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 .
Claim Objections
Claims 1-10 are objected to because of the following informalities: There are limitations within the claims which can be confusing as they appear to actively claim a process step within an apparatus claim. The examiner encourages the applicant to amend such limitations so as to recite how the apparatus is configured to provide the corresponding functions when the action is performed in order to avoid any confusion as to the scope of the claim. A specific example is in claim 1 wherein the limitation “the sealing portion being annularly and sealingly engaged with an inner wall of the chamber” should be amended to recite “wherein the sealing portion is configured to be annularly and sealingly engaged with an inner wall of the chamber when the sample collection member is fully inserted into the container” or similar. Other claim limitations having similar issues include: “the cover portion covers the opening, and the sample collection member is received in the connection portion” of claims 9 and 10
Appropriate correction is required.
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.
There are no claim limitations in the instant claims which invoke a 35 USC 112(f) interpretation.
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.
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.
Claims 3-6 and 10 are 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.
The phrase “in the vicinity” in claim 3 is a relative term which renders the claim indefinite. The term “in the vicinity” 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. Essentially, the scope of the claim is indefinite because it is unclear as to when a through hole is considered to be within the vicinity of the opening (i.e. is on the same device considered to be in the vicinity, is directly abutting only considered in the vicinity, etc…).
For the purpose of advancing examination and promoting compact prosecution, the examiner will interpret the claim limitation “in the vicinity of the opening” to mean the through hole is adjacent to the opening.
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.
Claims 1, 2, and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumaier (DE 10 2021 115 185 A1 hereinafter Neumaier, citations are drawn to examiner provided English machine translation) in view of Haupt et al (US 2023/0293068 A1).
Regarding claims 1 and 2; Neumaier discloses a sample collection device including:
a container (element 30) including a chamber (spaced defined inside container element 30) and a squeeze portion (element 50 and 50’) within the chamber, the container including an opening (element 31), the opening being in communication with the chamber (figures 2a-c and 5a-c); and
a sampling unit (combined elements 10, 20 and 40) including a main body (element 20), the main body including a sample collection member (element 10) which is made of deformable absorbent material (wherein sponges are absorbent and deformable; abstract), and a sealing portion (element 40), the sample collection member being insertable into the chamber and radially urging the squeeze portion (see figure 2b and 5b), the sealing portion being annularly and sealingly engaged with an inner wall of the chamber (wherein cap element 40 seals the container closed and the inner surface of cap element forms a seal with inner wall of the chamber when the cap is screwed onto the threads completely as depicted in figures 2b and 5b).
However, Neumaier does not explicitly disclose that the container comprises an outlet at an opposite side from the opening.
Haupt teaches a container for receiving a sample extracted from a sampling member comprising an opening (top of container where swab is inserted) and an outlet (base opening covered by base cap) such that the extracted sample can be dispensed (paragraphs [0062]-[0063]; figures 1, 2 and 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Neumaier to include an outlet and base cap at the opposite side of the container opening as taught by Haupt in order to allow for dispensing of the sample for testing after it is extracted from the sampling member.
Further regarding claim 2; Neumaier/Haupt combination teaches the squeeze portion includes a channel in communication with the with the outlet (wherein the channel is the reduced dimension part defined by element 50 and 50’ where the sample collection element is squeezed; see figures 2b and 5b of Neumaier and the outlet of the Neumaier/Haupt combination would be on the bottom near element 34 of Neumaier’s container), and the sample collection member has an outer diameter dimension larger than an outer diametric dimension of the channel (wherein the sample collection member element 10 has a smaller diameter than channel as depicted in figures 2b and 5b of Neumaier where the sample collection element is compressed in element 50 and 50’).
Further regarding claim 7; the Neumaier/Haupt combination teaches the container further includes a large diameter section (section of container 30 located above element 50 and 50’) and a small diameter section (wherein the examiner notes that the inner diameter of the section including element 50 meets the BRI of the claim as the section has a small diameter i.e. the inner diameter where the sample element is compressed) connected to each other (wherein they are connected when element 50 and 50’ are within the container element 30), the small diameter section includes the squeeze portion, the squeeze portion includes a plurality of protrusions projecting radially and arranged circumferentially (elements 56 as depicted in figure 4c which is perspective view of element 50 and 50’ from figures 2a-b and 5a-b), the plurality of protrusions form the channel, and the plurality of protrusions are configured to squeeze the sample collection member (see rejection of claim 2 above).
Further regarding claim 8; Neumaier further discloses a filtration sheet (element 59), wherein the filtration sheet is received in the small diameter section (wherein filtration element 59 is includes with element 50 and 50’ which define the small diameter section).
Further regarding claim 9; Neumaier further discloses the main body (element 20) includes a grip portion (outer surface of element 40) and a connection portion (where element 10 is connected and held on element 20) at opposing ends (see figures 2a-b and 5a-b), respectively, the main body further includes a cover portion (inner surface of element 40) extending radially and located between the grip portion and the connection portion (wherein the inner surface of element 40 is connected to the main body element 20 and located between element 20 and outer surface of element 40), the sealing portion is located between the cover portion and the connection portion (wherein the portion of the inner surface of element 40 that forms the seal with the inner surface of container element 30 is between the outer surface of element 40 and the connection between element 20 and element 10), the cover portion covers the opening (see figures 2b and 5b of Neumaier), and the sample collection member is received the connection portion (see figures 2b and 5b of Neumaier).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Neumaier in view of Haupt as applied to claim 1 above, and further in view of Deutsch et al (US 5,211,182) and Ling (WO 2018/188458, hereinafter Ling, citations are drawn to examiner provided English machine translation).
Regarding claims 3-5; The Neumaier/Haupt combination is described in the rejection of claim 1 above; however it does not explicitly disclose a through hole in vicinity to the opening and extending radially, the through hole in communication with the chamber, the main body configured to drive the sealing portion to move axially in the chamber, and the sealing portion can pass over the through hole (claim 3); wherein the through hole defines an axial dimension, and the sealing portion has a thickness dimension smaller than the axial dimension (claim 4); a blocking portion and the through hole are arranged in interval in an axial direction, and the sealing portion is radially abuttable against the blocking portion in a direction away from the opening (claim 5); or .
Deutsch teaches a sample collection device (figure 2) for collecting a sample from an sample collection member (element 14) wherein the container (element 21) which receives the sample collection element (element 14) includes a through hole (element 50) in the peripheral wall of the container and adjacent to the opening (opening at top of container near element 20) wherein the through hole provides an air vent to allow air to escape as the sampling member is compressed to express the sample making it easier to insert the sampling unit into the chamber (column 3, lines 56-68; figure 4).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Neumaier/Haupt combination to further include a through hole radially disposed therethrough and adjacent to the opening in communication with the chamber as taught by Deutsch in order to allow for air to escape as the sampling unit is advanced into the container to make it easier to insert.
Ling teaches a sample collecting device (figure 7) that includes a sampling unit (figures 3-5), wherein the sampling unit includes a sealing member (element 112) assembled to the main body (element 110), the sealing member configured to seal around an inner wall of the chamber to block the chamber (see figure 9 where element 112 seals around an inner wall of the chamber) wherein the sealing member is axially blocked by a blocking portion (element 320) of the sample collecting device projecting radially inward in the chamber in order to provide a stop to show when the sample collection member is fully extended in the part of the chamber which expresses the sample from the sample collection member (2nd paragraph of page 12, “The bump 320 blocks the second tab 112 on the collector within the collection, so that the collector 100 can no longer continue into the collection chamber 200 and into the barrel 210”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Neumaier/Haupt/Deutsch combination to further the sealing member (element 112) and include a blocking portion projecting radially inward in the chamber as taught Ling in order to seal the sample in the container and provide a stop to show when the sample collection member is fully inserted into the protrusions of the chamber.
Further regarding claim 3; the described Neumaier/Haupt/Deutsch/Ling combination teaches the container includes a through hole in vicinity to the opening and extending radially (element 50 of Deutsch in Neumaier’s container adjacent the opening element 31), the through hole is in communication with the chamber (element 50 of Deutsch would extend into chamber to release air as sample collection element is advanced), the main body (element 20 of Neumaier) is configured to drive the sealing portion (element 112 of Ling on Neumaier’s main body element 20) to move axially in the chamber, and the sealing portion can pass over the through hole (wherein element 112 would advance passed throughhole element 50 until it abuts blocking portion which would be located at element 50 or 50’ of Neumaier).
Further regarding claim 4; the described Neumaier/Haupt/Deutsch/Ling combination discloses that vent hole and sealing portion, which inherently have dimensions. However, it does not explicitly disclose that the sealing portion has a thickness less than the axial dimension of the vent hole.
It would have been obvious to one of ordinary skill in the art at the time of filing to further modify the thickness dimension of the sealing portion of the described Neumaier/Haupt/Deutsch/Ling combination to be less than the axial dimension of the through hole as obvious to try, choosing from a finite number of identified predictable solutions with a reasonable expectation of success (wherein either the thickness of the sealing portion is less than, equal to, or greater than the axial dimension of the through hole).
Further regarding claim 5; the described Neumaier/Haupt/Deutsch/Ling combination teaches container further includes a blocking portion projecting radially inward in the chamber, the blocking portion and the through hole are arranged in interval in an axial direction (wherein they blocking portion would be lower in the container than the through hole in the combination, and thus arranged in interval), and the sealing portion is radially abutable against the blocking portion (wherein Ling teaches a sealing portion element 112 that abuts against a blocking portion 312 in the Neumaier/Haupt/Deutsch/Ling combination as described above).
Allowable Subject Matter
Claims 6 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and to overcome the instant 35 USC 112(b) rejection noted above.
The following is a statement of reasons for the indication of allowable subject matter: Instant claims 6 and 10 recite limitations to the through hole dimensions and functions that are not anticipated or made obvious by the prior art of record. Specifically, the dimensions of the through hole in instant invention in relation to the blocking portion such that the travel distance is less than the axial dimension of the through hole allows for air to vent through the through hole in the larger diameter section of the container until it the sampling member is fully inserted so as to abut against the blocking portion such that the container is then sealed. The specific dimensions of the through hole in relation to the travel distance provides such that the air can vent until the sample member is fully inserted, thus both allowing for easier advancement of the sampling unit and to fully seal off the extracted sample from outside contamination only once the sample unit is fully inserted to the blocking portion. The prior art of record to Deutsch discloses providing a vent hole, but does not provide any teachings to vary the axial dimension of the through hole as claimed to provide the functions outlined in the specification of the instant invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The provided PTO-892 form lists a plurality of prior art references that disclose similar sample collection devices with various features to show the state of the art. References of particular relevance from the PTO-892 are further described here:
US 2020/0100774 A1 to Lei et al; discloses an apparatus for detecting an analyte in a liquid sample wherein a sample collection element is expressed in a chamber to collect the sample (see figure 11, 14 and 20 and corresponding sections of spec for particular relevance).
US 2006/0057027 A1 to Hudak et al; discloses a fluid collection and testing device with a container and a sampling unit wherein the sample collection element is squeezed to express a sample (see figures 1-4).
US 2009/0030342 A1 to Flanigan et al; discloses an apparatus and method for releasing a sample material wherein protrusions within a chamber are used to express a sample from a sample collection element wherein it discloses the protrusions as a variety of different styles and shapes (see figures 3-5c, 10a-12b).
US 2004/0237674 A1 to Wu et al; discloses a fluid collection device wherein a sample collection element is compressed to express a sample in a container (see figures 1-4).
WO2009/050666 A1 to Philips et al; discloses a sample testing device utilizing a conical surface to express a sample from a sample collection element (see figures 2 and 3).
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).
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, 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.
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.
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
Prosecution Insights