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 .
DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-8, drawn to a container.
Group II, claim(s) 9, drawn to a device for collecting and transferring.
Group III, claim(s) 10, drawn to a kit.
Group IV, claim(s) 11, drawn to a method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of a device for collection and transfer of samples comprising a graduated scale associated therewith having a plurality of measurement markings realized according to a predetermined distance measurement unit the markings being configured to provide an at least visual and/or tactile indication of a measurement of a distance, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of CN 108836403A. CN 108836403A discloses a graduated scale 11 comprising a plurality of measurement markings (fig. 1) realized according to a predetermine distance measurement unit and configured to supply an at least visual and/or tactile indication of a measurement of a distance (e.g. depth of insertion; par.[0014]).
During a telephone conversation with Joshua Griswold on September 11th, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8. Affirmation of this election must be made by applicant in replying to this Office action. Claims 9-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Interpretation
The recitations throughout the claims to “destined to” are treated as recitations to “capable of.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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.
Regarding claim 1, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
This is further seen as the claims provides several levels/sublevels of “preferably” with respect to parts of a body.
Herein, it is also noted that such language is not necessitated to be disclosed by the prior art and the recitation remains drawn to the initial recitation in being configured to allow a measurement between a first portion and a second portion of [a] body.
This is likewise seen in claim 2 with respect to instances of “preferably,” in claim 4 with respect to “in particular,” in claim 5 with respect to “in particular,” and in claim 8 to “in particular.”
Claim 1 recites the limitation "the body" . There is insufficient antecedent basis for this limitation in the claim.
Herein, it appears that Applicant intends to recite “a body.”
The preamble of claim 1 references the functionality of the container being for a device, and within the claim it is provided that the main body has functionality to contain and/or support at least a test device in which the usage of general “device” in both instances renders unclear if these are drawn to the same, prospective element (i.e. the preamble intends to recite “at least a device” and with respect to the main body it is intended to recite “said at least a device”), or if Applicant intends different functionality with respect to the “at least a device” and the main body.
With regard to claim 4, the metes and bounds of the sought “predefined opening portion” of the graduated scale in the context of “weakened” are indefinitely understood herein.
“Weakened” itself implicitly references past acts/events that have occurred from a baseline state in which the claims are drawn to a device and no such acts/events have particular weight herein. By this, the structural constitution intended by “weakened” is indefinitely understood.
With regard to claims 6 and 7, the sought relative arrangement of the graduated scale “positioned in substantial correspondence of at least one between the main body and/or the auxiliary body” are indefinitely understood.
A “between” orientation with respect to the graduated scale and the main body/auxiliary body relies on a three-part boundary wherein the graduated scale is the middle part so as to realize a “between” nature, or if it is desired that the graduated scale is to be between the main body/auxiliary body and another, different element, the another/different element needs to be claimed and established in the sought relative comparison.
The present recitation in claims 6 and 7 to “positioned in substantial correspondence of at least one between the main body and/or the auxiliary body” does not clearly provide a “between” arrangement or a plurality of “between” arrangements.
With regard to claim 8, the recitation “comprising an identification code…configured to identify…said container and/or said device,” is not particularly understood. The preamble of claim 1 references the functionality of the container being for a device, and within the claim it is provided that the main body has functionality to contain and/or support at least a test device. Clarification is required with respect to the desired prospective workpiece of a device or at least a device as likewise discussed above with respect to claim 1 is required.
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.
Claim(s) 1, 2, and 4-7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by CN 108836403A, hereafter CN.
CN discloses a container for a device for collecting and transferring samples of biological material comprising a main body 1 destined to (treated as functionally capable of or “designed for” providing a likewise functionally capable of recitation) to contain and/or support at least temporarily at least a device 3,4 for collecting and transferring samples of biological material. CN further discloses a graduated scale 11 comprising a plurality of measurement markings (fig. 1) realized according to a predetermine distance measurement unit and configured to supply an at least visual and/or tactile indication of a measurement of a distance (e.g. depth of insertion; par.[0014]), and wherein the container is configured to allow a measurement of a distance between a first portion and a second portion of the body of a subject as claimed. This is further seen as CN discloses all of the commensurately and positively recited structural elements of container, as claimed, along with the commensurate functionality thereto the main body and graduated scale, wherein the container of CN is thus said to be fully capable of such measurement of a distance between 1st/2nd portion of a body of a subject in as much as recited and provided herein. With regard to claim 2, CN discloses the container having at least a closed configuration wherein it (the container) is configured to contain said at least a device in a condition of substantial sterility and/or of air insulation with respect to an outer environment (Examiner notes that no particular sterilization mechanism/structure(s) or air insulation mechanism/structure(s) are required and the recitation is drawn to a capability to hold as claimed, which is afforded to the container of CN), and further wherein the container is disposable or functionally capable of (“destined to”) to contain a single device, and/or a first element and a second element (figs. 1&2, for example). With regard to claim 4, CN discloses that the graduated scale 11 is positioned at an end position (fig. 1; the placement of the scale corresponds with an “end position” in as much as claimed and wherein “end” position is drawn to a nominal descriptor met herein wherein the claim does not set forth particular, relative structural placement thereof within particular confines of the claimed device). With regard to claim 5, CN discloses the graduated scale 11 is realized on the main body (fig. 1, for example). With regard to claim 6, CN discloses an auxiliary body 3 operatively connected to the main body, wherein the graduated scale is positioned in substantial correspondence of at least one of between the main body and/or the auxiliary body (fig. 1, for example). With regard to claim 7, CN discloses an auxiliary body 3 operatively connected with the main body wherein the graduated scale is positioned in substantial correspondence of at least one of between the main body and/or the auxiliary body, and/or wherein the auxiliary body 3 is fully capable of being removed from the main body by a given, sufficient applied force (fig. 1, for example).
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.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN in view of CN 111504972, hereafter CN-111.
CN has been discussed above.
CN does not specifically disclose that the container comprises a substantially transparent or translucid wherein the graduated scale is at least partially positioned in correspondence of said substantially transparent or translucid portion.
CN-111 discloses a PCR sampling detection device in which the sampler comprises a cylinder wherein a side surface of the cylinder is provided with scale marks and the cylinder is made of transparent materials (claim 6, figs., for example).
It would have been obvious to one of ordinary skill in the art to provide a substantially transparent or translucid portion wherein the graduated scale is at least partially positioned in correspondence of said substantially transparent or translucid portion such as suggested by the analogous art of CN-111 to a PCR sampling detection device in which it is afforded that the sampling device and its sampling distance may be easily viewed by a user/practitioner for desired operation.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN in view of Neel et al. (US 2006/0189895), hereafter Neel.
CN has been discussed above.
CN does not specifically disclose an identification code configured to identify the container and/or said device.
Neel discloses a test strip container in which the container comprises test strips and including a code embedded and readable by the controller to identify data particular to the test strip, and also reading code information that identifies the particular test to be performed or confirmation of a proper operating status (pars.[0017,0018,0105]).
It would have been obvious to one of ordinary skill in the art to modify CN to provide an identification code configured to identify the container and/or said device such as suggested by the analogous art of Neel to a diagnostic test strip container in which an identification code affords to ability to identify the device as in the at least one test strip and aid in properly managing use and correlation of the container and test strip(s) for the correct, particular strip(s) therefor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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