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 .
This Office action is responsive to an amdment filed February 27, 2023. Claims 1-20 are pending. Claims 1-20 have been amended. Claims 21-27 have been canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "102" and "103" have both been used to designate the docking arm (see at least par 0091 & 0130). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “103” has been used to designate both a docking arm (see par 0130) and a docking structure (see par 0095). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "3" and "5" have both been used to designate support base. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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: “one or more alignment aide for enabling a visual and/or physical alignment with at least one cutting mechanism” in claim 10. The limitations “aide” is a generic placeholder that is coupled with functional language such as “enabling a visual and/or physical alignment with at least one cutting mechanism,” without sufficient structure. The original specification describes fins, at least one clamp, (see par 0121). The limitations “a flexible catch for temporarily engaging the receptacle and maintaining a one of the open, closed and/or partially closed configurations” in claim 17. The limitations “catch” is a generic placeholder coupled with a function “engaging the receptacle and maintaining a one of the open, closed and/or partially closed configurations.” The Original specification describes a flexible protrusion (see par 0111 & 0127-0128).
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 Objections
Claims 1-11 & 13 is/are objected to because of the following informalities:
The claims are objected to because they include reference characters (“X” such as “longitudinal axis X” at line 4 of claim 1) which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 27, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 9, 13, 16 & 20 is/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.
In regards to claim 9, the limitations “wherein the receptacle has two angled projections and/or the one or two projections define an angle (A) relative to the longitudinal axis X measuring between 10-40 degrees” render the claim indefinite; for example, it is unclear whether the receptacle includes two angled projections because the language alternatively recites that the one projection defines an angle (A) relative to the longitudinal axis X measuring between 10-40 degrees, without first requiring two angled projections.
In regards to claim 13, at line 2, the limitations “a base” renders the claim indefinite; for example, since the claim depends from claim 1, which recites “a support base” at line 3 thereof, it is unclear whether the limitations “a base” refers to the “support” of claim 1. For examination purposes, the term “a base” has been construed as referring to --a docking base-- consistent with the instant specification.
In regards to claim 16, at lines 2-3, the limitations “the top surface engagement structure” lack sufficient antecedent basis.
In regards to claim 20, at line 3, the limitations “the aperture” lack sufficient antecedent basis.
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) 1-5 & 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorrels (US 2003/0056274).
In regards to claim 1, Sorrels discloses a finger receptacle comprising:
an elongated, flexible sleeve 20 having a length defined between a proximal end and a distal end, the sleeve 20 further comprising a support base 40, a ceiling 34 and a top surface having a longitudinal axis X (see at least figs. 1-2 & 5 and par 0040-0041), whereby the sleeve 20 is adapted to bias toward a radially contracted state and when urged into a radially expanded state effects a radial compression action about the length to releasably secure a finger within the receptacle (see at least par 0047); and
at least one angled projection 36 extending from the ceiling 34 and top surface at the distal end of the sleeve 20 (see at least figs. 2 & 5), the at least one angled projection 36 angled inwardly from the longitudinal axis X of the ceiling 34 and adapted to contact a nail 38 of the finger releasably secured in the sleeve 20 at the distal end of the receptacle to affect a second compression action (see at least par 0021 & 0040).
In regards to claim 2, Sorrels discloses the finger receptacle according to claim 1, wherein the base and the ceiling 34 of the receptacle are flexibly connected by sides of the sleeve 20 (see at least figs. 5 & 7 and par 0011, 0013-0014, 0017-0019 & 0045).
In regards to claim 3, Sorrels discloses the finger receptacle according to claim 1, wherein the base 40 and ceiling 34 are connected by sides defining a flexible (see at least figs. 5 & 7 and par 0011, 0013-0014, 0017-0019 & 0045).
In regards to claim 4, Sorrels discloses the finger receptacle according to claim 2, wherein the base, the ceiling 34, and the sides of the sleeve 20 are integrally formed (see at least figs. 5 & 7 and par 0011, 0013-0014, 0017-0019 & 0045).
In regards to claim 5, Sorrels discloses the finger receptacle according to claim 1, wherein the distal end of the sleeve 20 comprises a flared edge or an outwardly-curved perimeter (see at least figs. 2, 5 & 7).
In regards to claim 8, Sorrels discloses the finger receptacle according to claim 1, wherein sides of the receptacle define a window or cutaway (i.e., undercut) toward the distal end of the sleeve 20, the window configured to visibly frame or part frame an optimal incision area 44 (see at least fig. 6-9 and par 0041 & 0070).
In regards to claim 9, Sorrels discloses the finger receptacle according to claim 1, wherein the receptacle the one projection 36 define an angle (A) relative to the longitudinal axis X measuring between 10-40 degrees (see at least figs. 2 & 5).
In regards to claim 10, Sorrels discloses the finger receptacle according to claim 1, further comprising one or more alignment aide (i.e., shape at fingertip or color of protective portion) capable of enabling a visual and/or physical alignment with at least one cutting mechanism (i.e., shape at a fingertip tip end of the guard allows pad 44 of medical practitioner to remain uncovered, see par 0041; material that forms protective portion 46 of guard 20 may be dyed a different color than the material that forms less protective portion 48, see par 0049) (see at least figs. 1-2, 5 & 7 and par 0041 & 0049).
In regards to claim 11, Sorrels discloses the finger receptacle according to claim 10, wherein the alignment aide (i.e., shape at fingertip or color of protective portion) facilitates a connection with one or more cutting tools (i.e., a lancet or other cutting tools may be positioned to pierce the dorsal side of the finger in the guard 20) (see at least figs. 1-2, 5 & 7 and par 0041 & 0049).
Claim(s) 12 & 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Matsumoto (JP 2005-131009).
In regards to claim 12, Matsumoto discloses a finger holding device comprising:
a (docking) base 30;
an elongate docking structure 3 comprising a docking arm 31 and docking foot (see at least figs. 1-2 & 19-21);
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a finger receptacle 40, for finger compression, wherein the docking arm 31 is engaged with the finger receptacle 40 and movable there along, such that the device has a closed configuration (see at least fig. 1) in which the receptacle 40 is aligned alongside the docking arm 31 and rests adjacent the docking foot and an open configuration (see at least fig. 2) in which the receptacle 40 extends from the docking arm 31 and is non-adjacent the docking foot (see at least figs. 1-2 & 19-21); and
an attachment interface 50 associated with the base 30 for releasably mounting an interchangeable collector attachment 22 to the device (see at least figs. 1-2, 5-7 & 19-21).
In regards to claim 14, Matsumoto discloses the finger holding device of claim 12 wherein the device further comprises an interchangeable collector attachment 22, wherein the collector attachment 22 is adapted to temporarily secure one or more fluid collectors 23 to the device (“the accommodating portion 22 is for holding the lancet body 20 and the biosensor 23,” “the blood B moves inside the capillary 23d by the capillary force generated in the capillary 23d [of the biosensor 23],” see machine translation) (see at least figs. 5-7, 10, 13-15 & 20).
In regards to claim 15, Matsumoto discloses the finger holding device according to claim numbered 12, wherein the docking arm 31 is engaged with a top surface engagement structure of the finger receptacle 40 and is slidable there along to facilitate movement of the device between the open (see fig. 2), closed (see fig. 1), and/or partially closed configurations (see at least fig. 1).
In regards to claim 16, Matsumoto discloses the finger holding device according to claim 12, wherein the docking arm 31 comprises a channel (i.e., groove) for receiving the top surface engagement structure of the finger receptacle 40 (i.e., “[t]he housing 30 accommodates various elements… and pair of guide portions 31 are provided…Each guide portion 31 is formed as a groove extending in the directions of arrows N’ and N”,” see machine translation) (see fig. 2).
In regards to claim 17, Matsumoto discloses the finger holding device according to claim 12, wherein the docking arm 31 further comprises a flexible catch (i.e., groove) for temporarily engaging the receptacle 40 and maintaining a one of the open, closed and/or partially closed configurations (i.e., “[t]he housing 30 accommodates various elements… and pair of guide portions 31 are provided…Each guide portion 31 is formed as a groove extending in the directions of arrows N’ and N”,” see machine translation) (see fig. 2).
In regards to claim 18, Matsumoto discloses the finger holding device according to claim 12, wherein the base 30 defines an inner compartment partially defining a fluidic pathway 23d within the device (i.e., “the blood B moves inside the capillary 23d by the capillary force generated in the capillary 23d [of the biosensor 23],” see machine translation) (see at least figs. 1 & 20).
In regards to claim 19, Matsumoto discloses the finger holding device according to claim 18, wherein the base 30 further comprises an aperture 53 connecting the fluidic pathway 23d from the inner compartment to the collector attachment 22 (i.e., “the blood B moves inside the capillary 23d by the capillary force generated in the capillary 23d [of the biosensor 23],” see machine translation) (see at least figs. 1-2 & 20).
In regards to claim 20, Matsumoto discloses the finger holding device according to claim 12, wherein the collector attachment 22 is slidable relative to the base 30 to selectively block the aperture 53 (“[a]s shown in FIGS. 2 and 3, the opening 53 is used when the lancet 2 is inserted, and has a notch 53 a. The notch 53a is for engaging a convex portion 22C of the lancet 2…,” see machine translation) (see at least figs. 1-2).
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sorrels (US 2003/0056274) in view of Geyer et al. (US 2007/0226866) (“Geyer” hereinafter).
In regards to claim 6, Sorrels discloses the finger receptacle according to claim 1, that fails to explicitly teach a finger receptacle wherein the top surface comprises an elongated ridge, centrally aligned with the axis X and having one, two, or three cutaway or recessed sections formed therein. However, Geyer teaches that it is known to provide a finger receptacle wherein the top surface comprises an elongated ridge 21, centrally aligned with the axis X and having one, two, or three cutaway or recessed sections 10 formed therein (see at least figs. 1 & 2A-B and par 0043-0051). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the finger receptacle of Sorrels wherein the top surface comprises an elongated ridge, centrally aligned with the axis X and having one, two, or three cutaway or recessed sections formed therein as taught by Geyer since such a modification would amount to applying a known technique (i.e., as taught by Geyer) to a known device (i.e., as taught by Geyer) ready for improvement to achieve a predictable result such as providing a reinforcing element that provides a high degree of stiffness and allows bending in a longitudinal direction but blocks bending in a lateral direction (see at least par 0015 & 0046-0047 of Geyer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 7, Sorrels discloses the finger receptacle according to claim 1, that fails to explicitly teach a finger receptacle wherein the top surface defines an engagement structure, extending along a length thereof. However, Geyer teaches that it is known to provide a finger receptacle wherein the top surface defines an engagement structure 1, extending along a length thereof (see at least figs. 1 & 2A-B and par 0043-0051). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the finger receptacle of Sorrels wherein the top surface defines an engagement structure, extending along a length thereof as taught by Geyer since such a modification would amount to applying a known technique (i.e., as taught by Geyer) to a known device (i.e., as taught by Geyer) ready for improvement to achieve a predictable result such as providing a reinforcing element that provides a high degree of stiffness and allows bending in a longitudinal direction but blocks bending in a lateral direction (see at least par 0015 & 0046-0047 of Geyer)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sorrels (US 2003/0056274).
Although Sorrels discloses a finger receptacle having a single angled projection 36 define an angle (A) relative to the longitudinal axis X measuring between 10-40 degrees (see at least figs. 2 & 5), Sorrels discloses the finger receptacle according to claim 1, wherein the receptacle has two angled projections. However, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the finger receptacle of Sorrels with two or more angled projections as claimed in order to limit an insertion depth of the protective guard on a user’s finger and inhibit protective guard from sliding up the finger during use (see at least par 0040 of Sorrels).
Allowable Subject Matter
Claim 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6,213,952 to Finarov et al. discloses an optical device for non-invasive measure of blood related signals utilizing a finger holder.
US 2018/0077978 to Destro et al. discloses a finger guard.
CN 111248925 to Zhao et al. discloses a finger for blood collecting puncture device.
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/RENE T TOWA/Primary Examiner, Art Unit 3791