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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 5/19/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Initially, the Examiner respectfully directs Applicants attention to apparent erroneous claim status identifiers, rendering the amendment apparently non-compliant. However, in the interest of compact prosecution the Examiner is examining the elected claims on the merits herein. Meanwhile, claims 4, 11, 19-35, 38, and 42 were previously cancelled in a preliminary amendment on 9/29/22 but are indicated as withdrawn on 5/19/26. Similarly, although claims 13-18, 36-37, 40-41, and 43 are withdrawn as being drawn to non-elected subject matter, the text of those claims is not present and it is unclear if Applicant may have intended to cancel them since they are indicated in the same manner as cancelled claims 4, 11, 19-35, 38, and 42. Applicant’s attention is respectfully directed thereto.
Claim Objections
Claim 12 is objected to because of the following informalities: the positive recitation of “the cutting blade is made in one piece of material” should apparently read “the cutting blade is made of one piece of material” for grammatical accuracy. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 2-3 and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 and 45 as newly amended and presented, respectively, positively recite inter alia …”the vacuum tube is a medical analysis tube having dimensions compatible with automated blood analysis equipment”. The claimed dimensionality of the vacuum tube comprises new matter that was not originally disclosed. Although the instant disclosure contemplates compatibility of medical sampling tubes with standard automated analysis equipment, the instant Specification did not disclose any “dimensions” of the vacuum tube to achieve compatibility such that it comprises new matter.
Claim 3 positively recites inter alia “an app running on a portable computer, the combination adapted for collecting a sample, wherein the portable computer is encoded with instructions to execute a verification method” further including steps of “recognizing… saving… analyzing video in real-time… and storing the video an encrypted manner…”. The claimed subject matter does not appear disclosed in the specification with any sufficient specificity to convey to one of skill in the art that possession was demonstrated. The instant Specification appears devoid of any mention of, for example at least, particular details regarding computer executable “instructions” and/or programming for a “verification method”, let alone instructions for steps of verification, recognizing, saving, or analyzing. Although some of the functionality may be cursorily mentioned (using applications on a smartphone and storing data for example), the instant Specification does not disclose with any corresponding sufficient detail, the actual required coding, or programming of computer executable instructions the accomplish the claimed computerized functionality. Conversely, the “an app running an app running on a computer, the combination adapted for collecting a sample, wherein the computer is encoded with instructions to execute a verification method” further including steps of “recognizing… saving… analyzing… and storing…” appears to be a black-box devoid of detail regarding computerized instructions while instead having a description that merely describes an accomplished functionality.
Claim Rejections - 35 USC § 112(b)
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 1-3, 5-10, 12, 44 and 45 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.
The term “non-medically trained user” in claim 1 is a relative term which renders the claim indefinite. The term “non-medically trained user” 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 instant Specification merely indicates the patient themselves may be “a non-medically trained user”. However, the degree or magnitude of non-medical training required is indeterminate. A patient completing body fluid testing must be medically fluent enough from instructions and/or medical professional advice to complete an independent blood test, rendering them at least partially trained despite an apparent lack of medical degree? The scope of the claim is unclear as to what is explicitly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “a non-medically trained user”, particularly in light of further specificity not readily apparent in the instant Specification. Depending claims 2-3, 5-10, 12, 44 and 45 inherit and do not remedy the indefiniteness.
The term “dimensions” in claim 2 is a relative term which renders the claim indefinite. The term “dimensions” 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. A standard medical analysis tube may be embodied in my relative forms, functions, and structures with relative standards that change over time, rendering the scope of the claim indeterminate and particularly in light of particular details not disclosed.
Regarding claims 7 and 10, the phrases "preferably within" and “more preferably within” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 positively recites “a cutting blade” while claim 1 positively recites “one or more cutting blades”. The scope of the claim is indeterminate with respect to the required and/or excluded relationships amongst the “a cutting blade” and the “one or more cutting blades”, rendering the claim indefinite. For the purposes of examination on the merits “a cutting blade” of claim 12 is being treated as reciting “the one or more cutting blades”.
Claim Rejections - 35 USC § 112(d)
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 44 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. Claim 44 positively recites inter alia “the vacuum tube constitutes the sample collection tube”. This fails to further limit the limitations of claim 1 when apparently less elements and/or structures are required. 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5-10, 12, 44, and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Queval (WO 2019/220340 A1)
For claim 1, Queval discloses a disposable body fluid sampling device (300) (Figs 37-42) ([0020-0158, especially 0143-0158]) inherently capable of use by a non-medically trainer user and/or a medically trained user, comprising inter alia:
a suction chamber (201) (Figs 37-42) ([0020-0158, especially 0143-0158]) configured to receive body fluid sampled from a user’s skin (Figs 37-42) ([0020-0158, especially 0143-0158]);
one or more cutting blades (206) (Figs 39) ([0020-0158]) configured to lacerate the skin of the user (Figs 7-29) ([0020-0158]), each rotatably supported within a housing of the device such that an arc traced by a tip of the cutting blade extends partially outside the housing (Figs 7-29) ([0020-0158]), wherein, with the housing in contact with the skin, each cutting blade undergoes a rotation limited by the housing such that the tip of the butting blade wounds the user’s skin without completely lacerating it, and thereafter retracts into the housing by reverse rotational movement (Figs 7-29) ([0020-0158]);
an interface (receiver for 212) configured to receive a vacuum tube (212) (Figs 37-42) ([0020-0158, especially 0143-0158]), the vacuum tube providing suction necessary to fill a sample collection tube (212) with the body fluid (Figs 37-42) ([0020-0158, especially 0143-0158]), the sample collection tube being configured for delivery to and analysis in a medical laboratory (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 2, Queval discloses the disposable body fluid sampling device of claim 1, wherein the vacuum tube is a medical analysis tube (212) having dimensions compatible with automated blood analysis equipment (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 5, Queval discloses the disposable body fluid sampling device of claim 1, having a sample containment chamber (interior of 212) made of a material having a thermal inertia permitting the maintenance of sample temperature over a known period of time (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 6, Queval discloses the disposable body fluid sampling device of claim 5, wherein the thermal inertia is selected to provide a known period of time in an ambient environment permitting non-refrigerated transport to a collection point (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 7, Queval discloses the disposable body fluid sampling device of claim 6, wherein the known period of time is inherently within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 8, Queval discloses the disposable body fluid sampling device of claim 5, including a thermally insulating sleeve (202) configured to be manually or automatically triggered to slide over the sample container chamber (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 9, Queval discloses the disposable body fluid sampling device of claim 8, wherein the thermal inertia is selected to provide a known period of time permitting non-refrigerated transport to a collection point (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 10, Queval discloses the disposable body fluid sampling device of claim 9, wherein the known period of time is inherently within a range of 1 hour to 2 hours under normal ambient conditions, and preferably within a range of 1 hour to 6 hours, and more preferably within a range of 1 hour to 8 hours (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 12, Queval discloses the one or more cutting blades made for making a laceration in the skin of a user/patient for the disposable body fluid sampling device of claim 1, wherein the cutting blade construction is made in one piece of material (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 44, Queval discloses the disposable body fluid sampling device of claim 1, wherein the vacuum tube constitutes the sample collection tube (Figs 37-42) ([0020-0158, especially 0143-0158]).
For claim 45, Queval discloses the body fluid sampling device of claim 44, wherein the vacuum tube is a medical analysis tube having dimensions compatible with automated blood analysis equipment (Figs 37-42) ([0020-0158, especially 0143-0158]).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Queval in view of Anderson (US 2019/0168210 A1).
For claim 3, Queval discloses the claimed invention, including labeled identification information on the bodily fluid sampling container ([0132-0133]) such as patient information, blood collection time and quantity, etc…, as set forth and cited above, except for expressly disclosing the portable computer and app functionality.
For claim 3, Anderson in the same field of bodily fluid sampling endeavor discloses the disposable body fluid sampling device of claim 1 combined with an app running on a portable computer (iPhone 31) (Figs 7, 12) ([0287-0307]), the combination adapted for collecting a sample (Figs 7, 12) ([0287-0307]), wherein the portable computer is encoded with instructions to execute a verification method comprising the steps of:
a) recognizing unique biometric characteristics of a user/patient and identifying the disposable body fluid sampling device (Figs 7, 12) ([0287-0307]);
b) saving a video of the user/patient and the disposable body fluid sampling device throughout the entire process using a camera of the portable computer (Figs 7, 12) ([0287-0307]);
c) analyzing the video in real time and providing instructions to the user/patient for the execution of the medical process (Figs 7, 12) ([0287-0307]); and
d) storing the video in an encrypted manner in the portable computer or in a remotely accessible database through the portable computer (Figs 7, 12) ([0287-0307]),
wherein the disposable body fluid sampling device includes at least one visible feature that visibly signals the progress of the body fluid collection process (Figs 7, 12) ([0287-0307]).
For claim 3, Queval and Anderson are both considered to be analogous to the claimed invention because they are in the same field of patient self-sampling of bodily fluid for laboratory analysis. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Queval to incorporate the teachings of Anderson to provide a computerized tracking of the sampling. Doing so would achieve the predictable result of documenting patient self-sampling of medical procedures while permitting future correlation with laboratory analysis.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 5-10, 12, 44, and 45 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 5/19/26 have been fully considered but they are not persuasive, wherein Applicant argues the following: amended claim 3 finds support in the instant disclosure and does not require source code or specific algorithms.
In response the Examiner respectfully disagrees and notes the following: indeed no source code or algorithm is required to be disclosed, however the instant Specification appears devoid of any mention of, for example at least, particular details regarding computer executable “instructions” and/or programming for a “verification method”.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights