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 .
Specification
The abstract of the disclosure is objected to because it exceeds 150 words in length and because it includes “[Fig. 1]” at the bottom thereof. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
The phrase “the tip” on line 11 lacks proper antecedent basis because this is the first time that a “tip” has been introduced in claim; accordingly, the term “the” in this phrase should be replaced with the term “a”.
The claim is grammatically incorrect. In order to be grammatically correct, commas should be placed around the phrase “in an initial position of the needle safety device” on line 9; alternatively, lines 9-11 could be amended to recite “wherein when the needle safety device is in an initial position”. In order to be grammatically correct, commas should be placed around the phrase “in the injection position” on line 22; alternatively, lines 22-23 could be amended to recite “wherein in the injection position”. In order to be grammatically correct, commas should be placed around the phrase “in the final position” on line 29; alternatively, lines 29-30 could be amended to recite “whereinin the final position”.
The claim is grammatically incorrect. In order to be grammatically correct, the term “into” on line 27 should be replaced with the term “to”.
Appropriate correction is required.
Claim 2 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, commas should be inserted around the phrase “in the initial position” on line 2; alternatively, lines 2-3 could be amended to recite “wherein when in the initial position”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, the term “hold” on line 4 should be replaced by the term “held” and commas should be placed around the phrase “in the initial position” on line 2; alternatively, lines 2-3 could be amended to recite “wherein in the initial position” Appropriate correction is required.
Claim 4 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, commas should be placed around the phrase “in the initial position” on lines 1-2; alternatively, lines 1-3 could be amended to recite “wherein in the initial position”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, the term “into” on line 4 should be replaced with the term “to”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, the term “into” on line 5 should be replaced with the term “to” and the phrase “to engage” on line 7 should be replaced with the term “engaging”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, commas should be inserted around the phrase “in the initial position” on line 2; alternatively, lines 2-3 could be amended to recite “wherein in the initial position”. In order to be grammatically correct, commas should be inserted around the phrase “in the initial position” on line 5; alternatively, lines 5-6 could be amended to recite “wherein in the initial position”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The claim is grammatically incorrect. In order to be grammatically correct, a comma should be placed after the term “wherein” on line 4 and before the term “then” on line 6. In order to be grammatically correct commas should be placed around the phrase “in the final position” on line 4; alternatively, line 4 could be amended to recite “if in the final position”. 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 1-15 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 1 recites the phrase “wherein the separable element is removed from the protection element and thereby separates into the at least two locking parts when the contact surface is released from the pressure contact with the injection area” on lines 24-26. The claim is grammatically incorrect. It is unclear how the separable element “separates into” the at least two locking parts when they always exist as required by this limitation. Based on the disclosure, it appears that the at least two locking parts separate from each other when the separable element is removed from the protection element; therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend lines 24-26 to recite “wherein the separable element is removed from the protection element and thereby separates from each other when the contact surface is released from the pressure contact with the injection area”.
Claims 2-13 are rejected due to their dependence on claim 1 and claims 14-15 re rejected due to their incorporation of claim 1.
Claim 7 recites the phrase “wherein optionally the separable element is in rotatable sliding engagement with the protection element”. The term “optionally” renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim is interpreted such that the limitation following the term “optionally” is not a part of the claimed invention.
Claim 9 recites the phrase “the retention means” on line 6. This phrase lacks proper antecedent basis. It is unclear whether claim 9 intended to introduce “retention means” or intended to depend from claim 8 which already introduces “retention means”. For the sake of examination, the claim is interpreted such that it depends on claim 8 instead of claim 1.
Claim 10 recites the phrase “wherein optionally the protection element comprises a protrusion and the separable element comprises a groove, wherein in the initial position the protrusion and the groove are in engagement”. The term “optionally” renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim is interpreted such that the limitation following the term “optionally” is not a part of the claimed invention.
Claim 11 recites the phrase “wherein optionally the hub portion and/or the separable element have separating means for moving the at least two locking parts radially outward”. The term “optionally” renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim is interpreted such that the limitation following the term “optionally” is not a part of the claimed invention.
Claim 12 recites the phrase “wherein if in the final position, a pressure is applied onto the contact surface such that at least one of the separated locking parts abuts the first abutment surface and the second abutment surface then the protection element is blocked by said separated locking part from returning into the injection position”. The term “if” renders the claim indefinite because it is unclear whether the limitation following the term is a part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim is interpreted such that the limitation following the term “if” is not a part of the claimed invention.
Additionally, the phrase “said separated locking part” on line 7 lacks proper antecedent basis. Claim 1 sets forth that the at least two locking parts are “separated” and line 5 refers to “at least one” of the separated locking parts. Because line 7 does not say “said at least one separated locking part”, it is unclear if line 7 is intended to refer to any of the separated locking parts or the “at least one” separated locking part of line 5. For the sake of examination, the latter is the interpretation applied to the claim. Accordingly, it is suggested to amend line 7 to recite “”said at least one separated locking part”.
Allowable Subject Matter
Claims 1-15 would be allowable if rewritten or amended to overcome the objections and the 35 U.S.C. 112(b) rejections set forth above.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the independent claims could not be found nor was suggested in the prior art of record.
Independent claim 1 requires a needle safety device comprising: (a) an elongated hub portion with a cannula having a tip; (b) a tubular protection element comprising a contact surface for establishing pressure contact with an injection area; the tubular protection element movable along a longitudinal axis of the hub portion relative to the hub portion; the tubular protection element having an initial position wherein the contact surface is further spaced apart from the hub portion than the tip of the cannula, an injection position when the contact surface is brought into pressure contact with the injection area wherein the tip of the cannula is further spaced apart from the hub portion along the longitudinal axis than the contact surface, and a final position wherein the contact surface is further spaced apart from the hub portion along the longitudinal axis than the tip of the cannula; (c) a tubular separable element comprising at least two locking portions and removably arranged in the protection element in the initial position such that the separable element is movable along the longitudinal axis with the protection element; the separable element being removed from the protection element and thereby separating the at least two locking parts from each other when the contact surface is released from the pressure contact with the injection area, such that the separated at least two locking parts block the protection element from returning into the injection position when the protection element has moved to the final position; and (d) a spring element which biases the protection element in a distal direction relative to the hub portion such that the contact surface is further spaced apart from the hub portion along the longitudinal axis than the tip of the cannula when the contact surface is not in pressure contact with the injection area.
Independent claim 16 requires a medical injection device comprising the device of claim 1 and, therefore, incorporates all the required features of claim 1.
The closest prior art of record is PG PUB 2018/0147366 to Aneas which discloses a needle safety device (Fig 1-19) comprising (a) an elongated hub portion 8 with a cannula 10 having a tip 10.1; (b) a tubular protection element 18 comprising a contact surface 182 for establishing pressure contact with an injection area (as seen in Para 68); the tubular protection element movable along a longitudinal axis of the hub portion relative to the hub portion (as seen in Fig 17 to 19); the tubular protection element having an initial position (seen in Fig 17) wherein the contact surface is further spaced apart from the hub portion than the tip of the cannula, an injection position (seen in Fig 8) when the contact surface is brought into pressure contact with the injection area wherein the tip of the cannula is further spaced apart from the hub portion along the longitudinal axis than the contact surface, and a final position (as seen in Fig 14) wherein the contact surface is further spaced apart from the hub portion along the longitudinal axis than the tip of the cannula; (c) a tubular separable element 16b comprising at least two locking portions 166 and removably arranged in the protection element in the initial position such that the separable element is movable along the longitudinal axis with the protection element (as seen in Fig 17,18); the at least two locking parts separating from each other, such that the separated at least two locking parts block the protection element from returning into the injection position when the protection element has moved to the final position (Para 62); and (d) a spring element 20 which biases the protection element in a distal direction relative to the hub portion such that the contact surface is further spaced apart from the hub portion along the longitudinal axis than the tip of the cannula when the contact surface is not in pressure contact with the injection area (Para 70). Aneas discloses that the at least two locking parts separate from each other between the initial position and the injection position (as seen in Fig 18, Para 72) and remain the same distance from each other when the contact surface is released from the pressure contact with the injection (as seen in Fig 10); additionally, Aneas’s separable element is removed from the protection after the at least two locking portions have been separated from each other (as seen in Fig 6). Therefore, Aneas does not disclose that the separable element is removed from the protection element and thereby separates the at least two locking parts separate from each other when the contact surface is released from the pressure contact with the injection area, as claimed.
Another close prior art of record is PG PUB 2013/0197474 to Bilton which discloses a needle safety device 100 (Fig 1,2) comprising (a) an elongated hub portion 112 with a cannula 116 having a tip 156, (b) a tubular protection element 136 with a contact surface (at the distal most end thereof) configured to be in an initial position (Fig 2), an injection position (Fig 3) and a final position (Fig 4A), (c) a tubular separable element 134 comprising two locking parts 306,308 (Fig 3) movable with the tubular protection element (as seen in Fig 2 to Fig 3) and removable from the protection element when the contact surface is released from pressure contact with the injection element such that the at least two locking parts block the protection element from returning into the injection position when the protection element has moved to the final position (Para 104), and (d) a spring element 138. However, Bilton fails to disclose that the contact surface is further spaced apart from the hub than the tip of the cannula in the initial position, that the tubular separable element is arranged in the protection element in the initial position, and that the two locking parts separate from each other when the contact surface is released. Although it would have been obvious to one of ordinary skill in the art to modify the device to include the tubular protection element such that its contact surface is further spaced apart from the hub than the tip of the cannula (in order to more securely protect the user from piercing by the cannula before use), it would not have been obvious to one of ordinary skill in the art to modify the device so that the two locking parts separate from each other when the contact surface is released or to include the tubular separable element such that it is arranged in the protection element in the first position because doing so would prevent the operation of the device (since the locking parts 306,308 engage with clip features 302,304 prior to the contact surface being released from pressure contact with the injection area in order for the tubular separable element to be removed from the protection element – Para 103).
Other relevant prior art directed to similar needle safety devices includes PG PUB 2015/0343154 to Liversidge, PG PUB 2022/0370720 to Fiard et al., US Pat 11,738,156 to Perot et al. and PG PUB 2024/0091462 to Yin.
However, none of these references – alone or in combination – disclose or suggest a needle safety device comprising all of the features and configurations recited in claim 1. Additionally, such a needle safety device could not be found nor was suggested elsewhere in the prior art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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