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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in CN on 12/01/2023. It is noted, however, that applicant has not filed a certified copy of the CN 202311637760.9 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 05/07/2026 ] fails to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered. The examiner notes that said IDS has no information in it and is thus not considered. The IDS filed 05/28/2026 has been considered.
Claim Objections
Claims 1,10 objected to because of the following informalities:
The claims have grammatical issues that require correction.
Claim 1: the components are claimed to be placed (is/are) “arranged” and should just read “arranged”. For examiner “a diverter arranged in the shell”, heat exchange part and oxygenation part arranged”, and “a blood inlet and a blood outlet arranged”. The same issue persists in the rest of claim 1.
Claim 10 appears to be a run-on, “a second area and a third area, and the second area has two blocks, and each second area is adjacent.” The examiner notes that for clarity and ease of read semicolons and removal of the term and is suggested. “second and a third area; wherein the second area has two blocks, each second area is adjacent to the first area”. The same applies to the rest of the claim.
Appropriate correction is required.
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.
Claim1-10 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 claim 1, language in the claim is directed to a method of use/operation in that “blood flows…”. Thus, the claim is rejected under 112b. It is interpreted that blood is configured to flow through the pathway defined in the claims. Further, the terms “the inside” and “the outside”, “the circumferential direction”, and “the upper end surface” (of the diverter column) lack antecedent basis and thus are rejected under 112b.
Regarding claim 1, the terms “close” and “far away” are used to define locations. Said terms are indefinite where one of ordinary skill in the art would not reasonably ascertain what close and or far away would be in a device such as this, as said terms are subjective (i.e. one’s close may be interpreted differently from another’s close). Therefore, it is unclear as to what the terms close and far away define. It is interpreted that so long as the “close” surface is more near the outlet than at least a portion of the “far away” surface, the limitation is met.
Claim 10 also uses the term “close” and therefore is rejected for the same reasons as claim 1.
Regarding claim 2, the lower tangent limitation is unclear. First, there is no antecedent basis for the term. Second, it is unclear as to what a lower tangent line is compared to an upper tangent line, as the tangent line is an imaginary line drawn from the intersection of the two faces. Therefore, it is unclear as to what the lower tangent line is referring to. The examiner notes that so long as at least a portion of the second upper face extends in a direction away from the blood outlet, the limitation is read to by the prior art. Further, the terms “the intersection,” “the first upper end face,” “the second upper end face” which lack antecedent basis. With regard to the term upper end face, it is unclear if this is a new structure of is supposed to be “upper end surface” (as the surface is claimed previously). Additionally, “the radial direction of the blood outlet” lacks antecedent basis since there are no specific details of the blood outlet that would require a radial direction, “the bottom” and “the side of the diverter column away from the blood outlet” also lack antecedent basis.
Claim 3 requires the limitation of -“the diameter of the circle”. However, as no circle is claimed, the term lacks antecedent basis.
Claim 4 requires the limitation of “the same straight line”, while said limitation is unclear and thus indefinite, it is interpreted that the straight line between the two center points is the longitudinal axis. Similar to claim 3, the term “circle” is not introduced previously and thus “the circle” lack antecedent basis. Further, “the first upper end face” and “the lower end face,” both lack antecedent basis.
Claim 5 requires the term “near”. This limitation is indefinite as one of ordinary skill would not reasonably determine what “near” is as said term is subjective (i.e. one’s near may be interpreted differently from another’s near). Therefore, it is unclear as to what the term near defines. It is interpreted that so long as the components are adjacent, they are near. Further, claim 5 requires “the first upper end face,” “the second upper end face” which both lack antecedent basis. With regard to the term upper end face, it is unclear if this is a new structure of is supposed to be “upper end surface” (as the surface is claimed previously).
Regarding Claim 6, much like claims 2 and 5, requires the terms “the first upper end face,” “the second upper end face” which both lack antecedent basis. With regard to the term upper end face, it is unclear if this is a new structure of is supposed to be “upper end surface” (as the surface is claimed previously). Claim 6 also requires the term “the first line” which lacks antecedent basis and is thus unclear.
Regarding Claim 7, much like claims 2,5, and 6, requires the terms “the first upper end face,” “the second upper end face” which both lack antecedent basis. With regard to the term upper end face, it is unclear if this is a new structure of is supposed to be “upper end surface” (as the surface is claimed previously). Claim 6 also requires the term “the second line” which lacks antecedent basis and is thus unclear.
Claim 8 requires “the width”, lacking antecedent basis and is thus indefinite. The claim should read “a width of the connector” for both widths in the claim. Claim 8 also requires the terms “the first upper end face,” “the second upper end face” which both lack antecedent basis. With regard to the term upper end face, it is unclear if this is a new structure of is supposed to be “upper end surface” (as the surface is claimed previously).
Claim 9, details a use of the device in a device claim. The limitation of “the guide grid is used” should read “the guide grid is configured to guide blood”
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) 1-2,4-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yijiang CN 113599605, hereafter Yijiang.
The examiner notes that said reference was provided in the IDS, but the citation used by the examiner are directed to the examiner attached copy.
Regarding claim 1, Yijiang discloses a membrane oxygenation device (abstract, para. 0052)comprising: a shell (Figure 4,[1], where the shell is interpreted as the outer body. A shell is defined in para. 0052), a diverter column is arranged in the shell (first flow guiding structure [3] where para. 0060 details that that the first guiding structure diverts blood flow, and para), a heat exchange part (heat exchange structure [4]) and an oxygenation part (oxygenation structure [6]) are arranged between the diverter column and the shell from the inside to the outside (figure 4, where the reference numbers [4] and [6] are seen to be within the external casing of the device and the defined diverter column [3]), and a blood inlet ([13]) and a blood outlet ([71]) are arranged on the shell (see figure 4); blood flows into the shell from the blood inlet and is diverted by the diverter column (para. 0052,0064), and then flows into the heat exchange part along the circumferential direction of the shell (para. 0052,0066), the heat exchange part heats the blood, and then the blood enters the oxygenation part for oxygenation (para. 0009,0052), and finally flows out of the shell from the blood outlet (para. 0052, defining the flow path out the bleeding channel [71]).
The examiner notes that as seen in figure 4, there is not a defined connector arranged above the diverter column, and the connector and the diverter column are connected by a plurality of spaced connectors. However, the examiner notes that as seen in a second embodiment of Yijiang (figure 14), the oxygenator may have a first flow guiding structure of a different construction, comprising an upper flow guiding structure [31] and a lower flow guiding structure [32] (para. 0078). Said upper and lower guiding structures are connected by strip-shaped connectors [34]. Therefore, as Yijiang teaches that a suitable first guide structure may include an upper and lower section connector by a plurality of connectors disposed between and around the circumference of the guide structures, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use said construction as the first flow guide structure in the embodiment of figure 4. Doing so would merely require the Simple substitution of one known element for another to obtain predictable results, that being the diversion of flow in an oxygenator, and thus a prima facie case of obviousness exists.
The examiner notes that upon said combination, Yijiang further teaches wherein the upper end surface of the diverter column includes a first upper end surface (interpreted as the upper end of the upper guide structure) and a second upper end surface arranged adjacently (interpreted as the upper end of the lower guide structure), the first upper end surface is close to the blood outlet of the oxygenation device, and the second upper end surface is far away from the blood outlet of the oxygenation device, the first upper end surface is a plane, and the second upper end surface is an oblique cut surface (see annotated figure below). The examiner notes that per the 112b rejection of “close” and “far”, it can be seen that a least a portion of the “far” second upper surface is further away from the outlet than the “close” first surface, and thus the prior art reads to the claimed limitation. The annotated figure below depicts the diverter column including the connecters. As seen in the annotated figure said first and second upper surfaces are marked. As further seen in the figure the defined first surface is planar, and the second upper surface extends outward and downward, at an angle, from the first surface and is thus interpreted as an oblique cut surface
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Regarding claim 2, Yijiang discloses the membrane oxygenation device of claim 1, wherein the intersection of the first upper end face and the second upper end face forms an upper tangent of the second upper end face, the upper tangent of the second upper end face is perpendicular to the radial direction of the blood outlet of the oxygenation device (see annotated figure below), and the bottom of the lower tangent of the second upper end face is set on the side of the diverter column away from the blood outlet. Per the rejection under 112b, the claim is interpreted such as long as a portion of the second upper face extends on a side opposite the outlet, the limitation is met. As seen in the figures, the second upper face extends circumferentially within the device, and thus at least a portion is set on the side away from the outlet.
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Regarding claim 4, Yijiang discloses the membrane oxygenation device of claim 1, characterized in that the center point of the circle where the first upper end face of the diverter column is located is on the same straight line as the center point of the lower end face of the diverter column (see figure 14 and 15), However, Yijiang does not specifically disclose that the difference in diameter between the first upper end face of the diverter column and the lower end face of the diverter column is greater than or equal to 2.5 mm and less than or equal to 5 mm. Per MPEP Section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Therefore as the claim merely recites relative dimension, where the prior art was disclosed to teach the same structure as the instant claims per the rejection of claims 1 and 2 and teaches the faces aligned (required in claim 4), where modifying the prior art to have the dimensions claimed would not have affected the operation of the device, it would therefore have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yijiang to have the claimed dimensions.
Regarding claim 5, Yijiang discloses the membrane oxygenation device of claim 2, wherein a plurality of the connectors are spaced and distributed on the edge of the first upper end face and/or the edge of the second upper end face of the diverter column near one end of the diverter column (See figure 14 and 15, para. 0012, 0064).
Regarding claim 6, Yijiang discloses the membrane oxygenation device of claim 5 wherein the connectors located on the edge of the first upper end face of the diverter column are symmetrically arranged on both sides of the first line perpendicular to the upper tangent of the second upper end face and/or are arranged on the end point of the first line away from the upper tangent of the second upper end face column (See figure 14 and 15, para. 0012, 0064). As the connectors are detailed to be located radially around the face of the guide structure, it is interpreted that the connectors are arranged (Seen to be symmetrically in the figures) on both side of a second line perpendicular to the upper tangent.
Regarding claim 7, Yijiang discloses the membrane oxygenation device of claim 5 wherein the connectors located on the edge of the second upper end face are symmetrically arranged on both sides of the second line perpendicular to the upper tangent of the second upper end face and/or are arranged on the end point of the second line away from the upper tangent of the second upper end face column (See figure 14 and 15, para. 0012, 0064). As the connectors are detailed to be located radially around the face of the guide structure, it is interpreted that the connectors are arranged (Seen to be symmetrically in the figures) on both side of a second line perpendicular to the upper tangent.
Regarding claim 8, Yijiang discloses the membrane oxygenation device of claim 5 but fails to specifically teach wherein the width of the connector located on the second upper end face of the diverter column is greater than the width of the connector located on the first upper end face of the diverter column. Per MPEP Section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Therefore, as the claim merely recites relative dimension, where the prior art was disclosed to teach the same structure as the instant claims per the rejection of claims 1 and 2, where modifying the prior art to have the dimensions claimed would not have affected the operation of the device, it would therefore have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yijiang to have the claimed dimensions.
Regarding claim 9, Yijiang discloses the membrane oxygenation device of claim 1 wherein a guide grid (second flow guiding structure [5]) is provided between the heat exchange part and the oxygenation part (see figure 4, where said guide structure [5] is seen to be between the heat exchange [4] and oxygenator [6]), and the guide grid is used to guide blood from the heat exchange part to the oxygenation part (para. 0057).
Regarding claim 10, Yijiang discloses the membrane oxygenation device of claim 9 wherein through holes for blood circulation (figure 10, holes [51], para. 0056) are arranged in sequence in the circumferential direction and axial direction of the guide grid (figure 10) but fails to teach specifically wherein the guide grid is axially separated into a first area, a second area and a third area, and the second area has two blocks, and each second area is adjacent to the first area and the second area respectively; and in the same circumferential direction, the through holes are successively smaller in the first area, the second area and the third area; the third area is close to the side of the blood outlet.
The examiner notes that one of ordinary skill in the art could axially separate the guide grid into a first, second, and third area (for instance first 1/3 of the grid is the first area, the second 1/3 of the grid is the second area, and the third 1/3 of the grid is the third area), but there is no disclosure of the second area having two blocks, and that the holes are successively smaller in the first, second and third areas. Yijiang however does disclose that the size of the guide holes can be the same or different, where the upper part can be larger and the lower part can be smaller to facilitate uniform distribution of blood. Therefore, as Yijiang teaches that the holes may vary in size, and In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the openings of Yijiang to be different sizes from top to bottom.
As detailed above, the examiner notes that the “areas” are arbitrarily defined by the size of the hole located at them. Based on the examiner’s understanding the instant application figure 7, the sequence of areas is first area (largest hole), second area (medium hole), third area (smallest hole), second area [again] (medium hole), first area [again] (largest hole). As Yijiang states that the holes in the grid may vary in size and thus it would have been obvious to modify the size of the holes, one having ordinary skill in the art would reasonably apply the claimed configuration as a manner of "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, where the expectation of success is blood flowing through the grid, which is disclosed to be done in Yijiang. As such it would have been obvious to one having ordinary skill in the art to modify the holes of the prior art to be in the claimed configuration as a manner of “Obvious to try” and thus a prima face case of obviousness exists.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yijiang in view of Wang US 7524277, hereafter Wang.
Regarding claim 3, Yijiang discloses the membrane oxygenation device of claim 2, wherein the diameter of the circle where the first upper end face is located is L1 (where the diameter of the upper face of Yijiang is interpreted to be L1), the height of the diverter column is H (where the diverter of the art has a height), but fails to disclose where the upper tangent is set at a position between 1/2L1 and 3/4L1 away from the radial direction of the blood outlet, and the lower tangent is set at a position between 1/2H and 3/4H away from the blood outlet. However, the examiner notes, per MPEP Section 2144.04 IV A, In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Therefore, as the claim merely recites relative dimension, where the prior art was disclosed to teach the same structure as the instant claims per the rejection of claims 1 and 2, where modifying the prior art to have the dimensions claimed would not have affected the operation of the device, it would therefore have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed inventio to modify the device of Yijiang to have the claimed dimensions.
The examiner notes that the prior art Yijiang depicts a sloped or slanted face. However, should applicant disagree, due to the fact that the instant application requires the tangent line to be sloped as a means to prevent thrombosis (see instant para. 0051), and thus the claimed dimensions are specific to a function, the examiner includes Wang as a prior art reference. Wang teaches a blood flow assisting device and is thus considered analogous to the claimed invention. Wang teaches that the structure of the device may comprise a transition cone for coupling to a larger portion, where said cone is formed at an angle. Said angle can vary in accordance to desired flow rates, flow locations, or to avoid thrombosis (column 7, lines 12-30). As such said angle is disclosed to be a result effective variable in that changing the angle changes the desired flow rates, locations, and avoidance of thrombosis. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Yijiang to have the angle (such that the tangent line is sloped as claimed), as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Yijiang by sloping the tangent line as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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