DETAILED ACTION
This action is responsive to the RESPONSE TO OFFICE ACTION filed 29 September 2025. The Examiner acknowledges that no amendments were made. Claims 1-22 are pending.
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 .
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10, 12-13, 15-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw (US-20190090798-A1, previously presented) in view of Wilkinson (WO-2019213097-A1, previously presented) and Shaw (US-20110230844-A1, previously presented), hereinafter referred to as Wisner [second named inventor].
Regarding claim 1, Shaw teaches
A blood collection device for medical use, comprising:
a body [body 22 (Shaw ¶0017, Figure 2)];
a slide assembly [frontal attachment 24 (Shaw ¶0017, Figure 2)] disposed in laterally slidable engagement with the body and comprising a forwardly projecting nose [Needle support tube 48 desirably projects forwardly from slid block 46 (Shaw ¶0020); Frontal attachment 24 of medical device 20 preferably further comprises slide block 46 having transverse, laterally extending upper and lower rails 50, 52 slidably engageable with laterally extending upper and lower recesses 38, 40 of body 22 to provide transverse sliding engagement between body 22 and frontal attachment 24 (Shaw ¶0020)];
a device stabilization member [Wing member 26 (Shaw ¶0022, Figure 2)] comprising a central cylindrical hub [hub 62 (Shaw ¶0022, Figure 2)] coupled to the nose and two wings [opposed, laterally extending wings 70, 72 (Shaw ¶0022, Figure 2)] projecting oppositely from the cylindrical hub [Hub 62…engageable with needle support tube 48 (Shaw ¶0022, Figure 2)], wherein the cylindrical hub is considered to be in a relaxed position [wherein the lack of any outside forces acting on the hub 62 is considered to read on the cylindrical hub being in a relaxed position];
a rearwardly biased venipuncture needle projecting forwardly through the nose [Front opening 60 of needle support tube 48 is desirably sized and configured to allow the forwardly extending end 82 of the needle holder and the front portion of needle 84 and needle tip 86 to project forwardly from needle support tube 48 (Shaw ¶0022, Figure 2); the needle retraction assembly further comprising a rearwardly biased needle holder and a needle that projects forwardly from the frontal attachment prior to and during use of the subject medical device (Shaw ¶0004)]; and
a tubular needle cap comprising a proximal end and a distal end [a needle cap is not depicted in the drawings but would be provided to protect the forwardly projecting needle tip 86 (FIG. 2) prior, to use (Shaw ¶0023); wherein it is understood that a cap as defined to protect the needle would have a proximal end and a distal end], wherein the proximal end of the tubular needle cap is slidably insertable over at least a portion of the nose [Such a needle cap will frictionally engage the outside wall of the needle support tube 48 forwardly of wing member 26 and is easily removable and disposed of just prior to inserting needle 84 into a patient (Shaw ¶0023)], wherein the proximal end of the tubular needle cap comprises a smooth cylindrical inside wall that is frictionally engaged with the nose, and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body or the nose [Shaw ¶0023; wherein the needle cap of Shaw being disclosed as frictionally engaging the outside wall of the needle support tube 48 is considered to define the inside wall of the proximal end as being sufficiently smooth (under the broadest reasonable interpretation of “smooth”) and sufficiently cylindrical in order to frictionally engage the cylindrical needle support tube 48 that is depicted as being smooth in Figure 2 of Shaw; and wherein the lack of particular disclosure of any “structural elements” with respect to the needle cap of Shaw is considered to read on the claimed limitation of being free of any structural elements at or near the proximal end that are configured to engage the nose].
However, while Shaw discloses that the body [body 22 (Shaw ¶0017, Figure 2)] and slide assembly [frontal attachment 24 (Shaw ¶0017, Figure 2)] are formed from a flexible polymeric material [the body and frontal attachment are each made of a moldable polymeric material (Shaw Claim 6)], Shaw fails to explicitly disclose that the device stabilization member is formed from a flexible polymeric material.
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 the blood collection device of Shaw to employ a device stabilization member formed from a flexible polymeric material, as Shaw teaches forming components of the blood collection device from a flexible polymeric material, such that the modification would amount to mere simple substitution of one kind of material for forming the device stabilization member for another [a moldable polymeric material (Shaw Claim 6)], with the similar expected result of providing a device formed of a medical grade material [MPEP § 2143(I)(B)].
However, Shaw fails to explicitly disclose wherein the proximal end of the tubular needle cap is slidably insertable into the cylindrical hub and wherein the proximal end of the tubular needle cap comprises a smooth cylindrical outside wall that is frictionally retained and releasably held by a constrictive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is in the relaxed position.
Wilkinson discloses a tubular needle cap [cannula guard 30 Figs. 1-2], wherein a proximal end of the tubular needle cap is slidably insertable into a hub [Cannula guard 30 is a rigid cylindrical tube with a length that exceeds the projecting length of needle cannula 28 from needle hub 44. Cannula guard 30 is sized such that it can be telescoped over needle cannula 28 and frictionally retained on the tip guard distal 24 (Wilkinson ¶0031, Figs. 1-3], and wherein the proximal end of the tubular needle cap comprises a smooth cylindrical outside wall that is frictionally retained and releasably held by a constrictive holding force exerted radially inward by the hub when the hub is in the relaxed position [Wilkinson ¶0031, Figs. 1-2, wherein no outside forces being applied to the device of Wilkinson is considered to define a “relaxed” state], and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body [wherein as depicted in Wilkinson Figs. 1-3, the cannula guard 30 is only defined as a cylindrical tube and is not further defined by any structural elements at or near the proximal end that are configured to engage a portion of a body of the device].
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 the blood collection device of Shaw to employ the proximal end being slidably insertable into the cylindrical hub, wherein the proximal end comprises a smooth cylindrical outside wall that is frictionally retained and releasably held by a constructive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is in the relaxed position, wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body, so as to further secure the tubular needle cap to protect the needle [Wilkinson ¶0031] [wherein the modified Shaw in view of Wilkinson disclosing a smooth cylindrical outside wall of the tubular needle cap that is frictionally retained and releasably held by a constrictive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is considered to read on the limitation “when the cylindrical hub is in the relaxed position” as no outside forces are considered to be acting on the cylindrical hub].
However, Shaw fails to explicitly disclose wherein the cylindrical hub is configurable between a stretched position and a relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub and over at least a portion of the nose when the cylindrical hub is in the stretched position.
Wisner discloses blood collection devices comprising a tubular element [barrel tip cap 38 (Wisner Fig. 4)] and a cylindrical element [barrel 32 (Wisner Fig. 4)] that may be coupled to one another by stretching the tubular element to frictionally fit around the cylindrical element [Barrel tip cap 38 can be attached to barrel 32 in various ways, such as by friction, snap-fit, or using an adhesive, or in any other known manner or using an attachment device that may become evident to one of ordinary skill in the art upon reading this disclosure. One preferred attachment method is frictional engagement between barrel tip cap 38 and barrel 32, which can be enhanced by slightly stretching open end 42 over the slightly projecting annular flange 35 at the front of barrel 32 (Wisner ¶0045, see Fig. 4)].
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 the blood collection device of Shaw in view of Wilkinson to configure the cylindrical hub to be configurable between a stretched position and the relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub and over at least a portion of the nose when the cylindrical hub is in the stretched position, so as to facilitate frictional fit coupling between the tubular needle cap and the nose to maintain the tubular needle cap in place [Wisner ¶0045].
Regarding claim 2, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the tubular needle cap is supported by the nose [Such a needle cap will frictionally engage the outside wall of the needle support tube 48 forwardly of wing member 26 and is easily removable and disposed of just prior to inserting needle 84 into a patient (Shaw ¶0023)] and frictionally retained and releasably held by the constrictive holding force exerted radially inward by an inwardly facing surface of the cylindrical hub [see Wilkinson ¶0031, Figs. 1-2; see § 103 modification of claim 1 above].
Regarding claim 3, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the flexible polymeric material is an elastomeric material [see § 103 modification of claim 1 above, wherein the flexible polymeric material is considered to read on “an elastomeric material”] that allows the cylindrical hub to be stretched outwardly in the stretched position to receive the tubular needle cap and relax and constrict in the relaxed position to exert the constrictive holding force around the smooth cylindrical outside wall of the proximal end of the tubular needle cap [see § 103 modification of claim 1 above, wherein the modified cylindrical hub of Shaw in view of Wilkinson and Wisner is considered to read on the claimed limitation].
Regarding claim 4, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the nose comprises an outwardly projecting boss [outwardly projecting lugs 58, 59 (Shaw ¶0022, Figure 2)] and the cylindrical hub comprises a window [slots 66, 68 (Shaw ¶0022, Figure 2) configured to receive the boss to position and attach the cylindrical hub to the slide assembly [Hub 62 comprises bore 64 and opposed slots 66, 68 that are engageable with needle support tube 48 and its outwardly projecting lugs 58, 59 during assembly of medical device 20 (Shaw ¶0022)].
Regarding claim 5, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 2, wherein the tubular needle cap is releasably held by sliding frictional engagement with both the nose [Such a needle cap will frictionally engage the outside wall of the needle support tube 48 forwardly of wing member 26 and is easily removable and disposed of just prior to inserting needle 84 into a patient (Shaw ¶0023)] and the cylindrical hub [wherein based off of the modification of Shaw in view of Wilkinson and Wisner of claim 1 above, the tubular needle cap (as modified) being held by frictional engagement with the inwardly facing surface of the cylindrical hub is considered to read the present limitation].
Regarding claim 6, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the body comprises a longitudinally extending cylindrical flow channel [flexible tubing 30 (Shaw ¶0017, Figure 2)] comprising proximal [Distal end 94 of flexible plastic tubing 30 (Shaw ¶0017, Figure 2), wherein the terms “distal” and “proximal” are considered relative, such that any end of the flexible tubing 30 may be a “proximal end” or a “distal end”; regarding Shaw, the Examiner has interpreted the distal end 94 of Shaw to read on the proximal end of the claimed invention] and distal ends [a forwardly facing proximal end 90 (Shaw ¶0019, Figure 2), wherein the terms “distal” and “proximal” are considered relative, such that the Examiner has interpreted the proximal end 90 of Shaw to read on the claimed distal end], and a needle retraction chamber [laterally spaced-apart needle retraction cavity 34 (Shaw ¶0018, Figure 2)] that is parallel to and laterally spaced apart from the cylindrical flow channel [see Figure 4 of Shaw, which depicts the needle retraction cavity 34 as being parallel to and laterally spaced apart from the flexible plastic tube 30 (identified by tubular outer wall 92 in Figure 4)].
Regarding claim 7, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 6, wherein the needle retraction chamber comprises an open distal end [open front end 44 (Shaw ¶0018, Figure 2)] and a closed proximal end [closed back end (Shaw ¶0018, Figure 2)].
Regarding claim 8, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 6, further comprising: a compressible annular fluid seal seated inside the distal end of the cylindrical flow channel in abutting engagement with a rearwardly facing surface portion of the slide assembly [According to one embodiment of the invention, proximal end 90 extends slightly forward of open front end 42 and forwardly facing surface 37 of slide mount 36 so that it can cooperate with the rearwardly facing end 80 of the needle holder to create a fluid seal around the fluid flow path between body 22 and frontal attachment 24 during assembly and use. The rearwardly facing annular surface of rearwardly biased needle holder, discussed in greater detail below, can desirably slightly compress proximal end 90 of flexible plastic tubing 30 during assembly to help effectuate the fluid seal (Shaw ¶0019, Figure 2), wherein the interfacing portions of the flexible plastic tube 30 and the rearwardly biased needle holder are considered to form an annular fluid seal as positioned within a rearwardly facing surface portion of the slide assembly].
Regarding claim 9, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the slide assembly comprises a needle retraction assembly [Both head 80 and the forwardly extending end of compression spring 88 are desirably seated on rearwardly facing annular surfaces inside stepped inside bore 55 of frontal attachment 24… During assembly, the needle holder is inserted into the coils of spring 88, which are compressed as they are inserted into the rear of stepped inside bore 55 of needle support tube 48 (Shaw ¶0021, Figure 2), wherein the spring 88 and the needle holder 78 are considered to form the needle retraction assembly of Shaw].
Regarding claim 10, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 9, wherein the needle retraction assembly comprises a tubular needle holder [needle holder 78 (Shaw ¶0021, Figure 2)] and a compressed needle retraction spring [spring 88 (Shaw ¶0021, Figure 2)] surrounding a forwardly extending portion of the tubular needle holder [Both head 80 and the forwardly extending end of compression spring 88 are desirably seated on rearwardly facing annular surfaces inside stepped inside bore 55 of frontal attachment 24… During assembly, the needle holder is inserted into the coils of spring 88, which are compressed as they are inserted into the rear of stepped inside bore 55 of needle support tube 48 (Shaw ¶0021, Figure 2), wherein the spring 88 and the needle holder (identified as elements 78 and 80 in Figure 2 of Shaw) are considered to form the needle retraction assembly of Shaw], wherein the compressed needle retraction spring comprises a distal end seated inside the nose [Shaw ¶0021] and a proximal end abutting against a forwardly facing annular shoulder [rearwardly facing end 80 of the needle holder (Shaw ¶0019, Figure 2)] of the needle holder [Shaw ¶0021].
Regarding claim 12, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 6, further comprising: a section of flexible tubing projecting rearwardly from a proximal end of the cylindrical flow channel, the flexible tubing providing fluid communication with an end fitting connectable to a receptacle for collected blood [wherein ¶0017 of Shaw discloses that it is understood by one having ordinary skill in the art that distal end 94 (wherein as noted in the rejection of claim 6 under 35 U.S.C. 103 above, the Examiner has interpreted the distal end 94 of Shaw to read on the claimed proximal end) may extend to provide fluid communication with a fluid receptacle for collecting fluid; wherein ¶0003 of Shaw discloses that the fluid collected by the device is blood].
Regarding claim 13, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the slide assembly comprises a first set of upper and lower ramps [upper and lower rails 50, 52 (Shaw ¶0020, Figure 2)], wherein the body comprises a second set of oppositely configured upper and lower ramps [upper and lower recesses 38, 40 of body 22 (Shaw ¶0020, Figure 2)], and wherein the first set of upper and lower ramps and the second set of oppositely configured upper and lower ramps are slidably engageable to allow relative sliding movement of the slide assembly with respect to the body to initiate needle retraction [laterally extending upper and lower rails 50, 52 slidably engageable with laterally extending upper and lower recesses 38, 40 of body 22 to provide transverse sliding engagement between body 22 and frontal attachment 24 (Shaw ¶0020); Referring to FIG. 7, arrow 57 indicates the direction that body 22 is moved relative to slide block 46 of frontal attachment 24 to initiate needle retraction (Shaw ¶0024, Figure 7)].
Regarding claim 15, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the body of the device is molded from a medical grade polymeric material [the body and frontal attachment are each made of a moldable polymeric material (Shaw Claim 6)].
However, Shaw fails to explicitly disclose that the medical grade polymeric material is transparent or sufficiently translucent to permit blood flowing through the body to be viewed by a user.
Wilkinson discloses molding a body of a blood collection device from a medical grade polymeric material that is transparent or sufficiently translucent to permit blood flowing through the body to be viewed by a user [Needle hub 44 can be molded unitarily from a plastic material, such as, polycarbonate, polypropylene, polyethylene, acrylic, polystyrene and acrylonitrile butadiene styrene (ABS). According to one design, the needle hub 44 can be molded from a transparent or translucent material to enable observation of blood or other fluid flowing through needle hub 44 (Wilkinson ¶0030), wherein the polymers as disclosed by Wilkinson are considered to be “medical grade” as the device of Wilkinson is used for medical purposes].
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 the blood collection device of Shaw in view of Wilkinson and Wisner to employ a medical grade polymeric material that is transparent or sufficiently translucent to permit blood flowing through the body to be viewed by a user, so as to enable observation of blood flowing through the body [Wilkinson ¶0030].
Regarding claim 16, Shaw teaches
A blood collection device, comprising:
a body [body 22 (Shaw ¶0017, Figure 2)] comprising a longitudinally extending flow channel [flexible tubing 30 (Shaw ¶0017, Figure 2)] and a laterally offset needle retraction cavity [laterally spaced-apart needle retraction cavity 34 (Shaw ¶0018, Figure 2); see Figure 4 of Shaw, which depicts the needle retraction cavity 34 as being laterally spaced apart from the flexible plastic tube 30 (identified by tubular outer wall 92 in Figure 4)];
a slide assembly [frontal attachment 24 (Shaw ¶0017, Figure 2)] configured to slidably engage the body [Frontal attachment 24 of medical device 20 preferably further comprises slide block 46 having transverse, laterally extending upper and lower rails 50, 52 slidably engageable with laterally extending upper and lower recesses 38, 40 of body 22 to provide transverse sliding engagement between body 22 and frontal attachment 24 (Shaw ¶0020)] and comprising a forwardly projecting nose [Needle support tube 48 desirably projects forwardly from slid block 46 (Shaw ¶0020)];
a rearwardly biased needle assembly comprising a needle projecting forwardly through the nose [Front opening 60 of needle support tube 48 is desirably sized and configured to allow the forwardly extending end 82 of the needle holder and the front portion of needle 84 and needle tip 86 to project forwardly from needle support tube 48 (Shaw ¶0022, Figure 2); the needle retraction assembly further comprising a rearwardly biased needle holder and a needle that projects forwardly from the frontal attachment prior to and during use of the subject medical device (Shaw ¶0004)];
a device stabilization member [Wing member 26 (Shaw ¶0022, Figure 2)] coupled to the nose [Hub 62…engageable with needle support tube 48 (Shaw ¶0022, Figure 2)], wherein the device stabilization member comprises a central cylindrical hub [hub 62 (Shaw ¶0022, Figure 2)] and two wings projecting oppositely therefrom [opposed, laterally extending wings 70, 72 (Shaw ¶0022, Figure 2)], and wherein the cylindrical hub is considered to be in a relaxed position [wherein the lack of any outside forces acting on the hub 62 is considered to read on the cylindrical hub being in a relaxed position], and
a tubular needle cap, wherein a smooth cylindrical inside wall of the tubular needle cap is retained by frictional engagement with the nose [Such a needle cap will frictionally engage the outside wall of the needle support tube 48 forwardly of wing member 26 and is easily removable and disposed of just prior to inserting needle 84 into a patient (Shaw ¶0023), wherein the needle cap of Shaw being disclosed as frictionally engaging the outside wall of the needle support tube 48 is considered to define the inside wall of the proximal end as being sufficiently smooth (under the broadest reasonable interpretation of “smooth”) and sufficiently cylindrical in order to frictionally engage the cylindrical needle support tube 48 that is depicted as being smooth in Figure 2 of Shaw], and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body or the nose [Shaw ¶0023; wherein the lack of particular disclosure of any “structural elements” with respect to the needle cap of Shaw is considered to read on the claimed limitation of being free of any structural elements at or near the proximal end that are configured to engage the nose].
However, while Shaw discloses that the body [body 22 (Shaw ¶0017, Figure 2)] and slide assembly [frontal attachment 24 (Shaw ¶0017, Figure 2)] are formed from a flexible polymeric material [the body and frontal attachment are each made of a moldable polymeric material (Shaw Claim 6)], Shaw fails to explicitly disclose that the device stabilization member is formed from a flexible polymeric material.
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 the blood collection device of Shaw to employ a device stabilization member is formed from a flexible polymeric material, as Shaw teaches forming components of the blood collection device from a flexible polymeric material, such that the modification would amount to mere simple substitution of one kind of material for forming the device stabilization member for another [a moldable polymeric material (Shaw Claim 6)], with the similar expected result of providing a device formed of a medical grade material [MPEP § 2143(I)(B)].
However, Shaw fails to explicitly disclose the tubular needle cap is slidably insertable into the cylindrical hub, wherein a smooth cylindrical outside wall of the tubular needle cap is retained by a constrictive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is in the relaxed position.
Wilkinson discloses a tubular needle cap [cannula guard 30 Figs. 1-2], wherein the tubular needle cap is slidably insertable into a hub [Cannula guard 30 is a rigid cylindrical tube with a length that exceeds the projecting length of needle cannula 28 from needle hub 44. Cannula guard 30 is sized such that it can be telescoped over needle cannula 28 and frictionally retained on the tip guard distal 24 (Wilkinson ¶0031, Figs. 1-3], and wherein a smooth cylindrical outside wall of the tubular needle cap is retained by a constrictive holding force exerted radially inward by the hub when the hub is in the relaxed position [Wilkinson ¶0031, Figs. 1-2, wherein no outside forces being applied to the device of Wilkinson is considered to define a “relaxed” state], and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body [wherein as depicted in Wilkinson Figs. 1-3, the cannula guard 30 is only defined as a cylindrical tube and is not further defined by any structural elements at or near the proximal end that are configured to engage a portion of a body of the device].
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 the blood collection device of Shaw to employ the proximal end being slidably insertable into the cylindrical hub, wherein a smooth cylindrical outside wall of the tubular needle cap is retained by a constrictive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is in the relaxed position, and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body, so as to further secure the tubular needle cap to protect the needle [Wilkinson ¶0031] [wherein the modified Shaw in view of Wilkinson disclosing a smooth cylindrical outside wall of the tubular needle cap that is frictionally retained and releasably held by a constrictive holding force exerted radially inward by the cylindrical hub when the cylindrical hub is considered to read on the limitation “when the cylindrical hub is in the relaxed position” as no outside forces are considered to be acting on the cylindrical hub].
However, Shaw in view of Wilkinson fails to explicitly disclose the cylindrical hub is configurable between a stretched position and a relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub when the cylindrical hub is in the stretched position.
Wisner discloses blood collection devices comprising a tubular element [barrel tip cap 38] and a cylindrical element [barrel 32] that may be coupled to one another by stretching the tubular element to frictionally fit around the cylindrical element [Barrel tip cap 38 can be attached to barrel 32 in various ways, such as by friction, snap-fit, or using an adhesive, or in any other known manner or using an attachment device that may become evident to one of ordinary skill in the art upon reading this disclosure. One preferred attachment method is frictional engagement between barrel tip cap 38 and barrel 32, which can be enhanced by slightly stretching open end 42 over the slightly projecting annular flange 35 at the front of barrel 32 (Wisner ¶0045, see Figure 4)].
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 the blood collection device of Shaw in view of Wilkinson to configure the cylindrical hub to be configurable between a stretched position and the relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub when the cylindrical hub is in the stretched position, so as to facilitate frictional fit coupling between the tubular needle cap and the nose to maintain the tubular needle cap in place [Wisner ¶0045].
Regarding claim 17, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 16, wherein the needle assembly comprises a tubular needle holder [needle holder 78 (Shaw ¶0021, Figure 2)] and a compression spring [spring 88 (Shaw ¶0021, Figure 2)] comprising a proximal end disposed around a forwardly extending portion of the tubular needle holder [Both head 80 and the forwardly extending end of compression spring 88 are desirably seated on rearwardly facing annular surfaces inside stepped inside bore 55 of frontal attachment 24… During assembly, the needle holder is inserted into the coils of spring 88, which are compressed as they are inserted into the rear of stepped inside bore 55 of needle support tube 48 (Shaw ¶0021, Figure 2)] and a distal end seated inside the nose of the slide assembly to rearwardly bias the needle assembly [Shaw ¶0021].
However, Shaw fails to explicitly disclose that the collar of the nose is slotted. Shaw does disclose that the cylindrical hub is slotted [opposed slots 66, 68] and is further configured to engage with the collar of the nose [Hub 62 comprises bore 64 and opposed slots 66, 68 that are engageable with needle support tube 48 and its outwardly projecting lugs 58, 59 during assembly of medical device 20 (Shaw ¶0022, Figure 2)].
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 the blood collection device of Shaw in view of Steele and Wisner to employ the collar of the nose being slotted, as Shaw teaches configuring separate parts of a blood collection device being slotted so as to engage with other separate parts of the blood collection device for assembly [Shaw ¶0022], so as to allow for connection between the device stabilization member and the nose [Shaw ¶0022].
Regarding claim 18, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 16, wherein the central cylindrical hub of the device stabilization member is disposed around a collar of the nose [Shaw Figures 1-2].
Regarding claim 19, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 18, wherein the nose comprises an outwardly projecting boss [outwardly projecting lugs 58, 59 (Shaw Figure 2)], and wherein the cylindrical hub comprises a window [opposed slots 66, 68 (Shaw Figure 2)] configured to receive the boss to couple the device stabilization member to the slide assembly [Hub 62 comprises bore 64 and opposed slots 66, 68 that are engageable with needle support tube 48 and its outwardly projecting lugs 58, 59 during assembly of medical device 20 (Shaw ¶0022, Figure 2)].
Regarding claim 20, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 16, wherein lateral sliding movement of the slide assembly with respect to the body initiates retraction of the needle assembly within the needle retraction cavity in response to longitudinal alignment of the needle assembly with the needle retraction cavity [Referring to FIG. 7, arrow 57 indicates the direction that body 22 is moved relative to slide block 46 of frontal attachment 24 to initiate needle retraction…Needle 88 is fully contained inside medical device 20 to protect the user, patient and bystanders or subsequent handlers of medical device 20 from accidental needle sticks and possible contamination by fluid-borne pathogens during fluid collection procedures (Shaw ¶0024, Figures 7, 9-10)].
Regarding claim 21, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the smooth cylindrical inner wall of the tubular cap is free of any structural elements configured to engage the nose of the slide assembly [wherein the lack of particular disclosure of any “structural elements” with respect to the needle cap of Shaw is considered to read on the claimed limitation of being free of any structural elements configured to engage the nose].
However, Shaw is not particular regarding the dimensions or structure of the tubular cap [Shaw ¶0023], wherein Shaw fails to explicitly disclose that the tubular cap comprises a constant inner diameter along an entire length of the tubular needle cap.
Wilkinson discloses a tubular needle cap that is considered to be defined by a constant inner diameter along an entire length of the tubular needle cap [Wilkinson ¶0031, Fig. 1; wherein the cannula guard 30 being defined as a “cylindrical tube” that “telescopes” over the needle canula 28 is considered to read on the claimed property, based on the plain definition of “cylindrical” meaning the surface traced by a straight line moving parallel to a fixed straight line and intersecting a fixed planar closed curve (https://www.merriam-webster.com/dictionary/cylinder), “tube” meaning any of various usually cylindrical structures or devices: such as a hollow elongated cylinder (https://www.merriam-webster.com/dictionary/tube), and “telescope” meaning to slide or pass one within another like the cylindrical sections of a collapsible hand telescope (https://www.merriam-webster.com/dictionary/telescope)].
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 the tubular cap of Shaw in view of Wilkinson and Wisner to employ a constant inner diameter along an entire length of the tubular needle cap, as this modification would amount to mere simple substitution of one known element [tubular cap of Shaw ¶0023] for another [tubular cap of Wilkinson ¶0031] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 22, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 1, wherein the smooth cylindrical outside wall of the tubular needle cap comprises a constant outer diameter along an entire length of the tubular needle cap that is free of any structural elements configured to engage the body of the blood collection device [Wilkinson Figs. 1-2, wherein as depicted in Wilkinson there are not any particular “structural elements” along the outside of the tubular needle cap, and the lack of disclosure of any “structural elements” in Wilkinson ¶0031 is further considered to read on the claimed limitation of being free of any structural elements configured to engage the body of the blood collection device].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Wilkinson and Wisner as applied to claim 10 above, and further in view of Shaw (US-20150073303-A1, previously presented), hereinafter Shaw II.
Regarding claim 11, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 10.
However, while Shaw discloses that a rearwardly facing surface (considered to read on a proximal surface) of the tubular needle holder [needle holder 78 of Shaw] may form a coaxially aligned annular fluid seal disposed inside a fluid flow channel in the body [According to one embodiment of the invention, proximal end 90 extends slightly forward of open front end 42 and forwardly facing surface 37 of slide mount 36 so that it can cooperate with the rearwardly facing end 80 of the needle holder to create a fluid seal around the fluid flow path between body 22 and frontal attachment 24 during assembly and use. The rearwardly facing annular surface of rearwardly biased needle holder, discussed in greater detail below, can desirably slightly compress proximal end 90 of flexible plastic tubing 30 during assembly to help effectuate the fluid seal (Shaw ¶0019, Figure 2)], Shaw fails to explicitly disclose that the annular fluid seal is separate such that the tubular needle holder [needle holder 78 of Shaw] abuts against the annular fluid seal.
Shaw II discloses blood collection device [Shaw II abstract], wherein Shaw II discloses positioning a separate annular fluid seal [fluid seal 68 of Shaw II] inside a fluid flow channel in a body of the blood collection device, such that a tubular needle of the blood collection device comprises a proximal end that is coaxially aligned with and abuts against the annular fluid seal [As frontal attachment 34 is attached to connector housing 32, fluid seal 68 is squeezed into abutting contact with the rearwardly facing end of head 76 of needle holder 72 (Shaw II ¶0093)].
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 the blood collection device of Shaw in view of Wilkinson and Wisner to employ the tubular needle holder comprising a proximal end that is coaxially aligned with and abuts against an annular fluid seal disposed inside a fluid flow channel in the body, so as to prevent fluid leakage along the fluid flow channel between the tubular needle holder and the body [Annular fluid seal 68 desirably prevents fluid leakage between connector housing 32 and frontal attachment 34 during use of medical device 30 (Shaw II ¶0093 Figure 11)].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaw in view of Wilkinson and Wisner as applied to claim 13 above, and further in view of Shaw (US-20180243515-A1, previously presented), hereinafter Shaw III.
Regarding claim 14, Shaw in view of Wilkinson and Wisner teaches
The blood collection device of claim 13.
However, Shaw fails to explicitly disclose wherein the slide assembly comprises a first set of upper and lower stop surfaces adjacent to the first set of upper and lower ramps, wherein the body comprises a second set of oppositely facing upper and lower stop surfaces adjacent to the second set of oppositely configured upper and lower ramps, wherein the first set of upper and lower stop surfaces and the second set of oppositely facing upper and lower stop surfaces are positioned to abut each other to prevent disengagement of the body from the slide assembly prior to needle retraction and to prevent relative sliding movement of the body away from the slide assembly following needle retraction.
Shaw III discloses a blood collection device [Shaw III abstract], wherein Shaw III discloses a slide assembly [frontal attachment 34 (Shaw III Figure 5)], wherein the slide assembly comprises a first set of upper and lower stop surfaces [Referring to FIGS. 5, 17 and 20, stop members 62, 63 are desirably provided to engage in abutting contact with opposed upper and lower shoulders (lower shoulder 65 visible in FIG. 20) of rear surface 87 adjacent to base 82 of frontal attachment 34 to limit or restrict the range of lateral sliding motion of connector housing 32 relative to frontal attachment 34 to prevent accidental separation (Shaw III ¶0076, Figures 5, 17, 20), wherein the upper and lower shoulders are considered to read on the claimed stop surfaces (Shaw III only specifically identifies lower shoulder 65 by an element number in Figure 20)] adjacent to a first set of upper and lower ramps of the slide assembly [opposed rails 91, 93 (Shaw III ¶0075, Figures 20-21)] and the body comprises a second set of oppositely facing upper and lower stop surfaces [wherein the stop members 62, 63 are considered to read on the claimed second set of oppositely facing upper and lower stop surfaces (Shaw III ¶0076, Figures 5, 17, 20)] adjacent to a second set of oppositely configured upper and lower ramps [opposed rails 64, 66 (Shaw III ¶0075, Figure 5)], wherein the first set and the second set of upper and lower stop surfaces are positioned to abut each other to prevent disengagement of the body from the slide assembly prior to needle retraction and to prevent relative sliding movement of the body away from the slide assembly following needle retraction [Shaw ¶0076].
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 the blood collection device of Shaw in view of Wilkinson and Wisner to employ a slide assembly that comprises a first set of upper and lower stop surfaces adjacent to the first set of upper and lower ramps, wherein the body comprises a second set of oppositely facing upper and lower stop surfaces adjacent to the second set of oppositely configured upper and lower ramps, wherein the first set of upper and lower stop surfaces and the second set of oppositely facing upper and lower stop surfaces are positioned to abut each other to prevent disengagement of the body from the slide assembly prior to needle retraction and to prevent relative sliding movement of the body away from the slide assembly following needle retraction, so as to prevent accidental separation between the body and the slide assembly by limiting/restricting the range of lateral sliding motion of the slide assembly relative to the body [Shaw III ¶0076].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 7-9, filed 29 September 2025, with respect to the previously applied claim rejections under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that Shaw does not disclose or reasonably teach any structure of the claimed needle cap, as the Applicant notes that Shaw fails to disclose or reasonably teach that the needle cap comprises a smooth cylindrical inside wall that engages with the nose and is free of any structural elements that engage a portion of the body or nose, wherein the Applicant notes that Shaw is altogether silent as to any structure or design and method of securing the needle cap to the syringe. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that Shaw does disclose some portions of the claimed needle cap based on the recited functionality and depiction of other elements of the device of Shaw that are configured to interact with the needle cap as claimed [Shaw ¶0023; wherein it is understood that a cap as defined to protect the needle would have a proximal end and a distal end; wherein the needle cap of Shaw being disclosed as frictionally engaging the outside wall of the needle support tube 48 is considered to define the inside wall of the proximal end as being sufficiently smooth (under the broadest reasonable interpretation of “smooth”) and sufficiently cylindrical in order to frictionally engage the cylindrical needle support tube 48 that is depicted as being smooth in Figure 2 of Shaw; and wherein the lack of particular disclosure of any “structural elements” with respect to the needle cap of Shaw is considered to read on the claimed limitation of being free of any structural elements at or near the proximal end that are configured to engage the nose]. The Examiner further notes that in response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Shaw is further modified by Wilkinson and Wisner to employ additionally claimed functions and structure of the claimed needle cap.
The Applicant further asserts that Shaw fails to disclose that the device stabilization member is formed from a flexible polymeric material, wherein the Applicant notes that the Examiner’s reasoning to modify Shaw to employ such a limitation is flawed, as the Applicant’s purpose of forming the device stabilization member from a flexible polymeric material is for the device stabilization member to be flexible to be stretched over the needle cap then be allowed to relax to exert a constrictive holding force on the tubular needle cap to retain the needle cap on the syringe, which the Applicant notes is neither disclosed or reasonably taught or suggested by any of the cited prior art references. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that as Shaw discloses that certain elements may be formed of a medical grade moldable polymeric material, it would be reasonable for one of ordinary skill in the art to employ that material for other elements of the claimed invention. The Examiner further notes that in response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Examiner notes that Wisner discloses functionality regarding a tubular element [barrel tip cap 38] and a cylindrical element [barrel 32] that may be coupled to one another by stretching the tubular element to frictionally fit around the cylindrical element [Wisner ¶0045, see Figure 4], which is considered to be applicable regarding the limitation wherein the cylindrical hub of the device stabilization member is configurable between a stretched position and a relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub when the cylindrical hub is in the stretched position.
The Applicant also asserts that the application of Wilkinson as disclosing a tubular needle cap having a smooth cylindrical outside wall is improper, as the Applicant notes that Wilkinson Fig. 1 depicts that the needle cap (30) of Wilkinson is not cylindrical, and is depicted as having hexagonal planar sides. However, the Examiner disagrees with the Applicant’s argument and notes that Wilkinson explicitly discloses that the needle cap (30) is cylindrical [Cannula guard 30 is a rigid cylindrical tube with a length that exceeds the projecting length of needle cannula 28 from needle hub 44 (Wilkinson ¶0031)] and that the Figures of Wilkinson are considered to be exemplary embodiments that do not limit the invention as disclosed by Wilkinson [It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting (Wilkinson ¶0027)]. As such, Wilkinson is considered to teach a needle cap wherein a proximal end is slidably insertable into a cylindrical hub, wherein a smooth cylindrical outside wall of the tubular needle cap is retained by a constrictive holding force exerted radially inward by the hub when the hub is in the relaxed position, and wherein the tubular needle cap is free of any structural elements at or near the proximal end that are configured to engage a portion of the body.
The Applicant asserts that Wisner fails to disclose stretching any portion of the disclosed syringe [Applicant refers to element 30 in Fig. 1 of Wisner] that exerts a constrictive holding force radially inward to retain a needle cap, or any portion, on the syringe, such that Wisner fails to remedy any alleged shortcomings of Shaw and Wilkinson. However, the Examiner disagrees with the Applicant’s argument as the Examiner notes that Wisner does disclose a tubular element [barrel tip cap 38] and a cylindrical element [barrel 32] that may be coupled to one another by stretching the tubular element to frictionally fit around the cylindrical element [Wisner ¶0045, see Figure 4], which is considered to be applicable regarding the limitation wherein the cylindrical hub is configurable between a stretched position and a relaxed position, wherein the tubular needle cap is slidably insertable into the cylindrical hub when the cylindrical hub is in the stretched position.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791