DETAILED ACTION
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement(s) have been considered by the examiner.
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 2, 5, 8, and 11 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.
Regarding claim 2 and 8
The claims each recite “…wherein at least one of the first end and the second end has an end extending to protrude from an outer circumferential surface of the first holder…”, however it is unclear how an element on an end of the second holder may protrude from a surface of the first holder when each holder is a distinct element. For examination purposes the claim language is to be interpreted as “…wherein at least one of the first end and the second end has an end extending to protrude radially relative to an outer circumferential surface of the first holder” in view of applicant’s disclosure page 19 line 24 to page 20 line 3 and fig 5-7.
Regarding claim 5 and 11
There is a lack of antecedent basis for “the other side” as it is unclear what side of what element is being referred to. For examination purposes to be interpreted as “…the second end extends to another side of the second holder”, in view of page 21 line 5-6 and fig 7.
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) 1-5 and 7-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210069410 A1, henceforth written as DeStefano.
Regarding claim 1, DeStefano discloses:
A needle assembly comprising:
(paragraph 139; needle insertion mechanism (not enumerated) of the embodiment of fig 17-23)
a needle;
(needle 3214; fig 17-23)
a cannula into which the needle is inserted;
(cannula 3260; fig 17-23)
a first holder supporting the needle;
(needle hub 3212; fig 17-23)
a sleeve in which the first holder is disposed in an inner space thereof; and
(housing 3202 is illustrated in fig 17-23 as retaining needle hub 3212 radially within housing 3202)
a second holder supporting the cannula, disposed to face one side of the first holder, and
(the claimed second holder comprises the retainer 3282 and clip 3286; fig 17-23)
having a first end
(end (not enumerated) of clip 3286 extending toward surfaces 3286b; fig 20; see examiner's annotation of DeStefano's fig 20 below)
and a second end which extend outward,
(end (not enumerated) of clip 3286 extending toward arms 3286a; fig 20; see examiner's annotation of DeStefano's fig 20 below)
wherein at least one of the first end and the second end has an cutout part with a part removed by a preset length.
(paragraph 145; the portion (not enumerated), therein the cutout part, of the end (not enumerated) of clip 3286 containing surfaces 3286b is an undercut ramped surface, therein a part removed by a preset length, of a set length to engage arms 3320d ; see examiner's annotation of DeStefano's fig 20 below)
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Regarding claim 2, DeStefano discloses:
The needle assembly of claim 1, wherein at least one of the first end and the second end has an end extending to protrude from an outer circumferential surface of the first holder, and a part of the cutout part is disposed outside the outer circumferential surface of the first holder in a radial direction.
(See examiner's annotation of DeStefano's fig 19b demonstrating a part of the cutout part extends so as to protrude radially relative to outer circumferential surface of hub 3212)
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Regarding claim 3, DeStefano discloses:
The needle assembly of claim 2, wherein another part of the cutout part is disposed between an inner circumferential surface and the outer circumferential surface of the first holder.
(See examiner's annotation of DeStefano's fig 19b demonstrating a part of the cutout part which is disposed between the inner and outer circumferential surfaces of hub 3212)
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Regarding claim 4, DeStefano discloses:
The needle assembly of claim 1, wherein the first end extends to one side and has a first cutout part having a slit shape with an open end.
Examiner notes that broadest reasonable interpretation of the claim term " slit" to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by Merriam-Webster's dictionary: " a long narrow cut or opening".
(Examiner notes that the under cut ramped surface 3286b can be considered to have a slit shape by the manner by which it is cut depression in a surface which is longer in one dimension as compared to another, and further it may be considered to have an open end defined by the opening (not enumerated) defined by the rim (not enumerated) of the ramped surface 3286b; see examiner's annotation of fig 20 below for exact delineation of the opening/rim of DeStefano's disclosure)
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Regarding claim 5, DeStefano discloses:
The needle assembly of claim 4, wherein the second end extends to the other side and has a second cutout part extending in a longitudinal direction and having an opening with a closed end.
(The second cutout part is defined as the inwardly facing curvi-linear surface (not enumerated) of arms 3286a, which includes an opening (not enumerated) defined by the longitudinal scallop (not enumerated) in arms 3286a forming the thin portion of arms 3286a which defines the closed end/boundary of the opening; see examiner's annotation of DeStefano's figure 20 below)
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Regarding claim 7, DeStefano discloses:
A medical liquid injection device comprising:
(paragraph 139; drug pump 10 including insertion mechanism (not enumerated) of the embodiment of fig 17-23; fig 1)
a base body;
(sleeve 3220; fig 17-19)
a housing disposed above the base body;
(paragraph 75+139; housing 12 encompassing, therein above, insertion mechanism of fig 17-23; fig 1) Housing = Housing 12?
a sleeve mounted to the base body and the housing;
( housing 3202 can be considered mounted to sleeve 3220 and housing 12 in the manner by which in the inventions assembled form, illustrated in fig 1-2, housing 3202 is fixedly secured to housing 12 and sleeve 3220 is axially retained within housing 3202, illustrated in fig 17-19)
a first holder inserted into an inner space of the sleeve and supporting a needle; and
(needle hub 3212 within housing 3203 and supporting needle 3214; fig 17-23)
a second holder supporting
(the claimed second holder comprises the retainer 3282 and clip 3286; fig 17-23)
a cannula into which the needle is inserted, disposed to face one side of the first holder, and
(cannula 3260; fig 17-23)
having a first end
(end (not enumerated) of clip 3286 extending toward surfaces 3286b; fig 20; see examiner's annotation of DeStefano's fig 20 below)
and a second end which extend outward,
(end (not enumerated) of clip 3286 extending toward arms 3286a; fig 20; see examiner's annotation of DeStefano's fig 20 below)
wherein at least one of the first end and the second end has an cutout part with a part removed by a preset length.
(paragraph 145; the portion (not enumerated), therein the cutout part, of the end (not enumerated) of clip 3286 containing surfaces 3286b is an undercut ramped surface, therein a part removed by a preset length, of a set length to engage arms 3320d ; see examiner's annotation of DeStefano's fig 20 below)
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Regarding claim 8, DeStefano discloses:
The medical liquid injection device of claim 7, wherein at least one of the first end and the second end has an end extending to protrude from an outer circumferential surface of the first holder, and a part of the cutout part is disposed outside the outer circumferential surface of the first holder in a radial direction.
(See examiner's annotation of DeStefano's fig 19b demonstrating a part of the cutout part extends so as to protrude radially relative to outer circumferential surface of hub 3212)
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Regarding claim 9, DeStefano discloses:
The medical liquid injection device of claim 7, wherein at least one of the first end and the second end has a locking protrusion protruding from an outside of the cutout part, and the base body has a ledge supporting the locking protrusion when the second holder descends.
(a ramped surface (not enumerated), therein the claimed ledge, Flex arms 3220d for a certain period during the downward travel of clip 3286 supports the outer protruding edge (not enumerated) of the claimed first end, therein locking protrusion, as arms 3220d are flexed outwardly to begin the process for locking the proximal return travel of clip 3286; see examiner's annotation of fig 19-20 delineating the disclosure of DeStefano relied upon for the claimed ledge and locking protrusion)
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Regarding claim 10, DeStefano discloses:
The medical liquid injection device of claim 7, wherein the first end extends to one side and has a first cutout part with a slit shape with an open end.
Examiner notes that broadest reasonable interpretation of the claim term " slit" to a person of ordinary skill in the art, not inconsistent with the disclosure, may be best provided by Merriam-Webster's dictionary: " a long narrow cut or opening".
(Examiner notes that the under cut ramped surface 3286b can be considered to have a slit shape by the manner by which it is cut depression in a surface which is longer in one dimension as compared to another, and further it may be considered to have an open end defined by the opening (not enumerated) defined by the rim (not enumerated) of the ramped surface 3286b; see examiner's annotation of fig 20 below for exact delineation of the opening/rim of DeStefano's disclosure)
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Regarding claim 11, DeStefano discloses:
The medical liquid injection device of claim 10, wherein the second end extends to the other side and has a second cutout part extending in a longitudinal direction and having an opening with a closed end.
(The second cutout part is defined as the inwardly facing curvi-linear surface (not enumerated) of arms 3286a, which includes an opening (not enumerated) defined by the longitudinal scallop (not enumerated) in arms 3286a forming the thin portion of arms 3286a which defines the closed end/boundary of the opening; see examiner's annotation of DeStefano's figure 20 below)
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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.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over DeStefano, as applied to claims above, in view of US 20190009020 A1, henceforth written as Kim.
Regarding Claim 6,
DeStefano discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The needle assembly of claim 1, wherein the second holder is formed such that the second end is disposed at a higher position than the first end, and
(fig 19-20 demonstrates that a proximal end of the claimed second end is disposed axially higher than the proximal end of the claimed first end)
However, DeStefano is silent regarding:
a sensor is disposed at an end of the second end.
However, Kim teaches a needle holder with a sensor wherein:
a sensor is disposed at an end of the second end of a needle holder.
(paragraph 53-54+94+96; sensor 183 has one sensing member 183b arranged on needle holder 140 and another sensing member 183a on casing 150 such that when a member 183b contacts member 183a then a determination that the needle holder 140 contacts the base of casing 150 and consequently the needle protrudes outside the cover, penetrating the patient and triggering an alarm for the user via alarm device 184 to communicate to a user that the needle is exposed; fig 2+5+8)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the needle holder to base member sensor triggering an alarm teachings of Kim to the invention of DeStefano, by disposing Kim's sensing member 183b on an underside of DeStefano's arms 3286a to contact Kim's sensing member 183a disposed on DeStefano's sleeve 3220 such that Kim's alarm device 184 is triggered when DeStefano's needle 3214 and cannula 3260 are fully exposed, in order to advantageously arrive at an invention which can provide an alert to an operator that its needle and cannula are exposed permitting an injection to occur and raising risks to an operator associated with inadvertent needle stick injuries.
Regarding Claim 12,
DeStefano discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The medical liquid injection device of claim 7, wherein the second holder is formed such that the second end is disposed at a higher position than the first end,
(fig 19-20 demonstrates that a proximal end of the claimed second end is disposed axially higher than the proximal end of the claimed first end)
However, DeStefano is silent regarding:
a sensor is disposed at an end of the second end, and the sensor contacts one side of the base body when the second holder descends
However, Kim teaches a needle holder with a sensor wherein:
a sensor is disposed at an end of the second end, and the sensor contacts one side of the base body when the needle holder descends
(paragraph 53-54+94+96; sensor 183 has one sensing member 183b arranged on needle holder 140 and another sensing member 183a on casing 150 such that when a member 183b contacts member 183a then a determination that the needle holder 140 contacts the base of casing 150 and consequently the needle protrudes outside the cover, penetrating the patient and triggering an alarm for the user via alarm device 184 to communicate to a user that the needle is exposed; fig 2+5+8)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the needle holder to base member sensor triggering an alarm teachings of Kim to the invention of DeStefano, by disposing Kim's sensing member 183b on an underside of DeStefano's arms 3286a to contact Kim's sensing member 183a disposed on DeStefano's sleeve 3220 such that Kim's alarm device 184 is triggered when DeStefano's needle 3214 and cannula 3260 are fully exposed, in order to advantageously arrive at an invention which can provide an alert to an operator that its needle and cannula are exposed permitting an injection to occur and raising risks to an operator associated with inadvertent needle stick injuries.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-3pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST BLAKE DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783