DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
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 claim limitations
Means (claim 14)
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
Means (claim 14 – means)
coupled with functional language
For guiding the body into or out of the oral cavity of a patient (claim 14 – means)
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) 14 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:
Tapers or a hole (¶75)(claim 14 – means)
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 § 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.
Claims 1, 12, 14-15, 17-20, 23-24, 27-29, 32 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20030054044 A1 to Potter et al. (Potter) as evidenced by US 3993073 A to Zaffaroni.
Potter discloses:
Regarding claim 1:
A buccal implant device configured to provide sustained drug delivery (figure 1a-8b and 9), the buccal implant device comprising:
a body (10 and 42) having a non-cylindrical geometry (see figures 1a-8b with the implant device having triangular shapes, circular shapes or pyramid shapes for example), the body (10/42) adapted to be disposed within the oral mucosa of a patient (this has been interpreted as intended use however implants such as these can be used in a variety of locations as further evidenced by US 3993073 A to Zaffaroni which teaches that such implants can be used at a variety of locations including mucous membranes of the mouth; column 10, lines 45-60); and
one or more active pharmaceutical ingredients (42, therapeutic compound that can include antibiotics or insulin injections (¶0056)) disposed within the body (10/42).
Regarding claim 12:
The buccal implant device of claim 1, further comprising a hole (18 as shown in figures 2a or 4a) formed in the body (10/42).
Regarding claim 14:
A buccal implant device configured to provide sustained drug delivery (figure 1a-8b), the buccal implant device comprising:
a body (10/42) adapted to be disposed within the oral mucosa of a patient (this has been interpreted as intended use however implants such as these can be used in a variety of locations as further evidenced by US 3993073 A to Zaffaroni which teaches that such implants can be used at a variety of locations including mucous membranes of the mouth);
means (see tapered edge 12 or hole 18 as shown in figure 2a in accordance with the 35 USC 112(f) interpretation above) for guiding the body (10) into or out of the oral cavity of a patient (edge 12 aids in insertion of the implant; ¶0173); and
one or more active pharmaceutical ingredients (42, therapeutic compound that can include antibiotics or insulin injections (¶0056)) disposed within the body (10).
Regarding claim 15:
The buccal implant device of claim 14, wherein the means for guiding the body (10) into or out of the oral cavity comprises a hole (see the hole 18 as shown in figure 2a) formed in the body (10/42).
Regarding claim 17:
The buccal implant device of claim14,wherein the means for guiding the body (10/42) into or out of the oral cavity comprises one or more tapers (see the taper 12 in figures 1a-4c) of the body (10/42) and/or one or more curved edges (12 in figure 5a) of the body (10).
Regarding claim 18:
The buccal implant device of claim14,wherein the body (10/42) has a non-cylindrical geometry (see figures 1a-8b).
Regarding claim 19:
The buccal implant device of claim14, wherein the buccal implant device is of a matrix-type, a reservoir type (see the ¶’s 0173 and 000 where the implant 10/42 is a head 10 and the therapeutic compound in a reservoir behind the head as shown in figure 9), or a hybrid type.
Regarding claim 20:
The buccal implant device of claim14,wherein the body (10/42) has a saw shape (see figure 3b which has a saw shape) or a saber shape.
Regarding claim 23:
The buccal implant device of claim 14,wherein the body (10/42) is tapered (as shown in figures 1a-8b).
Regarding claim 24:
The buccal implant device of claim 23, wherein the body (10/42) includes a single taper (see the single taper as shown in figure 3b), two tapers (see the two tapers as shown in figure 1c), or three tapers.
Regarding claim 27:
The buccal implant device of claim14,wherein the body (10/42) has one or more curved edges (see the curved edge 22/14 as shown in figure 2c) configured to direct the buccal implant device into a specific orientation within the oral cavity (directed to implant into the body as shown in figures 9 and 10).
Regarding claim 28:
The buccal implant device of claim 27, wherein the one or more curved edges (see the curved edge 12 as shown in figure 5a) form a point at an end of the body (10/42).
Regarding claim 29:
The buccal implant device of claim 1, wherein the buccal implant device has a shape or geometry which minimizes impediment of physical jaw function and/or discomfort to the patient (the shape 12 of the body allows for easier insertion into the body and therefore reduces damage to the surrounding tissue; ¶0173).
Regarding claim 32:
The buccal implant device of claim 14, wherein the body comprises a sealed tube (see the sealed tube portion 40 of 42 as shown in figure 9).
Regarding claim 39:
The buccal implant device of claim 1, wherein the one or more active pharmaceutical ingredients are selected from antiretrovirals, antimicrobial agents, antibacterial agents (therapeutic compound that can include antibiotics or insulin injections (¶0056)), antivirals, hormones, statins, p-blockers, ACE inhibitors, angiotensin receptor blockers, vitamins, steroids, biologics, anti-cancer drugs, allergy medications, anticoagulants, antiplatelet therapies, non-steroidal anti-inflammatory drugs, vaccines, and combinations thereof.
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) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20030054044 A1 to Potter et al. (Potter) in view of US 3993073 A to Zaffaroni.
Regarding claim 46:
Potter discloses:
A method of treating or preventing a medical condition in a patient in need thereof (figure 1a-8b and 9), comprising
implanting a sustained release drug delivery device (10 and 42) into the patient (¶0173; implant or projectile into the body), the sustained-release drug delivery device comprising a matrix, reservoir (see the ¶’s 0173 and 000 where the implant 10/42 is a head 10 and the therapeutic compound in a reservoir behind the head as shown in figure 9), or hybrid design and a therapeutically effective amount of one or more active pharmaceutical ingredients (42, therapeutic compound that can include antibiotics or insulin injections (¶0056)),.
Potter fails to disclose:
Implanting a sustained release drug delivery device into the oral mucosa of a subject,
device comprising one or more thermoplastic polymers, elastomer materials, or metals suitable for pharmaceutical use, and
wherein the sustained-release delivery device is adapted to be disposed within the oral mucosa.
Zaffaroni teaches:
An implant (see figures 1 and 2) that includes a pill shaped (10). The implant further includes a pharmaceutical ingredients (13). The reference further teaches that the implants or pharmaceutical ingredients can be implanted into the oral mucous membranes of a subject (column 10, lines 45-60). Also, the reference teaches that the implant can use elastomer materials (column 25-35; column 21, lines 50-60; column 22, lines 49-55).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Potter to further insert the device into the oral membranes and to include elastomer material for the reservoir or the drug delivery device as taught by Zaffaroni. In regards to inserting the device into the oral membranes, this is a simple substitution of one known element (inserting the device into the skin as taught by Potter) for another (to insert the device into oral membranes/mucosa as taught by Zaffaroni) to obtain predictable results (to apply therapeutic ingredients to the body). In regards to the elastomer material, this is a simple substitution of one known element (material of device in Potter) for another (elastomer material as taught by Zaffaroni) to obtain predictable results (to support the therapeutic material applied to the body).
Claim(s) 30, 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20030054044 A1 to Potter et al. (Potter) as applied to claim 1 above, and further in view of WO 0183017 A1 to Reydel et al. (Reydel).
Regarding claim 30:
Potter fails to disclose:
The buccal implant device of claim 1, wherein the buccal implant device comprises expanded polytetrafluoroethylene (ePTFE) having microscopic pores.
Reydel teaches:
An introducer device (10) for a catheter (figure 1) that includes a sleeve (13) and an attachment mechanism (14). The reference further teaches the sleeve can be made from expanded polytetrafluoroethylene (ePTFE) having microscopic pores in order to increase the linear strength of the sleeve (page 11).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Potter to make portions of the device of ePTFE having microscopic pores as taught by Reydel in order to increase the linear strength of the device (Reydel, page 11).
Regarding claim 37:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 30 by Potter and Reydel:
The buccal implant device of claim 1, wherein the buccal implant device comprises a rate-limiting skin (see the ePTFE incorporated into Potter from Reydel).
Regarding claim 38:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 30 by Potter and Reydel:
The buccal implant device of claim 37, wherein the rate-limiting skin comprises expanded polytetrafluoroethylene (ePTFE) (see the ePTFE incorporated into Potter from Reydel).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20030054044 A1 to Potter et al. (Potter) as applied to claim 1 above, and further in view of JP 2016503424 A (JP ‘424)(see English language machine translation attached to this or a previous office action).
Regarding claim 33:
Potter fails to disclose:
The buccal implant device of claim 32, wherein the sealed tube has an inner diameter of 1 mm to 3 mm, or 2 mm, or a wall thickness of 0.1 to 0.3 mm, or 0.125 mm.
JP ‘424 teaches:
An implantable device (figure 2) that is tube (100) in shape. The reference further teaches the tube having a wall thickness between 0.05-0.3mm in order control the rate of dissolution rate (see page 1 of the translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Potter to make the wall thickness of the tube in Potter between 0.05-0.3mm as taught by JP ‘424in order to control the dissolution rate of the tube (JP ‘424, page 1).
Response to Arguments
Applicant's arguments filed 8/7/25 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 and 103 rejections of independent claims 1, 14 and 46:
The applicant has provided several reasons as to why the above rejections are improper however the office is not persuaded.
First, the applicant argues “The Office appears to recognize this difference, but asserts that the term "body adapted to be disposed within the oral mucosa of a patient" recited in the instant claims is an intended use. However, contrary to this assertion, the term "body adapted to be disposed within the oral mucosa of a patient" denotes structural features that are critical to the use of the claimed implants” (see page 5 of the remarks). However, this office disagrees with this assertion that the functional language denotes critical structural features beyond what is claimed. First, the applicant assigns this function to the structure recited in the claim which the Potter reference includes. For the stand point of the claim, the structure (a body with non-cylindrical geometry) recited in the claim performs this function and the applicant’s argument that this function requires additional function that is not recited is unclear since the function is assigned to the structure recited in the claim and further taught by Potter. Further, the applicant argues that the it’s the material, geometry and sizes that perform this function (see page 5 or the remarks) which are also taught by the Potter reference or taught when the Potter reference is combined with others. Also, the functional language has been interpreted as intended use since the structure of the claim is taught completely by the Potter reference. The Zaffaroni reference is added as an evidentiary reference to demonstrate that these structures of Potter can be used as in the oral mucosa. Zaffaroni does not modify the Potter reference since Potter already includes all of the structure required by the claim.
Second, the applicant argues “However, the case law and discussion in the M.P.E.P. regarding multiple reference anticipation rejections makes it clear that it is only proper to rely on additional references where the relevant disclosure is identical to that of the primary reference” and “These devices are fundamentally different than the pioneer projectile devices of Potter that comprise a skin-penetrating face and are typically followed by a bolus of drug” (see page 6 of the remarks). However, the office disagrees with these arguments. First, its unclear where in the case law and MPEP the references disclosure needs to be identical. Second, both references (Potter and Zaffaroni) are directed to implants that include reservoirs where the reservoirs are connected to other parts for their insertion (see Potter 10/42 and Zaffaroni 10/27 or 10/18). The applicant’s argument that these implants are fundamentally different conflicts with the references since they both include multiple structures that are inserted into the skin.
Third, the applicant argues “Zaffaroni does not cure these defects because it does not disclose devices having a body adapted to be disposed within the oral mucosa of a patient. As discussed above, notwithstanding Zaffaroni's disclosure that its pill-shaped devices can be inserted into various mucous membranes, a skilled artisan would have understood that such devices are unsuitable for disposal in the oral mucosa at least because a pill shape does not allow for unimpeded jaw function or minimize discomfort. Accordingly, a skilled artisan would not have reasonably expected to arrive at the claimed invention based on the combination of Potter and Zaffaroni” (see page 8 of the remarks). However, the office is not persuaded by this argument since the Zaffaroni reference teaches in column 10, lines 45-60 that these implants/device can be insert in mucous membranes of the mouth (oral), anus or vagina. This would teach that the implants can be inserted into the mouth and would conflict with the applicant’s arguments. This combined with the primary reference teaches the required method of the claim. Further, the applicant’s arguments regarding the shape of the body (saw shape) are already taught by Potter which would indicate that it could be used as a buccal implant.
For these reasons, the above rejections are maintained.
Regarding the claim objections:
The applicant’s amendments and arguments are persuasive and for this reason the objections are withdrawn.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims and arguments are persuasive and the rejections are withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783