DETAILED ACTION
This is a non-final rejection in response to amendment filed 5/14/26. Claims 1-15 are currently pending.
Response to Arguments
Applicant’s arguments, filed 5/14/26, with respect to 35 USC 112, claim 1, have been fully considered and are persuasive. The rejection of claim 1 has been withdrawn.
It should be noted amendment to claim 4 has introduced more issues. Additionally new art has been found and thus all claims are now rejected based on prior art as shown below.
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.
Claim 4 is 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.
Claim 4 recites the limitation "an upper end". The claims previously require a distal part and proximal part but it is unclear how upper end relates to those parts.
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 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dean (US 2017/0164978).
Regarding independent claim 1, Dean teaches a composition injection device comprising: a needle 428 having a distal part and a proximal part, wherein the distal part defines an open distal end and the proximal part defines an open proximal end (hollow cavity 344 extends from proximal to distal end) and which is provided to be wherein the needle is hollow for a composition 24 to be injected into the needle or discharged from the needle; a pressing member 20,520 inserted into the needle to press the composition injected into the needle and cause the composition to be discharged from the needle; and a paddle 330,430 disposed at the open distal end of the needle and configured to allow application of the composition discharged from the needle, wherein a maximum width of the paddle is formed to be less than or equal to an outer diameter of the needle [0050].
Regarding dependent claim 3, Dean teaches wherein one portion of the paddle is bent to have a shape that is convex in one direction [0033].
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) 2 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dean in view of Maaskamp (US 2021/0146103).
Regarding dependent claim 2, Dean teaches the invention as claimed and discussed. Dean is silent to wherein, in at least one portion, a width of the paddle is formed to gradually increase away from the distal part of the needle.
Maaskamp teaches wherein, in at least one portion, a width of the paddle is formed to gradually increase away from the distal part of the needle [0069].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the paddle design of Liberatore, as part of an obvious combination of known prior art structures, in this case a width of the paddle is formed to gradually increase away from the distal part of the needle as taught by Maaskamp to achieve predictable results, in this case, a paddle that spreads a wider area of composition. See KSR; MPEP 2141 III A.
Regarding dependent claim 5-7, Dean teaches the invention as claimed and discussed. Dean is silent to any protrusions.
Maaskamp teaches wherein, wherein one or more protrusions are formed to protrude from one surface of the paddle; wherein the protrusions are formed as at least one of a dot-type and a line-type [0062]; and wherein: the protrusions are provided as a plurality of protrusions; and the plurality of protrusions are formed to be spaced apart at predetermined intervals on one surface of the paddle [0062-0063].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the protrusions of Maaskamp, as Maaskamp teaches improved spreading and dispersion of composition [0063].
Claim(s) 4 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dean in view of Schmieding et al. (US 2015/0045768).
Regarding dependent claim 4, Dean teaches the invention as claimed and discussed. Dean teaches paddle with a curved shape but is silent to wherein the one portion of the paddle having the convex shape curved and extends outwardly from an upper end of the needle.
Schmieding teaches wherein the one portion of the paddle having the convex shape curved and extends outwardly from an upper end of the needle [0026].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the paddle design where the paddle is shaped to extend outwardly away from the paddle body and extending outwardly of Schmieding, as Schmieding teaches it allows the paddle to act as a bulldozer and push material better [026].
Regarding dependent claim 8, Dean teaches the invention as claimed and discussed. Dean teaches needle with a paddle but is silent to wherein a tip that enables cutting of the composition discharged through the needle is formed at an end of the paddle.
Schmieding teaches wherein a tip that enables cutting of the composition discharged through the needle is formed at an end of the paddle [0039-0040].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the paddle design wherein a tip that enables cutting of the composition discharged through the needle is formed at an end of the paddle as taught by Schmieding, as Schmieding teaches it allows for the cutting and removal of tissue at defect site [0039]. It should be noted it would be capable of cutting through both composition and tissue.
Regarding dependent claim 9, Dean teaches the invention as claimed and discussed. Dean teaches needle with a paddle but is silent to wherein the end of the distal part of the needle is provided to be obliquely cut and have a cross-section that is inclined in one direction.
Schmieding teaches wherein the end of the distal part of the needle is provided to be obliquely cut and have a cross-section that is inclined in one direction [0024].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the paddle design wherein the end of the distal part of the needle is provided to be obliquely cut and have a cross-section that is inclined in one direction as taught by Schmieding, as Schmieding teaches it allows the paddle to allow injection of material to take place at an angle of insertion [0024].
Regarding dependent claim 10, Dean teaches the invention as claimed and discussed. Dean teaches needle with a paddle but is silent to further comprising a needle handle provided at the end of the proximal part of the needle and configured to support the needle into which the pressing member is inserted, wherein a grip portion is formed on an outer portion of the needle handle.
Schmieding teaches further comprising a needle handle provided at the end of the proximal part of the needle and configured to support the needle into which the pressing member is inserted, wherein a grip portion is formed on an outer portion of the needle handle [0020, 0024].
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the paddle design wherein the further comprising a needle handle provided at the end of the proximal part of the needle and configured to support the needle into which the pressing member is inserted, wherein a grip portion is formed on an outer portion of the needle handle as taught by Schmieding, as Schmieding teaches allows the needle to be handled universally in a 360 degree fashion [0028].
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dean in view of Schmieding and further in view of Maissami (US 6913464).
Regarding dependent claim 11, Dean in view of Schmieding teaches the invention as claimed and discussed. Dean in view of Schmieding teaches needle with a needle handle but is silent to wherein: a through-hole communicating with the needle is formed in the needle handle; and a width of the through-hole is formed to be larger than or equal to an inner diameter of the needle.
Maissami teaches wherein: a through-hole communicating with the needle is formed in the needle handle; and a width of the through-hole is formed to be larger than or equal to an inner diameter of the needle (col. 4, ll. 54-65).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean in view of Schmieding with the through-hole of Maissami, as part of an obvious combination of known prior art structures, in this case a chamber that extends through and providing adequate sizing as taught by Maissami to achieve predictable results, in this case, unimpeded flow of the composition from the handle into the needle during actuation of the pressing member. See KSR; MPEP 2141 III A.
Regarding dependent claim 12, Dean in view of Schmieding and further in view Maissami teaches the invention as claimed and discussed. Maissami further teaches wherein: a connecting portion is additionally provided on the needle handle; an inside of the connecting portion communicates with the through-hole of the needle handle; and a composition-containing device having a composition contained therein and configured to cause the contained composition to be discharged through the needle in response to an external force applied thereto is connected to the connecting portion (col. 4, ll. 54-65).
Regarding dependent claim 13, Dean in view of Schmieding and further in view Maissami teaches the invention as claimed and discussed. Schmieding further teaches wherein the pressing member includes: a push rod inserted into the needle through the needle handle to press the composition injected into the needle; and a rod handle coupled to an end of the push rod to press the push rod [0020,0028].
Regarding dependent claim 14, Dean in view of Schmieding and further in view Maissami teaches the invention as claimed and discussed. Dean further teaches wherein a width of the push rod is formed to be smaller than the inner diameter of the needle [0055].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dean in view of Maissami.
Regarding independent claim 15, Dean teaches a composition injection device comprising: a needle 428 which is provided in a state in which an end of each of a distal part and a proximal part is open and which is provided to be hollow 428,418 for a composition 24 to be injected into the needle; a paddle 330,430 provided at the end of the distal part of the needle and configured to allow application of the composition discharged from the needle [0050]; a needle handle 30 provided at the end of the proximal part of the needle to support the needle. Dean is silent to the needle handle having a connecting portion provided thereon; and a composition-containing device coupled to the connecting portion while containing a composition therein and configured to, in response to an external force applied thereto, press the contained composition so that the contained composition is discharged through the needle, wherein a maximum width of the paddle is formed to be less than or equal to an outer diameter of the needle.
Maissami a connecting portion provided thereon; and a composition-containing device coupled to the connecting portion while containing a composition therein and configured to, in response to an external force applied thereto (col. 4, ll. 41-53), press the contained composition so that the contained composition is discharged through the needle, wherein a maximum width of the paddle is formed to be less than or equal to an outer diameter of the needle (col. 4, ll. 54-65).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Dean with the applicator tip of Maissami, as part of an obvious combination of known prior art structures, in this case a detachable syringe arrangement that allows for precise control of spreading composition through a connectable reservoir as taught by Maissami to achieve predictable results, in this case, a needle/paddle delivery device usable with an interchangeable, controllable and refillable composition supply. See KSR; MPEP 2141 III A.
Conclusion
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/CRAIG KIM/
Primary Examiner
Art Unit 3741
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