DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on September 30, 2024. As directed by the amendment: no claims have been amended, claims 1-20 have been cancelled, and claims 21-28 have been added. Thus, claims 21-28 are presently pending in this application.
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 21-28 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.
Claim 21 line 7 recites the units “cps”. It is not clear what these units are in reference to. For purposes of examination, “cps” is interpreted as “centipoise”. Claims 22-28 are rejected at least because they depend from claim 21.
Claim 21 lines 8-9 recite “…measured at about 25 °C with a controlled stress rheometer (RS600) and a cone plate geometry (40 mm, 2°)…”. It is not clear if these are the standard testing conditions for reporting the viscosity of a hyaluronic acid based dermal filler. For purposes of examination, the recited testing conditions are interpreted to be standard testing conditions for reporting viscosity of a hyaluronic acid based dermal filler. Claims 22-28 are rejected at least because they depend from claim 21.
Claim 27 line 2 recites “…a single circumference double lead screw thread…”. This written description does not describe what is meant by “single circumference”, and it is not clear what this limitation requires as it is not standard terminology. For purposes of examination, this is interpreted as “a double lead screw thread”.
The term “about” in claims 21 and 28 is a relative term which renders the claim indefinite. The term “about” 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. For purposes of examination, “about” is interpreted to be +/- 10%.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 21-24 and 28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over David US 2007/0212385 A1 in view Caizza US 2004/0220532 A1 in view of Liao US 6,436,075 B1.
Regarding claim 21, David discloses an injection device for delivering a dermal filler (kit, P0180), the injection device comprising: a syringe (prefilled syringe P0180, for subcutaneous injection P0034 and P0037); a hyaluronic acid-based dermal filler (prefilled syringe containing a dermal filler composition containing a hyaluronic acid composition, P0180) having a viscosity between about 50,000 cps and about 500,000 centipoise (Restylane, P0020, wherein Restylane has a viscosity of approximately 119,000 centipoise, see Anderson et al. US 2018/0177587 A1). David is silent as to the testing method used to determine the viscosity of the hyaluronic acid-based dermal filler. Specifically, the claim recites that viscosity is measured at about 25 °C with a controlled stress rheometer (RS600) and a cone plate geometry (40 mm, 20). However, since David teaches use of a common dermal filler, one of ordinary skill in the art would expect its viscosity to continue to fall within the claimed range.
David does not explicitly teach the syringe having a body with an open distal end; a needle assembly comprising a cannula and a luer connector engageable with the syringe distal end, the luer connector comprising a hub with a distal end supporting the cannula and a proximal end mateable with the syringe distal end; a hub retention cavity, disposed in the hub, for preventing detachment of the hub from the syringe distal end during injection of the dermal filler, the hub retention cavity being defined by an inside surface of the hub and a step; and internal threads disposed in the syringe distal end and external threads disposed on the hub enabling mating engagement and ejection of the viscous fluid through the cannula.
However, Caizza teaches a medical device having a releasable retainer (Fig. 9) wherein the syringe has a body (barrel 151, P0036) with an open distal end (tip 157, P0036); a needle assembly (20, P0030) comprising a cannula (21, P0030) and a luer connector engageable with the syringe distal end (luer locking, P0036), the luer connector comprising a hub (31, P0030) with a distal end supporting the cannula and a proximal end mateable with the syringe distal end (Fig. 9); a hub retention cavity (33, P0030), disposed in the hub, for preventing detachment of the hub from the syringe distal end during injection of the dermal filler, the hub retention cavity being defined by an inside surface of the hub and a step (step, see annotated Fig. 9 below); and internal threads (internal threads 160, P0036) disposed in the syringe distal end and external threads (radial projections 37, P0036) disposed on the hub enabling mating engagement and ejection of the viscous fluid through the cannula.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the syringe of David as taught by Caizza for the purpose of improving retention of the needle assembly, Caizza P0033.
David in view of Caizza does not explicitly teach a piston disposed in the syringe body.
However, Liao teaches a syringe having a piston 15 disposed in the syringe body 10, c 2 ln 20-24.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the syringe of David in view of Caizza with a piston as taught by Liao for the purpose of expelling the contents of the syringe, Liao c 3 ln 19-24, thereby enabling ejection of the viscous fluid through the cannula upon operation of the piston, wherein the dermal filler is disposed in the body and injectable by the piston into a peripheral location of a human or animal body through the cannula.
Regarding claim 22, David in view of Caizza in view of Liao teaches the device according to claim 21, wherein the syringe includes a tapered syringe cone and the inside surface of the hub is correspondingly tapered to the tapered syringe cone, to thereby provide a seal therebetween (Caizza, Fig. 9).
Regarding claim 23, David in view of Caizza in view of Liao teaches the device according to claim 22, wherein, when the hub is torqued to the syringe and maximally seated (Caizza, Fig. 9 showing the hub maximally seated due to the reduction of the inner diameter within the hub), the tapered syringe cone stops short of the step and creates a dead space which is reduced by the step (Caizza, see annotated Fig. 9 above).
Regarding claim 24, David in view of Caizza in view of Liao teaches the device according to claim 21, wherein the hub is formed from polycarbonate (Caizza, polycarbonate hub P0031).
Regarding claim 28, David in view of Caizza in view of Liao teaches the device according to claim 21, wherein the hyaluronic acid-based dermal filler has a viscosity of at least about 130,000 cps (David, Restylane, P0020, wherein Restylane has a viscosity of approximately 119,000 +/- 11,900 centipoise, see Anderson et al. US 2018/0177587 A1).
Claims 25-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over David in view Caizza in view of Liao as applied to claim 21 above, and further in view of DeSantis et al. (DeSantis) US 5,817,033.
Regarding claim 25, The device according to claim 21.
David in view of Caizza in view of Liao does not teach wherein the internal threads comprise double lead screw threads.
DeSantis teaches a needle core biopsy device wherein the external threads comprise double lead screw threads (double lead screw, c 6 ln 28-34, wherein one of ordinary skill the art would understand the luer fitting internal threads to comprise double lead screw threads).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the internal threads of Caizza with double lead screw threads as taught by DeSantis to speed linear translation during installation and removal of the needle assembly.
Regarding claim 26, David in view of Caizza in view of Liao teaches the device according to claim 21.
David in view of Caizza in view of Liao does not teach wherein the external threads comprise double lead screw threads.
However, DeSantis teaches a needle core biopsy device wherein the external threads comprise double lead screw threads (double lead screw, c 6 ln 28-34, wherein one of ordinary skill in the art would understand the external threads to comprise double lead screw threads).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the external threads of Caizza with double lead screw threads as taught by DeSantis to speed linear translation during installation and removal of the needle assembly.
Regarding claim 27, David in view of Caizza in view of Liao in view of DeSantis teaches the device according to claim 26, wherein the external threads comprise single circumference double lead screw threads (DeSantis, double lead screw, c 6 ln 28-34, wherein one of ordinary skill in the art would understand the external threads to comprise single circumference double lead screw threads).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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