Notice of Pre-AIA or AIA Status
1The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Applicants Arguments and Remarks
The Amendment/Request for Reconsideration After Non-Final Rejection filed 04/01/2026 has been entered. Claim 8 has been amended. Claims 1-14 remain pending in the application.
Applicant' s Arguments/Remarks, filed 06/22/2026, are persuasive with respect to the objections to the Specification, Drawings, and Claims except as specifically noted below.
Applicant’ Arguments/Remarks, see pages 4-8, filed 06/22/2026, with respect to Claims 1-7 rejected under 35 U.S.C 103 have been fully considered but they are not persuasive.
Applicant’ Arguments/Remarks, see pages 8-10, filed 06/22/2026, with respect to Claims 8-13 rejected under 35 U.S.C 103 have been fully considered but are moot due to the new grounds of rejection necessitated by the amendment to claim 8 filed 06/22/2026.
The Examiner will address applicable arguments.
Regarding Claim 1 the Applicant argues that,
a) Streltsov does not teach a glass impeller for a blood pump and only teaches laser forming articles from glass sheet; The PHOSITA will clearly and easily recognize that a glass impeller for a blood pump cannot be formed from a glass sheet and it is unclear why the PHOSITA would look to the teachings of Streltsov for a method of manufacturing a glass impeller for a blood pump.
b) Cao does not teach an impeller made of glass by laser irradiation and wet chemical etching, nor disclose and impeller made of glass, modifying a glass block by laser radiation, wet-etching or forming a glass impeller by such a process.
c) The combination of Streltsov and Cao requires more than the predictable use of prior art elements and must articulate why a PHOSITA would have combined to support the combination would have been predictable (MPEP 2143). Obviousness for a glass impeller blood pump was based on “known material/suitability for intended use” to make more components that are biocompatible/corrosion resistant. Obviousness rejections must include articulated reasoning with rational underpinnings. The cited art does not establish glass suitable for an impeller. Cao teaches placing ceramic material in structural members between magnetic rotor/stator, not that the impeller should be made of glass, and extending the teaching of Cao to the impeller is not a selection of known material for known intended use. It is a substitution into a different component with rotating, blood-contacting, load bearing requirements that performs hydrodynamic pumping and the Office does not identify that glass was known to be suitable for this use.
d) The Examiner’s reasoning treat “biocompatible and corrosion resistant” as sufficient motivation to make every blood-contacting component from glass. But Cao uses different material for different portions of the pump, and Cao does not provide a teaching that “more glass is better” or that the impeller should be glass because other components may be ceramic.
e) The rejection relies on hindsight.
Regarding Claims 5, 12 the Applicant argues that,
Patentable as Claims 5 and 12 depend on Claim 1 and Matsuo does not rectify the shortcomings of Streltsov and Cao.
Regarding Claims 6-7 the Applicant argues that,
Patentable as Claims 6-7 depend on Claim 1 and Kushida does not rectify the shortcomings of Streltsov and Cao.
Regarding Claim 8 the Applicant argues that,
a) Amended claim 8 with the amendment “wherein the glass impeller is a one-piece glass impeller comprising a main body, a skirt disposed around at least a portion of the main body, and at least one impeller blade extending outwardly from the main body and disposed between the main body and an inner surface of the skirt”, has the same arguments listed in Claim 1a)-1d). Further, Streltsov and Cao are absent teachings regarding a one-piece impeller structure made of glass that would predictably produce a blood pump structure.
Regarding Claim 12 the Applicant argues that,
Patentable as Claim 12 depends on Claim 8 and Matsuo does not rectify the shortcomings of Streltsov and Cao.
Regarding Claims 13-14 the Applicant argues that,
Patentable as Claims 13-14 depend on Claim 8 and Kushida does not rectify the shortcomings of Streltsov and Cao.
In response to the Applicant’s argument Regarding Claim 1, the Examiner replies that,
a) Streltsov is not relied upon to teach an impeller for a blood pump. Streltsov is relied upon to teach a manufacturing method of a strengthened glass articles can be formed, unbounded by a particular application. Streltsov even cites other applications (televisions, appliances, vehicles, signs, [0086]) and three dimensional shapes ([0015]); so that a PHOSITA would have no reason to reference Streltsov for a glass impeller for blood pump is based on opinion, where the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). Hence the argument is moot.
b) Cao is not relied upon to teach an impeller made of glass by laser irradiation and wet chemical etching, modifying a glass block by laser radiation, wet-etching or forming a glass impeller by such a process. Streltsov is relied upon to teach a manufacturing process where a piece of glass is processed by laser irradiation and wet chemical etching, and modifying a glass block by laser radiation. that is unbounded by a particular application. Cao is relied upon to teach a rotary blood pump that has components made of ceramic (structural members, housing portions, covers, discharge tubes), where the possible ceramic materials include fused silica (glass) that are biocompatible, corrosion resistant ceramic materials. Original FIGURE below is the rotary pump and Annotated FIGURE below, and Table I, illustrate the components (grey) of the rotary pump that are made of a biocompatible, corrosion resistant ceramic material and the impeller (circle) that is not made of biocompatible, corrosion resistant ceramic material.
FIGURE
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ANNOTATED FIGURE
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TABLE I
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With the plurality of ceramic components in contact with the blood/blood flow, even the housings next to the impeller, it would have been obvious to have the impeller of Cao made by the method of Streltsov, using a glass starting material. Cao teaches glass is a known material for biocompatible, corrosion resistant environments and specifically blood contact environments.
c) Respectful disagreement. While Cao does not disclose a glass impeller, Cao does disclose glass as a known material for biocompatible, corrosion resistant environments and specifically blood contact environments. The impeller of the rotary pump is in a blood contact environment where biocompatibility and corrosion resistance are required. All materials as known use materials are substituted for a different material in a component. While the impeller component maybe different than other components in the rotary pump, all the blood contacting components have the same requirement of biocompatibility and corrosion resistance, which would make the impeller a candidate for the same materials used for the other blood contact environment, biocompatible, and corrosion resistant components in the rotary pump. Hence the argument is moot.
d) Respectful disagreement. Cao, not the Examiner, cites that the materials in the rotary pump are biocompatible and corrosion resistant and provides for this motivation. Further, Cao indicates that elements 12, 16, 21, 30, 36, and 38 may be made from “of biocompatible, non-thrombogenic, electrically non-conducting and corrosion resistant ceramic materials, such as aluminum oxide, zirconium oxide, yttria partial stabilized zirconia, magnesia-partial-stabilized zirconia, ceria-partial-stabilized zirconia, titanium oxide, magnesia, zirconia-toughened alumina, ruby, sapphire, single crystal alumina, cubic zirconia, quartz, fused silica, silicon nitride and aluminum nitride. These ceramic materials have excellent biocompatibility and corrosion resistance in implant applications; and then provides “For Example” only to further describe how the materials may be used an explanatory exercise. Cao provides the teaching that many components may be made of ceramic materials for the purpose of being biocompatible and corrosion resistant in the blood contact environment. It would be reasonable for a PHOSITA to make the impeller of a ceramic material, including glass, for the same reason. Further,
It has been held that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiment. In re Susi, 169 USPQ 423.
Hence the argument is moot.
e) Respectful disagreement. a)-d) have addressed .
The rejection of Claim 1 is maintained. Further rejections for dependent Claims 2-4 are also maintained.
In response to the Applicant’s argument Regarding Claims 5-12, the Examiner replies that,
As the same argument for Claim 1 applies to Claims 5 and 12, the same Examiners response to arguments for Claim 1 apply to Claims 5 and 12.
The rejection of Claims 5 and 12 is maintained.
In response to the Applicant’s argument Regarding Claims 6-7, the Examiner replies that,
As the same argument for Claim 1 applies to Claims 6 and 7, the same Examiners response to arguments for Claim 1 apply to Claims 6 and 7.
The rejection of Claims 6 and 7 is maintained.
In response to the Applicant’s argument Regarding Claim 8 the Applicant argues that,
Cao teaches all the limitations of Claim 8 except for a one-piece impeller. Yet, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to make the impeller in one piece instead of multiple components, since it has been held that making in one piece an article which has formerly been formed in multiple pieces involves only routine skill in the art. One would have been motivated to make the impeller in one piece in order reduce cost and assembly of multiple components of the impeller. In re Larson, 340 F.2d 965, 968, 133 USPQ 347, 349 (CCPA 1965). Further, It has been repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. And because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983); See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006).
The rejection of Claim 8 is maintained.
In response to the Applicant’s argument Regarding Claim 12, the Examiner replies that,
As the same argument for Claim 8 applies to Claim 12, the same Examiners response to arguments for Claim 8 apply to Claim 12.
The rejection of Claim 12 is maintained.
In response to the Applicant’s argument Regarding Claims 13-14, the Examiner replies that,
As the same argument for Claim 8 applies to Claim 13-14, the same Examiners response to arguments for Claim 8 apply to Claim 13-14.
The rejection of Claims 13-14 is maintained.
Drawings
The Examiner apologizes for missing an item related to the drawings in the Non Final Office Action dated 11/21/2025.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in Fig. 2A, reference characters 224 and 222 have both been used to designate the skirt and reference characters 224 and 222 have both been used to designate the main body.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 228, assembly housing, in Fig. 2A. Specification [0059] cites “assembly housing 208”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The claim interpretations presented in the CTNF are maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB
20140147624A1 by Streltsov et. al (herein “Streltsov”), in further view of U.S. Patent 6,158,984 by Cao
et. al (herein “Cao”).
Regarding Claim 1, Streltsov teaches,
A method of manufacturing a glass impeller for a blood pump, the method comprising,
providing a block of a glass; [0013] line 2-3, “ a method of forming a glass article includes providing a glass substrate sheet”. Alumina borosilicate glasses are cited in [0035] and [0036].
modifying the glass by laser radiation; [0013] lines 3-7, “… and translating a pulsed laser beam on the glass substrate sheet to form a laser damage region extending from a first surface of the glass substrate sheet to a second surface of the glass substrate sheet, the laser damage region having an initial geometry.”
and selectively removing a portion of the modified glass by wet chemical etching to form the glass impeller; [0013] lines 19-22, [0015], [0086], “The method further includes submerging the glass substrate sheet in a bath of etchant solution to remove a portion of the glass substrate sheet about the laser damage region”,” …the glass article may be a shaped glass article having a three-dimensional shape. In such embodiments, the laser damage and etching process may be integral to forming the three-dimensional features of the shaped glass article”, “It should be understood that embodiments are not limited to the shaped glass articles depicted throughout the figures, and that the shaped glass articles may be used in any application…without limitation”.
While Streltsov teaches the use of laser radiation modified and wet chemical etch to form integral three-dimensional features of a shaped glass article that may be used for any application, Streltsov fails to disclose directly the application of a glass impeller for a blood pump. In a similar endeavor of blood pumps, Cao teaches the construction of a rotary blood pump comprising a pump housing, a motor mounted for rotation in the housing, the rotor with a shaft portion, and an impeller carried by the shaft portion (Col 1 lines 61-65). The structural members comprise biocompatible corrosion resistant ceramic material. “The housings 12, 36 and 38, impeller housing 21, structural members 28 and 30, and discharge tube 16, are preferably formed of corrosion resistant ceramic materials. For example, structural members 28 and 30…are made of biocompatible, non-thrombogenic, electrically non-conducting and corrosion resistant ceramic materials, such as aluminum oxide, zirconium oxide, yttria partial stabilized zirconia…fused silica, silicon nitride and aluminum nitride. These ceramic materials have excellent biocompatibility and corrosion resistance in implant applications” (Col 3 lines 33-49). As one skilled in the art would know many of the oxides noted above are contained in glass compositions, particularly aluminum oxide (alumina), as well as fused silica is a glass material.
Cao discloses structural components of ceramic and glass but does not disclose the claimed invention of a glass impeller. It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to have a glass impeller in a blood pump, since it has been held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to have a glass impeller for the purpose of having more components (the impeller) that are biocompatible and corrosion resistant (like the structural members) ( Cao, Col 2 lines 34-35). The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Further, while Cao fails to disclose a glass impeller manufacturing method, It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to have the glass material impeller of Cao used in the manufacturing method of Streltsov, as one would be motivated to do so for the purpose of producing a stronger glass impeller. It has been repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. And because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006
Regarding Claim 2 - Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
Streltsov teaches wherein,
the glass is a chemically strengthened glass; “In one embodiment, the shaped glass article is chemically strengthened by ion-exchange...”.
Regarding Claim 3 - Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
Streltsov teaches wherein,
the glass comprises a surface enriched with potassium ions; [0073] lines 2-5, “…by ion-exchange
in which smaller sodium ions near the surface of the glass are exchanged with larger potassium
ions when the glass article is placed in an ion exchange bath.” Further, alumina borosilicate
glasses containing Na2O are cited, supporting sodium ion for potassium ion exchange ([0035],
[0036]).
Regarding Claim 4 - Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
Streltsov teaches wherein,
the glass comprises a surface in a state of compression and a core in a state of tension; [0073] lines 5-13, “Replacement of the smaller sodium ions with the larger potassium ions causes a layer of compressive stress to develop in the surfaces of the glass article. The compressive stress extends below the surfaces of the glass article to a specified depth of layer (compressive surface layer). A compressive surface layer extends from the upper surface and the underside surface to the depth of layer. The compressive surface layer is balanced by the development of the internal tension layer at the center of the glass article.”
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB 20140147624A1
by Streltsov et. al (herein “Streltsov”), in further view of U.S. Patent 6,158,984 by Cao et. al (herein
“Cao”) and in further view of NPL “Femtosecond laser-assisted etching of Pyrex glass with aqueous
solution of KOH” by Matsuo et. al. (herein “Matsuo”).
Regarding Claim 5 – Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
Streltsov teaches an alumina borosilicate glass modified with laser radiation that is etched with HF
(hydrofluoric acid) ([0059]) and that the etch ratio between the laser damage regions and the non-
damaged regions may increase with agitation ([0061]) but fails to teach wherein,
the glass impeller has a selectivity greater than 500:1
In a similar endeavor of laser assisted etching of glass, Matsuo teaches laser assisted etching using a pulsed femto-laser (fs) (Page 9758, 2. Experimental) and an etching solution of KOH (potassium hydroxide) on Pyrex glass (a borosilicate glass) (Page 9758, 1. Introduction). The results indicated the etching selectivity (the ratio of etching rates between modified and unmodified regions) was roughly more than 500 (Page 9760, Results and Discussion). It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the laser assisted etching process of Matsuo in the method of Streltsov, as one would be motivated to do so as KOH is safer to use than HF and improved 3D optical resolution, as noted by Matsuo (Page 9758, 1Introduction, lines 31-32; Page 9760, 3. Results and Discussion, lines 42-43).
Claims 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB
20140147624A1 by Streltsov et. al (herein “Streltsov”), in further view of U.S. Patent 6,158,984 by Cao
et. al (herein “Cao”) in further view of USPGPUB 20150093543A1 by Kushida et. al. (herein “Kushida”),
Regarding Claim 6 – Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
Streltsov fails to teach wherein,
the glass impeller has a root mean square surface roughness of less than 5 nm with a 1 x 1 mm2 measuring field.
In an analogous endeavor of producing blood compatible materials, Kushida teaches a method of coating medical devices or part of medical devices, including blood pumps inside or outside the patient ([0009]), to provide curved three-dimensional curved features to roughen the surface ([0011]). Further, Kushida cites the RMS roughness value of the blood compatible coating is less than about 10 nm, or between about 0.5 nm and about 10 nm ([0010]). Example 1 provides a process for a silica nanoparticle coating applied to the surface of Si substrates ([0059], [0060]) where a 500nm x 500nm area was measured for roughness as shown in Table 3, where the RMS roughness for a sample with a nominal particle diameter of 12nm was 0.93nm. While Kushida does not teach a coating on a glass substrate, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the coating method of Kushida on the glass impeller of Streltsov, as one would be motived to do so to inhibit the activation of intrinsic blood coagulation, as noted by Kushida ([0073]).
Further, in regard to the measuring field, overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the portion of Kushida’s measuring field size that corresponds to the claimed range. See MPEP 2144.05.
Regarding Claim 7 – Streltsov and Cao in the rejection of claim 1 above teach all of the limitations of
claim 1.
The combination fails to disclose wherein,
the glass impeller has a root mean square micro roughness of less than 0.4 nm with a 50 x 70 um2 measuring field.
Kushida teaches a method of coating medical devices or part of medical devices, including blood pumps inside or outside the patient ([0009]), to provide curved three-dimensional curved features to roughen the surface ([0011]). Further, Kushida cites the RMS roughness value of the blood compatible coating is less than about 10 nm, or between about 0.5 nm and about 10 nm ([0010]). Example 1 provides a process for a silica nanoparticle coating applied to the surface of Si substrates ([0059], [0060]) where a 500nm x 500nm area was measured for roughness as shown in Table 3, where the RMS roughness for a sample with a nominal particle diameter of 12nm was 0.93nm.
While Kushida does not teach a coating on a glass substrate, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the coating method of Kushida on the glass impeller of the combination, as one would be motived to do so to inhibit the activation of intrinsic blood coagulation, as noted by Kushida ([0073]).
Further, in regard to the measuring field, overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the portion of Kushida’s measuring field size that corresponds to the claimed range. See MPEP 2144.05.
Kushida teaches, in regard to intrinsic blood coagulation, that Example 1/sample with 12nm nominal diameter with 0.93 RMS roughness, provides essentially the same result as Example 1/sample with 4nm nominal diameter. As shown in the bar graph of FIG. 8, the intrinsic coagulation activity after five hours of incubation has a clear dependence on the size of the nanoparticles, with the intrinsic coagulation activity decreasing with decreasing nanoparticle size. The intrinsic coagulation activity of the smallest nanoparticles (4 nm and 12 nm) at 2 cm2 surface area is generally comparable to the biologically inert MPC control sample ([0075]), providing a similar intrinsic coagulation property. Further, Kushida suggests a smaller RMS surface roughness for 4nm particles as compared to the RMS surface roughness of 12nm particles (0.93nm), as evidenced by the trend of nominal particle diameter vs. RMS roughness in Table 3 and that RMS roughness decreases monotonically with decreasing particle diameter ([0064]). Analyzing the data in Table 3 monotonically with linear regression, the nominal diameter of 4nm corresponds to an RMS roughness of 0.31nm.
While Kushida does not directly teach an RMS surface roughness < 0.4nm, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention was made to use a nominal particle size of 4nm (i.e. suggested monotonic RMS surface roughness < 0.4nm) since the claimed ranges and the prior art ranges are close enough that one skilled in the art would have expected them to have the same property of reduced intrinsic coagulation for particle surface area, as evidenced above, as one would be motivated to do so to have the capability to increase the intrinsic coagulation threshold of the coating by increasing the concentration of the 4nm nominal particle diameter coating, as noted by Kushida ([0076], Fig. 9). A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985).
Claims 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB
20140147624A1 by Streltsov et. al (herein “Streltsov”) ”), in further view of U.S. Patent 6,158,984 by
Cao et. al (herein “Cao”).
Regarding Claim 8 Streltsov teaches,
providing a block of a glass; [0013] line 2-3, “ a method of forming a glass article includes
providing a glass substrate sheet”. alumina borosilicate glasses are cited in [0035] and [0036].
modifying the glass by laser radiation; [0013] lines 3-7, “… and translating a pulsed laser beam on the glass substrate sheet to form a laser damage region extending from a first surface of the glass substrate sheet to a second surface of the glass substrate sheet, the laser damage region having an initial geometry.”
and selectively removing a portion of the modified glass by wet chemical etching to form the glass impeller; [0013] lines 19-22, [0015], [0086], “The method further includes submerging the glass substrate sheet in a bath of etchant solution to remove a portion of the glass substrate sheet about the laser damage region”,” …the glass article may be a shaped glass article having a three-dimensional shape. In such embodiments, the laser damage and etching process may be integral to forming the three-dimensional features of the shaped glass article”, “It should be understood that embodiments are not limited to the shaped glass articles depicted throughout the figures, and that the shaped glass articles may be used in any application…without limitation”.
While Streltsov teaches the use of laser radiation modified and wet chemical etch to form integral three-dimensional features of a shaped glass article that may be used for any application, Streltsov fails to disclose directly a glass impeller for a blood pump. In a similar endeavor of blood pumps, Cao teaches the construction of a rotary blood pump, including an impeller. The structural members comprise biocompatible corrosion resistant ceramic material. “The housings 12, 36 and 38, impeller housing 21, structural members 28 and 30, and discharge tube 16, are preferably formed of corrosion resistant ceramic materials. For example, structural members 28 and 30…are made of biocompatible, non-thrombogenic, electrically non-conducting and corrosion resistant ceramic materials, such as aluminum oxide, zirconium oxide, yttria partial stabilized zirconia…fused silica, silicon nitride and aluminum nitride. These ceramic materials have excellent biocompatibility and corrosion resistance in implant applications” (Col 3 lines 33-49). As one skilled in the art would know many of the oxides noted above are contained in glass compositions, particularly aluminum oxide (alumina), as well as fused silica is a glass material.
Cao discloses structural components of ceramic and glass but does not disclose the claimed invention of a glass impeller. It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to have a glass impeller in a blood pump, since it has been held to be within the ordinary skill of worker in the art to select a known material on the basis of its suitability for the intended use. One would have been motivated to have a glass impeller for the purpose of having more components (the impeller) that are biocompatible and corrosion resistant (like the structural members) ( Col 2 lines 34-35). The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Further, while Cao fails to disclose a glass impeller manufacturing method, It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to have the glass material impeller of Cao used in the manufacturing method of Streltsov, as one would be motivated to do so for the purpose of producing a stronger glass impeller. It has been repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’ is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. And because the desire to enhance commercial opportunities by improving a product or process is universal—and even common-sensical—we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006).
the glass impeller is a one-piece glass impeller comprising,
a main body;
a skirt disposed around at least a portion of the main body;
at least one impeller blade extending outwardly from the main body and disposed between the main body and an inner surface of the skirt;
Cao discloses all limitations of the instant claim in the Annotated Fig. that corresponds to the claimed impeller structure. See Fig. 2A of the claimed structure and the Annotated Fig below.
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Cao discloses an impeller extending outward from a main body. Cao does not disclose a one-piece impeller (total impeller = multiple individual components). Yet, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to make the impeller in one piece instead of multiple components, since it has been held that making in one piece an article which has formerly been formed in multiple pieces involves only routine skill in the art. One would have been motivated to make the impeller in one piece in order reduce cost and assembly of multiple components of the impeller. In re Larson, 340 F.2d 965, 968, 133 USPQ 347, 349 (CCPA 1965).
Further, It has been repeatedly held that an implicit motivation to combine exists
not only when a suggestion may be gleaned from the prior art as a whole, but when the ‘improvement’
is technology-independent and the combination of references results in a product or process that is
more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more
durable, or more efficient. And because the desire to enhance commercial opportunities by improving a
product or process is universal—and even common-sensical—we have held that there exists in these
situations a motivation to combine prior art references even absent any hint of suggestion in the
references themselves. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983); See
also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d
1641, 1651 (Fed. Cir. 2006).
Streltsov fails to disclose,
Coupling the glass impeller to a drive shaft with a housing of the blood pump.
Cao teaches the instant claim previously in Claim 1.
Regarding Claim 9 - Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov teaches wherein,
the glass is a chemically strengthened glass; “In one embodiment, the shaped glass article is chemically strengthened by ion-exchange...”.
Regarding Claim 10 - Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov teaches wherein,
the glass comprises a surface enriched with potassium ions; [0073] lines 2-5, “…by ion-exchange
in which smaller sodium ions near the surface of the glass are exchanged with larger potassium
ions when the glass article is placed in an ion exchange bath.” Further, alumina borosilicate
glasses containing Na2O are cited, supporting sodium ion for potassium ion exchange ([0035],
[0036]).
Regarding Claim 11 - Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov teaches wherein,
the glass comprises a surface in a state of compression and a core in a state of tension; [0073] lines 5-13, “Replacement of the smaller sodium ions with the larger potassium ions causes a layer of compressive stress to develop in the surfaces of the glass article. The compressive stress extends below the surfaces of the glass article to a specified depth of layer (compressive surface layer). A compressive surface layer extends from the upper surface and the underside surface to the depth of layer. The compressive surface layer is balanced by the development of the internal tension layer at the center of the glass article.”
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB 20140147624A1
by Streltsov et. al (herein “Streltsov”), in further view of U.S. Patent 6,158,984 by Cao et. al (herein
“Cao”) and in further view of NPL “Femtosecond laser-assisted etching of Pyrex glass with aqueous
solution of KOH” by Matsuo et. al. (herein “Matsuo”).
Regarding Claim 12 – Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov teaches an alumina borosilicate glass modified with laser radiation that is etched with HF
(hydrofluoric acid) ([0059]) and that the etch ratio between the laser damage regions and the non-
damaged regions may increase with agitation ([0061]) but fails to teach wherein,
the glass impeller has a selectivity greater than 500:1
In a similar endeavor of laser assisted etching of glass, Matsuo teaches laser assisted etching using a pulsed femto-laser (fs) (Page 9758, 2. Experimental) and an etching solution of KOH (potassium hydroxide) on Pyrex glass (a borosilicate glass) (Page 9758, 1. Introduction). The results indicated the etching selectivity (the ratio of etching rates between modified and unmodified regions) was roughly more than 500 (Page 9760, Results and Discussion). It would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the laser assisted etching process of Matsuo in the method of Streltsov, as one would be motivated to do so as KOH is safer to use than HF and 3D optical resolution, as noted by Matsuo (Page 9758, 1. Introduction, lines 31-
32; Page 9760, 3. Results and Discussion, lines 42-43).
Claims 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable in view of USPGPUB
20140147624A1 by Streltsov et. al (herein “Streltsov”), in further view of U.S. Patent 6,158,984 by
Cao et. al (herein “Cao”).in further view of USPGPUB 20150093543A1 by Kushida et. al. (herein
“Kushida”).
Regarding Claim 13 – Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov fails to teach wherein,
the glass impeller has a root mean square surface roughness of less than 5 nm with a 1 x 1 mm2 measuring field.
In an analogous endeavor of producing blood compatible materials, Kushida teaches a method of coating medical devices or part of medical devices, including blood pumps inside or outside the patient ([0009]), to provide curved three-dimensional curved features to roughen the surface ([0011]). Further, Kushida cites the RMS roughness value of the blood compatible coating is less than about 10 nm, or between about 0.5 nm and about 10 nm ([0010]). Example 1 provides a process for a silica nanoparticle coating applied to the surface of Si substrates ([0059], [0060]) where a 500nm x 500nm area was measured for roughness as shown in Table 3, where the RMS roughness for a sample with a nominal particle diameter of 12nm was 0.93nm. While Kushida does not teach a coating on a glass substrate, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the coating method of Kushida on the glass impeller of Streltsov, as one would be motived to do so to inhibit the activation of intrinsic blood coagulation, as noted by Kushida ([0073]).
Further, in regard to the measuring field, overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the portion of Kushida’s measuring field size that corresponds to the claimed range. See MPEP 2144.05.
Regarding Claim 14 – Streltsov and Cao in the rejection of claim 8 above teach all of the limitations of
claim 8.
Streltsov fails to teach wherein,
the glass impeller has a root mean square micro roughness of less than 0.4 nm with a 50 x 70 um2 measuring field.
Kushida teaches a method of coating medical devices or part of medical devices, including blood pumps inside or outside the patient ([0009]), to provide curved three-dimensional curved features to roughen the surface ([0011]). Further, Kushida cites the RMS roughness value of the blood compatible coating is less than about 10 nm, or between about 0.5 nm and about 10 nm ([0010]). Example 1 provides a process for a silica nanoparticle coating applied to the surface of Si substrates ([0059], [0060]) where a 500nm x 500nm area was measured for roughness as shown in Table 3, where the RMS roughness for a sample with a nominal particle diameter of 12nm was 0.93nm.
While Kushida does not teach a coating on a glass substrate, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention to use the coating method of Kushida on the glass impeller of Streltsov, as one would be motived to do so to inhibit the activation of intrinsic blood coagulation, as noted by Kushida ([0073]).
Further, in regard to the measuring field, overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the portion of Kushida’s measuring field size that corresponds to the claimed range. See MPEP 2144.05.
Kushida teaches, in regard to intrinsic blood coagulation, that Example 1/sample with 12nm nominal diameter with 0.93 RMS roughness, provides essentially the same result as Example 1/sample with 4nm nominal diameter. As shown in the bar graph of FIG. 8, the intrinsic coagulation activity after five hours of incubation has a clear dependence on the size of the nanoparticles, with the intrinsic coagulation activity decreasing with decreasing nanoparticle size. The intrinsic coagulation activity of the smallest nanoparticles (4 nm and 12 nm) at 2 cm2 surface area is generally comparable to the biologically inert MPC control sample ([0075]), providing a similar intrinsic coagulation property. Further, Kushida suggests a smaller RMS surface roughness for 4nm particles as compared to the RMS surface roughness of 12nm particles (0.93nm), as evidenced by the trend of nominal particle diameter vs. RMS roughness in Table 3 and that RMS roughness decreases monotonically with decreasing particle diameter ([0064]). Analyzing the data in Table 3 monotonically with linear regression, the nominal diameter of 4nm corresponds to an RMS roughness of 0.31nm.
While Kushida does not directly teach an RMS surface roughness < 0.4nm, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date of the claimed invention was made to use a nominal particle size of 4nm (i.e. suggested monotonic RMS surface roughness < 0.4nm) since the claimed ranges and the prior art ranges are close enough that one skilled in the art would have expected them to have the same property of reduced intrinsic coagulation for particle surface area, as evidenced above, as one would be motivated to do to have the capability to increase the intrinsic coagulation threshold of the coating by increasing the concentration of the 4nm nominal particle diameter coating, as noted by Kushida ([0076], Fig. 9).
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 CHRISTOPHER PAUL DAIGLER whose telephone number is (571)272-1066. The examiner can normally be reached Monday-Friday 7:30-4:30 CT.
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/CHRISTOPHER PAUL DAIGLER/ Examiner, Art Unit 1741
/ERIN SNELTING/Primary Examiner, Art Unit 1741
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