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
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 07, 2026.
Applicant's election with traverse of Group I (claims 1-7) in the reply filed on July 07, 2026 is acknowledged. The traversal is on the grounds that Groups I and II share overlapping subject matter, such that a search and examination of these Groups together would not pose an undue burden. Applicant point to dependent claim 3 in Group I, which recites the first part and the second part of the sieve container similar to independent claims 8 and 15. Thus, the search and examination of the claims of Group I-II would not be a serious burden on the examiner.
This is not found persuasive because the restriction between Group I and Group II is based on the independent claims 1 and 8. Furthermore, the prior art pertinent to one group would not necessarily be relevant to the other group. While a search of the prior art for on group may overlap with that of another group, the searches are not co-extensive and thus would be an undue burden on Office resources.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications 19/043,913; 18/952,403; 18/403,550 and 18/514,870 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The disclosures in these prior applications do not support the embodiment of claims 2-7. That is, the prior applications do not support the bottom sieve surface having a flat bottom and the receiving container has a generally flat watertight bottom, as recited in claim 2. In addition, these prior-filed applications do not support the sieve container which includes a first and second part which are detachable, as recited in claims 3-7. Thus, claims 2-7 are not entitled to the benefit effective filing dates of the prior applications list above. The effective filing date for claims 2-7 is considered filing date of the instant application, July 24, 2025.
While applicant’s instant independent claim 1 appears to find to support in parent application 18/514,870, discloses a biopsy container apparatus 10 comprising a basket sieve 14 (corresponds to the instant claimed sieve container) and a sample collection container 16 (corresponds to receiving container), which are separable elements that can be attached and separated. Thus, the effective filing date for claim 1 is considered the filing date of ‘870, November 20, 2023.
Claim Interpretation
In the patentability analysis of apparatus claims 1-7, aspects or limitations examiner interprets as functional/process/intended use and/or not positively recited as part the claimed invention have been generally italicized whereas aspects interpreted as positively recited structural components are normally bolded. The bold font and italics are shown when the structure and functional/process/intended use and/or elements not positively recited are initially introduced though not necessarily repeated, particularly in dependent claims. The examiner applies this formatting for both the examiner and applicant’s convenience. However, absent the referenced typestyles, the patentability analysis will still be clear regarding which limitations the examiner interprets as structural versus functional/process/intended use and/or elements not positively recited as part of the invention. Also note that it has been held that recitations in which an element is "adapted to/for", “configured to/for”, “positionable”, “moveable/immovable”, etc., only requires the ability to so perform (i.e., functional/process/intended use).
The functional/process/intended use and/or elements not positively recited as part of the apparatus do not constitute a limitation in any patentable sense with respect to the prior art. Please note that these recitations have not been ignored by the examiner. All of the claimed recitations in applicant’s claims 1-7 have been considered by the examiner and afforded the appropriate amount of patentable weight. In certain instances during prosecution, the examiner’s current interpretations regarding the patentable weight of these limitation may change based on applicant’s future responses/arguments.
The patentability analysis provides one or more interpretations and claim mappings of the claimed structures and steps although other interpretations may be possible. In the patentability analysis, the Office applies the broadest reasonable interpretation (BRI) consistent with the specification and specific limitations from the specification have not been read into the claims.
See MPEP at least §2111.02, 2173.01 I 2114, and 2173.05(g).
Claim Rejections - 35 USC § 112
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.
Claim 2 is rejected under 35 U.S.C. 112(b) 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.
The term “generally” in claim 2 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear from the claims what applicant considers a “generally” flat surface.
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 1-4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Williams et al., (US 2016/0341641; hereinafter “Williams”).
Regarding claim 1, Williams teaches a biopsy container apparatus for recovering solid tissue and dislodged cells (D-cells) from a biopsy, the biopsy container apparatus comprising:
a receiving container 80 having a receiving chamber with an upper opening 104 and a watertight bottom surface 84 (Williams teaches a coupling the filter unit to be received in a processing tube open end 104, see para [0052a] et seq. and Figs. 1-10); and
a sieve container 70 configured to be located at least partially within the receiving chamber and removed from the receiving chamber through the upper opening,
the sieve container having a bottom sieve surface 130 including a plurality of apertures (pores in a filter; see para [0038] et seq.) configured to pass the D-cells from the biopsy but not the solid tissue from the biopsy into the receiving chamber after the solid tissue and the D-cells from the biopsy are placed into the sieve container.
Relative positional terms such as "top" and "bottom" may be used in connection with a method, system and device, however, it should be understood that those terms are used in their relative sense only. For example, when used in connection with the devices, "top" and "bottom" are used to signify opposing sides of the devices. In actual use, elements described as "top" or "bottom" may be found in any orientation or location and not considered as limiting the methods, systems, and devices to any particular orientation or location. For example, the top surface of the device may actually be located below the bottom surface of the device in use (although it would still be found on the opposite side of the device from the bottom surface).
Regarding claim 2, Williams teaches the bottom sieve surface is a generally flat bottom sieve surface 103 the watertight bottom surface 84 is a generally flat watertight bottom surface, and the bottom sieve surface is located adjacent to the watertight bottom surface when the sieve container is located within the receiving chamber (note that the term adjacent is a broad term), see Fig. 6.
Regarding claim 3, Williams teaches the sieve container includes a first part 102 and a second part 103, the second part is configured to be detached from the first part after the sieve container is removed from the receiving container, and the second part includes the bottom sieve surface (see Fig. 6 for example).
Regarding claim 4, Williams teaches the second part 103 is configured to be detached from the first part 102 by rotating the second part with respect to the first part and then translating the second part away from the first part (see para [0052] et seq.)
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Videbaek et al., (US 2010/0106053; hereinafter “Videbaek”).
Regarding claim 5, Williams teaches one of the first part and the second part includes a first detachment mechanism, the other of the first part and the second part includes a second detachment mechanism. Williams teaches in one example, the filter top 10a and the filter base 10b may be integrated by a twist-lock mechanism, wherein openings 30 (shown in FIG. 5) on the filter top 10a may mate with locking lugs (not shown) in the filter base, securing the filter top to the filter base. Other mechanisms of coupling, such as corresponding male and female threads in the filter top 10a and the filter base 10b may couple the filter top 10a to the filter base 10b. However, Williams does not explicitly teach the first detachment mechanism includes a cavity having a longitudinal portion and a circumferential portion, and the second detachment mechanism includes a protrusion configured to move through the circumferential portion and the longitudinal portion when the second part is detached from the first part. The use of protrusions and cavities are well known in the in the art of fastening biopsy containers assemblies together, see Videbaek.
Videbaek teaches connecting a first part and a second part of the container using a first and second detachment mechanisms, wherein the first detachment mechanism includes a cavity (L-shaped projections 74) having a longitudinal portion and a circumferential portion (see Figs. 21-24), and the second detachment mechanism includes a protrusion 87 configured to move through the circumferential portion and the longitudinal portion when the first and second parts are attached/detached. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have joined the sieve container parts in Williams, with the well-known means of attachment taught by Videbaek, since Videbaek teaches that these types of attachment/detachment mechanism provide an easy and well known attachment to protect the operator from liquid or gaseous components of potentially toxic and/or carcinogenic preserving agents leaking out (see para [0055] et seq.) The applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, "[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp." An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See MPEP § 2143.
Regarding claims 6 and 7, modified Williams teaches the second detachment mechanism includes a recessed inner surface, and the protrusion extends radially outward from the recessed inner surface wherein the first detachment mechanism includes at least two cavities having respective longitudinal portions and circumferential portions, and the second detachment mechanism includes at least two protrusions each configured to translate through a respective longitudinal portion and a respective circumferential portion of one of the cavities. However, if not then, it would have been obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formal disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See MPEP 2143. In this case, the location and design of the first and second means of detachment/attachment between parts in a container are well known to provide the predictable result of quick and reliable attachment.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
While the following prior art listed below is not specifically discussed in this Official action, the examiner considers the listed prior art relevant to the overall prosecution and may be relied upon during subsequent examination(s) based on applicant’s future response(s).
Fiebig et al., (US 2016/0199048) teach a biopsy device having an outer cup (303) is configured to engage probe (100) in a bayonet fashion, such that outer cup (303) may be selectively removed from or secured to probe (100). More specifically, the distal end of outer cup (303) includes a plurality of slots (305) capable of engaging protrusions (not shown) of probe (100) upon sufficient rotation of outer cup (303) relative to probe (100). Other suitable configurations for providing selective engagement between outer cup (303) and probe (100) will be apparent to those skilled in the art in view of the teachings herein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached between 9:30am-7pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on 571-270-3638. 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.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
Prosecution Insights