DETAILED ACTION
This office action is responsive to the response filed 5/26/2026. Claims 1-15 remain pending and under prosecution.
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 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(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-5, 7, 9-10, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Destoumieux et al (US Pub No. 20110295148) in view of Wilson et al (US Pub No. 20100094170) and Berner (US Pub No. 20160192621) – all cited by applicant.
In regard to Claim 1, Destoumieux et al disclose
a storage container holding region (right side, Figure 8A-B – tube support) at where a removable (0089) storage container 51, 52 is located, best seen in Figure 8A-B (0099), the sample collector holding region includes a bore (in clamp, 0099) in which the sample collector is located when in the pre-sampling condition, and
a sample collector holding region (left side, Figure 8A-B) at where a removable (0083, 0088-0089) sample collector 21, 22, 23 is located, best seen in Figure 8A-B (0098),
the sample collector and storage container in alignment with each other in a pre-sampling condition spaced apart with a sufficient gap to allow part of a tissue 84 to be sampled to locate at said gap, best seen in Figure 8A-D (0102-0112),
such that the driver is aligned with the sample collector and allows the sample collector to be moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container, best seen in Figure 8A-D (0102-0112).
However, Destoumieux et al do not expressly disclose a bridge section extending between the storage container holding region and the sample collector holding region such that they comprise a sampling cartridge, the bridge section spanning the gap, and wherein the sampling cartridge is adapted and configured to be loadable to the sampler device to align the driver with the sample collector and allow the sample collector to be moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container.
Wilson et al teach that it is well-known in the art to provide an analogous sampler that is a sampling cartridge 810 with a bridge section 816 extending between two sections 818, 814 including a storage container holding region 818, 830 as well as a sample collector 844a,b, 852, 856, the sample collector and storage container in alignment with each other in a pre-sampling condition spaced apart with a sufficient gap to allow part of a tissue to be sampled to locate at said gap (Figure 16), the bridge section spanning the gap, wherein the sampling cartridge is adapted and configured to be loadable to the sampler device 882 (Figure 14) to align the driver 884 (Figure 9c) to collect a sample as an effective configuration that provides a disposable sampling cartridge (0160-0167, 0177).
2. Wilson et al teach the gap is substantially U shaped, due to the curved portion 816, best seen in Figure 12A.
Berner teach that it is well-known in the art to provide an analogous sampler device with a driver 5’, sampling cartridge receptacle region (U-shaped area, Figure 1) for receipt of a sampling cartridge 22 having bridge 16, 16a, b, wherein at least the bridge section of the sampling cartridge body is adapted and configured to conform with the receptacle region of the sampler device such that, when the sampling cartridge is loaded to the sampler device and is received by the receptacle region, at least the bridge section of the sampling cartridge body shields at least the receptacle region of the sampler device from contact with the tissue to be sampled when the tissue is placed at the gap, together with any exudates expressed or expelled from the tissue during sampling, best seen in Figure 1 and 3 (0094, 0098, 0101, 0107, 0108, 0153, 0164, 0177).
Berner also teaches the sampling cartridge 22 is adapted and configured, such that, when the sampling cartridge is loaded to the sampler device and received by the receptacle region, the sample collector of the sampling cartridge is aligned with the driver of the sampling device, best seen in Figure 1 and 3 (0094, 0098, 0101, 0107, 0108, 0153, 0164, 0177).
Since Destoumieux et al already disclose the sample collector moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Destoumieux et al such that there is included a bridge section extending between the storage container holding region and the sample collector holding region such that they comprise a sampling cartridge, the bridge section spanning the gap, and wherein the sampling cartridge is adapted and configured to be loadable to the sampler device to align the driver with the sample collector, as taught by Wilson et al with the details above, to provide an equally as effective convenient disposable cartridge for sampling, wherein in combination, allow the sample collector to be moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container as already taught by Destoumieux et al.
Further, it would have been obvious to a skilled artisan to modify Destoumieux et al and Wilson et al such that at least the bridge section of the sampling cartridge body is adapted and configured to conform with the receptacle region of the sampler device such that, when the sampling cartridge is loaded to the sampler device and is received by the receptacle region, at least the bridge section of the sampling cartridge body shields at least the receptacle region of the sampler device from contact with the tissue to be sampled when the tissue is placed at the gap, together with any exudates expressed or expelled from the tissue during sampling, as taught by Berner, to effectively use the sampling cartridge of Wilson et al with the sampling device and driver of Destoumieux et al which already includes a receptacle region in Figure 8A-D, for reasons such as at least the bridge section of the sampling cartridge body shields at least the receptacle region of the sampler device from contact with the tissue to be sampled when the tissue is placed at the gap, together with any exudates expressed or expelled from the tissue during sampling. Further, the combination of Destoumieux et al, Wilson et al, and Berner teach the sampling cartridge is adapted and configured, such that, when the sampling cartridge is loaded to the sampler device and received by the receptacle region, the sample collector of the sampling cartridge is aligned with the driver of the sampling device to allow the sample collector to be moved by the driver from the sample collector holding region across the gap and into the aligned sample storage container, as already taught by Destoumieux et al, best seen in Figure 8A-D (0102-0112).
3. Destoumieux et al disclose a sampling cartridge as claimed in claim 1 wherein said storage container holding region (Figure 8A-B right) and said sample collector holding region (Figure 8A-B left) are contiguous – defined as “next to” – respective opposed sides of said gap.
4. Destoumieux et al disclose a sampling cartridge as claimed in claim 1 wherein said storage container holding region (Figure 8A-B right) comprises a cavity (tube support 0099) of said sampling cartridge body in which at least part of said storage container 51, 52 is located, best seen in Figure 8A-D.
5. Destoumieux et al disclose a sampling cartridge as claimed in claim 4 wherein a passage (inner portion of tube support – leftmost side of arm on right side of Figure 8A-B) leads from said cavity to said gap (as taught by Wilson et al above) and via which the sample collector 21, 22, 23 can move to engage with said storage container (0102-0112).
7. Destoumieux et al disclose a sampling cartridge as claimed in claim 5 wherein the passage includes a mouth opening presented at said gap (as taught by Wilson et al above) at where said sample collector 21, 22, 23 enters the passage, upon the taking of a sample from the tissue to be sampled placed at the gap, to advance for engagement via an opening of and into said storage container 51, 52, best seen in Figure 8A-D (0102-0112).
9. Destoumieux et al disclose a sampling cartridge as claimed in claim 7 wherein at said mouth opening said sampling cartridge body together with said sample collector 21, 22, 23 acts as a punch and die set, the mouth opening acting as the die acting in shear with the sample collector acting as said punch to facility the removal of the sample from the tissue to be sampled (0102-0112).
10. Destoumieux et al disclose a sampling cartridge as claimed in claim 9 wherein said mouth opening is of a shape and configuration to allow said sample collector 21, 23 to enter into said passage in a snug fit manner, best seen in Figure 8A-D (0102-0112).
In regard to Claim 12, Destoumieux et al in combination with Wilson et al and Berner disclose the structure of the sampling cartridge as laid out in Claim 1 (see details above). Destoumieux et al also disclose a method of taking and storing a sample from the tissue using the sampling cartridge comprising:
i. loading the sampling cartridge to a sampler device (other portions of clamp tool 0094, for example see US Pub No. 20130204159) so that the sample collector 21, 22, 23 and the storage container 51, 52 are in alignment with a driver (0095-0096) of said sampler device, the driver to act, directly or indirectly on said sample collector, best seen in Figure 8A
ii. placing a part of the tissue 84 to be sampled in said gap so that part of the tissue is also in alignment, best seen in Figure 8A (0102-0112)
iii. causing the driver to move in a driving direction to drive said sample collector from the sample collector holding region, across the gap and towards said storage container so that said sample collector is driven into the storage container so that said punch becomes held by said storage container, best seen in Figure 8B-C (0102-0112)
iv. causing the driver to move in a direction opposite said driving direction, best seen in Figure 8D (0102-0112).
13. Destoumieux et al disclose the method as claimed in claim 12 wherein an identification carried by or of the tissue from which the sample is taken is recorded at the time of taking of the sample (0115-0120, 0123).
14. Destoumieux et al disclose the method as claimed in claim 13 wherein the identification is matched to an identification of said sampling cartridge (0115-0120, 0123).
15. Destoumieux et al in combination with Wilson et al and Berner disclose as a set, a sampling device comprising a driver and a sampling cartridge receptacle region for receipt of at least one sampling cartridges (see Destoumieux et al Figure 8A-D and Figure 1 of Berner) and a plurality of sampling cartridges (Berner Figure 18A-B) including at least one of a sampling cartridge as claimed in claim 1 (see details above), wherein it would be obvious to a skilled artisan to have a plurality of cartridges as taught by Berner, each cartridge individually and successively loadable with the sampling device to align the driver with the sample collector and allow the sample collector to be moved by the driver from sample collector holding region across the gap and into the aligned sample storage container to allow each sampling cartridge to collect one sample from an item to be sampled, as taught by Destoumieux et al, best seen in Figure 8A-D (0102-0112), wherein it would have been obvious to a skilled artisan to have the set contain a plurality of the sampling cartridges, to allow multiple individual sampling of tissue with each sample in a separate sampling cartridge, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. It is noted that applicant does not disclose any criticality toward having a plurality of the sampling cartridges as solving a particular problem, conferring a specific advantage, or providing a desired result other than providing multiple opportunities for individual sampling as discussed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Destoumieux et al in view of Wilson et al and Berner as applied to claim 1 above, and further in view of Bladen et al (WO 2014196876 A1) – cited by applicant.
Destoumieux et al in combination with Wilson et al and Berner disclose the invention above but do not expressly disclose the passage is blocked by a removable seal. Bladen et al teach that it is well-known in the art to provide an analogous sampling cartridge comprising a removable seal 557 to protect the interior of the storage container 550, 500 from contaminants prior to tissue sampling, at which point the seal will be pierced/removed by the sample collector during the tissue collection process, which operates in the same way as Destoumieux et al, best seen in Figure 18-23a (pg. 16 line 11-26). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Destoumieux et al as modified by Wilson et al and Berner such that the passage is blocked by a removable seal as taught by Bladen et al, to effectively protect the interior of the storage container from contaminants prior to the tissue sampling.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Destoumieux et al in view of Wilson et al and Berner as applied to claim 1 above, and further in view of Brielmeier et al (US Pub No. 20070021684 A1) – cited by applicant.
Destoumieux et al in combination with Wilson et al and Berner disclose the invention above but do not expressly disclose the material about said mouth is harder than said material of the storage container about its said opening. Destoumieux et al disclose the material of element 52 which is held inside the opening of storage container 51 as made of rubber (0087), element 51 being in contact with the mouth of the passage that leads to the sample container. Destoumieux et al is silent as to the material of the rest of the device.
Brielmeier et al teach that it is well-known in the art to provide an analogous sampling cartridge 10 made of metal as an effective material for its use during the tissue sampling process (0048). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Destoumieux et al as modified by Wilson et al and Berner such that the rest of the device is made of metal, as taught by Brielmeier et al, such that in combination, the material about said mouth is harder (i.e. metal) than said material of the storage container about its said opening (i.e. rubber), as an effective material for the use of the device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Destoumieux et al in view of Wilson et al as and Berner applied to claim 1 above, and further in view of Destoumieux et al (US Pub No. 20130204159 – referred to as ‘159) – cited by applicant.
Destoumieux et al in combination with Wilson et al and Berner disclose the invention above said storage container holding region (Figure 8A-B right side) comprises a cavity (tube support – 0099) and at least one of the components selected from the following list: b. the storage container 51, 52, c. the sample collector 21, 22, 23, d. the sampling cartridge body, comprises at least one form of visible and/or machine readable identification (0115-0120, 0123).
However, Destoumieux et al as modified do not expressly disclose a removable closure to close the cavity. Destoumieux et al (‘159) teach that it is well-known in the art to provide an analogous sampling cartridge comprising locking means 81 to removably close a cavity of the storage container holding region containing the sample container 31 to effectively retain the sample container during the tissue sampling process, best seen in Figure 8A (0116). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Destoumieux et al as modified by Wilson et al and Berner such that said storage container holding region cavity is closed by a removable closure as taught by Destoumieux et al (‘159), to effectively retain the storage container within the cavity during tissue sampling procedure.
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive. Applicant contends that Destoumieux et al does not contemplate a cartridge configuration and points to various details in the reference that indicate advantages to having the structures as such (Remarks pg. 8). However, it is submitted that the combination of Wilson et al and Berner provide an equally as effective configuration for the device of Destoumieux et al by providing said cartridge which would align with the driver with the sample collector in manner already taught by Destoumieux et al. It is also submitted that the nature of the cartridge as recited does not detract from advantages such as preventing hairs in the device. Additionally, while applicant cites that the cutting element 21 of Destoumieux et al includes an ejection mechanism and this is not addressed by Wilson et al (Remarks pg. 9), these features are not claimed and applicant appears to argue bodily incorporation. It is noted that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding Wilson et al, applicant contends that the reference is not analogous art to Destoumieux et al because it not a tissue sampler but is directed to blood sampling (Remarks pg. 19). However, it is noted that both biological material samplers are considered analogous art especially as both pertain to sampling from animals. Additionally, the fact that the bridge of Wilson et al provides another use does not detract from its obvious configuration being an effective equivalent for that found in Destoumieux et al (Remarks pg. 9-10).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant also contends that Wilson et al do not provide the bridge section adapted and configured to conform with the receptacle region of the sampler device to shield at least the receptacle region of the sampler device from contact with the tissue to be sampled as claimed (Remarks pg. 11). It is agreed that Wilson et al do not teach such, which is why Berner et al was set forth to teach said limitation. Regarding Berner et al, applicant contends that the reference does not teach the bridge adapted and configured to conform with the receptacle region of the sampler device to shield at least the receptacle region of the sampler device from contact with the tissue to be sampled because it has a flat base and not appear to “have the same contour or shape” of the receptacle region of Berner et al (Remarks pg. 12). It is noted that applicant appears to be reading into the limitation; it is submitted that the bridge of Berner “conforms” as broadly as has been claimed and given the structure, “shields” adequately from contact with the tissue to be sampled (Remarks pg. 12). The claims do not require that “zero amount of tissue and/or exudates” contact the receptacle region any more than an umbrella prevents zero rain from contacting the user during use. Since Berner et al already teach the bridge structure as recited, it is noted that the shield limitation constitutes functional use, as broadly as has been claimed. Therefore, the rejection is maintained.
The previous Claim Objections are moot in light of applicant’s amendments.
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 on 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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