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 .
Response to Amendment
The amendments and remarks, filed on 12/17/2025, has been entered. No amendments were made and the Applicant’s arguments are addressed below.
Claim Status
Claims 1-19 are pending and being examined.
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 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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Fry et al (US 20200155127 A1; hereinafter “Fry”; already of record on IDS filed 3/21/2025) in view of Fruchter et al (US 20210215585 A1; hereinafter “Fruchter”).
Regarding claim 1, Fry teaches a specimen transport medium tube for transporting a sample disposed on a swab tip of a swab (Fry; Abstract), the specimen transport medium tube comprising:
a mouth end comprising an opening (Fry; Fig. 1B, 2; para [98]; a main opening 135) configured to receive the swab tip (Fry; Fig. 1B, 2; para [104]; the main opening 135 through which the absorbent element 111 of the sample collector 110 can enter the internal chamber 131);
a cap configured to engage the mouth end so as to seal the opening (Fry; Fig. 1B, 2; para [99]; the opening 135 in a tight fit manner, and also by a screw-fitting 113, 138 between the cap 112), the cap comprising a cap insert (Fry; Fig. 1B, 2; para [96]; the elongate body 116 and the absorbent portion 111 can be considered to provide an insertion portion 1160 of the sample collector 110);
a distal end opposite the mouth end and defining a longitudinal axis therewith (Fry; Fig. 1B, 2; para [104]; The lower section 134 of the dropper 130); and at least one side wall extending longitudinally between the mouth end and the distal end to define and enclose an interior space inside the specimen transport medium tube (Fry; Fig. 1B, 2; the upper section 133 and lower section 134 are connected which forms the interior space and walls 1331); wherein the interior space is in fluid communication with the opening of the mouth end and wherein the interior space (Fry; Fig. 1B, 2; para [104]; The upper section 133 of the dropper 130 includes the main opening 135 through which the absorbent element 111 of the sample collector 110 can enter the internal chamber 131 of the dropper 130) comprises:
a mouth portion at the mouth end having an inner diameter thereof (Fry; Fig. 1B, 2; the inner diameter is the diameter within the main opening 135);
a transport medium compartment longitudinally aligned with the longitudinal axis and configured to contain a transport medium and the swab tip (Fry; Fig. 1B, 2; para [104, 108]; the absorbent element 111 of the sample collector 110 can enter the internal chamber 131 of the dropper 130…reagents may be located in the internal chamber 131), the transport medium compartment having an inner diameter thereof and an inner volume thereof (Fry; Fig. 1B; the examiner notes that the internal chamber is interpreted to be the transport medium compartment which comprises the inner diameter and inner volume), wherein the inner diameter of the transport medium compartment is smaller than the inner diameter of the mouth portion (Fry; Fig. 1B; the examiner notes that the internal chamber is interpreted to be the transport medium compartment which gets smaller in diameter towards the tapered portion);
a tapered portion disposed between the mouth portion and the transport medium compartment (Fry; the bottom of the dropper is tapered as seen in Fig. 2), wherein the tapered portion is in fluid communication with the mouth portion and with the transport medium compartment (Fry; para [104]; The lower section 134 of the dropper 130 has the aperture 132 to dispense the sample from the dropper 130; examiner notes that the sample and reagents are added to the lower portion from the mouth portion and held in the transport medium compartment), and is configured to permit unhindered passage of the swab tip from the opening at the mouth end to the transport medium compartment (Fry; para [30, 32]; The method may comprise depositing a liquid and/or reagents into the internal chamber of the dropper…the absorbent portion may mix or form a solute with the liquid contained in the dropper),
wherein an inner diameter of the tapered portion decreases from the inner diameter of the mouth portion at a junction between the tapered portion and the mouth portion to the inner diameter of the transport medium compartment at a junction between the tapered portion and the transport medium compartment (Fry; Fig. 2; the examiner interprets the junction to be the slanted wall before the dropper is tapered);
wherein the cap insert is configured to prevent fluid communication between the mouth portion and the transport medium compartment when the cap engages the mouth end (Fry; para [99]; The closing or sealing is achieved by a combination of the elongate body 116 extending through the opening 135 of the dropper 130 and contacting inner side walls adjacent the opening 135 in a tight fit manner, a screw-fitting 113, 138 between the cap 112 and the dropper 130; the cap insert secures the dropper, thus any liquid within the transport medium compartment would be prevented from reaching the mouth portion).
Fry does not teach wherein the inner diameter of the transport medium compartment is less than or equal to 10 mm, and the inner volume of the transport medium compartment is less than 1 ml.
However, Fruchter teaches a testing device (Fruchter; Abstract) comprising a transport medium compartment (Fruchter; Fig. 1A; para [255]; liquid container 30), wherein an inner diameter of the transport medium compartment is less than or equal to 10 mm (Fruchter; para [55, 303]; the liquid container is shaped so as to define a filter-support…The support may be perforated with openings, e.g., having an average diameter of between 0.2 and 5 mm), and an inner volume of the transport medium compartment is less than 1 ml (Fruchter; para [222]; liquid container 30 has an internal volume of at least 0.5 ml). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the transport medium compartment of Fry to comprise the inner volume of less than 1 ml and the inner diameter of less than 10 mm as this are known and suitable dimensions for liquid containers in the art. Further, it is a matter of engineering design to arrange the ----liquid containers in different ways, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Finally, one would have a reasonable expectation of success by changing the dimensions of the transport medium compartment of Fry to claimed inner volume and claimed inner diameter as Fruchter teaches the dimensions are a known and suitable substitution in the art. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 2, modified Fry teaches the specimen transport medium tube according to claim 1, wherein the distal end comprises a distal opening in fluid communication with the transport medium compartment (Fry; Fig. 2, 3E; para [104]; The lower section 134 of the dropper 130 has the aperture 132 to dispense the sample from the dropper 130) and wherein the specimen transport medium tube further comprises a distal cap configured to engage the distal end so as to seal the distal opening (Fry; Fig. 1C; para [111]; The sample collector 110, dropper 130 and base 140 may remain secured/engaged together, as illustrated in FIG. 3d, for a period of time sufficient to form a desired fluid sample mixture). The base 140 engages with the dropper which closes/covers the distal opening/aperture.
Regarding claim 3, modified Fry teaches the specimen transport medium tube according to claim 1, wherein the distal end comprises a distal end wall aligned perpendicular to the one or more side walls and unitary therewith (Fry; Fig. 1B, 1C). The bottom wall which is aligned with the aperture would be perpendicular to the walls 1331.
Regarding claim 4, modified Fry teaches the specimen transport medium tube according to claim 1 further containing a support structure configured to stably support the specimen transport medium tube at rest on the distal end thereof (Fry; para [106]; The releasable engagement between the dropper 130 and the base 140 can be overcome by applying opposing axial forces to the dropper and the base). The support structure is interpreted as the base 140, which holds the dropper until the dropper is removed as taught by Fry.
Regarding claim 5, modified Fry teaches the specimen transport medium tube according to claim 1 further comprising one or more external side walls longitudinally aligned with the longitudinal axis and external of at least the one or more side walls at the tapered portion and at the transport medium compartment (Fry; Fig. 1B, 1C; para [103]; the base 140 includes two separate components, the cup 150 as described above and an insert 160). The base comprises one or more external side walls which is aligned with the tapered portion of the dropper as seen in Fig. 1B and the walls 1331 of the dropper.
Regarding claim 6, modified Fry teaches the specimen transport medium tube according to claim 5 wherein the specimen transport medium tube is configured for use in an automated liquid handling system. The limitations are directed to the function and/or the manner of operating the specimen transport medium tube, all the structural limitations of the claim has been disclosed by Fry in view of Fruchter and the specimen transport medium tube of modified Fry is capable of “use in an automated liquid handling system”. As such, it is deemed that the claimed specimen transport medium tube is not differentiated from the specimen transport medium tube of modified Fry (see MPEP §2114).
Regarding claim 7, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the cap insert is configured to engage a handle of the swab (Fry; para [96]; the swab 114 also including a rod 115 that is inserted into an opening at a distal end 1162 of an elongate body 116 that projects from a bottom surface of the inner cap 112 b).
Regarding claim 8, modified Fry teaches the specimen transport medium tube according to claim 1 further including the transport medium within the transport medium compartment (Fry; para [108]; reagents may be located in the internal chamber 131).
Regarding claim 9, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the inner diameter of the transport medium compartment is less than or equal to 8 mm (Fruchter; para [55, 303]; the liquid container is shaped so as to define a filter-support…The support may be perforated with openings, e.g., having an average diameter of between 0.2 and 5 mm).
Regarding claim 10, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the inner diameter of the transport medium compartment is less than or equal to 5 mm (Fruchter; para [55, 303]; the liquid container is shaped so as to define a filter-support…The support may be perforated with openings, e.g., having an average diameter of between 0.2 and 5 mm).
Regarding claim 11, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the inner volume of the transport medium compartment is less than or equal to 0.8 ml (Fruchter; para [222]; liquid container 30 has an internal volume of at least 0.5 ml).
Regarding claim 12, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the inner volume of the transport medium compartment is less than or equal to 0.5 ml. (Fruchter; para [222]; liquid container 30 has an internal volume of at least 0.5 ml).
Regarding claim 13, modified Fry teaches the specimen transport medium tube according to claim 1 wherein the cap insert forms a seal against the one or more side walls of the tapered portion when the cap engages the mouth end (Fry; para [99]; The closing or sealing is achieved by a combination of the elongate body 116 extending through the opening 135 of the dropper 130 and contacting inner side walls adjacent the opening 135 in a tight fit manner, a screw-fitting 113, 138 between the cap 112 and the dropper 130).
Regarding claim 14, modified Fry teaches the specimen collection kit comprising a swab (Fry; para [96]; The absorbent portion 111 forms part of a swab 114); a transport medium (Fry; para [108]; reagents may be located in the internal chamber 131); and a specimen transport medium tube as defined in claim 1.
Regarding claim 15, modified Fry teaches the specimen collection kit according to claim 14 further containing instructions for use of the kit. The only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art (see MPEP 2112.01 III). Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists (see MPEP 2111.05 B). For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals (In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864).
Regarding claim 16, modified Fry teaches the specimen collection kit according to claim 14 wherein the transport medium is contained in the transport medium compartment of the specimen transport medium tube (Fry; para [108]; reagents may be located in the internal chamber 131).
Regarding claim 17, modified Fry teaches the specimen collection kit according to claim 14 wherein the swab is affixed to the cap of the specimen transport medium tube (Fry; para [96]; the swab 114 also including a rod 115 that is inserted into an opening at a distal end 1162 of an elongate body 116 that projects from a bottom surface of the inner cap 112 b).
Regarding claim 18, modified Fry teaches the specimen collection kit according to claim 14 wherein the swab is a nasopharyngeal swab (Fry; Fig. 3B; para [109]).
Regarding claim 19, modified Fry teaches the specimen collection kit according to claim 14 wherein the swab is an oropharyngeal swab (Fry; Fig. 3B; para [109]). The limitation “oropharyngeal” is directed to the function and/or the manner of operating the swab, all the structural limitations of the claim has been disclosed by Fry in view of Rothberg and the swab of modified Fry is capable of being “oropharyngeal”. As such, it is deemed that the claimed swab is not differentiated from the swab of modified Fry (see MPEP §2114).
Response to Arguments
Applicant’s arguments, filed 12/17/2025, with respect to the rejection of independent claim 1 and dependent claims 2-19 under 35 U.S.C. 103 have been fully considered and are not persuasive.
In the Applicant’s arguments, on pages 2-3, the Applicant argues that the prior art fails to teach the inner dimeter of the transport medium compartment is smaller than the inner diameter of the mouth portion and is less than or equal to 10 mm, and that the inner volume of the transport medium compartment is less than 1 ml, and that the cap insert is configured to prevent fluid communication between the mouth portion and the transport medium compartment when the cap engages the mouth end. The arguments are addressed below.
In the Applicant’s arguments, on pages 3-4, the Applicant argues Fry fails to teach claim limitations such as “the tapered portion disposed between the mouth portion and the transport medium compartment. As indicated by the Applicant, the examiner interprets the internal chamber as the transport medium compartment and the mouth portion as the main opening 135. The “tapered portion” is interpreted as the area that is getting smaller as recited above. The broadest reasonable interpretation of “the tapered portion” is an area/portion that reduces in size and not a separate structure. The internal chamber 131, interpreted as the transport medium compartment is getting smaller depicted in Fig. 1b. Further, the entire internal chamber is interpreted as the transport medium compartment, thus the lower portion of the internal chamber and the opening comprises the “tapered portion” being disposed between.
In the Applicant’s arguments, on pages 4-5, the Applicant argues Fry fails to teach “wherein the cap insert is configured to prevent fluid communication between the mouth portion and the transport medium compartment when the cap engages the mouth end”. The examiner respectfully disagrees. The arguments are directed to the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As previously, the cap insert secures the dropper. Thus, the opening 135 is prevented from fluidically communicating with any source because the opening is sealed.
In the Applicant’s arguments, on page 6-7, the Applicant argues that the prior art fails to teach the inner dimeter of the transport medium compartment is smaller than the inner diameter of the mouth portion and is less than or equal to 10 mm, and that the inner volume of the transport medium compartment is less than 1 ml.
First, the Applicant argues that Fruchter fails to disclose a specimen transport medium tube for transporting a sample disposed on the tip of a swab. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The examiner relies on Fruchter to modify the volume of the internal chamber.
Next, the Applicant argues that the prior art’s modification would not have been made because there is no suggested desirability to make the modification. The examiner respectfully disagrees. The premise of the case law provided is based on the prior art not being capable of being combined successfully. Fry teaches that the sample could be different biological samples (Fry; para [75]), and Fruchter teaches that the smaller internal volume is capable of holding the same samples (Fruchter; para [279]). Thus, there would be no reason that the modification of Fry in view of Fruchter would not be successful.
Further, Applicant argues that the transport medium compartment of Fry is not equivalent internal chamber of the liquid container of Fruchter. The Applicant arguments directed to the filter does not change the compartment size. The examiner relies on Fruchter to modify the transport medium compartment size as described above. The intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796