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 .
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.
Claim(s) 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8888836 B2 (Berglund).
Regarding Claim 11, Berglund teaches a blood flow restrictor, the blood flow restrictor comprising:
a restrictor body (102) (Fig. 1) defining a longitudinal flow passage (108) having an inlet opening (104) and an opposite outlet flow orifice (106), the restrictor body is configured to direct blood flow into the longitudinal flow passage, from the inlet opening through the outlet flow orifice (Col. 3: ll. 32-34), at a first blood flow rate (the initial flow rate) when the blood flow restrictor is implanted in the collateral vein, wherein the restrictor body comprises a biodegradable material (110) configured to biodegrade (Col. 3: ll. 44-49) in the collateral vein after a predetermined amount of time to increase blood flow through the longitudinal flow passage from the first blood flow rate to a second blood flow rate greater than the first blood flow rate (Col. 3: ll. 46-49).
The device of Berglund is considered to be a blood flow restrictor which is capable of implantation in a collateral vein of a primary vein of an AV fistula to promote maturation of the AV fistula. Statements in the preamble reciting the purpose or intended use of the claimed invention which do not result in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art do not limit the claim and do not distinguish over the prior art apparatus (or process). See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) and cases cited therein, as it has been held that the recitation of a new intended use for an old product does not make a claim to that old product patentable. In re Schreiber, 44 USPQ2d 1429 (Fed. Cir. 1997). See also MPEP § 2111.02, §2112.02 and 2114-2115.
“[W]hen the blood flow restrictor is implanted in the collateral vein” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
“[C]onfigured to biodegrade in the collateral vein” is a statement of intended use that does not further limit the claimed invention. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) [MPEP 2114]. Since the structure of the prior art teaches all structural limitations of the claim, the same is considered capable of meeting the intended use limitations.
Regarding Claims 12-16, Berglund further teaches the biodegradable material (110) is configured to maintain the blood flow through the longitudinal flow passage (108) at a blood flow rate that is less than the second blood flow rate over a range of times ranging from one hour to one year (Col. 6: ll. 23-26, 45-48), further citing specific time ranges which may be choses based on material and thickness (Col. 7: ll. 10-17), and is therefore considered to teach the claimed ranges of:
4 weeks
3 months
4 months
about 6 months
between about 6 months and 1 year
Regarding Claim 17, Berglund further teaches the restrictor body includes a membrane formed from the biodegradable material (110) (the band described in Col. 5: ll. 10-12 being considered a membrane), and a valve portion ((100) and (112)) defining the longitudinal flow passage (108) (Fig. 1), wherein the membrane is coupled to the valve portion (Fig. 1) and configured to restrict blood flow through the valve portion (Col. 3: ll. 46-49).
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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berglund in view of WO 2017011402 A1 (Brenneman et al.).
Regarding Claim 20, while Berglund teaches a blood flow restrictor comprising configured to biodegrade (Col. 3: ll. 44-49) in the collateral vein after a predetermined amount of time to increase blood flow through the longitudinal flow passage from the first blood flow rate to a second blood flow rate greater than the first blood flow rate (Col. 3: ll. 46-49), the reference fails to teach implanting the blood flow restrictor in a collateral vein of a primary vein of the arteriovenous (AV) fistula.
Brenneman teaches a method of promoting maturation of an AV fistula [036] comprising:
implanting a blood flow restrictor in a collateral vein of a primary vein of the arteriovenous (AV) fistula [0103] to restrict blood flow in the collateral vein to a first blood flow rate [0103].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Berglund to incorporate the method of Brenneman to allow for modification of flow at various intervals after original fistula creation [Brenneman 0106-0107].
Claim(s) 21-26, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman in view of Berglund.
Regarding Claim 21, Brenneman teaches a method of promoting maturation of an AV fistula [036] comprising:
implanting a blood flow restrictor in a collateral vein of a primary vein of the arteriovenous (AV) fistula [0103] to restrict blood flow in the collateral vein to a first blood flow rate [0103], wherein
Brenneman teaches the desire to modify flow characteristics over time [0106] and the use of biodegrading material [034], but fails to teach the blood flow restrictor biodegrades in the collateral vein after a predetermined amount of time to increase blood flow through the collateral vein from the first blood flow rate to a second blood flow rate greater than the first blood flow rate.
Berglund teaches a blood flow restrictor comprising configured to biodegrade (Col. 3: ll. 44-49) in the collateral vein after a predetermined amount of time to increase blood flow through the longitudinal flow passage from the first blood flow rate to a second blood flow rate greater than the first blood flow rate (Col. 3: ll. 46-49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Brenneman to incorporate the device of Berglund to allow for modification of flow at various intervals after original fistula creation [Brenneman 0106-0107].
Regarding Claims 22-26, Brenneman fails to teach the blood flow restrictor biodegrades at the time ranges as claimed.
Berglund further teaches the biodegradable material (110) is configured to maintain the blood flow through the longitudinal flow passage (108) at a blood flow rate that is less than the second blood flow rate over a range of times ranging from one hour to one year (Col. 6: ll. 23-26, 45-48), further citing specific time ranges which may be choses based on material and thickness (Col. 7: ll. 10-17), and is therefore considered to teach the claimed ranges of:
4 weeks
3 months
4 months
about 6 months
between about 6 months and 1 year
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Brenneman to incorporate the device of Berglund to allow for modification of flow at various intervals after original fistula creation [Brenneman 0106-0107].
Regarding Claim 29, Brenneman further teaches assessing, before said implanting a blood flow restrictor in a collateral vein, a flow performance of a primary outflow path defined within the primary vein of the AV fistula [037].
Regarding Claim 30, Brenneman further teaches anchoring the blood flow restrictor to a wall of the collateral vein ([0124] describing the use of distal arms to engage vessel walls, thereby anchoring the device).
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berglund.
Regarding Claims 18 and 19, Berglund fails to teach the valve portion further defines additional blood flow paths, wherein the membrane blocks the additional blood flow paths to restrict blood flow through the valve portion to the first blood flow rate, wherein biodegradation of the membrane opens the additional blood flow paths to increase the blood flow through the valve portion to the second blood flow rate.
The mere duplication of parts, without any new or unexpected results, is within the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA 1960) (see MPEP § 2144.04).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the single flow path of Berglund to comprise a plurality of flow paths, multi-lumen flow restrictors being well-known in the art.
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brenneman in view of Berglund and further in view US 20170202603 A1 (Cohn et al.).
Regarding Claims 27 and 28, Brenneman fails to teach said implanting a blood flow restrictor in a collateral vein comprises implanting a plurality of blood flow restrictors in a plurality of collateral veins.
Cohn teaches a method of promoting maturation of an AV fistula comprising implanting a plurality of flow restrictors in a plurality of collateral veins [0028], wherein the blood flow restrictors biodegrade at different biodegradation rates in the corresponding collateral veins [0046-0047].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Brenneman to incorporate the multiple devices and varied degradation taught by Cohn in order to control the maturation of multiple fistulas [Cohn 0005, 0046-0047].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/HANS KALIHER/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
Prosecution Insights