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
Claims 1-15 are hereby under examination.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 11/20/2022 has been considered except where lined through because the reference was not provided in English.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The disclosure is objected to because of the following informalities:
On page 8, the Applicant states "The specimen tool, as shown in FIG. 1, may include… a specimen collection swab 400". However, FIG. 1 does not show a specimen collection swab 400.
On page 10, the Applicant states “the number of the swab entry hole part 200 is one or more and, as shown in FIGS. 3a and 3". However, there is no FIG. 3 and FIGS. 3a and 3b only show one swab entry hole part 200.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim limitation(s) being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is/are: “opening means” in claim 1.
Three Prong Analysis for Claim 1:
The claim recites “means”.
“For guiding the specimen collection cotton swab into the passage of the swab entry hole part” has been interpreted as functional language.
There is not sufficient structure recited in the claim to perform the aforementioned function. Therefore, this claim limitation is being interpreted under 35 U.S.C. 112(f).
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. All instances of “opening means” are herein interpreted to be the incision lines because the incision lines are what allows the specimen collection cotton swab to enter the detachable cap as stated in pages 11-13 of the specification.
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.
Claims 3, 5-7, and 9-15 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 3, the claim recites "the sight glass corresponding to the mouth of the subject" and "the sight glass corresponding to the nose of the subject". Claim 2 recites “the swab entry hole is formed on a sight glass corresponding to the mouth/nose of the subject”. Based on claim 2, from which claim 3 is dependent, the “a sight glass” corresponds to either the mouth or the nose of the subject. Therefore, it is unclear how there can be both "the sight glass corresponding to the mouth of the subject" and "the sight glass corresponding to the nose of the subject". The claim also recites “the swab entry hole part corresponding to the nose of the subject” and “the swab entry hole part corresponding to the mouth of the subject”. There is insufficient antecedent basis for these claim limitations. For the purposes of examination, “the swab entry hole part corresponding to the nose of the subject” and “the swab entry hole part corresponding to the mouth of the subject” are herein interpreted to be the swab entry hole. Furthermore, it is noted that “so that an examiner inserts the tongue depressor into the guide groove in order to suppress the tongue of the subject received in the receiving groove” is herein interpreted as intended use language and not given patentable weight. If this phrase were to be given patentable weight, it would constitute a rejection under 35 U.S.C. 101 as being directed to or encompassing a human organism. Due to the aforementioned reasons, claim 3 is rendered indefinite. Claims 9, 11, 13, and 15 are rejected due to their dependence on claim 3.
Regarding Claims 5 and 10-11, the claims recite “the diameter of the swab entry hole part, thereby forming a step due to a difference in diameters”. There is insufficient antecedent basis for “the diameter of the swab entry hole part”. Claim 1 recites “a swab entry hole part formed in the mask and having a passage with a diameter”. For the purposes of examination, “the diameter of the swab entry hole part” is herein interpreted to be the diameter of the passage of the swab entry hole part. It is unclear what is meant by “a difference of diameters”. What are the two diameters being compared? It is unclear whether “the diameter of the swab entry hole part” is referring to the diameter of the passage of the swab entry hole part, as recited in claim 1, or of the swab entry hole part as a whole (passage plus its walls). For the purposes of examination, “a difference of diameters” is herein interpreted to be a difference between a diameter of the tip of the swab entry hole part and the diameter of the passage of the swab entry hole part or the diameter of the swab entry hole part as a whole. Due to the aforementioned reasons, claims 5 and 10-11 are rendered indefinite.
Regarding Claims 6 and 12-13, the claims recite “the opening means is cut to form an incision by an external force and the incision is rolled into the detachable cap to enable the detachable cap to be kept airtight when the specimen collection cotton swab is inserted”. This is a method step, however, claims 6 and 10-11 are dependent on an apparatus claim. It is unclear what further structural limitations are imparted with this claim limitation or what structural elements would perform this method step. For the purposes of examination, these claim limitations are herein interpreted such that the opening means are configured to be cut to form an incision by an external force, wherein the incision is rolled into the detachable cap to enable the detachable cap to be kept airtight when the specimen collection cotton swab is inserted. Therefore, claims 6 and 12-13 are rendered indefinite.
Regarding Claims 7, 14, and 15, the claims recite “to thus separate the detachable cap”. It is unclear what the detachable cap is being separated from. For the purposes of examination, “to thus separate the detachable cap” is herein interpreted to be to thus separate the detachable cap from the swab entry hole part. Therefore, claims 7, 14, and 15 are rendered indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 1, the claim recites “a specimen collection cotton swab which is inserted into a mouth or a nose of the subject wearing the mask to collect a specimen”. Therefore, the claim is directed to or encompasses a human organism (a mouth or a nose of the subject, the subject wearing the mask) and is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act. Claims 2-15 are rejected due to their dependence on claim 1. It is suggested that the claim be amended to recite “a specimen collection cotton swab which is configured to be inserted into a mouth or a nose of the subject when the subject wears the mask to collect a specimen” in order to remove the recitation of human tissue.
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.
Claim(s) 1-5 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US Patent Pub. No. 20130296653) hereinafter Brown, and further in view of Matsuzaki et al. (JP 2011120647 A – cited by Applicant) hereinafter Matsuzaki. The English translation of JP 2011120647 A used for the rejections has been provided.
Regarding Claim 1, Brown discloses a subject specimen tool for virus inspection (system 100 [0032]; fig 3; Examiner notes system 100 can be used for virus inspection), comprising:
a mask for shielding a face or a part of the face of a subject (a mask 102 that can be configured for placement over the mouth and/or nose of a patient (see, e.g., FIG. 6A) [0032]);
an instrument which is inserted into a mouth or a nose of the subject wearing the mask (the medical instrument 209 can comprise any suitable device or probe [0068]; instruments may be passed through the mask 102 and into the airway of a patient. [0044]; fig 6B);
an entry hole part formed in the mask and having a passage with a diameter, through which the instrument can enter and exit (The shell 150 can define an adapter opening 152 through which instruments may be passed through the mask 102 and into the airway of a patient. [0044]; figs 2-3);
and a detachable cap which is configured to be detachable on the entry hole part (the adapter 110 comprises two separate assemblies 117... An insertion assembly 117, which may also be referred to as an insertion portal or insertion adapter, is configured to allow the insertion of various devices into the airway of a patient through the mask 102. [0034]; The adapter 110 can be attached to the mask 102 at the adapter opening 152. [0044]; fig 2)
and is provided with an opening means for guiding the instrument into the passage of the entry hole part (the insertion assembly 117 can include a valve 118 of any suitable variety [0036]; fig 2), wherein the opening means is opened only in one direction toward the entry hole part (element 118 fig 6B).
Brown fails to disclose a specimen collection cotton swab which is inserted into a mouth or a nose of the subject wearing the mask to collect a specimen;
a swab entry hole part formed in the mask and having a passage with a diameter, through which the specimen collection cotton swab can enter and exit;
and a detachable cap which is configured to be detachable on the swab entry hole part and is provided with an opening means for guiding the specimen collection cotton swab into the passage of the swab entry hole part, wherein the opening means is opened only in one direction toward the swab entry hole part.
However, Matsuzaki teaches a subject specimen tool for virus inspection (When diagnosing or diagnosing influenza, the doctor can insert a cotton swab through the access hole in the transparent part, insert it into the nasal cavity or oral cavity, and thus collect the specimen [0020]; figs 1-4), comprising:
a specimen collection cotton swab which is inserted into a mouth or a nose of the subject wearing the mask to collect a specimen (the cotton swab 9 is inserted from the access hole 7 [0030]; the cotton swab 9 is pulled out from the access hole 7 [0031]; figs 3-4).
Matsuzaki is considered analogous art to the present invention because it is directed to the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the subject specimen tool of Brown such that a specimen collection cotton swab which is inserted into a mouth or a nose of the subject wearing the mask to collect a specimen is included as one of the instruments, as taught by Matsuzaki, because it would allow the subject specimen tool of Brown to be used to test for influenza or other respiratory/infectious viruses. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
The modified subject specimen tool of Brown in view of Matsuzaki teaches a swab entry hole part formed in the mask and having a passage with a diameter, through which the specimen collection cotton swab can enter and exit; and a detachable cap which is configured to be detachable on the swab entry hole part and is provided with an opening means for guiding the specimen collection cotton swab into the passage of the swab entry hole part, wherein the opening means is opened only in one direction toward the swab entry hole part.
Regarding Claim 2, Brown in view of Matsuzaki teaches the invention as discussed above in claim 1. Brown in view of Matsuzaki further teaches the swab entry hole part is formed on a sight glass corresponding to the mouth/nose of the subject (The shell 150 can define an adapter opening 152 through which instruments may be passed through the mask 102 and into the airway of a patient. [0044 of Brown]; figs 2-3 of Brown);
Brown in view of Matsuzaki fails to teach the sight glass is composed of a transparent material protruding forward from a body of the mask.
However, Matsuzaki teaches a swab entry hole part is formed on a sight glass corresponding to a mouth/nose of a subject (a transparent portion 5 corresponding to a corresponding portion of the nose and mouth of the wearer 4 or a portion in the vicinity thereof [0026]; An access hole 7 constituting the valve mechanism 6 is formed in the transparent portion 5 [0027]; figs 1-4); and the sight glass is composed of a transparent material protruding forward from a body of a mask (the transparent portion 5 can be configured by cutting out a corresponding portion of the ventilation filter portion 3 to form an opening, and attaching a transparent sheet to that portion [0026]; figs 2-4). Matsuzaki also teaches an advantage to having the sight glass composed of a transparent material (diagnosis such as redness of the mucous membrane in the oral cavity can be performed through the transparent portion 5 [0029]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the sight glass is composed of a transparent material protruding forward from a body of the mask, as taught by Matsuzaki, because a transparent sight glass would allow for a physician to visually examine the mouth or nose of the subject.
Regarding Claim 3, Brown in view of Matsuzaki teaches the invention as discussed above in claim 2. Brown in view of Matsuzaki further teaches a tongue pressing part (the base plate 179 can be configured to contact a tongue of a patient, and may hold down the tongue so as to prevent it from blocking a pathway through the oral cavity and into the pharynx [0056 of Brown]; figs 5A-5D of Brown), in which a receiving groove is formed to be spaced apart from the swab entry hole part corresponding to the nose of the subject and to receive a tongue of the subject (The rearward edges of the base plate 179 and the sidewalls 176, 178 may be shaped to accommodate and/or rest against the tongue of a patient. [0056 of Brown]; figs 5A-5D of Brown);
a guide groove is formed between the tongue pressing part and the sight glass corresponding to the nose of the subject (Sidewalls 176, 178 can extend downwardly from the guide plate 174 at lateral sides of the bite block 108. [0055 of Brown]; For example, a distal tip of a fiberscope can be inserted into the passageway 173 and urged along the lower surface of the guide plate 174. Due to the curvature of the guide plate 174, the distal tip can be directed to a center line of the guide plate 174 (e.g., a line defined by the central longitudinal plane LP), which can be generally aligned with a midline of the patient. [0059 of Brown]; figs 5A-5D of Brown; Examiner notes that sidewalls are formed between base plate 179 and sight glass 150), through which a tongue depressor can be inserted (As evidenced by Burdumy (US Patent Pub. No. 20090050161), a bite block with protruding sidewalls can receive a tongue depressor [0026]);
and the swab entry hole part corresponding to the mouth of the subject is present on the guide groove (fig 3 of Brown), so that an examiner inserts the tongue depressor into the guide groove in order to suppress the tongue of the subject received in the receiving groove (As stated in the 35 U.S.C. 112(b) rejection, no patentable weight is given to this limitation. Therefore, no prior art rejections are needed).
Brown in view of Matsuzaki fails to teach the sight glass corresponding to the mouth of the subject is further provided with a tongue pressing part.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the sight glass corresponding to the mouth of the subject is further provided with a tongue pressing part instead of having a detached, separate tongue pressing part. The use of a one-piece, integrated construction instead of the structure disclosed or taught in the prior art would have been within the ambit of a person of ordinary skill in the art. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (see MPEP § 2144.04).
Regarding Claim 4, Brown in view of Matsuzaki teaches the invention as discussed above in claim 1. Brown in view of Matsuzaki further teaches the swab entry hole part protrudes from the mask (fig 2 of Brown) and is formed to have a diameter becoming narrower in a protruded direction (Any suitable arrangement for coupling the adapter 110 to the mask 102 is contemplated… the housing 112 of the adapter 110 includes a connector 125 of any suitable variety, such as a deformable snap or clip, which interacts with an inwardly projecting rim 155 that is defined about the adapter opening 152 [0044 of Brown]; fig 2 of Brown; Examiner notes that adapter opening 152 can be formed to have a diameter becoming narrower in a protruded direction because the adapter 110 is fitted onto the adapter opening 152 and therefore, must be narrower in the protruded direction);
and the detachable cap is configured in a hollow shape (fig 2 of Brown) which can be forcedly fitted to the swab entry hole part (Any suitable arrangement for coupling the adapter 110 to the mask 102 is contemplated… the housing 112 of the adapter 110 includes a connector 125 of any suitable variety, such as a deformable snap or clip, which interacts with an inwardly projecting rim 155 that is defined about the adapter opening 152 [0044 of Brown]).
Furthermore, it is noted that Applicant has failed to provide details of critically or unexpected results in the specification with regard to the shape of the swab entry hole and the detachable cap. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the swab entry hole part is formed to have a diameter becoming narrower in a protruded direction; and the detachable cap is configured in a hollow shape which can be forcedly fitted to the swab entry hole part. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding Claim 5, Brown in view of Matsuzaki teaches the invention as discussed above in claim 1. Brown in view of Matsuzaki further teaches the swab entry hole part protrudes from the mask (fig 2 of Brown), in which a tip of the swab entry hole part is formed to be larger than the diameter of the swab entry hole part, thereby forming a step due to a difference in diameters (Any suitable arrangement for coupling the adapter 110 to the mask 102 is contemplated… the housing 112 of the adapter 110 includes a connector 125 of any suitable variety, such as a deformable snap or clip, which interacts with an inwardly projecting rim 155 that is defined about the adapter opening 152 [0044 of Brown]; fig 2 of Brown; Examiner notes that a tip of the adapter opening 152 can be formed to be larger than the diameter of the adapter opening because the adapter 110 is fitted onto the adapter opening 152 via a snap or fit connecter and therefore, there needs to be a lip/step on the adaptor opening 152 for the adaptor to attach to);
and the detachable cap has a hook part to be caught and coupled to the step (The valve 118 can be held against an open end of the housing 112 via a collar 122. [0036 of Brown]; fig 3 of Brown).
Furthermore, it is noted that Applicant has failed to provide details of critically or unexpected results in the specification with regard to the shape of the swab entry hole and the detachable cap. As such, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the swab entry hole part protrudes from the mask, in which a tip of the swab entry hole part is formed to be larger than the diameter of the swab entry hole part, thereby forming a step due to a difference in diameters; and the detachable cap has a hook part to be caught and coupled to the step. The change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding Claim 8, Brown in view of Matsuzaki teaches the invention as discussed above in claim 2. Brown in view of Matsuzaki also teaches claim 8. See the 35 U.S.C. 103 rejection for claim 4 above.
Regarding Claim 9, Brown in view of Matsuzaki teaches the invention as discussed above in claim 3. Brown in view of Matsuzaki also teaches claim 9. See the 35 U.S.C. 103 rejection for claim 4 above.
Regarding Claim 10, Brown in view of Matsuzaki teaches the invention as discussed above in claim 2. Brown in view of Matsuzaki also teaches claim 10. See the 35 U.S.C. 103 rejection for claim 5 above.
Regarding Claim 11, Brown in view of Matsuzaki teaches the invention as discussed above in claim 3. Brown in view of Matsuzaki also teaches claim 11. See the 35 U.S.C. 103 rejection for claim 5 above.
Claim(s) 6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent Pub. No. 20130296653) in view of Matsuzaki (JP 2011120647 A – cited by Applicant) as applied to claims 1-3 above, and further in view of Lentz et al. (US Patent Pub. No. 20140011292) hereinafter Lentz.
Regarding Claim 6, Brown in view of Matsuzaki teaches the invention as discussed above in claim 1. Brown in view of Matsuzaki further teaches the opening means is configured as an incision line provided on a portion of the detachable cap (a septum that includes one or more slits 120 [0036 of Brown]; fig 2 of Brown);
the opening means is cut to form an incision by an external force and the incision is rolled into the detachable cap to enable the detachable cap to be kept airtight when the specimen collection cotton swab is inserted (As the fiberscope 210 is inserted through the port 123, the valve (118) can maintain a seal therewith so as to prevent oxygen or air from exiting the adapter 110 thereat. [0068 of Brown]; fig 6B of Brown).
Brown in view of Matsuzaki fails to teach the detachable cap is made of a resin material having a restoration force.
However, Lentz teaches a detachable cap made of a resin material having a restoration force (The shell 13 may be generally cylindrical in shape or any other shape suitable for covering an opening 19 of a vessel 21. The shell 13 is preferably made of plastic resin, but may be made of any suitable material… Based on the guidance provided herein, those skilled in the will be able to select a resin or mixture of resins having hardness and penetration characteristics which are suitable for a particular application, without having to engage in anything more than routine experimentation. [0082]; Examiner notes that all resin material would have a restoration force).
Lentz is considered analogous art to the present invention because it is reasonably pertinent to a problem faced by the inventors.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the detachable cap is made of a resin material having a restoration force, as taught by Lentz. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960), Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945), and MPEP § 2144.07.
Regarding Claim 12, Brown in view of Matsuzaki teaches the invention as discussed above in claim 2. Brown in view of Matsuzaki and further in view of Lentz teaches claim 12. See the 35 U.S.C. 103 rejection for claim 6 above.
Regarding Claim 13, Brown in view of Matsuzaki teaches the invention as discussed above in claim 3. Brown in view of Matsuzaki and further in view of Lentz teaches claim 13. See the 35 U.S.C. 103 rejection for claim 6 above.
Claim(s) 7 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US Patent Pub. No. 20130296653) in view of Matsuzaki (JP 2011120647 A – cited by Applicant) as applied to claims 1-3 above, and further in view of Jivanjee (US Patent No. 11577040).
Regarding Claim 7, Brown in view of Matsuzaki teaches the invention as discussed above in claim 1. Brown in view of Matsuzaki fails to teach the specimen collection cotton swab is provided with an interference plate that has a diameter larger than a diameter of the specimen collection cotton swab; and the interference plate interferes with the opening means to thus separate the detachable cap when the interference plate is inserted into and then exits from the swab entry hole part.
However, Jivanjee teaches a specimen collection cotton swab is provided with an interference plate (plate 44 (col. 3, line 54); fig 3) that has a diameter larger than a diameter of the specimen collection cotton swab (swab 46 (col. 3, line 64); fig 3) to be used as a guiding mechanism (plate 44 is used to position tubing 42 over nose area 24 and mouth area 25. A swab 46 is then inserted within tubing 42 as observed in FIG. 3 (col. 3, lines 59-61)).
Jivanjee is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have further modified the subject specimen tool of Brown in view of Matsuzaki such that the specimen collection cotton swab is provided with an interference plate that has a diameter larger than a diameter of the specimen collection cotton swab, as taught by Jivanjee, because it would serve as a guiding mechanism for a medical professional when collecting a specimen sample from a user. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
The modified subject specimen tool of Brown in view of Matsuzaki and further in view of Jivanjee would teach the interference plate interferes with the opening means to thus separate the detachable cap when the interference plate is inserted into and then exits from the swab entry hole part. The opening means only opens in one direction towards the swab entry hole part (fig 6B of Brown), so inserting the specimen collection cotton swab along with the interference plate would cause the opening means to be rolled into the detachable cap. The detachable cap is connected to the swab entry hole part via a deformable snap or clip (the housing 112 of the adapter 110 includes a connector 125 of any suitable variety, such as a deformable snap or clip, which interacts with an inwardly projecting rim 155 that is defined about the adapter opening 152 [0044 of Brown]). Since the one-way opening means was rolled into the detachable cap during insertion, the interference plate would not be able to exit through the opening means of the detachable cap. Thus, removing the inserted interference plate and the specimen collection cotton swab from the swab entry hole part would completely separate the snap-fit/clip-fit detachable cap from the swab entry hole part, as the opening means would not allow for removal.
Regarding Claim 14, Brown in view of Matsuzaki teaches the invention as discussed above in claim 2. Brown in view of Matsuzaki and further in view of Jivanjee teaches claim 14. See the 35 U.S.C. 103 rejection for claim 7 above.
Regarding Claim 15, Brown in view of Matsuzaki teaches the invention as discussed above in claim 3. Brown in view of Matsuzaki and further in view of Jivanjee teaches claim 15. See the 35 U.S.C. 103 rejection for claim 7 above.
Conclusion
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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791