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 02/02/2026 has been entered. Claims 1-14 remain pending in the application.
Applicant' s Arguments/Remarks, filed 02/02/2026, with respect to the objections to the Specification, Drawings, and Claims are persuasive have been withdrawn, but there are new grounds of rejection based on a new interpretation of the references. Thus the Examiner will address applicable arguments for Claim 1 and Claim 8, as arguments for other claims depend on Claim 1 and Claim 8.
Regarding Claim 1 the Applicant argues that,
a) Streltsov does not teach a glass impeller for a blood pump and only teaches 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.
c) the instant claim is non-obvious over the cited references, citing hindsight ATD Corp. v. Lydall, Inc., 48 USPQ2d 1321 (Fed Cir. 1998).
d) motivation to combine, “to further reduce metal components in the blood pump to reduce eddy current related electrical power loss” is a hypothetical problem not shown in Streltsov and that the “eddy current related to electrical power loss” is already solved by Cao, citing MPEP 2143 Section I, Subsection A, Example 3, (In re Omeprazole Patent Litigation, 536 F.3d 1361, 87 USPQ2d 1865 (Fed. Cir. 2008)).
Regarding Claim 8 the Applicant argues that,
e) all of the items a)-d) of the arguments of Claim 1.
f) the modifications must be structured to modify Streltsov, not Cao.
In response to the Applicant’s argument the Examiner replies that,
In general, agreement with the Applicant, as well as the means of the rejection structure and motivations. Upon further review,
Regarding Claim 1 - In response to the Applicant’s argument the Examiner replies that,
a), c) 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).
c), d) the Examiner notes that Cao cites of the use of fused silica (glass) (Col 3 lines 33-49) for components of a blood pump. Cao does not cite the use of fused silica (glass) for the impeller but it would seem reasonable to have the impeller component made from glass (known material) with a motivation that the impeller is biocompatible and corrosion resistant, similar to the structural components of the blood pump. Further, the glass of Streltsov can be modified with the glass of Cao (Streltsov to use fused silica) in the Streltsov manufacturing method to produce a stronger glass impeller (See 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 8 - In response to the Applicant’s argument the Examiner replies that,
e) all item a)-d) from Claim 1 have been addresses
f) due to Cao teaching fused silica structures, which would seem reasonable for fused silica to be use for
a glass impeller, the rejection structure has been made proper.
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
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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison Hindenlang can be reached on 571-270-7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER PAUL DAIGLER/ Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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