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 .
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.
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 1-16 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.
Claims 1-16 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claim 1 recites the limitation "the length direction" in Lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the male genital urethral orifice" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the shedding cells" in Lines 5-6 and 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the mucosa" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the urethral orifice" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the epithelial tissue" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the male genital" in Line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites ‘at one end’ but it is unclear what structure this is meant to be relative to or is the end of. For examination purposes it will be treated as an end of the first sampling portion.
The term “near” in claim 2 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 3 recites the limitation "the hardness" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites ‘that of’ and it is unclear what ‘that of’ is referring to’ For examination purposes it will be treated as ‘a hardness of’.
The term “different” in claim 4 is a relative term which renders the claim indefinite. The term “different” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 6 recites the limitation "the bristles" in Lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the outer peripheral surface" in Lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the stem portion" in Lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the rod portion’.
Claim 7 recites the limitation "the rod body part" in Line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the rod portion’.
Claim 7 recites the limitation "the depth" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the urethra" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the limiting position portion" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the limiting part’.
Claim 9 recites the limitation "the first sampling part" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the first sampling portion’.
Claim 9 recites the limitation "the second sampling part" in Lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the second sampling portion’.
Claim 9 is rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Claim 9 recites the limitation "the stem portion" multiple times in the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the rod portion’.
Claim 9 recites the limitation "the depth" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the urethra" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the diameter" multiple times in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the thickness" in Lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
The term “far” in claim 9 is a relative term which renders the claim indefinite. The term “far” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 9 recites the limitation "the cross-sectional shape" in Line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the outer diameter" in Line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the circumscribed circle" in Lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the surface" in Line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the breaking portion" in Line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the main portion" in Line 17. There is insufficient antecedent basis for this limitation in the claim.
The term “main” in claim 9 is a relative term which renders the claim indefinite. The term “main” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites the limitation "the smaller width" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
The term “smaller” in claim 10 is a relative term which renders the claim indefinite. The term “smaller” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “close” in claim 10 is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites the limitation "the stem portion" in Line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the rod portion’.
Claim 10 recites the limitation "the larger" in Line 10. There is insufficient antecedent basis for this limitation in the claim.
The term “larger” in claim 10 is a relative term which renders the claim indefinite. The term “larger” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 10 recites the limitation "the end" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the second sampling part" in Line 2, 3, and 4-5. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the second sampling portion’.
Claim 11 recites the limitation "the width dimension" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the maximum width dimension" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the first sampling part" in Line 5-6. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the first sampling portion’.
Claim 12 recites the limitation "the second sampling part" multiple times in the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the second sampling portion’.
Claim 12 recites the limitation "the first sampling part" multiple times in the claim. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the first sampling portion’.
Claim 12 recites the limitation "the width dimension" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the maximum width dimension" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the first sampling part" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the first sampling portion’.
Claim 13 recites the limitation "the second sampling part" in Line 5-6. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the second sampling portion’.
Claim 14 recites the limitation "the first sampling part" in Line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the first sampling portion’.
Claim 14 recites the limitation "the second sampling part" in Line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the second sampling portion’.
Claim 14 recites the limitation "the rod body part" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes this appear this should read ‘the rod portion’.
Claim 15 recites the limitation "the first sampling part" in Line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it appears this should read ‘the first sampling portion’.
Claim 16 appears to have been intended to be a dependent claim but it is not claimed as such and instead appears to not recite a statutory category of invention. Claim 16 will not be further treated on the merits.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim 16 will not be further treated on the merits.
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.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because it is directed to a dimension which is not one of the four categories of patent eligible subject matter. Claim 16 will not be further treated on the merits as per the 112 rejections above.
Claim Rejections - 35 USC § 102
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 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Triva (US 2016/0367227).
Regarding claim 1, Triva teaches a male genital shedding cell sampling device (Abstract; Paragraph 0011), comprising a rod portion (2), wherein the rod portion (2) is provided with a first sampling portion (3a) and a second sampling portion (3b) along the length direction of the rod portion (Figure 1), the first sampling portion (3a) is used for inserting into the male genital urethral orifice to sample the shedding cells of the mucosa near the urethral orifice (Paragraph 0011), and the second sampling portion (3b) is used for sampling the shedding cells of the epithelial tissue on multiple parts of the male genital (Paragraph 0011).
Regarding claim 2, Triva teaches wherein the first sampling portion (3a) is located at one end near the rod portion (Figure 1), and the second sampling portion (3b) is located at the other end of the first sampling portion (Figure 1).
Regarding claim 5, Triva teaches wherein the first sampling portion is made of cotton, cotton cloth, sponge, polyester fiber, velvet, polyamide fiber, nylon material, or polyethylene (Paragraph 0023; last eighth of the 2nd column on Page 2; ‘ The fibres 6 can be made of a substantially non-hydrophilic or non-adsorbent material with respect to the sample, and/or of a substantially hydrophilic or adsorbent material with respect to the sample and/or of a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of the materials. The fibres 6 are preferably made of nylon.’), and/or the second sampling portion is made of cotton, cotton cloth, sponge, polyester fiber, velvet, polyamide fiber, nylon material, or polyethylene (Paragraph 0023; last eighth of the 2nd column on Page 2; ‘ The fibres 6 can be made of a substantially non-hydrophilic or non-adsorbent material with respect to the sample, and/or of a substantially hydrophilic or adsorbent material with respect to the sample and/or of a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of the materials. The fibres 6 are preferably made of nylon.’)
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) 3-4, 6, 10-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva (US 2016/0367227) in view of Roush et al. (US 2014/0088459).
Regarding claim 3, Triva is silent on wherein the hardness of the second sampling portion is greater than that of the first sampling portion. Roush teaches wherein the hardness of the second sampling portion is greater than that of the first sampling portion (Paragraph 0045). Roush teaches the sampling portions having different hardness of bristles as being a design choice (Paragraph 0045 of Roush). The applicant's specification provides no specifical reasoning or critical functionality for the use of wherein the hardness of the second sampling portion is greater than that of the first sampling portion, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the hardnesses as desired by the user since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07.
Regarding claim 4, Triva is silent on the different hardnesses of the sampling portions. Roush teaches wherein the first sampling portion and the second sampling portion are made of different hardness of bristles or velvets (Paragraph 0045). Roush teaches the sampling portions having different hardness of bristles as being a design choice (Paragraph 0045 of Roush). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use wherein the first sampling portion and the second sampling portion are made of different hardness of bristles or velvets as desired by the user since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07.
Regarding claim 6, Triva is silent on the bristles being spirally distributed. Roush teaches characterized in that the bristles of the first sampling portion (2) are spirally distributed on the outer peripheral surface of the stem portion (5); and/or the bristles of the second sampling portion (4) are spirally distributed on the outer peripheral surface of the stem portion (5). (Paragraph 0030). It would have been obvious to one of ordinary skill in the art to have modified Triva with Roush because it is a common in the art design for cytology/sampling brushes and changing the shape of the bristles being attached to the shaft could be done as desired by the user as a matter of routine engineering design choice and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Regarding claim 10, Triva is silent on characterized in that the first sampling portion is a spiral cone-shaped structure, or the first sampling portion is a laminated cone-shaped structure, and the smaller width of the first sampling portion is close to one end of the stem portion, and the larger width of the first sampling portion is close to the end of the second sampling portion. The applicant's specification provides no specifical reasoning or critical functionality for the use of characterized in that the first sampling portion is a spiral cone-shaped structure, or the first sampling portion is a laminated cone-shaped structure, and the smaller width of the first sampling portion is close to one end of the stem portion, and the larger width of the first sampling portion is close to the end of the second sampling portion, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the first sampling portion is a spiral cone-shaped structure, or the first sampling portion is a laminated cone-shaped structure, and the smaller width of the first sampling portion is close to one end of the stem portion, and the larger width of the first sampling portion is close to the end of the second sampling portion as desired by the user as a matter of routine engineering design choice and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996) and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C)
Regarding claim 11, Triva is silent on characterized in that the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part. The applicant's specification provides no specifical reasoning or critical functionality for the use of characterized in that the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use characterized in that the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part as desired by the user as a matter of routine engineering design choice and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996) and the courts have held the following: In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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. MPEP § 2144.04-IV-A.
Regarding claim 12, Triva is silent on characterized in that the first sampling part is an elliptical spherical structure, the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part. The applicant's specification provides no specifical reasoning or critical functionality for the use of characterized in that the first sampling part is an elliptical spherical structure, the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use characterized in that the first sampling part is an elliptical spherical structure, the second sampling part is a spiral cylindrical structure, or the second sampling part is a stacked cylindrical structure, and the width dimension of the second sampling part is greater than the maximum width dimension of the first sampling part as desired by the user as a matter of routine engineering design choice and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996) and the courts have held the following: In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit 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. MPEP § 2144.04-IV-A.
Regarding claim 13, Triva teaches characterized in that the first sampling part is made of cotton, cotton cloth, sponge, polyester fiber, flocking, polyamide fiber, nylon material, or polyethylene (Paragraph 0023; last eighth of the 2nd column on Page 2; ‘ The fibres 6 can be made of a substantially non-hydrophilic or non-adsorbent material with respect to the sample, and/or of a substantially hydrophilic or adsorbent material with respect to the sample and/or of a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of the materials. The fibres 6 are preferably made of nylon.’); and/or the second sampling part is made of cotton, cotton cloth, sponge, polyester fiber, flocking, polyamide fiber, nylon material, or polyethylene (Paragraph 0023; last eighth of the 2nd column on Page 2; ‘ The fibres 6 can be made of a substantially non-hydrophilic or non-adsorbent material with respect to the sample, and/or of a substantially hydrophilic or adsorbent material with respect to the sample and/or of a material selected from among: polyamide (PA or nylon), rayon, polyester, carbon fibre, alginate, natural fibre, or a mixture of the materials. The fibres 6 are preferably made of nylon.’).
Regarding claim 15, Triva teaches characterized in that the first sampling part (2) has a maximum width dimension of 2mm-14mm and a length dimension of 4mm-20mm. (Paragraph 0023; ‘The collecting portion 3 can exhibit a longitudinal extension comprised between 3 mm and 40 mm or between 10 mm and 30 mm or between 15 mm and 20 mm and/or a diameter or thickness, including the fibres 6, comprised between 2 and 7 mm or between 3 and 6 mm or between 4.5 and 5.5 mm, or exhibits a diameter of the first portion, in a perpendicular section to the longitudinal extension thereof, without the fibres, comprised between 1 mm and 6 mm or between 2 mm and 5 mm or between 3.5 mm and 4.5 mm.’)
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva (US 2016/0367227) in view of House (US 2008/0146985).
Regarding claim 7, Triva is silent on the limiting part. House teaches characterized in that a limiting part (262) is provided on the rod body part (260), the limiting part (262) is used to limit the depth of insertion of the first sampling part into the urethra (Paragraph 0030). It would have been obvious to one of ordinary skill in the art to have modified Triva with House to allow for a stopping point and guide to the insertion length of the device into the urethra (Paragraph 0030 of House).
Regarding claim 8, Triva is silent on the limited position part. Triva in view of House is silent on characterized in that the limited position portion is located between the first sampling portion and the second sampling portion. But it would have been obvious to one of ordinary skill in the art to have done so since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C) and It would have been obvious to one of ordinary skill in the art to have modified Triva with House to allow for a stopping point and guide to the insertion length of the device into the urethra (Paragraph 0030 of House) thus modifying the position of the limited position part would be obvious to one of ordinary skill in the art as it would allow a desired insertion length.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva (US 2016/0367227) in view of House (US 2008/0146985) and Suciu et al. (US Patent No. 4227537).
Regarding claim 9, Triva teaches characterized in that the first sampling part has a diameter of 2mm-14mm and a length of 4mm-20mm and the second sampling part has a diameter of 3mm-20mm and a length of 5mm-30mm (Paragraph 0023; ‘The collecting portion 3 can exhibit a longitudinal extension comprised between 3 mm and 40 mm or between 10 mm and 30 mm or between 15 mm and 20 mm and/or a diameter or thickness, including the fibres 6, comprised between 2 and 7 mm or between 3 and 6 mm or between 4.5 and 5.5 mm, or exhibits a diameter of the first portion, in a perpendicular section to the longitudinal extension thereof, without the fibres, comprised between 1 mm and 6 mm or between 2 mm and 5 mm or between 3.5 mm and 4.5 mm.’).
Triva is silent on the limited position portion. House teaches characterized in that a limited position portion (262) is provided on the stem portion (260), the limited position portion (262) is used to limit the depth of insertion of the first sampling part into the urethra (Paragraph 0030). It would have been obvious to one of ordinary skill in the art to have modified Triva with House to allow for a stopping point and guide to the insertion length of the device into the urethra (Paragraph 0030 of House).
Triva in view of House are silent on the dimensions of the limited position portion. The applicant' s specification provides no specifical reasoning or critical functionality for the use of the diameter of the limited position portion is 4mm-15mm, and the thickness is 0.5mm-5mm, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the diameter of the limited position portion is 4mm-15mm, and the thickness is 0.5mm-5mm as desired by the user as a matter of routine engineering design choice.
The applicant' s specification provides no specifical reasoning or critical functionality for the use of the limited position portion is made of polymer material, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the limited position portion is made of polymer material as desired by the user since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. MPEP 2144.07
Triva is silent on the ball head portion. Suciu teaches the stem portion (12) is provided with a ball head portion (rounded bead 16) at one end far from the second sampling portion (Figures 1-3), the diameter of the ball head portion is 1mm-6mm (Column 4, Lines 52-54; 0.125 inches is about 3mm). It would have been obvious to one of ordinary skill in the art to have modified Triva with Suciu because it allows for sealing engagement with a sleeve to protect the sampling portions (Column 3, Lines 18-21 of Suciu).
Triva is silent on the cross-sectional shape of the stem portion is square, hexagonal or octagonal. The applicant' s specification provides no specifical reasoning or critical functionality for the use of the cross-sectional shape of the stem portion is square, hexagonal or octagonal, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the cross-sectional shape of the stem portion is square, hexagonal or octagonal as desired by the user as a matter of routine engineering design choice and so a person of ordinary skill in the art at the time of invention would have found that the change in shape did not sufficiently alter the device as it was an obvious change motivated by manufacturing parameters or user preference. See re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1996).
Triva teaches the outer diameter of the circumscribed circle of the stem portion (5) is 3mm-8mm (Paragraph 0023; ‘The flocked swab 1 or the support body 2 can exhibit a longitudinal extension comprised between 50 mm and 200 mm or between 100 mm and 200 mm, or between 130 mm and 170 mm and/or a thickness or diameter in a perpendicular section to the central axis thereof comprised between 0.8 mm and 5 mm or between 1 mm and 4 mm or between 2 mm and 3 mm or between 2.3 mm and 2.7 mm.’).
Triva teaches the surface of the stem portion has frictional patterns (patterns formed by reinforcing ribs 12; Figures 1-2; Paragraph 0023).
Triva teaches the stem portion has a breaking portion, and the breaking portion is used to detach the stem portion with the first sampling portion and the second sampling portion from the main portion of the stem portion (Paragraph 0023; weakening portions at least 4a, 4b, that enable breaking and separation of different parts).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva (US 2016/0367227) in view of Suciu et al. (US Patent No. 4227537).
Regarding claim 14, Triva is silent on the ball head part. Suciu teaches characterized in that the rod body part (12) is provided with a ball head part (rounded bead 16) at one end of the first sampling part away from the second sampling part (Figures 1-3), the ball head part (1) having a diameter of 1mm-6mm (Column 4, Lines 52-54; 0.125 inches is about 3mm). It would have been obvious to one of ordinary skill in the art to have modified Triva with Suciu because it allows for sealing engagement with a sleeve to protect the sampling portions (Column 3, Lines 18-21 of Suciu).
Examiner’s Note
Claim 16 cannot be examined in light of the prior art due to the 101 and 112 rejections above.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791