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 .
Response to Arguments
Applicant's arguments filed 1/16/2026 have been fully considered.
Regarding the rejection under 112(b), Applicant’s arguments have been considered and are persuasive. The amendments to the claims overcome the rejection and the rejection is therefore withdrawn.
Regarding the rejection of claim 24 under deCiutiis, Applicant’s arguments are considered and are persuasive. deCiutiis does not teach any of the three claims alternatives (1), (2), or (3). Therefore, the rejection is withdrawn.
Regarding the rejection of claim 24 over Steube, Applicant’s arguments are considered and are persuasive. Steube does not teach any of the three claims alternatives (1), (2), or (3). Therefore, the rejection is withdrawn.
Regarding the rejection of claim 24 over Luther, Applicant’s argument have been considered and are not convincing. Applicant argues that Luther does not teach any of the three alternatives now recited in claim 24. This argument is not convincing as Luther teaches spaced apart fingers 56b located on the first connection end that engage through holes 54b on the second connection end at a coupling point that is exposed (fig. 5).
Regarding the rejection of claim 24 over Moorehead, Applicant’s arguments are considered and are persuasive. Moorehead does not teach any of the three claims alternatives (1), (2), or (3). Therefore, the rejection is withdrawn.
Regarding the rejection of claim 24 over Van Heugten, Applicant’s arguments are considered and are persuasive. Van Heugten does not teach any of the three claims alternatives (1), (2), or (3). Therefore, the rejection is withdrawn.
Upon further consideration in light of the amendments to the claims, new rejections are made below over Luther. As noted in the prior Office action, not every possible rejection was made using the cited reference for the sake of brevity, and therefore, in light of the amendments to the claims, Luther is now applied to claims previously rejected under other prior.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 33, 34, 36-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 33 calls for the second material to be formed onto the first material, thereby to form the needle shaft. This limitation conflicts with amendment to claim 24, from which claim 33 depends, which calls for the needle tip to be separately formed and subsequently attached to the needle shaft by one of three listed alternatives. All of these alternatives require the needle tip and the needle shaft to be formed separately and subsequently attached by means other than the second material formed onto the first material. Therefore, the combination of claim 24 and 33 constitute subject matter not described in the specification.
Claim 34 calls for the needle tip to be integral with the needle shaft, the needle tip attached to the needle shaft by depositing the first material over an integral needle tip form. As discussed above with regard to claim 33, newly amended claim 24 calls for the needle tip to be separately formed and subsequently attached to the needle shaft by one of three listed alternatives. All of these alternatives require the needle tip and the needle shaft to be formed separately and subsequently attached by means other than depositing the first material over an integral needle tip form, and they do not form an integral needle tip and shaft. Therefore, the combination of claim 24 and 34 constitute subject matter not described in the specification.
Claims 36-39 inherit the deficiencies of claims 33, 34.
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.
Claim 35 is 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 35 recites that the needle tip comprises “a proximal end comprising one of a depression and a protrusion.” It is not clear if this depression or protrusion is different from the three alternatives listed in claim 24, from which claim 35 depends, or if this depression or protrusion is a further limitation of one or more of those options. Therefore, the scope of the claim is not clear.
Additionally, claim 35 recites, “wherein forming the second material onto the needle tip…”. There is no antecedent basis for this limitation as claim 24, from which claim 35 depends recites that the needle tip is separately formed and subsequently attached to the needle shaft. There is no previously recited step of forming the second material onto the needle tip.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 24-27, 33-38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luther (US 6,500,157).
Regarding claim 24, Luther discloses a needle comprising a needle tip 20 formed from a first rigid material (col. 6, lines 22-23; fig. 3), the needle tip comprising a bevel for puncturing the subject and a cylindrical portion having a first connection end extending proximally from the bevel (fig. 5), and a needle shaft 16 comprising a second material (col. 5, lines 31-32; fig. 3), the needle shaft having a connection end at a distal end of the needle shaft (fig, 5), wherein spaced apart fingers 56b on the second connection end engaging through holes on the first connection end at a coupling point that is exposed (fig. 5; col. 8, lines 22-28). Claim 24 calls for the needle tip to be separately formed and subsequently attached to the needle shaft to form the needle. This is interpreted to be a product by process limitation. Such limitations are not limited to the recited steps but rather the structure implied by the steps. See MPEP 2113. In this case, the structure implied by the recited steps is a needle tip and a needle shaft that are formed separately and attached. Luther discloses that the needle tip is formed from a different material than the needle shaft and therefore they are formed separately, and the needle tip and the shaft are connected to each other. Therefore, the structure disclosed by Luther is the same as the structure implied by the recited steps.
Regarding claim 25, Luther discloses that the first material has a higher rigidity than the second material (col. 10, lines 23-34).
Regarding claim 26, Luther discloses that the first material is metal (col. 6, lines 22-23).
Regarding claim 27, Luther discloses that the second material is plastic (col. 5, lines 26-27).
Regarding claim 33, Luther discloses that the first material has a bevel (fig. 3). The needle shaft is formed from a different material that the needle tip and connected thereto and therefore the needle shaft is formed from the second material and thereafter connected to the first material. This is a product by process limitation.
Regarding claim 34, Luther discloses that the needle tip is integral with the needle shaft at a distal end of the needle shaft (fig. 3). The limitation “the needle tip is attached to the needle shaft by depositing the first material over an integral needle tip form” is interpreted to be a product by process limitation. The scope of the claim is not limited to the recited steps but rather to the structure implied by the recited steps. In this case, the structure implied by the recited steps is an integral needle tip and needle shaft. This is the structure disclosed by Luther as discussed above.
Regarding claim 35, Luther discloses that the needle tip 20 comprises a proximal end comprising a depression (fig. 5). The limitation “wherein forming the second material onto the needle tip comprises depositing the second material over a length of the needle tip from a position distal of the depression or protrusion to, and past, the proximal end of the needle tip” is interpreted to be a product by process limitation. The scope of the claim is not limited to the recited steps but rather to the structure implied by the recited steps. In this case, the structure implied by the recited steps is taught by Luther as the second material extends over the length of the needle tip from a position distal to of the depression to and past the proximal end of the needle tip (fig. 5).
Regarding claim 36, Luther discloses and intermediate material 52 attached to the needle tip (fig. 4). This material is touching the needle tip and the needle shaft and therefore is capable of dissipating heat.
Claim 37 calls for the second material to be formed by molding onto the first material. This is interpreted to be a product by process limitation. The scope of the claim is not limited to the recited steps, but rather to the structure implied by the recited steps. See MPEP 2113. In this case, the structure implied by molding the second material onto the first material is a unitary structure. This is the structure disclosed by Luther (fig. 3).
Regarding claim 38, “the first material is bound to the second material during cooling or curing of the second material” is interpreted to be a product by process limitation. The structure implied by the recited steps is the first material and the second material bound to each other. This structure is taught by Luther (fig. 3).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 28, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luther in view of Steube (US 9,066,690).
Claim 28 calls for the second material to be light permeable to enable visible detection of primary flashback in the needle shaft. Luther teaches that flashback can be detected in the hub, but fails to disclose that the shaft is light permeable. Steube teaches a needle shaft wherein the needle shaft is formed from a translucent or transparent plastic material that allows better visualization of the flashback (col. 3, lines 10-12, 26-31). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the needle shaft to be translucent or transparent to allow visualization of flashback in the shaft as taught by Steube to allow for faster visualization of flashback than having only flashback visible in the hub.
Claim 29 differs from Luther in calling for the second material to be transparent or translucent. Steube teaches a needle shaft wherein the needle shaft is formed from a translucent or transparent plastic material that allows better visualization of the flashback (col. 3, lines 10-12, 26-31). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the needle shaft to be translucent or transparent as taught by Steube to allow for fast visualization of flashback as the needle enters a vein.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luther in view of Rieger (DE 4 104 091 A). See machine translation of Abstract previously provided.
Claim 39 differs from Luther in calling for the needle tip to comprise an aperture to form a window for viewing primary flashback. Rieger teaches a needle tip having an aperture to form a window for viewing primary flashback so that correct placement of the cannula is immediately indicated (abstract; figs. 1-4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle tip of Luther to include an aperture to form a window for viewing flashback as taught by Rieger to allow the user to immediately determine correct placement of the cannula.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luther in view of Woehr et al (US 2016/0175563).
Claim 41 differs from Luther in calling for the needle shaft to comprise a marking, the marking located on the needle shaft to be visible during primary flashback. Woehr teaches a needle comprising a marking 120 located on the needle shaft to be visible during primary flashback (page 6, para. 0120). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Luther to include a marking that is visible during primary flashback as taught by Woehr to allow the user to readily determine when the needle is properly placed.
Claim(s) 42-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woehr et al (US 2016/017563) in view of Van Heugten (5,312,376) in view of Luther.
Regarding claim 42, Woehr discloses a catheter assembly comprising a needle 110, a catheter hub 101 and a catheter 140 connected to the catheter hub and surrounding the needle (page 5, para. 0111; fig. 1).
Claim 42 calls for the needle to be the needle of claim 24. Woehr discloses the needle having a beveled edge (fig. 1), but fails to disclose the needle tip and needle shaft as described in claim 24. Van Heugten teaches the needle of claim 24 as discussed above, and further that the needle is used as an over the catheter needle (abstract) as described by Woehr and allows for a sharp needle tip and visualization of flashback within the needle (abstract; col. 1, lines 40-55). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Woehr to include a needle tip and needle shaft as taught by Van Heugten to provide a sharp piercing tip and allow for immediate flashback visualization so that the user can view that the needle has been properly placed.
Claim 42 further differs from Woehr and Van Heugten in calling for (1) spaced apart fingers or claws located on the first connection end or the second end engages through holes on the other one of the first connection end or the second connection end at a coupling point that is exposed, (2) an annular bump located on the first connection end or the second end engages a complementary annular recess on the other one of the first connection end or the second connection end, or (3) an arm with a slot and a recess on the first connection end or the second end engages a metal rib located on the other one of the first connection end or the second connection end. Luther teaches a needle having a needle tip connected to a needle shaft, wherein spaced apart fingers 56b on the second connection end engage through holes on the first connection end at a coupling point that is exposed (fig. 5; col. 8, lines 22-28) to provide a secure connection between a flexible body and a rigid tip. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection taught by Van Heugten to include the fingers and through holes as taught by Luther to provide secure connection between the two elements.
Regarding claim 43, Van Heugten teaches that the shaft comprises a marking (transparent body) that is visible during primary flashback (col. 2, lines 9-11). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include these features in the combination described above to provide immediate indication that the tip of the needle is properly placed.
Regarding claim 44, Woehr discloses that the catheter is transparent or translucent (page 11, para. 0156) and that the marking is obscured by bodily fluid between the catheter and the needle shaft during secondary flashback (page 12, para. 0159).
Regarding claim 45, Woehr discloses a needle hub 102 attached to the needle (page 5, para. 0111).
Regarding claim 46, the limitation “the needle hub is integrally formed with the needle” is interpreted to be a product by process limitation. The scope of such a limitation is not limited to the recited steps, but rather the structure implied by the recited steps. In this case, the structure implied by “integrally formed” is a unitary body. Woehr shows that the needle hub and the needle are permanently affixed to each other and therefore form a unitary body.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783