Prosecution Insights
Last updated: October 21, 2026
Application No. 18/655,072

SAMPLE COLLECTION DEVICE

Final Rejection §103
Filed
May 03, 2024
Priority
Aug 16, 2011 — provisional 61/524,208 +5 more
Examiner
NGUYEN, HUONG Q
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Exact Sciences Corporation
OA Round
2 (Final)
46%
Grant Probability
Moderate
3-4
OA Rounds
2y 0m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
275 granted / 595 resolved
-23.8% vs TC avg
Strong +44% interview lift
Without
With
+44.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
30 currently pending
Career history
635
Total Applications
across all art units

Statute-Specific Performance

§101
7.2%
-32.8% vs TC avg
§103
48.6%
+8.6% vs TC avg
§102
13.0%
-27.0% vs TC avg
§112
27.7%
-12.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 595 resolved cases

Office Action

§103
DETAILED ACTION This office action is responsive to the response filed 8/6/2026. Claims 42-61 remain pending and under prosecution. Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Claim Objections Claim 56 is objected to because of the following informalities: Step II should recite “one or more of the one or a plurality of metering ridges with the sample” to be consistent with the following step. 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. No claim elements are interpreted under 112 sixth paragraph. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). Claims 42-44, 46, 50-53, and 55-59 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhou et al (US Pub No. 20050036910) in view of Anderson et al (US Pub No. 20010041336) or Slonim (US Pat No. 6116426). In regard to Claim 42, Zhou et al disclose a device for collecting a sample, the device comprising: a) a body 2 comprising a sample collection chamber 18, best seen in Figure 1, bounded on a distal end by a penetrable seal 4, 5 – “an access port 4 which is releasably sealed by a hollow nib 5” (0010) and bounded on a proximal end by a septum 17 comprising an aperture 20, best seen in Figure 1 (0011), the penetrable seal being penetrable by a pipette tip or needle; b) a cap 8 attached to a proximal end of a flexible sampling rod 12 necessarily having some flexibility in stick structure, best seen in Figure 1 (0010), the sampling rod adapted to fit through and seal the aperture when a distal portion of the sampling rod is in the sample collection chamber – “the shank of the stick is dimensioned to seal the aperture once the stopper has been screwed upon the open end of the vessel” (abst); “an aperture or passageway 20 in the middle of the septum is axially lined up with the stick 12 and has a cross-sectional geometry substantially symmetrical with that of the stick, that is a radius substantially equal to the radius of the shank 14 and sample-holding portion 15… thereby providing a positive seal over a larger range of plunger positions” (0011), wherein the distal portion of the sampling rod comprises: i) a tip at a distal end, best seen in Figure 1; and ii) one or a plurality of metering ridges at sample-holding portion 15, best seen in Figure 1 (0010);   wherein the cap is engaged with a proximal end of the body, and the distal portion of the sampling rod is in the sample collection chamber, best seen in Figure 1. However, Zhou et al do not expressly disclose the tip of the sampling rod is an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod. Anderson et al teach that it is well-known in the art to provide an analogous sampling rod 70 with an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod, best seen in Figure 12, to effectively enable penetration of the cap 20A-D, which is similar to that of the instant invention – “To further facilitate penetration of the cap 20A-D, the fluid transfer devices 70A-F of the present invention preferably include a beveled tip 71A-D, as shown in FIGS. 10, 12, 14, 16, 18 and 20-22” (0103). Slonim teach that it is well-known in the art to provide an analogous sampling rod 8 with an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod – “a beveled shovel end” (Col.4: 25). The bevel is asymmetrical and thus necessarily creates an apex at a circumference of the shovel end. This tip structure would be effective in removing the desired sample or foreign matter. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al such that the tip of the sampling rod is an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod as taught by Anderson et al or Slonim to provide advantages such as improved penetration of the septum of Zhou et al, as taught by Anderson et al, or to provide an effective sampling end as taught by Slonim. 43. Zhou et al disclose the device of claim 42, wherein the cap 8 and the proximal end of the body 2 have mated threads 9 securing the cap 8 to the body 2, best seen in Figure 1 (0010). 44. Zhou et al disclose the device of claim 42, wherein the device comprises a solution – extraction buffer/preserving solution – in the sample collection chamber 18 for preserving a metered sample of stool, best seen in Figure 1 (0003, 0014, abst). 46. Zhou et al disclose the device of claim 42, wherein the one or plurality of metering ridges 15 are capable and thus configured to retain 20 milligrams of stool (0016). 50. Zhou et al disclose the device of claim 42, wherein the penetrable seal 4, 5 is capable and thus configured to hold 30 psi when the device is internally pressurized with air – when the threaded portions are screwed together, the device is capable of holding 30 psi because the device forms a fluid seal of the chamber 18, since the device has substantially similar construction to that disclosed by the applicant which has the same functional limitation, see MPEP 2112. 51. Zhou et al disclose the device of claim 42, wherein the body 2 further comprises a sealing surface 24, wherein the penetrable seal 4, 5 is affixed to the sealing surface, best seen in Figure 1 (0014). 52. Zhou et al disclose the device of claim 51, wherein the sealing surface 24 is recessed relative the bottom of the seal 4, 5, as broadly as has been claimed, best seen in Figure 1. 53. Zhou et al disclose the device of claim 42, further comprising a protective cap 21 fitted on a distal end of the body 2 and covering the penetrable seal 4, 5, best seen in Figure 1 (0013). 55. Zhou et al disclose the device of claim 42, wherein the device is enclosed in enclosed in packaging 33 for transporting or mailing the device, best seen in Figure 2 (0018). In regard to Claim 56, Zhou et al disclose a method of collecting a metered sample of material to be sampled, the method comprising: I) providing a device for collecting a sample, the device comprising: a) a body 2 comprising a sample collection chamber 18, best seen in Figure 1, bounded on a distal end by a penetrable seal 4, 5 – “an access port 4 which is releasably sealed by a hollow nib 5” (0010) and bounded on a proximal end by a septum 17 comprising an aperture 20, best seen in Figure 1 (0011), the penetrable seal being penetrable by a pipette tip or needle; b) a cap 8 attached to a proximal end of a flexible sampling rod 12 necessarily having some flexibility in stick structure, best seen in Figure 1 (0010), the sampling rod adapted to fit through and seal the aperture when a distal portion of the sampling rod is in the sample collection chamber – “the shank of the stick is dimensioned to seal the aperture once the stopper has been screwed upon the open end of the vessel” (abst); “an aperture or passageway 20 in the middle of the septum is axially lined up with the stick 12 and has a cross-sectional geometry substantially symmetrical with that of the stick, that is a radius substantially equal to the radius of the shank 14 and sample-holding portion 15… thereby providing a positive seal over a larger range of plunger positions” (0011), wherein the distal portion of the sampling rod comprises: i) a tip at a distal end, best seen in Figure 1; and ii) one or a plurality of metering ridges at sample-holding portion 15, best seen in Figure 1 (0010); II) contacting the distal portion of the sampling rod with material to be sampled to cover one or more of the one or a plurality of metering ridges with sample – “the user plunges the sample-holding portion 15 of the stick into a volume of matter to be analyzed” (0016); III) engaging the cap with a proximal end of the body to form a sealed device, wherein, when the cap is engaged with the proximal end of the body, the distal portion of the sampling rod and the metered sample are in the sample collection chamber – “the stick is then inserted back into the vessel and the stopper is screwed down until the sample-holding portion passes completely through the aperture 20 of the septum. During this procedure, the walls of the aperture coming into intimate contact with the non-threaded part of the sample-holding portion and shank, wipe out any excess material which is not held within the helicoidal groove, preventing that excess material from reaching the first chamber. Accordingly, only a quantitively metered amount of specimen matter is allowed into the first chamber” (0016). However, Zhou et al do not expressly disclose the tip of the sampling rod is an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod. Anderson et al teach that it is well-known in the art to provide an analogous sampling rod 70 with an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod, best seen in Figure 12, to effectively enable penetration of the cap 20A-D, which is similar to that of the instant invention – “To further facilitate penetration of the cap 20A-D, the fluid transfer devices 70A-F of the present invention preferably include a beveled tip 71A-D, as shown in FIGS. 10, 12, 14, 16, 18 and 20-22” (0103). Slonim teach that it is well-known in the art to provide an analogous sampling rod 8 with an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod – “a beveled shovel end” (Col.4: 25). The bevel is asymmetrical and thus necessarily creates an apex at a circumference of the shovel end. This tip structure would be effective in removing the desired sample or foreign matter. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al such that the tip of the sampling rod is an asymmetrical beveled tip at the distal end, the beveled tip having an apex at a circumference of the flexible sampling rod as taught by Anderson et al or Slonim to provide advantages such as improved penetration of the septum of Zhou et al, as taught by Anderson et al, or to provide an effective sampling end as taught by Slonim. 57. Zhou et al disclose the method of claim 56, wherein the cap 8 and the proximal end of the body 2 have mated threads 9 that engage with each other to secure the cap to the proximal end of the body, best seen in Figure 1 (0010). 58. Zhou et al disclose the method of claim 56, wherein the device comprises a solution – extraction buffer/preserving solution – in the sample collection chamber 18 for preserving the metered sample, best seen in Figure 1 (abst, 0003, 0014). In regard to Claim 59, Zhou et al as modified above disclose the metered sample and the solution form a suspension (0015) but do not expressly disclose a step of withdrawing at least a portion of the suspension from the device from the sealed device. Anderson et al teach that it is well-known in the art to subsequently withdraw at least a portion of the suspension from the device from the sealed device for further testing such as nucleic acid analyte amplification (abst, 0035). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified to include a step of withdrawing at least a portion of the suspension from the device from the sealed device as taught by Anderson et al to effectively enable subsequent testing. Claims 45 and 47 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou et al in view of Anderson et al or Slonim, further in view of Liang et al. (US 2009/0004058 A1). In regard to Claim 45, Zhou et al as modified disclose the invention above but do not expressly disclose the sample collection chamber has a volume of 1-5 milliliters. Liang teaches an analogous sample collection device with sample collection chamber has a volume of 1-5 milliliters as listed among different suitable volumes (0089-0090). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified such that the sample collection chamber has a volume of 1-5 milliliters as taught by Liang to provide an effective volume in the sample collection chamber for the desired sampling. In regard to Claim 47, Zhou et al as modified disclose the invention above but do not expressly disclose the solution has a volume of 2 milliliters. Liang teaches an analogous sample collection device comprising a buffer solution with a volume of 2 milliliters – the sample chamber sized to holds the buffer solution wherein the volume of the sample chamber is between 0.01ml and 1000ml including 0.5, 1, 2, 3 and 4 ml (0089). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified such that the solution has a volume of 2 milliliters as taught by Liang to provide an effective volume of the solution for the desired sampling so that the sample can be preserved, as already taught by Zhou et al (abst, 0003, 0014). Claim 48 is rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou et al in view of Anderson et al or Slonim, further in view of Maher et al. (US 2008/0081341 A1). Zhou et al as modified disclose the invention above but do not expressly disclose the solution comprises Tris buffer, bovine serum albumin, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin. Maher discloses an immunoassay device comprising a diluting solution wherein the solution comprises Tris buffer, bovine serum albumen, Tween-20, sodium azide, sodium chloride, EDTA, and gentamicin (see paragraphs 95-98, paragraphs 117-121, evidenced by Arnold et al. “Phase separation in the isolation and purification of membrane proteins" teaches the various detergents uses, advantages and interchangeability). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified such that the solution comprises Tris buffer, bovine serum albumin, polysorbate 20, sodium azide, sodium chloride, ethylenediaminetetraacetic acid, and gentamicin as taught by Maher et al to effectively prepare the sample for analysis, see paragraphs 95-98, 117-121. Claim 49 is rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou et al in view of Anderson et al or Slonim, further in view of Kikuiri (US 20080034899 A1). Zhou et al as modified disclose the invention above but do not expressly disclose the penetrable seal has a composition comprising one or more of: a) a foil; b) a foil layer and a polyester layer; and c) a material selected from the group consisting of paper, rubber, wax, and plastic. Kikuiri teaches an analogous sample collection device wherein the seal is made from foil, sealing film 21 as an effective material for its use, see paragraph 32 and Figures 2b and 2d. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified such that the seal is foil as taught by Kikuiri in order to seal the distal end of the device by substituting one sealable material for another, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Claim 54 is rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou et al in view of Anderson et al or Slonim, further in view of Ostrowski et al. (US 2007/0208274 A1). Zhou et al as modified disclose the invention above but do not expressly disclose the body is made from a material selected from the group consisting of polypropylene, polyethylene, polystyrene, and polytetrafluoroethylene. Ostrowski teaches an analogous sampling device comprising a container body 26 and a rod 24 wherein the container body 26 is formed of polypropylene as an effective material for its use, see paragraphs 20 and 26. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Zhou et al as modified such that the body is made from a material selected from the group consisting of polypropylene, polyethylene, polystyrene, and polytetrafluoroethylene as taught by Ostrowski et al to provide an effective material for its use, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Claims 60-61 are rejected under 35 U.S.C. 103(a) as being unpatentable over Zhou et al in view of Anderson et al or Slonim, further in view of O’Connell (US 7,232,681 B2). Zhou et al as modified disclose the device comprising a packaging 33 in which to mail or transport said device containing the collected sample (the sample is loadable into shipping capsule 33 for shipping – 0018). However, Zhou et al do not expressly disclose providing a kit with instructions. O’Connell teaches a mailable sampling kit comprising instructions for the user on how to collect a sample, see column 11. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the kit/device of Zhou et al as modified above to include instructions as taught by O’Connell in order to inform the user on how to collect samples, see column 11. Response to Arguments Applicant's arguments filed with respect to Anderson et al and Slonim have been fully considered but they are not persuasive. Applicant contends that Anderson et al is not analogous art because it “is not directed to a sampling rod at all” and is a fluid transfer device that is rigid for piercing a penetrable cap to transfer fluid and neither collects nor meters a specimen and thus is not a flexible sampling rod (Remarks pg. 11). However, it is noted Anderson et al provides a sampling rod as broadly as has been claimed. Anderson et al teach the sampling rod for use with stool (“the present invention also contemplates materials other than these specific biological fluids, including, but not limited to… stool” – 0068) as similarly taught by Zhou et al (abst – “A device for quantitively collecting, preserving and mailing a fresh and wet specimen of fecal or other biological matter”), further showing analogousness. Lastly, Anderson et al teach that the sampling rod 70 is “a fluid transfer device consisting of a plastic pipette tip” (0015) that is necessarily flexible as broadly as has been claimed since plastic is broadly known in the art as a flexible material. In fact, Anderson et al expressly teach “the ribs are also expected to improve the strength characteristics of a fluid transfer device, so that the fluid transfer device (e.g., plastic pipette tips) is less likely to bend or buckle when contacting a penetrable surface” (0013). This clearly states that the sampling rod of Anderson et al that is the fluid transfer device is flexible in nature. Although applicant’s remarks regarding non-analogousness are drawn to features not necessarily relied upon by Anderson et al in the rejection above, i.e. the flexible nature of the rod and the type of specimen collection that “neither collects nor meters a specimen” (Remarks pg. 11), the features are in fact also found in Anderson et al as described above. Moreover, 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). While applicant contends that there is “no rational basis to graft Anderson’s cap-piercing believe onto Zhou’s specimen-collecting stick” because “Zhou’s stick does not penetrate its septum. Stick 12 passes through a pre-existing aperture 20, and the shank of the stick is ‘dimensioned to seal the aperture’” per Zhou (Remarks, pg. 11), this is not persuasive. It is submitted that the motivation provided by Anderson et al to enable improved penetration due the beveled tip having an apex at a circumference of the sampling rod (which is clearly disclosed as “flexible” as elaborated above) would apply to “the penetration” of the sampling rod of Zhou et al through its aperture 20, as broadly as has been claimed, because the sampling rod must pass from one side of the septum to the other. The structure of the beveled tip having an apex at a circumference of the sampling rod would clearly enhance the passage of the sampling rod of Zhou et al through the aperture of its septum given the beveled shape of the tip and thus motivate a skilled artisan to make said modification. Additionally, Anderson et al teach its sampling rod as flexible as elaborated above. Applicant also contends that since Anderson’s tip is not a circular cross-section because of the longitudinal ribs, the “apex is thus located on a radially projecting rib structure, not ‘at a circumference of’ a flexible sampling rod” as claimed (Remarks pg. 12). However, it is noted that the claims do not preclude additional structures on the flexible sampling rod given the “comprising” nature of the claims. Thus, the configuration of Anderson et al even with the ribs as disclosed provide an apex at a circumference of the flexible sampling rod, as broadly as has been recited. Lastly, applicant contends that since Anderson et al teaches the ribs used to prevent bending of the sampling rod, this teaches away from the claimed flexible sampling rod (Remarks pg. 12). However, as noted above, the plastic material construction of the sampling rod of Anderson et al makes it flexible as broadly as has been claimed. Furthermore, the claims currently do not require bending of the sampling rod. Therefore, said arguments against Anderson et al are not persuasive. Regarding Slonim, applicant contends the reference is not prior art because it does not fall within applicant’s field of endeavor (Remarks pg. 12). This is not persuasive because applicant’s invention clearly falls under sampling, which Slonim also falls under. The criteria for analogousness is at least one of same field of endeavor or problem solving area. There is no requirement that analogous prior art must classify as both. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). Additionally, although applicant contends that one would not look to Slonim “for configuring a flexible sampling rod to bend away and/or to deflect collisions with a pipette tip or needle inserted in a penetrable seal of the device” as disclosed in the specification of the instant invention (Remarks pg. 13), such limitations are not presently claimed and therefore are not pertinent to analysis of prior art. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Lastly, applicant contends that the “beveled shovel end” of Slonim does not disclose “an apex located at a circumference” as claimed (Remarks pg. 13). However, it is noted that Figure 1 show the beveled shovel of the sampling rod of Slonim which necessarily has a pointed side giving it the bevel shape as stated. The bevel therefore provides for the apex located at a circumference (of the cross-sectional shape of the shovel) as broadly as has been claimed. Additionally, Zhou et al already is set forth to teach the sampling rod being flexible as broadly as has been claimed and therefore, Slonim is not relied upon for said teaching. See piece-meal arguments above. It is noted that the claims merely require the sampling rod be flexible in a very broad and generic way. As previously set forth, the thin stick-like construction of the sampling rod 12 of Zhou et al lends itself to a certain form of flexibility as broadly as has been recited as the claims do not specify any materials or function that must result from said flexibility. Anderson et al also teach said sampling rod as flexible given the plastic construction as described above. Therefore, the previous rejection is maintained. The AIA status has been updated above as noted as being considered under pre-AIA first to invent provisions. The amendment to the Specification to correct spelling is acknowledged and Entered. The previous double patenting rejections are withdrawn in light of the Terminal Disclaimer filed by applicant on 8/6/2026 disclaiming the previously listed patents. 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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 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, Jennifer Robertson can be reached at (571)272-5001. 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. /H.Q.N/Examiner, Art Unit 3791 /JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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Prosecution Timeline

May 03, 2024
Application Filed
May 06, 2026
Non-Final Rejection mailed — §103
Aug 06, 2026
Response Filed
Oct 02, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
46%
Grant Probability
91%
With Interview (+44.4%)
4y 6m (~2y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 595 resolved cases by this examiner. Grant probability derived from career allowance rate.

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