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 .
Drawings
The drawings are objected to for the following reasons:
Photos should be represented by line drawings. All lines should be solid, dark, and continuous.
Fig. 27 is difficult to decern which elements are being pointed to.
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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 4 is objected to because of the following informalities: the end of the sentence should contain a period (.).
Claim 153 is objected to because of the following informalities: “comprise” should read “comprises”.
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.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, Claim 134 recites the broad recitation about 7 um , and the claim also recites 7 um to 300 um which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 141 recites the broad recitation about 6.5 to about 7.0, and the claim also recites 6.5 to 7.0 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 141 recites the limitation "multi-component" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets this to mean “multi-component fluid”
Claim 153 recites the broad recitation about 1 to about 3, and the claim also recites 1 to 3 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 133, 134, 141, and 165 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 133 and 134 depend upon cancelled claim 132. Examiner interprets claims 133 and 134 to depend upon claim 131.
Claim 141 depends upon canceled claim 140. Examiner interprets claim 141 to depend upon claim 128.
Claim 165 depends upon a canceled claim 163. Examiner interprets claim 165 to depend upon claim 161.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 4, 161, 162, and 165 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hull et al. (US 8210453, herein Hull).
Regarding Claim 1, Hull discloses a device for delivering a multi-component fluid (Figure 1, Column 1 lines 42-53), the device comprising:
a) a tube having a distal end (at 70 in Fig. 1) and a proximal end (at 20 in Fig. 1), wherein the tube comprising a first lumen (Col. 1 Lines 55-57), a second lumen (Col. 1 Lines 57-59), and a dispersant lumen (Col. 1 Lines 59-60), each lumen extending from the proximal end (Col. 4 Lines 66 through Col. 5 Line 1) to the distal end of the tube (Col. 5 Lines 11-14), wherein:
(i) the first lumen is configured to receive a first component (Col. 5 Lines 1-3) of the multi-component fluid (Col. 1 Lines 53-57),
(ii) the second lumen is configured to receive a second component (Col. 5 Lines 1-3) of the multi-component fluid (Col. 1 Lines 57-59), and
(iii) the dispersant lumen (Col. 1 Lines 59-60) is configured to receive a dispersant fluid (Col. 5 lines 5-6);
b) a mixer (70, 74, 81) coupled to the distal end of the tube (Fig. 10), the mixer comprising a chamber (74) disposed within a housing (70) and a mixer body (81) disposed within the chamber, wherein a proximal end of the chamber is in fluid communication with the first lumen and with the second lumen to receive the first component and the second component within the chamber and mix the first component and the second component using the mixer body to form the multi-component fluid (Col. 4 Lines 17-24), wherein the mixer body comprises a dispersant passageway therein that extends from a proximal end of the mixer body to a distal end of the mixer body (81a, 81b, Fig. 13A-C) and is in fluid communication with the dispersant lumen to receive the dispersant fluid therefrom, so as to deliver the dispersant fluid to a distal end of the chamber or to a location distal to the distal end of the chamber (Col. 5 lines 15-19); and
c) a nozzle (74a, 76) disposed distal to the mixer body and/or distal to the chamber (Fig. 14), wherein the nozzle comprises a nozzle inlet (74a), a nozzle body (Fig. 12), and a nozzle outlet (76), wherein the nozzle receives the multi-component fluid from the chamber and the dispersant from the dispersant passageway, so as to deliver the multi-component fluid and the dispersant through the nozzle outlet (Col. 5 Lines 15-24).
Regarding Claim 2, Hull discloses the device of claim 1, wherein the dispersant passageway extends along a central axis (Line 13D in Fig. 13A) of the mixer body from the mixer proximal end to the mixer distal end (Fig. 9, 13B-C, Col. 4 Lines 17-22).
Regarding Claim 3, Hull discloses the device of claim 1, wherein the dispersant passageway is proximally coupled to the dispersant lumen (Fig. 10, Col. 4 Lines 17-22).
Regarding Claim 4, Hull the device of claim 1, wherein the first lumen is in fluid communication with a first container (Col. 4 Line 66 through Col. 5 Line 1), such that the first lumen is configured to receive the first component of the multi-component fluid from the first container (Col. 1 Lines 55-57).
Regarding Claim 161, Hull discloses a device for delivering a fluid (Figure 1, Col. 1 Lines 42-53), the device comprising:
a) a tube having a distal end (at 70 in Fig. 1) and a proximal end (at 20 in Fig. 1) , wherein the tube comprises a plurality of lumens (Col. 1 Lines 55-62), wherein:
(i) a first lumen of the plurality of lumens is configured to receive a first fluid (Col. 1 Lines 55-57), and
(ii) a second lumen of the plurality of lumens is configured to receive a second fluid (Col. 1 Lines 57-59);
b) a mixer coupled to the tube (Fig. 10, 14), the mixer comprising a chamber is in fluid communication at least one lumen to receive the first fluid (Col. 1 Lines 59-60), and a dispersant passageway therein that extends through the mixer and which is in fluid communication with the second lumen to receive the second fluid (81a, 81b, Fig. 13A-C, Col. 4 lines 17-24); and
c) a nozzle (74a, 76) disposed distal to the chamber (Fig. 14), wherein the nozzle receives the first fluid from the mixer and the second fluid from the dispersant passageway, so as to deliver the first and second fluids through a nozzle outlet (Col. 4 Lines 19-24).
Regarding Claim 162, Hull discloses the device of claim 161 further comprising: a third lumen of the plurality of lumens configured to receive a third fluid (Col. 1 Lines 59-60).
Regarding Claim 165, Hull discloses the device of claim 163, wherein the nozzle is configured to disperse the mixture with the second fluid (Col 4. Lines 23-24).
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.
Claim(s) 128-130, and 142-144 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly et al. (Pub. No. US 20190321291 A1).
Regarding Claim 128, Hull discloses a system comprising:
a) device for delivering a multicomponent fluid (Figure 1, Column 1 lines 42-53), the device comprising:
i) a tube having a distal end (at 70 in Fig. 1) and a proximal end (at 20 in Fig. 1), wherein the tube comprising a first lumen (Col. 1 Lines 55-57), a second lumen (Col. 1 Lines 57-59), and a dispersant lumen (Col. 1 Lines 59-60), each lumen extending from the proximal end to the distal end of the tube (Col. 4 Lines 66 through Col. 5 Line 1), wherein:
(1) the first lumen is configured to receive a first component (Col. 5 Lines 1-3) of the multi-component fluid (Col. 1 Lines 53-57),
(2) the second lumen is configured to receive a second component (Col. 5 Lines 1-3) of the multi- component fluid (Col. 1 Lines 57-59), and
(3) the dispersant lumen is configured to receive a dispersant fluid (Col. 1 Lines 59-60);
ii) a mixer (70, 74, 81) coupled to the distal end of the tube (Fig. 10), the mixer comprising a chamber (74) disposed within a housing (70) and a mixer body (81) disposed within the chamber, wherein a proximal end of the chamber is in fluid communication with the first lumen and with the second lumen to receive the first component and the second component within the chamber and mix the first component and the second component using the mixer body to form the multi- component fluid (Col. 4 Lines 17-24), wherein the mixer body comprises a dispersant passageway therein that extends from a proximal end of the mixer body to a distal end of the mixer body (81a, 81b, Fig. 13A-C) and is in fluid communication with the dispersant lumen to receive the dispersant fluid therefrom, so as to deliver the dispersant fluid to a distal end of the chamber or to a location distal to the distal end of the chamber (Col. 5 lines 15-19);
iii) a nozzle (74a, 76) disposed distal to the mixer body and/or distal to the chamber (Fig. 14), wherein the nozzle comprises a nozzle inlet (74a), a nozzle body (Fig. 12), and a nozzle outlet (76), wherein the nozzle receives the multi-component fluid from the chamber and the dispersant from the dispersant passageway, so as to deliver the multi-component fluid and the dispersant through the nozzle outlet (Col. 5 Lines 15-24);
iv) a dispersant nozzle (74a, 76) coupled to a distal end of the mixer body (Fig. 14), wherein the dispersant nozzle comprises a dispersant nozzle outlet (76), wherein the dispersant nozzle is in fluid communication with the dispersant passageway (Col. 5 Lines 15-24); and
b) a multi component fluid in fluidic communication with the device (Col. 1 Lines 42-53)
c) a pressurized dispersant fluid (Col. 1 Line 60) in fluidic communication with the device (Col. 1 Lines 59-60).
Hull does not expressly disclose the multi component fluid comprising:
i) an extracellular (ECM) matrix;
ii) a buffering solution.
However, Hull does disclose the delivery device can deliver two or more components, more particularly for mixing and applying a bioadhesive (Col. 1 Lines 14-17)
Connolly teaches the multi component fluid comprising:
i) an extracellular (ECM) matrix (Paragraph [0092]);
ii) a buffering solution (“a buffer such as PBS” - Paragraph [0106]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by Hull so that the multi component fluid comprises an extracellular (ECM) matrix; and a buffering solution as taught by Connolly in order to promote cell growth (Connolly, Paragraph [0092]).
Regarding Claim 129, modified Hull in view of Connolly discloses the system of claim 128 wherein the pressurized dispersant fluid comprises CO2 (Hull, Col. 5 Lines 6-10).
Regarding Claim 130, Modified Hull in view of Connolly discloses the system of claim 129 wherein the buffering solution comprises phosphate-buffered saline (Connolly, Paragraph [0106]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by Hull wherein the buffering solution comprises phosphate-buffered saline as disclosed by Connolly in order to promote cell growth (Connolly, Paragraph [0092]).
Regarding Claim 142, modified Hull in view of Connolly discloses the system of claim 128, wherein the multicomponent fluid comprises an ECM hydrogel scaffold (Connolly, Paragraph [0119]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by Hull wherein the multicomponent fluid comprises an ECM hydrogel scaffold as disclosed by Connolly in order to promote cell growth (Connolly, Paragraph [0092]).
Regarding Claim 143, modified Hull in view of Connolly discloses the system of claim 128 wherein the extracellular (ECM) matrix (Connolly, Paragraph [0092]), the buffering solution (Connolly, Paragraph [0106]), and the pressurized dispersant fluid (Hull, Col. 5 Lines 5-6) collectively comprise an ECM hydrogel scaffold (Connolly, Paragraph [0119]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by Hull wherein the extracellular (ECM) matrix, the buffering solution, and the pressurized dispersant fluid collectively comprise an ECM hydrogel scaffold as taught by Connolly in order to promote cell growth (Connolly, Paragraph [0092]).
Regarding Claim 144, modified Hull in view of Connolly discloses the system of claim 143 wherein the ECM hydrogel scaffold comprises a storage modulus of at least 1000 Pa (Connolly, Fig. 7-8, Paragraph [0234]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by Hull wherein the ECM hydrogel scaffold comprises a storage modulus of at least 1000 Pa as taught by Connolly in order to provide a composition suitable for growth of cells (Connolly, Paragraph [0119]).
Claim(s) 131 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly, further in view of Hayakawa (Pub. No. US 20090234326 A1).
Regarding Claim 131, Modified Hull in view of Connolly discloses the system of claim 130.
Modified Hull in view of Connolly does not expressly disclose wherein the dispersant nozzle outlet is between 0.3 and 0.9 mm in diameter.
Hayakawa discloses wherein the dispersant nozzle outlet is between 0.3 and 0.9 mm in diameter (Paragraph [0049]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly wherein the dispersant nozzle outlet is between 0.3 and 0.9 mm in diameter as taught by Hayakawa so that the different liquids are able to be uniformly mixed (Hayakawa, Paragraph [0048]).
Claim(s) 133, 134, and 150 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly and Hayakawa, further in view of Gittard (US 9867931)
Regarding Claim 133, Modified Hull in view of Connolly and Hayakawa discloses the system of claim 132.
Modified Hull in view of Connolly and Hayakawa does not expressly disclose wherein the dispersant fluid aerosolizes the multi-component fluid upon delivery from the nozzle outlet into an ECM hydrogel mist comprising particles.
Gittard teaches wherein the dispersant fluid aerosolizes (Col. 7 Lines 5-9) the multi-component fluid upon delivery from the nozzle outlet into an ECM hydrogel mist comprising particles (Col. 1 Lines 51-56).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly and Hayakawa so that the dispersant fluid aerosolizes the multi-component fluid upon delivery from the nozzle outlet into an ECM hydrogel mist comprising particles as taught by Gittard so that a therapeutic agent is able to be delivered to a target site (Gittard, Col. 3 Lines 4-12).
Regarding Claim 134, Modified Hull in view of Connolly, Hayakawa, and Gittard discloses the system of claim 133 wherein the particles comprise an average particle diameter from about 7 um to about 300 um (Gittard, Col. 1 Lines 51-56).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly and Hayakawa wherein the particles comprise an average particle diameter from about 7 um to about 300 um as taught by Gittard so that the fluid is suitable for delivery (Gittard, Col. 11 Lines 61-66).
Regarding Claim 150, modified Hull in view of Connolly, Hayakawa, and Gittard disclose the system of claim 133 wherein the particles comprise droplets. Examiner interprets the particles to be droplets since a droplet is a very small drop of a liquid (“https://dictionary.cambridge.org/us/dictionary/english/droplet”).
Claim(s) 141 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly further in view of Hodde et al. (US 8741352 B2, herein Hodde)
Regarding claim 141, modified Hull in view of Connolly and discloses the system of claim 140.
Modified Hull in view of Connolly does not expressly disclose wherein the multi-component is buffered to a pH from about 6.5 to about 7.0.
Hodde teaches wherein the multi-component is buffered to a pH from about 6.5 to about 7.0 (Col. 12 Lines 6-10).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly wherein the multi-component is buffered to a pH from about 6.5 to about 7.0 as taught by Hodde so that the gel may serve as scaffolding for tissue growth (Hodde, Col. 13 Lines 6-11).
Claim(s) 153 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly, Hayakawa, and Gittard further in view of Hodde et al. (US 8741352 B2, herein Hodde)
Regarding Claim 153, modified Hull in view of Connolly, Hayakawa, and Gittard disclose the system of claim 133.
Modified Hull in view of Connolly, Hayakawa, and Gittard does not expressly disclose wherein the ECM comprise a pH of about 1 to about 3.
Hodde teaches wherein the ECM comprise a pH of about 1 to about 3 (Col. 9 Lines 39-42).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly, Hayakawa, and Gittard wherein the ECM comprise a pH of about 1 to about 3 as taught by Hodde so that the gel may serve as scaffolding for tissue growth (Hodde, Col. 13 Lines 6-11).
Claim(s) 156 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hull in view of Connolly, Hayakawa, Gittard, and Hodde further in view Epstein et al. (US 7803141 B2, herein Epstein)
Regarding Claim 156, modified Hull in view of Connolly, Hayakawa, and Gittard discloses the system of claim 133.
Modified Hull in view of Connolly, Hayakawa, and Gittard does not expressly disclose wherein the ECM, the multicomponent fluid, or both, is a shear thinning fluid.
Epstein teaches wherein the ECM, the multicomponent fluid, or both, is a shear thinning fluid (Paragraph [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the device for delivering a multi-component fluid as disclosed by modified Hull in view of Connolly, Hayakawa, Gittard, and Hodde wherein the ECM, the multicomponent fluid, or both, is a shear thinning fluid as taught by Epstein so that therapeutic has easy passage through the delivery device (Epstein, Paragraph [0018]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30-4:30am Alt. Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783