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 .
Status of Claims
The most recent claim set submitted on 13 AUGUST 2024 is acknowledged and considered.
In the claim set, Claims 1-20 are presented and are indicated with status identifiers. Claims 1-20 are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 JANUARY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because Figure 3, reference character are blurry and illegible. 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
An “integrated system for monitoring and tracking…” in claim 1.
A “system” does not connote any particular structure. The specification is devoid of any description of what this “system” is.
A “tamper element to identify …” in claim 1.
An “element” does not connote any particular structure. The “tamper element is described as a seal, lock, tap, threaded element or microchip. Additional, the tamper element may include at least one of: a tamper-proof element, a tamper resistant element, and a tamper evident element”, [0013].
A “purifying element configured to prevent or reduce contamination…” in claim 3.
An “element” ” does not connote any particular structure. The purifying element “may include at least one of: a seal, a lock, a tape, a threaded element, or any combination thereof”, [0015].
An “application provision system configured to provide a central application…” and “application provision system is further configured to confirm…” in claim 17 and 18.
A “system” does not connote any particular structure. The specification describes the “application provision system comprise webservers and application servers”, [0076].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is 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 limitation “integrated system for monitoring and tracking…” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states the claimed function of monitoring and tracking done by just that. There is no disclosure of any particular structure, either explicitly or inherently, to describe “integrated system for monitoring and tracking…” The use of the term “monitoring and tracking” is not adequate structure for performing the function because it does not describe a particular structure for the function and does not provide enough description for one of ordinary skill in the art to understand which brightening structure or structures perform(s) the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 1 is 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. As described above, the disclosure does not provide adequate structure to perform the claimed function of monitoring and tracking in the systems. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Dependent Claims 2-20 are also rejected under 112(b) and112(a) as being dependent upon Claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by MORHET, US Publication No 2014/0017676 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 1
Applicant’s invention is directed towards a kit.
Regarding Claim 1, the reference MORHET discloses a self-use sample collection kit , abstract, collection devices and kits, comprising:
one or more swabs configured to collect a sample, Figure 1 and 2, sample collection device 20 having a soluble and hydrophilic PCL 24 attached to carrier 22, [0004, 0061] ;
one or more sample collection containers configured to receive the one or more swabs, Figure 2, container 38, [0061];
and a unique identifier label affixed to at least a portion of the one or more sample collection containers, Figure 2, label 44, [0061, 0069], and
wherein the unique identifier label uniquely identifies the one or more sample collection containers from a population of sample collection containers, Figure 2, [0058, 0061-0062]wherein the unique identifier label is linked to an integrated system for monitoring and tracking the one or more sample collection containers, [0058, 0061, 0062, 0065].
Additional Disclosures Included are: Claim 3: wherein the sample collection kit of claim 1 further comprising: a purifying element configured to prevent or reduce contamination of the one or more swabs, Figure 2, cap 32, [0061, 0069].; Claim 4: wherein the sample collection kit of claim 1, wherein the one or more swabs is substantially free of DNA, [0007, 0013, 0097].; Claim 5: wherein the sample collection kit of claim 1, wherein the one or more swabs are dry swabs, [0027, 0094-0097].; Claim 6: wherein the sample collection kit of claim 1, wherein the one or more swabs are sterile, [0007, 0011, 0097].; Claim 7: wherein the sample collection kit of claim 1, wherein the one or more swabs comprise a natural fiber, a polymer fiber, or a combination thereof, [0077].; Claim 8: wherein the sample collection kit of claim 1, wherein the one or more swabs comprise flocked fibers, [0011-001, 0071], polyester. ; Claim 9: wherein the sample collection kit of claim 1, wherein the unique identifier label is located on a sticker attached to the one or more sample collection containers, Figure 2, label 44 connected by glue, [0069].; Claim 10: wherein the sample collection kit of claim 1, wherein the unique identifier label comprises a barcode, an RFID element, a QRS code, or a combination thereof, [0011, 0013, 0061, 0063].; Claim 11: wherein the sample collection kit of claim 1, wherein the unique identifier label is configured to communicate with a digital platform or remote user, [0061-0064].; Claim 12: wherein the sample collection kit of claim 1, wherein the unique identifier label is configured to store data, [0063].; Claim 13: wherein the sample collection kit of claim 1 further comprising: an outer packaging material configured to house the sample collection kit, Figure 2, second container 34, [0061].; Claim 14: wherein the sample collection kit of claim 1 further comprising: a sample bag, Claim 26, [0012, 0061], Figure 2.; Claim 15: wherein the sample collection kit of claim 1 further comprising: an aqueous solution, Figure 1, solution 28, [0061].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over MORHET, US Publication No 2014/0017676 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 1, and further in view of SANGHA, US Publication No. 2007/0299364 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 2.
Regarding Claim 2, the MORHET reference discloses the kit of Claim 1, but is silent in regards to wherein the sample collection kit of claim 1 further comprising: tape configured to seal the one or more sample collection containers, the tape comprising a tamper element to identify whether the one or more sample collection containers have been opened.
The SANGHA reference discloses a self-use sample collection kit , Figure 1, comprising:
one or more swabs configured to collect a sample, Figure 1 , swab assembly 11, [0030];
one or more sample collection containers configured to receive the one or more swabs, Figure 1, container or bag 12, [0030];
and a unique identifier label affixed to at least a portion of the one or more sample collection containers, Figure 1, see barcode, [0033]
wherein the unique identifier label uniquely identifies the one or more sample collection containers from a population of sample collection containers, [0022, 0033], wherein the unique identifier label is linked to an integrated system for monitoring and tracking the one or more sample collection containers, [0033, 0034, 0042], further comprising: tape configured to seal the one or more sample collection containers, the tape comprising a tamper element to identify whether the one or more sample collection containers have been opened, [0022, 0046, 0047].
It would be obvious to one having ordinary skill in the art before the effective filing date to have the kit include a tape configured to seal the containers to provide tamper evident packaging so that once the tape has been applied, entry to the container can only be achieved by destruction of the tape, [0046].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over MORHET, US Publication No 2014/0017676 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 1, and further in view of PEREZ, US Publication No. 2009/0023219 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 4.
Regarding Claim 16, the MORHET reference discloses the kit of Claim 15, but is silent in regards to wherein the sample collection kit of claim 15, wherein the aqueous solution comprises distilled water.
The PEREZ reference discloses a self-use sample collection kit, abstract, comprising:
one or more swabs configured to collect a sample, Figure 1, swab 12/tip 24/shaft 22, [0040];
one or more sample collection containers configured to receive the one or more swabs, Figure 1, housing 14/16, [0041]; and
a unique identifier label, Figure 13, [0064, 0066], herein the unique identifier label uniquely identifies the one or more sample collection containers from a population of sample collection containers, wherein the unique identifier label is linked to an integrated system for monitoring and tracking the one or more sample collection containers, [0064, 0066], further comprising: an aqueous solution, and the aqueous solution comprises distilled water, [0044], Claim 2. It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the aqueous solution of MORHET to comprise distilled water to have a compatible solution as a preservative, Claim 1, [0011, 0015].
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over MORHET, US Publication No 2014/0017676 A1, submitted on the Information Disclosure Statement on 17 JANUARY 2024, US Patent Application Publications Cite No. 1.
Applicant’s invention is directed towards a system.
Regarding Claim 17, the MORHET discloses an integrated sample collection system, [0068], comprising:
the sample collection kit of claim 1, See Rejection to Claim 1 above; and
an application provision system configured to provide a central application assigning an identification code to one of a plurality of the sample collection kits, [0064, 0068], the application provision system configured to: receive an identification code related to one of the sample collection kits, [0064, 0065]; record a sample collection kit location and a timestamp, [0065, 0067]; record the sample collection kit location and timestamp in a blockchain system, [0019, 0064, 0068]; and receive the smart contract address and a block Tx Hash to central processor, [0064].
The MORHET reference discloses the claimed invention, but is silent in regards to specifically teaching a smart contract in a blockchain system and a block Tx Hash.
MORHET discloses and teaches the system and kits are utilized so that data such as authenticity and origin of the samples and, with a clear record of the chain-of-custody for the sample, represent information for the sample to be admitted into evidence in court proceedings may be recorded and stored. MORHET discloses using conventional methods, sample/specimen identification is either by written record accompanying the sample collection device or by a barcode present on the container in which the device is stored awaiting analysis, [0065].
While MORHET does not specifically disclose a ‘smart contract’ or a ‘block Tx Hash’ to a central processor, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the system of MORHET so that what MORHET already performs such as verifying data and recording chain of custody of sample, a ‘smart contract’ or a ‘block Tx Hash’ to a central processor so that transactions may be executed automatically, lower costs by removing intermediaries, increases transparency and increase security. In addition, the process of automating a manual activity accomplishes the same result and would not distinguish it over the prior art. In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958).
Additional Disclosures Included are: Claim 18: wherein the sample collection system of claim 17, wherein the application provision system is further configured to confirm the received identification code, [0065]. ; Claim 19: wherein the sample collection system of claim 17, wherein the identification code comprises a numeric code, a letter-based code, an alphanumeric code, a bar code, a QR code, an image, or any combination thereof, [0010, 0011, 0012, 0061, 0062]. ; and Claim 20: wherein the sample collection system of claim 17, wherein the identification code comprises a kit identification code, a container identification code, or both, [0010, 0011, 0012, 0061, 0062].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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