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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/4/26 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, lines 14-15, “has correspondingly conically shaped” should recite “has a correspondingly conically shaped”.
Regarding claim 1, line 18, “inner cannular” should recite “inner cannula”
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.
Claims 1 and 3-21 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 1, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1, 19, and 20, “their longitudinal extension” appears indefinite and atypical for accepted claim language. For clarity, the Examiner suggests amending the claims to “a longitudinal extension of the inner cannula and the outer cannula”.
Regarding claims 1, 19, and 20, the Examiner has noticed that the disclosure appears to only have one of the clamping inserts connected to both cannulas. The claim can be interpreted as each of the clamping inserts attaching to both the inner and outer cannulas. Clarification is requested. The Examiner potentially suggests particularly claiming each of the first and second clamping insert with one attached to both cannulas and the other attached to only the inner cannula since this is what appears to be disclosed in figure 5 of the instant application.
Regarding claim 1, line 7, “adapted to receiving means” appears grammatically incorrect and should likely recite “adapted as receiving means”.
Regarding claim 1, line 18, it is unclear whether the “receiving means” is referring back to the receiving means of line 8.
Regarding claim 4, “the gap or a ring gap” appears indefinite. It is unclear whether the claim is further limiting “the gap” of claim 1 or if it is introducing an additional “a ring gap”.
Regarding claim 8, “for supplying compressed air or inert gas” has already been introduced in claim 1 and should recite “for supplying the compressed air or inert gas” unless this is an additional set of that component.
Regarding claim 10, “for compressed air” should recite “for the compressed air” as it is already recited in claim 1.
Claim 11 recites the limitation "the side" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 19, lines 8-11, “clamping inserts…of the inner cannula for the media and of the outer cannula for the compressed air in the form of hollow needles”, it is unclear whether the hollow needles are further limiting the inner and outer cannula or the clamping inserts. Clarification is requested. The Examiner suggests amending the claim to “…for the compressed air, the inner cannula and the outer cannula in the form of hollow needles, which are provided…”
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, 5, 8, 10-12, and 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wachs (6,478,238).
Regarding claim 1, Wachs discloses a device (fig. 2D) for spraying or applying a medium (via 172) using an auxiliary gas in the form of compressed air or inert gas under pressure (capable of via passage 170) of medical products or vessels (capable of), the device comprising:
a two-substance nozzle formed from an inner cannula (item 100) and of an outer cannula (item 104 or 122) inserted one in the other (see figure 4), with substantially constant diameter along their longitudinal extension (see figure 4);
a nozzle body (item 92) formed as a holding means for the two-substance nozzle, which has at least in each case an inlet (items 94, 98) for the medium and for the auxiliary gas; and
clamping inserts (items 124) at the nozzle body, the clamping inserts adapted to receiving means are arranged for a sealingly holding and fixedly holding of the inner cannula and of the outer cannula (see figure 2A, it is noted that inner cannula is sealed with both 5 and 6 of instant application but outer cannula is only sealed through first clamping insert 5, this is the same configuration of Wachs), wherein the clamping inserts are provided for attaching the inner canula and the outer cannula inserted one in the other with the formation of a predefined gap between inner cannula and outer cannula (see figure 2A), and wherein the clamping inserts have a conically tapered shape (see figure 2A, items 124 all are conically formed on the outside) and the nozzle body has correspondingly conically shaped receiving means with a continuously inclined and threadless conical inner surface of the nozzle body and a continuously inclined and threadless corresponding conical surface of the clamping inserts at least in portions for forming a clamping connection and receiving means for said inner and outer cannula (see figure 2A, conical sections of 124 match conical sections of 94, 96, etc.).
Claim 19 is substantially taught by Wachs.
Claim 20 is substantially taught by Wachs additionally teaching a threaded clamp cap that abuts one of the clamping inserts and threads onto the nozzle body (item 130).
Regarding claim 5, Wachs further discloses wherein at least one of the clamping inserts is fixedly held by means of a threaded clamp cap (item 130) at the nozzle body.
Regarding claim 8, Wachs further discloses wherein a hollow space (item 102) is provided in the nozzle body for supplying compressed air or inert gas into the two-substance nozzle.
Regarding claim 10, Wachs further discloses wherein at the nozzle body in relation to the longitudinal direction of the inner cannula and the outer cannula, a laterally arranged connections for compressed air is provided (item 98 is laterally arranged).
Regarding claim 11, Wachs further discloses wherein a clamp cap on the side of the inner and the outer cannulas is outside conically tapered (threads are tapered).
Regarding claim 12, Wachs further discloses wherein the clamping inserts are adapted for centering the inner and the outer cannula of the two-substance nozzle in relation to a middle axis of the nozzle body (cap of Wachs finishes assembly which the total assembly allows for a centered configuration).
Regarding claim 17, Wachs further discloses wherein an air guide element or flow directing element (item 146 or any structural component in the body allows for guiding or directing flow) for compressed air or an inert gas under pressure is provided in the nozzle body.
Regarding claim 18, Tan further discloses a first clamping insert (item 246) has an opening or bore (opening of 246) which corresponds at least section wise to an outer diameter of the outer cannula (see figure 4, opening of 246 matches outer diameter of cannula 200), wherein a second clamping insert (item 320) has an opening or bore (opening of 320), the diameter of which is different from the diameter of the first receiving means (see figure 4, they have different internal diameters) and corresponds at least section wise to an outer diameter of the inner cannular (noting at 310 diameter matches inner cannula) and wherein the bores are arranged concentrically in relation to a common middle axis (see figure 4).
Regarding claim 21, Wachs further discloses a first threaded clamp cap (item 130) and a second threaded clamp cap (item 140) that abuts a second one of the clamping inserts and threads onto the nozzle body (see figure 2A).
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, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wachs (6,478,238).
Regarding claims 3, 4, and 9, Wachs discloses the structure of the system but fails to specify the exact wall thickness dimensions or gap dimensions.
Applicant has disclosed no criticality for the claimed dimensions.
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to have a wall thickness of 20% to 30% of the diameter of the inner diameter of the cannulas and the gap has a dimension of less than 6% of the diameter of the inner cannula, and thin walled in the range of wall thicknesses between .1mm and .5 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is flow rate which achieves the recognized result of different spray characteristics, therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980). It is noted that adjusting the inner versus outer flow rate by adjusting the diameters/thickness of the cannulas will result in distinct spray for the intended use. If more aerosolization was required, then more of the outer flow area should be increased and vice versa.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wachs (6,478,238) in view of Tan (5,884,846).
Regarding claim 6, Wachs fails to teach wherein the inner and outer cannula are arranged at a front-end discharge end aligned or flush with one another.
Tan teaches a similar system wherein the front ends of the cannulas are flush with one another.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to adjust the outlet/mixing section as taught by Tan to the system of Wachs, the motivation being this allows for a particular mixing of fluids with distinct Reynolds vs. laminar flows or mixing coefficients.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wachs (6,478,238) in view of Cairo (2007/0246575).
Regarding claims 15 and 16, Wachs fails to disclose the clamping insert and holding caps are held at the nozzle by a resilient spring, bayonet lock, or a latch snap lock and by means of a flanging, crimping, or bonding.
Cairo teaches a similar system in the same field of endeavor that teaches that crimping, clamping, snap fits, as well as many other attachment features could be used to attach tube portions to housing (par. 33).
The substitution of one known element (resilient spring, bayonet, latching snap lock, flanging, crimping, or bonding) as taught by Cairo for another (swaged connection) as taught by Wachs would have been obvious to one of ordinary skill in the art at the filing date of the invention since the substitution would have yielded predictable results, namely, a known attachment means within the art.
Allowable Subject Matter
Claims 7, 13, and 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX M VALVIS whose telephone number is (571)272-4233. The examiner can normally be reached 9:00-5:00 M-F.
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ALEX M. VALVIS
Supervisory Patent Examiner
Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791
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