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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 21, 2023; January 23, 2024; and August 06, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on December 21, 2023 are accepted.
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 1-14 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.
Claim 1 recites the limitation “a port formed on the holder”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 already recites, “a port” in line 3. It is unclear if they are the same. It is interpreted that they are the same and the claim in intended to read, “wherein the lancet is connected to the holder via the port”. Claim 8 has the same issues.
The term “substantially similar” in claims 7 and 14 is a relative term which renders the claim indefinite. The term “substantially similar” 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. It is not clear to what degree of similar sizing is defined.
The dependent claims are rejected as depending on a rejected claim.
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 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 1-4, 6-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ivosevic et al. (US 2019/0216380 A1) (“Ivosevic”).
Regarding claim 1, Ivosevic discloses A device for obtaining a blood sample, the device comprising (Abstract and entire document):
a holder for receiving a sample source, the holder having an actuation portion and a port (See at least FIG. 1-9 and associated paragraphs showing holder 12 for receiving finger 19 and see [0060], “A holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 5), an actuation portion 24, a port 26 having a second opening 28,”); and
a lancet removably connected to the holder (See at least FIG. 1-9 and associated paragraphs. See [0062], “a lancet housing 14” and [0074], “Referring to FIGS. 8-10, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12.”),
wherein the lancet is connected to the holder via a port formed on the holder (See at least FIG. 1-9 and associated paragraphs. See [0074], “Referring to FIGS. 8-10, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12.”), and
wherein an opening defined by the port is dimensioned so as to receive the lancet at at least one of a predetermined location and orientation that ensures a desired puncture on a patient's finger lanced by the lancet (See at least FIG. 1-9 and associated paragraphs. Opening 28 defined by port 26 is capable of receiving lancet 14, see [0060] the holder 12 is designed to hold finger 19 at a position aligned with the opening 28 defined by the port 26 and dimensioned to receive the lancet 14 at a location and orientation, ensuring a desired puncture as defined by the location and orientation).
Regarding claim 2, Ivosevic discloses The device of claim 1, wherein a lancing end of the lancet has a diameter that is smaller than a diameter of the opening defined by the port (FIG. 8, opening 50 of lancet 14 has a smaller diameter than opening 28 of port 26).
Regarding claim 3, Ivosevic discloses The device of claim 1, wherein the port and the lancet has corresponding design features that visually identify to a user a proper orientation for inserting the lancet into the port (FIG. 9 and [0074], “Referring to FIG. 9, in one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12.”).
Regarding claim 4, Ivosevic discloses The device of claim 3, wherein the corresponding design features comprise corresponding ribs located on the port and the lancing end of the lancet (FIG. 8-9 and [0074], “In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26.”).
Regarding claim 6, Ivosevic discloses The device of claim 1, wherein the opening defined by the port is dimensioned to ensure the lancet is inserted into the port a sufficient distance to puncture the patient's finger (FIG. 8-9 and [0054] and [0062], the opening 28 of port 26 is dimensioned for securely receiving the lancet housing 14 ensuring proper blood collection).
Regarding claim 7, Ivosevic discloses The device of claim 1, wherein a diameter of the opening defined by the port and a diameter of a lancing end of the lancet are substantially similar (FIG. 8-9 and [0073 – 0074], the diameter of opening 28 of port 26 and the diameter of opening 50 of lancet 14 are substantially similar and are mated).
Regarding claim 8, Ivosevic discloses A device for obtaining a blood sample, the device comprising (Abstract and entire document):
a holder for receiving a sample source, the holder having an actuation portion and a port (See at least FIG. 1-9 and associated paragraphs showing holder 12 for receiving finger 19 and see [0060], “A holder 12 of the present disclosure generally includes a finger receiving portion 20 having a first opening 22 (FIG. 5), an actuation portion 24, a port 26 having a second opening 28,”);
a lancet removably connected to the holder (See at least FIG. 1-9 and associated paragraphs. See [0062], “a lancet housing 14” and [0074], “Referring to FIGS. 8-10, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12.”); and
a collection container removably connected to the holder (See at least FIG. 1-9 and associated paragraphs, collection container 16 see [0080] discussing removably connected),
wherein the lancet is connected to the holder via a port formed on the holder (See at least FIG. 1-9 and associated paragraphs. See [0074], “Referring to FIGS. 8-10, in one embodiment, with the holder 12 and the lancet housing 14 being separate components, the lancet housing 14 is removably connectable to the port 26 of the holder 12.”), and
wherein an opening defined by the port is dimensioned so as to receive the lancet at at least one of a predetermined location and orientation that ensures a desired puncture on a patient's finger lanced by the lancet (See at least FIG. 1-9 and associated paragraphs. Opening 28 defined by port 26 is capable of receiving lancet 14, see [0060] the holder 12 is designed to hold finger 19 at a position aligned with the opening 28 defined by the port 26 and dimensioned to receive the lancet 14 at a location and orientation, ensuring a desired puncture as defined by the location and orientation).
Regarding claim 9, Ivosevic discloses The device of claim 8, wherein a lancing end of the lancet has a diameter that is smaller than a diameter of the opening defined by the port (FIG. 8, opening 50 of lancet 14 has a smaller diameter than opening 28 of port 26).
Regarding claim 10, Ivosevic discloses The device of claim 8, wherein the port and the lancet has corresponding design features that visually identify to a user a proper orientation for inserting the lancet into the port (FIG. 9 and [0074], “Referring to FIG. 9, in one embodiment, the lancet housing 14 is pushed into the port 26 of the holder 12 such that the engagement portion 56 of the lancet housing 14 is locked within the locking portion 32 of the holder 12.”).
Regarding claim 11, Ivosevic discloses The device of claim 10, wherein the corresponding design features comprise corresponding ribs located on the port and the lancing end of the lancet (FIG. 8-9 and [0074], “In some embodiments, the port 26 of the holder 12 includes a plurality of ribs for securing and locking the lancet 14 or the collection container 16 in the port 26.”).
Regarding claim 13, Ivosevic discloses The device of claim 8, wherein the opening defined by the port is dimensioned to ensure the lancet is inserted into the port a sufficient distance to puncture the patient's finger (FIG. 8-9 and [0054] and [0062], the opening 28 of port 26 is dimensioned for securely receiving the lancet housing 14 ensuring proper blood collection).
Regarding claim 14, Ivosevic discloses The device of claim 8, wherein a diameter of the opening defined by the port and a diameter of a lancing end of the lancet are substantially similar (FIG. 8-9 and [0073 – 0074], the diameter of opening 28 of port 26 and the diameter of opening 50 of lancet 14 are substantially similar and are mated).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ivosevic et al. (US 2019/0216380 A1) (“Ivosevic”) in view of Strong et al. (US 5324303 A) (“Strong”).
Regarding claims 5 and 12, Ivosevic discloses The device of claim 3/10, Ivosevic fails to disclose wherein the corresponding design features comprise a material used by the port and the lancing end of the lancet that has a same color.
However, in the same field of endeavor, Strong teaches wherein the corresponding design features comprise a material used by the port and the lancing end of the lancet that has a same color (FIG. 14-15, and claim 18, “said plastic material of which said lancet and cap are made, having color corresponding to the thickness of the ring of the cap, thereby making it possible to know the depth of penetration allowed by said ring as a function of said color and thus to determine whether said combined lancet and multi-function cap is suitable for a given patient,”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device as taught by Ivosevic to include wherein the corresponding design features comprise a material used by the port and the lancing end of the lancet that has a same color as taught by Strong to match corresponding colors to indicate location, orientation, size (See claim 18, “said plastic material of which said lancet and cap are made, having color corresponding to the thickness of the ring of the cap, thereby making it possible to know the depth of penetration allowed by said ring as a function of said color and thus to determine whether said combined lancet and multi-function cap is suitable for a given patient,”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH A TOMBERS/Examiner, Art Unit 3791