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 § 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) 29, 32, 44, 46, 73, and 74 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,077,251 (“Ting”).
Regarding Claim 29, Ting discloses a method of injecting fluid into a substrate (Abstract) comprising:
(a) inserting a coaxial needle (600) into the substrate, wherein the coaxial needle comprises:
(I) a proximal end (626);
(II) a distal end (610); and
(III) an inner elongate tubular body (604) and an outer elongate tubular body (602) that are arranged concentrically, wherein the inner elongate tubular body and the outer elongate tubular body each comprise:
a cylindrical side wall forming a lumen that extends along a longitudinal axis between the proximal end and the distal end (see Figs. 7-8); and
a plurality of side wall openings (606, 608) arranged along the cylindrical side wall (see Figs. 7-8);
wherein at least one of the inner or outer elongate tubular bodies is movable relative to the other to form a plurality of configurations (Col. 7-9), wherein at least one of the plurality of configurations comprises a paired opening formed by an overlap of at least one of the plurality of side wall openings of the inner elongate tubular body and at least one of the plurality of side wall openings of the outer elongate tubular body (Col. 7-9), wherein the plurality of side wall openings of the inner elongate tubular body and the outer elongate tubular body are arranged in a pattern (see Fig. 7 or 8) and wherein the pattern is linear (see Fig. 8), radial (see Fig. 8), or spiral/zig-zag (see Fig. 7); and
(b) flowing a fluid into the lumen of the inner elongate tubular body such that the fluid passes through the paired opening and into the substrate (Col. 7-9).
Regarding Claim 32, Ting discloses controlling a position of the inner elongate tubular body relative to the outer elongate tubular body (Col. 7-9).
Regarding Claim 44, Ting discloses that the fluid may comprise a plurality of cells (Abstract).
Regarding Claim 46, in the instant case Examiner submits the phrase “distal end” is a nebulous region that would encompass a general location in Ting located distal to then midpoint of the needle and would therefore include the disclosed distal-most, terminal openings (700, 710 – see Col. 8, Ln. 52-Col. 9, Ln. 22) as well as other openings (606, 608) located in the general “distal end” region.
Regarding Claim 73, Ting discloses that the substrate is biological tissue (Abstract).
Regarding Claim 74, Ting discloses that the substrate is human tissue (Abstract).
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.
Claim(s) 47, 48, is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,077,251 (“Ting”) as applied above, and further in view of WO 2017/053572 (“Joseph”).
Regarding Claims 47 and 48, Ting discloses the invention substantially as claimed except that that the opening located at the distal end of the coaxial needle increases in size/the coaxial needle changes in shape after being inserted into the substrate. However, Joseph discloses a related needle (1400) which is formed from a compound that changes shape following an increase in temperature associated with insertion into the patient tissue in order to increase the lumen diameter to thereby increase fluid flow rate upon insertion (Par. 88). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the needle of the invention of Ting of a shape-memory material which is configured to change in shape/increase in size after being inserted into the substrate, as disclosed by Joseph, in order to allow the needle lumen and outlets to increase in size incident to insertion into patient tissue to increase flow rate responsive to insertion to thereby assist in further opening of the apertures only after the needle has been effectively introduced into the patient’s body.
Claim(s) 76, 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,077,251 (“Ting”) as applied above, and further in view of U.S. Publication No. 2004/0176855 (“Badylak”).
Regarding Claims 76 and 77, Ting discloses the invention substantially as claimed except that that the substrate is an acellular scaffold comprising one of a solubilized basement membrane matrix, a devitalized tissue allograft, an alginate scaffold, a collagen scaffold, a hydrogel scaffold, a fibrous scaffold, a polyethylene glycol scaffold, or a silk scaffold. Specifically, while Ting does suggest that cells may be delivered to an “organ” or “tissue”, Ting fails to explicitly identify that such tissue may comprise an “acellular scaffold”. However, Badylak discloses the use of a decellularized organ (e.g. liver) for use in treatment of organ deficiency wherein a devitalized tissue allograft can be seeded with stem cells (Par. 6, 13, 28) in order provide for tissue repair, restoration, augmentation, or regeneration as a transplant organ. It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the methods of Ting to seed live cells to an acellular scaffold formed of devitalized tissue, as disclosed by Badylak, in order to create artificial organs for transplant to a host to provide proper and appropriate treatment.
Response to Arguments
Applicant's arguments filed 14 November 2025 have been fully considered but they are not persuasive.
Applicant argues (Pg. 6) “Ting does not disclose each and every element of amended claim 29” with the implication that Applicant is specifically referring to the new limitation(s) which pertain to the pattern by which the openings of the inner elongate tubular body and the outer elongate tubular bodies are arranged. However, Examiner submits that such arguments are conclusory in nature and do not seek to particularly point out or explain any supposed differences between the Ting patterns (see Fig. 7 or 8) and the patterns claimed (and disclosed). In the instant disclosure Applicant makes reference to a variety of different patterns characterized as “random, linear, spiral, radial Fibonacci spiral, logarithmic spiral, Archimedean spiral, zig-zag, or checkerboard pattern”. Although, only one pattern is particularly illustrated (see Figs. 1-5) and is not particularly identified as being one from the listed species, but does not appear to be dissimilar from the pattern(s) illustrated by Ting (see Fig. 8). Here, Ting illustrates two exemplary patterns which may be reasonably considered either linear, spiral, or zig zag under the broadest reasonable interpretation of the claims. Specifically, as shown in Fig. 8 the openings (606, 608) of the respective elongate tubular bodies are arranged in discrete, linear rows (see below) while in Fig. 3 the openings are arranged in a pattern that traces a helical (re: spiral) path about the circumference of the tubular bodies or which may be considered “zig zag” (i.e. veering alternatingly from left to right in an abrupt manner) (see below).
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127
590
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A spiral/zig-zag pattern – see that the apertures are arranged in a helical offset spirally around the circumference of the tubular body when viewed in three-dimensions or arranged in zig-zag pattern undulating left and right when viewed in two-dimensions.
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127
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A linear pattern – see that the apertures are arranged in a pattern of discrete longitudinal lines
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410
552
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A radial pattern – see that the apertures are arranged on opposite sides of a common radius/diameter about the circumference of the tubular body
Here, without clear exposition by the specification and particularly without any further explanation or editorialization by Applicant there is no basis to conclude that the patterns described by Ting would NOT be considered linear (i.e. arranged in discrete rows extending along the longitudinal length), radial (i.e. provided at the same longitudinal location on the circumference radiating away from the center), spiral (i.e. wrapping around the circumference of the tubular body in an offset manner), or zig-zag (i.e. alternating in a left to right offset pattern along the longitudinal length). The claim terminology must be afforded its broadest reasonable interpretation and in the instant case the configurations illustrated by Ting are found to read upon the broadest reasonable interpretation of configurations which are afforded their ordinary definitions of “linear”, “radial”, “spiral”, and “zig-zag”.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/15/2026
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