Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-13, in the reply filed on March 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 27, 2026.
Therefore, after the election, claim 14 is withdrawn and claims 1-13 are pending for examination as filed with the election of March 27, 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 1, “long-acting” and “super-hydrophobic” and “anticoagulant” are vague and indefinite as to what is actually covered by these terms. How long would something have to act to be considered “long-acting” as opposed to “short” or “average” lasting, for example. Moreover, how hydrophobic would something have to be to be considered “super-hydrophobic” as opposed to simply “hydrophobic”? Moreover, how much opposition to coagulation is needed to be “anticoagulant”. For the purpose of examination, performing steps (1)-(3) of claim 1 is understood to provide a “long-acting” and “super-hydrophobic” and “anticoagulant” valve to the extent claimed, but applicant should clarify what is intended, without adding new matter.
Claim 9, “in particular, at least one of hydrogen peroxide . . .” is unclear if the oxidant must be one of the listed “in particular” materials or whether this is just an option, and the oxidant only needs to be water soluble? For the purpose of examination, either is understood to meet the claim requirements, but applicant should clarify what is intended, without adding new matter.
The dependent claims do not cure the defects of the claims from which they depend and are therefore also rejected.
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 1-5, 7, 9-10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Oviatt et al (US 2006/0047343) in view of Levy et al (US 5368608) and Simionescu et al (US 2004/0153145), EITHER alone OR further in view of Ogle (US 6113636).
Claim 1: Oviatt teaches a preparation method for making a biological valve that has hydrophobic groups on the surface to prevent calcification (note 0011, 0014, 0035-0036). The method includes providing a biological valve material/tissue (note 0019, 0025, 0026,0052, 0055, 0057), and there would be a step (1) of treating the material with glutaraldehyde (to provide a glutaraldehyde fixed tissue) (note 0019, 0036, claims 1, 3), where thereafter (after the fixation step), the glutaraldehyde fixed tissue is treated in in a step (3) with a hydrophobic substance (such as perfluorocarbons, or siloxanes) (note 0015, 0052, 0057, which would be understood to react with the treated material, note 0022).
Oviatt does not provide the claimed step (2) between step (1) and step (3). However,
Levy describes providing treatment of biological valve material to help prevent calcification, where it is indicated to provide a first step of treating the material with glutaraldehyde, and thereafter a second step of treating the glutaraldehyde treated material with a solution containing metallic cations (ions) (note column 5, lines 50-65, column 6, lines 1-20, column 4, lines 20-30, column 4, line 65 to column 5, line 10), where the cations can be ions from Fe and also Al (note column 54, line 65 to column 5, lined 10, column 7, lines 1-40, where, at the least, it would be expected that both the Fe and Al can be used as both help prevent calcification). The described Fe material can be FeCl3 (ferric chloride) the material indicated in claim 9 as an oxidant (note column 5, lines 1-5, column 7, lines 15-50). The solution can also contain citric acid along with the iron and aluminum ion, helping to improve the solution (column 7, lines 25-45). Thus, Levy describes treating with a solution that can contain aluminum ions (metal ions), and oxidant (FeCl3) and an acid (citric acid), and thus would be describing the material in an acid solution. For treatment the valve material can be placed in the solution of the material (note column 7, lines 1-40).
Additionally, Simionescu further describes that fixative for biological valves can be provided, where the valve material is first treated with glutaraldehyde and then with a solution containing a polyphenol compound (such as tannic acid), which allows for fixing valve material containing elastin (0009-0011, 0043). For fixing, the tannic acid can be provided an a solution, that is acidic (pH can be less than 6) (note 0044-0046) and the material fixed in the solution (note 0060, 0069-0072).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oviatt to provide, between steps (1) and (2) a further placing of the valve material in an acid solution containing a polyphenol component (such as tannic acid) and metal ions (such as aluminum ions) and also adding an oxidant (FeCl3) to the solution, giving a reaction to the extent claims as suggested by Levy and Simionescu to provide further desirable treatment, because Oviatt provides treating biological valve material with glutaraldehyde to fix, and thereafter providing a hydrophobic substance treatment to help prevent calcification, and where Levy indicates that when treating biological valve material providing a treatment with solution containing aluminum ions, citric acid, and ferric chloride (FeCl3, an oxidant indicated by applicant) helps provide further anticalcification, and Simionescu further indicates also providing the fixing of biological valve material with glutaraldehyde followed by a treatment with a solution containing tannic acid (polyphenol) that can also be in an acidic solution to help further treat elastin in the biological valve material. Therefore, it would have been suggested to provide treatment of the biological valve with glutaraldehyde followed by treatment with an acidic solution that contains tannic acid, metallic ions (aluminum ions) and an oxidant (FeCl3), and followed by treatment with the hydrophobic substance, since Levy and Simionescu indicate that their treatment material solutions are applied after glutaraldehyde treatment, and in Oviatt the hydrophobic substance treatment provides hydrophobic groups on the surface (note 0011), so would want to be applied last. The solutions of Levy and Simionescu would be understood to be predictably and acceptably provided as a combined solution, as each of these references provides using materials in an acidic solution, and further that in combining the materials the oxidant would predictably and acceptably be added last, since as indicated by In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (so one would predictably and acceptably provide the tannic acid solution and metal solution together, so as to efficiently provide one treatment step), and as indicated by In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930), Selection of any order of mixing ingredients is prima facie obvious, so for example, to control the time of treatment of materials, a first treating solution of tannic acid can be provided to the valve material, then later the metal solution materials added, with the oxidant added last, so as to give a longer treating time to the tannic acid material. By providing all of the steps claimed with the materials claimed, it is understood that the resulting biological valve will be long-acting, super-hydrophobic and acnticoagulant as claimed.
Optionally, further using Ogle, if for treatment to get the valve features claimed the metal ion material needs to be materials as in claim 6, Ogle further teaches biological valve material can be provided (note column 5,lines 30-68) and first treated with glutaraldehyde (note column 6, lines 5-15, column 12, lines 40-50). The valve material is then desirably treated with a solution containing silver ions or copper ions to inhibit infections (antimicrobial) (note column 2, lines 30-60, column 3, lines 20-45). It is further indicted that compositions containing Fe ions to reduce calcifications along with the antimicrobial composition can be used (note column 11, liens 30-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oviatt in view of Levy and Simionescu to provide, between steps (1) and (2) a further placing of the valve material in an acid solution containing a polyphenol component (such as tannic acid) and metal ions (such as silver or copper ions) and also adding an oxidant (FeCl3) to the solution, giving a reaction to the extent claims as suggested by Ogle to provide further desirable antimicrobial treatment, because Oviatt in view of Levy and Simionescu would suggest a step (2) treatment with polyphenol and oxidant (FeCl3) as claimed, and Ogle further indicates that the solutions as in Levy could also contain silver or copper ions for antimicrobial purposes, which would predictably and acceptably be used so that the oxidant was added last,
Claim 2: as to treating with glutaraldehyde by immersing the biological valve material in glutaraldehyde solution, this is indicated by Levy (note 6, lines 1-10, or Simionescu, note 0060-0062, 0070-0071, 0077-0080, where as noted by these paragraphs, a variety of times can be used, including 24 hours, 7 days, 44 hours, 1 hour, etc, and therefore, it would have been obvious to one of ordinary skill in the art to optimize the time use, giving a value in the claimed range. Note "[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).
Claim 3: As to the oxidant concentration, Levy notes 0.001-1 M (note col7umn 5, lines 1-10) and also as low as o.00001 – 0.1 M (note column 7, lines 50-60) for the FeCl3, and one of ordinary skill in the art would optimize from this range, giving a value in the claimed range. As to the temperature and time, Levy notes 4-25 degrees C and 1-24 hours, both overlapping the claimed ranges (note column 5, lines 1-10), and one of ordinary skill in the art would optimize from these ranges, giving values in the claimed range. Simionescu also notes overlapping temperature, and to variations in time (note 0045). Note "[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).
Claim 4: as to the molar mass of polyphenol compound (tannic acid), Simionescu notes 0.0001 g/100 m.l (0.001g/L) to 10g/100 ml (100 g/L) (note 0044), With a molar mass of about 1701 g/mol, this gives about 5.9 x10-4 mM to about 0.059 M (about 59 mM). Levy notes 0.00001 – 0.1 M (0.01 to 100 mM) of the aluminum ions (note column 7, lines 50-60). Therefore, given the related molar amouts, the molar mass ratio would overlap that claimed and it would be obvious to optimize the amount of each, giving a value in the claimed range. When using Ogle, an amount of silver, copper to give 0.01 mg/gram of tissue would be desired (note claim 1), and therefore one would optimize the amount, leading to a molar mass ratio in the claimed range. Note "[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).
Claim 5: from Simionescu, the polyphenol can be tannic acid (note 0040), and can also be flavonoid (note 0040).
Claim 7: from Simionescu, it is suggested that the acid solution have a pH of below 6 or also 4-9, both overlapping the claimed range (note 0045), and one would optimize from this range, giving a value in the claimed range. Note In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claim 9: Levy suggests the oxidant of FeCl3 as discussed for claim 1 above, understood to be water soluble, as a listed material for this.
Claim 10: As to the treating with the valve in step (3) with the hydrophobic material in a solution, by immersion, this is indicated by Oviatt (note 0057-0058, where the contact is at least suggested to be immersing to cover all surfaces), where as to the time, an example is given of hours to days (note 0058), such that one would optimize the time for the material used, giving a value in the claimed range. As to the amount, Oviatt does not limit the amount, so it would be obvious to optimize and select for the desired use. Note MPEP 2144.05 (II)(A).
Claim 12: As to the valve material as an aortic valve, etc. Oviatt notes valve tissue (note 0019), and Simionescu notes aortic wall material (note 0011, so understood to be usable for aortic valve) and also heart valve (note 0011, so understood to include pulmonary valve, aortic valve, etc.). Levy notes using porcine aortic valves as well (note column 1, lines 40-45, giving a suggested biological valve material).
Claim 13: As to the valve material selected from porcine pericardium or bovine pericardium, this would be suggested by Oviatt (note 0004, 0019), Levy (note column 1, liens 20-25), Simionescu (note 0011).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Ley and Simionescu, EITHER alone OR further in view of Ogle as applied to claims 1-5, 7, 9-10 and 12-13 above, and further specifically in view of Ogle.
Claim 6: as to the metal ions, Ogle further teaches biological valve material can be provided (note column 5, lines 30-68) and first treated with glutaraldehyde (note column 6, lines 5-15, column 12, lines 40-50). The valve material is then desirably treated with a solution containing silver ions or copper ions (antimicrobial) to inhibit infections (note column 2, lines 30-60, column 3, lines 20-45). It is further indicted that compositions containing Fe ions to reduce calcifications along with the antimicrobial composition can be used (note column 11, liens 30-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oviatt in view of Levy and Simionescu, EITHER alone OR further in view of Ogle to provide, between steps (1) and (2) a further placing of the valve material in an acid solution containing a polyphenol component (such as tannic acid) and metal ions (such as silver or copper ions) and also adding an oxidant (FeCl3) to the solution, giving a reaction to the extent claims as suggested by Ogle to provide further desirable antimicrobial treatment, because Oviatt in view of Levy and Simionescu would suggest a step (2) treatment with polyphenol and oxidant (FeCl3) as claimed, and Ogle further indicates that the solutions as in Levy could also contain silver or copper ions for antimicrobial purposes, which would predictably and acceptably be used so that the oxidant was added last,
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Ley and Simionescu, EITHER alone OR further in view of Ogle as applied to claims 1-5, 7, 9-10 and 12-13 above, and further in view of EP 0 172 716 (hereinafter ‘716).
Claim 8: as to the use of an acid solution with acetic acid-acetate buffer, for example, as discussed for claim 1 above, Levy would indicate using acid (such as citric acid) in the solution.
‘716 also teaches treating biological valve material with glutaraldehyde and treating with acidic solutions (note pages 2-3). It is described treating with a buffered acidic solution, and also using such as solution for the glutaraldehyde treatment with a controlled pH(note pages 5-6). The solution using acetic acid-acetate buffer (note page 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oviatt in view of Levy and Simionescu, EITHER alone OR further in view of Ogle to provide that the acid solution has controlled pH using acetic acid-acetate buffering as suggested by ‘716 with an expectation of predictably acceptable results, since Simionescu notes using controlled pH in acid conditions (note 0045), Levy indicates using solutions with acid, and ‘716 indicts how solutions with controlled pH can be used for biological valve material treatment by providing a solution with acetic acid-acetate buffer system.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Oviatt in view of Ley and Simionescu, EITHER alone OR further in view of Ogle as applied to claims 1-5, 7, 9-10 and 12-13 above, and further in view of Li et al (2020/0233245).
Claim 11: as to the specific hydrophobic substances claimed, Oviatt would indicate using perfluorocarbon material (note 0015).
Li indicates that perfluorododcanoic acid as a known perfluorocarbon that can be used for coating and giving super-hydrophobic property (note 0036).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oviatt in view of Levy and Simionescu, EITHER alone OR further in view of Ogle to provide that perfluorododecanoic acid is used as the perfluorocarbon as suggested by Li to give desirable results, since Oviatt indicates that perfluorocarbon material can be used, and Li indicates that perfluorododcanoic acid as a known perfluorocarbon that can be used for coating and giving a desirable super-hydrophobic property.
CN 110152066, as cited on the IDS of June 18, 2023, also notes the use of glutaradehyde, polyphenol compounds and metal ions to treat biomaterial valves (note the abstract, for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE A BAREFORD whose telephone number is (571)272-1413. The examiner can normally be reached M-Th 6:00 am -3:30 pm, 2nd F 6:00 am -2:30 pm.
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/KATHERINE A BAREFORD/Primary Examiner, Art Unit 1718
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