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 .
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
The Applicant amends claims 1-3, 5, 8, 10-11, and 34-35 are amended. The 35 U.S.C §112(b) rejection of claims 1-7, 10-11, and 34-36 for using the term ‘about’ were amended to advance the application to an allowance.
The Applicant argues of the use of ‘substantially’ in claim 8 as part of the description of the witness features that protrude from an exterior surface of the pipette's tubular body. More specifically, the claim phrase of claim 8 states, "each witness feature . . has a maximum lengthwise dimension that is substantially parallel to the longitudinal axis." Claim 8 explains where the longitudinal axis is on the pipette. See claim 8 ("[a] pipette comprising: a tubular body arranged between a tip and a mouthpiece, and having a longitudinal axis extending between the tip and the mouthpiece"). It is the long axis running through the middle of the pipette between the tip (see character reference 15 in the figures) and the mouth (see character reference 13 in the figures and so something that is "substantially parallel" to this axis is approximately parallel. The Applicant refers to such uses of the word "substantially" as a degree have been deemed to be definite by courts across the country in post-Nautilus cases, vvhich further supports that "substantially parallel to the longitudinal axis" is indeed definite. fYEB, Inc. v. NuVasive, Inc., 2025 US Dist. LEXIS 28680, *49-50 (S.D. Cal., Feb. 18, 2025).
It is understood by the Examiner that patents found regarding volumetric markings and circumferential witness features in manufacturing primarily relate to the production of thin-walled plastic pipettes and similar tubular devices.
Specifically, the patents reviewed address the challenge of manufacturing precise, slender pipettes (such as serological pipettes) where the mold creates "witness lines" or "witness features" (e.g., seams, circumferential markings) that can interfere with the printed graduation marks.
WO2017091540A1 - Pipette sérologique unitaire (Unitary serological pipette): Mentions that circumferential witness lines (molding lines) can serve as or interfere with volumetric markings. Therefore, witness features and volumetric markings are known to those with ordinary skill in the art.
Although claims 1-3, 5, 8, 10-11, and 34-35 are amended to specify height, width and workable ranges. It is obvious for those in the art that height, width, and length is an obvious matter of design choice. It appears that the claimed invention would perform equally well with any other geometric configuration. In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)
The range 0.25 mm to 0.5 mm of the tubular body is a workable range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Cadotte (WO2017/091540).
Cadotte teaches:
In regards to claim 1, Cadotte teaches a pipette comprising: (para [0027]; 10 fig. 1a, ‘pipette’)
a tubular body (14 fig. 1a, ‘body region’) arranged between a tip (16 fig. 1a, ‘tip region’) and a mouthpiece, (12-13 fig. 1a, ‘mouth region’, ‘mouth’) and having a longitudinal axis extending between the tip (15 fig 1a, ‘tip’) and the mouthpiece; (13 fig. 1a, ‘mouth’)
wherein the tubular body comprises a biaxially oriented thermoplastic material; (para [0031], ‘polymers such as polystyrene and polypropylene’; ‘biaxial expansion during blow molding’; 50, 42, 44, 46, 58, 64, 66 100fig. 2(a-d))
wherein the tubular body comprises a nominal thickness of no greater than 0.5 mm; and (para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
wherein any optionally present witness features, protruding from an exterior surface of the tubular body and having a maximum lengthwise dimension non-parallel to the longitudinal axis, comprise a maximum height of no greater than 0.02 mm. (Table 1, ‘these features are optional, and the dimensions can be changed.’; para [0028-0029])
Cadotte essentially discloses that the invention, however, not specifically discloses witness features comprising a maximum height of no greater than 0.02 mm.
It would have been obvious before the effective filing date of the invention, to provide witness features comprising a maximum height of no greater than 0.02 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 2, Cadotte teaches a pipette of claim 1, (see claim rejection 1) wherein the nominal thickness of the tubular body is no greater than 0.35 mm. (Cadotte: para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
Cadotte essentially discloses that the invention, however, not specifically discloses wherein the nominal thickness of the tubular body is no greater than 0.35 mm.
It would have been obvious before the effective filing date of the invention, to provide wherein the nominal thickness of the tubular body is no greater than 0.35 mm., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 3, Cadotte teaches pipette of claim 1, (see claim rejection 1) wherein the nominal thickness of the tubular body is in a range of from 0.25 mm to 0.5 mm. (Cadotte: para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
In regards to claim 4, Cadotte teaches a pipette of claim 3, (see claim rejection 3) wherein the pipette is devoid of witness features protruding from the exterior surface of the tubular body. (Cadotte: para [0040], ‘teaches witness lines may be formed, thus clearly even if implicitly disclosing that the pipette may actually be devoid of witness features.’)
In regards to claim 5, Cadotte teaches a pipette of claim3, (see claim rejection 3) wherein any optionally present witness features, protruding from the exterior surface of the tubular body (Cadotte: para [0040], ‘teaches witness lines may be formed.’) and having a maximum lengthwise dimension non-parallel to the longitudinal axis, comprise a height of no greater than 0.01 mm. (Table 1, ‘these features are optional, and the dimensions can be changed.’; para [0028-0029])
In regards to claim 6, Cadotte teaches a pipette of claim 3, (see claim rejection 3) wherein the exterior surface of the tubular body comprises a plurality of graduated markings corresponding to volumetric capacity of portions of an interior of the tubular body.( Cadotte: 10, 17 fig. 1, ‘pipette’, ‘volumetric markings’; para [0031]))
In regards to claim 7, Cadotte teaches a pipette of claim 3, (see claim rejection 3) wherein the tubular body is produced by vacuum forming. (Cadotte: para [0032]; fig(s) 3(a-c))
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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) 8-13 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Cadotte (WO2017/091540).
Cadotte teaches:
In regards to claim 8, Cadotte teaches a pipette comprising: (para [0027]; 10 fig. 1a, ‘pipette’)
a tubular body(14 fig. 1a, ‘body region’) arranged between a tip (16 fig. 1a, ‘tip region’) and a mouthpiece, (12-13 fig. 1a, ‘mouth region’, ‘mouth’) and having a longitudinal axis extending between the tip (15 fig 1a, ‘tip’) and the mouthpiece; and (13 fig. 1a, ‘mouth’)
at least three witness features protruding from an exterior surface of the tubular body, wherein each witness feature of the at least three witness features (para [0040], ‘teaches witness lines may be formed.’) has a maximum lengthwise dimension that is substantially parallel to the longitudinal axis, and is radially spaced apart from each other witness feature of the at least three witness features; (Table 1, ‘these features are optional, and the dimensions can be changed.’; para(s) [0028-0029, 0040], ‘witness lines may be formed.’)
wherein the tubular body comprises a biaxially oriented thermoplastic material, and wherein the maximum height of witness feature is no greater than 0.02 mm. (para [0031], ‘polymers such as polystyrene and polypropylene’; ‘biaxial expansion during blow molding’; 50, 42, 44, 46, 58, 64, 66 100fig. 2(a-d); para [0040], ‘Aspects where a parison is not preformed may enhance production speeds. Radial witness lines may be formed from the mold assembly segments 122 and axial witness lines may be formed from the molds contacting the mold assembly 120 on a parting line. These witness lines could be surface features that may function as volumetric markings in various pipette applications.’)
Cadotte essentially discloses that the invention, however, not specifically discloses witness features comprising a maximum height of no greater than 0.02 mm.
It would have been obvious before the effective filing date of the invention, to provide witness features comprising a maximum height of no greater than 0.02 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 9, Cadotte teaches a pipette of claim 8, (see claim rejection 8) wherein the nominal thickness of the tubular body is no greater than 0.5 mm. (Cadotte: para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
In regards to claim 10, Cadotte teaches a pipette of claim 8, (see claim rejection 8) wherein the nominal thickness of the tubular body is no greater than 0.35 mm. (Cadotte: para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
Cadotte essentially discloses that the invention, however, not specifically discloses wherein the nominal thickness of the tubular body is no greater than 0.35 mm.
It would have been obvious before the effective filing date of the invention, to provide wherein the nominal thickness of the tubular body is no greater than 0.35 mm., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 11, Cadotte teaches a pipette of claim 8, (see claim rejection 8) wherein the nominal thickness of the tubular body is in a range of from 0.25 mm to 0.5 mm. (Cadotte: para [0028], recites: ‘’body thickness 24 may each be between 0.4 mm and 1.5 mm, or between 0.6 mm and 1.0 mm, or 0.75 mm.’)
In regards to claim 12, Cadotte teaches a pipette of claim 8, (see claim rejection 8) wherein the exterior surface of the tubular body comprises a plurality of graduated markings corresponding to volumetric capacity of portions of an interior of the tubular body. (Cadotte: 10, 17 fig. 1, ‘pipette’, ‘volumetric markings’; para [0031]))
In regards to claim 13, Cadotte teaches a pipette of claim 8, (see claim rejection 8) wherein the tubular body is formed by vacuum forming. (Cadotte: para [0032]; fig(s) 3(a-c))
.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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) 34-36 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Cadotte (WO2017/091540).
Cadotte teaches:
In regards to claim 34, Cadotte teaches a pipette comprising: (para [0027]; 10 fig. 1a, ‘pipette’)
a tubular body(14 fig. 1a, ‘body region’) arranged between a tip (16 fig. 1a, ‘tip region’) and a mouthpiece, (12-13 fig. 1a, ‘mouth region’, ‘mouth’) and having a longitudinal axis extending between the tip (15 fig 1a, ‘tip’) and the mouthpiece; and (13 fig. 1a, ‘mouth’)
wherein the tubular body comprises a biaxially oriented thermoplastic material; . (para [0031], ‘polymers such as polystyrene and polypropylene’; ‘biaxial expansion during blow molding’; 50, 42, 44, 46, 58, 64, 66 100fig. 2(a-d))
wherein the tubular body comprises a nominal thickness in a range of from 0.25 mm to 0.5 mm; (Table 1, ‘these features are optional, and the dimensions can be changed.’; para(s) [0028-0029, 0040], ‘witness lines may be formed.’)
wherein any optionally present witness features, protruding from an exterior surface of the tubular body (para [0040], ‘teaches witness lines may be formed.’) and having a maximum lengthwise dimension non-parallel to the longitudinal axis, comprise a maximum height of no greater than 0.01 mm; and (Table 1, ‘these features are optional, and the dimensions can be changed.’; para(s) [0028-0029, 0040], ‘witness lines may be formed.’)
wherein the exterior surface of the tubular body comprises a plurality of graduated markings corresponding to volumetric capacity of portions of an interior of the tubular body. (para [0032]; fig(s) 3(a-c))
Cadotte essentially discloses that the invention, however, not specifically discloses witness features comprising a maximum height of no greater than 0.01 mm.
It would have been obvious before the effective filing date of the invention, to provide witness features comprising a maximum height of no greater than 0.01 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 35, Cadotte teaches a pipette of claim 34, (see claim rejection 34) wherein the nominal thickness of the tubular body is no greater than 0.35 mm. (Table 1, ‘these features are optional, and the dimensions can be changed.’; para(s) [0028-0029, 0040], ‘witness lines may be formed.’)
Cadotte essentially discloses that the invention, however, not specifically discloses wherein the nominal thickness of the tubular body is no greater than 0.35 mm.
It would have been obvious before the effective filing date of the invention, to provide wherein the nominal thickness of the tubular body is no greater than 0.35 mm., since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); Peterson 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In regards to claim 36, Cadotte teaches a pipette of claim 35, (see claim rejection 35) wherein the tubular body is produced by vacuum forming. (para [0032]; fig(s) 3(a-c))
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited Fang (CN-207546548), Albrecht (DE-102015110681), and Cadotte (WO-2016/200849) references further describe methods of providing pipettes as described by the claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C BUTLER whose telephone number is (571)270-3973. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephanie E Bloss can be reached at (571)272-3555. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.C.B/Examiner, Art Unit 2852
/STEPHANIE E BLOSS/Supervisory Primary Examiner, Art Unit 2852