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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/14/26 has been entered.
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 § 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 1, 12, 14-15, 18-20, 24, 27-30, 32-33, 37-39, 46 and 62-63 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 1:
The claim limitation “a body” in lines 5-8 is unclear. The limitation is unclear since it makes the following limitations including “the body” unclear as to which “body” limitation is being referred to (see “the body” in the final line of the claim for example). For the sake of examination, the office has assumed that “the body” limitations in the claim refer to the “body” established in line 3 of the claim.
Claims 12, 29, 30, 37-39, 46 and 62 are rejected due to their dependence on claim 1.
Regarding claim 14:
The claim limitation “a body” in lines 5-8 is unclear. The limitation is unclear for the same reason indicated in the claim 1 rejection above. the office has taken the same interpretation.
Claims 15, 19-20, 24, 27-28, 32-33, 63 are rejected due to their dependence on claim 14.
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 WO 2007033353 A2 to Daniloff.
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 WO 2007033353 to Daniloff which teaches that such implants can be used at a variety of locations including mucous membranes of the mouth; ¶00040) the body comprising at least two of:
(i) a body having one or more planar faces (see planar surface 14 of embodiment in figure 3a; see the planar surface 14 in figure 4b);
(ii) a body having one, two, or three curved edges;
(iii) a body having one, two, or three tapers (see tapered surface 12 of embodiment in figure 3a; see tapered surface 12 of embodiment in figure 4b); and
(iv) a ribbed body; 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 WO 2007033353 to Daniloff which teaches that such implants can be used at a variety of locations including mucous membranes of the mouth; ¶00040) the body comprising at least two of:
(i) a body having one or more planar faces (see planar surface 14 of embodiment in figure 3a; see the planar surface 14 in figure 4b);
(ii) a body having one, two, or three curved edges;
(iii) a body having one, two, or three tapers (see tapered surface 12 of embodiment in figure 3a; see tapered surface 12 of embodiment in figure 4b); and
(iv) a ribbed body;
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) ,(ii) one, two, or three tapers of the body, and/or (iii) one, two, or three curved edges of the body.
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 claim 14, wherein the buccal implant device is of a reservoir type (see the ¶’s 0173 and 000 where the implant 10/42/44 is a head 10 and the therapeutic compound 44/42 in a reservoir behind the head as shown in figure 9; ¶0202 further indicates 44 can be made of membranes with a contained liquid or solid indicating that 44 is a reservoir).
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 24:
The buccal implant device of claim 14, wherein the body (10/42) includes one, two or three tapers (see the two tapers as shown in figure 1c).
Regarding claim 27:
The buccal implant device of claim14,wherein the body (10/42) has one, two or three 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, two or three 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.
Regarding claim 62:
The buccal implant device of claim 1, wherein the body has a saw shape or a saber shape (see the saber shape as shown in figure 3a-3d).
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 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20030054044 A1 to Potter et al. (Potter) as applied to claims 1 and 14 above, and further in view of WO 2007033353 A2 to Daniloff.
Regarding claim 46:
Potter fails to disclose:
A method of treating or preventing a medical condition in a patient in need thereof, comprising implanting the buccal implant device of claim 1 into the oral mucosa of the patient.
Daniloff teaches:
The reference further teaches that the implants (composition or object) can be implanted into the skin, oral mucosa, teeth, nails, eye, and ear-nose-throat passages, or can be placed inside of pulmonary system, or digestive system, or urinary system, or intestinal tract, or reproductive system, or vascular system, or surgically placed subcutaneously, intramuscularly, intraperitoneally, or in any other location in the body (¶0040).
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 implant into the oral mucosa as taught by Daniloff in order to address diagnostic, therapeutic, or aesthetic functions (Daniloff, ¶00040).
Regarding claim 63:
Potter fails to disclose:
A method of treating or preventing a medical condition in a patient in need thereof, comprising implanting the buccal implant device of claim 14 into the oral mucosa of the patient.
Daniloff teaches:
The reference further teaches that the implants (composition or object) can be implanted into the skin, oral mucosa, teeth, nails, eye, and ear-nose-throat passages, or can be placed inside of pulmonary system, or digestive system, or urinary system, or intestinal tract, or reproductive system, or vascular system, or surgically placed subcutaneously, intramuscularly, intraperitoneally, or in any other location in the body (¶0040).
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 implant into the oral mucosa as taught by Daniloff in order to address diagnostic, therapeutic, or aesthetic functions (Daniloff, ¶00040).
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, see remarks, filed 4/14/26, with respect to the rejection(s) of claim(s) 1, 12, 14, 15, 19, 20, 24, 28-29, 30, 32-33, 37-39, 46, 62, 63 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20030054044 A1 to Potter et al. (Potter) as evidenced by WO 2007033353 A2 to Daniloff.
Regarding the 35 USC 102 claim 19 rejection:
The applicant has argued that Potter does not teach that structure 42 is a membrane and for this reason the rejection of claim 15 is improper (see page 9 of the remarks). However, the office is not persuaded by this argument since ¶0202 indicates the 44 can be a membrane that contains liquid or solids indicating that the structure is a reservoir.
Regarding the 35 USC 103 claim 33 rejection:
The applicant has argued that the secondary reference does not disclose the structure of the inner diameter as required by the claim. The secondary reference English language translation has been included to show that the reference does teach the diameter as required by the claim.
Regarding 35 USC 102 claims 1 and 14 rejection:
The applicant has amended the independent claims to overcome the rejection however the office is not persuaded. As indicated above, these amended limitation are taught by the Potter reference and for this reason the above rejection is maintained.
Conclusion
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
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