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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 August 2024 was filed after the mailing date. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim1-6, drawn to a medical device and components thereof, classified in A61M 60/13.
II. Claim7, drawn to the method of manufacturing a medical device, classified in A61M 2207/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In this case, the product can be manufactured using a different process that is not specifically a mandrel.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Group 2 would require a search for a mandrel in a separate classification where group 1 would not.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Alan Pattillo on November 6, 2025 a provisional election was made without traverse to prosecute the invention of elected group I, claims 1-6. Affirmation of this election must be made by applicant in replying to this Office action. Claim 7 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "702-706" have been used to designate “holes” (synonymous with “apertures”). 702-706 are the same structure with multiple reference characters. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. (Ask Jennifer since holes 702-706 increase “monotonically.” Maybe necessary to have each hole designated with different number).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “714-716” has been used to designate both “helical curves” and “adjacent struts”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0048]; “material708” needs a space. Appropriate correction is required.
Additionally, the specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The limitation in claim 5 of “a flexible tubular member” that is connected to an outflow tube assembly does not have antecedent support in the specification. The examiner was unable to find in the originally filed disclosure any particular structure that corresponds to the “flexible tubular member”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding 1, the applicant claims “a proximal end” in line 2 and “one or more openings at a proximal end” in line 4. It is unclear if the proximal end of line 4 is the same proximal end recited in line 2. The recitation of “the proximal end” in claim 1 line 6 lacks clear antecedence due to the recitation of “a proximal end” and “a proximal end” in both of lines 2 and 4. Further, claim 1 recites a “a distal end” in both line 2 and line 8. It is unclear if the distal end of line 2 is the same distal end recited in line 8.
Regarding claim 2, “the distal end” is recited, which lacks clear antecedence due to the recitation of “a distal end” in both lines 2 and 8 of claim 1. Claim 2 is also rejected due to its dependence on claim 1.
Regarding claim 3, applicant claims “an expandable housing defining an inflow and outflow”. Claim 3 further states “a one-piece outflow tube balloon according to claim 1”, wherein claim 1 also uses the term “an expandable housing” in the last line of the claim. Claim 3 then states “coupled to the expandable housing”. Applicant has effectively claimed two separate expandable housings, and it is unclear which housing is being referred to with the phrase “the expandable housing” in the last line of claim 3. It is also unclear if applicant intended only one expandable housing instead of two. Therefore, the metes and bounds of the claim cannot be determined.
Regarding Claim 5, the claim requires a “flexible tubular member” and an outflow assembly device operably coupled to the flexible tubular member on the distal and proximal ends. However, the flexible tubular member is not clearly distinguished in the originally filed disclosure from the outflow tube assembly, and the originally filed disclosure does not set forth any particular connections of the flexible tubular member to a proximal and distal end of the outflow tube assembly. A review of the specification provides 4 paragraphs in which an outflow tube assembly was mentioned ([006], [0010], [0028], and [[0037], see PG-Pub 2024/0238580 which is the publication of the present application). As a result, the particular structure of claim 5 and how they are interconnected is ultimately unclear.
Claims 4 and 6 are rejected due to their dependence on claims 3 and 5.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Keenan et al. (2021/0275793 A1).
Regarding claim 1, since the phrase “a one-piece outflow tube balloon” is located in the preamble of the claim, and the body of the claim does not require any specific balloon structure, the claims do not require a balloon as currently constructed. Furthermore, the claim structure only requires four components, and therefore, the structure having those components can be considered the claimed “one-piece outflow tube balloon.” Keenan’s cylindrical sleeve meets the broadest reasonable interpretation of the claimed ‘balloon’, which is a flexible layer capable of holding fluid with at least one hole or opening.
Keenan teaches a flexible tubular polymeric layer (para. [008]; “elongate polymeric catheter body”; see figure below; para. [0014]; “elongate flexible body”), having a distal end (Fig. 5; right end (moving away from 220) of 216) and proximal end (Fig. 5; Left end (moving towards 220) of 216), and having an outer surface (Fig. 5; the outside of 216) and inner surface (Fig. 5; The inside of 216); one or more openings (See Fig. 5 below; “apertures”; para. [0058]; see also Fig. 8, which labels apertures) at a proximal end (Fig. 5; left end of 216); a slot (220; para. [0050]; “the slots 220”) extending from the proximal end (Fig. 5; left end of 216) to a proximal end of the one or more openings (slot 220 traverses a direction from the proximal end to a proximal end of the openings (the openings highlighted in Fig. 5 below). Lastly, Keenan discloses a distal end (Fig. 4; Right end; see explanation below) configured to be disposed over an expandable housing (see Fig. 4, 5, and explanation below).
Nothing in the claim states that the polymer layer has to be a uniform layer of polymer with no other structure; instead, it only has to include a polymer in the layer. The section shown in Fig. 5 has a proximal end (anything to the left not shown in the figure). It also has a distal end (anything to the right of the labeled tube 104 in the figure). The one or more openings (see annotated Fig. 5 below) are at a proximal end (i.e. to the right of label 104). Applicant uses the term "a proximal end" with respect to "a flexible tubular polymeric layer" and then uses the term "a proximal end" with respect to the "one or more openings" thus indicating there are two, distinct proximal ends. Therefore, the right edge of element 104 meets the first proximal end limitation and the area that is at a different location that contains the opening can be considered the second proximal end claimed.
Additionally, if applicant intends for the proximal ends to be the same, element 222 can be considered part of the cannula, and Fig. 5 shows that the opening extends through the wall of the cannula 104 and thus extends from the outer surface to the inner surface as claimed. Annotated Fig. 5 also shows the slot that extends from the proximal end to the proximal end of one or more openings. The examiner notes that the limitation "to a proximal end" does not define any particular extent to which the slot extends from one proximal end to another and that, given the broadest reasonable interpretation of the claim, could encompass merely extending toward a proximal end. Additionally, or alternately, the third reference to "a proximal end" could be any arbitrary area that is at a different location than the first and second claimed proximal ends. Lastly, the entire assembly has a distal end configured to be disposed over an expandable housing (i.e. element 108 that is over an expandable impeller (see annotated Fig. 4; 112A))
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lostetter (US 2019/0247213) in view of Brady et al. (US 2003/0093106), herein after Brady.
Lostetter teaches a stent graft delivery system for use within patient vasculature (Fig. 3A-4D; para. [0046]; 28; “flexible sheath”; Abstract), comprising: a flexible tubular layer (28, Fig. 3A-B, para. [0042]), having a distal end (Fig. 3A-B; the right end of the sheath) and a proximal end (Fig. 3A-B; the left end of the sheath), and having an outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) and an inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28); one or more openings (Fig. 3A; 34; [0042] - [0043]; at a proximal end (Fig. 3A-b; the left end of the flexible sheath (28)), the one or more openings (Fig. 3A; 34; para. [0042] - [0043]) extending from the outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) to the inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28)); a slot (Fig. 3B; The slit formed between the fenestration (34) and the left end of the flexible sheath (28)) extending from the proximal end (Fig. 3A-B; the left end of the flexible sheath (28)) to a proximal end (Fig. 3A; The left end of flexible sheath (34)) of one of the one or more openings (Fig. 3A; 34; para. [0042] - [0043]); and a distal end (Fig. 3A-B: The right end of the flexible sheath (28)) configured to be disposed over an expandable housing (Fig 3A-B; para. [0043]; “radial expansion of a self-expanding stent graft (not shown) previously radially constricted within flexible sheath 28”; The flexible sheath is the distal end, and the stent graft is configured to be disposed within the expandable stent graft.). However, Lostetter’s flexible sheath is not disclosed as being made of a polymer.
Brady discloses a catheter device used for rapid delivery into a desired vasculature site. Brady, in the same field of endeavor as Lostetter of delivering a medical device through vasculature, teaches a flexible tubular layer (Abstract; Fig. 1-2; para. [0136]; 10; "A suitable material for the sheath 10 is polyethyleneterephthalate (PET)"; para. [0137); “the relatively flexible sheath 10). Both Lostetter and Brady are concerned with reduced friction and a strong, biocompatible material suitable for delivery into a vascular site.
It would have been obvious for one of ordinary skill in the art to modify the material of the flexible tubular layer of Lostetter with the flexible tubular polymeric layer of Brady to provide the necessary strength, stiffness, biocompatibility, and material characteristics required for vascular insertion. Both Lostetter and Brady describe medical devices with the requirement for flexible tubular layers.
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lostetter (US 2019/0247213, " Lostetter"), Brady (US 2003/0093106, "Brady"), and Kleshinski (US 6,245,012 B1, " Kleshinski").
Regarding claim 3, the one-piece outflow tube balloon according to claim 1 is obvious over Lostetter, et al. and Brady, et al. as indicated hereinabove, (see rejection of claim 1 under 35 USC 103 over Lostetter, et al. and Brady, et al.).
Lostetter further discloses an expandable housing (Fig 3A-B; para. [0043]; “radial expansion of a self-expanding stent graft (not shown) previously radially constricted within flexible sheath 28”; The flexible sheath is the distal end, and the stent graft is configured to be disposed within the expandable stent graft.) defining an inflow (the right side of the expandable stent graft previously radially constricted within the flexible sheath 28) and an outflow (the left side of the expandable stent graft previously radially constricted within the flexible sheath 28).
However, Lostetter does not disclose an inner coating disposed against an expandable housing between the inflow and outflow.
Kleshinski, concerned with the common problem of preventing clots within the vasculature upon implantation of the device, discloses an expandable housing (Abstract; “expandable and contractible frame surrounds the elongate guidewire receiving member”) defining an inflow and an outflow (see Fig. 2; “blood flow” labeled with arrows defining the inflow and outflow of the expandable housing); an inner coating (Fig. 1-2; Abstract; col. 4, line 21-25; “The fine filter mesh may be formed of suitable biocompatible material such as polyester or material and is coated with thromboresistent materials such as, for example, Phosophoral Chlorine or Hylauronic Acid”) disposed against an inner surface (Fig. 2; column 5, lines 55-67) of the expandable housing (Abstract; “expandable and contractible frame surrounds the elongate guidewire receiving member”) between the inflow (Fig. 2; Left end of the mesh (82)) and outflow (Fig. 2; Right end of the mesh (82)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Lostetter and Brady combination to include inner coating, as taught and suggested by Kleshinski, for the purpose of preventing blood clots. Further, it would have been obvious to one of ordinary skill in the art to operably couple the one-piece outflow tube balloon combination of Lostetter and Brady with the expandable housing and coating of Kleshinski since doing so would result in reduced blood clots in both the expandable housing and balloon tube balloon device. Additionally, coupling the housing and tube balloon would allow the device to withstand variable blood flow moving through the device, thus reducing complications after implantation.
Regarding claim 5, Lostetter discloses the outflow tube assembly of claim 3 (detailed above in 21-14). A flexible tubular member operably coupled to the outflow assembly (the tubular member right before the sheath in Fig. 4A-D), the outflow assembly comprising a one-piece outflow tube balloon (Fig. 3A-4D; para. [0046]; 28; “flexible sheath”; Abstract), comprising: a flexible tubular layer (28, Fig. 3A-B, para. [0042]), having a distal end (Fig. 3A-B; the right end of the sheath) and a proximal end (Fig. 3A-B; the left end of the sheath), and having an outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) and an inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28); one or more openings (Fig. 3A; 34; [0042] - [0043]; at a proximal end (Fig. 3A-b; the left end of the flexible sheath (28)), the one or more openings (Fig. 3A; 34; para. [0042] - [0043]) extending from the outer surface (Fig. 3A-B; the outer surface of the flexible sheath (28)) to the inner surface (Fig. 3A-B; the inner surface of the flexible sheath (28)); a slot (Fig. 3B; The slit formed between the fenestration (34) and the left end of the flexible sheath (28)) extending from the proximal end (Fig. 3A-B; the left end of the flexible sheath (28)) to a proximal end (Fig. 3A; The left end of flexible sheath (34)) of one of the one or more openings (Fig. 3A; 34; para. [0042] - [0043]); and a distal end (Fig. 3A-B: The right end of the flexible sheath (28)) configured to be disposed over an expandable housing (Fig 4A-D; 42; paragraph [0045]). However, Lostetter does not specifically teach a flexible polymeric tubular layer.
Brady, in the same field of endeavor as catheters, teaches a flexible tubular layer (Abstract; Fig. 1-2; para. [0136]; 10; "A suitable material for the sheath 10 is polyethyleneterephthalate (PET)"), for the purpose of improving biocompatibility for the device.
It would have been obvious for one of ordinary skill in the art to modify the material of the flexible tubular layer of Lostetter with the flexible tubular polymeric layer of Brady to provide the necessary strength, stiffness, and biocompatibility required for implantation. Both Lostetter and Brady describe medical devices with flexible tubular layers. Brady addresses the limitation of a polymeric material that Lostetter does not specify.
The combination of Lostetter and Brady do not disclose a coating disposed against the surface of the expandable housing between the inflow and outflow. However, Kleshinski, concerned with the common problem of preventing clots within the vasculature upon implantation of the device, discloses an inner coating (Fig. 1-2; Abstract; column 4, line 21-25; “The fine filter mesh may be formed of suitable biocompatible material such as polyester or material and is coated with thromboresistent materials such as, for example, Phosophoral Chlorine or Hylauronic Acid”) disposed against the inner surface (Fig. 2; column 5, lines 55-67) between the inflow (Fig. 2; Left end of the mesh (82)) and outflow Fig. 2 (Right end of the mesh (82)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Lostetter and Brady combination to include inner coating, as taught and suggested by Kleshinski, for the purpose of preventing blood clots.
Brady further details a medical device (abstract), comprising: a flexible tubular member (Fig. 7; para. [0137}; “flexible sheath”; 10); an outflow tube assembly (Fig. 3) having a distal end (Fig. 7; para. [0137]; “the distal end of the shaft”; 12) and proximal end (Fig. 7; The left end of the shaft), where the distal and proximal end are operably coupled (Fig. 7; para. [0130]; “A connector shaft 12 is fixed to the sheath 10 with the shaft 12) to the flexible tubular member (Fig. 7; para. [0137}; “flexible sheath”; 10).
It would have been obvious for one of ordinary skill to combine the flexible tubular member taught by Brady with the previously mentioned outflow tube assembly according to claim 3 since doing so would prevent buckling during the implementation procedure. Combining the known element of a flexible tubular member would yield the predictable result of buckling prevention as the device would conform to the vessel shape. Lostetter, Brady, and Kleshinkski all describe inventions used in vasculature that where flexibility would be desirable.
Claim(s) 2, is/are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (2021/0275793 A1) in view of Seiss et al. (2019/0105437).
Regarding claim 2, Keenan discloses all of the claimed invention except for an inflow mesh. However, in the same field of endeavor of blood pumps, Seiss discloses incorporating a mesh structure (10; Fig. 2) for the purpose filtering out blood clots of a predetermined size (see para. [008]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Keenan to include a mesh filter, as taught and suggested by Seiss, for the purpose filtering out blood clots of a predetermined size.
Claim(s) 3, 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keenan (2021/0275793 A1) in view of Kleshinkski (US 6,245,012 B1).
Regarding claim 3, Keenan discloses an expandable housing (“expandable cannula”; see para. [0062], figure 11; 308) defining inflow (Fig. 4; proximal (left) end of the impeller assembly) and outflow (Fig. 4; distal (right) end of the impeller assembly); the one-piece outflow tube balloon according to claim one (see 102 rejection) operably coupled (Fig. 15; See circled region in figure below where 308 is coupled) to the expandable housing (“expandable cannula”; see para. [0062], figure 11; 308).
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However, Keenan does not disclose an inner coating. Kleshinski, concerned with the common problem of preventing clots within the vasculature upon implantation of the device, discloses an inner coating (Fig. 1-2; col. 4, ln. 21-25, "The fine filter mesh may be formed of suitable biocompatible material such as polyester or material and is coated with thromboresistent materials such as, for example, Phosophoral Chlorine or Hylauronic Acid") disposed against an inner surface (col. 5, ln 57-67) of the expandable housing between the inflow (Fig. 2: the left end of the mesh 82) and the outflow (Fig. 2; the right end of the mesh 82).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Keenan to include inner coating, as taught and suggested by Kleshinski, for the purpose of preventing blood clots.
Regarding claim 5, due to the indefiniteness rejection, the examiner notes the interpretation of the claim language is made with the best understanding of the claimed invention in light of the specification. The examiner is interpreting element 108 of figure 4 of Keenan as the part of the outflow tube assembly that has proximal and distal ends operably coupled to a flexible tubular member (104). This interpretation coincides with similar structure shown in figure 3 of applicant’s disclosure. The remainder of the structure incorporated by claim 3 is obvious over Keenan in view of Kleshinski (see rejection of claim 3 above).
Regarding claim 6, Keenan discloses an impeller (312; [0062]; “expandable impeller”) disposed within the outflow tube assembly (Fig. 15; Disposed within the expandable housing of 308).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keenan (2021/0275793 A1, “Keenan”), Kleshinkski (US 6,245,012 B1, “Kleshinski”), and Seiss (2019/0105437, “Seiss”).
Regarding claim 4, the combination of Keenan and Kleshinski discloses all the claimed invention except for a filter at the inflow. However, in the same field of endeavor of blood pumps, Seiss discloses incorporating a mesh structure (10; Fig. 2) for the purpose filtering out blood clots of a predetermined size (see para. [008]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Keenan and Kleshinski combination to include a mesh filter, as taught and suggested by Seiss, for the purpose filtering out blood clots of a predetermined size.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5:00 pm (M-Th); 8am-5pm (F).
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, Jennifer McDonald can be reached at (571) 270-3061. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached PTA week 5 schedule.
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, Jennifer McDonald can be reached at (571) 270-3061. 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.
/OWEN LEWIS MARSH/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796