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 .
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1- 14, drawn to a combined powder and liquid delivery device.
Group II, claim(s) 15- 17, drawn to a powder vial assembly.
Group III, claim(s) 18- 20, drawn to a combined powder and liquid delivery device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
1. Group I and Group II lack unity of invention because the groups do not share the same or corresponding technical feature.
Invention 1 in claim 1 is directed at a combined powder and liquid delivery device. The technical effect can be construed as to provide a device which is adapted to guide powder as well as liquid separated from each other to a bodily tissue. The problem solved by these technical features can be construed as to provide an improved device for performing sealing of tissue and/or controlling bleeding.
Invention 2 in claim 15 is directed at a vial for storing powder. The technical effect can be construed as to provide a vial for powder having a housing and a dispensing opening within the housing. The problem solved by these technical features can be construed as to pressurize powder inside the vial housing in direction of a powder dispensing opening in this housing.
As the technical problems are different, the different technical features cannot be considered as being “corresponding special technical features.”
As the claims of Group I and Group II comprise neither the same, nor corresponding special technical features, the technical relationship between the subject-matter of the claims is lacking and the claims are not so linked as to form a single general inventive concept in the sense of Rule 13.1 PCT.
Thus, the common matter cannot constitute a single general inventive concept linking together claims 1- 14 and claims 15- 17. Therefore, the application does not fulfill the requirement for unity of invention.
2. Group I and Group III lack unity of invention because even though the inventions of these groups require the technical feature of powder and liquid delivery device with a delivery housing with powder and liquid chamber, an applicator tip with delivery channels for both liquid and powder, inlet ports for powder and liquid and a delivery system for liquid, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Nipro Corp (WO 2013/183476 A1 - - cited in the IDS filed 7/09/24).
Nipro discloses a combined powder and liquid delivery device (1000) (Figs. 1- 2) comprising:
a delivery device housing having a powder chamber (68) (Figs. 3- 10, 15, 17, 19, 21, 23) and a liquid chamber (98) (Figs. 2, 5- 8, 16, 18, 20, 22, 24), wherein said powder and liquid chambers (68, 98) are isolated from one another (See Fig. 6);
an applicator tip (63, 61) (Fig. 1) having a powder delivery channel (T15) extending between a proximal end and a distal end of said applicator tip (63, 61) that is in fluid communication with said powder chamber (68) (See Fig. 6);
said applicator tip (63, 61) having a liquid delivery channel (T18) that extends from the proximal end to the distal end of said applicator tip (63, 61) that is in fluid communication with said liquid chamber (98) (See Fig. 6);
a powder inlet port (33) (Figs. 3- 4, 7- 9, 15, 17, 19, 21, 23) in fluid communication with said powder chamber (68);
a liquid inlet port (43) (Figs. 3- 6, 15, 17, 19, 21, 23) in fluid communication with said liquid chamber (98);
a liquid delivery system (200) (Figs. 1- 2, 5- 8, 16, 18, 20, 22, 24) in fluid communication with said liquid inlet port (43), said liquid chamber (98), and said liquid delivery channel (200).
3. Group II and Group III lack unity of invention because even though the inventions of these groups require the technical feature of a powder vial assembly, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Ilan et al. (US Pub. No. 2016/0074579 A1 - - cited in the IDS filed 7/09/24).
Ilan discloses a powder vial assembly (30) (Fig. 2) (P. [0057] - - FIG. 2 shows an addition 30 to a medical applicator 10 configured for providing a mixture of a gas and a powdered component to the medical applicator. The addition 30 comprising a turbulating unit 35 configured for mixing gas, such as a medical gas, with a powder stored in a vial 5. The turbulating unit 35 includes an inlet port 37a (shown in FIG. 3) connectable to the exterior source, such as a gas tank (not shown), and an outlet port 37b connectable to the lumen inlet 25 of the medical applicator 10).
During a telephone conversation with David Crichton on 11/04/25 a provisional election was made without traverse to prosecute the invention of Group I, claims 1- 14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15- 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Drawings
The drawings have been received on 4/11/24 and these drawings have been objected to under 37 CFR 1.84 for the following reasons:
Regarding Figs. 2- 8, 11- 17, 19- 22, 24- 26, 27B- 30 and 36A- 36B, lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the reasons stated above. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 7 is objected to because of the following informalities: lines 2- 3 “being in fluid communication with powder delivery system” should be amended - -being in fluid communication with said powder delivery system - - to correct an apparent typographical error. Appropriate correction is required.
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 2- 5 and 8- 14 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.
Regarding claim 2, it is not clear whether “a powder vial” and “a liquid vial” has been positively recited in the claim.
Claim 2 recites “The combined powder and liquid delivery device as claimed in claim 1, further comprising: a powder vial connector secured to said delivery device housing, said powder vial including said powder inlet port” in lines 1- 3. It is not clear whether applicant intended to introduce a powder vial such that the claim would recite - - a powder vial connector secured to said delivery device housing, [[said]] a powder vial including said powder inlet port - - or whether applicant intended to refer back to the introduced powder vial connector such that the claim would recite - - a powder vial connector secured to said delivery device housing, said powder vial connector including said powder inlet port - - . For the purposes of examination, claim 2 is interpreted as reciting - - a powder vial connector secured to said delivery device housing, said powder vial connector including said powder inlet port - - .
Claims 3- 5 and 8- 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 2.
Claim 2 recites “The combined powder and liquid delivery device as claimed in claim 1, further comprising: a powder vial connector secured to said delivery device housing, said powder vial including said powder inlet port; a liquid vial connector secured to said delivery device housing, said liquid vial including said liquid inlet port” in lines 1- 5. It is not clear whether applicant intended to introduce a liquid vial such that the claim would recite - - a liquid vial connector secured to said delivery device housing, [[said]] a liquid vial including said liquid inlet port - - or whether applicant intended to refer back to the introduced liquid vial connector such that the claim would recite - - a liquid vial connector secured to said delivery device housing, said liquid vial connector including said liquid inlet port - - . For the purposes of examination, claim 2 is interpreted as reciting - - a liquid vial connector secured to said delivery device housing, said liquid vial connector including said powder inlet port - - .
It is noted that claim 2 includes limitations written in the alternative:
“optionally, the combined powder and liquid delivery device further comprising:
a powder vial coupled with said powder vial connector, wherein said powder vial has an opening that is in fluid communication with powder inlet port;
a liquid vial coupled with said liquid vial connector, wherein said liquid vial has an opening that is in fluid communication with said liquid inlet port.”
As such, there exists a claimed embodiment that does NOT positively recite “a powder vial” and “a liquid vial,” given the above 35 U.S. C. 112(b) rejections of claim 2 above.
Claim 3 recites the limitation "said powder vial" in line 2. There is insufficient antecedent basis for this limitation in the claim. See the rejection of claim 2 above.
Claims 4- 5 and 8- 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 3.
Claim 3 recites the limitation "said liquid vial" in line 3. There is insufficient antecedent basis for this limitation in the claim. See the rejection of claim 2 above.
Claims 4- 5 and 8- 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 3.
Claim 4 recites the limitation "said powder vial" in line 4. There is insufficient antecedent basis for this limitation in the claim. See the rejection of claim 2 above.
Claims 8 and 11- 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 4.
Claim 5 recites the limitation "said liquid vial" in line 4. There is insufficient antecedent basis for this limitation in the claim. See the rejection of claim 2 above.
Claims 9- 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 4.
Claim 10 recites the limitation "said liquid vial" in line 3. There is insufficient antecedent basis for this limitation in the claim. See the rejection of claim 2 above.
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- 6 and 8- 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nipro Corp (WO 2013/183476 A1). Nipro Corp is cited in the IDS filed 7/09/24.
Regarding claim 1, Nipro discloses a combined powder and liquid delivery device (1000) (Figs. 1- 2) comprising:
a delivery device housing (100) (Figs. 1- 4, 15- 24) having a powder chamber (68) (Figs. 3- 10, 15, 17, 19, 21, 23) and a liquid chamber (98) (Figs. 2, 5- 8, 16, 18, 20, 22, 24), wherein said powder and liquid chambers (68, 98) are isolated from one another (See Fig. 6);
an applicator tip (63, 61) (Fig. 1) having a powder delivery channel (T15) extending between a proximal end and a distal end of said applicator tip (63, 61) that is in fluid communication with said powder chamber (68) (See Fig. 6);
said applicator tip (63, 61) having a liquid delivery channel (T18) that extends from the proximal end to the distal end of said applicator tip (63, 61) that is in fluid communication with said liquid chamber (98) (See Fig. 6);
a powder inlet port (33) (Figs. 3- 4, 7- 9, 15, 17, 19, 21, 23) in fluid communication with said powder chamber (68);
a liquid inlet port (43) (Figs. 3- 6, 15, 17, 19, 21, 23) in fluid communication with said liquid chamber (98);
a powder delivery system (50) (Figs. 3- 6) in fluid communication with said powder inlet port (33), said powder chamber (68), and said powder delivery channel (T15);
a liquid delivery system (200) (Figs. 1- 2, 5- 8, 16, 18, 20, 22, 24) in fluid communication with said liquid inlet port (43), said liquid chamber (98), and said liquid delivery channel (T18).
Regarding claim 2 in view of the rejection under 35 U.S.C. 112(b) above, Nipro further discloses further comprising:
a powder vial connector (30) (Figs. 1- 9, 15- 24) secured to said delivery device housing (100), said powder vial connector (30) including said powder inlet port (33);
a liquid vial connector (40) (Figs. 1- 9, 15- 24) secured to said delivery device housing (100), said liquid vial including said liquid inlet port (43). It is noted that following limitations regarding “a powder vial” and “a liquid vial” are written in the alternative and are not required by claim 2.
Regarding claim 3 in view of the rejection under 35 U.S.C. 112(b) above, Nipro further discloses further comprising:
a powder (310) (Figs. 15, 17, 19, 21, 23) disposed inside said powder vial (300) (Figs. 1- 2, 15- 24); and
a liquid (410) (Figs. 15, 17, 19, 21, 23) disposed inside said liquid vial (400) (Figs. 1- 2, 15- 24). It is noted that “a powder vial” and “a liquid vial” have not been positively recited in the claim. It is noted that following limitations regarding “a hemostatic powder” and “an activation liquid” are written in the alternative and are not required by claim 3.
Regarding claim 4 in view of the rejection under 35 U.S.C. 112(b) above, Nipro further discloses wherein said powder delivery system (50) is moveable between a depressed configuration (Figs. 15, 16, 19, 20, 21, 22) and an extended configuration (Figs. 17, 18), wherein when moving from the depressed configuration (Figs. 15, 16, 19, 20, 21, 22) to the extended configuration (Figs. 17, 18) said powder delivery system (50) generates a vacuum within said powder chamber (68) for drawing a dose of powder from said powder vial (300) into said powder chamber (68) (See Figs. 17, 19 - - showing powder 310, 320 falling due to action of gravity in a vacuum), and wherein when moving from the extended configuration (Figs. 17, 18) to the depressed configuration (Figs. 15, 16, 19, 20, 21, 22) said powder delivery system (50) generates positive pressure within said powder chamber (68) for expressing said dose of powder from said powder chamber (68) and forcing said powder (310, 320) to flow into said powder delivery channel (T15) (See Fig. 21 - - showing compressed air positive pressure ejecting powder 310, 320). It is noted that “said powder vial” has not been positively recited in the claim.
Regarding claim 5 in view of the rejection under 35 U.S.C. 112(b) above, Nipro further discloses wherein said liquid delivery system (200) is moveable between a depressed configuration (Figs. 15, 16, 19, 20, 21, 22, 23, 24) and an extended configuration (Figs. 17, 18), wherein when moving from the depressed configuration (Figs. 15, 16, 19, 20, 21, 22, 23, 24) to the extended configuration (Figs. 17, 18) said liquid delivery system (200) generates a vacuum within said liquid chamber (98) for drawing a dose of liquid (410) from said liquid vial (400) into said liquid chamber (98) (See Fig. 18 - - showing plunger direction DR11 generating negative pressure in liquid chamber), and wherein when moving from the extended configuration (Figs. 17, 18) to the depressed configuration (Figs. 15, 16, 19, 20, 21, 22, 23, 24) said liquid delivery system (200) generates positive pressure within said liquid chamber (98) for expressing said dose of liquid (420) from said liquid chamber (98) and forcing said liquid (420) to flow into said liquid delivery channel (T16, T18) (See Fig. 23 - - showing compressed air supplied from tube 11, T11 as positive pressure liquid compressed air). It is noted that “said liquid vial” has not been positively recited in the claim.
Regarding claim 6, Nipro further discloses further comprising a dual-lumen powder and liquid connector (100- opening for applicator tip (63, 61) in distal face of housing 100) (See Fig. 1) secured to the distal end of said applicator tip (63, 61), wherein said dual-lumen powder and liquid connector (100- opening for applicator tip (63, 61) in distal face of housing 100) (See Fig. 1) has a powder exit opening in fluid communication with said powder delivery channel (T15), and a liquid spray opening in fluid communication with said liquid delivery channel (T18), optionally, said powder exit opening and said liquid spray opening being staggered from one another wherein said liquid spray opening is located downstream of said powder exit opening for preventing moisture in said liquid delivery channel (T18) from entering said powder delivery channel (T15) (See Fig. 15 - - showing liquid spray opening 61 portion of applicator tip (63, 61) located downstream of powder exit opening 63 portion of applicator tip (63, 61)).
Regarding claim 8, Nipro further discloses wherein said powder delivery system (50) further comprises a first air inlet (66L) (Fig. 13 - -connected to T14) in fluid communication with said powder chamber (68) and a one-way valve (78L) (Fig. 13) disposed in said first air inlet (66L) that enables ambient air to be drawn into said powder chamber (68) as said powder delivery system (50) moves from the depressed configuration (Figs. 15, 16, 19, 20, 21, 22, 23, 24) to the extended configuration (Figs. 17, 18) (See Figs. 13, 21 - - showing the first compressed air introduction part 66L (see FIG. 13) is inserted into the valve member 78L (the state shown in FIG. 13 is obtained)).
Regarding claim 9, Nipro further discloses wherein said liquid delivery system (200) further comprising a second air inlet (66R) (Fig. 13 - - connected to T16) in fluid communication with said liquid chamber (98) (opening 62 communicates with liquid chamber via opening portion 61 of applicator nozzle (63, 61)) and a one-way valve (78R) (Fig. 13) disposed in said second air inlet (66R) that enables ambient air to be drawn into said liquid chamber (98) as said liquid delivery system (200) moves from the depressed configuration (Figs. 15, 16, 19, 20, 21, 22, 23, 24) to the extended configuration (Figs. 17, 18) (See Figs. 13, 21 - - showing the first compressed air introduction part 66R (see FIG. 13) is inserted into the valve member 78R (the state shown in FIG. 13 is obtained)).
Regarding claim 10 in view of the rejection under 35 U.S.C. 112(b) above, Nipro further discloses wherein said liquid delivery system (200) further comprises a first one way valve (96) (Figs. 2, 5- 6) disposed within said liquid inlet port (43) that enables the liquid (410) to be drawn from said liquid vial (400) into said liquid chamber (98) of said delivery device housing (100), and a second one way valve (92) (Figs. 2, 5- 6) disposed within said liquid delivery channel (T18) and downstream of said first one way valve (96) disposed within in said liquid inlet port (43) that enables the liquid (410) in said liquid chamber (98) to flow downstream into said liquid delivery channel (T18) (See Fig. 6).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to correct the claim informality set forth in this Office action and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 11- 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, further comprising a one-way valve located downstream of said powder chamber and being in fluid communication with powder delivery system, optionally, said one-way valve being disposed within said powder delivery channel and is located between said powder chamber and the proximal end of said applicator tip.
The closest cited prior art reference Nipro Corp (WO 2013/183476 A1) teaches a one-way valve (78L) (Fig. 13) located upstream of said powder chamber and being in fluid communication with powder delivery system (See Figs. 13, 21 - - showing the first compressed air introduction part 66L (see FIG. 13) is inserted into the valve member 78L (the state shown in FIG. 13 is obtained)), but Nipro does not teach or suggest, alone or in combination, further comprising a one-way valve located downstream of said powder chamber and being in fluid communication with powder delivery system, optionally, said one-way valve being disposed within said powder delivery channel and is located between said powder chamber and the proximal end of said applicator tip.
Regarding claim 11, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein said powder delivery system comprises a bellows assembly having threads for releasably securing said bellows assembly to a proximal end of said delivery device housing, wherein said bellows assembly is configured for being unscrewed from said delivery device housing for enabling powder to be loaded into said powder chamber, optionally, the proximal end of said delivery device housing having an access opening for providing access to said powder chamber wherein said access opening has internal threads that are configured to mesh with the threads of said bellows assembly for securing said bellows assembly to the proximal end of said delivery device housing.
Trexler et al. (US Pub. No. 2021/0402106 A1) teaches a powder delivery system (100) comprising a bellows assembly (120) having threads (121) for releasably securing said bellows assembly (120) to a proximal end of said delivery device housing (102), wherein said bellows assembly (120) is configured for being unscrewed from said delivery device housing (102) for enabling powder (112) to be loaded into said powder chamber (110) (Figs. 1, 4A- 6, 9A- 11) (P. [0053] - - an operating/medical room gas supply or a gas canister may be fluidly connected to the applicator by an associated tubing 120a or other appropriate connection in fluid communication with the first gas inlet 121 of the applicator … The tubing may be attached to the first gas inlet by any suitable connection including … a threaded connection). However, Trexler teaches a powder delivery device by itself. Since modifying the combined powder and liquid delivery device associated with Nipro to include a bellows assembly taught by Trexler would require significantly altering the mode of operation of the Nipro device, a person having ordinary skill in the art would not have made the combination without using improper hindsight reasoning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771