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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 10, 2024 has been entered.
Claims 6-10, 17-19, 25-27 have been cancelled without prejudice. Claims 1-5, 11-16, 20-24, and new claim 28 are pending and will be prosecuted on the merits.
Applicant’s arguments with respect to claims 1-5, 11-16 and 20-24 have been considered but are moot in view of the new ground of rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The “support ring fixed within the aperture of the base” limitation in claim 28 does not appear to find support in the specification.
Although the specification does appear to provide support for a support ring and a portion passing through the aperture of the base, there is nothing in the disclosure that explains that a portion of the support ring is fixed within the aperture or anything that explains how the support ring is fixed within the aperture. For example, there is nothing in the specification stating that a support ring is secured, welded, glued, fixed etc. to the base or aperture that would imply that the support ring is fixed within the aperture of the base. For the purpose of examination, the Examiner is interpreting any part of the support ring that passes through the aperture of the base to be fixed laterally from moving out of the aperture.
Claim Objections
Claim 28 is objected to because of the following informalities: claim 28 states “wherein the pressure comprises a perimeter”, the Examiner suggests inserting –pad—after “pressure”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 11-12, 20-21, 24, 28 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Guillot (US 2012/0191127)
Regarding claim 1, Guillot discloses a medical device for applying pressure to a body vessel in a patient (Figures 1, 4a), the medical device comprising: a base comprising a first face and a second face opposite the first face (Ref 10; See Figure 4a below), the base defining an aperture through the first face and the second face (Ref 10; See Figure 4a below); a support ring (Ref 22) comprising a flat portion configured to contact the body vessel (Ref 22; Figure 4a see below; where the flat portion is capable of contacting a body vessel), a cylindrical portion extending from the flat portion (Ref 22), and a lumen formed through the cylindrical portion (Ref 22; Figure 2a), the support ring within the aperture of the base (Ref 22; Figure 2a, 4a) such that the cylindrical portion extends from the first face (Ref 22; where Figures 1, 2b, 4a show that the cylindrical portion Ref 22 extends from the first face of base Ref 10); and a plunger disposed through the lumen of the cylindrical portion of the support ring (Ref 12; where Figure 4a shows that the plunger Ref 12 is disposed through the lumen of Ref 22), the plunger being movable from a retracted position to an engaged position (Ref 12; Para [0027], [0043]), the plunger comprising a pressure pad (Ref 14), wherein the pressure pad is disposed at least partially within the lumen of the support ring in the retracted position (Ref 14, 22; where Figure 4a shows that the pressure pad Ref 14 is disposed at least partially within the lumen of Ref 22 in the retracted position) and extends from the flat portion of the support ring in the engaged position (Ref 14, 22; Para [0027], [0043]; Figure 4a; where the pressure pad extends from the support ring to apply increased pressure to the vessel and therefore extends from the flat portion of the support ring in the engaged position to contact the vessel), such that when the plunger is moved from the retracted position to the engaged position, the pressure pad applies increased pressure to the body vessel (Ref 14; Para [0027], [0043]), wherein the pressure pad is circular (Ref 14; Figure 3a, 3b; Para [0039]-[0040]; where the pad is spherical and is therefore interpreted as being circular in cross-section) and comprises a first diameter (Ref 14; Figure 3a, 3b, 4a; where Figures 3a, 3b, 4a show a first diameter of the pressure pad Ref 14) and a convex surface, and wherein the convex surface is along the first diameter for contacting the patient (Ref 14; where Figures 3a, 3b, 4a show that the convex surface is along the first diameter for contacting the patient).
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Regarding claim 2, Guillot discloses a handle disposed on the first face of the base (Ref 18; where Figure 4a shows that the handle Ref 18 is on the first face of the base).
Regarding claim 4, Guillot discloses that the plunger (Ref 12) moves toward the retracted position when the handle is rotated in a first rotational direction (Ref 12, 18; Para [0027], [0043]), and wherein the plunger moves toward the engaged position when the handle is rotated in a second rotational direction (Ref 12, 18; Para [0027], [0043]).
Regarding claim 11, Guillot discloses that the plunger (Ref 12) comprises a support cylinder (Ref 50) extending into the handle (Ref 18; where Figure 4a shows that the support cylinder Ref 50 of plunger Ref 12 extends into handle Ref 18), the support cylinder having an outer surface (Ref 50; Figure 3a) on which at least one first thread is formed (Ref 56b; Figure 3a, 3b), the handle comprising an inner surface (Ref 18, Figure 4b) on which at least one second thread is formed (Ref 62; Figure 4b; Para [0041]), the at least one second thread being configured to engage with the at least one first thread (Ref 56b, 62; Para [0041]; Figure 3a, 4a, 4b).
Regarding claim 12, Guillot discloses that the pressure pad defines the first diameter (Ref 14; Figure 4a), and the handle defines a second diameter greater than the first diameter (Ref 18; Figure 4a; where Figure 4a shows that the handle extends outside of the pressure pad Ref 14 and therefore the diameter of the handle is greater than the first diameter of the pressure pad).
Regarding claim 20, Guillot discloses a method of applying pressure to a body vessel of a patient, the method comprising: placing a medical device over the body vessel (Figures 1, 4a; Para [0001], [0002], [0005] ), the medical device comprising: a base comprising a first face and a second face opposite the first face (Ref 10; See Figure 4a above), the base defining an aperture through the first face and the second face (Ref 10; See Figure 4a above); a support ring (Re 22) comprising a flat portion configured to contact the body vessel (Ref 22; Figure 4a see above; where the flat portion is capable of contacting the body vessel), a cylindrical portion extending from the flat portion (Ref 22), and a lumen formed through the cylindrical portion (Ref 22; Figure 2a), the support ring within the aperture of the base (Ref 22; Figure 2a, 4a) such that the cylindrical portion extends from the first face (Ref 22; where Figures 1, 2b, 4a show that the cylindrical portion Ref 22 extends from the first face of the base Ref 10); and a plunger disposed through the lumen of the cylindrical portion of the support ring (Ref 12; where Figure 4a shows that the plunger Ref 12 is disposed through the lumen of Ref 22), the plunger being movable from the retracted position to an engaged position (Ref 12; Para [0027], [0043]), the plunger comprising a pressure pad (Ref 14), wherein the pressure pad is disposed at least partially within the lumen of the support ring in the retracted position (Ref 14, 22; where Figure 4a shows that the pressure pad Ref 14 is disposed at least partially within the lumen of Ref 22 in the retracted position) and extends from the flat portion of the support ring in the engaged position (Ref 14, 22; Para [0027], [0043]; Figure 4a; where the pressure pad extends from the support ring to apply increased pressure to the vessel and therefore extends from the flat portion of the support ring in the engaged position to contact the vessel), such that when the plunger is moved from the retracted position to the engaged position, the pressure pad applies increased pressure to the body vessel (Ref 14; Para [0]), wherein the pressure pad is circular (Ref 14; Figure 3a, 3b; Para [0039]-[0040]) and comprises a first diameter (Ref 14; Figure 3a, 3b, 4a; where Figures 3a, 3b, 4a show a first diameter of the pressure pad Ref 14) and a convex surface, wherein the convex surface is along the first diameter for contacting the patient (Ref 14; where Figures 3a, 3b, 4a show that the convex surface is along the first diameter for contacting the patient); the medical device being in the retracted position and placed such that the pressure pad is positioned over the body vessel (Para [0027], [0043]; where the device is rotated to translate the plunger toward the injection or puncture zone and therefore is in the retracted position when placed over the body vessel and is then manipulated to translate the plunger toward the site); and manipulating the plunger to move the pressure pad to apply a focal pressure to the body vessel, such that the medical device is in the engaged position (Ref 12; Para [0027], [0043]; where the device is rotated to translate the plunger toward the injection or puncture zone and therefore is in the retracted position when placed over the body vessel and is then manipulated to translate the plunger toward the site).
Regarding claim 21, Guillot discloses a handle disposed on the first face of the base and configured to manipulate the plunger (Ref 18; where Figure 4a shows that the handle Ref 18 is on the first face of the base; where the handle is capable of manipulating the plunger Ref 12).
Regarding claim 24, Guillot discloses a securement ring (Ref 16; where Ref 16 forms a ring around the user’s wrist and secures the device to the wrist and is therefore interpreted as a securement ring).
Regarding claim 28, Guillot discloses a medical device for applying pressure to a body vessel in a patient (Figures 1, 4a), the medical device comprising: a base comprising a first face and a second face opposite the first face (Ref 10; See Figure 4a above), the base defining an aperture through the first face and the second face (Ref 10; See Figure 4a above); a support ring (Ref 22) comprising a flat portion configured to contact the body vessel (Ref 22; Figure 4a see above), a cylindrical portion extending from the flat portion (Ref 22), and a lumen formed through the cylindrical portion (Ref 22; Figure 2a), the support ring fixed within the aperture of the base such that the cylindrical portion extends from the first face (Ref 22; Figure 2a, 4a; where Ref 22 passes through the aperture in the base and as descripted in the 112 section above, meets the limitation; where Figure 1, 2b, 4a show that the cylindrical portion Ref 22 extends from the first face of base Ref 10); and a plunger disposed through the lumen of the cylindrical portion of the support ring (Ref 12; where Figure 4a shows that the plunger Ref 12 is disposed through the lumen of Ref 22), the plunger being movable from a retracted position to an engaged position (Ref 12; Para [0027], [0043]), the plunger comprising a pressure pad (Ref 14), wherein the pressure pad is disposed at least partially within the lumen of the support ring in the retracted position (Ref 14, 22; where Figure 4a shows that the pressure pad Ref 14 is disposed at least partially within the lumen of Ref 22 in the retracted position) and extends from the flat portion of the support ring in the engaged position (Ref 14, 22; Para [0027], [0043]; Figure 4a; where the pressure pad extends from the support ring to apply increased pressure to the vessel and therefore extends from the flat portion of the support ring in the engaged position to contact the vessel), such that when the plunger is moved from the retracted position to the engaged position, the pressure pad applies increased pressure to the body vessel (Ref 14; Para [0027], [0043]), wherein the pressure comprises a perimeter, a diameter (Ref 14; Figure 3a, 3b, 4a; where Figures 3a, 3b, 4a show a first diameter of the pressure pad Ref 14; and show that the pressure pad comprises a perimeter) and a convex surface, wherein the convex surface is along the diameter of the pressure pad for contacting the patient (Ref 14; where Figures 3a, 3b, 4a show that the convex surface is along the first diameter for contacting the patient), and wherein the diameter is the same along the length of the perimeter of the pressure pad (Ref 14; where Figures 3a, 3b, 4a show that the diameter is the same along the perimeter of the pressure pad).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guillot (US 2012/0191127) in view of ZHU (CN109846525).
Regarding claim 3, Guillot discloses all of the claimed limitation above including a handle that is rotatable to translate a pressure pad but fails to explicitly disclose that the handle is operably connected to the pressure pad by a spring.
However, ZHU, in the same field of endeavor (i.e. radial compression device), teaches that it is well known for the rotatable handle (Ref 4) of radial compression device to be operably connected to a pressure pad (Ref 6) by a spring (Ref 9) which allows the pressure adjustment to be easier to control and allows the pressure of the pressure pad to be easier known (Para [0072]-[0073], [0082] of the English Translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Guillot to include a spring within the handle to operably connect the handle to the pressure pad as suggested by ZHU, since such a modification allows the pressure adjustment to be easier to control and allows the pressure of the pressure pad to be easier known.
Claim(s) 5 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guillot (US 2012/0191127) in view of Rioux (US 2005/0125025).
Regarding claim 5, Guillot discloses all of the claim limitations above including that the handle defines a round shape but fails to explicitly disclose that the handle can include a plurality of grooves formed along a circumference.
However, Rioux, which similarly teaches a compression device, additionally teaches that it is well known in the art for a handle of a compression device to define a round shape and include a plurality of grooves formed along a circumference thereof (Ref 38, 42, 46; para [0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the handle of Guillot to includes a plurality of grooves formed along a circumference thereof as suggested by Rioux since such a modification enhances the friction/gripability of the handle.
Regarding claim 22, Guillot discloses all of the claimed limitations above but fails to explicitly disclose that the base can include a sticky or textured surface for gripping the patient.
However, Rioux, which similarly teaches a compression device, additionally teaches that it is well known in the art for a base to include a sticky surface for gripping the patient (Para [0076], [0112]-[0113], [0120]; Ref 88, 90).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify portions of the base that contact the surrounding area to include a sticky surface as suggested by Rioux, since such a modification helps secure portions of the device to the surrounding area.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guillot (US 2012/0191127) in view of Lampropoulos et al. (US 2010/0280541).
Regarding claims 13-14, Guillot discloses all of the claimed limitations above including a base to be positioned on a radial artery but fails to explicitly disclose that the base defines an indentation sized to accommodate an intravenous line.
However, Lampropoulos, in the same field of endeavor (i.e. a radial artery compression device), teaches that it is well known for the base to define an indentation sized to accommodate an intravenous line; where the intravenous line is a central line (Ref 24a, 24b, 22, 36; where Figure 5 shows that the base includes an indentation between sections of base Ref 24a, 24b and under Ref 22, 20; where when Ref 30 is positioned in Ref 20; the indentation between sections of the base Ref 24a, 24b and under Ref 22 aligns with Ref 36 and is capable of accommodating an intravenous line such as a central line, where the Examiner notes that an intravenous line/central line are not positively claimed and therefore the indentation merely needs to be capable of accommodating an intravenous line).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base of Guillot to include an indentation sized to accommodate an intravenous line as suggested by Lampropoulos since such a modification allows the device of Guillot to easily place on a patient’s radial artery immediately following an operation.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guillot (US 2012/0191127) in view of Gavriely (WO 03/049623).
Regarding claims 15-16, Guillot discloses that the pressure pad applies pressure to a body vessel when the medical device is in the engaged position but is silent with respect to the amount of pressure that is applied.
However, Gavriely, in the same field of endeavor (i.e. a device to apply pressure to a body part) teaches a compression device and teaches that the pressure needed to compress veins is in the range from 20-60mmHg (Background).
Since Guillot discloses all of the claimed limitations above including applying pressure to body vessel and Gavriely teaches that it is known to need to compress a vein in the range of 20-60mmHg (which falls within both ranges of 15-180mmHg and 15-70mmHg), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure applied by the device of Guillot to be about 20-60mmHg as suggested by Gavriely since such a modification utilizes a well-known compression pressure and would have yielded predictable results, namely, allowing the device of Guillot to successfully compress a radial artery site.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guillot (US 2012/0191127).
Regarding claim 23, Guillot discloses that the lumen of the support ring comprises a inner surface and comprises at least one tab extending from the inner surface (Ref 23; 22; See Figure 2a) and the plunger further comprises at least one flat portion (Ref 52a; where Ref 52a is a flat recess that does not protrude from the surface of the plunger and is therefore interpreted as a flat portion; see Figure 3b; Para [0037]) corresponding to the tab of the lumen (Ref 23) and offset from the support cylinder (Ref 50); where the tab is positioned against the flat portion to prevent rotational movement of the plunger within the support ring (Ref 23, 52a; Para [0037]; where the interaction of Ref 23, 52a allows the plunger Ref 12 to translation with rotation of the handle Ref 18 instead of rotate and therefore the interaction of Ref 23, 52a is interpreted as preventing rotational movement of the plunger within the support ring).
Guillot discloses that the at least one tab is on the inner surface of the lumen of the support ring and the at least one flat portion (i.e. flat recess) is on the plunger instead of the tab being on the plunger extending from the pressure pad offset from the support cylinder and the flat portion being on the inner surface of the lumen of the support ring.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the at least one tab to be on the plunger extending from the pressure pad and offset from the support cylinder and to modify the at least one flat portion to be on the inner surface of the lumen of the support ring, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Where one of ordinary skill in the art at the time the invention was made would recognize that such a modification would have yielded predictable results, namely, allowing the plunger and support ring to be engaged in such a way that prevents rotational movement of the plunger within the support ring, while allowing the plunger to translation with rotational movement of the handle.
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 11-16 and 20-24 have been considered but are moot in view of the new ground of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Akerfeldt et al (US 2004/0122469), Zhu (US20210145454), LI (CN207627367).- handle is operably connected to the pressure pad by a spring
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN L COLELLO whose telephone number is (571)270-3212. The examiner can normally be reached Mondays 8-5pm, Tuesday-Thursdays 10-2pm.
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/ERIN L COLELLO/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771