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 amendment and response filed on 6/4/2026 has been received and entered into the case.
Claims 4 and 6 have been canceled, and claims 1-3, 5 and 7-21 have been considered on the merits. All arguments have been considered.
Specification
The use of the term ShandonTM , TBD 1TM , MultiskanTM , Gibco® which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
As marks should be identified by capitalizing each letter of the mark (in the case of word or letter marks), applicant is requested to correct each letter of the marks to all capital letters. E.g. SHANDONTM, MULTISKANTM, GIBCO®, etc.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC 112(a) and (b) have been withdrawn due to the instant amendment.
Claim Rejections - 35 USC § 103 (modified)
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 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 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.
Claim(s) 1-3, 5, 7-10 and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Karalashvili et al. (2018, iMedPub Journals; of record) in view of DePaula et al. (US2008/0188939; of record), Grayson et al. (2011, of record), Cornu et al. (2000, J. Orthol. Res.), Morse et al. (US 5,513,662; of record), Chen et al. (2021, J. Func. Biomat.; of record), Mansour et al. (2017, Tissue Engineering; of record) and Malagon-Escandon et al. (2021, Polymers).
Karalashvili et al. teach a method of decellularization of bovine cancellous bone fragment (femur bones) including placing bone fragments in deionized water containing heparin for 24 hr to remove blood components; rinsing the bone fragments with phosphate-buffered saline (PBS) (RE: Claim 1, step (f), Claims 8 and 9); treating with sequential washes in 0.01, 0.1 and 1% SDS (RE: step (g)) and then 1% TX-100 (non-ionic detergent) (RE: Claim 1, step (h) and Claim 10); treating the bone fragment with chloroform and ethanol mixture for 24 hr in a stirrer (RE: step (b)), removing chloroform and ethanol by placing the bone fragment in deionized water, and rotate with a gentle shaking speed of 50 rpm for 12 h (RE: step (d)), and then bone fragments are rinsed with deionized water (p.1-2). The bone fragments are then treated with 4% sodium hypochlorite for 24 hours (p.2, 1st col., Deproteinization of bone) (RE: claim 1, step (e) and claim 7). Karalashvili et al. teach lyophilization protocol, which would meet the steps (k) and (l), and claim 17. Karalashvili et al. teach that following lyophilization, the decellularized bovine bone grafts are packed in disposable plastic bags and sterilized with gamma-ray (p.2, 2nd col., 2nd par.), and thus meet the step (m).
Regarding the step (a) of claim 1 directed to washing with a distilled pressurized water using a high-pressure water-jet spray having a pressure not exceeding 160 psi, while Karalashvili et al. teach distilled water for rinsing bone fragment (p.2, 1st col., 2nd complete para.), Karalashvili et al. do not teach washing the bone body (i.e. bone blocks) with a pressurized water.
DePaula et al. teach a method of cleaning bone graft and the method involves a pressurized rinse with purified water (para. 57).
Grayson et al. teach bone can be washed using a high velocity water jet to remove marrow from the pore spaces (p.236, 3.2. Scaffold Preparation, #4).
Cornu et al. teach the slices of femoral heads were washed under a jet of deionized water to remove bone marrow and bone cells (p.426-427; Materials and Methods).
Based on these teachings, it would have been obvious to a person skilled in the art to use a pressurized water jet taught by DePaula et al., Grayson et al. and Cornu et al. for the step of washing the bone fragment with distilled water taught by Karalashvili et al. Because the use of water jet for washing bone to remove bone marrow and bone cells is known in the art according to DePaula et al., Grayson et al. and Cornu et al. The use of a known technique in the art to improve similar method in the same way is obvious (see MPEP2143). It is noted that the high velocity water jet of Grayson et al. and the jet of deionized water of Cornu et al. would meet the limitation of “high-pressure water-jet spray.”
Regarding the high-pressure not exceeding 160 psi in step (a), Karalashvili et al. in view of DePaula et al., Grayson et al. and Cornu et al. do not particularly teach the limitation.
Morse et al. teach a method of cleaning cancellous bone using high pressure liquid jet stream (i.e. water jet) and the liquid jet stream is 100 to 3,000 psi (col. 6, lines 25-36).
It would have been obvious to a person skilled in the art to adjust the pressure of a water jet for cleaning to effectively remove bone marrow and bone cells from the bone fragments as one skilled in the art would recognize that the pressure used for cleaning/washing bone using a water jet is a result-effective parameter for the purpose of cleaning/washing the bone fragment, and such parameter is routinely optimized. One skilled in the art would adjust the water pressure within the workable range of 100 to 3,000 psi taught by Morse et al. to effectively remove bone marrow and bone cells or any undesired materials present in the bone fragment of Karalashvili et al. with a reasonable expectation of success. The range of water pressure taught by Morse et al. is overlapping with the claimed range of 160 psi or less.
Regarding the step (b), Karalashvili et al. do not teach the mixture of alcohol-chloroform at a 1:1 ratio or gentle shaking at the speed of approximately 25 to 75 rpm at room temperature after the step (a).
Chen et al. teach a method of preparing bone graft materials, and the method utilizes a mixture of methanol and chloroform at 1:1 for 12 hr to remove lipid from the bones (p.3, Materials and Methods).
It would have been obvious to a person skilled in the art to use the chloroform:methanol mixture of Chen et al. for the delipidation in the method of Karalashvili et al. using chloroform:ethanol mixture for the same purpose of delipidating process with a reasonable expectation of success.
Regarding the gentle shaking with the claimed speed (claims 1, step (b) and claim 5), Karalashvili et al. in view of Chen et al. do not teach the limitation. However, it would have been obvious to a person skilled in the art to use a shaking condition for treating the bone fragment with a mixture of methanol and chloroform with a reasonable expectation of success. This is because Karalashvili et al. teach the use of shaking in the step of removing the detergent (TX-100) using a gentle shaking speed of 50 rpm for 12 h (p.2, 1st col., 3rd full para.), and the step of removing chloroform and ethanol mixture being in a stirrer (p.2, 1st col., 2nd full para.). Thus, one skilled in the art would recognize that the gentle shaking and the stirrer taught by Karalashvili et al. are for facilitating the removal processes, and thus, one would be an alternative means to the other for treating the bone with a solution as both are known to produce shear force in the solution that facilitate the treatment.
While Karalashvili et al. do not teach the room temperature for treating bone fragments with chloroform and ethanol (RE: claim 1, step (b)), however, as the temperature is not particularly defined for the treating chloroform and ethanol in Karalashvili et al., one skilled in the art would consider that this procedure is carried out at room temperature.
Regarding the step (c) and step (j) directed to rinsing with deionized water at least three times or for approximately 3 hr., Karalashvili et al. do not particularly teach the limitation. However, it would have been obvious to a person skilled in the art to rinse the bone graft with deionized water to remove chloroform-alcohol mixture or DNase and RNase after the treatment for the subsequent process of the bone graft. As Karalashvili et al. disclose washing/rinsing steps with deionized water (e.g. rinsing in deionized water after deproteinization), one skilled in the art would use deionized water to remove chloroform/alcohol or DNase/RNase after each treatment. Regarding the duration of such rinsing, it is considered as a routine optimization to sufficiently remove all of DNase and RNase for the subsequent process steps, and thus, one skilled in the art would readily modify the duration for the optimal outcome of the method.
Regarding the step (d) directed to placing the cancellous bone body in distilled water under rotation at approximately 80 rpm for approximately 24 hr (claim 1), this step is interpreted as an additional rinsing step to the step (c), i.e. rinsing the cancellous bone body with (c) deionized water, and (d) distilled water. While Karalashvili et al. teach the use of deionized water for removing the chloroform and ethanol, they do not teach “distilled water” for rinsing after the treatment with chloroform-alcohol mixture. However, as Karalashvili et al. utilize “distilled water” for rinsing SDS (p.2, 1st col., 2nd full para.), one skilled in the art would consider “distilled water” and “deionized water” can be used in rinsing steps for the decellularization processes interchangeably. Thus, it would have been obvious to a person skilled in the art to use distilled water in addition to deionized water for rinsing chloroform-ethanol mixture, particularly in the absence of any evidence of criticality in using deionized water over distilled water, or vice versa.
Regarding the step (i) directed to the treating with DNase and RNase for approximately a week, Karalashvili et al. do not teach the limitation.
Mansour et al. teach that bone ECM decellularization involves chemical detergents to solubilize the cellular membrane (SDS or TX-100) and enzymatic treatment to remove the nucleic acid material (i.e. DNase or RNase solution), and the use of enzymatic solutions comprising DNase and RNase and incubation is at 37°C (p.1439, 2nd col., “Bone ECM Decellularization”).
It would have been obvious to a person skilled in the art to use DNase and RNase to remove nucleic acids from the bone fragment of Karalashvili et al. as Mansour et al. teach removal of nucleic acids is a part of decellularization of bone.
Regarding the duration of “a week” for DNase and RNase treatment, Mansour et al. teach that decellularization of compact bone is challenging due to its density that requires using cold isostatic pressure at 30°C for 10 min followed by DNase treatment for 3 weeks (p. 1440, 1st col., 1st par.). This indicates that the duration of DNase and RNase can be modified as needed to remove nucleic acids from the bone completely. Thus, it would have been obvious to a person skilled in the art to modify the duration of DNase/RNase treatment up to 3 weeks as taught by Mansour et al. to obtain desired outcome of the process by routine experimentations.
Regarding the steps being sequential (claim 1), the steps disclosed by Karalashvili et al. (i.e. alcohol-chloroform treatment, sodium hypochlorite treatment and SDS/TX-100 treatment) is in a different order than the claimed steps.
However, it would have been obvious to a person skilled in the art to carry out the Karalashvili et al.’s steps in any order, and by doing so, one skilled in the art would have a reasonable expectation of reaching to the same order of the steps as claimed. M.P.E.P. § 2144 recites, “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law…If the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court.” In In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), the court found that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), the court found that selection of any order of mixing ingredients is prima facie obvious.
Regarding the limitation in claim 1 directed to the bovine bone scaffold in the preamble, this limitation is directed to the intended purpose of the product produced by the claimed method. The intended purpose/use does not require any active step to be carried out for the claimed method, and does not provide any patentable weight in determining the patentability of the claimed method. Thus, this limitation does not limit the method of preparing the bovine bone scaffold by the claimed processing steps. Nevertheless, Karalashvili et al. teach that the decellularized bovine bone graft is for bone reconstruction (see Abstract), and thus, it teaches the intended purpose.
Regarding the newly added wherein clause directed to the average pore size being approximately 365.87+62.2 micrometers (claim 1), Karalashvili et al. do not particularly disclose the claimed pore size.
Malagon-Escandon et al. teach the pore size of the decellularized bovine cancellous bone being 356.69 mm + 125.36, 352.82 mm + 96.65, and 300.08 mm + 94.96 after treating with different HCl concentrations (p.3 and 8). While the treatment for decellularization taught by Malagon-Escandon et al. is not identical to the claimed processing steps, however, as the decellularization and demineralized steps of Malagon-Escandon et al. would produce the bone scaffold having the pore size as claimed, the decellularized bovine cancellous bone treated with the steps taught by the cited reference as above would be capable of producing the substantially similar, if not identical, results of the porosity as claimed pore size with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to obtain the claimed average pore size from decellularization of the bovine cancellous bone because Malagon-Escandon et al. teach that a pore size of 300 to 500 mm has been shown to allow the growth of neoformed bone and blood vessels (p.8, last para.).
Regarding the limitation directed to the decellularized cancellous bone body supporting attachment and proliferation of osteoblasts, this limitation is directed to the property of the product resulted from the claimed method of making when the product is used for culturing osteoblasts. As the combined teachings of the cited references teach all the steps of the claimed method, the resulted product produced by the process would be substantially similar, if not identical, to the claimed product. Thus, the property of supporting attachment and proliferation of osteoblasts would be inherently met. Furthermore, this limitation is considered as an intended use of the product for supporting attachment and proliferation of osteoblast, and this intended use is not an active step required by the claimed method. Thus, it does not provide any patentable weight in determining patentability of the claimed method of making.
Regarding the decellularized bovine bone scaffold being suitable for bone replacement and regeneration (claim 1), this limitation in the preamble is considered as an intended purpose of the product produced by the claimed method. This intended use is not an active step required by the claimed method. Thus, it does not provide any patentable weight in determining patentability of the claimed method of making. See MPEP2111.02(II).
Regarding claim 2, while Karalashvili et al. teach femoral bone, it does not teach a femoral head. However, it would have been obvious to a person skilled in the art to use femoral head as it is a part of a femoral bone taught by Karalashvili et al.
Regarding claim 3, the bone fragment of Karalashvili et al. is considered the same as fragmented in blocks as the size of bone fragments of Karalashvili et al. are 15x4x2 cm (p.1, 2nd col., last par.).
Regarding claim 6, under the interpretation that the limitation is directed to the step (d) of claim 1, as discussed above, Karalashvili et al. teach rinsing to remove chloroform and ethanol, and thus, treating the bone fragments with chloroform and alcohol would be under the similar condition. Based on this reasoning, the step of treating chloroform-alcohol mixture would be with rotation at about 50 rpm, which is not 80 rpm as claimed. However, it would have been obvious to a person skilled in the art to modify the speed of rotation up to 120 rpm as Karalashvili et al. teach the treatment of bone fragment with sodium hypochlorite is under stirred condition at 120 rpm. Thus, one skilled in the art would view that treating bone graft with chemical compounds can be around 50 rpm up to 120 rpm, and modify the speed within this range by routine experimentation to obtain desired outcome of the treatments.
Regarding claims 13-16 and 18-19, they are directed to the properties of the product produced by the claimed method, while the cited references do not teach the limitation, however, as the combined teachings would meet the claimed method steps, it is expected that the bone graft produced by the treatment taught by the cited references would necessarily possess the claimed characteristics.
Regarding claim 20, directed to the cryopreservation step (step (k)) utilizing deep freezing at -80°C, while Karalashvili et al. teach lyophilization step at -40°C (p.2, 1st col., last para.), Karalashvili et al. do not teach a step of cryopreserving the decellularized cancellous bone body. However, Morse et al. teach that bone graft may be lyophilized or cryopreserved or fresh frozen for storage (col. 7, lines 40-41). While Morse et al. do not particularly teach the temperature being -80°C for cryopreservation, however, it is extremely well known in the art that cryopreservation can be carried out at -80°C. Furthermore, Karalashvili et al. teach -80°C for freezing the bone fragment (p.2, 1st col., 1st full para.). Thus, it would have been obvious to a person skilled in the art to cryopreserve the decellularized bovine cancellous bone fragment of Karalashvili et al. in view of DePaula et al., Grayson et al., Cornu et al., Morse et al., Chen et al. and Mansour et al. at -80°C for storage with a reasonable expectation of success.
Regarding claim 21 directed to the duration of steps (a)-(h) is two weeks, the combined teachings of Karalashvili et al. in view of DePaula et al., Grayson et al., Cornu et al., Morse et al., Chen et al. and Mansour et al. do not particularly teach the limitation. However, it is submitted that the duration for each of the process steps of Karalashvili et al. in view of DePaula et al., Grayson et al., Cornu et al., Morse et al., Chen et al. and Mansour et al. can be readily modified for the desired outcome, and one skilled in the art would carry out the steps for preparing decellularized bone graft for two week with a reasonable expectation of success. In the absence of any evidence to the contrary, the duration of the process steps as claimed is considered as a result-effective parameter that can be routinely optimized. Furthermore, the steps taught by Karalashvili et al. include rinsing and freezing for at least 12h, sequential wash in SDS for 72h, chloroform/ethanol wash for 48h, deproteinization for 24h, wash in deionized water for 72h would be about 7.5 days, and the rinsing and freezing step, or other washing and rinsing steps can be readily modifiable for the desired outcome. Thus, it would have been obvious to carry out these steps for 2 weeks as claimed with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Karalashvili et al. in view of DePaula et al., Grayson et al., Cornu et al., Morse et al., Chen et al., Mansour et al. and Malagon-Escandon et al. as applied to claims 1-3, 5, 7-10 and 13-21 above, and further in view of ResearchGate (2017, How fast does DNase I lose activity at 37°C; of record) and Gardin et al. (2015, PLoS ONE; of record).
Regarding claim 11, Karalashvili et al. in view of DePaula et al., Grayson et al., Cornu et al., Morse et al., Chen et al., Mansour et al. and Malagon-Escandon et al. do not teach replacing DNase and RNase every 12 hr with freshly prepared DNase and RNase. However, one skilled in the art would recognize that for the treatment with longer duration (up to 3 weeks as taught by Mansour et al.), the nuclease treatment would be replenished with fresh enzymes as these enzymes lose their activity over the time. In support, DNase would be active about 6-12 hr at 37°C, pH 7.4 (see ResearchGate Q&R). Thus, it would have been obvious to a person skilled in the art to refresh the DNase and RNase every 6-12 hours during the entire duration of the treatment up to 3 weeks with a reasonable expectation of success as the enzymes would lose their activity over the hours.
Regarding claim 12 directed to the DNase/RNase treatment is carried out in PBS under continuous shaking, as discussed above, Mansour et al. teach 37°C for enzymatic treatment (DNase/RNase), but does not teach PBS or continuous shaking. It is known in the art that DNase/RNase treatment for decellularization process is carried out in PBS at 37°C according to Gardin et al. (see Table 2), and Gardin et al. also teach that all of the decellularization steps are conducted under continuous shaking (p.3, “Decellularization protocols of bovine bone”). Thus, it would have been obvious to a person skilled in the art to carry out the treatment step using DNase/RNase in PBS at 37°C under continuous shaking with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
As indicated above, the claim rejections under 112 have been withdrawn due to the instant amendment.
Applicant's arguments filed on 6/4/2026 with regard to the 103 rejection have been fully considered but they are not persuasive. It is noted that the 103 rejection above has been modified (in bold) in order to address the newly amended limitation.
Applicant alleged that the claim rejection relied on a combination of 8 separate prior art references, which underscores the complexity and non-obviousness of the claimed invention, and it is impermissible to engage in hindsight reconstruction of the claimed invention.
In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding the applicant’s argument directed to the claimed pore size, applicant asserted that Malagon-Escandon employs fundamentally different decellularization protocol based on HCl treatment, not the sequential multi-step detergent-based protocol of the present claims. The Examiner does not agree with this argument. As acknowledged in the claim rejection above, while Malagon-Escandon does not teach the claimed method steps, however, based on the teaching of Malagon-Escandon, one skilled in the art would understand that the claimed pore size can be obtainable by decellularization, and the decellularization method other than Malagon-Escandon can produce the bone tissue with the pore size as claimed. Furthermore, as discussed above, Malagon-Escandon et al. teach that a pore size of 300 to 500 mm has been shown to allow the growth of neoformed bone and blood vessels, thus, one skilled in the art would modify the treatments (i.e. decellularization/delipidation, etc. taught by the combined teachings of the cited references) to obtain the average pore size within the claimed range.
Still further, as the pore size of bovine cancellous bone is known to be 300-600 mm diameter according to Lee et al. (2012, Mater. Res. Soc. Symp. Proc.; p.178, 1st para.), and the final pore size after demineralization of the bovine cancellous bone must be within 300-600 mm regardless the decellularization technique. Rather as the final pore size seems dependent on the degree of cells/minerals being removed from the starting bone tissue, one skilled in the art would modify the degree of the decellularization by adjusting the treatment steps in order to obtain the desired pore size of decellularized bovine cancellous bone.
Applicant alleged that the claimed average pore size is unexpected in view of the recognized damage that detergents inflict on the ECM, and none of the cited references demonstrate that such a pore size and such functional osteoblast behavior (attachment and proliferation of osteoblasts) could be achieved using a detergent-based decellularization protocol. There is no evidence to support that the claimed pore size is an unexpected result. Rather, considering the pore size of bovine cancellous bone is 300-500 mm, the claimed pore size after decellularization is expected within the claimed range. Applicant is advised to provide factual evidence showing that one skilled in the art cannot expect the pore size by the detergent-based decellularization from the bovine cancellous bone. Furthermore, factual evidence is required to support the alleged unexpected results of attachment and proliferation of osteoblasts to the bovine cancellous bone decellularized by the claimed detergent-based decellularization. Without such evidence, it is the Examiner’s position that the alleged pore size and the osteoblast behavior are not unexpected.
Applicant asserted that the claimed sequential order is not merely an arbitrary ordering, and there is no teachings for the specific order from the combined teachings of the cited references. In the absence of any unexpected results of the alleged specific order, it is the Examiner’s position that the order of the method steps can be modified.
M.P.E.P. § 2144 recites, “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law…If the facts in a prior legal decision are sufficiently similar to those in an application under examination, the examiner may use the rationale used by the court.” In In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), the court found that selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), the court found that selection of any order of mixing ingredients is prima facie obvious.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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