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 11/25/25 substitute specification is accepted.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-2, 5-9, 34-35, and 37-44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huitema (US 6007497 A).
For claim(s) 1, 5, 38, 39 Huitema teaches A biopsy device, [12] comprising:
an elongated housing [10] having a manifold [58] with a distal end; [end nearest 114]
an outer cannula [50] partially and slidably disposed in the manifold;
the outer cannula having a tip projecting from the distal end of the manifold; [Fig(s). 3]
a manifold cap [55] coupled to the distal end of the manifold
an inner cannula [60] partially and slidably disposed in a lumen of the outer cannula;
and an outer cannula seal [114] disposed between the manifold and the outer cannula,
the outer cannula seal comprising an interference ring portion [116] coupled to the distal end of the manifold [Fig(s). 11] and compressed at least partially between the manifold and the manifold cap to form an interference fit, [116 shown disposed in 55 in Fig. 11]
a beaded ring portion [118] having a free end with a radially inward projecting partially rounded section [118 shown resiliently bent inward against 63 in Fig(s). 11] that contacts an outer surface of the outer cannula, [Fig(s). 3]
and a flexible portion extending between the interference ring portion and the beaded ring portion. [portion of 114 between 116 and 118]
For claim 2, Huitema teaches The biopsy device of claim 1,
wherein the outer cannula seal is configured to allow longitudinal movement of the outer cannula relative to the manifold while maintaining a fluid-tight seal therebetween. [col. 8 ll. 10-30]
For claim 5, Huitema teaches The biopsy device of claim 1, further comprising a manifold cap [55] coupled to a distal end of the manifold,
wherein the manifold cap and the manifold together define an annular space adjacent to the distal end of the manifold, and wherein the interference ring portion of the outer cannula seal is at least partially disposed in the annular space. [116 shown disposed in 55 in Fig. 11]
For claim 6, Huitema teaches The biopsy device of claim 5,
wherein the interference ring portion of the outer cannula seal forms an interference fit between the inner surface of the manifold and an inner surface of the manifold cap. [Fig. 11]
For claim 7, Huitema teaches The biopsy device of claim 5,
wherein the interference ring portion of the outer cannula seal defines a distally facing annular detent configured to engage a proximally facing annular lip of the manifold cap. [Fig. 11]
For claim 8, Huitema teaches The biopsy device of claim 1,
wherein the flexible portion of the outer cannula seal is biased to cause the beaded ring portion to apply a force against the outer surface of the outer cannula to create a fluid-tight seal between the beaded ring portion and the outer surface of the outer cannula. [118 seals 60 against 50 and thus seals 50 per col. 8 ll. 10-30]
For claim 9, Huitema teaches The biopsy device of claim 1,
wherein the flexible portion of the outer cannula seal is configured to allow the interference ring portion and the beaded ring portion to move longitudinally relative to each other while maintaining a fluid-tight seal between the outer cannula and the manifold. [col. 8 ll. 10-30]
For claim 34, Huitema teaches The biopsy device of claim 1,
wherein the outer cannula seal has a partial conical shape. [Fig. 10]
For claim 35, Huitema teaches The biopsy device of claim 1,
wherein the outer cannula seal has a V- shaped cross-section. [Fig. 11]
For claim 37, Huitema teaches The biopsy device of claim 1,
wherein the outer cannula seal is manufactured using a mold-forming process. [this is a product-by-process claim(s) — see MPEP § 2113; since Huitema teaches the seal, then Huitema still teaches claim(s) 37]
For claim 40, Huitema teaches The biopsy device of claim 38,
wherein the interference ring portion of the outer cannula seal defines a distally facing annular detent configured to engage a proximally facing annular lip of the manifold cap. [flange configuration of overlapping lips of 55 and 116 shown in Fig(s). 11]
For claim 41, Huitema teaches The biopsy device of claim 38,
wherein the flexible portion of the outer cannula seal is biased to cause the beaded ring portion to apply a force against the outer surface of the outer cannula to create a fluid-tight seal between the beaded ring portion and the outer surface of the outer cannula. [116 fitting with 55 and 58 and thus an fluid tight seal with 56 and onto 50 as in Fig(s). 3]
For claim 42, Huitema teaches The biopsy device of claim 38,
wherein the flexible portion of the outer cannula seal is configured to allow the interference ring portion and the beaded ring portion to move longitudinally relative to each other while maintaining a fluid-tight seal between the outer cannula and the manifold. [114 is elastomer per col. 11 ll. 30-35 and thus 116 and 118 can move relative to one another while maintaining a seal with 50 and 55]
For claim 43, Huitema teaches The biopsy device of claim 38,
wherein the outer cannula seal has a partial conical shape. [Fig(s). 11]
For claim 44, Huitema teaches The biopsy device of claim 38,
wherein the outer cannula seal has a V- shaped cross-section. [Fig(s). 11]
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huitema in view of Bates (US 6273861 B1).
For claim(s) 36, Huitema fails to teach the seal comprising EPDM. Bates teaches a cannula seal [41] comprising EPDM. [Col. 11 ll. 40-65]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the seal of to incorporate the EPDM of Bates in order to ensure the seal has desirable performance and structural properties (for sealing and retention). As motivated by Bates col. 11 ll. 40-65.
Response to Arguments
Applicant's 11/25/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 9 that Huitema fails to teach tube 53 slidably disposed within shank 56 and seal 114 coupled to shank 56. Examiner respectfully disagrees. Tube 53 and shank 56 slidably operate within piercer 21 via entry through bushing 46 and thus 53 is “slidably disposed” within 56 and 58 under BRI. Further, seal 114 is coupled to 55 which is coupled to 56 and thus 114 is coupled to 56.
Applicant argues in remarks p. 9 that Huitema fails to teach the beaded portion contacting an outer surface of the outer cannula. Examiner respectfully disagrees. Portion 118 is an opening which is part of seal 114 which is connected to and seals end 58 and thus 114 seals in turn with an contiguous portion of outer surface of 53 (58 being connected to 53).
Applicant argues in remarks p. 10-11 that Huitema fails to teach the interference ring portion compressed between the manifold and the manifold cap as claimed. Examiner respectfully disagrees. Huitema Fig(s). 11 shows portion 116 in a snap fit with rib 55 of end 58 and thus the interference ring portion does couple to an end of the manifold.
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
Prosecution Insights