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 .
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-4, 9-10, 12, 15-16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0239631 A1 to Sattig et al. (hereinafter “Sattig”) (cited in an IDS dated 12/06/2024).
Regarding claim 1, Sattig discloses (see abstract; Figs. 1-13; and [0011]-[0136]) a fluid applicator comprising: a main housing (2/3) comprising a first end (near #9, Fig. 2) and a second end (near #3, Fig. 1) opposite to the first end, the main housing extending along a longitudinal axis defined between the first end and the second end (see Fig. 1), wherein the main housing defines an applicator outlet (connection of 8 to 9) disposed at the first end; a first cylinder (10) disposed within the main housing and comprising a first seal (17, Fig. 4) for holding a first fluid; a second cylinder (10) spaced apart from the first cylinder and disposed within the main housing (see Fig. 3), the second cylinder comprising a second seal (17) for holding a second fluid different from the first fluid (see [0017]); a mixing chamber (13) housing disposed within the main housing and spaced apart from each of the first cylinder and the second cylinder along the longitudinal axis (see Fig. 3); a first piercing element (14) substantially aligned with the first seal along the longitudinal axis and disposed between the mixing chamber housing and the first cylinder (see Figs. 3-4 & 10-13), the first piercing element comprising a first cylindrical base (shown in Fig. 13, portion attached to #12 that doesn't include lateral slots per [0134]) connected to the mixing chamber housing and extending towards the first cylinder (see Figs. 3-4 & 10-13 and [0132]), a first tip spaced apart from the mixing chamber housing and disposed proximal to the first seal (see Figs. 3-4 & 10-13), and a plurality of first walls (defined by the lateral slots in the needle around the circumference of the needle as shown in Fig. 13 and as per [0134]) extending from the first cylindrical base obliquely along the longitudinal axis, the plurality of first walls being angularly spaced apart from each other at the first cylindrical base and converging towards each other to intersect at the first tip (see Fig. 13); a second piercing element (14) substantially aligned with the second seal along the longitudinal axis and disposed between the mixing chamber housing and the second cylinder (see Figs. 3-4 & 10-13), the second piercing element comprising a second cylindrical base (shown in Fig. 13, portion attached to #12 that doesn't include lateral slots as per [0134]) connected to the mixing chamber housing and extending towards the second cylinder (see Figs. 3-4 & 10-13 and [0132]), a second tip spaced apart from the mixing chamber housing and disposed proximal to the second seal (see Figs. 3-4 & 10-13), and a plurality of second walls (defined by the lateral slots in the needle around the circumference of the needle as shown in Fig. 13 and as per [0134]) extending from the second cylindrical base obliquely along the longitudinal axis, the plurality of second walls being angularly spaced apart from each other at the second cylindrical base and converging towards each other to intersect at the second tip (see Fig. 13); and a nozzle (9/interior of 13) connected to the mixing chamber housing opposite to each of the first piercing element and the second piercing element, the nozzle extending from the mixing chamber housing to the applicator outlet, wherein the nozzle and the mixing chamber housing define a mixing chamber cavity (see [0096]/[0125]; wherein, upon application of a force at the second end of the main housing (see [0092]): the first tip engages and pierces the first seal into a plurality of first flaps corresponding to the plurality of first walls (the shape of the needle along with the lateral slots as per [0134] when penetrating through a septum will result in forming a plurality of flaps in the septum), thereby creating a first fluid path between the first cylinder and the mixing chamber cavity, wherein the first fluid flows through the first fluid path from the first cylinder to the mixing chamber cavity (see [0093]/[0096]/[0125]); and the second tip engages and pierces the second seal into a plurality of second flaps corresponding to the plurality of second walls (the shape of the needle along with the lateral slots as per [0134] when penetrating through a septum will result in forming a plurality of flaps in the septum), thereby creating a second fluid path between the second cylinder and the mixing chamber cavity, wherein the second fluid flows through the second fluid path from the second cylinder to the mixing chamber cavity (see [0093]/[0096]/[0125]).
Regarding claim 1, Sattig fails to explicitly disclose wherein at least 85% of a total volume of the first cylinder is filled with the first fluid, wherein at least 85% of a total volume of the second cylinder is filled with the second fluid, and with respect to claim 2, wherein a first viscosity of the first fluid is different from a second viscosity of the second fluid, and claim 3 wherein a ratio between the second viscosity of the second fluid and the first viscosity of the first fluid is greater than or equal to 2. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sattig's fluid applicator to be filled at least 85% with fluids having differing viscosities as claimed because one of ordinary skill would understand based on the disclosure of Sattig that Sattig's ampoules are fully capable of being filled at any level from 1-100% by volume (and that it is commonly understood to fill chambers with fluids at a level of higher than 85% in order to be "substantially filled"), and further that the ampoules are capable of being used with different liquids (see [0017]) having differing viscosities because the ampoules can be used with a variety of liquids known in the surgical art as needed for a particular case and can certainly be used with two different fluids having viscosities vary by a ratio greater than or equal to 2.
Sattig further discloses, with respect to claim 4, wherein: the plurality of first walls is three first walls and the plurality of first flaps is three first flaps corresponding to the three first walls; and the plurality of second walls is three second walls and the plurality of second flaps is three second flaps corresponding to the three second walls (see Fig. 13, there appear to be three lateral slots in each needle 14 which are spaced equally around the circumference of the needle, this corresponds to three raised walls in the needle and will result in three flaps formed when the needle is inserted into the septum).
Sattig further discloses, with respect to claim 9, wherein the nozzle further comprises: a nozzle body (8) in fluid communication with the mixing chamber cavity; a static mixer disposed inside the nozzle body (paddle - see [0020]/[0084]); and a nozzle tip (distal end of 8) defining a nozzle outlet for dispensing at least one of the first and second fluids from the nozzle, the nozzle tip connected to and extending from the nozzle body, wherein the nozzle outlet has a substantially circular cross-section (see Figs. 1/2 & 10).
Sattig further discloses, with respect to claim 10, wherein the main housing comprises a capture well adjacent the applicator outlet (see Fig. 9, near bottom), such that a portion of at least one of the first and second fluids which flows from the nozzle outlet is trapped within the capture well (fluid can accumulate in this portion prior to entering manifold 13's fluid pathway).
With respect to claim 12, Sattig doesn't specifically disclose wherein the applicator outlet has a substantially rectangular cross-section or an elliptical cross-section, however, it has been held that a mere change in shape is a matter of choice which a person of ordinary skill in the art would find obvious absent evidence that the particular shape is significant (see In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) and MPEP 2144.04(IV)(B)) - Applicant's specification does not establish that a rectangular or elliptical cross-section provides any benefit or criticality or significance to the applicator outlet as compared to a circular cross-section, therefore, the mere change in shape would be obvious to one of ordinary skill in the art because there is no evidence that the rectangular/elliptical shape is significant or would function differently.
With respect to claim 15, Sattig doesn't specifically disclose wherein a ratio between an applicator exit area of the applicator outlet and a nozzle exit area of the nozzle outlet is greater than or equal to about 5 and less than or equal to about 20, however, it would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to have modified Sattig's device to have the claimed ratio as a matter of mere design choice since Applicant has not disclosed that the claimed ratio of applicator exit area to nozzle exit area provides an advantage, is used for a particular purpose, or solves a stated problem (see page 18, lines 11-15 of the spec. as filed). One of ordinary skill in the art, furthermore, would have expected Sattig's applicator, and Applicant's invention, to perform equally well with either the unspecified ratio implied in Sattig's device or the claimed ratio because both options would still perform the same function of dispensing the mixed fluids out the end of the applicator. Therefore, it would have been prima facie obvious to modify Sattig to obtain the invention specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over Sattig.
Sattig further discloses, with respect to claim 16, wherein the main housing further comprises an outlet interface (9) proximal to the applicator outlet, and wherein the nozzle tip is configured to be coupled to the outlet interface (see Fig. 2 and [0086])
Sattig further discloses, with respect to claims 19-20, wherein the plurality of first and second walls are substantially triangular (see Fig. 13).
Allowable Subject Matter
Claims 5-6, 7-8, 11, 13-14, and 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: Sattig is considered the closest prior art of record, however, there is no apparent reason or motivation to modify Sattig as set forth in the various dependent claims below. Further, no other prior art of record teaches or suggests the various dependent claims below in combination with the features of independent claim 1.
Re: claims 5-6, Sattig fails to teach or suggest a flow restrictor on the nozzle in the location and configuration claimed along with the mixing through aperture pathway claimed.
Re: claims 7-8, Sattig fails to teach or suggest a nozzle gasket forming a sealing contact as claimed.
Re: claim 11, while Sattig’s device presumably could retain some unspecified amount of fluid trapped in the capture well, there is no motivation to arrive at the claimed amounts, and criticality is provided in Applicant’s spec. at page 10, lines 5-14.
Re: claims 13-14, Sattig does not specify a maximum outlet width and maximum thickness in the ratio as claimed and there is no motivation to arrive at the claimed ratio, and criticality is provided in Applicant’s spec. at page 10, lines 16-25.
Re: claims 17-18, Sattig does not disclose a fluid separator in the location and orientation as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892 Notice of References cited for additional relevant prior art disclosing dual chamber fluid applicators.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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