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 Objections
Claims 5-6 and 10 are objected to because of the following informalities:
Regarding claim 5, the phrase “the radially resilient gripping member“ in line 4 should read “the at least one radially resilient gripping member” for proper antecedent basis,
Regarding claim 6, the phrase “the tissue penetration member” in line 4 should read “the tissue penetrating member” for proper antecedent basis
Regarding claim 10, the phrase “wherein the pushing portion and the holder portion comprises a protruding section” in lines 1-3 should read “wherein each of the pushing portion and the holder portion comprise a protruding section” for clarity and proper grammar,
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:
“a tissue penetrating member” in claim 1,
“a pushing portion” in claim 1,
“a holder portion” in claim 1,
“an energy source” in claim 13,
“a trigger arrangement” in claim 13,
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.
Regarding “a tissue penetrating member” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (member), (ii) it is coupled with functional language (tissue penetrating), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 2c and p.5, line 30 – p.6, line 3 disclose that the in some forms the tissue penetrating member is a solid formed partly or entirely from a preparation comprising a therapeutic payload made from a dissolvable material that dissolves when inserted into tissue to deliver at least a part of the payload into the tissue or an exterior portion of the tissue penetrating member defines an enclosure with a preparation comprising an active therapeutic as a liquid, gel, or powder accommodated therein. Examiner is interpreting the limitations as these structures and equivalents thereof.
Regarding “a pushing portion” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (portion), (ii) it is coupled with functional language (pushing), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 2c and p.21, lines 5-10 discloses that the pushing portion is in the form of a push rod (260) configured for movement along an axis and configured to provide a force onto the tissue penetrating member (230). Examiner is interpreting the limitation as a push rod and equivalents thereof.
Regarding “a holder portion” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (portion), (ii) it is coupled with functional language (holder), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 2c and p.21, lines 5-10 disclose the holder portion provided as a holder sleeve (270) encircling both the push rod (260) and a proximal portion of the payload. Examiner is interpreting the limitation as a sleeve-like structure and equivalents thereof.
Regarding “an energy source” in claim 13, 112(f) is invoked because: (i) it uses a generic placeholder (source), (ii) it is coupled with functional language (energy), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 2a-2b and P.8, lines 8-15 disclose that the energy source is or comprises at least one spring configured as a drive spring such as a compression spring, torsion spring, leaf spring, or a constant-force spring. Further, the energy source may include compressed gas actuators or gas generators. Examiner is interpreting the limitation as these structures and equivalents thereof.
Regarding “a trigger arrangement” in claim 13, 112(f) is invoked because: (i) it uses a generic placeholder (arrangement), (ii) it is coupled with functional language (trigger), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. P.9, lines 8-19 discloses that the trigger member is characterized by at least one of the following groups: a material that degrades, erodes, and/or dissolves due to a change in pH in the GI tract, a material that degrades, erodes, and/or dissolves due to a pH in the GI tract, a material that degrades, erodes, and/or dissolves due to a presence of an enzyme in the GI tract, a material that degrades, erodes, and/or dissolves due to a change in concentration of an enzyme in the GI tract, or an electronic trigger.
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 2-4 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.
Regarding claim 2, the phrase “wherein the holder portion is moved from the start position towards the stop geometry by slaved movement relative to the pushing portion” in lines 3-5 renders the claim indefinite because it is unclear. It is unclear in light of claim 1, Fig. 2a-2b, and p.23, lines 14-17 of the specification state “ As drive spring 240 exerts load onto hub 250, the push rod 260 [pushing portion], the holder sleeve 270 [holder portion] and the payload portion 230 [tissue penetrating member] are caused to travel unhindered towards the exit hole 224 as slaved with the hub 250.” Thus, it is unclear how the holder portion is moved by slaved movement relative to the pushing portion when moving towards the stop geometry as Fig. 2a-2b and the specification discusses that the holder portion and pushing portion are in axial retaining engagement until the holder portion enters into engagement with the stop geometry. During the movement of the holder portion towards the stop geometry, there is no disclosed movement of the holder portion relative to the pushing portion. Examiner is interpreting this limitation as the holder portion is moved from the start position towards the stop geometry by slaved movement. Examiner suggests application amend to state “wherein the holder portion is moved from the start position towards the stop geometry by slaved movement
Regarding claim 4, the phrase “when the holder portion slaved relative to the pushing portion” in lines 2-3 renders the claim indefinite as it is unclear for the above discussed reasons surrounding the holder portion not being disclosed as moving relative to the pushing portion during this phase of movement. Examiner is interpreting this limitation as when the holder portion is slaved, the pushing portion is interconnected with the tissue penetrating member. Examiner suggests application amend to state “when the holder portion is slaved said slaved movement interconnects the pushing portion with the tissue penetrating member.”
Regarding claim 3, this claim is rejected due to its dependency upon a rejected base claim.
Allowable Subject Matter
Claims 1 and 5-17 are allowed.
Claims 2-4 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.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is Frederiksen et al. (W.O Patent Pub. No. 2020245448 A1, “Frederiksen”), Imran (W.O Patent Pub. No. 2021146296 A1), and Hvitfeld et al. (W.O Patent Pub. No. 2021013907 A1, “Hvitfeld”).
Frederikson discloses an ingestible device (100 in Fig. 1a-1b) suitable for swallowing into a lumen of a gastrointestinal tract of a patient, the lumen having a lumen wall (see p.9, lines 4-12), the ingestible device (100) comprising:
- a housing (110 and 120 in Fig. 1A-1B) defining an internal hollow and comprising a stop geometry (128 in Fig. 1a-1b) arranged within the internal hollow and an exit hole (123 in Fig. 1A, see p.9, lines 28-35 for hollow and exit hole, see p.10, lines 17-20 for stop geometry),
- a tissue penetrating member (130 in Fig. 1a-1b) disposable in the housing (110 and 120, see p.10, lines 31-35), the tissue penetrating member (130) having a tissue penetrating first end (distal end of 130), a second end (proximal end of 130) opposite the first end (distal end of 130) and a radially outwards facing surface between the first end (distal end of 130) and the second end (proximal end of 130, see Fig. 1a-1b for radially outwards facing surface), and
- an actuator arrangement comprising:
a) a pushing portion (151 in Fig. 1a-1b) configured for movement along an axis (see Fig. 1a-1b) from a first position (Fig. 1a) and into a second position (Fig. 1b), the pushing portion (151) being configured for providing a force onto the tissue penetrating member (130) to move the tissue penetrating member (130) from an initial position (Fig. 1a) within the housing (110 and 120) to a lodged position (Fig. 1b) where at least a portion of the tissue penetration member (130) is external to the housing (110 and 120) and at least partially lodged in tissue of the lumen wall (see p.11, lines4-5 and 9-11 for pushing portion 151 and p.12, lines 13-18), and
b) a holder portion (155 in Fig. 1a-1b) coupled with the pushing portion (151) for initial axial movement with the pushing portion (151, see p.11, lines 4-11), wherein when the pushing portion (151) assumes the first position (Fig. 1a) the holder portion (155) releasably holds the tissue penetrating member (130) in axial retaining engagement (see p.11, lines 5-7 and p.12, line 35-p.13, lines 5),
wherein, as the pushing portion (151) moves towards the second position (Fig. 1b), the tissue penetrating member (130) is moved into tissue until the holder portion (155) enters into engagement with the stop geometry (128) of the housing (110 and 120) thereby axially stopping the holder portion (155, see Fig. 1b and p.12, lines 13-18 and p.13, lines 17-21), whereafter the pushing portion (151) moves further to release the axial retaining engagement (see p.12, line 13 – p.13, line 5 – pushing portion 151 moves further by tilting to release the connection between the holder portion 155 and tissue penetrating member 130).
However, Frederikson fails to disclose after the pushing portion (151) moving to the second position, that the pushing portion (151) moves further to release the engagement with the tissue penetrating member (130) and advance the tissue penetrating member (130) into its lodged position. Instead, Frederikson discloses that the tissue penetrating member (130) is in its lodged position when the pushing portion (151) is in its second position (see Fig. 1b), and that the further movement of the pushing portion (151) is actually a tilting motion of the ram (150) which breaks the connection with the tissue penetrating member (130) so that the device (100) can continue moving through the GI tract leaving the tissue penetrating member (130) at its lodged position. This tilting motion does not further advance the tissue penetrating member (130). Therefore, Frederikson fails to disclose claim 1. There is no reference to modify the pushing portion and holder portion of Frederikson to operate in the way of claim 1.
Imran discloses an ingestible drug delivery device (100 in Fig. 1A-1C) suitable for swallowing into the GI tract (see para. 0032-0033), the ingestible device (100) comprising a housing (110 in Fig. 1a), a tissue penetrating member (130 in Fig. 1B-1C) in the form of a degradable enclosure accommodating a drug (140 in Fig. 1B-1C, see para. 0033), and an actuator arrangement (see Fig. 1B-1C) comprising a pushing portion (152 in Fig. 1B-1C) in the form of a driving piston or plunger (see para. 0043) configured for movement from a first position (Fig. 1B) to a second position (1C) and for providing a force onto the tissue penetrating member (130) to move the tissue penetrating member (130) from an initial position (Fig. 1B) within the housing (110) to a lodged position (Fig. 1C, see para. 0043), and a holder portion (125 in Fig. 1B-1C) in the form of a guide tube (see para. 0042) coupled with the pushing portion (152) and releasably holding the tissue penetrating member (130) in axial retaining engagement (see para. 0043 – guide tube 125 contains seals 122 and 124 that axially retain the tissue penetrating member 130 until they are pierced and tissue penetrating member 130 is released). However, Imran fails to disclose that the holder portion (125) is configured for initial axial movement with the pushing portion (151) and that when the pushing portion (152) moves towards the second position that the tissue penetrating member (130) is moved until the holder portion enters into engagement with the stop geometry of the housing to axial stop the holder and the pushing portion then moves further as claimed in claim 1. Rather, Imran is silent to the guide tube (125) moving at all and thus fails to disclose the device of claim 1.
Hvitfeld is a related application to Frederikson and discusses the same subject matter thereof as discussed above.
Therefore, there is no reference that teaches or discloses the ingestible device of claim 1.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
