. Feyeux teaches that at least one microcompartment is the 3D cellular microcompartment (Paragraphs 1 and 43 of Feyeux) as in instant Claim 24.
The reference anticipates the claim limitations.
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 1,3-12,14-24, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Feyeux (US 20190330589)
Feyeux applies as above to teach claims 1,3-12,14-20,23-24, and 39. Feyeux teaches that the cells can be allowed to grow and divide to achieve a population of two cells to about a thousand cells (Paragraph 57 of Feyeux). The number of cells present would be controlled by the number of cell divisions permitted in the encapsulated cells. MPEP § 2144.05 (II) states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed concentration of cells within the microcompartments are critical. Absent such evidence, it would have been obvious to an artisan of ordinary skill at the time of effective filing to have allowed as many divisions as needed in order to produce the desired amount of cells. An artisan would have had a reasonable expectation of success in optimizing the concentrations because determining the number of cells desired in the microcompartments were long established in the art as demonstrated by Feyeux (Paragraph 57). Thus, Feyeux renders the cell concentrations and the number of divisions recited in claims 20-22.
Claims 1-10,14,16-25, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Feyeux (US 20190330589) in view of Feyeux II (WO2019224467) . Because Feyeux II is in French, Feyeux (20210123013) will be used as the English translation.
Feyeux applies as above to teach claims 1,3-10,14,16-24, and 39. Feyeux does not clearly state that appropriate concentration/volume of the cells within the microcompartment. However, Feyeux II states that the microcompartments can comprise between 10% to 98% of cells by volume (Paragraph 81 of Feyeux II). An artisan would have been motivated to have used microcompartments with such a concentration of cells because Feyeux II states that alginate microcompartments can successfully comprise between 10% to 98% by volume of cells (Paragraph 81 of Feyeux). Because Feyeux II teaches that the alginate microcompartments can hold such a high volume of cells (Paragraph 81 of Feyeux II), there would have been a high expectation for success as in instant Claim 2.
Feyeux does not expressly disclose that the microcompartments are arranged in a bioreactor. However, Feyeux II teaches that the assembly of microcompartments can be successfully arranged in a bioreactor (Abstract). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have arranged the assembly of microcompartments in a bioreactor. An artisan would have been motivated to have placed such an assembly in a bioreactor because such bioreactors can be used to successfully grow the cells within the microcompartments and/or can be used to establish organoids formed from the microcompartments (Abstract of Feyeux II). It is also advantageous to use bioreactors to better control the culture conditions such as the perfusion of fresh culture medium (Paragraph 3 of Feyeux II). Because Feyeux II teaches that the bioreactors can be used to grow cells/the microcompartments (Abstract of Feyeux II), there would have been a high expectation for success as in instant Claim 25.
Feyeux teaches a microcompartment containing cells that is surrounded by an outer hydrogel. Feyeux does not teach the volume of cells within the microcompartments; however, an artisan would have been motivated to have used the cell volume for microcompartments taught by Feyeux II since Feyeux II teaches the appropriate concentration of cells for the microcompartments. An artisan would have been further motivated to have used the bioreactor taught by Feyeux II since the bioreactor can promote cell growth and/or organoid development by carefully controlling the culture conditions that the microcompartments are exposed to. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture. Therefore, the level of o0rdianry skill in this art is high.
Claims 1,3-10,13-14,16-24, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Feyeux (US 20190330589) in view of Takebe (US 20170067014)
Feyeux applies as above to teach claims 1,3-10,14,16-24, and 39. Feyeux teaches a cellular microcompartment comprising at least one external hydrogel layer and inside said external layer, at least one layer of cells. Between the cells and the hydrogel layer, multiple “intermediate layers” can be found that are composed of both Matrigel (an extracellular matrix component that includes an isotonic solution) and medium (an isotonic solution). Feyeux fails to teach the appropriate Young’s modulus measurement of stiffness/elasticity for these intermediate layers. However, Takebe teaches that an appropriate stiffness/Young’s Modulus measurement for gel like substrates such as Matrigel and mediums is 200kPa or less, more preferably 1-50 kPa (Paragraph 88 of Takebe). The range taught by Takebe encompasses a Young’s modulus range between 0.05 and 3kPa. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the stiffness taught by Takebe for supportive gel structures disclosed in Feyeux. An artisan would have been motivated to have used such a stiffness because Takebe teaches that gel substances can adequately support cells with a Young Modulus of 200kPa or less (preferably 1-50 kPa) (Paragraph 88 of Takebe). Because Takebe teaches that gel substances at that Young’s modulus measurement recited in the claims can adequately support cells (Paragraph 88 of Takebe), there would have been a high expectation for success using gel structures such as Matrigel and/or isotonic solutions/media with a Young Modulus of 200 kPa for less as in instant Claim 13.
Feyeux teaches a microcompartment containing cells that is surrounded by an outer hydrogel. Feyeux does not teach the appropriate stiffness/elasticity of the intermediate layers. However, an artisan would have been motivated to have used a Young Modulus of 200kPa or less (preferably 1-50 kPa) since Takebe states that such as stiffness can adequately support cells (Paragraph 88 of Takebe). Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in cell culture. Therefore, the level of o0rdianry skill in this art is high.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claim 1,3-8,17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 of U.S. Patent No. 11,807,870. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 11,807,870 is a more detailed species of instant claim 1 that possesses a 3D cellular microcompartment comprising at least one hydrogel/external layer, inside said external layer at least one layer of cells/cellular base, and wherein human pluripotent cells are polarized and wherein the cell density is between one and several thousand cells per microcompartment, wherein the cellular microcompartment maintains the central lumen after five days in culture. The microcompartment recited in claim 1 of Patent 11,807,870 has a protective outer hydrogel in place which would prevent the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) in instant claims 1,3-8. Instant claim 17 corresponds to claim 2 of Patent 11,807,870. Instant claim 18 corresponds to claim 3 of Patent 11,807,870. Instant claim 19 corresponds to claim 4 of Patent 11,807,870.
Claim 1,3-8,14-15,17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5-9 of copending Application 18/027,203. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 18/027,203 is a more specific species of instant claim 1 since it includes an external hydrogel layer, an internal layer of cells/cell base, and an intermediate layer of an isotonic solution. Claim 1 of Application 18/027,203 has a protective hydrogel which would drastically reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. The human pluripotent cells mentioned in claim 5 of Application 18/027,203 correspond to instant claim 14. Claim 1 of Application 18/027,203 teaches the limitations present in instant claim 15. Instant claim 17 corresponds to claim 6 of Application 18/027,203. Instant claim 18 corresponds to claim 7 of Application 18/027,203. Instant claim 19 corresponds to claims 8-9 of Application 18/027,203. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,10,16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-4,6-9 of copending Application 18/223,164. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of Application 18/223,164 requires an inner layer of cells, a hydrogel, and a fibrin mesh arranged between the outer layer of hydrogel and the layer of cells. Therefore, claim 1 of Application 18/223,164 is a species of instant claim 1. The hydrogel layer recited in claim 1 of Application 18/223,164 would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 18 corresponds to claim 3 of Application 18/223,164. Instant claim 17 corresponds to claim 4 of Application 18/223,164. Instant claim 19 corresponds to claim 6 of Application 18/223,164. Instant claim 16 corresponds to claim 7 of Application 18/223,164. Instant claim 10 corresponds to claims 8 and 9 of Application 18/223,164. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,16-18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3,7-8, and 10 of copending Application 18/270,931. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 18/270,931 including claim 1 are species of the instant set of claims including instant claim 1 since Application 18/270,931 claims recite a microcompartment containing cells/two cysts on the interior, an exterior hydrogel, and a extracellular matrix element. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 16 corresponds to claim 3 of Application 18/270,931. Instant claim 17 corresponds to claim 7 of Application 18/270,931. Instant claim 18 corresponds to claim 8 of Application 18/270,931. Instant claim 20 corresponds to claim 10 of Application 18/270,931. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8,17-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4,7, and 9 of copending Application 18/374,889. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 18/374,889 recites, “a cellular microcompartment comprising successively, organized around a lumen: at least one layer of human pluripotent cells, wherein the human pluripotent cells are polarized and the inner/apical side of the pluripotent cell layer is adjacent to the lumen; an extracellular matrix layer, and an outer hydrogel layer, wherein the said outer layer thickness is between 5 to 40 µm. This is a species of instant claim 1 because claim 1 of 18/374,889 has all the limitations present in instant claim 1 and also requires an outer layer thickness between 5 to 40 µm.” The hydrogel recited in claim 1 of 18/374,889 protects the cells from developing mutations. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 17 corresponds to claim 2 of Application 18/374,889. Instant claim 2 corresponds to claim 3 of Application 18/374,889. Instant claim 18 corresponds to claim 4 of Application 18/374,889. Instant claim 19 corresponds to claim 7 of Application 18/374,889. Instant claims 20-22 correspond to claim 9 of Application 18/374,889. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,17, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,13,and 17 of copending Application No. 18/853,479. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 18/853,479 recites “A closed 3D cellular microcompartment of ovoid, cylindrical, spheroid, or spherical shape or of substantially ovoid, cylindrical, spheroid or spherical shape, the smallest dimension of which is between 200 and 400 µm, comprising an outer hydrogel layer that delimits an internal part, said internal part comprising, in a medium, between 500 and 5000 lymphocytes forming a grouped 3D culture and having a TNF alpha of less than 100 ng/ml of the medium.” Claim 1 of Application 18/853,479 is a more detailed species of instant claim 1. Like instant claim 1, claim 1 of Application 18/853,479 has an outer hydrogel that would successfully reduce occurrence of mutation in the cells within the microcompartment. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 17 corresponds to claim 13 of Application 18/853,479. Instant claim 25 corresponds to claim 17 of Application 18/853,479. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/854,162. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 18/854,162 recites a detailed species of instant claim 1. Claim 1 of Application 18/854,162 recites, “a 3D cellular microcompartment of ovoid, cylindrical, spheroid, or spherical shape or of substantially ovoid, cylindrical, spheroid, or spheroid shape, the smallest dimension of which is between 200 and 400 µm, comprising an outer hydrogel layer that delimits an internal part, said internal part comprising, in a medium, between 500 and 5000 lymphocytes forming a grouped 3D dimensional culture and having a granzyme B content of less than 1 µg/ml of the medium.” Claim 1 of Application of 18/854,162 is a more detailed species of instant claim 1. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/916,118. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 18/916,118 teaches a method of making the composition recited in instant claim 1. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1,3-8,17-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,3-4, and 6 of copending Application No. 19/101,327. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 19/101,327 is actually a species of instant claim 1 since it recites a layer of cells, an outer layer of hydrogel, and a fibrin mesh. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 18 corresponds to claim 3 of Application 19/101,327. Instant claim 17 corresponds to claim 4 of Application 19/101,327. Instant claim 19 corresponds to claim 6 of Application 19/101,327. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,3-8,16-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,6,12-15 of copending Application No. 19/129,986. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Application 19/129,986 is a more detailed species instant claim 1. Claim 1 of Application 19,129,986 recites an outer hydrogel, cells located within the hydrogel, and at least one layer or a mesh of a hydrogel of plant or synthetic origin. The hydrogel layer recited in both sets of claims would significantly reduce the occurrence of mutations (i.e. genetic, epigenetic, functional, oncogenic, and/or other types of recited mutations) as in instant claims 1,3-8. Instant claim 18 corresponds to claim 6 of Application 19,129,986. Instant claim 17 corresponds to claim 12 of Application 19,129,986. Instant claim 19 corresponds to claim 13 of Application 19,129,986. Instant claim 16 corresponds to claims 14-15 of Application 19,129,986. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 35 of copending Application No. 19/233,809. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 35 of Application 19/233,809 produces the composition recited in instant claim 1. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638