Patent Application 16139730 - PCR TUBE HOLDER

Title: PCR TUBE HOLDER

Application Information

Invention Title: PCR TUBE HOLDER
Application Number: 16139730
Submission Date: 2025-04-10T00:00:00.000Z
Effective Filing Date: 2018-09-24T00:00:00.000Z
Filing Date: 2018-09-24T00:00:00.000Z
National Class: 206
National Sub-Class: 446000
Examiner Employee Number: 85842
Art Unit: 3735
Tech Center: 3700

Rejection Summary

102 Rejections: 1
103 Rejections: 3

Cited Patents

The following patents were cited in the rejection:

US 3669566🔗
US 0072894🔗

Office Action Text

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 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 1, 6-8, 18, 21-22, 26-28 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 test for definiteness under 35 U.S.C. § 112(b) is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). During prosecution, ““[a] claim is indefinite when it contains words or phrases whose meaning 1s unclear.” Ex parte McAward, Appeal No. 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (quoting /n re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir. 2014)); see Packard, 751 F.3d at 1313 (“claims are required to be cast in clear—as opposed to ambiguous, vague, indefinite—terms’’) (per curiam).

Claim 1 recites, in relevant part, “the elongated strip body is adapted to retain the ink through a PCR cycle performed in a PCR cycler” (the “retaining ink limitation’’) and “a material of the elongated strip body has a minimum flexural rigidity such that the elongated strip is adapted to support a filled and capped PCR tube without folding” (the “rigidity limitation’’). Claims 6-8, 18, 21, 22, and 26-28 ultimately depend from, and include every limitation recited in, claim 1. Claim 1’s retaining ink and rigidity limitations are ambiguous and, therefore, fail to clearly define the scope of the claim.
In particular, the retaining ink limitation introduces ambiguity into the scope of the claims because the ability of the strip to retain ink through a PCR cycle depends on the type of ink used, the interaction between the ink and the strip body’s material, the method by which the ink is applied to the strip body, and the details of the PCR cycle being run, the type of PCY cycler. For example, as disclosed by Appellant, a PCR cycler (“the most common tool used” to run PCR cycles) is “programmed to cycle through the different temperatures required during the amplification process” and “[t]here are many variations of the PCR technology.” Spec. 45. “The amplification cycles, protocols and conditions may have significant variations.” Spec. 95. Regarding ink, the invention contemplates any of various types of ink or application methods. See, e.g., Spec. { 44 (“The writable zone 24 is devised to receive information or data thereon, in the form of ink from a marker, a pen, a pencil, a stamp, or from a printer, or originate from the direct thermal material from which the PCR tube holder 20 may be made. Other printing possibilities are considered, including ink jet, laser, thermal transfer, direct-thermal, thermal, flexographic, offset, digital, Liquid electrophotography, laser etching, impact printer, UV printer, type writer.”).
Additionally, the rigidity limitation recites a minimum flexural rigidity of the elongated strip’s material such that the strip does not fold when supporting a PCR tube. There are at least three reasons we determine the rigidity limitation fails to clearly define the scope of claim 1. First, the claim does not recite the size or, perhaps more importantly, mass of the PCR tube. Even assuming that a person of ordinary skill in the art would have understood a “PCR tube” to define a particular type of container, the claim does not define the specific size or material of the PCR tube that the claimed PCR strip is adapted to support without folding. Given potential variations in PCR tubes, different PCR tubes may have different weights. Second, and relatedly, the claim does not clearly define whether the PCR tube must include content and the amount of content. Accordingly, the rigidity limitation defines the maximum flexural ngidity of the PCR strip’s material only by the fact that the strip is adapted to support a filled and capped PCR tube without bending. However, a potential infringer would not know whether a PCR strip infringes if it can, for example, support an empty 0.1 mL PCR tube without folding, but the PCR strip folds when a 0.5 mL PCR tube filled with contents placed therein.
Third, it is unclear how the minimum flexural rigidity of the PCR strip’s material can be determinative of whether the PCR strip is adapted to support a PCR tube without folding. In addition to the material used, the shape and structure of the PCR strip affect its ability to support a PCR tube without folding (i.¢., the claimed “flexural rigidity’). Cf Ambartsoumian Decl. 2 (Mar. 16, 2022) (stating, regarding Rowe’s materials that are similar to Appellant’s disclosed materials, “the listed possible materials for the carrier strip in Rowe do not necessarily impart the carrier strip with the minimum flexural rigidity to prevent folding, as each of the listed materials are broad material types that may have varying structural properties based on the specific material and thickness selected”). Thus, a first PCR strip made of a certain material may support any PCR tube without folding whereas a second PCR strip formed of the same material that is thinner and/or has a different structure than the first PCR strip may fold when an empty 0.1 mL PCR tube is placed therein. Thus, it is unclear whether any PCR strip made from that material would infringe because it is possible to manufacture a PCR strip of that material that cannot support a PCR tube without folding.
Because the rigidity limitation is unclear for at least the reasons mentioned above, the rejection of claim 1 under 35 U.S.C. § 112(b) as indefinite is maintained. Because claims 6-8, 18, 21, 22, and 26-28 ultimately depend from, and incorporate every limitation recited in, claim 1, claims 6-8, 18, 21, 22, and 26-28 under 35 U.S.C. § 112(b) are also indefinite. Even though claim 26-28 further quantifies the minimum flexural rigidity of the PCR strip’s material, claim 26-28 still suffers from the same ambiguity concerns as claim 1.
Regarding claim 1, the scope of the claims is unclear with the recitation of “the at least one hole having a diameter corresponding to an outer diameter of the single PCR tube” for the following reasons. First, the scope of the claims is unclear because applicant has not defined what “corresponding” means and second, the single PCR tube is not explicitly claimed and thus it is unclear how the structure of the tube holder can be defined based on properties of an unclaimed feature. For example, it is unclear if applicant intends for the hole diameter to be the same or similar size of the PCR tube and thus “corresponds” to it or if applicant intends for the hole having a size that can hold a single PCR tube and thus “corresponds” to it.

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 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) 1, 7, 26, 28 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US Patent No. 5,242,053 to Rowe.
Regarding claim 1, Rowe discloses a holder (Fig 1) for tubular structure capable of holding a PCR tube comprising an elongated strip body (10) having an upper surface (A, Fig 1 below) and an undersurface (B, Fig 1 below) and at least a first portion (lower half of the body, Fig 2) and a second portion (upper half of the body, Fig 2), the elongated strip body formed of a thermoplastic material (col. 2, ll. 65-68, col. 3, ll. 1-5), at least one hole (11) defined in the first portion of the strip body, the at least one hole capable of receiving a single tube (12), the at least one hole having a diameter corresponding to an outer diameter of a PCR tube (the hole has a diameter that can hold a PCR tube having a similar or smaller outer diameter) and a printable zone (13) integral in the second portion of the strip body (col. 3, ll. 18-20) and defined by the upper surface (A, Fig 1 below) and/or undersurface (B, Fig 1 below) of the elongated strip body, the printable zone configured to receive ink directly thereon and on the upper surface (A, Fig 1 below) and/or the undersurface (B, Fig 1 below) of the elongated strip body via the printing methods as recited since it has the structure as recited, wherein the upper surface (A, Fig 1 below) and/or the undersurface (B, Fig 1 below) of the strip body adapted to retain the ink through a PCR cycle performed in a PCR cycler since it has the structure as recited and is comprised of same material as disclosed and depending on the ink property (col. 3, ll. 1-5), further wherein the material of the strip body has a minimum flexural rigidity such that the elongated strip is adapted to support a filled and capped PCR tube without folding depending on the properties of the tube being held in the holder (col. 2, ll. 65-68).

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Regarding claim 7, Rowe further discloses the material being nylon.
Regarding claim 26, Rowe further discloses minimum flexural rigidity being a deformation of less than 15 degrees relative to a clamped end of the strip body supporting a PCR tube since Rowe discloses the structure of the holder as recited. In particular, the Rowe holder can support a PCR tube such that the strip body does not deform less than 15 degrees depending on the PCR tube being used in conjunction with the holder.
Regarding claim 28, as best understood, Rowe further discloses material of elongated strip (plastic) having a minimum flexural rigidity such that the strip is capable of supporting a capped PCR tube filled with 0.1ml of liquid without folding depending on the size and overall mass of the container since it has the structure as recited.

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.

Claim 6, 21-22, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe.
Regarding claim 6, 21-22, Rowe teaches the holder of claim 1 but does not explicitly teach the dimensions of the hole. However, one of ordinary skill in the art would have found it obvious to change the dimensions of the hole diameter to the size range as recited in order to adapt for holding different size tubes since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform different than the prior art device, the claimed device was not patentably distinct from the prior art. Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830,225 USPQ 232 (1984).
Regarding claim 27, Rowe further teaches the elongated strip body formed of polyester (col. 2, ll. 65-68, col. 3, ll. 1-5) but does not teach the thickness of the polyester to be 7 mil. However, one of ordinary skill in the art would have found it obvious to change the thickness of the strip body to be at least 7 mil in order to optimize the strength of the strip body to hold the desired amount of tubes and their weight since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).

Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of US 2013/0072894 to Langley et al. (Langley).
Regarding claim 8, Rowe discloses the holder of claim 1 but does not teach varnish on the printable zone. However, Langley a label (Fig 6) with a writable zone (122) having varnish to facilitate writing of indicia (€0062). One of ordinary skill in the art would have found it obvious to include varnish on the writable zone as suggested Langley in order to facilitate writing and printing of indicia (Langley, €0062).

Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rowe in view of US Patent No. 4,341,303 to Britt.
Regarding claim 18, Rowe teaches the holder of claim 1 except for a tear off perforation line extending widthwise. However, Britt discloses holder strip (Fig 3) and in particular discloses perforation (60) widthwise of the strip to separate individual openings (20). One of ordinary skill in the art would have found it obvious to incorporate widthwise perforations to the Rowe strip as suggested by Britt in order to facilitate separation of individual openings to hold tubes separate from the strip.

Response to Arguments
Applicant's arguments filed 3/19/2025 have been fully considered but they are not persuasive. Initially, it is noted that applicant does not argue the rejection of the dependent claims. Applicant’s arguments regarding the rejection under 35 USC 112(b) is not persuasive because applicant has not defined the PCR cycle and/or the PCR tube and reciting the claims of the tube holder based on limitations not clearly define renders the scope of the claims unclear. Applicant argues that a person skilled in the art would clearly understand the specific types of ink to perform each printing technique. This is not persuasive because one of ordinary skill in the art would not understand the amount of ink applied and furthermore, one of ordinary skill in the art would not understand the exact process of “PCR cycle performed in a PCR cycler” that would retain the ink. Applicant further argues that the amended claims provide a direct and clear link between size of hold and size of PCR tube to be received in the hole. This is not persuasive because the amendment merely recites the hole having a diameter corresponding to an outer diameter of the PCR tube. Contrary to applicant’s assertion, the amendment does not provide a direct and clear link between the relationship but rather makes the scope of the claims more unclear because it fails to define what exactly the term “corresponding” encompasses and furthermore, if the single PCR tube is not explicitly claimed, it would be unclear how the hole has a diameter be defined by an unclaimed tube since there could be an infinite possibility of outer diameters of a single PCR tube. Applicant further argues the claims are directed to a filled and capped PCR tube and thus asserts that the claims are now clear; however, applicant fails to describe other characteristics such as the weight, volume and mass of the PCR tube.
Applicant argues that prior art does not teach the printable zone configured to receive ink and adapted to support a field and capped PCR tube without folding because the prior art is not specifically designed to accomplish the function. This is not persuasive because Rowe discloses the structure of the holder as recited and thus it has the specific design to accomplish the function claim. Applicant appears to be arguing that the intended use of Rowe is not to perform the recited function. However, in response to applicant's argument that the printable zone is not intended to receive ink directly or intended to support a filled and capped PCR tube without folding, a recitation of 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ROBERT POON/Examiner, Art Unit 3735