FINAL 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 second office action on the merits. This office action is in response to the amendment filed on 06/18/2026. Applicant has amended claims 1, 5, 8, 14-17, and 30 and canceled claims 4 and 6. Claims 1-3, 5, 7-17, 21, 30, and 34-35 are pending and being examined.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, line 1: “the actuator” is believed to be in error for --the vibrational actuator-- (see claim 1, lines 5-6)
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 1-3, 5, 7-12, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pic (US 2019/0232030 A1).
Regarding claim 1, Pic teaches (Figs. 1 and 4) a method of applying a therapeutic powder (54 – Fig. 4. See also Title: “methods for delivering powdered agents”), the method comprising:
positioning an outlet (26 – Fig. 4) of a powder applicator (10 – Fig. 1) containing the therapeutic powder (54) below a powder storage chamber (16 – Fig. 4) of the powder applicator (10) relative to a local direction of gravity (down direction of Fig. 4);
vibrationally agitating the therapeutic powder (54) – (¶ [0031], ll. 1-6) in response to activating a vibrational actuator (comprising weight 72, which is spun by a suitable actuator such as a motor – see ¶ [0036], ll. 4-6);
dispensing at least a portion of the therapeutic powder (54) through the outlet (26) of the powder applicator (10) under an influence of gravity when the vibrational actuator (72) is activated – (¶ [0030], ll. 10-11: “gravity may assist with moving powdered agent 54 down from powder chamber 16”); and
stopping the dispensing of the therapeutic powder (54) through the outlet (26) in response to deactivating the vibrational actuator (72) – (inherent in actuator 72 – see ¶ [0036], ll. 2-3: “Weight 72 may be configured to move when it is desired that powdered agent 54 be delivered”. Therefore, when weight 72 is deactivated, the dispensing of therapeutic powder 54 through outlet 26 is stopped).
Regarding claim 2, Pic teaches the invention as claimed and as discussed above for claim 1, and Pic further teaches (Figs. 1 and 4) positioning the outlet (26 – Fig. 4) of the powder applicator (10 – Fig. 1) above a target delivery site (junction 55 – Fig. 4, which connects to catheter 18 as shown in Fig. 1).
Regarding claim 3, Pic teaches the invention as claimed and as discussed above for claim 1, and Pic further teaches (Fig. 4) agitating the therapeutic powder (54) includes rotating an eccentric load (¶ [0036], ll. 8-11: “Weight 72 may spin on a rotational axis 73. Weight 72, and due to its eccentricity, may agitate mixing chamber 70, powder chamber 16, or another component of chassis 12 and/or apparatus 10”).
Regarding claim 5, Pic teaches the invention as claimed and as discussed above for claim 1, and Pic further teaches (Fig. 4) the actuator (72) is contained within an outer casing (16) of the powder applicator (10 – Fig. 1) – (note that ¶ [0035], ll. 4-7 teaches: “Weight 72 may be mounted on, within, or near any component of apparatus 10, such as powder chamber 16, mixing chamber 70, and/or another portion of chassis 12”).
Regarding claim 7, Pic teaches the invention as claimed and as discussed above for claim 1, and Pic further teaches (Fig. 4) the therapeutic powder (54) is a hemostatic powder (¶ [0020], ll. 10-11: “the powdered agent may include a hemostatic powder”).
Regarding claim 8, Pic teaches (Figs. 1 and 4) a vibrational powder applicator (10 – Fig. 1) comprising:
a powder storage chamber (16 – Fig. 4);
a therapeutic powder (54 – Fig. 4. See also Title: “methods for delivering powdered agents) disposed within the powder storage chamber (16);
an actuator (comprising weight 72, which is spun by a suitable actuator such as a motor – see ¶ [0036], ll. 4-6) operatively coupled to the powder storage chamber (16) – (as shown in Fig. 4) and configured to vibrationally agitate the therapeutic powder (54) when activated (¶ [0031], ll. 1-6); and
an outlet (26 – Fig. 4) in fluid communication (via passage 52) with the powder storage chamber (16),
wherein the actuator (72) and the outlet (26) are configured such that vibrational agitation by the actuator (72) when the actuator (72) is activated causes the therapeutic powder (54) to flow out from the outlet (26) under an influence of gravity (¶ [0030], ll. 10-11: “gravity may assist with moving powdered agent 54 down from powder chamber 16”), and wherein the actuator (72) and the outlet (26) are configured such that the flow of the therapeutic powder (54) out from the outlet (26) is configured to stop when the actuator (72) is deactivated (inherent in actuator 72 – see ¶ [0036], ll. 2-3: “Weight 72 may be configured to move when it is desired that powdered agent 54 be delivered”. Therefore, when weight 72 is deactivated, the dispensing of therapeutic powder 54 through outlet 26 is stopped).
Regarding claim 9, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the therapeutic powder (54) is a hemostatic powder (¶ [0020], ll. 10-11: “the powdered agent may include a hemostatic powder”).
Regarding claim 10, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the powder storage chamber (16) and the outlet (26) are configured such that the therapeutic powder (54) moves from the powder storage chamber (16) toward the outlet (26) when the therapeutic powder (54) is vibrationally agitated by the actuator (72) – (as discussed in ¶ [0031], ll. 12-14).
Regarding claim 11, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the actuator (72) includes a motor (¶ [0036], ll. 4-6: “Any suitable actuator (not shown), such as a motor, turbine, or other suitable rotational drive, may spin weight 72”) coupled to an eccentric load(¶ [0036], ll. 9-11: “Weight 72, and due to its eccentricity, may agitate mixing chamber 70, powder chamber 16, or another component of chassis 12 and/or apparatus 10”).
Regarding claim 12, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the actuator (72) is contained within an outer casing (16) of the powder applicator (10 – Fig. 1) – (note that ¶ [0035], ll. 4-7 teaches: “Weight 72 may be mounted on, within, or near any component of apparatus 10, such as powder chamber 16, mixing chamber 70, and/or another portion of chassis 12”).
Regarding claim 15, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the vibrational powder applicator (as shown in Fig. 4) includes a proximal end (Fig. 4: top side of 16) and a distal end (Fig. 4: bottom side of 52), wherein the outlet (26) is positioned on a distal portion (bottom side) of the vibrational powder applicator (as shown in Fig. 4, outlet 26 is on the bottom side of the figure), and wherein the actuator (72) is disposed proximally (in the up direction) relative to a distal portion (bottom portion) of the powder storage chamber (16). Note that ¶ [0035], ll. 4-7 teaches: “Weight 72 may be mounted on, within, or near any component of apparatus 10, such as powder chamber 16, mixing chamber 70, and/or another portion of chassis 12”.
Regarding claim 16, Pic teaches the invention as claimed and as discussed above for claim 8, and Pic further teaches (Fig. 4) the vibrational powder applicator (as shown in Fig. 4) includes a proximal end (Fig. 4: top side of 16) and a distal end (Fig. 4: bottom side of 52), wherein the outlet (26) is positioned on a distal portion (bottom side) of the vibrational powder applicator (as shown in Fig. 4, outlet 26 is on the bottom side of the figure), and wherein the actuator (72) is disposed distally (in the down direction) relative to a proximal portion (top portion) of the powder storage chamber (16). Note that ¶ [0035], ll. 4-7 teaches: “Weight 72 may be mounted on, within, or near any component of apparatus 10, such as powder chamber 16, mixing chamber 70, and/or another portion of chassis 12”.
Claims 17 and 21 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 (see annotated figure on next page) 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,
wherein the actuator (20) and the outlet are configured such that vibrational agitation by the actuator (20) when the actuator (20) is activated causes the powder (14) to flow out from the outlet under an influence of gravity (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”), and wherein the actuator (20) and the outlet are configured such that the flow of the powder (14) out from the outlet is configured to stop when the actuator (20) is deactivated (inherent in actuator 20 – see col. 5, ll. 63-65: “The vibrator 20 vibrates the powder so that it flows evenly through the metering valve 16 when the valve plate 18 is open”. Therefore, deactivating vibrator 20 would stop the dispensing of powder 14 through the outlet).
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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”).
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 30 and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Pic (US 2019/0232030 A1 - referred to as "Pic '030"), in view of Pic (US 2021/0275157 A1 - referred to as "Pic '157").
Regarding claim 30, Pic ‘030 teaches (Figs. 1 and 4) a vibrational powder applicator (10 – Fig. 1) comprising:
a powder storage chamber (16 – Fig. 4) configured to contain a powder (54 – Fig. 4. See also Title: “methods for delivering powdered agents);
an actuator (comprising weight 72, which is spun by a suitable actuator such as a motor – see ¶ [0036], ll. 4-6) operatively coupled to the powder storage chamber (16) – (as shown in Fig. 4) and configured to vibrationally agitate the powder (54) when activated (¶ [0031], ll. 1-6); and
an outlet (26 – Fig. 4) in fluid communication (via passage 52) with the powder storage chamber (16),
wherein the actuator (72) and the outlet (26) are configured such that vibrational agitation by the actuator (72) when the actuator (72) is activated causes the therapeutic powder (54) to flow out from the outlet (26) under an influence of gravity (¶ [0030], ll. 10-11: “gravity may assist with moving powdered agent 54 down from powder chamber 16”), and wherein the actuator (72) and the outlet (26) are configured such that the flow of the therapeutic powder (54) out from the outlet (26) is configured to stop when the actuator (72) is deactivated (inherent in actuator 72 – see ¶ [0036], ll. 2-3: “Weight 72 may be configured to move when it is desired that powdered agent 54 be delivered”. Therefore, when weight 72 is deactivated, the dispensing of therapeutic powder 54 through outlet 26 is stopped).
However, Pic ‘030 does not teach a valve disposed between the powder storage chamber and the outlet, the valve configured to selectively permit or prevent flow of the powder from the powder storage chamber to the outlet.
Pic ‘157 teaches (Figs. 4A-4B) a similar powder applicator (400) comprising a powder storage chamber (404), a powder (102), and an outlet (114), and further teaches:
a valve (460) disposed between the powder storage chamber (404) and the outlet (114), the valve (460) configured to selectively permit or prevent flow of the powder (102) from the powder storage chamber (404) to the outlet (114) – (Fig. 4B shows valve 460 permitting flow of powder 102, whereas Fig. 4A shows valve 460 preventing flow of powder 102).
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 Pic ‘030 by including a valve disposed between the powder storage chamber and the outlet, the valve configured to selectively permit or prevent flow of the powder from the powder storage chamber to the outlet, in order to bar the powder from entering a chamber between the powder storage chamber and the outlet, thereby facilitating depressurization of said chamber, which may prevent or minimize clogging of the powder in the outlet, as taught by Pic ‘157 (¶ [0077], ll. 8-14).
Regarding claim 34, Pic ‘030, in view of Pic ‘157, teaches the invention as claimed and as discussed above for claim 30, and the combination further teaches (Pic ‘157, Figs. 4A-4B) the valve (460) comprises a selectively moveable gate (as shown by the two-headed arrow in Figs. 4A-4B).
Regarding claim 35, Pic ‘030, in view of Pic ‘157, teaches the invention as claimed and as discussed above for claim 34, and the combination further teaches (Pic ‘157, Figs. 4A-4B) the selectively moveable gate (Pic ‘157, 460) is configured to control the flow of the powder (Pic ‘030, 54) – (Pic ‘157, ¶ [0077], ll. 1-4: “Following a delivery of a desired amount of agent 102, slider 460 may be transitioned from the second configuration to the first configuration, stopping a flow of agent 102 through outlet 114”).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pic (US 2019/0232030 A1), in view of Goodman (US 2020/0061310 A1: IDS reference).
Regarding claim 13, Pic 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 Pic 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, Pic, in view of Goodman as discussed so far, 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 further 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 Pic, in view of Goodman as discussed so far, 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.
Response to Arguments
Applicant’s arguments regarding the new limitations in claims 1, 8, and 30 have been considered but are moot in view of the new ground(s) of rejection, necessitated by Applicant's amendments. To the extent possible, Applicant's arguments have been addressed in the body of the rejections at the appropriate locations.
Applicant’s arguments regarding the prior art rejection of claim 17 have been fully considered but are not persuasive.
Regarding Applicant’s argument (pg. 10 of REMARKS) that “although a vibrator 20 is present in Baldwin, the arrangement of Baldwin relies on the movement of the sliding plate 18 to regulate the flow of powder therethrough. Therefore, Baldin does not disclose dispensing powder from the outlet under the influence of gravity in response to activation of a vibrational agitator and stopping the flow of powder from the outlet in response to deactivation of the vibrational actuator”, this is not persuasive because Baldwin also relies upon vibrator 20 to regulate the flow of powder therethrough. This is evident in the following excerpts of Baldwin (underlined for emphasis):
col. 5, ll. 15-17: “A vibrator 20 is provided on the valve 16 to assist in the flow of the powder therethrough”.
col. 5, ll. 63-65: “The vibrator 20 vibrates the powder so that it flows evenly through the metering valve 16 when the valve plate 18 is open”.
Thus, it is evident to a person of ordinary skill in the art that vibrator 20 is needed to assist in the flow of the powder through valve 16 when it is in the open position. If vibrator 20 were turned off, the powder would not be fluidized enough to flow through valve 16 when it is in the open position.
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.
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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