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
Claims 8 and 12 are cancelled. Claims 1-7, 9-11, and 13-20 are pending and under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/18/2025 has been entered.
Response to Arguments
With respect to the rejection of claims 1-7, 9-11, and 13-19 under 35 USC 103, Applicant's arguments filed 08/18/2025 have been fully considered.
Applicant’s argument that the invention of Biederman cannot be considered a plasma torch or gun, nor as having a nozzle is found persuasive as Biederman does not explicitly disclose the use of a torch or gun and there is a difference between standard dielectric barrier discharge (DBD) systems and DBD-based plasma torches/guns/jets, which Applicant has pointed out.
However, the additional arguments regarding the reference of Biederman are not considered persuasive. Applicant argues that the electrode configuration of the instant invention allows suitable integration with 3D printing on complex surfaces, which is not possible with the electrode configuration of Biederman. However, suitable integration with 3D printing is not a limitation recited in any of the instant claims. Applicant also argues that a personal of ordinary skill in the art would not have expected covalent attachment of biomolecules could be achieved based on the teachings of Biederman. The Examiner respectfully disagrees as Biederman explicitly states: “The invention is based on the use of plasma generated at atmospheric pressure for the modification of polymeric materials. This type of plasma generates energy electrons, ions and photons, as well as chemically active radicals, which in their interactions with co-materials form highly reactive radicals in the polymer surface layer, allowing the resulting radicals to subsequently immobilize biomolecules.” (p. 2, para. 4). Applicant argues that this is because the plasma formed at the surface of the polymer of Biederman is intense and contains discharge streamers but provides no evidence to support this allegation.
Applicant’s arguments regarding the Bilek, Marantz, and Monzon references are considered moot as the rejection presented in this Office action does not rely on said references.
Claim Objections
Claims 1, 5 and 19 are objected to because of the following informalities:
Claim 1 should be amended to recite: A method for covalent immobilization…
In claim 5, “compounds” in line 2 should be amended to “compound”.
In claim 19, the word “of” should be added after “consisting” in line 2.
Appropriate correction is required.
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.
Claim 14 is 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 14 recites: wherein the molecular compounds are configured for adhesion of cells/and or signaling to cells. It is unclear whether the claim term is more narrowly limited to cell adhesion molecules and/or cell signaling molecules, or something else.
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.
Claims 1-7, 9-11, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Biederman et al. (CZ 2014757 A3), previously cited, in view of Lietz (Electrode configurations in atmospheric pressure plasma jets: production of reactive species; Plasma Sources Sci. Technol. 27, 2018, 105020) and Hong et al., (Air plasma jet with hollow electrodes at atmospheric pressure; PHYSICS OF PLASMA, 14, 053503, 2007).
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 (Page 2, Paragraph 3). Biederman teaches that, following plasma-activation, the polymeric substrate (PTFE) film was exposed to BSA, i.e., a molecular compound, which formed a covalent bond with the PTFE surface (p. 3, para. 1).
Biederman does not teach that the system comprises a nozzle and a moveable electrode.
However, Lietz teaches an atmospheric pressure plasma jet comprising a powered ring electrode wrapped around a dielectric tube and a grounded ring electrode, wherein the powered electrode is moved to different positions along the tube (Abstract), i.e., the electrode is considered moveable. Lietz teaches that gas flows through the dielectric tube (Abstract)., i.e., the nozzle.
Biederman and Lietz do not teach a gas flow rate of at least 0.1 L/min.
However, Hong teaches a method of using an atmospheric-pressure plasma jet (Abstract) with air, nitrogen, and argon, i.e., gases, injected at 5 L/min (p. 053503-3, col. 1, para. 3), which is a flow rate of at least 0.1L/min.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the plasma jet of Lietz with a gas flow rate of 5 L/min, as taught by Hong, to activate a substrate surface to covalently attach biomolecules to polymeric substrates, as taught by Biederman. One of ordinary skill in the art would have been motivated to do so because Lietz teaches atmospheric pressure plasma jets are capable of producing reactive species (Introduction, para. 1), while Biederman teaches that reactive radicals have the ability to covalently bond with biomolecules (p. 2, para. 2). One of ordinary skill in the art would have had a reasonable expectation of success because Biederman, Lietz, and Hong are in the same field of endeavor of plasma-generating technologies.
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). Lietz teaches that atmospheric pressure plasma jets form reactive species (Introduction, para. 1).
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, Hong teaches that a discharge is fired in the gap between the two electrodes resulting in a plasma jet reaching lengths of up to 2 cm (053503-2, col. 1, para. 1; figure 1). Therefore, it is considered that with a gas flow rate of 5 L/min a substrate may be placed at a distance of up to 2 cm, i.e., 20 mm, from the nozzle of Hong, which falls within the range recited in the instant claim.
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). Biederman also teaches that the proteins may be applied in the form of drops (p. 2, last full paragraph).
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, Biederman teaches that the proteins may be applied in the form of drops (p. 2, last full paragraph). It would have been obvious to one of ordinary skill in the art that drops of proteins, i.e., molecular compounds, may be applied to specific areas of the plasma-activated substrate to achieve a predetermined pattern of immobilized compounds, based on the teachings of Biederman.
Regarding claim 18, Biederman teaches a substrate with covalently immobilized molecular compounds while Hong teaches plasma-treated surfaces with water contact angles of 14-80˚ (Figure 5b). Hong 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, Lietz teaches helium atmospheric pressure plasma jets (p. 23, concluding remarks).
Regarding claim 20, Lietz teaches an atmospheric pressure plasma jet comprising a powered ring electrode wrapped around a dielectric tube and a grounded ring electrode, wherein the powered electrode is moved to different positions along the tube (Abstract), i.e., the electrode is considered moveable. Lietz teaches that gas flows through the dielectric tube (Abstract)., i.e., the nozzle.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Biederman et al. (CZ 2014757 A3), Lietz (Electrode configurations in atmospheric pressure plasma jets: production of reactive species; Plasma Sources Sci. Technol. 27, 2018, 105020) and Hong et al., (Air plasma jet with hollow electrodes at atmospheric pressure; PHYSICS OF PLASMA, 14, 053503, 2007) 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), previously cited.
Regarding claim 13, Hong teaches a flow rate that results in plasma-treated surfaces with water contact angles of 14-80˚ (Figure 5b). Hong 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 of Hong. 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, Lietz, Hong, and Waterhouse are in the same field of endeavor of plasma-coating technology.
Conclusion
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
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