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 .
This is the first office action on the merits in response to the above identified patent application filed on 09/28/2023. Claims 1-17, 21, 30, and 34-35 are pending and being examined.
Claim Objections
Claims 1 and 14-16 are objected to because of the following informalities:
Claim 1, line 2: “a therapeutic powder” is believed to be in error for --the therapeutic powder-- (see claim 1, line 1)
Claim 14, lines 1-2: “a diameter of the therapeutic powder” is believed to refer to the same diameter of the therapeutic powder in claim 13, and should therefore be changed to --the diameter of the therapeutic powder--
Claim 15, lines 1 and 2: “the applicator” (two instances) is believed to be in error for --the vibrational powder applicator-- (see claim 8, line 1)
Claim 16, lines 1 and 2: “the applicator” (two instances) is believed to be in error for --the vibrational powder applicator-- (see claim 8, line 1)
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.
Claims 1-12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kubo (US 2013/0218072 A1: IDS reference).
Regarding claim 1, Kubo teaches (Fig. 1) A method of applying a therapeutic powder (Abstract, l. 5: “powder such as medical agents”), the method comprising:
positioning an outlet (3B) of a powder applicator (1) containing a therapeutic powder below a powder storage chamber (2) of the powder applicator (1) relative to a local direction of gravity (down direction of Fig. 1);
vibrationally agitating the therapeutic powder (via eccentric rotor 31 – see ¶ [0054], ll. 1-4: “Once the eccentric rotor 31 is rotated, vibrations start to occur…the vibrations are applied to the powder container 2”); and
dispensing at least a portion of the therapeutic powder through the outlet (3B) of the powder applicator (1) – (¶ [0051], ll. 13-18: “the powder…passes through the tube 18 to be sprayed out from the connector 3B”).
Regarding claim 2, Kubo teaches the invention as claimed and as discussed above for claim 1, and Kubo further teaches (Fig. 1) positioning the outlet (3B) of the powder applicator (1) above a target delivery site (¶ [0019], ll. 5-6: “to spray powder directly to the lesion from this connector 3B as necessary”).
Regarding claim 3, Kubo teaches the invention as claimed and as discussed above for claim 1, and Kubo further teaches (Fig. 1) agitating the therapeutic powder includes rotating an eccentric load (Abstract, ll. 11-12: “vibrations are applied to the main body and the powder container by a rotation of the eccentric rotor”).
Regarding claim 4, Kubo teaches the invention as claimed and as discussed above for claim 1, and Kubo further teaches (Fig. 1) agitating the therapeutic powder includes activating an actuator (switching valve 15 in combination with eccentric rotor 31 – as discussed in ¶ [0041]).
Regarding claim 5, Kubo teaches the invention as claimed and as discussed above for claim 4, and Kubo further teaches (Fig. 1) the actuator (15 and 31) is contained within an outer casing (outline of 1) of the powder applicator (1) – (as shown in Fig. 1, actuator components 15 and 31 are contained within the outline of main body 1).
Regarding claim 6, Kubo teaches the invention as claimed and as discussed above for claim 4, and Kubo further teaches (Fig. 1) deactivating the actuator (15 and 31) to stop dispensing the therapeutic powder (as discussed in ¶ [0041], when valve 15 is in the closed position, the supply of pressurized gas P to the powder container 2 and the eccentric rotor 31 is stopped, thereby preventing dispensing of powder).
Regarding claim 7, Kubo teaches the invention as claimed and as discussed above for claim 1, and Kubo further teaches (Fig. 1) the therapeutic powder is a hemostatic powder (¶ [0016], ll. 3-4: “a powder container 2 containing powder such as hemostatic agents”).
Regarding claim 8, Kubo teaches (Fig. 1) a vibrational powder applicator (1) comprising:
a powder storage chamber (2);
a therapeutic powder (Abstract, l. 5: “powder such as medical agents”) disposed within the powder storage chamber (2);
an actuator (switching valve 15 in combination with eccentric rotor 31 – as discussed in ¶ [0041]) operatively coupled (via support member 7 and cylinder portion 8 – see ¶ [0021], ll. 6-7) to the powder storage chamber (2) and configured to vibrationally agitate the therapeutic powder when activated (¶ [0054], ll. 1-4: “Once the eccentric rotor 31 is rotated, vibrations start to occur…the vibrations are applied to the powder container 2”); and
an outlet (3B) in fluid communication (via elements 18, 21, 23, and 24) with the powder storage chamber (2).
Regarding claim 9, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the therapeutic powder is a hemostatic powder (¶ [0016], ll. 3-4: “a powder container 2 containing powder such as hemostatic agents”).
Regarding claim 10, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the powder storage chamber (2) and the outlet (3B) are configured such that the therapeutic powder moves from the powder storage chamber (2) toward the outlet (3B) when the therapeutic powder is vibrationally agitated by the actuator (15 and 31) – (¶ [0054]: “Once the eccentric rotor 31 is rotated, vibrations start to occur…When the powder container 2 is vibrated…the powder is securely sucked in toward the channel 21 by the Venturi effect and supplied thereto to be sprayed onto the patient's lesion”).
Regarding claim 11, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the actuator (31) includes a motor (¶ [0062]: “the rotation drive means that rotates the above eccentric rotor 31…can be a motor drive as a matter of course”) coupled to an eccentric load (eccentric rotor 31).
Regarding claim 12, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the actuator (15 and 31) is contained within an outer casing (outline of 1) of the powder applicator (1) – (as shown in Fig. 1, actuator components 15 and 31 are contained within the outline of main body 1).
Regarding claim 15, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the applicator (1) includes a proximal end (Fig. 1: right side of 1) and a distal end (Fig. 1: left side of 1), wherein the outlet (3B) is positioned on a distal portion (left side) of the applicator (as shown in Fig. 1, outlet 3B is on the left side of 1), and wherein the actuator (31) is disposed proximally relative to a distal portion (bottom portion of 2) of the powder storage chamber (2) – (as shown in Fig. 1, actuator 31 is disposed close to the bottom portion of 2).
Regarding claim 16, Kubo teaches the invention as claimed and as discussed above for claim 8, and Kubo further teaches (Fig. 1) the applicator (1) includes a proximal end (Fig. 1: right side of 1) and a distal end (Fig. 1: left side of 1), wherein the outlet (3B) is positioned on a distal portion (left side) of the applicator (as shown in Fig. 1, outlet 3B is on the left side of 1), and wherein the actuator (31) is disposed distally relative to a proximal portion (top portion of 2) of the powder storage chamber (2) – (as shown in Fig. 1, actuator 31 is disposed far from the top portion of 2).
Claims 17, 21, 30, and 34-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldwin (US 4,016,894).
Regarding claim 17, Baldwin teaches (single figure) a vibrational powder applicator comprising:
a powder storage chamber (12) configured to contain a powder (14);
an actuator (vibrator 20) operatively coupled to the powder storage chamber (12) and configured to vibrationally agitate the powder (14) when activated (col. 5, ll. 15-17: “A vibrator 20 is provided on the valve 16 to assist in the flow of the powder therethrough”);
an outlet (30) in fluid communication with the powder storage chamber (12); and
a flow restrictor (dispersing cone 28) disposed between the powder storage chamber (12) and the outlet (30).
Regarding claim 21, Baldwin teaches the invention as claimed and as discussed above for claim 17, and Baldwin further teaches (single figure) the flow restrictor (28) comprises a body (cone 28) that forms one or more gaps (gaps are spaced by supports 29) between an interior surface of a housing (27) of the vibrational powder applicator and the body (28), wherein the one or more gaps are configured such that the powder (14) flows through the one or more gaps when the actuator (20) is activated (col. 5, ll. 63-65: “The vibrator 20 vibrates the powder so that it flows evenly through the metering valve 16”; col. 6, ll. 1-4: “ As the powder falls through the valve 16, it strikes the apex of the dispersing cone 28 and is dispersed substantially uniformly around the entire cone”).
Regarding claim 30, Baldwin teaches (single figure) a vibrational powder applicator comprising:
a powder storage chamber (12) configured to contain a powder (14);
an actuator (vibrator 20) operatively coupled to the powder storage chamber (12) and configured to vibrationally agitate the powder (14) when activated (col. 5, ll. 15-17: “A vibrator 20 is provided on the valve 16 to assist in the flow of the powder therethrough”);
an outlet (30) in fluid communication with the powder storage chamber (12); and
a valve (16, which comprises slidable valve plate 18) disposed between the powder storage chamber (12) and the outlet (30), the valve (16) configured to selectively permit or prevent flow of the powder (14) from the powder storage chamber (12) to the outlet (30) – (col. 5, ll. 66-67: “The valve plate 18 is open to permit the powder to flow therethrough”).
Regarding claim 34, Baldwin teaches the invention as claimed and as discussed above for claim 30, and Baldwin further teaches (single figure) the valve (16) comprises a selectively moveable gate (18).
Regarding claim 35, Baldwin teaches the invention as claimed and as discussed above for claim 34, and Baldwin further teaches (single figure) the selectively moveable gate (18) is configured to control the flow of the powder (14) – (col. 5, ll. 17-19: “A metering valve 16 having a slidable valve plate 18 is positioned in the hopper outlet to meter the powder therefrom”).
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.
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.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo (US 2013/0218072 A1: IDS reference), in view of Goodman (US 2020/0061310 A1: IDS reference).
Regarding claim 13, Kubo teaches the invention as claimed and as discussed above for claim 8, except for a diameter of the therapeutic powder is greater than or equal to 100 μm and less than or equal to 1000 μm.
Goodman teaches (Fig. 23) a powder applicator (23) for delivering hemostatic powder (Title), and teaches various diameters of the hemostatic powder, such as 0.05 mm, 0.1 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.5 mm (note that 0.5 mm = 500 μm, which is greater than or equal to 100 μm and less than or equal to 1000 μm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kubo such that a diameter of the therapeutic powder is greater than or equal to 100 μm and less than or equal to 1000 μm, because it has been held under the “obvious to try” provision, that choosing from a finite number of identified, predictable solutions (in this case, to choose between various particle sizes for a hemostatic powder), with a reasonable expectation of success (in this case, to select a specific particle size based on the desired fineness for rapid solubility) was an obvious extension of prior art teachings. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I)(E).
Examiner further notes that the type of powder being used in the vibrational powder applicator (in this case, a therapeutic powder having a diameter greater than or equal to 100 μm and less than or equal to 1000 μm) is an intended use recitation – “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims”, In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935); see MPEP 2115. In this case, the therapeutic powder is considered the material or article worked upon and does not impart patentability to the claims, since the recitation of the therapeutic powder having a diameter greater than or equal to 100 μm and less than or equal to 1000 μm is merely the material that the vibrational powder applicator works upon in its intended use.
Regarding claim 14, Kubo teaches the invention as claimed and as discussed above for claim 13, except for a diameter of the therapeutic powder is greater than or equal to 500 μm and less than or equal to 1000 μm.
Goodman teaches (Fig. 23) a powder applicator (23) for delivering hemostatic powder (Title), and teaches various diameters of the hemostatic powder, such as 0.05 mm, 0.1 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.3 mm, 0.35 mm, 0.5 mm (note that 0.5 mm = 500 μm, which is greater than or equal to 500 μm and less than or equal to 1000 μm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Kubo such that a diameter of the therapeutic powder is greater than or equal to 500 μm and less than or equal to 1000 μm, because it has been held under the “obvious to try” provision, that choosing from a finite number of identified, predictable solutions (in this case, to choose between various particle sizes for a hemostatic powder), with a reasonable expectation of success (in this case, to select a specific particle size based on the desired fineness for rapid solubility) was an obvious extension of prior art teachings. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I)(E).
Examiner further notes that the type of powder being used in the vibrational powder applicator (in this case, a therapeutic powder having a diameter greater than or equal to 500 μm and less than or equal to 1000 μm) is an intended use recitation – “inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims”, In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935); see MPEP 2115. In this case, the therapeutic powder is considered the material or article worked upon and does not impart patentability to the claims, since the recitation of the therapeutic powder having a diameter greater than or equal to 500 μm and less than or equal to 1000 μm is merely the material that the vibrational powder applicator works upon in its intended use.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see also attached form PTO-892 “Notice of References Cited”.
Haas (US 6,257,456 B1): Figs. 1-2 teaches a vibrational powder applicator comprising:
a powder storage chamber (2 – Fig. 1, 17 – Fig. 2) configured to contain a powder;
an actuator (vibrator 6 – Fig. 1) operatively coupled to the powder storage chamber (2, 17) and configured to vibrationally agitate the powder when activated (col. 3, ll. 32-36);
an outlet (4) in fluid communication with the powder storage chamber (2, 17); and
a flow restrictor (spherical sealing body 27) disposed between the powder storage chamber (2, 17) and the outlet (4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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