DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1, 5, 6, 8, 10, 14, 15 and 17 are objected to because of the following informalities: Each of these claims are grammatically incorrect due to them missing commas. It is suggested to insert a comma after the term “wherein” on lines 10, 14, and 16 of claim 1, line 1 of claim 5, line 3 of claim 6, line 1 of claim 8, lines 7, 11 and 14 of claim 10, line 1 of claim 14, line 3 of claim 15, and line 1 of claim 17 and to insert a comma after the term “and” on line 18 of claim 1 and line 16 of claim 10. Appropriate correction is required.
Claims 6 and 15 are objected to because of the following informalities: Line 5 of each of the claims should be amended to recite “the at least one radially protruding retaining element” to match the language used earlier in the claims. Appropriate correction is required.
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 4-7 and 13-16 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.
Claims 4 and 13 each recite “wherein the at least one radially protruding retaining element is arranged radially further away from a longitudinal axis of the injection device relative to the plunger rod”. This language renders it unclear if the position of the at least one radially protruding element is being compared to the plunger rod or if the statement is incomplete. Based on the specification, it appears that the position of the at least one radially protruding element is being compared to the position of the plunger rod; therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend claims 4 and 13 to each recite “wherein the at least one radially protruding retaining element is arranged radially further away from a longitudinal axis of the injection device than the plunger rod”. Claims 5 and 14 are rejected due to their dependence on claims 4 and 13, respectively.
Claims 6 and 15 recite “wherein during at least a portion of the dispensing operation, the at least one radially protruding retaining element is arranged radially closer to the longitudinal axis, and at an end of the dispensing operation, the retaining element is outwardly deflected and arranged radially further away from the longitudinal axis” on lines 3-6. The language of this limitation is indefinite as it does not specify what position the “radially closer” pertains to. Based on the specification, it appears that the “radially closer” pertains to the at least one radially protruding retaining element during the dispensing operation versus at the end of the dispensing operation; therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend claims 6 and 15 to each recite “wherein, during at least a portion of the dispensing operation, the at least one radially protruding retaining element is arranged radially closer to the longitudinal axis[[,]] [[and]] than at an end of the dispensing operation[[,]] in which the retaining element is outwardly deflected and arranged radially further away from the longitudinal axis”. Claims 7 and 16 are rejected due to their dependence on claims 6 and 15, respectively.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 8-10, 17 and 18 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Ratjen et al. (PG PUB 2011/0251553).
Re claim 1, Ratjen discloses an injection device (Fig 1; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) for administering a substance (Para 1), comprising: a housing 10+62; a plunger rod 60 which can be moved in the housing by an injection spring 64 (Para 44) which is supported against the housing or against an element 12 connected to the housing (as seen in Fig 1, the proximal end of the spring is supported against the housing); a syringe 14 fixedly mounted in the housing or to the element connected to the housing (Para 33; as seen in Fig 1 the syringe is mounted to element 12), the syringe configured to hold the substance to be administered (Para 33) and comprising a needle 32 (Para 41, “when the container is a syringe, the delivery member is already mounted on the container”) and a stopper 22 (as seen in Fig 1), wherein the plunger rod is configured to push against and move the stopper for dispensing the substance (Para 44); a protective sleeve 34 and a protective sleeve spring 40 configured to urge the protective sleeve in a distal direction (to the right in Fig 1) (Para 44), wherein when the protective sleeve is pushed against an injection surface, the protective sleeve moves in a proximal direction (to the left in Fig 1) and into the housing and the needle is caused to be manually inserted into the injection surface in an insertion position (seen in Fig 5) of the protective sleeve (Para 43), wherein when the protective sleeve is in the insertion position, a dispensing operation dispensing the substance from the syringe can be automatically triggered (Para 44), wherein upon removal of the injection device from the injection surface, the protective sleeve spring pushes the protective sleeve in the distal direction into a front-most position (seen in Fig 7) to a locked state (Para 44) and during movement to the locked state, an arm 42 of the protective sleeve is pushed radially outwardly by at least one radially protruding retaining element 26 associated with the plunger rod (it is noted that the term “associated” is broad and all components of the injection device are “associated with” each other) in the dispensed position until the arm of the protective sleeve and the at least one radially protruding retaining element snap over each other to reach the locked state such that the protective sleeve is blocked from moving relative to the housing (as seen in moving from Fig 6 to Fig 7, the arm 42 will be pushed outward by 26 as arm 42 moves thereover; Para 44).
Re claim 8, Ratjen discloses that prior to the protective sleeve reaching the insertion position, the dispensing operation is prevented (Para 43,44).
Re claim 9, Ratjen discloses that the protective sleeve is mounted in the housing so that the protective sleeve is prevented from rotating (due to the engagement of ledges 24 with slits 36, Para 34).
Re claim 10, Ratjen discloses an injection device (Fig 1; it is noted that all reference characters cited below refer to Fig 1,2 unless otherwise noted) for administering a substance (Para 1), comprising: a housing 10; a plunger rod 60 which can be moved from an initial position (seen in Fig 3) to a dispensed position (seen in Fig 6); a syringe 14 fixedly mounted in the housing or to an element 12 connected to the housing (Para 33), the syringe configured to hold the substance to be administered (Para 33) and comprising a needle 32 (Para 41, “when the container is a syringe, the delivery member is already mounted on the container”); a protective sleeve 34 and a protective sleeve spring 40 configured to urge the protective sleeve in a distal direction (to the right in Fig 1) (Para 44), wherein when the protective sleeve is pushed against an injection surface, the protective sleeve moves in a proximal direction (to the left in Fig 1) and into the housing and the needle is caused to be manually inserted into the injection surface in an insertion position (seen in Fig 5) of the protective sleeve (Para 43), wherein when the protective sleeve is in the insertion position, a dispensing operation dispensing the substance from the syringe can be automatically triggered to cause the plunger rod to be moved from the initial position to the dispensed position (Para 44), wherein upon removal of the injection device from the injection surface, the protective sleeve spring pushes the protective sleeve in the distal direction into a front-most position (seen in Fig 7) to a locked state (Para 44) and during movement to the locked state, an arm 42 of the protective sleeve is pushed radially outwardly by at least one radially protruding retaining element 26 associated with the plunger rod (it is noted that the term “associated” is broad and all components of the injection device are “associated with” each other) in the dispensed position until the arm of the protective sleeve and the at least one radially protruding retaining element snap over each other to reach the locked state such that the protective sleeve is blocked from moving relative to the housing (as seen in moving from Fig 6 to Fig 7, the arm 42 will be pushed outward by 26 as arm 42 moves thereover; Para 44).
Re claim 17, Ratjen discloses that prior to the protective sleeve reaching the insertion position, the dispensing operation is prevented (Para 43,44).
Re claim 18, Ratjen discloses that the plunger rod can be moved by an injection spring 64 (Para 44) which is supported against the housing or against the element connected to the housing (as seen in Fig 1).
Allowable Subject Matter
Claims 2-7 and 11-16 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and rewritten to overcome the objections and 35 U.S.C. 112, 2nd paragraph rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of dependent claims 2, 3 (upon which claims 4 and 5 depend), and 6 (upon which claim 7 depends) could not be found nor was suggested in the prior art of record in combination with the subject matter of claim 1 and the subject matter of claims 11, 12 (upon which claims 13 and 14 depend) , and 15 (upon which claim 16 depends) could not be found nor was suggested in the prior art of record in combination with the subject matter of claim 10.
Claims 2 and 11 require the at least one radially protruding retaining element to be “slaved by the plunger rod during the dispensing operation”. Ratjen’s retaining element 26 is formed on medicament container holder 12 and, therefore, not “slaved by the plunger rod during the dispensing operation” as claimed. It would not have been obvious to one of ordinary skill in the art to modify Ratjen to relocate retaining element 26 from the medicament container holder 12 to a structure that allows it to be “slaved by the plunger rod” as doing so would at least require substantial redesign of the entire device in order to ensure operation if not render the device inoperable.
Claims 3 and 12 require the plunger rod to cause the at least one radially protruding retaining element to be “outwardly deflected at an end of the dispensing operation”. Ratjen’s retaining element 26 is formed on medicament container holder 12 and is not “outwardly deflected” at any point in operation. It would not have been obvious to one of ordinary skill in the art to modify Ratjen to form the retaining element 26 as one that can be “outwardly deflected” as doing so would render the device inoperative since the retaining element must be static in order for the arm 42 to move thereover.
Claims 6 and 15 require the at least one radially protruding retaining element to be “radially deflected relative to a longitudinal axis of the injection device” wherein the at least one radially protruding retaining element is “arranged radially closer to the longitudinal axis” during at least a portion of the dispensing operation than at an end of the dispensing operation in which the at least one radially protruding retaining element is “outwardly deflected and arranged further away from the longitudinal axis”. Ratjen’s retaining element 26 is formed on medicament container holder 12 and is not “radially deflected” at any point in operation. It would not have been obvious to one of ordinary skill in the art to modify Ratjen to form the retaining element 26 as one that can be “radially deflected” as doing so would render the device inoperative since the retaining element must be static in order for the arm 42 to move thereover.
PG PUB 2010/0262083 to Grunhut et al. discloses the inventions of independent claims 1 and 10 in a similar manner to Ratjen, but do not disclose or teach the subject matter of claims 2-7 and 11-16. Additionally, the combination of features required in each of claims 2, 3, 6, 11, 12 and 15 could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Marshall et al. (PG PUB 2004/0215151) discloses all the claimed features of the independent claims except that Marshall’s arm is not pushed radially outward by the retaining element. Carrel et al. (PG PUB 2010/0268170) discloses all the claimed features of the independent claims except that Carrel’s arm is pushed circumferentially, not radially.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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