DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/10/2026.
Response to Arguments
The examiner notes the applicant’s request to not pursue color drawings.
Applicant's arguments filed 8/10/2026 have been fully considered but they are not persuasive. Applicant argues that the office action does not point to any portion of the reference that discloses that thin layer 1102 is deposited over and covers the exposed surface and the exposed sides of the diaphragm except for a region over which the dot is disposed. The examiner respectfully disagrees as Paragraph [0070] discloses the thin layer 1102 has a thickness of less than 0.2 microns and provides an example of 20 nanometers thick. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with a thickness of which is less than the thickness of the dot, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-12 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over D’Ambrosio et al (US Publication 2017/0348470) in view of Zhang et al (US Publication 2020/0405930).
Referring to Claim 1, D’Ambrosio et al teaches an optical sensor assembly for use in a blood pump assembly, the optical sensor assembly comprising: a visor having an inner surface and an outer surface (e.g. Figures 5, 8, 10 and 11, Elements 1022/1122/2022); an optical sensor disposed within the visor (e.g. Figures 5, 8, 10 and 11, Elements 1020/1120/2020), the optical sensor comprising an optical sensor inner surface, a diaphragm disposed over a cavity in a substrate, wherein the diaphragm has an exposed surface and exposed sides (e.g. Figures 5, 8, 10 and 11, Elements 1023/1123/2023), a dot (e.g. Figure 11, Element 1142); a protective layer being deposited over and covering the exposed surface and exposed sides of the diaphragm except for a region over which the dot is disposed (e.g. Figure 11, Element 1102 and Paragraphs [0069]-[0070] discloses the thin layer 1102 includes silicon oxide, oxide, metal, metal oxide (such as tantalum pentoxide (Ta2O5), titanium, or a titanium oxide), or any other coating commonly used in the processing of microelectromechanical systems (MEMS) or semiconductors). However, D’Ambrosio et al does not explicitly disclose wherein the protective layer is one of a platinum-containing layer, a platinum silicide layer, or parylene.
Zhang et al teaches that it is known to use a blood pump assembly comprising a visor (202) and an optical sensor (212) covered by a protective layer comprising platinum-based silicone as set forth in Figure 2 and Paragraph [0011] to provide a known technique to protect the optical sensor of the blood pump assembly from the shear forces exerted by blood on the optical sensor during the percutaneous insertion and operation of the pump within the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by D’Ambrosio et al, with the protective layer is one of a platinum-containing layer, a platinum silicide layer, or parylene as taught by Zhang et al, since such a modification would provide the predictable results of a known technique to protect the optical sensor of the blood pump assembly from the shear forces exerted by blood on the optical sensor during the percutaneous insertion and operation of the pump within the patient.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with a thickness of which is less than the thickness of the dot, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Additionally, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to deposit the protective layer over the diaphragm, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 2, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 1, wherein the protective layer is platinum silicide (e.g. Zhang et al Paragraph [0011]).
Referring to Claim 3, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 1, wherein the protective layer has a thickness of about 0.3 nanometers (nm) or greater (e.g. Paragraph [0070]).
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with a thickness of about 0.3 nanometers (nm) or greater, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Referring to Claim 4, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 3, wherein the thickness of the protective layer is about 0.31 nm to at least about 0.35 nm or greater (e.g. Paragraph [0070]).
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with the thickness of the protective layer is about 0.31 nm to at least about 0.35 nm or greater, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Referring to Claim 5, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 1, wherein the protective layer has a thickness of about 0.3 nm or less (e.g. Paragraph [0070]).
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with thickness of about 0.3 nm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Referring to Claim 6, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 5, wherein the thickness of the protective layer is about 0.29 nm to about 0.25 nm or less (e.g. Paragraph [0070]).
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with t a thickness of about 0.29 nm to about 0.25 nm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Referring to Claim 7, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 1, wherein the protective layer comprises a plurality of protective layers (e.g. Paragraph [0070]).
Referring to Claim 8, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 7, wherein the plurality of protective layers is the same protective layer material or different protective layer material (e.g. Paragraph [0070]).
Referring to Claim 9, D’Ambrosio et al in view of Zhang et al teaches the optical sensor assembly of claim 8, wherein each of the plurality of protective layers has a thickness and that thickness is either the same as or different from the thickness of the other protective layers (e.g. Paragraph [0070]).
Referring to Claim 10, D’Ambrosio et al teaches a blood pump assembly comprising: a pump, a motor (e.g. Figure 1, pump motor 110), a rotor (e.g. Figure 1, Element 113), a pump housing (e.g. Figure 1, Element 103), a cannula (e.g. Figure 1, Element 102), an atraumatic extension (e.g. Figure 1, Element 108), and an optical sensor assembly (e.g. Figures 1, 5, 8, 10 and 11, Elements 1020/1120/2020) comprising: a visor having an inner surface and an outer surface (e.g. Figures 5, 8, 10 and 11, Elements 1022/1122/2022); an optical sensor disposed within the visor (e.g. Figures 5, 8, 10 and 11, Elements 1020/1120/2020), the optical sensor comprising an optical sensor inner surface, a diaphragm disposed over a cavity in a substrate, wherein the diaphragm has an exposed surface and exposed sides (e.g. Figures 5, 8, 10 and 11, Elements 1023/1123/2023), and a dot (e.g. Figure 11, Element 1142); a protective layer being deposited over and covering the exposed surface and exposed sides of the diaphragm except for a region over which the dot is disposed (e.g. Figure 11, Element 1102 and Paragraphs [0069]-[0070] discloses the thin layer 1102 includes silicon oxide, oxide, metal, metal oxide (such as tantalum pentoxide (Ta2O5), titanium, or a titanium oxide), or any other coating commonly used in the processing of microelectromechanical systems (MEMS) or semiconductors). However, D’Ambrosio et al does not explicitly disclose wherein the protective layer is one of a platinum-containing layer, a platinum silicide layer, or parylene.
Zhang et al teaches that it is known to use a blood pump assembly comprising a visor (202) and an optical sensor (212) covered by a protective layer comprising platinum-based silicone as set forth in Figure 2 and Paragraph [0011] to provide a known technique to protect the optical sensor of the blood pump assembly from the shear forces exerted by blood on the optical sensor during the percutaneous insertion and operation of the pump within the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by D’Ambrosio et al, with the protective layer is one of a platinum-containing layer, a platinum silicide layer, or parylene as taught by Zhang et al, since such a modification would provide the predictable results of a known technique to protect the optical sensor of the blood pump assembly from the shear forces exerted by blood on the optical sensor during the percutaneous insertion and operation of the pump within the patient.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by D’Ambrosio et al with a thickness of which is less than the thickness of the dot, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that 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 (Please see MPEP 2144.05).
Additionally, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to deposit the protective layer over the diaphragm, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 11, D’Ambrosio et al in view of Zhang et al teaches the blood pump assembly of claim 10, wherein the optical sensor assembly is affixed to the pump housing (e.g. Paragraph [0063]).
In addition, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to affix the optical sensor to the pump housing, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 12, D’Ambrosio et al in view of Zhang et al teaches the blood pump assembly of claim 11, wherein the optical sensor assembly is affixed to the pump housing with a glue or epoxy (e.g. Paragraph [0063]). In addition, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to affix the optical sensor to the pump housing with glue or epoxy, since it has been held by the courts that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is disclosed, or suggested, by the Prior Art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985).
Referring to Claim 16, D’Ambrosio et al in view of Zhang et al teaches the blood pump assembly of claim 1, further comprising a biocompatibility layer formed over a surface of the optical sensor (e.g. Figure 11, Element 1102 and Paragraphs [0070] and [0076] disclose multiple layers being deposited over the sensor membrane to protect the sensor membrane from damage due to the flow of blood).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. D’Ambrosio et al (US Patent 11,027,114) discloses a blood pump with a visor and an optical sensor and protective layer.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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, David Hamaoui can be reached at (571)270-5625. 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.
/William J Levicky/Primary Examiner, Art Unit 3796
