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 without traverse of Group II in the reply filed on 7/15/2025 is acknowledged. Claims 6-9 and 21-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the third elastomeric material being:
Overmolded over at least a portion of the second end or at least a portion of the tube wall
Patterned on an exterior surface of the tube wall and comprises at least one textured surface
Overmolded around a periphery of the second end and on an exterior surface of the tube wall
Formed as a strip on the exterior surface of the tube wall extending from the second open along the entire length or a portion of the length of the tube wall
All must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 14 and 15 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.
Claim 14 recites the limitation "the second open" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the second elastomeric material" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2015/0048085, hereinafter Brown.
Regarding claim 10, Brown teaches a vial assembly (figure 1) comprising: a tubular body (item 110) comprising a cavity (the inside of item 110), a first end (the upper end), a second end (the lower end) for dispensing a sample (intended use MPEP § 2114 (II)), a tube wall (item 110), and a flexible bottom (item 120) disposed on an interior surface of the tube wall proximate the first end (figure 1), wherein the tube wall and flexible bottom comprise a first material (paragraph [0090]), wherein the flexible bottom has a first thickness less which is less than a second thickness of the tube wall (figure 1), and wherein the flexible bottom does not extend past the first end of the tubular body (figure 1).
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.
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.
Claim(s) 11-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of United States Application Publication No. 2017/0315028, hereinafter Suzaki with or without United States Application Publication No. 2009/0004064, hereinafter Liu.
Regarding claim 11, Brown teaches an extraction device (item 150) to remove the sample from the tube.
However, Brown fails to teach at least a portion of the second end or at least a portion of the tube wall is overmolded with a third elastomeric material.
Suzaki teaches a sample extraction kit which utilizes holding member (Suzaki, item 20) which is made of two flanges (Suzaki, item 21) which bend inwardly to apply force to the flexible bottom which increases the specimen extraction efficiency (Suzaki, paragraph [0005]).
Examiner further finds that the prior art contained a device/method/product (i.e., a third elastomeric material with two flanges) which differed from the claimed device by the substitution of component(s) (i.e., a plunger type extraction device) with other component(s) (i.e., a third elastomeric material with two flanges), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a plunger type extraction device with a third elastomeric material with two flanges), and the results of the substitution (i.e., extracting the specimen) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute a plunger type extraction device of reference Brown with a third elastomeric material with two flanges of reference Suzaki, since the result would have been predictable. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilized the holding member of Suzaki in the device of Brown because it would increase the specimen extraction efficiency (Suzaki, paragraph [0005]).
Regarding the method of overmolding the third elastomeric material is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Brown and Suzaki (MPEP § 2113). The burden is on applicants to show product differences in product by process claims. Here, the limitations as to the overmolding is given minimal patentable weight.
However, if it is determined that the combination of Brown and Suzaki fail to teach the third elastomeric material is overmolded with at least a portion of the second end or at least a portion of the tube wall, then Liu teaches the process of overmolding a vial and the holder of the vial (Liu, paragraph [0035]) so that a complete melt and bond can be achieved so that no interlocking features are required to ensure the wells are fixed to the holder (Liu, paragraph [0034]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have overmolded the holder of Suzaki onto the vial of Brown because it would ensure that a complete melt and bond can be achieved so that no interlocking features are required to ensure the wells are fixed to the holder (Liu, paragraph [0034]).
Regarding claim 12, modified Brown teaches wherein the third elastomeric material is patterned on an exterior surface of the tube wall and comprises at least one textured surface (Suzaki, item 22).
Regarding claim 13, modified Brown teaches wherein the third elastomeric material is overmolded around a periphery of the second end and on an exterior surface of the tube wall (Suzaki, figure 4).
Regarding claim 14, modified Brown teaches wherein the exterior surface of the tube wall comprises at least one strip of the third elastomeric material extending from the second open along the entire length or a portion of the length of the tube wall (Suzaki, figure 4).
Regarding claim 15, modified Brown teaches wherein the third elastomeric material is identical to or different from the second elastomeric material (Brown, paragraph [0090] and Suzaki, paragraphs [0041]-[0042]).
Regarding claim 16, Brown teaches an extraction device (item 150) to remove the sample from the tube.
However, Brown fails to teach the tube wall comprises at least two flanges proximate the flexible bottom, wherein the flanges are configured to hinge inwardly and apply force to the flexible bottom..
Suzaki teaches a sample extraction kit which utilizes holding member (Suzaki, item 20) which is made of two flanges (Suzaki, item 21) which bend inwardly to apply force to the flexible bottom which increases the specimen extraction efficiency (Suzaki, paragraph [0005]).
Examiner further finds that the prior art contained a device/method/product (i.e., a third elastomeric material with two flanges) which differed from the claimed device by the substitution of component(s) (i.e., a plunger type extraction device) with other component(s) (i.e., a third elastomeric material with two flanges), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a plunger type extraction device with a third elastomeric material with two flanges), and the results of the substitution (i.e., extracting the specimen) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute a plunger type extraction device of reference Brown with a third elastomeric material with two flanges of reference Suzaki, since the result would have been predictable. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilized the holding member of Suzaki in the device of Brown because it would increase the specimen extraction efficiency (Suzaki, paragraph [0005]).
Regarding the method of overmolding the third elastomeric material is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by Brown and Suzaki (MPEP § 2113). The burden is on applicants to show product differences in product by process claims. Here, the limitations as to the overmolding is given minimal patentable weight.
However, if it is determined that the combination of Brown and Suzaki fail to teach the third elastomeric material is overmolded with at least a portion of the second end or at least a portion of the tube wall, then Liu teaches the process of overmolding a vial and the holder of the vial (Liu, paragraph [0035]) so that a complete melt and bond can be achieved so that no interlocking features are required to ensure the wells are fixed to the holder (Liu, paragraph [0034]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have overmolded the holder of Suzaki onto the vial of Brown because it would ensure that a complete melt and bond can be achieved so that no interlocking features are required to ensure the wells are fixed to the holder (Liu, paragraph [0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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, Elizabeth Robinson can be reached at (571)272-7129. 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.
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796