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 .
Election/Restrictions
Applicant’s election with traverse of Group I drawn to claims 1-6 and 17-20 and Species A drawn to FIGS 1, 2, 11A, and 11B in the reply filed on 06/16/2025 is acknowledged. The traversal is on the grounds that “The search associated with the non-elected invention would likely extend into the same search areas as those associated with the elected invention.” This is not found persuasive because the method specifically requires promoting hemostasis at a puncture site formed in a first blood vessel and does not require some structural limitations of the device such as “a heat generating substance that generates heat by reacting with a first fluid and a first injection starting mechanism for starting injection of the first fluid into the first housing portion, and the cooling portion has a section housing portion housing a heat absorbing substance that absorbs heat by reacting with a second fluid and a second injection starting mechanism for starting injection of the second fluid into the second housing portion (Claim 10). Furthermore, the device with the heating and cooling portions can be used in a method that is not for promoting hemostasis but can be used for treating sprained or strained muscles or increasing blood flow to warm up muscles (Bowen US5545197A).
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
A complete action on the merits of claims 1-6 and 17-20 follows below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2020, 02/12/2021, 03/29/2023, and 07/10/2023 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 17-20 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.
Claim 1 recites the limitations “the first blood vessel and/or a peripheral blood vessel of the first vessel” in lines 5 and 8. It is unclear if the claim requires either or both blood vessels.
Claim 1 recites the limitations “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in lines 7 and 10. It is unclear if the claim requires either or both blood vessels.
Claims 2-6 are rejected due to their dependency on rejected claim 1 .
Claim 2 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in line 4 and 6. It is unclear if the claim requires either or both blood vessels.
Claim 3 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in lines 2 and 6 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in lines 4 and 7. It is unclear if the claim requires either or both blood vessels.
Claim 4 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in line 2 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in line 4. It is unclear if the claim requires either or both blood vessels.
Claim 5 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in line 2 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in line 4. It is unclear if the claim requires either or both blood vessels.
Claim 6 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in line 2 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in lines 4 , 6, and 7. It is unclear if the claim requires either or both blood vessels.
Claim 17 recites the limitation Claim 6 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in lines 9, 10, and 15, and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in lines 12, 14, and 16. It is unclear if the claim requires either or both blood vessels.
Furthermore, the claim recites applying heat ….and/or ..applying cooling in lines 8, 11, and 20. It is unclear if the claim requires either or both heating and cooling.
Claims 18-20 are rejected due to their dependency on rejected claim 17.
Claim 19 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in line 3 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in line 5. It is unclear if the claim requires either or both blood vessels.
Claim 20 recites “the first blood vessel and/or a peripheral blood vessel of the first vessel” in lines 3, and 6 and “the second blood vessel and/or a peripheral blood vessel of the second blood vessel” in lines 4 and 8. It is unclear if the claim requires either or both blood vessels.
Claim Rejections - 35 USC § 102
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) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fortson (2015/0327871).
Regarding claim 1, Fortson teaches a hemostasis promoting method for promoting hemostasis at a puncture site formed in a first blood vessel ([0007] systems and methods for applying targeted force to a radial access puncture site to provide hemostasis and closure of the site), the first blood vessel and a second blood vessel branching from a blood vessel in a limb and extending parallel to each other (Fig 1C the site of the puncture site includes a first vessel and parallel to it exits the second blood vessel), the hemostasis promoting method comprising:
making a temperature of a body surface around the first blood vessel and/or a peripheral blood vessel of the first blood vessel higher than a temperature of a body surface around the second blood vessel and/or a peripheral blood vessel of the second blood vessel such that the temperature of the first blood vessel and/or the peripheral blood vessel of the first blood vessel is higher than the temperature of the second blood vessel and/or the peripheral blood vessel of the second blood vessel (Paragraph [0026] discusses providing a heating pack within the cuff device to provide thermal therapy at the puncture site and accelerate hemostasis. It is the position of the Examiner that the puncture site will have a higher temperature than the temperature at the second blood vessel that is parallel to the first blood vessel).
Regarding claim 2, Fortson teaches the limitations of claim 1 as previously rejected above. Fortson teaches wherein the making of the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel higher than the temperature of the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel comprises: i) heating the body surface around the first blood vessel and/or the peripheral blood vessel [0026] ; or ii) cooling the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel.
Claim Rejections - 35 USC § 103
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) 3-4, 6, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson (2015/0327871) in view of Edwards (WO 98/46144).
Regarding claim 3, Fortson teaches the limitations of claim 1 as previously rejected above and wherein the making of the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel higher than the temperature of the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel comprises; i) heating the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel [0026].
While Fortson provides heating or cooling the puncture site, it is silent about specifically teaching cooling the body surface round the second blood vessel and/or the peripheral blood vessel of the second blood vessel.
However, Edwards teaches a method within the same field of invention (A hemostasis device and method is provide for closing wounds…the device may be used to close puncture wounds to blood vessels [Abstract] wherein the method includes both heating and cooling of the body surface where the vessels are located (page 12 lines 23-26 By using a multicompartment inflatable bladder and described above, it is also possible to heat and/or cool different regions of tissue underneath the multiple compartment inflatable bladder to different degrees).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide for both heating and cooling so that different temperatures can be applied to different regions on the body surface as desired to accelerate hemostasis or protect the tissue surrounding the puncture site.
Regarding claim 4, Fortson in view of Edwards teaches the limitations of claim 3 as previously rejected above. Fortson teaches wherein the making of the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel higher than the temperature of the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel comprises heating the body surface around a portion of the first blood vessel that is positioned more to an upstream side of the first blood vessel than the puncture site (Fig 1D illustrates an indicia that represents the puncture site; the inflatable balloon 104 and thermal fluid however encompasses a greater area that is more to an upstream side of the first blood vessel than the puncture site).
Regarding claim 6, Fortson teaches the limitations of claim 1 as previously rejected above. Fortson teaches wherein the making of the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel higher than the temperature of the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel comprises cooling the body surface [0026].
While Fortson generally provides for cooling and cooling to a range of 10°C to 27°C it is silent about specifically teaching cooling the body surface around the second blood vessel and/or peripheral blood vessel of the second blood vessel.
However, Edwards teaches a method within the same field of invention (A hemostasis device and method is provide for closing wounds…the device may be used to close puncture wounds to blood vessels [Abstract] wherein the method includes both heating and cooling of the body surface where the vessels are located (page 12 lines 23-26 By using a multicompartment inflatable bladder and described above, it is also possible to heat and/or cool different regions of tissue underneath the multiple compartment inflatable bladder to different degrees).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide for both heating and cooling so that different temperatures can be applied to different regions on the body surface and cooling the second blood vessel for the purpose of accelerating hemostasis or protecting the tissue surrounding the puncture site.
Regarding claim 17, Fortson teaches a hemostasis promoting method for promoting hemostasis at a puncture site formed in a first blood vessel of a limb of a living body, the first blood vessel and a second vessel branching from a blood vessel in the limb and extending parallel to one another ([0007] systems and methods for applying targeted force to a radial access puncture site to provide hemostasis and closure of the site… Fig 1C the site of the puncture site includes a first vessel and parallel to it exits the second blood vessel), the hemostasis promoting method comprising:
positioning a limb mount on the limb of the patient adjacent the puncture site so that the limb mount encircles the limb of the living body (Fig 1A-1D);
after positioning of the limb mount on the limb of the living body adjacent the puncture site: i) applying heat to the body surface of the limb around the first blood vessel and/or a peripheral blood vessel of the first blood vessel to increase a temperature of the body surface around the first blood vessel and/or a peripheral blood vessel of the first blood vessel (Paragraph [0026] discusses providing a heating pack within the cuff device to provide thermal therapy at the puncture site and accelerate hemostasis);
the applying of the heat and/or the applying of the cooling being accomplished by a part on the limb mount (cuff device 102)
While Forston provides heating or cooling the puncture site, it is silent about specifically teaching and applying cooling to the body surface of the limb around the second blood vessel and/or a peripheral blood vessel of the second blood vessel to decrease the temperature of the body surface around the second blood vessel and/or a peripheral blood vessel of the second blood vessel so that the temperature of the first blood vessel and/or the peripheral blood vessel of the first blood vessel is greater than the temperature of the second blood vessel and/or the peripheral blood vessel of the second blood vessel to thus cause a volume of blood flow in the first blood vessel to be increased and an amount of a blood coagulation factor in the first blood vessel to be increased so that hemostasis on the puncture site is promoted.
However, Edwards teaches a method within the same field of invention (A hemostasis device and method is provide for closing wounds…the device may be used to close puncture wounds to blood vessels [Abstract] wherein the method includes both heating and cooling of the body surface where the vessels are located (page 12 lines 23-26 By using a multicompartment inflatable bladder and described above, it is also possible to heat and/or cool different regions of tissue underneath the multiple compartment inflatable bladder to different degrees).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to provide for both heating and cooling so that different temperatures can be applied to different regions on the body surface as desired to accelerate hemostasis or protect the tissue surrounding the puncture site.
Regarding claim 18, Fortson in view of Edwards teaches the limitations of claim 17 as previously rejected above. Fortson teaches wherein the positioning of the limb mount on the limb of the living body comprises positioning a tubular member on the limb of the living body (cuff 102).
Regarding claim 19, Fortson in view of Edwards teaches the limitations of claim 17 as previously rejected above. Fortson teaches wherein the part on the limb mount is a heater fixed to the limb mount to apply the heat to the body surface of the limb around the first blood vessel and/or the peripheral blood vessel of the first blood vessel ([0026] heating the inflation fluid, a separate heating fluid, a heating pack, etc.).
While Fortson teaches a cooler (ice or cooling pack) Edwards provides for both heater and cooler on the part on the limb mount (page 12 lines 23-26).
Regarding claim 20, Fortson in view of Edwards teaches the limitations of claim 20 as previously rejected above. Fortson teaches wherein the applying of the heat to the body surface of the limb around the first blood vessel and/or a peripheral blood vessel of the first blood vessel and/or applying of the cooling to the body surface of the limb around the second blood vessel and/or a peripheral blood vessel of the second blood vessel includes applying both the heat to the body surface of the limb around the first blood vessel and/or a peripheral blood vessel of the first blood vessel and the cooling to the body surface of the limb around the second blood vessel and/or a peripheral blood vessel of the second blood vessel (see rejection of claim 3) .
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson (2015/0327871).
Regarding claim 5, Fortson teaches the limitations of claim 1 as previously rejected above and teaches wherein the making of the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel higher than the temperature of the body surface around the second blood vessel and/or the peripheral blood vessel of the second blood vessel comprises heating the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel [0026].
Fortson does not specifically teach to increase the temperature of the body surface around the first blood vessel and/or the peripheral blood vessel of the first blood vessel to a range of 33°C to 37°C.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for the claimed range of heating since Fortson provides the heating provides for hemostasis and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233(MPEP 2144.05 (II-A)).
Conclusion
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794