DETAILED ACTION
This office action is in response to the communication received March 19, 2026.
The amendments of claims 1 and 10; the cancellation of claims 7-8 and 11-12; and the addition of claims 16-25 are acknowledged.
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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, as there are modified rejections below to address the most recent amendments of claims 1 and 10. Additionally, new prior art and rejections are provided below to address the new added claims.
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 19, 23, and 25 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 claims 19, 23, and 25 render the claims indefinite as it is unclear exactly what the “cannular without the configuration” refers to in terms of definitive configuration in order to reach an actual comparison of two different cannulas. Furthermore, different people of ordinary skill in the art may interpret different configurations.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-6, 10, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallen (US 2018/0353326) in view of Lopez et al. (US 2011/0152774) and further in view of Gerbec et al. (US 2011/0218521) .
Regarding claim 1, Hallen discloses a cannula device for a surgical procedure (see Fig. 8), the cannula device comprising: a proximal segment comprising a first length and a first inner diameter (ID) (see Fig. 6a, annotated below, and Fig. 8); an intermediate segment coupled to the proximal segment (see Fig. 6a, annotated below), the intermediate segment comprising a second length and a second ID smaller than the first ID (see Figs. 6a and 8); and a distal segment coupled to the intermediate segment (see Fig. 6a, annotated below), the distal segment comprising a third length greater than the second length and a third ID smaller than the second ID (see Fig. 6a for the length and Fig. 8 and the third and second ID comparisons).
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Hallen further discloses the cannula device further comprising a first transition connecting a distal end of the proximal segment and a proximal end of the intermediate segment, the first transition comprising a first fillet and a second fillet (see Fig. 6a, annotated below).
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Additionally, Hallen discloses the cannula device further comprising a second transition connecting a distal end of the intermediate segment and a proximal end of the distal segment, the second transition comprising a third fillet and a fourth fillet (see Fig. 6a, annotated below).
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Hallen discloses the first ID being larger than the second ID (see Fig. 6a) but does not specifically teach the second ID of the intermediate segment is greater than half of the first ID of the proximal segment.
Hallen discloses that the dimensions of vent 601, which the first and second IDs are part of, are merely an example and other dimensions are contemplated, such as those that allow for the passage of instruments through the vent 601 (see par. 40). Consequently, the first ID is considered a result effective variable and changing a diameter relates to the passage of instruments through vent 601. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying such a diameter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to a person having ordinary skill before the effective filing date of the claimed invention to modify the device of Hallen making the first ID of the proximal second such that half of the first ID is less than the second ID (in other words, the second ID of the intermediate segment is greater than half of the first ID of the proximal segment) 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).
Alternatively, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen to have the second ID of the intermediate segment is greater than half of the first ID of the proximal segment since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen would not operate differently than the claimed relative dimensions as the device would still be for a surgical procedure. Additionally, it appears that applicant place no criticality on the claimed dimensions, indicating simply that they may have that dimension but there are also many other dimensions that are disclosed that will work (see par. 40-41 of filed Specification).
Hallen does not disclose the third length of the distal segment is shorter than a combined length of the intermediate segment and the second transition.
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment 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).
Regarding claim 3, Hallen, Lopez, and Gerbec discloses the limitations of claim 1 and Hallen further discloses at least one portion of the distal segment is configured to be disposed inside a shaft of a valved cannula 110 (see Figs. 3b for valved cannula and Fig. 8 for distal segment inside shaft of valved cannula) comprising a hub 103, the shaft 105, and a cannula transition between the hub and the shaft (see Fig. 2 and Fig. 3b, transition that widens from shaft base to connect with hub).
Regarding claim 4, Hallen, Lopez, and Gerbec discloses the limitations of claim 3 and Hallen further discloses the at least one portion of the distal segment is configured to frictionally engage with an inner surface of the shaft of the valved cannula (see Fig. 8, portion of distal segment that is right up against portion of the inner surface of shaft 105).
Regarding claim 5, Hallen, Lopez, and Gerbec discloses the limitations of claim 1 and Hallen further discloses at least one portion of the intermediate segment is configured to be disposed inside a hub or a cannula transition of a valved cannula comprising the hub 103, a shaft 105, and the cannula transition (see Fig. 3b, transition that widens from shaft base to connect with hub) between the hub and the shaft (see Figs. 2, 3b, and 8).
Regarding claim 6, Hallen, Lopez, and Gerbec discloses the limitations of claim 5 and Hallen further discloses the at least one portion of the intermediate segment is configured to frictionally engage with an inner surface of the hub (see Fig. 8, portion of intermediate segment that is up against hub inner surface).
Regarding claim 10, Hallen discloses a cannula device for a surgical procedure (see Fig. 8), the cannula device comprising: a proximal segment comprising a first inner diameter (ID), a first length, a first proximal end, and a first distal end (see Fig. 6a, annotated below and showing length of segment and Fig. 8 showing inner diameter of segment); an intermediate segment coupled to the proximal segment, the intermediate segment comprising a second ID smaller than the first ID, a second length, a second proximal end, and a second distal end (see Fig. 6a, annotated below and showing length of segment and Fig. 8 showing inner diameters of segments); a first transition connecting the proximal segment and the intermediate segment via the first distal end and the second proximal end, the first transition comprising a first fillet and a second fillet (see Fig. 6a, annotated below); a distal segment coupled to the intermediate segment, the distal segment comprising a third ID smaller than the second ID, a third length greater than the second length, a third proximal end, and a third distal end (see Fig. 6a, annotated below and showing length of segment and Fig. 8 showing inner diameters of segments); and a second transition connecting the intermediate segment and the distal segment via the second distal end and the third proximal end, the second transition comprising a third fillet and a fourth fillet (see Fig. 6a, annotated below).
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Hallen discloses the first ID being larger than the second ID (see Fig. 6a) but does not specifically teach the second ID of the intermediate segment is greater than half of the first ID of the proximal segment.
Hallen discloses that the dimensions of vent 601, which the first and second IDs are part of, are merely an example and other dimensions are contemplated, such as those that allow for the passage of instruments through the vent 601 (see par. 40). Consequently, the first ID is considered a result effective variable and changing a diameter relates to the passage of instruments through vent 601. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying such a diameter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to a person having ordinary skill before the effective filing date of the claimed invention to modify the device of Hallen making the first ID of the proximal second such that half of the first ID is less than the second ID (in other words, the second ID of the intermediate segment is greater than half of the first ID of the proximal segment) 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).
Alternatively, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen to have the second ID of the intermediate segment is greater than half of the first ID of the proximal segment since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen would not operate differently than the claimed relative dimensions as the device would still be for a surgical procedure. Additionally, it appears that applicant place no criticality on the claimed dimensions, indicating simply that they may have that dimension but there are also many other dimensions that are disclosed that will work (see par. 40-41 of filed Specification).
Hallen does not disclose the third length of the distal segment is shorter than a combined length of the intermediate segment and the second transition.
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment 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).
Regarding claim 13, Hallen, Lopez, and Gerbec disclose the limitations of claim 10 and Hallen further discloses at least one portion of the distal segment is configured to be disposed inside a shaft 105 of a valved cannula 110 (see Fig. 3b for valved cannula and Fig. 8 for distal segment inside shaft of valved cannula) comprising a hub 103, the shaft 105, and a cannula transition between the hub and the shaft (see Fig. 2 and Fig. 3b, transition that widens from shaft base to connect with hub).
Regarding claim 14, Hallen, Lopez, and Gerbec disclose the limitations of claim 13 and Hallen further discloses the at least one portion of the distal segment is configured to frictionally engage with an inner surface of the shaft of the valved cannula (see Fig. 8, portion of distal segment that is right up against portion of the inner surface of shaft 105).
Regarding claim 15, Hallen, Lopez, and Gerbec disclose the limitations of claim 10 and Hallen further discloses at least one portion of the intermediate segment is configured to be disposed inside a hub of a valved cannula comprising the hub 103, a shaft 105, and the cannula transition (see Fig. 3b, transition that widens from shaft base to connect with hub) between the hub and the shaft (see Figs. 2, 3b, and 8), and wherein the at leaset one portion of the intermediate segment is configured to frictionally engage with an inner surface of the hub (see Fig. 8, portion of intermediate segment that is up against hub inner surface).
Claim(s) 16-18, 20-22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallen in view of Lopez and further in view of Gerbec as applied to claim 1 or 10 above, and further in view of Mackay et al. (WO 2022/075840).
Regarding claim 16, Hallen, Lopez and Gerbec disclose the limitations of claim 1 but do not disclose the first length is between about 0.1496 inches and about 0.2024 inches and the first ID is between about 0.0723 inches and about 0.0978 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the first ID between about 0.0723 inches and about 0.0978 inches 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the first length between about 0.1496 inches and about 0.2024 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the first length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45-46).
Regarding claim 17, Hallen, Lopez and Gerbec disclose the limitations of claim 1 but do not disclose the second ID is between about 0.0247 inches and about 0.0334 inches and the second length is between about 0.034 inches and about 0.046 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the second ID is between about 0.0247 inches and about 0.0334 inches 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the second length is between about 0.034 inches and about 0.046 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the second length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45 and 47).
Regarding claim 18, Hallen, Lopez and Gerbec disclose the limitations of claim 1 but do not disclose the third ID is between about 0.0151 inches and about 0.0155 inches and the third length is between about 0.0425 inches and about 0.0575 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the third ID is between about 0.0151 inches and about 0.0155 inches 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).
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment, and therefore the third length is between about 0.0425 inches and about 0.0575 inches, 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).
Regarding claim 20, Hallen, Lopez and Gerbec disclose the limitations of claim 10 but do not disclose the first length is between about 0.1496 inches and about 0.2024 inches and the first ID is between about 0.0723 inches and about 0.0978 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the first ID between about 0.0723 inches and about 0.0978 inches 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the first length between about 0.1496 inches and about 0.2024 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the first length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45-46).
Regarding claim 21, Hallen, Lopez and Gerbec disclose the limitations of claim 10 but do not disclose the second ID is between about 0.0247 inches and about 0.0334 inches and the second length is between about 0.034 inches and about 0.046 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the second ID is between about 0.0247 inches and about 0.0334 inches 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the second length is between about 0.034 inches and about 0.046 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the second length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45 and 47).
Regarding claim 22, Hallen, Lopez and Gerbec disclose the limitations of claim 10 but do not disclose the third ID is between about 0.0151 inches and about 0.0155 inches and the third length is between about 0.0425 inches and about 0.0575 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the third ID is between about 0.0151 inches and about 0.0155 inches 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).
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment, and therefore the third length is between about 0.0425 inches and about 0.0575 inches, 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).
Regarding claim 24, Hallen discloses a cannula device for a surgical procedure (see Fig. 8), the cannula device comprising: a proximal segment comprising a first length and a first inner diameter (ID) (see Fig. 6a, annotated below, and Fig. 8); an intermediate segment coupled to the proximal segment (see Fig. 6a, annotated below), the intermediate segment comprising a second length and a second ID smaller than the first ID (see Figs. 6a and 8); and a distal segment coupled to the intermediate segment (see Fig. 6a, annotated below), the distal segment comprising a third length greater than the second length and a third ID smaller than the second ID (see Fig. 6a for the length and Fig. 8 and the third and second ID comparisons).
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Hallen further discloses the cannula device further comprising a first transition connecting a distal end of the proximal segment and a proximal end of the intermediate segment, the first transition comprising a first fillet and a second fillet (see Fig. 6a, annotated below).
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Additionally, Hallen discloses the cannula device further comprising a second transition connecting a distal end of the intermediate segment and a proximal end of the distal segment, the second transition comprising a third fillet and a fourth fillet (see Fig. 6a, annotated below).
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Hallen discloses the first ID being larger than the second ID (see Fig. 6a) but does not specifically teach the second ID of the intermediate segment is greater than half of the first ID of the proximal segment.
Hallen discloses that the dimensions of vent 601, which the first and second IDs are part of, are merely an example and other dimensions are contemplated, such as those that allow for the passage of instruments through the vent 601 (see par. 40). Consequently, the first ID is considered a result effective variable and changing a diameter relates to the passage of instruments through vent 601. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying such a diameter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to a person having ordinary skill before the effective filing date of the claimed invention to modify the device of Hallen making the first ID of the proximal second such that half of the first ID is less than the second ID (in other words, the second ID of the intermediate segment is greater than half of the first ID of the proximal segment) 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).
Alternatively, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen to have the second ID of the intermediate segment is greater than half of the first ID of the proximal segment since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen would not operate differently than the claimed relative dimensions as the device would still be for a surgical procedure. Additionally, it appears that applicant place no criticality on the claimed dimensions, indicating simply that they may have that dimension but there are also many other dimensions that are disclosed that will work (see par. 40-41 of filed Specification).
Hallen does not disclose the third length of the distal segment is shorter than a combined length of the intermediate segment and the second transition.
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment 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).
Hallen, Lopez and Gerbec do not disclose the first length is between about 0.1496 inches and about 0.2024 inches and the first ID is between about 0.0723 inches and about 0.0978 inches.
Mackay discloses a trocar for ophthalmic surgery with tube 52 through which fluid flows, the flow rate and fluid pressure limited by the internal diameter of the passage (see page 10, lines 3-5). Consequently, such an inner diameter through which fluid flows being disclosed as a result effective variable in that changing the diameter changes the allowed flow rate and fluid pressure through the passage. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter within the claimed range, 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 before the effective filing date of the claimed invention to modify the cannula device to have the first ID between about 0.0723 inches and about 0.0978 inches 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).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the first length between about 0.1496 inches and about 0.2024 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the first length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45-46).
Hallen, Lopez and Gerbec do not disclose the second length is between about 0.034 inches and about 0.046 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device to have the second length is between about 0.034 inches and about 0.046 inches since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Hallen, Lopez, and Gerbec would not operate differently with the claimed length of the second length as the proximal segment would function appropriately having the claimed length. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the length “in certain embodiments” is within the claimed range (specification pp. 45 and 47).
Hallen, Lopez and Gerbec do not disclose the third length is between about 0.0425 inches and about 0.0575 inches.
Lopez discloses a cannula device 901 for a surgical procedure, the cannula device comprising: a proximal segment, intermediate segment, and distal segment with varying diameters (see Figs. 9a-9b). Lopez also discloses that it is well known to vary the distal segment length (see Fig. 8, distal segment of this embodiment is longer than the distal segment of Figs. 9a-9b). It is common sense that a shorter length would result in less materials, therefore lower cost because of the use of less materials, and such sense that reducing amount of material results in reduced manufacturing costs is disclosed by Gerbec (see par. 53). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Hallen device to have a length as claimed that is shorter, as it involves only adjusting the dimension of a component that Lopez discloses can be adjusted. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hallen by making the length of the distal segment shorter, resulting in a combined length of the intermediate segment and the second transition that is longer than the length of the distal segment, and therefore the third length is between about 0.0425 inches and about 0.0575 inches, 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).
Claim(s) 19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallen in view of Lopez and further in view of Gerbec as applied to claims 1 or 10 above, and further in view of Murakami et al. (US 2020/0179166).
Regarding claims 19 and 23, Hallen, Lopez and Gerbec disclose limitations of claims 1 and 10 but do not disclose the third length and combined length of the intermediate segment and the second transition are configured to reduce a resistance to fluid flow by increasing a flow rate through the cannula by about 5 to 30% over a cannula without the configuration.
Murakami discloses the length of the length of parts of the cannula is related to resistance of the channel on the flowing water and therefore if a portion is made shorter then resistance becomes smaller and flow rate is increased (see par. 24). Therefore, the third length and combined length of the intermediate segment and the second transition are result effective variables that in changing the length affect the resistance to flow and therefore flow rate through the cannula device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the cannula device to have a length that results in the claimed range of 5 to 30% as it involves only adjusting the dimension, length, of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula device to result in the third length and combined length configured to reduce a resistance to fluid flow by increasing a flow rate through the cannula by about 5 to 30% over a cannula without the configuration 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).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hallen in view of Lopez and further in view of Gerbec in view of Mackay as applied to claim 24 above, and further in view of Murakami.
Regarding claim 25, Hallen, Lopez, Gerbec, and Mackkay disclose limitations of claim 24 but do not disclose the third length and combined length of the intermediate segment and the second transition are configured to reduce a resistance to fluid flow by increasing a flow rate through the cannula by about 5 to 30% over a cannula without the configuration.
Murakami discloses the length of the length of parts of the cannula is related to resistance of the channel on the flowing water and therefore if a portion is made shorter then resistance becomes smaller and flow rate is increased (see par. 24). Therefore, the third length and combined length of the intermediate segment and the second transition are result effective variables that in changing the length affect the resistance to flow and therefore flow rate through the cannula device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the cannula device to have a length that results in the claimed range of 5 to 30% as it involves only adjusting the dimension, length, of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula device to result in the third length and combined length configured to reduce a resistance to fluid flow by increasing a flow rate through the cannula by about 5 to 30% over a cannula without the configuration 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
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.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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