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 .
DETAILED ACTION
Drawings
The drawings are objected to because the figures have faded lines and numbers and/or are difficult to read. “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning” 37 CFR 1.84(l). “The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color” 37 CFR 1.84 (m). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, each of the claim elements that have not been labeled in the drawings must be shown or the feature(s) canceled from the claim(s). It is noted that reference characters applied to the specification and drawings are used to provide clear reference between the two. Several claim elements have no labels or reference in the drawings, including but not limited to: a pre-injection tube (claim 1), a central bore (cl 1), a central channel (cl 1, 15), a threaded base (cl 2), a needle fitting (cl 3), a top inlet (cl 5), a flexible seal (cl 5), a flange (cl 6, 7), a stylet cavity (cl 7), a removable cap (cl 12), a base flange, a plunger flange (cl 13), a bottom cavity, a middle cavity, a top cavity (cl 14), a spring or piston (cl 13). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 4-6, 8, 10-12, 15-19 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.
In claim 4, “the outer bore” lacks antecedent basis.
In claims 10-11, and 15, “an outer surface” is indefinite because an outer surface was previously defined. It is unclear if it refers to the same outer surface or a different one.
In claims 5-6, “the plunger” is not clearly differentiated from the “stylet plunger”. Examiner suggests making the “plunger” a “first plunger”, and referring to the “first plunger” thereafter.
In claim 8, “the stylet approximates an internal diameter of a desired needle gauge” is indefinite because the claim does not define the “desired needle gauge”. It is unclear how the stylet is being defined.
In claim 12, 16, “the Luer lock needle fitting” lacks antecedent basis.
In claim 16, the “stylet” lacks antecedent basis.
In claim 19, “prior to inserting the needle into the injury site, … the needle is inserted in the subject …”. It is unclear how inserting the needle in the subject can occur “prior to inserting the needle into the injury site”.
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) 1, 4-5, 7-8, 12, 14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188602 (Gusenoff) in view of US 5019045 (Lee).
Regarding claim 1, 4-5, 7-8, 12, 14, Gusenoff teaches an injection device (Fig 5-6) for delivery of viable neotissue comprising: a fluid exchange chamber having a funneled portion (chamber of 115 having funneled portion at the bottom, above tube 116a, para 70-71), the funneled portion having a bottom connected to a pre-injection tube (annotated below; funneled portion with bottom connected to pre-injection tube 116a), wherein the fluid exchange chamber comprises fluid transfer holes extending through an outer surface of the fluid exchange chamber (fluid transfer holes in and through outer surface of 115); a cylindrical outer shell comprising a central bore connecting a top inlet and a bottom outlet (cylindrical outer shell 110 with top inlet near 118 and bottom outlet near 111, para 80), wherein the fluid exchange chamber is disposed in the outer shell and wherein the pre-injection tube exits the shell via the bottom outlet (see Fig 5, 6); a plunger having a central channel (plunger 120 has central channel defined by the inner surface of 120); and a stylet plunger disposed in the central channel (stylet plunger 130), the shell comprises a male Luer lock needle fitting in the outer bore (male luer lock fitting 111 fitting in an outer bore of a female adaptor 154, para 70, Fig 6), the plunger comprises a flexible seal that prevents fluid from escaping the top inlet (flexible seal 119, para 70-71), the stylet plunger comprises a base having a flange and a stylet cavity, and wherein a stylet is disposed in the stylet cavity (base with flange 136; stylet cavity inside body 125; stylet 130 is inside the cavity), the stylet approximates an internal diameter of a desired needle gauge (Fig 5; 130 approximates the internal diameter of a needle gauge; the claim does not define the size of the needle gauge), a removable cap coupled to the Luer lock needle fitting when a needle is not attached to the device (removable cap 150, para 83), the central bore of the outer shell comprises a bottom cavity dimensioned to house the fluid exchange chamber (annotated below), a middle cavity dimensioned to receive the tapered bottom of the plunger when depressed, and a top cavity dimensioned to receive a top portion of the plunger (annotated below).
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Gusenoff fails to teach the plunger having a tapered bottom, wherein the tapered bottom mates with an inside of the funneled portion when depressed. However, Lee teaches a plunger having a tapered bottom and mating with an inside of a funneled portion when depressed (Fig 8-11; tapered bottom of 16 mates with a funneled portion when depressed – Fig 11). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the plunger with a tapered bottom, wherein the tapered bottom mates with an inside of the funneled portion when depressed, as taught by Lee. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing the plunger with a tapered bottom, wherein the tapered bottom mates with an inside of the funneled portion when depressed, yields predictable results (injection).
Regarding claim 16-18, Gusenoff teaches method for injecting viable neotissues into a subject, the method comprising: loading a fluid medium comprising transplant tissues into a device (Fig 5-6) according to claim 1, wherein the device comprises a removable cap coupled to the Luer lock needle fitting (removable cap 150 coupled luer lock needle fitting 111, para 70, 79, 83, Fig 5-6), wherein the fluid medium is loaded into the central bore of the outer shell (para 74, 80, 83; medium loaded into the central bore inside body 115); and inserting the plunger and stylet into the central bore (Fig 5-6), removing the cap and connecting a needle to the Luer lock fitting (Fig 6); and depressing the plunger to expel excess fluid from the fluid exchange chamber and to direct the transplant tissues into the funneled portion (para 74-84), inserting the needle into an injury site of the subject (para 82-84); and depressing the stylet plunger to direct the transplant tissues through the pre-injection tube through the needle to the injury site (para 84).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188602 (Gusenoff) in view of US 5019045 (Lee), and further in view of US 10702629 (Pilkington).
Regarding claim 6, Gusenoff in view of Lee fails to teach the plunger comprises a flange at a top end. However, Pilkington teaches a plunger comprising a flange at a top end (Fig 15-16, plunger with a flange 28 at the top end). It would have been obvious to one of ordinary skill in the art at the time of the invention to add a flange at a top end, as taught by Pilkington. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing a flange at a top end yields predictable results (moving the plunger).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188602 (Gusenoff) in view of US 5019045 (Lee), and further in view of US 2006/0063962 (Drobnik).
Regarding claim 9, Gusenoff in view of Lee fails to teach the stylet plunger further comprises a flexible seal that prevents fluid from escaping the central channel of the plunger. However, Drobnik teaches a stylet plunger further comprising a seal that prevents fluid from escaping the central channel of the plunger (para 26, 28-29; seal 135, 243 or 343). Gusenoff further teaches that seals may be flexible (para 70, silicone). It would have been obvious to one of ordinary skill in the art at the time of the invention to make the stylet plunger further comprises a flexible seal that prevents fluid from escaping the central channel of the plunger in order to prevent leakage, as taught by Drobnik and Gusenoff. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing the stylet plunger further comprising a flexible seal that prevents fluid from escaping the central channel of the plunger yields predictable results (sealing the central channel).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0188602 (Gusenoff) in view of US 5019045 (Lee), and further in view of JP 2009034190 (Yamamoto).
Regarding claim 19, Gusenoff in view of Lee teaches prior to inserting the needle into the injury site, the needle is detached from the device (Gusenoff para 82-84; need is detached to place the device 100 into a stand 150), but fails to teach the needle is inserted in the subject, and then the device is reattached to the needle before depressing the stylet plunger. However, Yamamoto teaches a needle inserted into a subject and then attaching an injection device to the needle before depressing the stylet plunger (see page 1-2 of the translation; a cannula/needle is inserted in the subject and then a syringe or the like may be reattached to the cannula/needle). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide the steps of the needle is inserted in the subject, and then the device is reattached to the needle before depressing the stylet plunger, as taught by Yamamoto. It has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, providing the steps of the needle is inserted in the subject, and then the device is reattached to the needle before depressing the stylet plunger yields predictable results (injecting the tissue).
Allowable Subject Matter
Claim 15 would be allowed and claims 2-3, 10-11, and 13 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, and if all 112 rejections and drawing objections were overcome.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to teach, in combination with the other claim limitations, the fluid exchange chamber comprises a threaded base surrounding the pre-injection tube and a complementary threaded ring inside a bottom of the outer shell such that the fluid exchange chamber is threadably coupled to an interior surface of the outer shell, the fluid transfer holes are angled upward from an inner surface of the fluid exchange chamber to an outer surface of the fluid exchange chamber, the fluid transfer holes have a smaller diameter on an inner surface of the fluid exchange chamber than on an outer surface, or a stylet base flange and a plunger flange are connected by a spring or a piston. Gusenoff fails to teach the fluid exchange chamber comprising a threaded base surrounding the pre-injection tube and a complementary threaded ring inside a bottom of the outer shell such that the fluid exchange chamber is threadably coupled to an interior surface of the outer shell; the fluid exchange chamber is rotatable and connected by bearings to the outer shell. Levine teaches a fluid exchange chamber threaded into a bottom of an outer shell (para 24, chamber 20 and shell 12), but fails to teach a stylet plunger disposed in the central channel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2013/0030322 teaches an injection device with a fluid exchange chamber comprising fluid transfer holes (Fig 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at 571-270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741