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 .
Claim Objections
Claim 19 is objected to because of the following informalities:
Claim 19 line 3 “a concavo-convex manner in the second direction” is suggested to read “the concavo-convex manner in the second direction” for better antecedent basis.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “movable member” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leskowich et al. (US PGPub 2016/0331292), hereinafter known as “Leskowich.”
With regards to claim 1, Leskowich discloses (Figures 1-8) an infant lancet assembly (figure 1) comprising: a housing 1/2; and a lancet 8/9, a movable member 6 (see Note below), and a compression coil spring 7 capable of biasing the movable member 6 in a predetermined first direction (paragraph 100), each of which is accommodated in the housing 1/2, wherein the housing 1/2 comprises:
a housing first portion (top half of 1/2) having a longitudinal side extending in the first direction (horizontally); and a housing second portion (bottom half of 1/2) having a longitudinal side extending in a second direction (vertically) from a side of the housing first portion (top half of 1/2), the second direction being perpendicular to the first direction (see figures 2-7 where the movable member 6 moves horizontally, and the lancet 8/9 moves vertically),
the lancet 8/9 comprises a lancet body 8 and a blade 9 attached to the lancet body 8 (paragraph 100),
the lancet body 8 includes: a body first portion (top half of 8 where pivot 15 is attached to the movable member 6) provided to be movable together with the movable member 6; and a body second portion (bottom half of 8 that’s fixed to the blade 9) that is engageable with the housing second portion (bottom half of 1/2) in a concavo-convex manner in the first direction (paragraph 100), and
the movable member 6 comprises: a movable member first portion (top half of 6 that is fixed to the pivot 5) that is movable in the first direction and is engageable with the housing first portion (top half of 1/2) in a concavo-convex manner in the second direction; and a movable member second portion (bottom half of 6 that is attached to the pivot 15 of the lancet body 8) on which the body first portion (top half of 8) is disposed in an axially rotatable manner (paragraph 100).
Note – 112(f) interpretation – Applicant’s movable member is a structure (figures 7-8) that has a protruding portion 440 and is connected to the lancet body for movement therewith (spec. [0032-0035]); Leskowich’s movable member is a lever arm 6 that has a protruding portion (see figure 1) and is connected to the lancet body for movement therewith (paragraph 100); therefore both movable members are equivalent in moving with the lancet body.
With regards to claim 2, Leskowich discloses wherein the housing first portion (top half of 1/2) and the housing second portion (bottom half of 1/2) are arranged to form a T-shape (see figures 3-4 – housing portions form a T shape when arranged together in connection with the blocking push-button 4 which is in a shape of a T).
With regards to claim 3, Leskowich discloses wherein a width dimension of the housing second portion (bottom half of 1/2) in the first direction (horizontally) is a dimension with which the body second portion (bottom half of 8) is slidable in the second direction (vertically) with respect to the housing second portion (bottom half of 1/2) (transition from figure 5 to figure 6; paragraph 108).
With regards to claim 4, Leskowich discloses wherein a width dimension of the housing first portion (top half of 1/2) in the second direction (vertically) is a dimension with which the movable member first portion (top half of 6) is slidable in the first direction (horizontally) with respect to the housing first portion (top half of 1/2) (transition from figures 5 to figure 6 to figure 7; paragraph 108).
With regards to claim 5, Leskowich discloses wherein one of the movable member first portion (top half of 6) is a protruding portion, and the other (housing first portion – top half of 1/2) is a recessed portion (see figure 1 where top half of 6 comprises a protruding element in which the dotted lines connect the protruding portion to the recess in the housing first portion).
With regards to claim 6, Leskowich discloses wherein one of the body second portion (bottom half of 8) is a protruding portion, and the other (housing second portion – bottom half of 1/2) is a recessed portion (see figure 1 where bottom half of 8 comprises a protruding element which connects to the recess in the housing second portion as seen in figures 2-7).
With regards to claim 7, Leskowich discloses wherein, when the movable member 6 moves in the first direction (horizontally), the body first portion (top half of 8) is movable in the first direction (horizontally) together with the movable member 6 (figures 4-7; paragraph 100), whereas movement of the body second portion (bottom half of 8) in the first direction (horizontally) is restricted by the housing second portion (bottom half of 1/2).
With regards to claim 8, Leskowich discloses wherein, between the body second portion (bottom half of 8) and the housing second portion (bottom half of 1/2), the protruding portion of the body second portion (bottom half of 8) is capable of coming into contact with an inner surface 10 (figure 3) forming the recessed portion of the other one of the housing second portion (bottom half of 1/2), which enables movement of the body second portion (bottom half of 1/2) in the first direction (horizontally) to be restricted (paragraph 100).
With regards to claim 9, Leskowich discloses wherein, when the movable member 6 moves in the first direction (horizontally), movement of the movable member first portion (top half of 6) in the second direction (vertically) is restricted by the housing first portion (top half of 1/2) (paragraphs 100 and 108).
With regards to claim 10, Leskowich discloses wherein, between the movable member first portion (top half of 6) and the housing first portion (top half of 1/2), the protruding portion of the movable member first portion (top half of 6) is capable of coming into contact with an inner surface forming the recessed portion (inner surface of the pivot 5 as seen in figures 1 and 3) of the other one of the housing first portion (top half of 1/2), which enables movement of the movable member first portion (top half of 6) in the second direction (vertically) to be restricted (paragraphs 100 and 108).
With regards to claim 11, Leskowich discloses wherein movement of the body second portion (bottom half of 8) in the first direction (horizontally) is restricted, to make the body first portion (top half of 8) axially rotatable with respect to the movable member 6 (paragraph 100 – “By a movable pivot 15 on the support arm 8, the lever arm 6 is rotatably coupled with the support arm 8”).
With regards to claim 12, Leskowich discloses wherein, when the movable member 6 moves in the first direction (horizontally), the body first portion (top half of 8) is movable in the first direction (horizontally) together with the movable member 6, and the body second portion (bottom half of 8) is movable in the second direction (vertically) (paragraphs 100 and 108; see transition from figure 5 to figure 6 to figure 7).
With regards to claim 13, Leskowich discloses wherein the longitudinal side of the housing second portion (bottom half of 1/2) comprises a first end proximal to the housing first portion (top half of 1/2) and a second end distal to the housing first portion (top half of 1/2), and the body second portion (bottom half of 8) is located between the first end and the second end of the housing second portion (bottom half of 1/2) before the movable member 6 starts moving in the first direction (horizontally) (figures 3 and 5, see where bottom half of 8 is between the first end (top) of the guide 10 and the second end (bottom) of the guide 10).
With regards to claim 14, Leskowich discloses wherein, when the movable member 6 moves in the first direction (horizontally), the body second portion (bottom half of 8) moves from a side of the first end to a side of the second end, and subsequently moves from the second end side to the first end side (see figure 3 and transition from figure 5 to figure 6 to figure 7 - bottom half of 8 moves between the first end (top) of the guide 10 and the second end (bottom) of the guide 10).
With regards to claim 15, Leskowich discloses wherein the housing 1/2 comprises an opening portion through which the blade 9 is able to protrude, and, when the body second portion (bottom half of 8) is located on a side of the second end, the blade 9 is able to protrude outward through the opening portion of the housing 1/2 (figure 6; paragraph 108).
With regards to claim 16, Leskowich discloses wherein the blade 9 is accommodatable in the housing 1/2 when the body second portion (bottom half of 8) is located between the first end and the second end of the longitudinal side of the housing second portion (bottom half of 1/2) (figures 3 and 5, see where bottom half of 8 is between the first end (top) of the guide 10 and the second end (bottom) of the guide 10; figure 7; paragraph 109).
With regards to claim 17, Leskowich discloses wherein the housing 1/2 comprises two or more housing first portions (top half of 1 and top half of 2) that have a longitudinal side extending in the first direction (horizontally) and are spaced apart from and facing each other (figure 1), and the movable member 6 is engageable with the two or more housing first portions (top half of 1 and top half of 2) in a concavo-convex manner (paragraph 100; figures 1-2 and 5).
With regards to claim 18, Leskowich discloses wherein the housing 1/2 comprises a first sub housing 1 and a second sub housing 2, each of the first sub housing 1 and the second sub housing 2 comprises the housing first portion (top half of 1 and top half of 2) and the housing second portion (bottom half of 1 and bottom half of 2), and respective housing first portions (top half of 1 and top half of 2) in the first sub housing 1 and the second sub housing 2 are disposed to be able to face each other and respective housing second portions (bottom half of 1 and bottom half of 2) in the first sub housing 1 and the second sub housing 2 are disposed to be able to face each other, at least (figures 1-2 and 5).
With regards to claim 19, Leskowich discloses wherein the housing 1/2 further comprises a housing third portion (middle portion of 1/2 that comprises the arc of the guide 10) that is engageable with the body first portion (top half of 8) in a concavo-convex manner in the second direction (vertically) (paragraphs 100 and 108 – see transition from figure 5 to figure 6 to figure 7 – top half of 8 moves in a net vertical motion from a top of the arc of the guide 10 to a bottom of the arc of the guide 10).
With regards to claim 20, Leskowich discloses wherein the body first portion (top half of 8) is disposable in a same row on each of two facing principal surfaces of the lancet body 8 (figures 1 and 5-7 – body first portion is interpreted as the entire top half of the lancet body 8 (including the front and back side), and therefore is disposable on the same row of each of the two facing principal surfaces (front and back side) of the lancet body 8 due to being interpreted as the whole top half of 8).
With regards to claim 21, Leskowich discloses wherein the body second portion (bottom half of 8) is disposable in a same row on each of two facing principal surfaces of the lancet body 8 (figures 1 and 5-7 – body second portion is interpreted as the entire bottom half of the lancet body 8 (including the front and back side), and therefore is disposable on the same row of each of the two facing principal surfaces (front and back side) of the lancet body 8 due to being interpreted as the whole bottom half of 8).
Claims 1 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mawhirt (US Patent 6,221,089).
With regards to claim 1, Mawhirt discloses (Figures 1-3B) an infant lancet assembly 10 (figure 1A) comprising: a housing 12; and a lancet 42, a movable member 40 (see Note below), and a compression coil spring 36 capable of biasing the movable member 40 in a predetermined first direction (Col 4 lines 37-64), each of which is accommodated in the housing 12, wherein the housing 12 comprises:
a housing first portion (see annotated figure 3A below) having a longitudinal side extending in the first direction (horizontally); and a housing second portion (see annotated figure 3A below) having a longitudinal side extending in a second direction 84 (vertically) from a side of the housing first portion, the second direction 84 being perpendicular to the first direction (see figures 3A-3B where the movable member 40 moves horizontally, and the lancet 42 moves vertically),
the lancet 42 comprises a lancet body (body 42 proximal of the tip) and a blade (distal tip of 42) attached to the lancet body 42,
the lancet body 42 includes: a body first portion (top half of 42) provided to be movable together with the movable member 40; and a body second portion (bottom half of 42) that is engageable with the housing second portion (see annotated figure 3A below) in a concavo-convex manner 82 in the first direction (Col 4 lines 37-64), and
the movable member 40 comprises: a movable member first portion (top half of 40) that is movable in the first direction and is engageable with the housing first portion (see annotated figure 3A below) in a concavo-convex manner 80 in the second direction; and a movable member second portion (bottom half of 40) on which the body first portion (top half of 42) is disposed in an axially rotatable manner (Col 4 lines 37-64).
Note – 112(f) interpretation – Applicant’s movable member is a structure (figures 7-8) that has a protruding portion 440 and is connected to the lancet body for movement therewith (spec. [0032-0035]); Mawhirt’s movable member is an arm link 40 that is connected to the lancet body 42 for movement therewith (Col 4 lines 37-64); therefore both movable members are equivalent in moving with the lancet body.
PNG
media_image1.png
452
639
media_image1.png
Greyscale
With regards to claim 22, Mawhirt discloses wherein the movable member 40 further comprises a flexible portion 56 (Col 3 lines 15-18 – “the lancet device 10 comprises a housing 12 molded from any suitable plastic. The housing 12 encloses a blade triggering mechanism”; Col 3 lines 64-66 – “The blade holder/follower 40 of the blade triggering mechanism 38 has a detent or notch 56 at a first end 52 thereof” – therefore since the housing 12 is molded from any suitable plastic and encloses the blade triggering mechanism 38 which comprises of the movable member 40 and the detent 56, the detent 56 is interpreted to be a flexible portion due to being molded from any suitable plastic) the infant lancet assembly 10 further comprises a trigger 14 capable of coming into contact with the flexible portion 56, the flexible portion 56 of the movable member 40 and a predetermined portion of the housing 12 are capable of being locked with each other before use (figure 3A), and the trigger 14 comes into contact with the flexible portion 56 upon a start of use, to be able to release locking between the flexible portion 56 and the predetermined portion of the housing 12 (figure 3B; Col 3 line 64 – Col 4 line 64).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMMED S ADAM/
Examiner, Art Unit 3771 07/10/2026
Prosecution Insights