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 .
Applicant’s responses on 11/10/2025 and 11/11/2025 have been received and entered. Claims 1, 4, and 13-23 are pending, all of which have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1: The word "the" should be removed from the phrase "wherein the each line".
Appropriate correction is required.
Status of Prior Rejections/ Response to Arguments
RE: Objection to claims 5, 10, and 19
Claims 5 and 10 have been amended rendering the objection moot.
Amendments to claim 19 overcome the objection. The objection over claim 19 is withdrawn.
RE: Rejection of claims 1, 4, 5, 7, and 13 - 21 under 35 U.S.C. 112(b)
Claims 5 and 7 have been cancelled rendering the rejection moot.
Amendments to claims 1 and 14 overcome the rejection of record. The rejection over claims 1, 4, and 13-21 is withdrawn.
RE: Rejection of claims 5, 7, and 12 are rejected under 35 U.S.C. 112(d)
Claims 5, 7, and 12 have been cancelled rendering the rejection moot.
RE: Rejection of claims 1, 10, 12, and 15 - 17 under 35 U.S.C. 102 over Hinds et al (Biomaterials, 2011)
Applicants traversed the rejection of record on the grounds that Hinds et al do not teach the specific arrangement of the claimed invention. Specifically, Hinds et al do not teach arranging multiple lines, by forming individual linear structures within a supporting bath, and bring them into proximity with support at both ends.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the bio-printing process of individually arranging multiple linear structures) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 requires muscle cells arranged to form multiple lines but is silent as to the method by which the muscle cells are arranged. Thus, the muscle cells of Hinds et al, contracting in a mold to form muscle bundles, reads on muscle cells arranging to form multiple lines.
Applicants further traversed the rejection of record on the grounds that the gel of Hinds et al. serves as the medium in which cells are placed which differs from the “supporting bath” in the amended claims. Claim 1 has been amended to recite “a supporting bath comprising a gel and a culture medium”.
In response, the argument has been considered but is not persuasive. Hinds et al teach injecting a cell hydrogel mixture into a mold, allowing the gel to polymerize, then culturing the cells in growth media. Thus, Hinds et al teach a supporting bath comprising a gel and a culture medium.
The rejection over claims 1 and 15-17 is maintained.
Claims 10 and 12 have been cancelled rendering their rejection moot.
RE: Rejection of claims 10 and 12 35 U.S.C. 102 over Feinberg et al (WO2015017421A2)
Claims 10 and 12 have been cancelled rendering the rejection moot.
RE: Rejection of claims 1, 4, 10, and 12 - 15 under 35 U.S.C. 103 over Feinberg et al (WO2015017421A2) in view of Hinton et al (Science Advances, 2015)
Applicants traverse the rejection of record on the grounds that Feinberg et al and Hinton et al do not disclose the specific process flow involving individually forming “multiple lines”.
In response, the argument has been fully considered but is not convincing. Feinberg et al disclose a method of 3-D printing muscle fascicles. Muscle fascicles comprise multiple lines of cells.
Additionally, applicants argue neither Feinberg et al nor Hinton et al teach gelling the first muscle tissue support and/or the second muscle tissue support.
In response, gelling of tissue supports is a limitation of claim 18 which is not included in the rejection.
The rejection over claims 1, 4, and 13-15 is maintained.
Claims 10 and 12 have been cancelled rendering their rejection moot
RE: Rejection of claims 1, 4, 10, 12, and 15 - 17 under 35 U.S.C. 103 over Hinds et al (Biomaterials, 2011) in view of Ostrovidov et al (Small, 2019).
Applicants argue Ostrovidov et al is a review article that does not teach the specific steps of the present claims.
In response to applicant's arguments, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The rejection over claims 1, 4, and 15-17 is maintained.
Claims 10 and 12 have been cancelled rendering their rejection moot.
RE: Rejection of claims 1, 5, 10, 12 and 15 - 17 under 35 U.S.C. 103 over Hinds et al (Biomaterials, 2011) in view of Merceron et al (Biofabrication, 2015).
Applicants argue the hydrogel of Merceron et al do not function as an environment to be removed and therefore does not read on the supporting bath comprising a gel of the present claims. Additionally, Merceron et al do not disclose the specific printing arrangement of individually arranging multiple lines.
In response to applicant's arguments, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The rejection over claims 1 and 15-17 is maintained.
Claims 5, 10, and 12 have been cancelled rendering their rejection moot
RE: Rejection of claims 1, 10, 12 and 15 - 19 under 35 U.S.C. 103 over Hinds et al (Biomaterials, 2011) in view of Cvetkovi et al et al (PNAS, 2014).
Applicants argue the method of Cvetkovi is different from the method of “linear printing in a supporting bath” of the instant claims.
In response to applicant's arguments, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The rejection over claims 1 and 15-19 is maintained.
Claims 10 and 12 have been cancelled rendering their rejection moot.
Re: Rejection of claims 1, 7, 10, 12 and 15 - 19 under 35 U.S.C. 103 over Hinds et al (Biomaterials, 2011) in view of Cvetkovi et al et al (PNAS, 2014) and Ostrovidov et al (Small, 2019).
Applicants argue Ostrovidov et al do not teach the specific steps of the present claims.
In response to applicant's arguments, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The rejection over claims 1 and 15-19 is maintained.
Claims 7, 10, and 12 have been cancelled rendering their rejection moot
RE: Rejection of claims 1, 10, 12 and 15 - 17 and 20 - 21 under 35 U.S.C. 103 over Hinds et al (Biomaterials, 2011) in view of Kayser et al (US20210235733A1).
Applicants have not presented any arguments regarding the rejection.
The rejection over claims 1, 15-17, and 20-21 is maintained.
Claims 10 and 12 have been cancelled rendering their rejection moot
New/Maintained Rejections
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 15 - 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hinds et al (Biomaterials, 2011).
Hinds et al teaches culturing and assembling bioengineered muscle bundles (See abstract). Hinds uses Velcro tabs at both ends of a mold to serve as attachment sites (See Sec. 2.2 Bioengineered muscle bundle assembly and culture and Fig. 1). The cells are mixed into a hydrogel, injected into the mold, and the gel is polymerized (See Sec. 2.2 Bioengineered muscle bundle assembly and culture). The cell bundles are maintained in growth media for 5 days then switched to low serum media and cultured until day 14 (See Sec. 2.2 Bioengineered muscle bundle assembly and culture). The resulting muscle bundle comprises aligned multinucleated myotubes (See Fig. 2C)Hinds et al further teaches the gel matrix can be dissolved using collagenase for protein/DNA quantification (See Sec. 2.7 Cellular Protein/DNA Quantification).
Regarding claim 1: Hinds et al teaches a method of culturing and assembling bioengineered muscle bundles which reads on a method for producing an artificial three-dimensional muscular tissue. The method of Hinds et al comprises fabricating a mold with Velcro tabs at each end which reads on disposing a first and second muscular tissue support. A hydrogel-cell mixture is added to the mold with the Velcro tabs serving as attachment sites for the longitudinal muscle bundles (reads on multiple lines with a first end and a second end) which reads on disposing muscle cells to constitute a three-dimensional muscular tissue precursor, wherein the muscle cells are arranged to form multiple lines with the first ends of the lines in close to the first muscular tissue support and the second ends a close to the second muscular tissue support. The cell bundles are then cultured for 14 days which reads on culturing the muscle cells of three-dimensional muscular tissue precursor in a culture medium to obtain an artificial three-dimensional muscular tissue. Hinds further teaches the gel matrix can be dissolved using collagenase (reads on dissolving or decomposing the gel) for quantification of protein and DNA.
Regarding claim 15: Following the discussion of claim 1 above, Hinds et al discloses maintaining the cells in growth medium for 5 days. Culturing in growth medium would require the addition of culture media to the cells prior to culturing which reads on additional culture medium is added before step (iii).
Regarding claim 16: Following the discussion of claim 1 above, Hinds et al discloses culturing in growth medium for 5 days then switching to a low serum differentiation medium and culturing the cells until day 14 which reads on step (iii) comprises exchanging the culture medium.
Regarding claim 17: Following the discussion of claim 1 above, Hinds et al teaches producing a bioengineered muscle bundle, comprising aligned multinucleated myotubes by culturing cell/gel bundles which reads on producing an artificial three-dimensional muscular tissue having a fascicle of muscle fibers, wherein the step(1) comprises disposing muscle cells in a form of a plurality of lines in the gel.
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.
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, 4, and 13 - 15 are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO2015017421A2) in view of Hinton et al (Science Advances, 2015).
Feinberg et al discloses a 3D cell printing method called Freeform Reversible Embedding of Suspended Hydrogels (FRESH) (See ¶0007). The method comprises blending blocks of gelatin gel to make a slurry which is used as a support bath (See ¶0059). The gelatin slurry particles act viscous under high stress but as a solid under low stress (See ¶0060). A cell laden hydrogel cells is then extruded into the gelatin slurry to create the 3D cell structure (See ¶0061 and claim 27). The slurry with the hydrogel/cells is then placed at 37° C which causes the gelatin slurry support bath to melt and release the tissue scaffold (See ¶0063). The support material can thus be removed (See ¶0038). The method can be used to print parallel muscle tissue types by printing muscle cell threads with or without support posts (See sec 0081 – 0082 and Fig. 18).
Regarding claims 1, 13-15: Feinberg et al discloses a method of producing a 3D printed muscle fascicle which reads on a method for producing an artificial three-dimensional muscular tissue comprising muscle cells arranged for form multiple lines. The method comprises making a gelatin gel slurry support bath into which a hydrogel comprising cells is printed (reads on one end of the line of cells is in a gel). Additionally support posts (reads on a first and second muscular tissue support) to which the muscle fascicle (reads on a 3D muscular tissue precursor and muscle cells arranged to form multiple lines) is attached can be printed along with the muscle cell fibers which reads on claim 1(i). The method of Feinberg et al further comprises melting the gelatin gel which reads on dissolving or decomposing the gel.
The method of Feinberg does not disclose culturing the muscle cells of three-dimensional muscular tissue precursor in a culture medium to obtain an artificial three-dimensional muscular tissue.
Hinton et al teaches a method of producing 3D biological structures using Freeform Reversible Embedding of Suspended Hydrogels (FRESH) (See Sec. Using a thermo-reversible support bath to enable freeform reversible embedding of suspended hydrogels). The method of Hinton et al further teaches that after the gelatin support bath is melted (reads on dissolving the gel), the gelatin support material can be removed (reads on step (ii) comprises removing the gel), and the hydrogel scaffolds comprising the cells were rinsed with culture medium and incubated at 37° C (See Sec. The FRESH 3D printing process).The prints including C2C12 myoblasts (reads on muscle cells) were cultured for up to 7 days in DMEM (reads on culturing the muscle cells of three-dimensional muscular tissue precursor in a culture medium to obtain an artificial three-dimensional muscular tissue and adding culture medium before step (iii)) at which point the cell growth is analyzed (See Sec. Cell culture and fluorescent staining). Additionally, Hinton et al discloses using the method to produce sheets of C2C12 myoblasts (reads on producing an artificial three-dimensional muscular tissue) (reads on muscle cells) (See Sec. 3D printing of complex biological structures).
Given that both Feinberg et al and Hinton et al teach methods of producing 3D muscular cell structures using FRESH, it would be prima facie obvious to modify the method of Feinberg et al to include the cell culturing steps of Hinton et al. One would be motivated to culture the muscle cells because Hinton et al discloses culturing the cells results in cell growth. There is a reasonable expectation of success because both methods are producing 3D muscle structures by FRESH and culturing cells is a known technique in the art.
Regarding claim 4: Following the discussion of claim 1 above, Feinberg discloses printing cells into a gelatin gel slurry. Feinberg further discloses the gelatin slurry particles act viscous under high stress but as a solid under low stress which reads on thixotropy. Therefore, the cells are disposed in a gel having thixotropy.
Claims 1, 4, 10, 12, and 15 - 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hinds et al (Biomaterials, 2011) in view of Ostrovidov et al (Small, 2019).
The teachings of Hinds et al are set forth above.
Hinds et al anticipates claims 1 and 15-17.
Regarding claim 4: Following the discussion of claim 1 above, Hinds et al discloses a method of producing an engineered muscle bundle comprising the steps of claim 1, including disposing muscle cells in a gel.
Hinds et al does not disclose the gel has thixotropy.
Ostrovidov et al reviews methods of 3D bioprinting skeletal muscle. One method teaches printing cells in a bioink comprising hyaluronic acid (HA) modified with adamantine or ß-cyclodextrin (reads on disposing cells in a gel). The modified HA bioink has shear-thinning properties which allow it to become less viscous under increasing shear rate and fast gelation after pressure is released which reads on the HA bioink has thixotropy.
Given that both Hinds et al and Ostrovidov et al teach methods of producing 3D muscle structures which include disposing muscle cells in a gel, it would be prima facie obvious to substitute the hydrogel of Hinds et al with the HA gel of Ostrovidov et al. One would have expected the HA gel of Ostrovidov et al and the hydrogel of Hinds et al to work equivocally, in the method of Hinds et al, because the HA gel of Ostrovidov et al is a hydrogel. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
Claims 1, 15 - 17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hinds et al (Biomaterials, 2011) in view of Merceron et al (Biofabrication, 2015).
The teachings of Hinds et al are set forth above.
Hinds et al anticipates claims 1 and 15-17.
Regarding claim 23: Following the discussion of claims 1 and 17 above, Hinds et al discloses a method of producing a 3D muscle bundle (reads on fascicle and a plurality of lines) according to the method of claim 1.
Hinds et al does not disclose the plurality of lines are produced by discharging using a multi-nozzle dispenser.
Merceron et al teaches bioprinting a muscle-tendon unit comprising multinucleated myotube structure (reads on a muscle fascicle) (See Sec. Cell viability, muscle-tendon interface fabrication and tissue development). The method of Merceron et al uses a multi-nozzle printer consisting of four cartridges that can process multiple types of materials and cells and is used to print a C2C12 myoblast laden hydrogel (reads on discharging using a multi-nozzle dispenser) (See Sec. Fabrication of MTU constructs using 3D integrated organ printing (IOP)). Merceron teaches 3D organ printing can overcome limitations of difficulty in seeding entire scaffold homogenously and poor scaffold architecture (See introduction).
Given that both Hinds et al and Merceron et al teach methods of producing muscle fascicles in a gel, it would be prima facie obvious to modify the method of Hinds et al to include disposing the muscle cells in the gel by using the multi-nozzle printer of Merceron et al. One would be motivated to modify the method because the multi-nozzles would allow multiple lines of muscle cells to be printed at once and Hinds et al teaches bioprinting can overcome poor scaffold architecture and seed cells more homogenously. There is a reasonable expectation of success because both Hinds et al and Merceron are producing muscle fascicles by disposing muscle cells in a gel.
Claims 1 and 15 - 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hinds et al (Biomaterials, 2011) in view of Cvetkovi et al et al (PNAS, 2014).
The teachings of Hinds et al are set forth above.
Hinds et al anticipates claims 1 and 15-17.
Regarding claim 18: Following the discussion of claim 1 above, Hinds et al teaches culturing muscle bundles according the method of claim 1, including using two Velcro supports.
Hinds et al does not teach gelating the first and second muscular tissue supports.
Cvetkovic et al. teaches culturing of 3D muscle strips in a cell-matrix solution (See Sec. Design and Fabrication of 3D Bio-bots). The strips are held between two hydrogel bio-bot pillars (reads on a first and second support) (See Sec. Design and Fabrication of 3D Bio-bots and Fig 1). Since the pillars are made of a hydrogel so they are therefore gelated.
Given that both Hinds et al and Cvetkovi et al teach methods of producing 3D muscle structures which include using , it would be prima facie obvious to substitute the Velcro anchors of Hinds et al with the hydrogel bio-bot pillars of Cvetkovi et al. One would have expected the pillars of Cvetkovi et al and the Velcro of Hinds et al to work equivocally, in the method of Hinds et al, because the pillars and the Velcro are both being used to support a 3D structure of muscle cells. Substitution of one element for another known in the field, wherein the result of the substitution would have been predictable is considered to be obvious. See KSR International Co. V Teleflex Inc 82 USPQ2d 1385 (US2007) at page 1395.
Regarding claim 19: Following the discussion of claims 1 and 18 above, Hinds et al teaches culturing muscle bundles according the method of claim 1, including using two Velcro supports.
Hinds et al does not teach gelating the first and second muscular tissue supports.
Cvetkovic et al teaches culturing of 3D muscle strips in a cell matrix wherein the muscle strips are supported by two hydrogel pillars.
Cvetkovic does not teach the first or second tissue support is gelated after the supports and cells have been disposed (step (i)).
However, in the absence of new or unexpected results, selection of any order of performing process steps is prima facie obvious (See MPEP 2144.04(IV)(C) and In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946)). Thus, because Hinds et al in view of Cvetkovic et al teach all the steps of the instant claim and the steps are used to produce the muscle tissue of the instant application, the instant claim is rendered obvious.
Claims 1, 15 - 19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hinds et al (Biomaterials, 2011) in view of Cvetkovi et al et al (PNAS, 2014) and Ostrovidov et al (Small, 2019).
The teachings of Hinds et al and Cvetkovi et al are set forth above.
Hinds et al anticipates claims 1 and 15-17.
Hinds et al in view of Cvetkovi et al render claims 18 and 19 obvious.
Regarding claim 23: Following the discussion of claims 1 and 18 above, Hinds et al teaches culturing muscle bundles according the method of claim 1, including using two Velcro supports.
Hinds et al does not teach the first and/or second muscular tissue support contains collagen.
Cvetkovi et al teaches culturing of 3D muscle strips in a cell matrix wherein the muscle strips are supported by two hydrogel pillars.
Cvetkovi et al does not teach the first and/or second muscular tissue support contains collagen.
Ostrovidov et al reviews methods of 3D bioprinting skeletal muscle including methods of printing cells onto scaffolds which can be used to support the cells (See table 1). Ostrovidov et al teaches coating scaffold material with collagen can improve alignment of muscle fibers (See Sec. State of the art and table 1).
Given that Hinds et al in view of Cvetkovi et al teach a method of producing a 3D muscle comprising gelating a first and second muscular tissue support, and Ostrovidov et al teaches coating support material used for 3D muscle tissue production with collagen improves alignment of muscle fibers, it would be prima facie obvious to coat the tissue support pillars taught by Hinds et al in view of Cvetkovi et al with collagen. One would be motivated to coat the tissue supports in collagen because Ostrovidov et al teaches coating a support material in collagen improves muscle cell alignment. There is a reasonable expectation of success because Hinds et al, Cvetkovi et al, and Ostrovidov et al all teach methods of producing a muscle tissue comprising a support.
Claims 1, 15 - 17, and 20 - 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hinds et al (Biomaterials, 2011) in view of Kayser et al (US20210235733A1).
The teachings of Hinds et al are set forth above.
Hinds et al anticipates claims 1 and 15-17.
Regarding claims 20 and 21: Following the discussion of claim 1 above, Hinds et al teaches a method of producing muscle tissue bundles according the method of claim 1.
Hinds et al does not teach adding and assembling adipocytes and vascular cells based on the ratio between the fat tissue, vascular, tissue, and muscular tissue of commercial beef.
Kayser et al discloses a slaughter free meat product made by culturing cells (reads on artificial muscle tissue). Kayser et al further discloses the overall cell culture composition or the ratio of myoblasts/ fibroblasts/ adipocytes/ endothelial cells (reads on vasculature), may be regulated in culture to produce meat products with optimal flavor and health effects because fattier meat is generally tastier (reads on adding fat for regulating taste) but is also associated with a greater risk of adverse health consequences (See ¶0144).
Given that Hinds et al and Kayser et al both teach producing artificial muscle tissue and Kayser et al further discloses optimizing the ratio of myoblasts to adipocytes to endothelial cells can be regulated to produce meat products with optimal flavor and health effects, it would be prima facie obvious to add and assemble adipocytes and vascular cells in the muscle tissue of Hinds et al in order to produce a cultured meat product. Additionally, it would be prima facie obvious to use routine optimization to optimize the ratio of fat tissue to vascular tissue to muscular tissue to arrive at the same ratio as commercial beef because Kayser et al teaches the ratio of fat to myoblasts (reads on muscle cells) to endothelial tissue (reads on vasculature) can affect flavor. Where 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. See MPEP2144.05(II).
Conclusion
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 MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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/MARISOL ANN O'NEILL/ Examiner, Art Unit 1633
/ALLISON M FOX/ Primary Examiner, Art Unit 1633