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 .
Claim Objections
Claims 41 and 43 are objected to because of the following informalities: “polysaccharide oligosaccharide” should be “polysaccharide, oligosaccharide”. Appropriate correction is required.
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 31 and 36 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation peroxide, and the claim also recites hydrogen peroxide and hydrogen peroxide in 30% w/w aqueous solution which is the narrower statement of the range/limitation. In the present instance, claim 36 recites the broad recitation peroxide, and the claim also recites hydrogen peroxide and hydrogen peroxide in 30% w/w aqueous solution which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claim(s) 26-35, 37-38, and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dao (WO 2020/039008). Dao (US 11,857,702) as English equivalent for citation.
Regarding claims 26, 28-30 and 32-34: Dao (US ‘702) discloses a method of functionalizing a surface [abstract; 1:3-8], wherein Example 3 [Ex. 3; 19:49-20:55] immerses polyethylene probes in a solution of 0.2% (m/v) hyaluronic acid in distilled water for 2h at room temperature to afford a polyethylene surface coated with hyaluronic acid [Ex. 3; 19:49-20:55].
Note hyaluronic acid:
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[see instant specification, Scheme 2].
Regarding claim 27: Dao (US ‘702) discloses polyethylene (PE) and cyclic olefin copolymers (COP) as the polymer substrate [8:7-27]; i.e. exchange PE with COP as the polymer in Ex. 3 [see MPEP 2131.02].
Regarding claim 31: Dao (US ‘702) discloses the basic claimed method [as set forth above with respect to claim 26].
Note: claim 31 further defines species of the oxidizing agent recited in claim 26. However, as claimed, such species only further define the genus of the optional oxidizing agent (i.e. claims 26 and 31 do not require the method to treat the surface with the oxidizing agent).
Regarding claim 35: Dao (US ‘702) discloses immersing the polyethylene surface coated with hyaluronic acid into a crosslinking solution (Tyzor TE [4:53-67]), to crosslink the hyaluronic acid, with subsequent immersion into 0.2% (m/v) hyaluronic acid [Ex. 3; 11:25-12:52; 19:49-20:55]. Dao (US ‘702) discloses repeating the crosslinking method [Ex. 3; 20:2-55].
Regarding claims 37-38: Dao (US ‘702) discloses treating surfaces [8:7-27] of medical devices such as probes, inside of syringe, stent, catheter, lens, etc. [7:44-62].
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim [see MPEP 2111.02; 2144.07].
Regarding claim 40: Dao (US ‘702) discloses treating surfaces [8:7-27] of medical devices such as probes, inside of syringe, stent, catheter, etc. [7:44-62].
Claim(s) 43-45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dao (WO 2020/039008). Dao (US 11,857,702) as English equivalent for citation.
Regarding claims 43 and 45: Dao (US ‘702) discloses functionalized surfaces [abstract; 1:3-8], wherein Example 3 [Ex. 3; 19:49-20:55] immerses polyethylene probes in a solution of 0.2% (m/v) hyaluronic acid in distilled water for 2h at room temperature to afford a polyethylene surface coated with hyaluronic acid [Ex. 3; 19:49-20:55].
Regarding claim 44: Dao (US ‘702) discloses polyethylene (PE) and cyclic olefin copolymers (COP) as the polymer substrate [8:7-27]; i.e. exchange PE with COP as the polymer in Ex. 3 [see MPEP 2131.02].
Claim(s) 26, 28-34 and 37-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry et al. (US 2006/0154894).
Regarding claims 26, 28-30 and 34: Berry et al. (US ‘894) discloses a method of immobilization of polysaccharides on a substrate [abstract], wherein Example 2 [Ex. 2; 0199-0256] treats a polystyrene substrate with a few drops of 5 mg/ml aqueous solutions of hyaluronic acid (HA [0060]) or heparin [0060] and spin coating for 10 seconds to afford a polystyrene substrate with a chemisorbed layer of HA or heparin [Ex. 2; 0199-0202].
Note hyaluronic acid:
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[see instant specification, Scheme 2].
Regarding claim 31: Berry et al. (US ‘894) discloses the basic claimed method [as set forth above with respect to claim 26].
Note: claim 31 further defines species of the oxidizing agent recited in claim 26. However, as claimed, such species only further define the genus of the optional oxidizing agent (i.e. claims 26 and 31 do not require the method to treat the surface with the oxidizing agent).
Regarding claim 32-33: Berry et al. (US ‘894) discloses surfaces digested with heparin for 30 minutes (at RT) [Ex. 2; 0202].
Regarding claims 37-39: Berry et al. (US ‘894) discloses the treated surfaces were investigated to prevent protein binding by distributing a solution of FN (fibronectin [0022]) (20 µg/ml in PBS) on the treated surface and incubating for 30 minutes {corresponding to a culture plate} [Ex. 2; 0205-0206; 0227; Figs. 8-9].
Regarding claim 40: Berry et al. (US ‘894) discloses medical devices, such as catheter, stent, tubes, filtering devices [0014-0015].
Claim(s) 41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry et al. (US 2006/0154894).
Regarding claim 41: Berry et al. (US ‘894) discloses a method of immobilization of polysaccharides on a substrate [abstract], wherein Example 2 [Ex. 2; 0199-0256] treats a polystyrene substrate with a few drops of 5 mg/ml aqueous solutions of hyaluronic acid (HA [0060]) or heparin [0060] and spin coating for 10 seconds to afford a polystyrene substrate with a chemisorbed layer of HA or heparin [Ex. 2; 0199-0202]. Berry et al. (US ‘894) discloses the treated surfaces were investigated to prevent protein binding by distributing a solution of FN (fibronectin [0022]) (20 µg/ml in PBS) on the treated surface [Ex. 2; 0205-0206; 0227; Figs. 8-9].
Claim(s) 43 and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berry et al. (US 2006/0154894).
Regarding claims 43 and 45: Berry et al. (US ‘894) discloses immobilization of polysaccharides on a substrate [abstract], wherein Example 2 [Ex. 2; 0199-0256] treats a polystyrene substrate with a few drops of 5 mg/ml aqueous solutions of hyaluronic acid (HA [0060]) or heparin [0060] and spin coating for 10 seconds to afford a polystyrene substrate with a chemisorbed layer of HA or heparin [Ex. 2; 0199-0202].
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.
Claim(s) 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Dao (WO 2020/039008). Dao (US 11,857,702) as English equivalent for citation.
Regarding claims 41-42: Dao (US ‘702) discloses a method of functionalizing a surface [abstract; 1:3-8], wherein Example 3 [Ex. 3; 19:49-20:55] immerses polyethylene probes in a solution of 0.2% (m/v) hyaluronic acid in distilled water for 2h at room temperature to afford a polyethylene surface coated with hyaluronic acid [Ex. 3; 19:49-20:55]. Dao (US ‘702) discloses treated surfaces [8:7-27] of medical devices such as probes, the inside of a syringe, stent, catheter, heart valves, etc. [7:44-62].
Dao (US ‘702) discloses does not specifically disclose contacting the treated probe surface of Ex. 3 (or medical device such as the inside of a syringe, stent, catheter, heart valves, etc. [7:44-62]) with a proteinaceous composition or a composition containing an oligonucleotide. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have contacted the treated surface of the medical device (probe, inside of syringe, stent, hart valve) with blood (blood containing insulin (peptide hormone)), and would have been motivated to do so since Dao (US ‘702) discloses the treated surface of the medical device for use in humans; i.e. the treated surface is in contact with blood when used in a surgical/medical procedure when blood is present [744-8:6].
Claim(s) 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Berry et al. (US 2006/0154894) as applied to claim 26 above.
Regarding claims 35-36: Berry et al. (US ‘894) discloses the basic claimed method [as set forth above with respect to claim 26]; wherein Berry et al. (US ‘894) discloses the surface can contain hydrogen peroxide [0110].
Berry et al. (US ‘894) does not specifically disclose Ex. 2 containing hydrogen peroxide. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included hydrogen peroxide based on the invention of Berry et al. (US ‘894), and would have been motivated to do so since Berry et al. (US ‘894) suggests that the surface can contain hydrogen peroxide to prevent infection [0110]. Additionally, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) [see MPEP 2144.06].
See attached form PTO-892.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached on 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
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