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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 05/11/2026. Claims 1-20 are currently pending and being examined.
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 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.
Election/Restrictions
No claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/11/2026.
Claim Objections
Claims 2, 3, 6, 16, 17, and 20 are objected to because of the following informalities: The claims recite “the top wall”. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the top surface”. Appropriate correction is required.
Claims 1, 3, 6, 10, 12, 15, 17, and 20 are objected to because of the following informalities: The claims recite “the sheath” in various locations. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the elongated sheath”. Claim language switches back and forth between “sheath” and “elongated sheath” throughout, applicant should be consistent. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim 9 recites “the joint portion” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the at least one joint portion”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim 9 recites “the bottom wall” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the bottom surface”. Appropriate correction is required.
Claim 14 recites “so that top surface”, examiner believes applicant meant it to read “so that the top surface”.
Claim 15 is objected to because of the following informalities: claim 15 recites “the needle” in line 8. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the elongated needle”. Appropriate correction is required.
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.
Claims 1, 2, 9, 11, 12, 15, and 16 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russell (USPN 5,066,279).
In reference to independent claim 1, Russell discloses a needle assembly (fig 1-4) including: an elongated needle (12 is interpreted to be an elongated needle as applicant’s specification sets no clear standard for what “elongated” means) including a proximal end (left side of fig 2) and a distal end (right side of fig 2); and an elongated sheath (10 is interpreted to be an elongated sheath as applicant’s specification sets no clear standard for what “elongated” means) configured to slidably receive the elongated needle (12) therein, the elongated sheath (10) including a top surface (top of 10), a bottom surface (bottom of 10), a proximal end (left of 10), a distal end (right side of 10), and at least one joint portion (38) formed adjacent or proximate the distal end of the sheath (seen in fig 2, the joint portion is adjacent the distal end of the sheath), wherein the at least one joint portion (38) is disposed adjacent or proximate the distal end of the sheath so that a bend in the elongated sheath at the at least one joint portion produces a bend in the needle adjacent or proximate the distal end thereof (fig 4 shows a bend in the needle 12 at least adjacent to the distal end of the sheath 10).
In reference to independent claim 15, Russell discloses a sheath assembly (10 in fig 1-4) for use with an elongated needle (12 is interpreted to be an elongated needle as applicant’s specification sets no clear standard for what “elongated” means), comprising: an elongated sheath (10 is interpreted to be an elongated sheath as applicant’s specification sets no clear standard for what “elongated” means) configured to slidably receive the elongated needle therein (seen in fig 2), the elongated sheath (10) including a top surface (top of 10), a bottom surface (bottom of 10), a proximal end (left of 10), a distal end (right side of 10), and at least one joint portion (38) formed adjacent or proximate the distal end of the sheath (seen in fig 2, the joint portion is adjacent the distal end of the sheath), wherein the elongated needle (12) is slidably received in the elongated sheath (10), and wherein the at least one joint portion (38) is disposed adjacent or proximate the distal end of the sheath so that a bend in the elongated sheath at least one joint portion produces a bend in the needle adjacent or proximate the distal end thereof (fig 4 shows a bend in the needle 12 at least adjacent to the distal end of the sheath 10).
In reference to dependent claim 2, Russell discloses the needle assembly of claim 1, wherein the at least one joint portion (38) includes an elongated groove that is formed in the top wall of the elongated sheath (38 is made up of multiple grooves), and a longitudinal axis of the elongated groove is perpendicular to a longitudinal axis of the elongated needle (the elongated grooves that make up 38 are perpendicular to the longitudinal axis of the needle).
In reference to dependent claim 9, Russell discloses the needle assembly of claim 2, wherein the joint portion (38) of the elongated sheath (10) further comprises an elongated groove formed in the bottom wall of the sheath opposite the elongated groove formed in the top wall of the sheath (38 is made up of multiple grooves that surround 10).
In reference to dependent claim 11, Russell discloses the needle assembly of claim 2, further comprising an injection device in fluid communication with the proximal end of the elongated needle (hypodermic needle 13 is shown attached to the needle 12).
In reference to dependent claim 12, Russell discloses the needle assembly of claim 2, wherein the at least one joint portion (36) comprises a first joint portion (right groove of 38) formed a first distance from the distal end of the sheath (10) and a second joint portion (left groove of 38) formed a second distance from the distal end of the sheath (10), wherein the first joint portion (right groove of 38) is disposed between the second joint portion (left groove of 38) and the distal end of the sheath (right end of 10).
In reference to dependent claim 16, Russell discloses the sheath assembly of claim 15, wherein the at least one joint portion (38) includes an elongated groove that is formed in the top wall of the elongated sheath (38 is made up of multiple grooves that surround 10), and a longitudinal axis of the elongated grove is perpendicular to longitudinal axis of the elongated needle (the elongated grooves that make up 38 are perpendicular to the longitudinal axis of the needle).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 3-5, 14, and 17-19 rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Owen (USPN 4,007,740).
In reference to dependent claim 3, Russell discloses the needle assembly of claim 2, wherein the elongated groove (38 is made up of multiple grooves that surround 10) depends inwardly (grooves extend inwardly) with respect to an outer surface of the top wall of the sheath (top wall of 10), however
Russell does not teach the outer surface is planar.
Owen, a similar needle cap, teaches wherein the elongated groove (40d, fig 9) depends inwardly with respect to a planar outer surface of the top wall of the sheath (top of 12d, fig 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the shape of Owen in the assembly of Russell “to provide an economical means for sealing a cannula and which offers a flat surface which can be used for leverage to break the cover” col 1, lines 49-51.
In reference to dependent claim 4, Russell in view of Owen discloses the needle assembly of claim 3, Russel further discloses a needle assembly wherein the elongated groove (38 is made up of multiple grooves that surround 10) is V-shaped groove (38 shows grooves that are V-shaped) having a first side wall and a second side wall that together define an internal angle of less than 200 and greater than zero degrees (the grooves appear to be about 90 degrees, within applicant’s claimed range, see fig 2).
In reference to dependent claim 5, Russell discloses the needle assembly of claim 4, Russel further discloses a needle assembly wherein the internal angle defined between the first side wall and the second side wall of the elongated groove is less than 100 and greater than zero degrees (the grooves appear to be about 90 degrees, within applicant’s claimed range, see fig 2).
In reference to dependent claim 14, Russell discloses the needle assembly of claim 2, Russell further discloses a needle assembly wherein the proximal end of the elongated sheath (32, fig 3 and 4) is cylindrical (32 is cylindrical), however
Russell does not teach the distal end of the elongated sheath is rectangular so that top surface and the bottom surface are substantially parallel at the distal end of the elongated sheath.
Owen, a similar needle cap, teaches the proximal end of the elongated sheath is cylindrical (right side of fig 9 is cylindrical) and the distal end of the elongated sheath is rectangular (left side of fig 9 is rectangular) so that top surface and the bottom surface are substantially parallel at the distal end of the elongated sheath (fig 9 shows a cap wherein the top and bottom are substantially parallel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the shape of Owen in the assembly of Russell “to provide an economical means for sealing a cannula and which offers a flat surface which can be used for leverage to break the cover” col 1, lines 49-51.
In reference to dependent claim 17, Russell discloses the sheath assembly of claim 16, wherein the elongated groove (38 is made up of multiple grooves that surround 10) depends inwardly (grooves extend inwardly) with respect to an outer surface of the top wall of the sheath (top wall of 10), however
Russell does not teach the outer surface is planar.
Owen, a similar needle cap, teaches wherein the elongated groove (40d, fig 9) depends inwardly with respect to a planar outer surface of the top wall of the sheath (top of 12d, fig 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the shape of Owen in the assembly of Russell “to provide an economical means for sealing a cannula and which offers a flat surface which can be used for leverage to break the cover” col 1, lines 49-51.
In reference to dependent claim 18, Russell in view of Owen discloses the sheath assembly of claim 17, Russel further discloses a needle assembly wherein the elongated groove (38 is made up of multiple grooves that surround 10) is V-shaped (38 shows grooves that are V-shaped) having a first side wall and a second side wall that define an internal angle of less than 200 (the grooves appear to be about 90 degrees, within applicant’s claimed range, see fig 2).
In reference to dependent claim 19, Russell in view of Owen discloses the sheath assembly of claim 18, Russel further discloses a needle assembly wherein the internal angle defined between the first side wall and the second side wall of the elongated grove is less than 100 (the grooves appear to be about 90 degrees, within applicant’s claimed range, see fig 2).
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Owen (USPN 4,007,740) further in view of Laub (USPN 2,959,170).
In reference to dependent claim 6, Russell in view of Owen discloses the needle assembly of claim 3, however
Russell, and Owen do not teach the distal end of the elongated needle further comprises a primary bevel disposed toward the top wall of the sheath so that a heel of the primary bevel is closer to the top wall of the sheath than is an apex of the primary bevel.
Laub, a similar needle cap, teaches the distal end of the elongated needle (13) further comprises a primary bevel (bevel in fig 2 and 4 of needle 13) disposed toward the top wall of the sheath (30) so that a heel of the primary bevel is closer to the top wall of the sheath than (30) is an apex of the primary bevel (fig 2 shows a bevel closer to the top of the sheath than the apex of the needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bevel orientation of Laub in the assembly of Russell in view of Owen so the needle fits into the sheath against the inside of the sheath.
In reference to dependent claim 20, Russell in view of Owen discloses the sheath assembly of claim 17, however
Russell and Owen do not teach the distal end of the elongated needle further comprises a bevel disposed toward the top wall of the elongated sheath so that a heel of the bevel is closed to the top wall of the sheath than is an apex of the bevel.
Laub, a similar needle cap, teaches the distal end of the elongated needle (13) further comprises a bevel (bevel in fig 2 and 4 of needle 13) disposed toward the top wall of the elongated sheath (30) so that a heel of the bevel is closed to the top wall of the sheath than is an apex of the bevel (fig 2 shows a bevel closer to the top of the sheath than the apex of the needle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bevel orientation of Laub in the assembly of Russell in view of Owen so the needle fits into the sheath against the inside of the sheath.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Owen (USPN 4,007,740) further in view of Laub (USPN 2,959,170) in reference to claim 6 above and further in view of Cumbo (USPAP 2018/0117263).
In reference to dependent claim 7, Russell in view of Owen and Laub discloses the needle assembly of claim 6, however
Russell, Owen and Laub do not teach the elongated needle further comprises a pair of secondary bevels formed in a face surface of the primary bevel at the apex of the primary bevel.
Cumbo, a similar needle, discloses the elongated needle further comprises a pair of secondary bevels (145 and 150, fig 4) formed in a face surface of the primary bevel at the apex of the primary bevel (as seen in fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the secondary bevels of Cumbo on the needle assembly of Russell in view of Owen and Laub so “the tip does not cause the tissue any damage” para 0011, Cumbo. By adding the secondary bevels the needle can enter easier decreasing trauma to the patient.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Owen (USPN 4,007,740) further in view of Laub (USPN 2,959,170) in reference to claim 6 above and further in view of Sjostrom (USPN 5,024,659).
In reference to dependent claim 8, Russell in view of Owen and Laub discloses the needle assembly of claim 6, however
Russell, Owen, and Laub does not teach an elongated stylet disposed within an interior of the elongated needle.
Sjostrom, a similar needle, discloses an elongated stylet (40) disposed within an interior of the elongated needle (14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the stylet of Sjostrom in the needle assembly of Russell in view of Owen and Laub because it “provides rigidity to the needle 14 which is beneficial when inserting the needle”, col 3, lines 44-46 Sjostrom.
Claim 10 are rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Parazynski (USPAP 2023/0381846).
In reference to dependent claim 10, Russell discloses the needle assembly of claim 2, however
Russell is silent to wherein the at least one joint portion of the sheath is disposed between 1.5 and 0.5 cm from the distal end of the elongated sheath
Parazynski, a similar needle system, teaches the at least one joint portion (area of 221, fig 3) of the sheath is disposed between 1.5 and 0.5 cm from the distal end of the elongated sheath (para 0068 discloses “the length of the first housing section 211 may be shorter than the length of the needle 201 by 0.5 inches, by 1 inch, by 1.5 inches, by 2 inches, by 2.5 inches, by 3 inches, by 3.5 inches” 0.5 inches is 1.27 cm which is within the range).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bending dimension of Parazynski in the needle assembly of Russell to “provide a consistent, predictable, and/or repeatable needle bending (e.g., bending a needle by a prescribed, predetermined, and/or desired angle)” para 0091, Parazynski.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Russell (USPN 5,066,279) in view of Haber (USPN 5,372,590).
In reference to dependent claim 13, Russell discloses the needle assembly of claim 12, wherein: the first joint portion (right groove of 38) comprises a first V-shaped elongated groove defined by a first and a second side wall intersecting at a first internal angle (groove has an angle), the second joint portion (left groove of 38) comprises a second V-shaped elongated groove (left groove is V-shaped), however
Russel is silent to a second groove defined by a first and a second side wall intersecting at a second internal angle, and the first internal angle, of the first groove is greater than the second internal angle.
Haber, a similar needle cap, teaches a second groove (area of 166) defined by a first and a second side wall intersecting at a second internal angle (152 and 164 form an angle), and the first internal angle, of the first groove (area of 154, fig 14a), is greater than the second internal angle (190 and 192 form an angle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the different sized grooves of Haber in the needle assembly of Russel “for preventing inadvertent needle sticks” col 1, lines 44; Haber. To be clear by controlling the order of bend in the bend locations the location of the bend can be controlled which can help prevent needle sticks.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burke (USPN 3,712,302) discloses a needle guard.
Scholl (USPN 5,158,550) discloses a syringe container.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (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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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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