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 .
Status of the Claims
Claims 1-20 responsive to communications on 12/12/2022 are pending.
Claims 1-20 have been examined on their merits.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Specifically, hypertext is found in the specification on p7, lines 22-23 in regards to a “toptiontech” website.
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.
Claims 1-5, 10, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation).
In regards to claims 1-3, it is noted that the term “and/or”, in the phrase “a hydrothermal and/or solvothermal treatment” has been interpreted as allowing for any of (1) a hydrothermal, (2) solvothermal, or (3) both a hydrothermal and solvothermal treatment, and is therefore synonymous with the word “or” which is inclusive as understood in formal logic.
Turning to the art, Wang discloses a method for producing cancellous bone for xenografts using a hydrothermal method (Title, Abstract; claim 1; Example 2, seventh through eighth pages).
Wang discloses that the method comprises placing bone in a distilled (purified) water (which is an inorganic solvent, and therefore, the method of Wang is also a solvothermal method) in a pressure-bearing closed container while the temperature is kept in the range of 100 to 240°C (Claim 1; Example 2, step (4), eight page). The temperature range of 100 to 240°C overlaps with the range as in claim 1 (see MPEP2131.03).
In regards to the pressure, while Wang is silent as to the pressure in the pressure-bearing closed container, as a matter of thermodynamics, it is well-established that the vapor pressure of water (the pressure exerted by water in a closed system) is 1 atm at 100°C. Thus, bones in water in a pressure-bearing closed container at any temperature above 100°C would be pressurized to more than 1 atm (e.g., a temperature of 240°C in a closed contained would specifically would produce pressure of about 33 atm in a closed system, which is greater than the ranged as in claim 1).
In regards to claim 4, Wang discloses that the method is performed for 1 to 12 hours (Claim 1; Example 2, Example 2, step (4), eight page), which overlaps with the ranges as in claim 4.
In regards to claim 5, in regards to step a), Wang discloses that prior to the hydrothermal/solvothermal treatment, mammalian (animal) cancellous bone is formed into a power (Abstract; Claim 1; Example 2, Example 2, step (4), eight page), which a person of ordinary skill in the art would have recognized requires the crushing of bone.
In regards to steps b), Wang discloses that the cancellous bone is repeatedly washed with water until no bone marrow tissue (organic phases) is visible (Example 2, step (1), eighth page). As this occurs “repeatedly”, a person of ordinary skill in the art would have recognized that it partially removes organic phases (i.e., organic material), with subsequent repeats.
In regards to step c), any subsequent repeated wash, as disclosed by Wang as above, that continually removes bone marrow reads on further removing organic phases as in step c). Additionally, Wang discloses another pretreatment step (with a solvent) (Example 2, step (2), seventh page) for removing organic phases (such as fat and protein; Contents of the invention, p4).
In regards to step d), as above, any subsequent repeated wash, as disclosed by Wang as above, that continually removes bone marrow reads on further removing organic phases as in step d). Additionally, Wang discloses that prior to the hydrothermal treatment, the bone is washed (Example 2, step (2)(a), seventh page).
In regards to claim 10, Wang discloses that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and dried (Example 2, step (3), seventh through eighth pages).
In regards to claims 13 and 14, Wang discloses that the hydrothermal step is performed for 12 hours (Claim 1; Example 2, step (4), eight page), which overlaps with the range as in claim 13.
Therefore, Wang anticipates the invention as clamed.
Claim Rejections - 35 USC § 103
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 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 6, 9, 11, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation) in view of Mao et al. (US2005266037, 2005).
Wang anticipates claims 1, 5, and 10, respectively, as discussed above.
In regards to claims 6 and 9, as above, Wang teaches that prior to the hydrothermal/solvothermal treatment the cancellous bone is washed with water (Example 2, steps (1) through (3), seventh page), Wang teaches that the water is deionized (a type purified water) (Example 2, steps (1) through (3), seventh page).
Wang is silent as to the timings and does not explicitly teach that the cancellous bone is also boiled.
However, Mao who teaches that, for preparing bone for implantable biomaterials, the bone may be boiled in distilled (purified) water to substantially disrupt the collagen and removing bone marrow and the extracellular matrix proteins (ECM) (paragraphs [0011-0014, 0067-0069]; claims 1 and 3-4).
In regards to the timings, Mao also teaches that boiling step may be repeated two or more times at a timing of most particularly 1-2 hours (paragraphs [0016, 0069]), which overlaps with the range as in claim 6 for both washing and boiling steps. It is noted that boiling is a type of washing, and the claim does not distinguish between washing and boiling.
A person of ordinary skill in the art would have been motivated to wash bones between 10 and 15 times or specifically boil bones 3 to 5 times in order to continually remove more organic material such as fat or collagen
Furthermore, because both Lee (paragraph [0005]) and Mao teach methods for boiling and treating bones for the removal of organic tissues to produce bone grafts (Abstract, paragraphs [0001, 0011-0014, 0067-0069), because Mao teaches that bones can be treated with water two or more times between 1-2 hours (paragraphs [0016, 0069]), and because Wang, Lee, and Mao are in the same technical field of producing bone for bone grafts, it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 11, as above, Wang teaches that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and dried 4 times with distilled/deionized (purified) water (Example 2, step (4); claims 1 and 2).
While Wang is silent as to the specific timings, a person of ordinary skill in the art could have arrived at a timing of 1 to 7 days by routine optimization and the disclosure does not point to a criticality in this amount (see MPEP 2144.05(II)(A), as discussed above; see also, In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art)).
In the instant case because Mao teaches that bones may be boiled, which is a type of washing, for 24 hours (paragraph [0069]), a person of ordinary skill in the art could have arrived at a timing of washing for 1 to 7 days by routine optimization with predictable result and a reasonable expectation of success.
Furthermore, a person of ordinary skill in the art would have been motivational to wash bones over a long period of time in order to remove and residual organic material or chemicals which would still could be present on the bones. Furthermore, because as above, Mao teaches that bones may be boiled, which is a type of washing, for 24 hours (paragraph [0069]), it could have been done with predictable results and a reasonable expectation of success.
In regards to claim 17, as above, Wang teaches that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and then dried (Example 2, step (4), eighth page).
In regards to claim 20, as above, Wang teaches that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and dried (Example 2, step (3), seventh through eighth pages).
Therefore, the combined teachings of Wang and Mao renders obvious the invention as claimed.
Claim 7-8 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation) in view of Guilminot et al. (Journal of Cultural Heritage, 2014).
Wang anticipates claims 1 and 5 as discussed above.
In regards to claims 7 and 8, Wang teaches that in order to remove organic material cancellous bone is also pre-treated with different solutions (Abstract; Claim 1; Example 2, steps (2) through (3), eight page), which as solutions necessarily requires a solvent (and thus, a second solvent). In one embodiment, cancellous bone is treated with a sodium hydroxide solution, which is well-known in the art as being capable of dissolving organic material, for 12 hours (Example 2, step (2), eights page). In another embodiment, cancellous bone is treated with hydrogen peroxide solution, for 48 days (Example 2, step (2), eights page). While less than a timing of 7 to 15 days, it is noted that the claims do not require any specific solvent, and a person of ordinary skill in the art would have recognized that the timing would depend on the solvent used, the species of animal, and the size and amount of bone.
Additionally, a person of ordinary skill in the art could have arrived at a timing of 7 to 15 days by routine optimization, and the disclosure does not point to a criticality in this timing.
According to MPEP 2144.05(II)(A), generally, differences in timings 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); 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 the instant case because Wang teaches that cancellous bones can be contacted with solvents for varying amounts of time, and because Guilminot teaches that bones can be contacted with a solvent (heptane) for at least 8 days for degreasing (in order to remove organic materials) (Fig. 4, p130; Fig. 5, p131; Organic solvents, p132), it could have been done with predictable results and a reasonable expectation of success.
In regards to claims 18 and 19, as above, Wang teaches that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and then dried (Example 2, step (4), eighth page).
Therefore, the combined teachings of Wang and Guilminot renders obvious the invention as claimed.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation) in view of Mao et al. (US 2005266037, 2005) and Lee et al. (US US20150098875A1, 2015, on IDS 12/22/2022).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation) in view of Mao et al. (US 2005266037, 2005), as applied to claims 1 and 10-11, above, and further in view of Lee et al. (US US20150098875A1, 2015, on IDS 12/22/2022).
Wang anticipates claims 1 and 10 as discussed above.
Wang and Mao teach claim 11 as discussed above.
In regards to claims 12 and 16, as above, Wang teaches that following the hydrothermal or solvothermal treatment, the cancellous bone is washed and then dried (Example 2, step (4), eighth page).
In regards to the timing, Wang teaches that the cancellous bone is dried for 12 hours (Example 2, step (4), eighth page).
While less than a timing of 1 to 2 days, it is nonetheless close, and according to MPEP 2144.05(I), a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Furthermore, a person of ordinary skill in the art could have arrived at a timing of 1 to 2 days by routine optimization, and the disclosure does not point to a criticality in this timing.
According to MPEP 2144.05(II)(A), 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 re Aller, 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 re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art).
In the instant case because Mao teaches that when drying in an oven timing is determined for a time suitable according to the kind and quantity of the bone tissue treated (paragraph [0072]), it could have been done with predictable results and a reasonable expectation of success.
Moreover, a person of ordinary skill in the art would have been motivated to extend drying in order to ensure that water is maximally devoid of water and eliminate contamination and a niche for microorganisms to survive.
In regards to the temperatures, while Wang is silent as to the temperate at which cancellous bone is dried.
However, a person of ordinary skill in the art could have arrived at a temperature range of 50°C to 100°C by routine optimization, and the disclosure does not point to a criticality in this temperature range.
Like the timing, as above, because Mao teaches that the temperature of the oven may be any suitable temperature according to the source from which the bone was obtained and to the type of bone (paragraph [0072]), and in specific embodiments that in specific embodiments bones are autoclaved at 80°C or 100°C (paragraph [0074]), it could have been done with predictable results and a reasonable expectation of success.
Furthermore, it would have been predicably obvious to dry bones at a temperature arrived at a temperature range of 50°C to 100°C because Lee indicates that this temperature is suitable for drying cancellous bone for use in bone grafts (Abstract; paragraph [0016; Fig. 1).
Therefore, the combined teachings of Wang, Mao, and Lee renders the invention unpatentable as claimed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN108653819A, 2018, on IDS 12/22/2022; citations per machine translation) in view of Mao et al. (US 2005266037, 2005), as applied to claims 1 and 5-6, above, and further in view of Guilminot et al. (Journal of Cultural Heritage, 2014).
Wang anticipates claims 1 and 5 as discussed above.
Wang and Mao teach claim 6 as discussed above.
In regards to claim 15, as above, Wang teaches that in order to remove organic material cancellous bone is also pre-treated with different solutions (Abstract; Claim 1; Example 2, steps (2) through (3), eight page), which as solutions necessarily requires a solvent (and thus, a second solvent). In one embodiment, cancellous bone is treated with a sodium hydroxide solution, which is well-known in the art as being capable of dissolving organic material, for 12 hours (Example 2, step (2), eights page). In another embodiment, cancellous bone is treated with hydrogen peroxide solution, for 48 days (Example 2, step (2), eights page). While less than a timing of 7 to 15 days, it is noted that the claims do not require any specific solvent, and a person of ordinary skill in the art would have recognized that the timing would depend on the solvent used, the species of animal, and the size and amount of bone.
Additionally, a person of ordinary skill in the art could have arrived at a timing of 7 to 15 days by routine optimization, and the disclosure does not point to a criticality in this timing.
According to MPEP 2144.05(II)(A), generally, differences in timings 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 re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); 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 re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art)).
In the instant case because Wang teaches that cancellous bones can be contacted with solvents for varying amounts of time, and because Guilminot teaches that bones can be contacted with a solvent (heptane) for at least 8 days for degreasing (in order to remove organic materials) (Fig. 4, p130; Fig. 5, p131; Organic solvents, p132), it could have been done with predictable results and a reasonable expectation of success.
Therefore, the combined teachings of Wang, Mao, and Guilminot render the invention unpatentable as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH (PAUL) MIANO whose telephone number is (571)272-0341. The examiner can normally be reached Mon-Fri from 8:30am to 5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH PAUL MIANO/Examiner, Art Unit 1631