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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/29/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 05/28/2025. As directed by the amendment: Claims 1 and 16 have been amended, claims 3,10, and 21 have been cancelled, and no claims have been added. Thus, claims 1-2, 4-9, and 11-20 are presently pending in the application.
Applicant' s amendments to the claims have overcome the previous 112 rejections previously set forth in the Final Office Action mailed 03/28/2025.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 05/28/2025, with respect to the rejection of the claims have been fully considered and are persuasive. Applicant argues that Hoffman does not disclose the amendments to the independent claims. Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Boylan (US 2002/0193824).
Claim Objections
Claims 13 and 18 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. Claims 14 and 19 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 7. Claims 15 and 20 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. Claim 17 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 1, 5-6, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2014/0276051); in view of Boylan (US 2002/0193824).
Regarding Claim 1, Hoffman discloses a biopsy needle (500; Fig.5) comprising: a monolithically-formed elongated body including: a first portion (502) including a proximal end (end away from the patient) of the monolithically-formed elongated body, the first portion (502) formed from a linear elastic nickel-titanium alloy (nitinol) (first sentence in parag. [0111]) and having a first flexibility (less flexible) (parags. [0108]- [0109]), and a second portion (504) distal to the first portion (Fig.5), the second portion formed from the linear elastic nickel-titanium alloy (nitinol) (first sentence in parag. [0111]) and having a second flexibility (more flexible) different than the first portion (parags. [0108]- [0109]).
Hoffman does not appear to disclose a linear elastic nickel-titanium alloy: accepts between about 2-5% strain while remaining substantially elastic before plastically deforming and comprises between substantially 54 to about 57 weight percent nickel with a remainder being titanium.
Boylan teaches it was known in the art to have a linear elastic nickel-titanium alloy that accepts up to 8% strain (within the range 2-5% stain) while remaining substantially elastic before plastically deforming (martensitic phase) (parags. [0058] and [0062]- [0063]) and comprises 55.8% nickel (within range 54-57 percent nickel) with remaining being titanium (parag. 0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Boylan to have a linear elastic nickel-titanium alloy: accepts between about 2-5% strain while remaining substantially elastic before plastically deforming in order to increase mechanical strength in medical devices (first sentence in parag. [0063]) and comprises between substantially 54 to about 57 weight percent nickel with a remainder being titanium in order for nitinol to remain martensitic without a phase change under stress (last sentence in parag. [0056]).
Regarding Claim 5, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the first portion (502) has a first outer diameter (D1; 514) and the second portion (504) has a second outer diameter (516; D2) different than the first outer diameter (Fig.5) (parag. [0110]).
Regarding Claim 6, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the first portion (502) has a central longitudinal axis that is coaxial with a central longitudinal axis of the second portion (504) (the first portion 502 and the second portion 504 have a coaxial central longitudinal axis as seen in Fig.5).
Regarding Claim 13, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the first portion (502) has a central longitudinal axis that is coaxial with a central longitudinal axis of the second portion (504) (the first portion 502 and the second portion 504 have a coaxial central longitudinal axis as seen in Fig.5).
Regarding Claim 18, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the first portion (502) has a central longitudinal axis that is coaxial with a central longitudinal axis of the second portion (504) (the first portion 502 and the second portion 504 have a coaxial central longitudinal axis as seen in Fig.5).
Claims 2, 4, 8, 11-12, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2014/0276051) and Boylan (US 2002/0193824) as applied to claim 1 above, and further in view of Wang (US 5533985).
Regarding Claim 2, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein an outer diameter of the monolithically- formed elongated body changes between the proximal end and the distal end (D1 and D2 are different as seen in Fig.5) (parag. [0110]).
Hoffman does not appear to disclose a lumen with a constant diameter extending from the proximal end to the distal end.
Wang teaches it was known in the art to have a passageway/lumen 14 (Fig.1A) with a constant diameter extending from a proximal end to a distal end (Fig.1A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a lumen with a constant diameter extending from the proximal end to the distal end in order to have a tubing with consistent diameter (lines 12-16 in column 11) to have better control of fluid delivery.
Regarding Claim 4, Hoffman as modified discloses all the limitation of claim 1 above.
Hoffman does not appear to disclose a first portion has a first wall thickness and a second portion has a second wall thickness different than the first wall thickness.
Wang teaches it was known in the art to have a first portion 18 with a first wall thickness and a second portion 16 with a second wall thickness different than the first wall thickness as seem om Fig.1A (lines 42-52 in column 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a first portion has a first wall thickness and a second portion has a second wall thickness different than the first wall thickness in order to ensure a flexible second portion (lines 42-52 in column 5).
Regarding Claim 8, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the monolithically-formed elongated body comprises a transition portion (524) having a length extending between a distal end (towards the patient) of the first portion (502) and a proximal end (away from the patient) of the second portion (504).
Hoffman does not appear to disclose a length of a transition portion is between 0.1 inches to 1.0 inch.
Wang teaches it was known in the art to have a length of a transition portion 19 between 0.1 inches and 1.0 inches (0.5- 10 inches) (lines 21-23 in column 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a length of a transition portion is between 0.1 inches to 1.0 inch in order to have a smooth and gradual transition between two materials to eliminate buckling and kinking (lines 15-18).
Regarding Claim 11, Hoffman as modified discloses all the limitations of claim 1 above.
Hoffman does not appear to disclose a lumen with a constant diameter extending from the proximal end to the distal end.
Wang teaches it was known in the art to have a passageway/lumen 14 (Fig.1A) with a constant diameter extending from a proximal end to a distal end (Fig.1A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a lumen with a constant diameter extending from the proximal end to the distal end in order to have a tubing with consistent diameter (lines 12-16 in column 11) to have better control of fluid delivery.
Regarding Claim 12, Hoffman as modified discloses the biopsy needle of claim 2, and further discloses wherein an outer diameter of the monolithically- formed elongated body changes between the proximal end and the distal end (D1 and D2 are different as seen in Fig.5) (parag. [0110]).
Regarding Claim 15, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the monolithically-formed elongated body comprises a transition portion (524) having a length extending between a distal end (towards the patient) of the first portion (502) and a proximal end (away from the patient) of the second portion (504).
Hoffman does not appear to disclose a length of a transition portion is between 0.1 inches to 1.0 inch.
Wang teaches it was known in the art to have a length of a transition portion 19 between 0.1 inches and 1.0 inches (0.5- 10 inches) (lines 21-23 in column 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a length of a transition portion is between 0.1 inches to 1.0 inch in order to have a smooth and gradual transition between two materials to eliminate buckling and kinking (lines 15-18).
Regarding Claim 16, Hoffman discloses a biopsy needle (500; Fig.5) comprising: an elongated body formed from a linear elastic nickel-titanium alloy (nitinol) (first sentence in parag. [0111]) and including: a first portion (502) including a proximal end (end away from the patient) of the elongated body, the first portion (502) having a first outer diameter (D1), and a second potion (504) distal to the distal portion (Fig.5), the second portion having a second outer diameter different (D2) from the first outer diameter (D1 and D2 are different as seen in Fig.5) (parag. [0110]), wherein the second outer diameter (D2) is smaller than the first outer diameter (D1) (Fig.5), wherein the second portion (504) to impart an increased flexibility (more flexible) to the second portion versus a flexibility (less flexible) of the first portion (502) (parags. [0108]- [0109]).
Hoffman does not appear to disclose a linear elastic nickel-titanium alloy: accepts between about 2-5% strain while remaining substantially elastic before plastically deforming and comprises between substantially 54 to about 57 weight percent nickel with a remainder being titanium. Hoffman does not disclose a second portion with a material removed.
Boylan teaches it was known in the art to have a linear elastic nickel-titanium alloy that accepts up to 8% strain (within the range 2-5% stain) while remaining substantially elastic before plastically deforming (martensitic phase) (parags. [0058] and [0062]- [0063]) and comprises 55.8% nickel (within range 54-57 percent nickel) with remaining being titanium (parag. 0056]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Boylan to have a linear elastic nickel-titanium alloy: accepts between about 2-5% strain while remaining substantially elastic before plastically deforming in order to increase mechanical strength in medical devices (first sentence in parag. [0063]) and comprises between substantially 54 to about 57 weight percent nickel with a remainder being titanium in order for nitinol to remain martensitic without a phase change under stress (last sentence in parag. [0056]).
Wang teaches it was known in the art to have a second portion 16 with removed material (less thickness) as seen in Fig.1A (lines 42-52 in column 5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a second portion with a material removed in order to increase flexibility of the second portion (lines 42-52 in column 5).
Regarding Claim 17, Hoffman as modified discloses all the limitations of claim 1 above.
Hoffman does not appear to disclose a lumen with a constant diameter extending from the proximal end to the distal end.
Wang teaches it was known in the art to have a passageway/lumen 14 (Fig.1A) with a constant diameter extending from a proximal end to a distal end (Fig.1A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a lumen with a constant diameter extending from the proximal end to the distal end in order to have a tubing with consistent diameter (lines 12-16 in column 11) to have better control of fluid delivery.
Regarding Claim 20, Hoffman as modified discloses the biopsy needle of claim 1, and further discloses wherein the monolithically-formed elongated body comprises a transition portion (524) having a length extending between a distal end (towards the patient) of the first portion (502) and a proximal end (away from the patient) of the second portion (504).
Hoffman does not appear to disclose a length of a transition portion is between 0.1 inches to 1.0 inch.
Wang teaches it was known in the art to have a length of a transition portion 19 between 0.1 inches and 1.0 inches (0.5- 10 inches) (lines 21-23 in column 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hoffman to incorporate the teachings of Wang to have a length of a transition portion is between 0.1 inches to 1.0 inch in order to have a smooth and gradual transition between two materials to eliminate buckling and kinking (lines 15-18).
Claims 7, 9, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2014/0276051).
Regarding Claim 7, Hoffman as modified discloses all the limitations of claim 1 above.
Hoffman does not appear to disclose a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the needle in Hoffman to have a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Hoffman would not operate differently with the claimed length. Further applicant places no criticality on the range claimed, indicating simply that the length “may have” been within the claimed ranges (specification; page 9, lines 17-21).
Regarding Claim 9, Hoffman as modified discloses all the limitations of claim above.
Hoffman does not appear to disclose the first flexibility is between 3.0 lbf/in and 4.0 lbf/in and the second flexibility is between 0.1 lbf/in and 1.0 lbf/in.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the needle in Hoffman to have a first flexibility is between 3.0 lbf/in and 4.0 lbf/in and the second flexibility is between 0.1 lbf/in and 1.0 lbf/in, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Hoffman would not operate differently with the claimed flexibility. Further applicant places no criticality on the range claimed, indicating simply that the flexibility “may be” within the claimed ranges (specification; page 15, lines 10-13).
Regarding Claim 14, Hoffman as modified discloses all the limitations of claim 1 above.
Hoffman does not appear to disclose a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the needle in Hoffman to have a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Hoffman would not operate differently with the claimed length. Further applicant places no criticality on the range claimed, indicating simply that the length “may have” been within the claimed ranges (specification; page 9, lines 17-21).
Regarding Claim 19, Hoffman discloses all the limitations of claim 1 above.
Hoffman does not appear to disclose a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the needle in Hoffman to have a length of the second portion of the monolithically-formed elongated body is between five inches and ten inches, since it has been held that “where the only difference between the prior art and the claims was recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the needle of Hoffman would not operate differently with the claimed length. Further applicant places no criticality on the range claimed, indicating simply that the length “may have” been within the claimed ranges (specification; page 9, lines 17-21).
Conclusion
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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783