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 Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites “the clip members” in line 2. This should be amended to “the one or more clip members” in order to be consistent with claim 11.
Claim 12 recites “the protrusions” in lines 2-3. This should be amended to “the one or more protrusions” in order to be consistent with claim 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-24 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.
As to claim 1, the wording of “an extended position and a retracted position in which a distal point of the needle is exposed” in lines 6-7 is ambiguous as to whether the distal point of the needle is exposed when the movable portion is in both the extended position and the retracted position, or exposed only when the movable portion is in the retracted position. Applicant could clarify the claim by amending to describe a condition of the distal point of the needle in the extended position. For the sake of compact prosecution, the examiner will assume that the distal point of the needle is exposed only when the movable portion is in the retracted position.
Claims 2-13 and 22-24 are rejected as they depend from and/or require all the limitations of rejected claim 1.
As to claim 14, the wording of “an extended position and a retracted position in which a distal point of the needle is exposed” in lines 9-10 is ambiguous as to whether the distal point of the needle is exposed when the movable portion is in both the extended position and the retracted position, or exposed only when the movable portion is in the retracted position. Applicant could clarify the claim by amending to describe a condition of the distal point of the needle in the extended position. For the sake of compact prosecution, the examiner will assume that the distal point of the needle is exposed only when the movable portion is in the retracted position.
Claims 15-21 are rejected as they depend from and/or require all the limitations of rejected claim 14.
Claim 23 introduces numerous components in the first stanza of the claim, however claim 22 required “providing an injection apparatus according to claim 1” wherein the injection apparatus according to claim 1 already requires similar components. In other words, it is unclear why claim 23 essentially reintroduces components such as one or more extension members, a head portion, a movable portion, etc… and this creates confusion over which component other sections of claim 23 refer to (for example whether “the movable portion” in line 10 refers to the movable portion introduced in claim 23 or the movable portion that is part of the injection apparatus of claim 1 introduced in claim 22). The first full stanza of claim 23 is likely unnecessary to include.
Claim 24 recites the step of “assembling the components to form an injection apparatus according to claim 1” in line 10. However, based on the first full stanza of claim 24, it could be argued that an apparatus is already “assembled”. In other words, the claim already recites many of the components being coupled (e.g. “a needle fluidly coupled to the base member”, “a safety cover removably coupled to the base member”, etc…) in a manner similar to claim 1. It is not clear what then is actually required by the step of “assembling” (i.e. what parts must additionally be coupled or when the apparatus is considered to be assembled vs not assembled).
Allowable Subject Matter
Claims 1-24 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The examiner notes that any claim amendments may affect the prior art considerations of each claim.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 1, the closest prior art appears to be Khalaj (US 2005/0261633 A1). Khalaj discloses:
An injection apparatus, comprising:
a hand-held unit (10) having a head portion (upper horizontal portion which includes at least buttons 20a-20b and cradle assembly 16) and a body portion (non-numbered handle portion and/or portion including battery 40), the head portion comprising
a base member (56 and/or 54),
a needle (52) fluidly coupled to the base member,
a movable portion (38) disposed over the needle and being axially movable relative to the base member between an extended position and a retracted position in which a distal point of the needle is exposed (see Figs. 1-2 and para 0030),
a safety cover (clamp 42) removably coupled to the base member (clamp is depicted with a tightening screw but it is also clear from description of locking/unlocking lid 64 that different syringes can be replaced – see para 0028, 0032), the safety cover comprising one or more extension members (two uppermost portions of the “Y” shape – see Figs. 1-4 and para 0028), and
an adjustment member (38b) coupled to the movable portion and configured to adjust a penetration depth of the needle by increasing or decreasing a distance between the movable portion and the base member (para 0030).
However, Khalaj is silent to the adjustment member being removably coupled to the movable portion as required by claim 1. None of the prior art of record appears to teach a manner of modifying Khalaj to satisfy this limitation in combination with the rest of the limitations of claim 1.
As to claim 1, the examiner also acknowledges the International Search Report in corresponding PCT/IB2021/057450, which indicated similar claim 1 as novel.
Claims 2-13 and 22-24 depend from and/or require all the limitations of claim 1.
As to claim 14, the closest prior art of record appears to be Khalaj. Khalaj discloses:
An injection apparatus, comprising:
a hand-held unit (10) having a head portion (upper horizontal portion which includes at least buttons 20a-20b and cradle assembly 16) and a body portion (non-numbered handle portion and/or portion including battery 40), the head portion comprising
a base member (56 and/or 54),
a needle (52),
a safety cover (clamp 42) coupled to the base member (see para 0028, 0032), the safety cover comprising one or more extension members (two uppermost portions of the “Y” shape – see Figs. 1-4 and para 0028),
a movable portion (38) disposed over the needle and being axially movable relative to the base member between an extended position and a retracted position in which a distal point of the needle is exposed (see Figs. 1-2 and para 0030),
an adjustment member coupled to the movable portion such that rotation of the adjustment member adjusts a penetration depth of the needle by increasing or decreasing a distance between the movable portion and the base member (para 0030).
However, Khalaj is silent to the base member comprising a connecting tube and an annular bore defined around the connecting tube, the needle fluidly coupled to the connecting tube, the one or more extension members extending past a distal end of the needle, a support member disposed within the annular bore of the base member, and the adjustment member being rotatably coupled to the support member and releasably coupled to the movable portion. No reference was found that would have made it obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Khalaj to satisfy all the limitations of claim 14.
Claims 15-21 depend from claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783