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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 29, 2025 has been entered. The Examiner acknowledges the amendments made to claims 15 & 27 and the cancellation of claims 1-14 & 20. Claims 15-19 & 21-27 are currently pending.
Response to Arguments
Applicant's arguments filed July 29, 2025 have been fully considered but they are not persuasive. Regarding Applicant's arguments that the rejection of the claims under 35 USC 112(a) should be withdrawn because claim 15 has been amended to overcome the rejection, the Examiner respectfully disagrees. There is insufficient disclosure of a thermo-moulded plastic member that is unremovably attached to a peripheral flange of a ring and a container component, as claimed, in the specification, drawings/figures, and the combination of both the specification and drawings/figures. Therefore, the scope of the thermo-moulded plastic member is beyond that provided in the original disclosure, and as such it does not appear that applicants were in possession of the claimed system for sampling tissue from an ear of an animal at the time of filing. As a result of this written description issue, there are also indefiniteness issues present within the claims. See 35 USC 112 rejections below.
Regarding the rejection of the claims under 35 USC 103 over Brem in view of Nehls and in further view of Hilmarcher, Applicant argues that these references either alone or in combination fail to disclose the claimed subject matter of any of the claims. Applicant further argues that specifically Nehls fails to teach the amended claim limitations because Nehls teaches the retaining ring is either clamped between the second tag part and the sample container or is embedded in the second tag part, which Applicant argues does not disclose a ring attached to a top of a housing of the tissue sample container by a plastic member thermo-moulded over a peripheral flange of the ring and the housing. Additionally, Applicant argues that Hilmarcher does not cure the deficiencies of Brem and Nehls with respect to claim 15 because Hilmarcher teaches a general plastic material formation process and does not disclose the specific arrangement of claim 15. Moreover, Applicant argues the combination of Brem, Nehls, and Hilmarcher lacks a rational underpinning because there is nothing in the teachings of the cited references that would provide a person of skill in the art with the motivation to modify Brem in view of Nehls to include a moulded component that is unremovably attached to a peripheral edge of a ring and a container component, and further because the references are not in the same field of endeavor. Also, Applicant argues that the combination of Brem, Nehls, and Hilmarcher relied on impermissible hindsight bias. Regarding the rejections of claims 17 & 25 that used additional references in combination with Brem, Nehls, and Hilmarcher, Applicant argues those rejections do not cure the deficiencies regarding the motivation to combine, differing fields of endeavor, and hindsight bias in the combination of Brem, Nehls, and Hilmarcher.
The Examiner respectfully disagrees with these arguments. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Hilmarcher teaches a method of manufacturing a plastics material part wherein the plastics material part is formed by thermoforming (i.e., overmolding thermoplastic material onto the faces of a multilayer structure) in a shape that is not a plane (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem in view of Nehls such that the plastic member that attaches the ring to the top of the tissue sample container is thermo-molded over a peripheral flange of the ring and the container component, and further that the thermo-molded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component because it is known in the art that plastics material parts can be formed in shapes that are non-planar using a multilayer structure/mold in a thermoforming process (i.e., such as in a shape that is configured to be molded over a flange, or molded in a shape that configures the plastic to be unremovably attached to other parts) (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). In response to applicant's argument that Nehls teaches the retaining ring is either clamped between the second tag part and the sample container or is embedded in the second tag part, which Applicant argues does not disclose a ring attached to a top of a housing of the tissue sample container by a plastic member thermo-moulded over a peripheral flange of the ring and the housing, 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). 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). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, the previous prior art references do teach the claim limitations of claim 15 and its dependents. As such, the claims are still rejected under 35 USC 103 over Brem in view of Nehls and in further view of Hilmarcher, Caisley, and Brem 775. See 35 USC 103 rejections below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the peripheral flange and thermo-moulded plastic member, wherein the thermo-moulded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-19 & 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 recites "wherein the thermo-moulded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component" [emphasis added]. Applicant fails to cite where in the specification it is disclosed the thermo-moulded plastic member is unremovably attached to the peripheral flange of the ring and to the container component. Paragraph 0058 of the specification of the instant application provides support for a plastic member that is thermo-moulded over a peripheral flange of the ring and the housing, but is silent as to disclosing the moulding provides an unremovable attachment to a container component. Furthermore, the plastic member and the peripheral flange are not illustrated in the drawings/figures and should therefore be included in the drawings/figures if such elements are being claimed. As such, it appears the specification is devoid of any disclosure that the thermo-moulded plastic member is unremovably attached to a container component. Therefore, the scope of the thermo-moulded plastic member is beyond that provided in the original disclosure, and as such it does not appear that applicants were in possession of the claimed system and method for sampling tissue from an ear of an animal at the time of filing. Dependent claims are similarly rejected as their base claim.
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 15-19 & 21-27 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 15 recites “wherein the thermo-moulded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component” (emphasis added) at lines 23-25. There is insufficient antecedent basis for “the container component” in the claim, and as such it is unclear as to what container component the claim is referring. For examination purposes, it will be interpreted that “the container component” is referring to the tissue sample container.
Claim 27 recites “wherein the ring remains unremovably attached to the container due to the thermos-moulded plastic member” (emphasis added). There is insufficient antecedent basis for “the container” in the claim, and as such it is unclear as to what container the claim is referring. For examination purposes, it will be interpreted that “the container” is referring to the tissue sample container.
Additionally, claims 15 & 27 both recite “unremovably attached”, and it is unclear what is meant by this recited unremovable attachment as the specification of the instant application does not clearly define this term (i.e., does unremovably attached mean the thermo-moulded plastic member cannot be intentionally removed, cannot be broken off or is permanently attached to the peripheral flange and container component or something else?). For examination purposes, this claim limitation will be interpreted as the thermo-moulded plastic member is attached to the peripheral flange of the ring and to the tissue sample container in a manner that the thermo-moulded plastic member cannot be broken off.
Dependent claims are similarly rejected and interpreted as their base claim.
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 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.
Claim(s) 15-16, 18-19, 21-24 & 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20020137033 -- previously cited, hereinafter referenced as "Brem", in view of US Patent Application Publication 20150289477 -- previously cited, hereinafter referenced as "Nehls", in further view of US Patent Application Publication 20010026851 –previously cited--, hereinafter referenced as “Hilmarcher”.
With respect to claim 15, Brem teaches a system for sampling tissue from an ear of an animal including:
a male component (10) including an engagement profile (10a) and a detachable sample collecting part (4) with a cutting edge (Brem, see par 0035);
a female component (11) including a hole (i.e., an opening in the female component) (see fig. 3);
retaining means (see par 0011) for retaining the engagement profile (10a) of the male component (10), once the engagement profile (10a) has passed the hole (see par 0011);
and a tissue sample container (1) including an opening (Brem, see par 0024, sample container inherently has an opening) arranged below the hole (Brem, see fig. 2) of the female component (11) when the female component (11) is attached to the tissue sample container (1), for receiving the sample collecting part (4) and the tissue sampled, the opening being closed by a sealed membrane or a cover (400) (Brem, see par 0020).
Brem does not teach that the tissue sample container includes a protrusion arranged in the hole of the female component when the female component is attached to the tissue sample container, wherein the tissue sample container includes support means arranged above the sealed membrane or cover, in that the support means include a ring disposed below the female component and faces said hole when the female component is attached to the tissue sample container, where the ring has at least one radial portion supporting the protrusion at the middle of the ring, and in that the support means are adapted to be cut by the cutting edge of the male component, wherein the ring is attached to a top of a housing of the tissue sample container by a plastic member thermo-molded over a peripheral flange of the ring and the container component, and the ring includes a fastening means projecting towards the opening of the tissue sample container, the detachable sample collecting part comprises an engagement profile adapted to be blocked by the fastening means, and the protrusion enters the tissue sample container with the sample collecting part.
Nehls teaches that a tissue sample container (10) includes a protrusion (30) arranged at least in part in the hole (5) of the female component (2) when the female component (2) is attached to the tissue sample container (10) (Nehls, see fig. 1a-1c, par 0026, 0027, 0073) wherein the tissue sample container (10) includes support means (32) arranged above the sealed membrane or cover (35) (Nehls, see fig. 9a-9c, par 0043, 0112), in that the support means (32) include a ring (32) (Nehls, see fig. 2, par 0026, 0080, 0081, 0091) disposed below the female component (2) and facing said hole (5) when the female component (2) is attached to the tissue sample container (10), the ring (32) having at least one radial portion (33, 36) supporting the protrusion (30) at the middle of the ring (32) (i.e. stabilizing portions supporting the protrusion) (Nehls, see figs. 1a-1c, par 0026, 0080, 0082, 0101), and in that the support means (32) are adapted to be cut by the cutting edge (21) of the male component (1) (Nehls, see par 0026, 0027, 0028, 0074, 0091), wherein the ring (32) is attached to (i.e., clampingly joined to) a top of a housing of the tissue sample container (10) by a plastic member (i.e., a circumferential bridge) that is injection-molded (see Nehls, par 0080-0081, figs. 1a-1c), and the ring (32) includes a fastening means (10a, 36) projecting towards the opening (5) of the tissue sample container (10), the detachable sample collecting part (20) comprises an engagement profile (20) adapted to be blocked by the fastening means (10a) (Nehls, see figs. 9a-9c, par 0101, 0115), and the protrusion (30) enters the tissue sample container (10) (see Nehls, par 0085, fig. 1c).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue sample container as taught by Brem such that a tissue sample container with a protrusion and support means for the protrusion are able to be cut by the cutting edge of the male component, because this improves the tissue sample container of Brem by permitting the protrusion to act as a stabilizer of the tissue as it is cut, as well as indicate to the user that the tissue sample is retained in the sample container (Nehls, see par 0072, 0074, 0089, 0101).
Brem in view of Nehls fails to teach that the plastic member that attaches the ring to the top of the tissue sample container is thermo-molded over a peripheral flange of the ring and the container component, and further that the thermo-molded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component.
Hilmarcher teaches a method of manufacturing a plastics material part wherein the plastics material part is formed by thermoforming (i.e., overmolding thermoplastic material onto the faces of a multilayer structure) in a shape that is not a plane (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). Hilmarcher further teaches that thermoplastics such as polyvinylidene fluoride (PVDF) are advantageous in that they are strong and durable and are able to provide protection against outside surroundings when used as an outer layer of a structure (see Hilmarcher, par 0001-0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem in view of Nehls such that the plastic member that attaches the ring to the top of the tissue sample container is thermo-molded over a peripheral flange of the ring and the container component, and further that the thermo-molded plastic member remains unremovably attached to the peripheral flange of the ring and to the container component because that would merely be the simple substitution of one plastics manufacturing process (the thermomoulding/thermoforming process for manufacturing plastic of Hilmarcher) for another (the injection-molding process for manufacturing plastic of Nehls), as Hilmarcher teaches that plastics material parts can be formed in shapes that are non-planar using a multilayer structure/mold in a thermoforming process (i.e., such as in a shape that is configured to be molded over a flange, or molded in a shape that configures the plastic to be unremovably attached to other parts) (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). Further, this would provide an advantage to the system of Brem in view of Nehls as thermoplastic materials such as PVDF are strong and durable (i.e., able to permit an unremovable attachment between the peripheral flange and the container component by the thermo-moulded plastic member) (see Hilmarcher, par 0001-0004).
With respect to claim 16, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem does not teach that the base of the sample collecting part includes a seat for an upper portion of the protrusion, the seat being adapted to keep the protrusion in the sample collection part after sampling, wherein the protrusion is visible in the tissue sample container for indicating the presence of a tissue in the sample container.
Nehls teaches that a base of the sample collecting part (20) includes a seat (22) for an upper portion of the protrusion (30), the seat being adapted to keep the protrusion (30) in the sample collecting part (20) (Nehls, see par 0022, 0066, 0073, 0100) after sampling, said protrusion (30) being visible in the tissue sample container (10) for indicating presence of a tissue sample in the sample container (10) (Nehls, see par 0017, 0029, 0070, 0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample collecting part as taught by Brem such that a sample collecting part has a seat for an upper part of the protrusion, and that after sampling, the protrusion is visible in the tissue sample container. This improves the tissue sample container of Brem by permitting the protrusion to act as a stabilizer of the tissue as it is cut by retaining it in the seat, as well as indicate to the user that the tissue sample is retained in the sample container (Nehls, see par 0072, 0074, 0089, 0101).
With respect to claim 18, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem does not teach a system wherein the ring has four radial protrusions, supporting the protrusion at the middle of the ring.
Nehls teaches that it is known to provide a system wherein the ring (32) has four radial portions (33, 36) supporting the protrusion (30) at the middle of the ring (32) (Nehls, see fig. 6, par 0101).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem such that the ring has four radial protrusions supporting the protrusion at the middle of the ring as taught by Nehls in order to stabilize the protrusion in the tissue sample container prior to sampling (Nehls, par 0101).
With respect to claim 19, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem do not teach that the radial portion includes at least one weakening line.
Nehls teaches that the radial portion (33, 36) includes at least one weakening line (i.e., the radial portions break to allow the protrusion to move into the sample container) (Nehls, see par 0026, 0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem such that the radial portion includes at least one weakening line in order to allow the protrusion to move into the sample container once sampling is complete (Nehls, see par 0026).
With respect to claim 21, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem does not teach that an upper portion of the protrusion is arranged at an opening of the hole when the female component is attached to the tissue sample container.
Nehls teaches an upper portion of the protrusion (30) is arranged at an opening of the hole (5) when a female component (2) is attached to the tissue sample container (10) (Nehls, see par 0072-0073, see figs. 1a-1b, 2-3, 8a-8b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem such that a protrusion is arranged at an opening of the hole when the female component is attached to the tissue sample container because that permits the protrusion to be stabilized and fixated to successfully retain the sample (Nehls, see par 0073).
With regards to claim 22, Brem in view of Nehls and in further view of Hilmarcher disclose the invention essentially as claimed as discussed above.
However, Brem as modified fails to expressly disclose that the protrusion has a cylindrical shape and a diameter of the protrusion is 1:6 and 1:2 of a diameter of the hole.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Brem as modified to have a protrusion with a diameter of 1:6 and 1:2 of a diameter of the hole 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 differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (see MPEP 2144.04 IV. A.). In the instant case, the device of Brem as modified would not operate differently with the claimed protrusion diameter in relation to the diameter of the hole and since Brem as modified is intended to function with the claimed protrusion range, the device would function appropriately having the claimed protrusion diameter. Further, applicant places no criticality on the range claimed, indicating simply that the protrusion diameter “may” be within the claimed ranges (see specification par 0029).
Moreover, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Brem as modified to have a protrusion that has a cylindrical shape since it has been held that “the configuration of [a] claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant” re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (see MPEP 2144.04 IV. B.). In the instant case, the device of Brem as modified would not operate differently with the claimed protrusion shape. Further, a person of ordinary skill in the art would have a reasonable expectation of success in adjusting the protrusion to have a cylindrical shape, and it appears that the protrusion would function as intended being given the claimed shape. Further, it appears that applicant places no criticality on the shape claimed, indicating simply that the protrusion shape and diameter “may” be the claimed shape (see specification par 0017, 0029).
With respect to claim 23, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem does not teach that the tissue sample container includes a sample conserving agent.
Nehls teaches that the tissue sample container (10) includes a sample conserving agent (Nehls, see par 0035-0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system for sampling tissue as taught by Brem, such that a sample conserving agent is used, because that would enable the preservation or conservation the sample after collection before further processing (Nehls, see par 0036, 0038).
With respect to claim 24, Brem in view of Nehls and in further view of Hilmarcher teach the system according to claim 15. Brem teaches a female component 11 including a hole (i.e., an opening in the female component as a result of the engagement profile penetrating through it) of the system for sampling tissue (Brem, see fig. 3, par 0050, 0055).
Brem does not teach that the tissue sample container includes locking means to lock the female component around the female hole, wherein the locking means are releasable for detaching the counter plate from the tissue sample container.
Nehls teaches that the tissue sample container (10) includes locking means (7) to lock a female component (2), the locking means (7) comprising an annular groove (7) having shape coupling with an annular projection (12) around a female hole, wherein the locking means (7) are releasable for detaching the counter plate from the tissue sample container (10) (Nehls, see figs. 1a-1c, par 0064).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem containing a female component such that it comprises a releasable locking means of the tissue sample container, so as to facilitate the removal of the sample container from the female component once tissue sampling is completed (Nehls, see figs. 1a-1c, par 0064).
With respect to claim 26, Brem teaches a method for sampling tissue from an ear of an animal comprising:
contacting a side of an ear to be sampled with a female component (11) having a hole (i.e., an opening in the female component) (see fig. 2), the female component (11) being attached to a removable tissue sample container (1) (Brem, see fig. 2),
coupling a male component (10) to the female component (11) by positioning a sample collecting part (4) having a cutting edge (Brem, see par 0035), on the opposite side of the ear of the animal;
and pushing the male component (10) towards the female component (11) to cut the tissue sample from the ear (Brem, see fig. 2, par 0035).
Brem does not teach that in the method for sampling tissue there is a protrusion associated to the tissue sample container, wherein the male component is coupled in a position where the protrusion enters the sample collecting part, guiding the tissue into the sample collecting part before the cut. Furthermore, Brem does not teach that the protrusion forces the sample into the sample collecting part during the pushing, and that when entering the sample collecting part, the sample tissue container contains support means with radial portions supporting the protrusion.
Nehls teaches a protrusion (30) that protrudes in or from the hole (5), to contact the ear of the animal;
coupling the male component in a position where the protrusion (30) may enter the sample collecting part (22), guiding the tissue of the animal into the sample collecting part (22) from before the cut (Nehls, see fig. 1a-1c, par 0026, 0027, 0073);
wherein the protrusion (30) forces the sample into the sample collecting part (22) during said step of pushing (Nehls, see fig. 1a-1c, par 0026, 0027, 0073, see par 0022, 0066, 0073, 0100);
and entering the sample collecting part (22) with the sampled tissue into the tissue sample container (10), wherein the tissue sample container (10) includes support means (32), arranged above the sealed membrane or cover (35) of the tissue sample container (10) and supporting the protrusion (30), the support means (32) being cut by the cutting edge (21) of the male component (1) so that the protrusion (30) enters the tissue sample container (10) with the sample collecting part (22), wherein the support means (32) includes a ring (32) disposed below a female component (2) facing the hole (5) when the female component (2) is attached to the tissue sample container (10), the ring (32) having at least one radial portion (33, 36) supporting the protrusion (30) at the middle of the ring (32), (Nehls, see figs. 1a-1c, 2, 9a-9c, par 0026, 0027, 0028, 0043, 0074, 0080, 0081, 0082, 0091, 0101, 0112), wherein the ring (32) is attached to (i.e., clampingly joined to) a top of a housing of the tissue sample container (10) by a plastic member (i.e., a circumferential bridge) that is injection-molded (see Nehls, par 0080-0081, figs. 1a-1c), wherein the ring (32) includes a fastening means (10a, 36) projecting towards the opening (5) of the tissue sample container (10), and wherein the detachable sample collecting part (20) comprises an engagement profile (20) adapted to be blocked by the fastening means (10a) when the sample collecting part enters the tissue sample container (Nehls, see figs. 9a-9c, par 0101, 0115).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of sampling tissue as taught by Brem such that it comprises steps of using a protrusion to guide the tissue of the animal into the sample collecting part, and having support means on the protrusion, as taught by Nehls, because doing so improves the method of Brem by ensuring that the sample is successfully retained in the sample container, by virtue of the protrusion and its support means that reinforce it (Nehls, see par 0072, 0074, 0089, 0101).
Brem in view of Nehls fails to teach that the plastic member that attaches the ring to the top of the tissue sample container is thermo-molded over a peripheral flange of the ring and the housing.
Hilmarcher teaches a method of manufacturing a plastics material part wherein the plastics material part is formed by thermoforming (i.e., overmolding thermoplastic material onto the faces of a multilayer structure) in a shape that is not a plane (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). Hilmarcher further teaches that thermoplastics such as polyvinylidene fluoride (PVDF) are advantageous in that they are strong and durable and are able to provide protection against outside surroundings when used as an outer layer of a structure (see Hilmarcher, par 0001-0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem in view of Nehls such that the plastic member that attaches the ring to the top of the tissue sample container is thermo-molded over a peripheral flange of the ring and the container component because that would merely be the simple substitution of one plastics manufacturing process (the thermomoulding/thermoforming process for manufacturing plastic of Hilmarcher) for another (the injection-molding process for manufacturing plastic of Nehls), as Hilmarcher teaches that plastics material parts can be formed in shapes that are non-planar using a multilayer structure/mold in a thermoforming process (i.e., such as in a shape that is configured to be molded over a flange, or molded in a shape that configures the plastic to be attached to other parts) (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5). Further, this would provide an advantage to the system of Brem in view of Nehls as thermoplastic materials such as PVDF are strong and durable (i.e., able to permit a strong attachment between the peripheral flange and the container component by the thermos-moulded plastic member) (see Hilmarcher, par 0001-0004). With respect to claim 27, Brem in view of Nehls and in further view of Hilmarcher teaches the system according to claim 15. Brem in view of Nehls and in further view of Hilmarcher teaches that the ring remains unremovably attached to the container due to the thermos-molded plastic member (i.e., the thermoformed plastic member can be configured in a shape, via the thermoforming process, to be unremovably attached to a housing and a ring) (see Hilmarcher, abstract, par 0016-0025, 0081, claim 1, figs. 1-5) .
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brem in view of Nehls and in further view of Hilmarcher as applied to claim 15 above in paragraph 8 , and further in view of US Patent Application Publication 20080044313 -- previously cited, hereinafter referenced as "Caisley".
With respect to claim 17, Brem in view of Nehls and in further view of Hilmarcher teaches the system according to claim 15.
Brem does not teach that the protrusion has a different color than the tissue sample container, nor that at least one of a peripheral edge, a bottom, or sealed membrane or a cover of the tissue sample container is transparent.
Nehls teaches that the protrusion (30) has a color different from a color of the tissue sample container (10) (Nehls, see par 0014, 0029, 0069, 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem such that a protrusion has a different color than the tissue sample container, because that permits inspection of the content of the filled sample container once sampling is complete (Nehls, see par 0029).
Brem in view of Nehls and in further view of Hilmarcher fails to teach that at least one of a peripheral edge, a bottom or sealed membrane or a cover of the tissue sample container is transparent.
Caisley teaches that at least one of a peripheral edge, a bottom or sealed membrane or a cover of the tissue sample container (10) is transparent (Caisley, see par 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem in view of Nehls and in further view of Hilmarcher such that the tissue sample container comprises a transparent peripheral edge, bottom, or a sealed membrane or cover, as the differing colors between the protrusion and the transparent edge, bottom, or sealed membrane or cover allows for a clear inspection of the contents of the filled sample container once sampling is complete (Caisley, see par 0042).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brem in view of Nehls and in further view of Hilmarcher as applied to claim 15 above in paragraph 12, and further in view of US Patent Application Publication 20040093775 -- previously cited, hereinafter referenced as "Brem 775".
With respect to claim 25, Brem in view of Nehls and in further view of Hilmarcher teaches the system according to claim 15. Brem as modified fails to teach that in the system the tissue sample container, the female component, and the male component comprise a respective flag, including identification information.
Brem 775 teaches an animal tagging system that comprises a tissue sample container (1), a female component (11) and a male component (10) that each comprise a respective flag, including identification information (Brem 775, see fig. 1, par 0005, 0072).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Brem as modified such that it comprises flags including identification information on the tissue sample container, the female component, and the male components because that improves the security of the system by ensuring samples are taken from the appropriate specimen (by virtue of the identification flags provided on the ear tag and the tissue sample container) (Brem 775, see fig. 1, par 0005, 0072).
Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791