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 II, species A, claims 17-19, in the reply filed on 3/26/2026 is acknowledged. The traversal is on the ground(s) that there would not be a serious burden on the examiner to search groups I and II together and are substantially related and because invention I was previously searched in the international search report (ISR); and that paragraphs [0071]-[0088] describe both species A and B. This is not found persuasive because although invention I and II are substantially related, there would be a serious search burden on the examiner because the inventions require different fields of search (i.e. searching different CPC symbols and classes and employing different search strategies and queries as searching the method steps and elements requires vastly different search than the structural features of the apparatus) and the inventions have divergent subject matter (i.e. the method of harvesting tissue is different than an apparatus that is used to harvesting tissue). Further, while the presence of an ISR for invention I provides information to the examiner, it does constitute a full search and the examiner would still need to complete a comprehensive search of invention I to examine the claims which is different than the search required for invention II. Regarding the traversal of the species restriction, the fact that paragraphs [0071]-[0088] does not negate the fact that the different apparatus 100 and 300 have mutually exclusive features and methods of use which do not overlap and would be a serious burden on the examiner to search.
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claims 1-16 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group I and species B, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/26/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/1/2023 and 4/29/2025 was received and placed in the record on file. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
In the instant application, the examined claims do not invoke any 35 USC 112(f) interpretations.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beck et al (US 2013/0053725 A1).
Regarding claims 17-18; Beck discloses a surgical method, comprising:
obtaining a harvesting system (combined core biopsy element 10 and introducer element 300; figures 1, 4, 12 and 19-23) and;
inserting a portion of the harvesting system (introducer cannula element 315, protective sleep element 320, and stylet element 330) into a harvest site of a patient to harvest tissue (distal end of introducer element 300 is inserted into the tissue; paragraphs [0078]-[0086]);
receiving the tissue in a cylinder of the harvesting system (core biopsy device is inserted into introducer cannula element 350 and extracts a tissue biopsy into the cylinder of the biopsy needle and introducer cannula; paragraphs [0078]-[0086], specifically [0080]-[0081]; figures 1, 4, 12 and 19-23); and
removing the harvesting system from the patient while a passive check valve (automatic valve element 370 or 380) in the harvesting system (combined elements 300 and biopsy element 10) passively closes off air flow in the opposite direction to maintain equal pressure in the cylinder and the harvest site to prevent loss of tissue during harvesting and removal of the harvesting system from the harvest site (wherein the examiner notes that automatic valves 370 and 380 only release to vent pressure when pressure inside the cannula exceeds a certain value, but are closed when not, and thus pressure is maintained when the valve is closed and the introducer and/or biopsy needle is withdrawn to passively close off air flow in the opposite direction towards the body; paragraphs [0083]-[0086], [0089]).
Further regarding claim 18; Beck discloses flowing air up, through and exiting the harvesting system during distal movement of the harvesting system into the harvest site (wherein increased pressure due to the advancement of the introducer and biopsy device into the body is vented out of the introducer automatic valve elements 370 or 380 on the vent element 352; paragraphs [0081]-[0086], specifically [0085]; figures 19-23).
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 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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Beck as applied to claim 17 above, and further in view of Kidman et al (US 2023/0338045 A1).
Beck is described in the rejection of claim 17 above; Beck further discloses inserting a harvesting member (biopsy device element 10) of the harvesting system into the patient the use of driving means to drive at least the outer needle into the tissue to be sampled (paragraph [0074]).
However, Beck does not explicitly disclose using a coupled drill as the driving means to cut the tissue.
Kidman teaches it is known to utilize a drill (element 210) extended through an introducer (element 44) to cut into bone tissue in order to take a sample (paragraph [0121]; figure 20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Beck’s surgical method to utilize a drill as the driving member of the biopsy device in order to penetrate bone to obtain a biopsy sample of the bone or to access the bone marrow within the bone as taught by Kidman.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 8,740,811 to Fortems et al; discloses a biopsy device having a pressure release valve to facilitate biopsy sampling (element 18; figure 8c).
US 5,395,379 to Deutschman et al; discloses a biopsy device having a pressure relief valve (element 50) as the handle to relief pressure during the biopsy (figure 6)
US 2018/0125465 A1 to Muse et al; discloses a biopsy device which utilizes a drill inserted through an introducer to biopsy a bone.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791