DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4, 6-14 and 16-20 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Shaw (US 20090306601 A1).
With respect to claim 1, Shaw discloses a medical device (see paragraph 0056 and Fig. 11, #200), comprising:
a body comprising an open-ended fluid flow chamber and a laterally offset needle retraction chamber (see paragraph 0056-0060 and Fig. 11-16: actuator #204 with fluid flow path #242 and retraction cavity #216);
a frontal attachment (see paragraph 0056 and Fig. 12, #226) slidably coupled to the body (see paragraph 0056-0060: Fig. 15-Fig. 16 shows #226 in two positions before and after sliding) and comprising a forwardly projecting needle support (see paragraph 0056-0060 and Fig. 15-16: #226); and
a retractable needle assembly (see Fig. 15-16) comprising a needle holder (see paragraph 0056-0058 and Fig. 15-16: needle holder #220), a retraction spring rearwardly biasing the needle holder against the forwardly projecting needle support (see paragraph 0056-0058 and Fig. 15-16: spring #222), and a needle extending forwardly from the forwardly projecting needle support (see paragraph 0056-0058 and Fig. 15-16: needle #224);
wherein the frontal attachment is laterally slidable with respect to the body from a first position in which the needle is aligned and in fluid communication with the open-ended fluid flow chamber to a second position in which the needle is aligned with the needle retraction chamber to cause retraction of the needle holder and the needle into the needle retraction chamber (see Fig. 15-16 and paragraph 0056-0060: frontal attachment #226 moved between a first and second position after sliding seen in Fig. 15 and Fig. 16 where sliding occurs where the distal opening of #216 starts next to #206 in Fig 15 and then ends up being positioned adjacent a central region #226 in Fig. 16 where #226 is laterally slidable to cause retraction of needle #224 and needle holder #226 into needle retraction chamber #216).
With respect to claim 2, all limitations of claim 1 apply in which Shaw further discloses wherein the open-ended fluid flow chamber comprises a forwardly facing opening and a rearwardly facing opening (see paragraph 0056-0060 and Fig. 15-16: #242 has two openings as a fluid flow path with passageways #248, #250)).
With respect to claim 3, all limitations of claim 2 apply in which Shaw further discloses wherein a fluid seal is disposed in an annular recess in the forwardly facing opening of the open-ended fluid flow chamber (see paragraph 0056-0060: sealing member #246 seated in recess #214 provides fluid tight sealing engagement of forward end of fluid flow path #242 and head of needle holder).
With respect to claim 4, all limitations of claim 3 apply in which Shaw further discloses wherein the fluid seal abuts a rearwardly facing end of the needle holder in the first position and prevents retraction of the needle into the open-ended fluid flow chamber (see paragraph 0056-0060: sealing member #246 seated in recess #214 provides fluid tight sealing engagement of forward end of fluid flow path #242 and head of needle holder and the end of needle holder when retracted to prevent retraction of needle into fluid flow path #242).
With respect to claim 6, all limitations of claim 1 apply in which Shaw further discloses wherein the body comprises a plurality of diametrically opposed luer locking tabs disposed proximally to a rearwardly facing opening of the open-ended fluid flow chamber and configured to threadably engage with a medical apparatus (see paragraph 0057: luer connectors are disposed on actuator #204 to facilitate attachment of device #200 to another fluid source or receptable depending on intended use).
With respect to claim 7, all limitations of claim 6 apply in which Shaw further discloses wherein the medical apparatus comprises a syringe, a catheter insertion device, an infusion set, or a fluid collection device (see paragraph 0057: fluid source or receptable).
With respect to claim 8, all limitations of claim 1 apply in which Shaw further discloses wherein each of the body and the frontal attachment comprises cooperatively configured opposing rails that allow relative sliding lateral movement between the body and the frontal attachment from the first position to the second position (see paragraph 0057: actuator #204 comprises outwardly projecting mounting bosses #212 insertable into mating engagement with apertures #230 of housing #204, retraction cavity #216 and recess 214 around the opening of the fluid flow path).
With respect to claim 9, all limitations of claim 1 apply in which Shaw further discloses further comprising: a removable needle cover disposed over the forwardly projecting needle support (see paragraph 0056 and Fig. 11-16: protective cover #232 provided to protect needle #224 prior to use).
With respect to claim 10, all limitations of claim 9 apply in which Shaw further discloses wherein the removable needle cover comprises a locking arm that extends into the needle retraction chamber to limit relative sliding movement between the body and the frontal attachment when the frontal attachment is in the first position (see paragraph 0056 and Fig. 11-16: protective cover #232 provided to protect needle #224 prior to use as seen in Fig. 15 specifically that extends into #216 to limit sliding movement between #226 and #204).
With respect to claim 11, Shaw discloses a medical device, comprising:
a body comprising a barrel and a laterally-spaced apart, substantially parallel, unitarily molded needle retraction chamber (see paragraph 0056-0060 and Fig. 11-16: actuator #204 with fluid flow path #242 interpreted to be a barrel with two openings and retraction cavity #216);
a frontal attachment (see paragraph 0056 and Fig. 12, #226) slidably coupled to the body (see paragraph 0056-0060: Fig. 15-Fig. 16 shows #226 in two positions before and after sliding) and comprising a forwardly projecting needle support (see paragraph 0056-0060 and Fig. 15-16: #226); and
a retractable needle assembly (see Fig. 15-16) comprising a needle holder (see paragraph 0056-0058 and Fig. 15-16: needle holder #220), a retraction spring rearwardly biasing the needle holder against the forwardly projecting needle support (see paragraph 0056-0058 and Fig. 15-16: spring #222), and a needle extending forwardly from the forwardly projecting needle support (see paragraph 0056-0058 and Fig. 15-16: needle #224);
wherein the frontal attachment is laterally slidable with respect to the body from a first position in which the needle is aligned and in fluid communication with the barrel to a second position in which the needle is aligned with the needle retraction chamber to cause retraction of the needle into the needle retraction chamber (see Fig. 15-16 and paragraph 0056-0060: frontal attachment #226 moved between a first and second position after sliding seen in Fig. 15 and Fig. 16 where sliding occurs where the distal opening of #216 starts next to #206 in Fig 15 and then ends up being positioned adjacent a central region #226 in Fig. 16 where #226 is laterally slidable to cause retraction of needle #224 and needle holder #226 into needle retraction chamber #216).
With respect to claim 12, all limitations of claim 11 apply in which Shaw further discloses wherein the barrel comprises a forwardly facing opening and a rearwardly facing opening (see paragraph 0056-0060 and Fig. 15-16: #242 has two openings as a fluid flow path with passageways #248, #250).
With respect to claim 13, all limitations of claim 12 apply in which Shaw further discloses wherein a fluid seal is disposed in an annular recess in the forwardly facing opening of the barrel (see paragraph 0056-0060: sealing member #246 seated in recess #214 provides fluid tight sealing engagement of forward end of fluid flow path #242 and head of needle holder).
With respect to claim 14, all limitations of claim 13 apply in which Shaw further discloses wherein the fluid seal abuts a rearwardly facing end of the needle holder in the first position and prevents retraction of the needle into the barrel (see paragraph 0056-0060: sealing member #246 seated in recess #214 provides fluid tight sealing engagement of forward end of fluid flow path #242 and head of needle holder and the end of needle holder when retracted to prevent retraction of needle into fluid flow path #242).
With respect to claim 16, all limitations of claim 11 apply in which Shaw further discloses wherein the body comprises a base comprising laterally spaced-apart openings into each of the barrel and the needle retraction chamber (see paragraph 0056-0060: actuator #204 comprises tubing connector #208 that acts as a base that extends into fluid flow path and needle cavity #216).
With respect to claim 17, all limitations of claim 11 apply in which Shaw further discloses wherein each of the body and the frontal attachment comprises cooperatively configured opposing rails that allow relative sliding lateral movement between the body and the frontal attachment from the first position to the second position (see paragraph 0057: actuator #204 comprises outwardly projecting mounting bosses #212 insertable into mating engagement with apertures #230 of housing #204, retraction cavity #216 and recess 214 around the opening of the fluid flow path).
With respect to claim 18, all limitations of claim 17 apply in which Shaw further discloses wherein the frontal attachment comprises a laterally facing textured surface (see paragraph 0056 and Fig. 12, #226 comprises hollow body having substantially flat top and bottom surfaces #202 oppositely disposed and integrally formed finger grips with textured gripping surfaces 206, a forwardly extending, tapered neck 238 with opening 228, an open side and back, and aligned, oppositely disposed apertures 230 for pivotably attaching actuator 204 to housing 226) configured for use in applying pressure in a direction transverse to the direction of fluid flow through the barrel and the needle to initiate needle retraction (see paragraph 0056-0060 and Fig. 11-16: Actuator 204 is disposed in its use position relative to housing 226 with mounting bosses 212 pivotably inserted into apertures 230 to start needle retraction).
With respect to claim 19, all limitations of claim 11 apply in which Shaw further discloses a removable needle cover disposed over the forwardly projecting needle support. (see paragraph 0056 and Fig. 11-16: protective cover #232 provided to protect needle #224 prior to use).
With respect to claim 20, all limitations of claim 19 apply in which Shaw further discloses wherein the removable needle cover comprises a locking arm that extends into the needle retraction chamber to limit relative sliding movement between the body and the frontal attachment when the frontal attachment is in the first position (see paragraph 0056 and Fig. 11-16: protective cover #232 provided to protect needle #224 prior to use as seen in Fig. 15 specifically that extends into #216 to limit sliding movement between #226 and #204).
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 5 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shaw in view of Dysarz (US 20020068907 A1).
With respect to claim 5, all limitations of claim 2 apply in which Shaw does not specifically disclose wherein the open-ended fluid flow chamber comprises a barrel, and wherein a plunger is slidably disposed inside the barrel through the rearwardly facing opening.
Dysarz teaches an open ended fluid flow chamber (see Fig. 1 and paragraph 0024: chamber #5) with a barrel (see Fig. 1 and paragraph 0024-0025: syringe barrel #7) wherein a plunger is slidably disposed inside the barrel through a rearwardly facing opening (see Fig. 1 and paragraph 0024-0028: a plunger #2 is disposed inside barrel #7 from bottom opening as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shaw in view of Dysarz to add a barrel and plunger because it would have resulted in the predictable result of serving as an actuator to create pressure in a chamber to cause fluid to flow (Dysarz: see [0025]).
With respect to claim 15, all limitations of claim 12 apply in which Shaw does not specifically disclose wherein a plunger is slidably disposed inside the barrel through the rearwardly facing opening.
Dysarz teaches an open ended fluid flow chamber (see Fig. 1 and paragraph 0024: chamber #5) with a barrel (see Fig. 1 and paragraph 0024-0025: syringe barrel #7) wherein a plunger is slidably disposed inside the barrel through a rearwardly facing opening (see Fig. 1 and paragraph 0024-0028: a plunger #2 is disposed inside barrel #7 from bottom opening as seen in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shaw in view of Dysarz to add a plunger to a barrel because it would have resulted in the predictable result of serving as an actuator to create pressure in a chamber to cause fluid to flow (Dysarz: see [0025]).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
