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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on 4/20/2026 is acknowledged. The traversal is on the ground(s) that Group I and Group III (claims 18-20) should be examined together in view of amended claim 1 which requires all the limitations of claim 18. In response, examiner has included Groups I and III together thereby examining claims 1-15 and 18-20.
Specification
The disclosure is objected to because of the following informalities:
The reference character “108” has been used to refer to “syringe on page 19, line 12 and “safety device” on page 19, line 11.
The reference character “118” has been used to refer to “safety device” on page 34, last line and “cylindrical body” on page 34, lines 29-30.
Appropriate correction is required.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities:
Claim 1 recites the limitation “the sheath portion” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation “the sheath portion” in line 5. There is insufficient antecedent basis for this limitation in the claim.
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 and 18-20 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 1, the recitation “a guard sheath including: … an internal member” renders the claim indefinite because the specification discloses on page 12, lines 23-24 that element 118 could be considered as guard sheath and element 108 includes element 124 which is referred as internal base member therefore, the guard sheath does not include an internal member as claimed in claim 1. For examination purposes, examiner construes that guard sheath is a combination of a sheath and the internal member together.
Claims 2-15 being dependent on claim 1 are also rejected.
Regarding claim 12, the recitation “an interface element” in line 1 renders the claim indefinite because the claim is unclear if “an interface element” refers to “an interface element” recited in claim 1, line 8 or additional. For examination purposes, examiner construes that “an interface element” in claim 12 refers to “an interface element” recited in claim 1. Claim 12 appears to overcome the rejection under 35 U.S.C. 112 if claim 12 is amended to recite “the interface element”.
Regarding claim 14, line 3, the recitation “a pathway” renders the claim indefinite because the claim is unclear if “a pathway” refers to “a pathway’ recited in claim 1 or additional. For examination purposes, examiner construes that “a pathway” recited in claim 14 refers to “a pathway” recited in claim 1.
Regarding claim 15, the recitation “an interface element” renders the claim indefinite because the claim is unclear if “an interface element” refers to “an interface element” recited in claim 1 or additional. For examination purposes, examiner construes that “an interface element” recited in claim 15 refers to “an interface element” recited in claim 1.
Regarding claim 18, the recitation “a sheath including: … an internal member” renders the claim indefinite because the specification discloses on page 12, lines 23-24 that element 118 could be considered as sheath and element 108 includes element 124 which is referred as internal base member therefore, the sheath does not include an internal member as claimed in claim 18. For examination purposes, examiner construes that sheath is a combination of a sheath and the internal member together.
Claims 19 and 20 being dependent on claim 18. are also rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4, 6, 8, 9, 12, 13, 15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hake (US 5,019,051).
Regarding claim 1, Hake teaches a system (figure 2), comprising:
a syringe 12;
a needle assembly 44 removably on the syringe 12, the needle assembly 44 including a needle (see “N” in figure 2 below) with a tip (see “T” in figure 2 below);
a safety structure (figure 1) separate and distinct from the needle assembly 44 on the syringe 12, the safety structure (figure 1) includes:
a guard sheath (integrated structure formed by elements 14, 16) including:
an interface element 36;
a pathway 24a, 24b delimited by the sheath 14, 16; and
an internal member 16 within the sheath portion 14, the internal member 16 including an extension 26a, 26b that mechanically cooperates with the pathway 24a, 24b and is configured to, during operation, allow the sheath portion 14 to move along the extension 26a, 26b;
a retracted position (position shown in figure 3) in which the tip (see “T” in figure 3 below) of the needle (see “N” in figure 3 below) is exposed from the guard sheath 14, 16 of the safety structure; and
an extended position (position shown in figure 4) in which the needle (see “N” in figure 2 below) is surrounded by the guard sheath 14, 16 of the safety structure.
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Regarding claim 2, Hake teaches wherein the guard sheath 14, 16 has a substantially cylindrical shape (see figure 2).
Regarding claim 3, Hake teaches wherein the guard sheath 14, 16 is movable along an exterior of the syringe 12 between the retracted position (position shown in figure 3) and the extended position (position shown in figure 4).
Regarding claim 4, Hake teaches wherein the safety structure includes a locking structure 42a, 42b, 28a, 28b, 34a, 34b that is configured to, during operation, lock the guard sheath 14, 16 in the extended position and in the retracted position (column 4, lines 49-60).
Regarding claim 6, Hake teaches wherein the locking structure 42a, 42b, 28a, 28b, 34a, 34b is a friction fit locking structure (column 4, lines 49-60).
Regarding claim 8, Hake teaches wherein the needle assembly 44 further comprises a hub structure (see “H” in figure 2 above) in which the needle (see “N” in figure 2 above) is present, the hub structure is removably mounted to the syringe 12.
Regarding claim 9, Hake teaches further comprises an interface element 36 at the guard sheath 16, 14 configured to, during operation, be actuated to mechanically engage (see figure 3 where element 36 is directly/indirectly mechanically engaged to element 44) with the hub structure (see “H” in figure 2 above).
Regarding claim 12, Hake teaches wherein the syringe includes a fastening structure 46 at an exterior of the syringe 12 to which the hub structure (see “H” in figure 2 above) is coupled; and the safety structure (figure 1) further includes a flange structure 40 that extends around the fastening structure 46 of the syringe 12, the flange structure is between the hub structure (see “H” in figure 2 above) and the exterior of the syringe 12 (column 4, line 68-column 5, line 12).
Regarding claim 13, Hake teaches wherein the guard sheath 14, 16 slides along the flange structure 40 between the retracted position (position shown in figure 3) and the extended position (position shown in figure 4).
Regarding claim 15, Hake teaches wherein the safety structure (figure 1) includes an interface element 36 at the guard sheath 14, 16, the interface element 36 is configured to, during operation, be actuated (see figure 3 where portion of element 16 is touching element 44 and since element 16 and element 44 are engaged by frictional engagement, pushing element 16 towards element 44 would also force element 44 to be moved and disengaged from element 12) to remove the needle (see “N” in figure 2 above) from the syringe 12.
Regarding claim 18, Hake teaches a device (figure 1), comprising:
a sheath (integrated structure formed by elements 14, 16) including:
an interface element 36;
a pathway 24a, 24b delimited by the sheath 14, 16; and
an internal member 16 within the sheath portion 14, the internal member 16 including an extension 26a, 26b that mechanically cooperates with the pathway 24a, 24b and is configured to, during operation, allow the sheath portion 14 to move along the extension 26a, 26b.
Claims 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vaillancourt (US 5,591,138).
Regarding claim 18, Vaillancourt teaches a device (figure 6), comprising:
a sheath 13, 17 including:
an interface element 27 (figure 5);
a pathway 22 delimited by the sheath 13, 17; and
an internal member 17 within the sheath portion 13, the internal member 17 including an extension 21 that mechanically cooperates with the pathway 22 and is configured to, during operation, allow the sheath portion 13 to move along the extension 21 (see figures 1-3).
Regarding claim 19, Vaillancourt teaches wherein the pathway 22 has a J-shape (figure 5, where shape of element 22 is J shaped) including:
a first end (end where element 27 is present in figure 5);
a second end (see “SE” in figure 5 below) opposite to the first end;
a first portion (see “FP” in figure 5 below) that extends from the first end of the pathway;
a second portion (see “SP” in figure 5 below) is transverse to the first portion (see “FP” in figure 5 below) and extends from the first portion (see “FP” in figure 5 below), the second portion (see “SP” in figure 5 below) is spaced apart from the first end; and
a third portion (see “TP” in figure 5 below) is transverse to the second portion (see “SP” in figure 5 below) and extends from the second portion to the second end of the pathway.
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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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hake (US 5,019,051) in view of Haibach (US 2015/0165152 A1).
Regarding claim 5, Hake discloses the claimed invention substantially as claimed, as set forth above, in claims 1 and 4 above. Hake is silent regarding wherein the locking structure is a ball detent locking structure.
However, Haibach teaches a design of an articulating headgear attachment comprising wherein the locking structure is a ball detent locking structure (paragraph 0046, lines 10-13) for the purpose using a well-known alternative configuration to lock two components together (paragraph 0046, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the locking structure of Hake to incorporate the locking structure is a ball detent locking structure as taught by Haibach for the purpose using a well-known alternative configuration to lock two components together (paragraph 0046, lines 10-13).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hake (US 5,019,051) in view of Carlsson et al. (US 2019/0001069 A1).
Regarding claim 7, Hake discloses the claimed invention substantially as claimed, as set forth above, in claims 1 and 4 above. Hake is silent regarding wherein the locking structure is a magnetic locking structure.
However, Carlsson teaches a design of an electrical information device for a drug delivery device comprising the locking structure wherein the locking structure is a magnetic locking structure (paragraph 0144, lines 8-19) for the purpose of locking engage two structures together using a well-known alternative structure (paragraph 0144, lines 8-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the locking structure of Hake to incorporate wherein the locking structure is a magnetic locking structure as taught by Carlsson for the purpose of locking engage two structures together using a well-known alternative structure (paragraph 0144, lines 8-19).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Hake (US 5,019,051) in view of Wang (US 2005/0027260 A1).
Regarding claim 10, Hake discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 9. Hake discloses the friction fit connection (column 4, lines 34-36) wherein the interface element 36 is configured to, during operation, be mechanically engage (see figure 3 where element 36 is directly/indirectly engaging to element 44) with the hub structure (see “H” in figure 2 above) in which the needle (see “N” in figure 2 above) is present to remove the hub structure and the needle from the syringe 12. However, Hake is silent regarding the interface element is a deformable element.
However, Wang teaches a design of a safety syringe comprising an interface element 23 (figure 8A) wherein the interface element 23 is a deformable element (paragraph 0037, lines 4-13) for the purpose of using a well-known alternative form of a connection system (paragraph 0037, lines 4-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the interface element of Hake to incorporate the interface element is a deformable element as taught by Wang for the purpose of using a well-known alternative form of a connection system (paragraph 0037, lines 4-13).
Regarding claim 11, Hake discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 9. Hake is silent regarding wherein the deformable element is configured to, during operation, be deformed towards the hub structure.
However, Wang teaches the deformable element is configured to, during operation, be deformed towards radially inwards (paragraph 0037, lines 4-13, element 23 is deforming towards element 36 when engaging element 36 due to presence of recess) for the purpose of using a well-known alternative form of a connection system (paragraph 0037, lines 4-13).
Hake modified in view of Wang will result in having the deformable element being configured to deformed towards the hub structure because hub structure is located along the radially inward direction from element 16 of Hake and therefore, modified structure of Hake in view of Wang will result in having element 23 of Wang to be deforming towards radially inward directly and thus towards the hub structure.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the interface element of Hake to incorporate wherein the deformable element is configured to, during operation, be deformed towards the hub structure as taught by Wang for the purpose of using a well-known alternative form of a connection system (paragraph 0037, lines 4-13).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Vaillancourt (US 5,591,138) and further in view of Restelli et al. (US 2005/0010136 A1).
Regarding claim 20, Vaillancourt discloses the claimed invention substantially as claimed, as set forth above in claim 18. Vaillancourt is silent regarding the interface element is an elastically deformable element. However, one can construe that element 27 has to be elastically deformable element in order for element 21 to enter into element 27.
However, Restelli teaches a design of a needle guard sheath wherein the interface element 24 (figure 1) is elastically deformable element (paragraph 0038, lines 2-5) for the purpose of allowing the engagement of the extension in locking manner (paragraph 0049, lines 7-14).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the interface element of Vaillancourt to incorporate an elastically deformable element as taught by Restelli for the purpose of allowing the engagement of the extension in locking manner (paragraph 0049, lines 7-14).
Allowable Subject Matter
Claim 14 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Vaillancourt (US 5,591,138), is silent regarding wherein: the flange structure includes an extension; and the guard sheath of the safety structure includes a pathway in the guard sheath, the pathway receives the extension, and the pathway is configured to, during operation, allow the guard sheath to slide along the extension between the retracted position and the extended position in combination with other claimed limitations of claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ranford (US 4,994,045): discloses a design of a syringe with a guard sheath comprising a pathway delimited by the sheath.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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