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 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 19 is 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 19 recites “further comprising an optical sensor disposed with respect to the drivetrain.” Claim 18, upon which claim 19 depends recites “an optical sensor disposed with respect to the drivetrain”. It is unclear if the “optical sensor” in claim 19 is the same as the “optical sensor” in claim 18 or another “optical sensor”. Based on the specification at para [0074] of the published application (US 2025/0177641), it appears that there is only one optical sensor. Therefore, the claim is unclear and indefinite.
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 19 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 19 recites “The medication delivery device of claim 18, further comprising an optical sensor disposed with respect to the drivetrain.” Claim 18, upon with claim 19 depends also recites “an optical sensor disposed with respect to the drivetrain” in line 5. It appears that claim 19 recites a substantial duplicate of claim features already recited in claim 18, and therefore does not further limit claim 18.
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 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 is: “pump drive mechanism” in claims 1 and 16.
The term “pump drive mechanism” contains the nonce term “mechanism” followed by functional language “for driving medication through the device”, and the terms pump or drive do not recite any other specific structure to perform the function. The pump drive mechanism is interpreted as a plunger driven by a leadscrew as stated in the instant specification at paras [0017] and [0061], Fig. 3 of the published application (US 2025/0177641).
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.
(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.
Claims 1-12, 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al, US 2012/0078170 A1.
Regarding claim 1, Smith discloses a medication delivery device (pump assembly 200, Figs. 1-40) comprising: a base plate (500, para [0221], Figs. 1 and 15) engaging a cover (202, Fig. 1, para [0255]) to form an interior (paras [0221]-[0222]; [0255]), the interior including: a pump drive mechanism (252) for driving medication through the device (para [0255]); a drivetrain (362, 360, Figs. 19, 23, para [0287]) engaged to the pump drive mechanism; a magnetic encoder (396) including an encoder hub (Fig. 19) mechanically coupled to the drivetrain, the encoder hub including a magnet (405); and a sensor (403) that measures a magnetic field from the magnet to determine a rotational position of the drivetrain (para [0340]).
Regarding claim 2, Smith discloses the medication delivery device of claim 1, wherein the medication delivery device includes one of a patch pump, an infusion pump and an automated insulin delivery device (paras [0221]-[0223]).
Regarding claim 3, Smith discloses the medication delivery device of claim 1, wherein the pump drive mechanism includes a plunger (350) driven by a leadscrew (360, Fig. 23, para [0291]).
Regarding claim 4, Smith discloses the medication delivery device of claim 3, wherein the drivetrain includes a drive gear (gears 362); the drivetrain engages a drive nut (364, Fig. 23, para [0291]); and the drive nut is a final rotating component that engages the leadscrew (para [0291]).
Regarding claim 5, Smith discloses the medication delivery device of claim 4, wherein the drive gear (362) is aligned to the sensor (encoder/sensor, Fig. 18, paras [0338]-[0340]).
Regarding claim 6, Smith discloses the medication delivery device of claim 4, wherein the encoder hub is coupled to the drive gear to measure the rotational position (paras [0338]-[0340]).
Regarding claim 7, Smith discloses the medication delivery device of claim 1, wherein the magnet includes a plurality of magnets evenly spaced around the encoder hub (405g, Fig. 40G, para [0340]).
Regarding claim 8, Smith discloses the medication delivery device of claim 7, wherein a polarity of the plurality of magnets facing away from a center axis of a drive gear remains constant (Figs. 40G-I, para [0340]).
Regarding claim 9, Smith discloses the medication delivery device of claim 7, wherein a polarity of the plurality of magnets facing away from a center axis of a drive gear alternates in series with respect to the drive gear (Figs. 40G-I, para [0340]).
Regarding claim 10, Smith discloses the medication delivery device of claim 1, wherein the magnet is axially polarized (Figs. 40G-I, para [0340]).
Regarding claim 11, Smith discloses the medication delivery device of claim 1, wherein the magnet is radially polarized (Figs. 40G-I, para [0340]).
Regarding claim 12, Smith discloses the medication delivery device of claim 1, wherein the magnet includes a single multi-pole magnet with a plurality of magnet arms equally spaced (Figs. 40G-I, para [0340]).
Regarding claim 16, Smith discloses the medication delivery device of claim 1, wherein the sensor includes one of a magnetic Hall Effect sensor and a magnetic resistance sensor (para [0340]).
Regarding claim 17, Smith discloses the medication delivery device of claim 1, wherein the magnetic encoder includes a ring magnet having one or more magnetized sections (Figs. 40G-I, para [0340]).
Regarding claims 18-19, Smith discloses a medication delivery device (pump assembly 200, Figs. 1-40) comprising: a base plate (500, para [0221], Figs. 1 and 15) engaging a cover (202, Fig. 1, para [0255]) to form an interior (paras [0221]-[0222]; [0255]), the interior including: a pump drive mechanism (252) for driving medication through the device (paras [0221]-[0222]; [0255]); a drivetrain (362, 360, Figs. 19, 23, para [0287]) engaged to the pump drive mechanism; and an optical sensor (399, Fig. 40A, para [0339]) disposed with respect to the drivetrain; wherein the optical sensor measures a rotational position of the drivetrain (para [0339]).
Regarding claim 20, Smith discloses the medication delivery device of claim 19, wherein the optical sensor includes an emitter that emits light including a laser light and a receiver that receives the light (397 and 399, Fig. 40A).
Regarding claim 21, Smith discloses the medication delivery device of claim 20, wherein the optical sensor includes optical fan blades (401, Fig. 40A) that are configured between an emitter and a receiver to split or block the light; and the optical sensor is configured to detect when the light is split or blocked (para [0339]).
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.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Smith.
Regarding claims 13-15, Smith discloses the medication delivery device of claim 1, wherein the pump assembly 236 including the sensor 403 can be mounted on a circuit board (para [0343]), but is silent as to the sensor is mounted on a top surface of a circuit board, or the sensor is mounted on a bottom surface of a circuit board, or wherein the sensor is aligned vertically with an axis of rotation of the drive gear.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to locate the sensor on either the top or bottom surface of the circuit board or align vertically with an axis of rotation of the drive gear, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI)(C). Alternatively, it would have been an obvious matter of design choice to locate the sensor on either the top or bottom surface of the circuit board or align vertically with an axis of rotation of the drive gear, since applicant has not disclosed that the location of the sensor solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the sensor on any portion of the circuit board and/or aligned vertically with an axis of rotation of the drive gear.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at (571)272-4647. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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