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 04/29/2025, 12/10/2024, and 03/06/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “configured automatically” in line 4 should be amended to read –configured to automatically--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “theone” in line 7 should be amended to read –the one--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the phrase “is” in line 2 should be amended to read –in--. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: the phrase “a physiological sample” in lines 5-6 should be amended to read –the physiological sample--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: the phrase “whole” in line 2 should be amended to read –while--. Appropriate correction is required.
Claim 18 objected to because of the following informalities: the phrase “a portion” in line 1 should be amended to read –the portion--. 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:
Limitation “mechanism for maintaining” in claim 8, the claim does not recite enough structure that corresponds to the claimed “mechanism” to perform the claimed function. The specification does not disclose any structure that corresponds to the claimed “mechanism”.
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 § 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 1-26 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.
Claim 8 recite the limitation “mechanism for maintaining” this limitation is not defined by the claim, which renders the claims indefinite. One with ordinary skill in the art would not be able to know what structural elements the claimed “mechanism” may or may not include. As broadly as claimed the scope of the claim is indeterminate with respect to the claimed. The Examiner respectfully notes, for the purpose of examination the term “mechanism” will be interpreted as any structure capable of holding/moving the spring.
Claim 1 recites the limitation "the skin” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the skin" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-3, 5-8, 12-16 and 19 is/are rejected under 35 U.S.C. 103 as being obvious over Groll et al (US 2010/0198107) in view of Beyerlein et al (US 2019/0000365).
As to claims 1 and 12, Groll teaches a system and method for obtaining a physiological sample from a subject (meter device 10 and/or 110 collect blood from a user, abstract, par.37 and par.44, fig.1-7), affixing a cartridge (affixing test strip 30 that is inserted into opening 13 in housing 11 with the skin of the user as best seen in fig.1, and/or test strip inserted into opening 113 in housing 111, par.38-41, fig.1-7) of the system/device to the skin of a subject,
a lancet includes one or more needles configured to puncture the subject's skin (housing 11 with lancet 20, wherein lancet 20 includes multiple lancets that extends upon firing to puncture subject's skin, par.38-39, and/or housing 111 with lancet 120, par.45, fig.1-7),
wherein engaging the lancet with the cartridge automatically moves the one or more needles from an undeployed position to a deployed position thereby drawing a physiological sample (test strip 30 is inserted into opening 13 and causes tip 21 to extend from housing 11, lancing device 20 is primed and fired only after the test strip 30 is inserted, end of par.39 and par.41, and tip 121 extends automatically upon insertion of a test strip into opening 113, end of par.44-45, fig.1-7).
Groll teaches the invention substantially as claimed above, but failed to explicitly teach the sampling system/device is a dermal patch. However, Beyerlein teaches an analogous lancet device for blood/fluid sampling (abstract, fig.1-3), wherein the device an be attached to the skin with an aid of adhesive (par.15, par.163).
As skin adhesive/dermal patches sampling device are well-known in the art, so it would have been obvious to one having an ordinary skill in re art before the effective filing date of the invention to include an adhesive to housing 11 of meter 10 and/or at the end of lancet 20 taught by Groll’s invention, as taught by Beyerlein’s invention, to securely attach the sampling device to the skin to ease the sampling process by create an airtight hermetic seal, as taught by Beyerlein’s invention (par.15 and par.163).
As to claims 2 and 13, Groll teaches the system and method, wherein the cartridge is configured to store the drawn physiological sample (sampled blood is stored/maintained in test strip 30, par.41, as best seen in fig.1).
As to claims 3 and 19, Groll teaches the system and method, wherein the one or more needles includes two needles (device may include at least two lancets located at least partially within the housing, par.7, containing multiple lancets located in lancing device 20, par.38, fig.1-7).
As to claim 5, Groll teaches the system, wherein the lancet includes a housing (housing 11 in fig.1-4 and/or housing 111 in fig.5-7), and the one or more needles are disposed within the housing when in the undeployed position and extend beyond the housing when in the deployed position (lancing device located at least partially within the housing and including a lancet movable from a first position located at least partially within the housing to a second position located at least partially outside the housing, par.7, lancing device 20 including the multiple needles is at least partially located in housing 11 and partially extends therefrom, par.38, lancing device 20 is inserted into housing 11 before firing, as best seen in fig.3-4, and extending beyond housing 11 after firing, as best seen in fig.1-2, par.38-39).
As to claims 6 and 15, Groll teaches the system and method, wherein the one or more needles are configured to automatically retract into the housing after puncturing the skin (lancing device for movement from the first position to the second position and back to the first position, par.7, After firing, the lancet moves back into tip 21 so as to prevent the user or others from accidentally contacting the used lancet, par.39).
As to claims 7 and 16, Groll teaches the system and method, wherein the lancet further includes: an injection spring configured to move the one or more needles to the deployed position (inherently the firing spring the fires lancet 20 out of housing 11, par.36-40), and a retraction spring (inherently the retracting spring the automatically returns lance 20 into housing 11 after firing, par.7 and par.39) configured to retract the one or more needles into the housing (Examiner respectfully notes, the firing mechanism includes various linear and/or rotary mechanisms, such as springs (linear, leaf, rotational, coil or other, par.36, also see U.S. Pat. Nos. 6,969,359 and 6,602,268 incorporated here by reference).
As to claim 8, Groll teaches the system, further comprising a mechanism for maintaining the retraction spring in a compressed state when the one or more needles are in the undeployed position and is configured to expand to retract the one or more needles (means for priming the lancing device for movement from the first position to the second position and back to the first position, par.7, lancing device integrated with the blood testing meter can utilize any one of a number of internal mechanisms for movement and/or priming. For example, various linear and/or rotary mechanisms, such as springs (linear, leaf, rotational, coil or other), manual slides or actuators, motor drives, a worm and rack, a rack and pinion, helical drives, solenoids, electromagnetic drives or other mechanisms can be used, par.36, and par.39, and safety mechanism to prevent accidental firing of the lancet until a certain condition is met, par.42-43).
As to claim 14, Groll teaches the method, further comprising:
retracting the one or more needles into the lancet (After firing, the lancet moves back into tip 21 so as to prevent the user or others from accidentally contacting the used lancet, par.7 and par.39), and
removing the cartridge from the skin of the subject (removing test strip 30 after sampling, par.36-45, as best seen in fig.1-7).
Claim(s) 4, 20, 21 and 24 is/are rejected under 35 U.S.C. 103 as being obvious over Groll et al (US 2010/0198107) in view of Beyerlein et al (US 2019/0000365).
As to claims 4, 20, 21 and 24, Groll teaches the lancet device includes multiple lancets/needles (par.38), but Groll/ Beyerlein combination failed to explicitly teach the one or more needles include three and/or four needles. However, it would have been an obvious to one having an ordinary skill in the art at the time the invention was made to have three or four needles in the lancet device, since it has been held that the mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 22, 23, 25 and 26 is/are rejected under 35 U.S.C. 103 as being obvious over Groll et al (US 2010/0198107) in view of Beyerlein et al (US 2019/0000365).
As to claims 22, 23, 25 and 26, Groll/ Beyerlein combination teaches the invention substantially as claimed above, but failed to teaches the one or more needles are equally spaced from one another, and wherein tips of the three needles form an equilateral triangle.
However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art at the time the invention was made to design the one or more needles equally spaced from one another and tips of the three needles form an equilateral triangle, because the Applicant has not disclosed that this specific design/arrangement of the needles provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected sampling device of Groll and the Applicant’s invention, to perform equally well with either the needles taught by Groll’s invention or the claimed specific design/arrangement of the needles because both sampling devices would perform the same function of sampling blood/fluid from the skin using multiple needles.
Therefore, it would have been prima facie obvious to modify the sampling device taught by Groll’s invention to obtain the invention as specified in claims 22, 23, 25 and 26 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Groll’s invention. In re Rose, 105 USPQ 237 (CCPA 1955).
Allowable Subject Matter
Claims 9-11, 17 and 18 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 5712725596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791