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 .
DETAILED ACTION
The amendment filed 01/22/2025 has been entered. Claims 8 and 12 are cancelled. Claim 19 has been newly added. Claims 1-7, 9-11, and 13-19 are pending and under examination.
The rejection of claims 2, 6, 7, 9-11, and 15 under 35 U.S.C. §112(b) as being indefinite is withdrawn in view of Applicant’s amendment.
The rejection of claims 1-10, 14-16, and 18 under 35 U.S.C. §102(a)(1) as being anticipated by Biederman et al. (CZ 2014757) is withdrawn in view of Applicant’s amendment.
The rejection of claims 11 and 17 under 35 U.S.C. §103 as being unpatentable over Biederman et al. (CZ 2014757) is withdrawn in view of Applicant’s amendment.
The rejection of claim 12 under 35 U.S.C. §103 as being unpatentable over Biederman et al. (CZ 2014757) in view of Andreacchi et al. (US 9,662,677) is withdrawn in view of the claim cancellation.
The rejection of claim 13 under 35 U.S.C. §103 as being unpatentable over Biederman et al. (CZ 2014757) in view of D’Sa et al. (2010) is withdrawn in view of Applicant’s amendment.
Response to Arguments
Applicant’s arguments with respect to claims 1-7, 9-11, and 13-19 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112(b)
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.
(New Rejection Necessitated by Amendment) Claims 1-7, 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 requires the new limitation of applying a gas towards the substrate surface “with a convective airflow”. The term “a convective airflow” is not defined in the specification. Convective airflow is considered to be the movement of air or other fluids due to temperature changes, which may be either natural or forced. However, “a convective airflow” is not applied, but is instead a result of an application of a force. Therefore, it is unclear whether the phrase means that heat, or another force, is applied with the gas to result in convection, or if the phrase refers to something else.
Claims 2-7, 9-11, and 13-19 are also rejected as they depend from claim 1.
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.
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.
The following new rejections are necessitated by amendment.
Claims 1-7, 9-11, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman et al. (CZ 2014757 A3), previously cited, in view of Bilek et al. (WO 2015/027297 A1) as evidenced by Marantz et al. (EP0368547B1) and Monzon et al. (Magnetic fields in electrochemistry: The Lorentz force, 2014).
Regarding claim 1, Biederman teaches a method for covalently attaching biomolecules to polymeric substrates (Page 1, Technical Field). Biederman teaches the use of plasma generated at atmospheric pressure to “activate” the polymeric substrates with a plasma generation system that has a dielectric-barrier discharge between two electrodes (Page 2, Paragraph 3). Biederman teaches that the substrate (PTFE) is placed on a dielectric-coated earth electrode that moves above the substrate surface after being exposed to plasma (Page 3, Paragraph 1). It is interpreted that a nozzle is an inherent feature of the plasma generation source of Biederman, as conventional commercial plasma torches or guns include a pointed rod-like cathode located in the body portion of the gun, and an anode located downstream of the cathode having a nozzle orifice coaxially aligned with the cathode, as evidenced by Marantz (Page 2, Description, Paragraph 1).
Biederman does not teach that the electrode is operated with a gas that is applied with a convective airflow having a flow rate of at least 0.1 L/min.
However, Bilek teaches a method of controlling predominant orientation of direct covalent binding of one or more peptides to a polymer surface by exposing the surface to energetic ion treatment (i.e., plasma treatment) to generate a plurality of activated sites comprising reactive radical species (Paragraph 0008). Bilek teaches that the term “plasma” or “gas plasma” is used to describe the state of ionized vapor (Paragraph 0057). Bilek teaches that suitable plasma forming vapors include inorganic and organic gases (Paragraph 0059). Bilek teaches that an electromagnetic field generated by a capacitive or inductive radiofrequency electrode is used to ionize the vapor (Paragraph 0057). It is interpreted that the electromagnetic field would inherently induce convection, as magnetic fields create convection in an electrochemical cell by the magnetohydrodynamic effect, as evidenced by Monzon et al., (Section 2.1, Paragraph 1). Bilek teaches a gas flow rate of about 1 to about 2000 cm3/min (i.e., 0.001 to 2 L/min) as a typical plasma treatment condition (para. [0060]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have utilized a gas with a flow rate of at least 0.1 L/min, as taught by Bilek, to generate plasma to modify a substrate surface, as taught by Biederman. One of ordinary skill in the art would have been motivated to do so because Bilek teaches that inorganic and/or organic gases are suitable plasma forming vapors that may be used to treat the polymer surface of a substrate (Paragraph 0059). One of ordinary skill in the art would have had a reasonable expectation of success because Biederman and Bilek are in the same field of endeavor of plasma-coating technology.
Regarding claim 2, Biederman teaches that the substrate is a polymer (Abstract).
Regarding claim 3, Biederman teaches that plasma action results in the formation of reactive radicals in the substrate surface layer (Page 2, Paragraph 5)
Regarding claim 4, Biederman teaches that the substrate is polytetrafluoroethylene (PTFE) (Abstract), which is a heteroatom containing organic polymer.
Regarding claim 5, Biederman teaches that the biomolecule is bovine serum albumin (BSA) (Abstract), which is a protein.
Regarding claim 6, Biederman teaches that plasma was exposed to the substrate surface for 10 seconds (Paragraph spanning pages 2 and 3).
Regarding claim 7, although Biederman does not disclose that the process of plasma treatment is repeated multiple times, it would have been obvious to one of ordinary skill in the art to repeat plasma treatment in order to further modify the substrate surface through the generation of more active sites.
Regarding claim 9, Biederman teaches a voltage of 11 kV (Paragraph spanning pages 2 and 3).
Regarding claim 10, it is interpreted that that “nozzle distance” is synonymous with “electrode distance”, as typical plasma generators contain an electrode within the nozzle, as evidenced by Marantz (Page 2, Description, Paragraph 1). Biederman teaches that the electrode moved at a distance of 1.5 mm above the PTFE film (Paragraph spanning pages 2 and 3).
Regarding claim 11, Biederman teaches that, after plasma exposure, the PTFE film (i.e., the activated substrate) was incubated with tropoelastin (i.e., the molecular compound) solution for 4 days (Page 3, Paragraph 2, Example 2).
Although the incubation period taught by Biederman differs from that of the instant claim, section 2144.05 II of the MPEP states: "[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.")” The selection of incubation period lengths would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that differing incubation periods would affect the amount of protein bound to the substrate.
Regarding claims 14 and 15, Biederman teaches a method of adhering epithelial cells to activated PTFE incubated with tropoelastin (i.e., a protein) and teaches that tropoelastin retains its adhesive character to cells after immobilization on the surface of a PTFE film treated with plasma (Page 3, Paragraph 3).
Regarding claim 16, Biederman teaches a step of applying epithelial cells to the immobilized tropoelastin (Page 3, Paragraph 3).
Regarding claim 17, Bilek teaches that, to achieve patterning, the surface area over which a peptide incubation solution is applied can be limited, which can be accomplished by using gaskets to limit the region over which each peptide containing solution can contact the surface (Paragraph [0067]).
Regarding claim 18, the combination of Biederman and Bilek teach a substrate with covalently immobilized molecular compounds. Bilek does teach that the most preferable water contact angle for hydrophilic surfaces is in the range of about 50 to about 70 degrees (Paragraph 004), but does not teach that the angle is measured using a Kruss DSA10-Mk2 contact angle goniometer by means of the sessile droplet method. However, the limitation of “using a Kruss DSA10-Mk2 contact angle goniometer by means of the sessile droplet method” is not part of the instantly claimed product of a substrate with molecular compounds immobilized covalently to its surface. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was measured by a different process to show the same property (i.e. contact angle).
Regarding claim 19, Bilek teaches that a suitable plasma forming vapors include inorganic and organic gases, which include helium, argon, and neon (Paragraph 0059).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Biederman et al. (CZ 2014757 A3) and Bilek et al. (WO 2015/027297 A1) as applied to claim 1 above, and further in view of Waterhouse et al., 2010 (The immobilization of recombinant human tropoelastin on metals using a plasma-activated coating to improve the biocompatibility of coronary stents).
Regarding claim 13, as stated above, Bilek teaches that the most preferable water contact angle for hydrophilic surfaces is in the range of about 50 to about 70 degrees (Paragraph 004), but does not teach that the angle is measured using a Kruss DSA10-Mk2 contact angle goniometer by means of the sessile droplet method.
However, Waterhouse teaches a method of measuring surface contact angle using a Kruss DSA10-MK2 contact angle analyzer, and teaches that sessile water drops were used for advancing contact angle (Page 8333, Column 2, Paragraph 1)
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to utilize the Kruss DSA10-Mk2 contact angle measuring system as taught by Waterhouse, to measure the water contact angle taught by Bilek. One of ordinary skill in the art would have been motivated to do so because the Kruss system was established as a suitable system for measuring water contact angle prior to the effective filing date of the claimed invention, as taught by Waterhouse. One of ordinary skill in the art would have had a reasonable expectation of success because Biederman, Bilek, and Waterhouse are in the same field of endeavor of plasma-coating technology.
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 RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657