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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “28” has been used to designate both the rough sample shape (possibly signifying a specimen itself) in Figure 6, a stick swab in Fig. 4, and what appears to be a stick swab and also a gap in Figure 3. It is not apparent if the area to which the 28 call-out points is a gap, since there is an opening in the line of the rounded shape in Fig. 3. 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. 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 Objections
Claim 6 is objected to because of the following informalities: it is suggested to add an “a” before “wireless transmitter” for readability and consistency in the claim. Appropriate correction is required.
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 8, and 17 - 20 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 8 (line 2) recites the limitation "the specimen". There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited specimen. For the purposes of examination, the term “the specimen” is deemed to claim “a specimen”.
Claim 17 (line 1), Claim 18 (line 1), Claim 19 (line 1), and Claim 20 (line 1) each recite the term “the method of securing a specimen”. It is unclear if this is intended to be the same or different specimen as that previously-recited in Claim 16, from which these claims depend. For the purposes of examination, the term “the method of securing a specimen” is deemed to claim “the method of securing the specimen”.
Claim 18 (lines 1 - 2) and Claim 19 (lines 1 - 2) each recite the limitation “wherein the step of at least partially sealing the tubular body further comprises the step of adhering.” There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited step of adhering. For the purposes of examination, the term “wherein the step of at least partially sealing the tubular body further comprises the step of adhering” is deemed to claim “wherein the step of at least partially sealing the tubular body further comprises adhering.” Claim 20 is similarly rejected due to its dependence on Claim 19.
Claim 20 (line 1) recites the limitation “further including the step of tracking”. There is insufficient antecedent basis for this limitation in the claim. There is no such previously-recited step of tracking. For the purposes of examination, the term “further including the step of tracking” is deemed to claim “further including tracking”.
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.
Claims 1 – 4, 6 – 7, 9 – 10, 12 – 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mead et. al., (US 2,973,131).
Regarding Claims 1 and 16, Mead discloses
For Claim 1: A specimen collection apparatus ([Col 1, Lines 15 – 19] “…bags for liquid…bags…securing samples of milk…as for test purposes…”) comprising:
For Claim 16: A method of securing a specimen ([Col 1, Lines 15 – 19] “…securing samples of milk…as for test purposes…”) comprising the steps of:
obtaining a specimen collection apparatus ([Col 1, Lines 15 – 19] “…bags for liquid…bags…securing samples of milk…as for test purposes…”)
inserting a specimen into the specimen collection opening and into the tubular body (Fig. 6 and 7; [Col 4, Lines 13 – 21] “…milk 22 or other liquid may be poured into the open upper end of the bag…”) and
at least partially sealing the tubular body by folding over the flared member over the specimen collection opening (Fig. 9, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…folded over against the rolled upper end of the bag…to maintain the upper end of the bag closed…”)
For both Claims 1 and 16, Mead discloses:
A specimen collection apparatus ([Col 1, Lines 15 – 19] “…bags for liquid…bags…securing samples of milk…as for test purposes…”) comprising:
a tubular body (Fig. 7; [Col 2, Lines 33 – 35] “The bag…formed from a flat strip of tubular material…”)(Examiner notes that with liquid therein, a portion of the bag is broadly tubular.), having a first end (Fig. 1, Fig. 6 and 7, [Col 4, Lines 14 – 19] “…the heat seal 14 at the lower end of the bag will maintain the lower end closed at all times.”) and a second end (Fig. 1, Fig. 6 and 7, [Col 4, Lines 14 – 19] “…milk 22 or other liquid may be poured into the open upper end of the bag….”);
a flared member extending from the second end (Fig. 1, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…”; [Col 3, Lines 69 – 75] “…tabs T…deformable members, such as wires 18 and 19…”);
the first end sealed ([Col 2, Lines 33 – 37] “…closed…at the bottom by a transverse heat seal 14…”; Fig 1, Fig. 7 and 8);
the second end having a specimen collection opening (Fig. 6, 7, and 8, opening of the T tabs; [Col 3, Lines 69 – 75] “…tabs T are pushed toward each other…upper end of the bag will be pushed open, as to the position of Fig. 5.); and
the flared member configured to fold over the specimen collection opening thereby at least partially sealing the tubular body (Fig. 9, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…folded over against the rolled upper end of the bag…to maintain the upper end of the bag closed…”).
Regarding Claim 2, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 2, Mead discloses wherein the first end is heat sealed together ([Col 2, Lines 33 – 37] “…closed…at the bottom by a transverse heat seal 14…”; Fig 1, Fig. 7 and 8).
Regarding Claim 3, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 3, Mead discloses wherein the flared member further comprises an adhesive assembled to an inside surface of the flared member ([Col 3, Lines 33 – 41] “The strips 16 and 17 are conveniently strips of a pressure sensitive tape…provided with an adhesive surface…the strips 16 and 17 will adhere to the front wall 10 and rear wall 11 of the bag…Since the adhesive surfaces are facing each other, the strips will adhere together at the tabs T…deformable member…placed on both sides of the bag and held in position by the strips 16 and 17…”) wherein the adhesive is configured to adhere to the tubular body upon the flared member being folded over ([Col 3, Lines 33 – 41] “…adhesive surfaces are facing each other, the strips will adhere together at the tabs T…deformable member…placed on both sides of the bag and held in position by the strips 16 and 17…”)(Examiner notes that the adhesive is configured to adhere to the tubular plastic body of the bag in all configurations to hold the deformable members onto the bag, including upon being folded over.)
Regarding Claim 4, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 4, Mead discloses further comprising an identifying adhesive label assembled to the tubular body (Fig. 8; [Col 4, Lines 41 – 45] “…Strip 24 may be provided with an adhesive surface on the underside, which will adhere to the bag, and a surface on the outside which will readily take pencil or ink writing.”)
Regarding Claim 6, Mead discloses as described above, The specimen collection apparatus of claim 4. For the remainder of Claim 6, Mead discloses wherein the identifying adhesive label comprise specimen identifying indicia (Fig. 8; [Col 4, Lines 41 – 45] “…the name or code designation of the milk farm operator may be written on one of the strips 16 or 17, or on a special writing strip, such as strip 24 of Fig. 7.…Strip 24 may be provided with an adhesive surface on the underside, which will adhere to the bag…”) a barcode, a QR code, or wireless transmitter.
Regarding Claim 7, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 7, Mead discloses wherein the tubular body comprises a plastic (Fig. 7; [Col 2, Lines 33 – 35] “The bag…formed from a flat strip of tubular material, such as extruded polyethylene…”) or paper lined with wax, plastic, or a metallic film.
Regarding Claim 9, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 9, Mead discloses wherein the specimen collection apparatus is fluid impermeable (Fig. 6 and 7; [Col 4, Lines 13 – 21] “…milk 22 or other liquid may be poured into the open upper end of the bag…the heat seal 14 at the lower end of the bag will maintain the lower end closed at all times...liquid 22 contained in the bag will be a suitable quantity…”)
Regarding Claim 10, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 10, Mead discloses wherein the tubular body or the flared member further comprise a perforated portion or cut-line indicia configured to unseal the specimen collection apparatus ([Col 2, Lines 47 - 51] “The bag of this invention may also be provided with a series of cuts 5, immediately below the upper heat Seal 13, so that the upper heat seal 13 may be removed, to permit the top of the bag to be opened when ready for use.”)
Regarding Claim 12, Mead discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 12, Mead discloses wherein the flared member is configured as a scoop or shovel shape configured to facilitate collection of an environmental specimen (Fig. 6 - 8, [Col 3, Lines 71 – 75] “… tabs T are pushed toward each other from opposite sides, the deformable members, such as wires 18 and 19, providing sufficient stability to the tabs, so that the upper end of the bag will be pushed open, as to the position of Fig. 5…”; [Col 4, lines 1 – 7] “…When so formed, the deformable members will retain the upper end of the bag open during filling…”)(Examiner notes that the kinked shape with concavity is broadly a scoop or shovel shape.)
Regarding Claim 13, Mead discloses as described above, The specimen collection apparatus of claim 12. For the remainder of Claim 13, Mead discloses herein the flared member is rotatably coupled to the tubular member (Fig. 9, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…folded over against the rolled upper end of the bag…to maintain the upper end of the bag closed…”).
Regarding Claim 14 (and Claim 15, which is a duplicate claim, see objection above), Mead discloses as described above, The specimen collection apparatus of claim 12. For the remainder of Claim 14, Mead discloses wherein the flared member ([Col 3, Lines 38 – 42] “…tabs T…deformable members may be soft iron wires of small diameter…”) is more rigid than the tubular member ([Col 2, Line 42] “…tubular, extruded polyethylene…”; Fig. 6 - 8, [Col 3, Lines 71 – 75] “… tabs T are pushed toward each other from opposite sides, the deformable members, such as wires 18 and 19, providing sufficient stability to the tabs, so that the upper end of the bag will be pushed open, as to the position of Fig. 5…”;
Regarding Claim 18, Mead discloses as described above , The specimen collection apparatus of claim 16. For the remainder of Claim 18, Mead discloses wherein the step of at least partially sealing the tubular body further comprises the step of adhering the flared member to the tubular body ([Col 3, Lines 33 – 41] “…adhesive surfaces are facing each other, the strips will adhere together at the tabs T…deformable member…placed on both sides of the bag and held in position by the strips 16 and 17…”; Fig. 9, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…folded over against the rolled upper end of the bag…to maintain the upper end of the bag closed…”)(Examiner notes that the flared member “deformable member” tabs T must be adhered to the tubular bag body so that the wires can fold over, bend, and seal the bag).
Claims 1, 8, 11, and 16 - 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voight (US 2006/0266816 A1).
Regarding Claims 1 and 16, Voight discloses
For Claim 1: A specimen collection apparatus ([Abstract]; [0025] “… scoop up foods when the lid is in the open configuration.”) comprising:
For Claim 16: A method of securing a specimen ([Abstract]; [0025] “… scoop up foods when the lid is in the open configuration.”) comprising the steps of:
obtaining a specimen collection apparatus (Fig. 1; “food container 20”; [0025] “… scoop up foods when the lid is in the open configuration.”)
inserting a specimen into the specimen collection opening and into the tubular body ([0025] “… scoop up foods when the lid is in the open configuration.”; Fig. 1, “Food container 20”’ with “food containing portion 22”; [0039] “…semi-cylindrical shape of the food portion 22”) and
at least partially sealing the tubular body ([0039] “…semi-cylindrical shape of the food portion 22”) by folding over the flared member ([0026] “…lid portion 24”; Fig. 1) over the specimen collection opening ([0025] “…the lid may be folded to cover the top opening of the container…”)
For both Claims 1 and 16, Mead discloses:
A specimen collection apparatus [Abstract]; [0025] “… scoop up foods when the lid is in the open configuration.”) comprising:
a tubular body (Fig. 1, “Food container 20”’ with “food containing portion 22”; [0039] “…semi-cylindrical shape of the food portion 22”) having a first end (Fig. 1, “Base 32”) and a second end (Fig. 1, “top opening 46”)
a flared member extending from the second end (Fig. 1, “lid portion 24”; [0044] including “the lid portion 24 reduces the amount of heat that escapes from the food through the top opening 46…lid portion 24…manufactured integrally with the food containing portion 22…”)
the first end sealed (Fig. 1, “Base 32”; Fig. 6a, closed bottom “base 32”; [0026] “…base 32…press fit or glued…”)
the second end having a specimen collection opening (Fig. 1, “top opening 46”; [0025] “… scoop up foods when the lid is in the open configuration.”)and
the flared member configured to fold over the specimen collection opening thereby at least partially sealing the tubular body (Fig. 1; Fig. 2; Fig. 4; [0025] “…the lid may be folded to cover the top opening of the container…”)
Regarding Claim 8, Voight discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 8, Voight teaches wherein the tubular body is chemically treated or coated to facilitate sterilization of the tubular body or proper storage of the specimen ([0026] “…the food container 20 may generally comprise paper with a coating…”, “…manufactured in accordance with standard manufacturing processes for producing common restaurant industry beverage cups…”; [0010] “…food container described herein is configured to…to reduce or prevent spillage from the food container…”)
Regarding Claim 11, Voight discloses as described above, The specimen collection apparatus of claim 1. For the remainder of Claim 11, Voight discloses wherein the tubular body comprises a pre-fold indentation configured to aid in the fold over of the flared member (Fig. 1; Fig. 2; Fig. 4 “arcuate crease 40”; [0028] “adjacent the lid portion 24 and the food containing portion 22 is an arcuate crease or score line 40 that extends toward the rear 28 and base 38 of the food container 20…”; [0040] “…the lid portion 24 folds along the arcuate crease 40 between the folding corners 36…”)
Regarding Claim 17, Voight discloses as described above, The method of securing a specimen of claim 16. For the remainder of Claim 17, Voight discloses wherein the step of inserting the specimen further comprises using the flared member to scoop the specimen from an environment and facilitate the specimen entering the specimen collection opening ([0025] “…lid of the container can also provide an integrated scoop that permits employees to scoop up foods when the lid is in the open configuration.”; Fig. 1., “lid portion 24” of “top opening 46”)
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, and 19 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mead et. al., (US 2,973,131) in view of Guardian Forensic Sciences (“Shipping and Sealing of Evidence to GFS”, Ref V on PTO-892)
Regarding Claim 5, Mead as described above, The specimen collection apparatus of claim 4. For the remainder of Claim 5, Mead does not specifically disclose wherein the identifying adhesive label is assembled to the second end and folded over the flared member thereby securing the flared member to the tubular body
Guardian Forensic Sciences teaches the chain-of-custody technique for sealing and shipping evidence that has been collected in bags, including folding the opening of the bag over “once or twice” and putting signed and dated tamper-evident adhesive tape across the folded edge to ensure the sample has not been opened before intended. Specifically for Claim 5, Guardian Forensic Sciences teaches wherein the identifying adhesive label is assembled to the second end and folded over the flared member thereby securing the flared member to the tubular body ([Page 1, Bullet 2 and 3] including “Seal each bag by folding the opening over once or twice, and then putting a piece of tamper-evident tape across the edge, like this…sign and date across the seal…”; Page 1 Figure, Page 2 Figure).
Guardian Forensic Sciences provides a motivation to combine at [Page 1, Paragraph under the figure] “Tamper-evident means that, if someone tries to open it, it will be apparent…” and [Page 2, Bottom] “…If the box is violated or compromised in some way, then we have the interior seals as a back-up, and if they are intact, then the integrity of the evidence remains intact.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that affixing an adhesive between the folded portion of a bag and the main section of the bag (such as the folded over flared portion to the tubular portion of Mead’s disclosed bag) would be useful for ensuring a proper chain of custody and lack of tampering with the contents of a sample during transport.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the fold-over sample bag disclosed by Mead with Guardian Forensic Sciences’ taught evidence chain-of-custody technique of folding over a sample bag, taping across the fold to hold it closed, with a sign and date confirmation, creating a single sample-gathering bag system that can show evidence of a lack of tampering during transport with closure tape across a folded top.
Regarding Claim 19, Mead discloses as described above , The specimen collection apparatus of claim 16. For the remainder of Claim 19, Mead discloses the step of at least partially sealing the tubular body (Fig. 9, [Col 3, Line 23 – 25] “…laterally extending tab T at each side…folded over against the rolled upper end of the bag…to maintain the upper end of the bag closed…”).
Mead does not specifically disclose wherein the step of at least partially sealing the tubular body further comprises the step of adhering an identifying adhesive label to the tubular body over the flared member.
Guardian Forensic Sciences teaches wherein the step of at least partially sealing the tubular body further comprises the step of adhering an identifying adhesive label to the tubular body over the flared member ([Page 1, Bullet 2 and 3] including “Seal each bag by folding the opening over once or twice, and then putting a piece of tamper-evident tape across the edge, like this…sign and date across the seal…”; Page 1 Figure, Page 2 Figure).
The motivation for Claim 19 to combine Mead with Guardian Forensic Sciences is the same as that explained in more detail above for Claim 5. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the fold-over sample bag disclosed by Mead with Guardian Forensic Sciences’ taught evidence chain-of-custody technique of folding over a sample bag, taping across the fold to hold it closed, with a sign and date confirmation, creating a single sample-gathering bag system that can show evidence of a lack of tampering during transport with closure tape across a folded top.
Regarding Claim 20, Mead discloses as described above , The specimen collection apparatus of claim 19. For the remainder of Claim 20, Mead discloses further including the step of tracking the specimen through the identifying adhesive label through identifying indicia ([Col 4, Lines 39 – 42] “name or code designation of the milk farm operator may be written on one of the strips 16 or 17, or on a special writing strip, such as strip 24…Strip 24 may be provided with an adhesive surface…”), a barcode, a QR code, or wireless transmitter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Putcha et. al., (US 6,133,036) teaches preserving a liquid biological sample by coating an inert plastic material or a plastic tube with a preservative mixture.
Distinctive Medical (“Self Adhesive Test Tube Seal”, Ref U on PTO-892) teaches adhesive labels to wrap over test tubes or stoppers for visual evidence of tampering to lab samples and specimens, with numbering barcodes for traceability of tube samples.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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, Alexander Valvis can be reached at (571) 272 - 4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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