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 § 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.
The term “preferentially” in claim 23 is a relative term which renders the claim indefinite. The term “preferentially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear from the claim whether or not the outer fluid must always wet a surface of the chamber or not. The term should be removed or the claim amended sufficiently for clarity of scope.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim sets forth that the article has an “eccentricity parameter (E) of less than 1 when a longitudinal axis of the needle is within 45 degrees of a line perpendicular to gravity for at least one period of time.” However, there is no disclosure of how the eccentricity parameter is derived. The term is simply stated in lines 18-20 without any reference or equation as to how one of ordinary skill in the art would derive the value from the provided fluids. The disclosure goes on to describe timescale of eccentricity as another variable, but fails to relate this to the general eccentricity parameter. The drawings depict how the two fluids might appear with different eccentricity values in Figures 10A-10C, but still fails to provide any information as to how one would derive such a value. It is understood that the eccentricity of two fluids, as depicted, would be a function of their densities, miscibility, and solubility. There is no clear definition of the term in the disclosure and it therefore lacks written description support as one of ordinary skill in the art would not understand, from the disclosure, how to calculate such a value.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 sets forth that the inner fluid, the outer fluid and the interior surface of the needle have a spreading coefficient greater than or equal to zero. However page 9 sets forth one spreading coefficient equation taking into account the three relative surface tension values, but page 10 sets forth equation 3 which uses a measurement of the cos(ϴon(i)) in some embodiments. Therefore, it is unclear from the disclosure which embodiments use equation 1 or equation 3 for the spreading coefficient calculation. Therefore, it would be impossible for one of ordinary skill in the art to read claim 14 and understand what values to use or what measurements are required to derive the claimed spreading coefficient as it claims multiple, different derivations without clear guidance for which is being claimed. The scope of the claim is therefore unable to be reasonably derived until it is clarified.
Claim Objections
Claim 14 is objected to because of the following informalities: the claim uses the variable Son(i) rather than defining the spreading coefficient in the claim. The claim should be amended to replace the variable with the term “spreading coefficient” and its derivation as set forth on pages 10 of the specification as filed to make it clear that the coefficient is a function of the surface tension between the inner and outer fluid, the surface tension between the needle and inner fluid. Similarly, for claim 21, the variable should be replaced with “…the needle comprising a texture, formed from squares with side lengths a, and nearest neighbor spacings b; wherein the surface solid fraction is less than or equal to 0.5.” The claim is not clear that the surface fraction is a texture derived from square features and their spacing without referring back to the disclosure, which only has support for square features. It is beneficial to the reader, and for purposes of clarity of scope, to clearly define the structural features in the claims rather than using only equation values which require readers to refer back to the disclosure to understand the scope of the limitation, even if it is sufficiently supported. Appropriate correction is required.
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) 1-2, 4-5, 10-13, 15-17, 19, 23, and 33-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scribben et al. (US 2014/0324022).
Regarding claims 1 and 2, Scribben et al. (henceforth Scribben) discloses an article for delivery of a fluid comprising: a chamber (barrel 210, Figure 2); a needle (160, Figure 1) fluidically connected to the chamber (Figure 1); an inner fluid (220) extending from the chamber into the needle and flowing through the needle (¶ [0102] discloses the core annular flow happens in the needle as well as in the barrel); and an outer fluid (230) extending from the chamber into the needle (¶ [0102]), axially surrounding the inner fluid (Figure 2), and flowing through the needle (¶ [0102], the core annular flow happens in the needle); wherein the outer fluid mixes with the inner fluid at most 50% while in the needle (¶ [0113] states that the two fluids may be immiscible and therefore will mix less than 50% as claimed).
Regarding claim 4, Scribben further discloses that the outer fluid and inner fluid are soluble in the other in an amount of more than 0.001 mass fraction (¶ [0113] discloses that the fluids may be miscible which denotes a high mutual solubility which would exceed 0.001 mass fraction as claimed).
Regarding claim 5, Scribben discloses the device as above for claim 1 and further teaches wherein the article has an eccentricity parameter (E) of less than 1 when a longitudinal axis of the needle is within 45 degrees of a line perpendicular to gravity for at least one period of time (this is understood as a functional limitation and the device of Scribben is considered fully capable of performing this function; the disclosure fails to provide sufficient evidence as to how or why this function happens as a result of fluid properties or the like; for this reason, the claim is being given its broadest reasonable interpretation in view of the disclosure; Scribben depicts the two fluids, in a concentric axial relationship in Figure 2. Scribben further describes that the high-viscosity formulation 220 does not contact the sidewall 216 of the barrel in ¶ [0099], and ¶ [0098] describes the outer fluid 230 as an “annulus” having an annular shape around the high-viscosity fluid; this disclosure is considered sufficient to teach that the high-viscosity fluid is substantially coaxial with the annuls formed by the lower-viscosity fluid throughout use which would produce the claimed eccentricity parameter).
Regarding claim 10, Scribben further discloses wherein the outer fluid is a Newtonian fluid (¶ [0112] discloses that the low-viscosity outer fluid can be water).
Regarding claim 11, Scribben further discloses wherein the outer fluid is a yield stress fluid (¶ [0105] discloses that the outer fluid may exhibit non-Newtonian behaviors and could be a lubricant with a yield stress greater than what can be overcome by buoyancy forces; Newtonian fluids are generally modeled as having zero yield stress so the disclosure of a lubricant with a yield stress which is non-Newtonian in function is considered to meet the limitation).
Regarding claims 12 and 13, Scribben further discloses that a ratio of the viscosity of the inner fluid to the viscosity of the outer fluid is greater than 1 or 10 (¶ [0014] discloses that the ratio can be from about 1-1000).
Regarding claims 15-16, Scribben further discloses wherein a capillary number of the inner fluid is greater than or equal to 0.01 and a capillary number of the outer fluid is greater than or equal to 0.001. Scribben, as above, describes core annular flow of the fluid through the device. According to the instant disclosure (Figure 11, page 21, line 18-page 22, line 8) core annular flow exists when the outer fluid has a capillary number from approximately 0.005-0.01 and the inner fluid has a capillary number of 0.1-0.45 (orders of magnitude larger than the outer fluid as per claim 16). Because Scribben explicitly describes the flow through the device as core annular flow, it must necessarily use inner and outer fluids having the claimed range of capillary numbers or else the core annular flow would not be present. The instant disclosure uses these values as a means for establishing core annular flow and since it is described by Scribben, it is considered to anticipate these ranges as currently claimed as inherently present, even if not explicitly described (i.e., the presence of core annular flow in Scribben requires the claimed capillary number values to be present).
Regarding claim 17, Scribben further discloses wherein the interior surface of the needle comprises a texture (all needles have a texture of some sort on their inner surface as no material is perfectly smooth).
Regarding claim 19, Scribben further discloses wherein the interior surface of the needle comprises a coating (¶ [0032] discloses that the interior surface of the needle may be “coated” by the low-viscosity fluid).
Regarding claim 23, Scribben further discloses wherein the outer fluid wets an interior surface of the chamber (the low-viscosity outer fluid is described as water-based, saline, or an oil such as safflower oil; all of these substances will “wet” the chamber to some extent as some adhesive forces will be present for spreading or producing a film).
Regarding claim 33, Scribben further discloses wherein the article is a syringe needle system (¶ [0093], Figure 1).
Regarding claim 34, Scribben further discloses wherein the article is non-manually actuated (¶ [0093] discloses that the device refers to both manual syringes and auto-injectors of any size or shape which is considered to read on “non-manually actuated” as Scribben makes a clear distinction between manually actuated and auto injectors).
Regarding claim 35, Scribben discloses the invention as set forth above for claim 1, and further discloses the method of delivery comprising initiating flow of at least a portion of the inner fluid and at least a portion of the outer fluid, such that at least a portion of the inner fluid and at least a portion of the outer fluid are transported from the chamber to the needle and ejected from the needle (¶ [0093]-[0101] disclose the process of injecting the high viscosity fluid, surrounded by the low viscosity fluid from the barrel through the needle; ¶ [0107] further discloses that the high and low viscosity fluids are present in the needle to maintain core annular flow during injection).
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) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scribben in view of Zenz (US 4,834,722).
Regarding claims 31-32, Scribben discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose the length of the needle.
Zenz teaches an injection device (Figure 1, needle 1) comprising a needle having a length of at greater than 5 microns and at least 10 mm (Col. 3, line 8).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the needle of Scribben to be of a length greater than 10 mm since Zenz teaches that it is known in the art to utilize needles of the claimed length for injection procedures. The preferred length is dependent on the procedure being performed and the depth of penetration required and Zenz provides explicit support for the use of injection needles of the claimed length.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scribben in view of Aizenberg et al. (US 2014/0147627).
Regarding claim 21, Scribben discloses the claimed invention substantially as set forth above for claim 1, but fails to explicitly disclose a texture on the interior surface of the needle formed from square features of a density defined by the equation referenced by claim 21.
Aizenberg et al. (henceforth Aizenberg) teaches a cylindrical conduit (e.g., Figure 7C) to which a square surface texture is applied (depicted in Figure 1) for receiving and retaining a lubricant (120) applied thereon for the purpose of wetting the surface to prevent the adherence of another fluid (140) to the surface to improve flow through the conduit (¶¶ [0132] and [0190]-[0191] discloses the application of the surface treatment to the inside and outside of other tubing structures such as needles). Aizenberg does not explicitly disclose the claimed solid fraction distribution of claim 21, however, Aizenberg further teaches the optimization of the textured surface based upon the properties of the lubricant which will wet the surface (¶¶ [0134] and [0138]). Furthermore, it appears one of ordinary skill in the art at the time of filing would have had a reasonable expectation of success in modifying the needle of the device of Scribben to have the claimed density of square features as it involves only adjusting a dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Scribben to comprise the features of Aizenberg over an area of the lumen as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See also MPEP 2144.05(II). Because Aizenberg teaches that it is known to form needles with square surface features for the purpose of retaining a lubricant therebetween, and for the purpose of wetting the surface to reduce friction through the device, it would have been obvious to one of ordinary skill to utilize this disclosure to modify the needle of Scribben in the manner disclosed by Aizenberg so as to optimize the annular core flow through the needle during use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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