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 .
Detailed Action
Claims 1-20 are pending and now under consideration.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a DIV of 16/862,342 filed on 04/29/2020 now ABN, which is a CIP of PCT/US2018/058214 filed on 10/30/2018, which claims the benefit of priority under 35 U.S.C. 119(e) to the US Provisional application: 62/579,067 filed on 10/30/2017.
Information disclosure statement
The information disclosure statements (IDS) submitted on 03/01/2024, 06/19/2024, 07/16/2024, 08/23/2024, 10/21/2024, 11/21/2024, 02/13/2025, 07/30/2025, 09/23/2025, 02/18/2026, 03/03/2026, 05/21/2026 and 07/21/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Claim Rejections: 35 USC § 112(b)
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.
I. Claim 1 and claims 2-6 and 9-20 depending therefrom 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 applicant regards as the invention. Claim 1 recitation of a use “using an additive manufacturing technique”, since the claim does not set forth any steps involved in the method, and it is unclear what method applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Furthermore, the scope and metes and bounds of “additive manufacturing technique” is not clear; specification is limited to teaching the method of making a hydrogel bioreactor comprising encapsulated cell, said method encompasses projection microstereolithography or direct ink writing.
Claim 1 and claims 2-6 and 9-20 depending therefrom are rejected under 35 U.S.C. 101 because the claimed recitation of a use “using an additive manufacturing technique”, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
II. Claim 15 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 applicant regards as the invention.
Claim 15 recites the phrase “…characterized by a cell optical density in a range from about 4.0 to about 160” is considered to be a relative term which renders the claim indefinite. Claim 15 does not recite the specific metric for ascertaining the requisite optical density? of the claimed “…characterized by a cell optical density in a range from about 4.0 to about 160”; does the method involve spectrophotometer and measuring the cell density utilizing light absorbance at a certain wave-length? In the art what is considered “…characterized by a cell optical density in a range from about 4.0 to about 160” varies widely depending on the individual situation as well as the person making the determination. It is not clear to the examiner as to how “…characterized by a cell optical density in a range from about 4.0 to about 160” is measured? and encompassed in the above phrase. Thus, the scope of the claim is unclear, as written does not recite the specific conditions in the claimed “…characterized by a cell optical density in a range from about 4.0 to about 160” the applicants' intend to encompass. As such it is unclear what concentration of cell? or growth phase? of interest must be to be included within the scope of the claims and one of ordinary skill in the art would not be able to reasonably determine the metes and bounds of the claims. Furthermore, phrase “characterized”, renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by “characterized”), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Clarification and correction is required.
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5)”.
Claim Rejections: 35 USC § 102 (AIA )
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
I. Claims 1-2, 4-11 and 14-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Blanchette et al., (Nature Commun., 2016, Vol. 7:11900, pages 1-9; published 06/15/2016, in IDS), discloses a method for forming a bioreactor, the method comprising: forming a three-dimensional structure using an additive manufacturing technique; infilling the at least one side of the three-dimensional structure with a mixture for forming a polymer-encapsulated whole cells; and curing the infilled three-dimensional structure; wherein the three-dimensional structure comprises a lattice; wherein the three-dimensional structure comprises a tube; wherein a wall of the tube is gas-permeable (see Abstract; Fig. 1, page 3; Fig. 4, page 5; Fig. 5, page 6; Direct ink printing of PEG-pMMO hydrogel, polymer architectures with resolution on the 10–100-mm scale by Projection microstereolithography (PmSL), 3D printing of light-curable materials by projecting a series of images on the material (col. 1, ¶ 2, page 6; Methods, 3D printing of PEG-pMMO hydrogels, col. 2, page 8); wherein in said reference method the living whole cells comprise methanotrophic organisms; wherein the living whole cells comprise methylotrophic organisms (see Results, page 2, col. 2); embedding whole cells, Methylococcus capsulatus (Bath) pMMO in a PEGDA-based polymer hydrogel; schematic of the method used to fabricate the PEG-pMMO hydrogels is shown in Fig. 1, and the synthesis of the PEG-pMMO materials required only membrane-bound pMMO, PEGDA macromer, photoinitiator and ultraviolet light (col. 1, ¶ 2, page 3 and see Methods); said process increases the mechanical stability, and embedded the PEG-pMMO material into a 3D silicone lattice (printed using Direct Ink Write), which also ensures easy tunability of the hydrogel’s size and shape (col. 1, ¶ 2, page 5); said reference also discloses harvesting of cells to construct the hydrogel when the cell growth attained at A600 (absorbance) reaches 5.0-8.0 optical density (see Methods, col. 1, ¶ 1, page 8; reproduced below):
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Therefore, Blanchette et al., (Nature Commun., 2016, Vol. 7:11900, pages 1-9; published 06/15/2016, in IDS) is deemed to anticipate claims 1-2, 4-11 and 14-20 as written and when given the broadest reasonable interpretation.
II. Claims 1-11 and 14-20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Baker et al., (US 2017/0209859 A1, priority 01/21/2016; in IDS), said reference discloses method for forming a bioreactor, the method comprising: forming a three-dimensional structure using an additive manufacturing technique; infilling the at least one side of the three-dimensional structure with a mixture for forming a polymer-encapsulated whole cells; and curing the infilled three-dimensional structure; wherein the three-dimensional structure comprises a lattice; wherein the three-dimensional structure comprises a cube; wherein the three-dimensional structure comprises a tube; wherein a wall of the tube is gas-permeable; wherein the living whole cells comprise methanotrophic organisms; wherein the living whole cells comprise methylotrophic organisms.
The cited document Baker et al., (US 2017/0209859 A1, in IDS), discloses a mixture for forming polymer-encapsulated whole cells (¶ [0158]), wherein the mixture comprises: (i) a pre-polymer or a polymer precursor (Abstract; ¶ [0147], [0158[, [0161]), (ii) a photo-initiator (¶ [0104], [0120], [0124]); and (iii) a plurality of whole cells as biocatalysts (Abstract), wherein the biocatalysts are cells (¶ [0139], [0150], ]0157]-0158]); and upon crosslinking, a product with encapsulated cells is provided (Abstract; Fig. 8, 15-17; ¶ [0147], [0169]); polymer-encapsulated whole cells; and curing the infilled three-dimensional structure; wherein the three-dimensional structure comprises a lattice; a cube; and a tube (Figs. 4-6, 8-9 and 14); 3-D structures formed/patterned according to Projection microstereolithography (PmSL) (Fig. 8) and Direct ink printing of PEG-pMMO hydrogel (¶ [0113], [0128]). The cited document discloses that cells are reconstituted, dried and/or live whole cells (¶ [0139], [0150], [0152], [0158]); and the cells are methanotrophic organisms, wherein a wall of the tube is gas-permeable (Figs. 1-3, 7 and 12; ¶ [0150]) capable to convert gas to liquid and/or methane to methanol and (¶ [0029], [0043], [0059], [0090], [0096], [0126]); embedding whole cells, Methylococcus capsulatus (Bath) pMMO in a PEGDA-based polymer hydrogel (¶ [0122]). said reference also discloses harvesting of cells to construct the hydrogel when the cell growth attained at A600 (absorbance) reaches 5.0-8.0 optical density (¶ [0121-0122]; reproduced below):
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Therefore, Baker et al., (US 2017/0209859 A1, in IDS) is deemed to anticipate claims 1-11 and 14-20 as written and when given the broadest reasonable interpretation.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable Blanchette et al., (Nature Commun., 2016, Vol. 7:11900, pages 1-9; published 06/15/2016, in IDS) as applied to claims 1-2, 4-11 and 14-20 and Baker et al., (US 2017/0209859 A1, in IDS) as applied to claims 1-11 and 14-20 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Bhattacharjee et al., (Lab Chip., 2016, Vol. 16: 1720-1742) and Jensen et al., (US 2004/0077075 A1).
The disclosures of Blanchette et al., and Baker et al., are silent regarding wherein the living whole cells comprise yeast (as in claims 12); and wherein the bioreactor is configured to maintain viability of the living whole cells for a duration of at least five days (as in claim 13).
Regarding claims 1-9, 13-14 and 16-20, Bhattacharjee et al., (Lab Chip., 2016, Vol. 16: 1720-1742) provide teaching, suggestion and motivation to a skilled artisan i.e., detail protocols regarding 3D-printing and microfluidics systems, obtaining said 3-D microfluidics systems of desired shape and size including size selection of cells and gas permeable; encapsulating cells and cell lines of interest depending on the experimental need (see Abstract; Fig. 1-5, pages 1721-1737; Table 1, pages 1728-1729); and viability of encapsulated cells in said 3-D microfluidics systems ranging from 3-11 days (see Fig. 6 & 9; and entire document).
Regarding claims 12, Jensen et al., (US 2004/0077075 A1) provides teaching, suggestion and motivation for generating 3-D microfluidics systems/hydrogels and encapsulating yeast cells (see Abstract; ¶ [0055], [0108], [0181-085], [0202]; and entire document).
As such, disclosure of strategy and methods including structural and functional elements for 3D-printing and microfluidics systems, obtaining said 3-D microfluidics systems of desired shape and size including size selection of cells and gas permeable; encapsulating cells, such as yeast and cell lines of interest depending on the experimental need in the claimed bioreactor, the method comprising: forming a three-dimensional structure, such as that of references of Bhattacharjee et al., and Jensen et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Blanchette et al., and Baker et al., and incorporate the structural and functional elements of Bhattacharjee et al., and Jensen et al., and adopt the methods for obtaining desired claimed bioreactor in the claimed method, as provided in the combined teachings of Blanchette et al., Baker et al., Bhattacharjee et al., and Jensen et al., and the combined references also provide teaching, suggestion and motivation including the structural and functional elements of the instant invention and are well known in the art (for details see the rejection above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claimed bioreactor in the claimed method, as suggested by the teachings of Bhattacharjee et al., and Jensen et al., and to modify the teachings of Blanchette et al., and Baker et al. A person of ordinary skill in the art is motivated to make such change depending on the experimental need i.e., wherein the living whole cells comprise yeast; and wherein the bioreactor is configured to maintain viability of the living whole cells for a duration of at least five days, because a skilled artisan would realize such a modification would be useful to efficiently produce and for generating bioreactor of interest in the claimed method. One of ordinary skill in the art has a reasonable expectation of success at adding the steps i.e., wherein the living whole cells comprise yeast; and wherein the bioreactor is configured to maintain viability of the living whole cells for a duration of at least five days of interest, as suggested in the teachings of Bhattacharjee et al., and Jensen et al., and are well known in the art. Therefore, the invention as a whole lack an inventive step over the prior art. The expectation of success is high, because the combined teachings of Blanchette et al., Baker et al., Bhattacharjee et al., and Jensen et al., also provide the structural and functional elements of the instant invention (Teaching, Suggestion and Motivation).
Regarding specific choice of encapsulated cells such as yeast and viability of encapsulated cells of claimed bioreactor in the claimed method are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in choice of encapsulated cells such as yeast and viability of encapsulated cells of claimed bioreactor in the claimed method t will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating 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". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two compositions or two methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
Therefore, claims 1-20 are rejected under 35 U.S.C. 103(a) as being unpatentable Blanchette et al., (Nature Commun., 2016, Vol. 7:11900, pages 1-9; published 06/15/2016, in IDS) as applied to claims 1-2, 4-11 and 14-20 and Baker et al., (US 2017/0209859 A1, in IDS) as applied to claims 1-11 and 14-20 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Bhattacharjee et al., (Lab Chip., 2016, Vol. 16: 1720-1742) and Jensen et al., (US 2004/0077075 A1).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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