DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 11-21 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 11 recites the limitation "A lancing device" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to say “The lancing device”. The same issue is present in claims 12-21
Claim 18 recites the limitation “the lower housing” in line 3. There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to say “the lower housing part”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10-17 and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garg (US 20180049687 A1).
In regards to claim 10 Garg teaches a lancing device comprising:
a housing (Fig. 2 Bottom Housing 20);
a lancet comprising a needle, the lancet being configured to be movable rearwardly within the housing from an initial operational position to a retracted position (Fig. 2 lancet 100, [0027] "Generally, the top housing 60 is configured for sliding engagement with the bottom housing 20, and the lancet 100 is positioned therebetween such that compression of the top housing 60 relative to the bottom housing 20 causes a sharp tip portion 113 and the lancing needle 112 to protrude from an opening 66 of the top housing 60, and then retract within the housings towards a second 24 of the bottom housing 20");
a shroud coupled movably to the housing and at least partially covering and extending forwards beyond a forward end of the needle before use of the lancing device (Fig. 2 Top Housing 60);
and a biasing member coupled between the lancet and the shroud, wherein the shroud is configured to, when pressed against skin around a sampling site, move rearwards relative to the housing and, at a first point of the rearward movement, allow the needle to contact the sampling site and subsequently, at a second point of the rearward movement, release energy stored in the biasing member to drive the lancet from the operational position to the retracted position, (Figs. 19-20 arm 126, [0036] “As the top housing 60 continues to move within the bottom housing 20, the arms 126 begin to flex due to engagement with the angles internal walls 90, for example, since the chamfered surfaces 122 are still contacting the chamfered surfaces 44 of the elongate fingers 42, which prevent the lancet 100 from retracting within the bottom housing 20. The cantilevered fingers 76 eventually reach the second positional indentations 34 such that the chamfered surfaces 80 (and lips 82) are fitted therein, and wherein at least a portion of the cantilevered fingers or an end surface near the second end 64 of the top housing 60 contacts the stop surface 36”)
and wherein the housing comprises lancet retaining features comprising one or more deflectable legs configured to retain the lancet in the operational position until the shroud reaches the second point of the rearward movement (Figs. 19-20 elongate fingers 42).
In regards to claim 11 Garg teaches the lancing device according to claim 10, wherein the shroud is configured to prime the biasing member during the rearward movement ([0036] "To charge and fire the lancing device 10, the top housing 60 is pressed to move further within the bottom housing 20 (see arrows), causing the arms 126 to begin contacting the angled internal walls 90 of the top housing 60 (see FIG. 19)").
In regards to claim 12 Garg teaches the lancing device according to claim 10, wherein the biasing member comprises one or more springs that are compressed during the rearward movement ([0036] "To charge and fire the lancing device 10, the top housing 60 is pressed to move further within the bottom housing 20 (see arrows), causing the arms 126 to begin contacting the angled internal walls 90 of the top housing 60 (see FIG. 19)").
In regards to claim 13 Garg teaches the lancing device according to claim 12, wherein the or each spring is a plastic spring (Figs. 19-20 cantilevered spring arms 126).
In regards to claim 14 Garg teaches the lancing device according to claim 13, wherein the or each plastic spring is formed integrally with the shroud (Figs. 19-20 cantilevered spring arms 126).
In regards to claim 15 Garg teaches the lancing device according to claim 14, wherein the or each plastic spring is a flexible leg (Figs. 19-20 cantilevered spring arms 126)..
In regards to claim 16 Garg teaches the lancing device according to claim 10, wherein the housing comprises one or more fingers configured to resist an initial rearward movement of the shroud until a level of force applied by the user exceeds a predefined threshold force ([0034] The second end 104 of the lancet 100 preferably comprises a locking feature for sliding engagement with the lock feature 40 of the bottom housing 20. According to one form, the locking feature generally comprises at least one chamfered surface 122 and at least one overhang or lip 124. In preferred forms, the locking feature comprises a pair of chamfered surfaces 122 and a pair of lips 124. The chamfered surfaces 122 are generally angled downward and inwardly relative to one another. Fig. 21).
In regards to claim 17 Garg teaches the lancing device according to claim 10, wherein the housing and the shroud comprise cooperating snap-fit fastening features for preventing resetting of the shroud, after the shroud reaches the second point of the rearward movement ([0034] According to one form, the locking feature generally comprises at least one chamfered surface 122 and at least one overhang or lip 124. In preferred forms, the locking feature comprises a pair of chamfered surfaces 122 and a pair of lips 124).
In regards to claim 20 Garg teaches the lancing device according to claim 10, wherein the one or each deflectable leg extends from an inner surface of the housing and is configured to engage with a shoulder of the lancet to restrict a rearward movement of the lancet with respect to the housing until the shroud reaches the second point of the rearward movement (Fig 20-21 elongate fingers 42).
In regards to claim 21 Garg teaches the lancing device according to claim 10, wherein the shroud is further configured to, at the second point of the rearward movement, deflect the or each leg so that rearward movement of the lancet is no longer restricted and energy stored in the biasing member is released to drive the lancet from the operational position to the retracted position ((Fig 20-21 shroud puts pressure on lancet with deflects the legs).
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.
Claim(s) 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garg (US 20180049687 A1) in view of Gelfand (US 20160015305 A1).
In regards to claim 18 Garg teaches the lancing device according to claim 10, wherein the housing comprises:
the lancet retaining features (Figs. 19-20 elongate fingers 42);
one or more fingers configured to resist an initial rearward movement of the shroud until a level of force applied by the user exceeds a predefined threshold force, and snap-fit fastening features for cooperatively engaging with features of the shroud for preventing resetting of the shroud, after the shroud reaches the second point of the rearward movement ([0037] “As shown in FIG. 21, when the top housing 60 is moved to its furthest extent within the bottom housing 20, a force caused by the compression or flexture of the arms 126 (e.g., engaging the angled internal walls 90) causes the locking feature (e.g., chamfered surfaces 122 and lips 124) to pass beyond the chamfered surfaces 44 and lips 46 of the elongate fingers 42 of the lock feature 40 of the bottom housing 20”).
Garg fails to teach a device wherein the housing comprises a lower housing part and an upper housing part in snap-fit engagement with one another, said lower housing part is configured to couple the shroud moveably to the lower housing. Gelfand teaches a lancing device wherein the housing is broken into an upper and lower housing that connect to each other ([0071] "Alternatively, main body 20 and rear cap 24 are separate elements which are affixed to each other to form housing 12, which aids in assembly of lancet device 10). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom housing of Garg to be two pieces that connect together like the device of Gelfand (see annotated Garg Fig. 2 below, housings split at dotted line). Doing so would merely be combining prior art elements according to known methods to yield the predictable result of aiding in the assembly of the lancet device
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Garg Figure 2 Annotated
In regards to claim 19 modified Garg teaches the lancing device according to claim 18, wherein components of the device are configured to facilitate assembly of the device by:
installing the shroud into the lower housing part by inserting the shroud from a lower end of the lower housing part and pushing the shroud rearwards into the lower housing part until the or each finger restricts further rearward movement of the shroud (Garg Fig 2 Upper housing 20 is inserted into one end of the lower housing);
Modified Garg does not explicitly teach how the lancet is installed within the device. However, it would be obvious to insert the lancet from the opposite end that the shroud was installed and to join the upper housing and lower housing together (Garg Fig 2 Upper lancet can be inserted in opposite end of lower housing and fastened by pushing until chamfered surfaces and lips of lancet pass the chamfered surfaces and lips and surfaces of the fingers). Doing so would allow for the lancet would be inserted needle side down into the device which would reduce the risk of accidental needle sticks.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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