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 .
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: “actuator mechanism” in claims 1, 24, 28 and 29 and, “a feature configured to change inertia” and “a feature configured to create turbulent flow” in claims 16 and 29, “locking mechanism” in claim 25.
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 17, 28 and all claims depending therefrom 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 17 recites “the second body part has a higher inertia than the first body part” lines 1-2. It is unclear how “a higher inertia” is measured between the second body part and the first body part. It is unclear if the “higher inertia” is determined due to the weight, mass, material of the body parts or some other means.
Claim 28 recited “the second body part has a higher inertia than the first body part” in the last line. It is unclear how “a higher inertia” is measured between the second body part and the first body part. It is unclear if the “higher inertia” is determined due to the weight, mass, material of the body parts or some other means.
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, 15, 19-20 and 25 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cabiri et al. (US Patent Pub. 20200222625 hereinafter “Cabiri”).
Regarding Claim 1, Cabiri teaches (Figs 4a-4d) a drug delivery device having a central axis, the drug delivery device comprising:
a first body part (422);
a second body part (404);
an attachment part (410) attached to the first body part (422) and having a distal end (428); and
an actuator mechanism (402) configured to rotate the first body (422) part in relation to the second body part (404) about a primary axis of the drug delivery device (See Figs 4a-4d; also see [0123-0124] teaching how pressing 402 against skin actuates the device such that 422 pivots/rotates relative to 404),[[;]]
wherein the drug delivery device comprises only a single attachment part (see Fig 4a, there is only one attachment part 410).
Regarding Claim 15, Cabiri teaches the drug delivery device according to claim 1, wherein the second body part (402) comprises a resistive feature (413; see [0123])).
Regarding Claim 19, Cabiri teaches the drug delivery device according to claim 1, wherein the actuator mechanism comprises a resilient part (413) configured to apply force to the first body part and/or the second body part (402; see [0123]).
Regarding Claim 20, Cabiri teaches the drug delivery device according to claim 1, wherein the first body part (422) is configured to rotate in a first direction (downwards from position in Fig 4a) and the second body part (402) is configured to rotate in a second direction (upwards from position in Fig 1) opposite to the first direction.
Regarding Claim 25, Cabiri teaches the drug delivery device according to claim 1, wherein the drug delivery device comprises a locking mechanism (see [0117] teaching the needle is locked, and the needle is attached to the first body part 422) configured to lock the first body part (422) in relation to the second body part (402) in a first state of the drug delivery device (See [0117]).
Claim(s) 1, 21-24 and 26-27 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mojarrad et al. (US 20230302264 hereinafter “Mojarrad”).
Regarding Claim 1, Mojarrad teaches (Figs 5a-5C) a drug delivery device (500) having a central axis, the drug delivery device comprising:
a first body part (540);
a second body part (514);
an attachment part (508) attached to the first body part (540) and having a distal end; and
an actuator mechanism (see [0080-0081]; it is interpreted that the inflation is the actuator) configured to rotate the first body part in relation to the second body part about a primary axis of the drug delivery device (see [0080-0081] teaching how inflation of 540 results in 540 rotating relative to walls 514 of the device 500),
wherein the drug delivery device comprises only a single attachment part ([0081] teaches 508 as “one or more microneedles”, the examiner is interpreting there is one microneedle 508 which is “a single attachment part”).
Regarding Claim 21, Mojarrad teaches the drug delivery device according to claim 1, wherein the distal end of the attachment part is provided with a tip configured to penetrate a biological tissue (see [0081] "the pointed ends of the tissue penetrating delivery members 508 may be oriented in such a way so as to facilitate penetration into the wall 118 of the gastrointestinal tract.")
Regarding Claim 22, Mojarrad teaches the drug delivery device according to claim 1, wherein the drug delivery device comprises a first compartment, (see [0082] teaching a drug compartment in 502) wherein the drug delivery device is configured to deliver an active drug substance from the first compartment to the surroundings of the drug delivery device (See [0081] teaching drug delivery).
Regarding Claim 23, Mojarrad teaches the drug delivery device according to claim 1, wherein the drug delivery device has a first state (fig 5A) where the first body part (540) and the second body part (514) are rotationally stationary relative to each other and a second state (Fig 5C) where the first body part (540) and the second body part (514) are rotationally mobile relative to each other (See [0080-0081]).
Regarding Claim 24, Mojarrad teaches the drug delivery device according to claim 1, wherein the actuator mechanism is configured to move the distal end (tip of 508) from a primary position (Fig 5a) with a primary radial distance (radial distance between 508 and central axis in Fig 5a) from the central axis of the delivery device to a secondary position (Fig 5C) with a secondary radial distance (radial distance of 508 and central axis in Fig 5C) from the central axis, wherein the secondary radial distance is larger than the primary radial distance (see Figs 5A and 5C, the radial distance in Fig 5C is greater than Fig 5A).
Regarding Claim 26, Mojarrad teaches the drug delivery device according to claim 1, wherein the attachment part (508) is rotationally attached to the first body part (540) by a hinge (See annotated Fig 5B) and configured to rotate about a first rotation axis perpendicular or parallel to the primary axis (See Fig 5b – 5c).
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Annotated Fig 5B (Mojarrad)
Regarding Claim 27, Mojarrad teaches the drug delivery device according to claim 1, wherein the drug delivery device is biodegradable (see [0055] teaching components of the device may be made of biodegradable materials).
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) 15-18, 25 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mojarrad (US 20230302264).
Regarding Claims 15-16, Mojarrad teaches all elements of claim 1 as described above. Mojarrad Figs 5a-5c do not specify the drug delivery device wherein the first body part and/or the second body part comprises a resistive feature; wherein the resistive feature is selected from one or more of: a high friction surface, a feature configured to change inertia, and a feature configured to create turbulent flow.
Mojarrad Figs 1a-1b teaches the second body part (102) frictionally engages the inner wall of the gastrointestinal tract. It is interpreted that the second body part 102 has a high friction surface which allows for this ‘frictional engagement’ (See [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second body part of the embodiment of Figs 5a-5c of Mojarrad such that it includes a resistive feature which is a high friction surface as taught by the embodiment of Mojarrad Fig 1a-1b. One of ordinary skill in the art would have been motivated to do so in order to ensure the device engages the gastrointestinal wall for delivery of the drug (Mojarrad [0066]).
Regarding Claim 17, Mojarrad teaches all elements of claim 1 as described above. Mojarrad does not specify the drug delivery device wherein the second body part has a higher inertia than the first body part (see 112 rejection above).
However, it would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Mojarrad to include the second body part having a higher inertia than the first body part since applicant has not disclosed that having the second body part having a higher inertia than the first body part solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (it is interpreted that the device would perform equally well if the second body part has a lower inertia than the first body part, the same inertia as the first body part or higher inertia than the first body part). Furthermore, absent a teaching as to the criticality of the second body part having a higher inertia than the first body part, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding Claim 18, Mojarrad teaches all elements of claim 1 as described above. Mojarrad does not specify the drug delivery device wherein the second body part has a higher or lower weight than the first body part.
However, it would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Mojarrad to include the second body part has a higher or lower weight than the first body part since applicant has not disclosed that having the second body part has a higher or lower weight than the first body part solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (the current design of Mojarrad or a design of Mojarrad where the second part has a different weight than the first part). Furthermore, absent a teaching as to the criticality of the second body part has a higher or lower weight than the first body part, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding Claim 25, Mojarrad teaches all elements of claim 1 as described above. Mojarrad Figs 5a-5C do not specify the drug delivery device wherein the drug delivery device comprises a locking mechanism configured to lock the first body part in relation to the second body part in a first state of the drug delivery device.
Mojarrad does teach in the embodiment of Figs 1a-1b that there is a locking mechanism (112) that locks the first body part (106) in relation to the second body part (114) in a first state of the drug delivery device (Fig 1A; see [0066] teaching how once coating 112 degrades it allows for 106 to rotate outward).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the embodiment of Figs 5a-5c of Mojarrad such that it includes a coating that functions as a locking mechanism configured to lock the first body part in relation to the second body part in a first state of the drug delivery device as taught by the embodiment of Mojarrad Fig 1a-1b. One of ordinary skill in the art would have been motivated to do so in order to ensure the device will deliver the drug at the desired location since the coating will only dissolve at certain locations within the GI tract based on the pH level of the environment (See [0062]).
Regarding Claim 28, Mojarrad teaches (Figs 5a-5C) a drug delivery device (500) suitable for oral administration (see [0023] teaching embodiment is swallowable) of a drug and having a central axis, the drug delivery device comprising:
a first body part (540);
a second body part (514);
an attachment part (508) attached to the first body part (540) and having a distal end, wherein the distal end of the attachment part is provided with a tip configured to penetrate a biological tissue (see [0081] "the pointed ends of the tissue penetrating delivery members 508 may be oriented in such a way so as to facilitate penetration into the wall 118 of the gastrointestinal tract."); and
an actuator mechanism (see [0080-0081]; it is interpreted that the structure causing the inflation is the actuator mechanism) configured to rotate the first body part in relation to the second body part about a primary axis of the drug delivery device (see [0080-0081] teaching how inflation of 540 results in 540 rotating relative to walls 514 of the device 500),
wherein the drug delivery device comprises only a single attachment part ([0081] teaches 508 as “one or more microneedles”, the examiner is interpreting there is one microneedle 508 which is “a single attachment part”).
Mojarrad does not specify the second body part has a higher inertia than the first body part (See 112 rejection above).
However, it would have been an obvious matter of design choice to a person having ordinary skill in the art before the effective filing date of the present invention to modify Mojarrad to include the second body part having a higher inertia than the first body part since applicant has not disclosed that having the second body part having a higher inertia than the first body part solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (it is interpreted that the device would perform equally well if the second body part has a lower inertia than the first body part, the same inertia as the first body part or higher inertia than the first body part). Furthermore, absent a teaching as to the criticality of the second body part having a higher inertia than the first body part, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Regarding Claim 29, Mojarrad teaches (Figs 5a-5C) a drug delivery device (500) having a central axis, the drug delivery device comprising:
a first body part (540);
a second body part (514);
an attachment part (508) attached to the first body part (540) and having a distal end; and
an actuator mechanism (see [0080-0081]; it is interpreted that the inflation is the actuator) configured to rotate the first body part in relation to the second body part about a primary axis of the drug delivery device (see [0080-0081] teaching how inflation of 540 results in 540 rotating relative to walls 514 of the device 500),
wherein the drug delivery device comprises only a single attachment part ([0081] teaches 508 as “one or more microneedles”, the examiner is interpreting there is one microneedle 508 which is “a single attachment part”).
Mojarrad Figs 5a-5c do not specify the drug delivery device wherein the first body part and/or the second body part comprises a resistive feature; wherein the resistive feature is selected from one or more of: a high friction surface, a feature configured to change inertia, and a feature configured to create turbulent flow.
Mojarrad Figs 1a-1b teaches the second body part (102) frictionally engages the inner wall of the gastrointestinal tract. It is interpreted that the second body part 102 has a high friction surface which allows for this ‘frictional engagement’ (See [0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second body part of the embodiment of Figs 5a-5c of Mojarrad such that it includes a resistive feature which is a high friction surface as taught by the embodiment of Mojarrad Fig 1a-1b. One of ordinary skill in the art would have been motivated to do so in order to ensure the device engages the gastrointestinal wall for delivery of the drug (Mojarrad [0066]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Traverso et al. (US 20200147298) teaches a device that has the inertia calculated along the weight of the portions of the device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783