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.
The following limitations
“a spring element” in claims 1 and 29
“a resistive feature” in claim 15
“a locking mechanism comprising a first locking element” in claim 25
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
“element”
“feature”
“element”
coupled with functional language
“configured to rotate the first body part in relation to the second body part about a primary axis of the drug delivery device” in claims 1 and 29
“resistive” in claim 15
“configured to lock the first body part in relation to the second body part”
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1, 15, 25, 29 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“spring element” is described as “The resilient part may e.g. be in the form of a spring or spring element, for example a torsional spring or a power spring” in instant paragraph [0052] of the PGPub.
“resistive feature” is described as “ a high friction surface” in instant paragraph [0056] of the PGPub.
“locking element” is described as “The first locking element may be a first locking band (e.g., ring, loop, partial ring, partial loop).” In instant paragraph [0115] of the PGPub.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mojarrad (US 20230302264).
Regarding Claim 29, Mojarrad teaches (Figs 5a-5C) a drug delivery device (500) configured for delivery of an active drug substance in the gastrointestinal tract, the drug delivery device 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] teaching 508 is microneedle that penetrates tissue); and
an actuator mechanism (see [0080-0081]; it is interpreted that the inflation fluid is the actuator) comprising a spring element (see [0080] teaching the inflatable bladder is elastic; therefore the inflation fluid that inflates 540 is considered to be a ‘spring element’ similar to the ‘power spring’ described in the instant application (See 112f interpretation above)) 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 a high friction surface,.
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]).
Allowable Subject Matter
Claims 1, 15-16, 18-20, 22-27 and 30-31 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, the prior art fails to disclose singly or in combination before the effective filing date, the claimed drug delivery device configured for delivery of an active drug substance in the gastrointestinal tract.
The closest prior art of record is Mojarrad (US 20230302264). Mojarrad teaches (Figs 5a-5C) a drug delivery device (500) configured for delivery of an active drug substance in the gastrointestinal tract, the drug delivery device 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] teaching 508 is microneedle that penetrates tissue); and
an actuator mechanism (see [0080-0081]; it is interpreted that the inflation fluid is the actuator) comprising a spring element (see [0080] teaching the inflatable bladder is elastic; therefore the inflation fluid that inflates 540 is considered to be a ‘spring element’ similar to the ‘power spring’ described in the instant application (See 112f interpretation above) 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 teach the drug delivery device wherein the second body part has a higher inertia than the first body part. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Mojarrad to satisfy these limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 29 have been considered but are moot because the new ground of rejection takes into consideration the amendments and respective and 112f considerations based on the amendments filed 4/10/2026.
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 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
/WESLEY G HARRIS/Examiner, Art Unit 3783
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