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 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 39 and 66 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 39 recites the limitation "the first chamber" in lines 6, 7 and 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 66 recites the limitation "the cured adhesive" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 4, 5, 11, 63 and 72 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 recites “wherein the drug reservoir comprises a rigid housing having a port for filling the drug reservoir with said pharmaceutical composition that is hermetically sealed with an elastomeric plug comprising a fluorocarbon elastomer that is biocompatible with the oral mucosa and compatible with the pharmaceutical composition.” This limitation is also included in independent claim 3 from which claim 4 depends.
Claim 5 recites “the pocket is configured to position the drug delivery device coplanar with an occlusal plane of the molar. This limitation is also included in independent claim 3 from which claim 5 depends.
Claim 11 recites “wherein the fastener is configured such that the patient’s oral anatomy would mechanically interfere with and prevent the removal of the drug delivery device from the fastener when the fastener is attached to the surface of the patient’s mouth.” This limitation is also included in independent claim 3 from which claim 11 depends.
Claim 63 recites “a first chamber.” This limitation has already been presented as “a drug reservoir” in claim 2 from which claim 63 depends.
Claim 72 recites “the second chamber comprises a propellant.” This limitation has already been presented as “a second chamber comprising a propellant” in claim 63 from which claim 72 depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 3 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2016/0278899 to Heller et al. (hereinafter “Heller”).
Regarding claim 3, it is noted that the limitations after the wherein clause on line 8 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller discloses a drug delivery device configured to be removably inserted in a patient's mouth and for continuous or semi-continuous intraoral administration of a pharmaceutical composition comprising a drug (see at least Figs. 1A, 1B, 2A and 2B), said device comprising: (i) a fastener (1/6) to removably secure said drug delivery device to a surface of said patient’s mouth (see Fig. 1A and Fig. 2A); (ii) a pump (2) comprising a drug reservoir (3) comprising said pharmaceutical composition, the volume of said drug reservoir being from 0.1 mL to 5 mL (see page 37 under Drug Delivery Devices second paragraph); and (c) wherein the fastener is configured such that the patient’s oral anatomy would mechanically interfere with and prevent the removal of the drug delivery device from the fastener when the fastener is attached to the surface of the patient’s mouth (see Fig. 2A and Fig. 4A).
Regarding claim 11, Heller meets the drug delivery device of claim 3 above and further teaches wherein the fastener is configured such that the patient’s oral anatomy would mechanically interfere with and prevent the removal of the drug delivery device from the fastener when the fastener is attached to the surface of the patient’s mouth (see Fig. 2A and Fig. 4A).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 25, 39, 42, 44, 58, 63, 72, 75 and 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2016/0278899 to Heller et al. (hereinafter “Heller”) in view of US Pub. No. 2013/0211312 to Gelvin (hereinafter “Gelvin”).
Regarding claim 2, Heller discloses a drug delivery device configured to be removably inserted in a patient's mouth and for continuous or semi-continuous intraoral administration of a pharmaceutical composition comprising a drug (see at least Figs. 1A, 1B, 2A and 2B), said device comprising: (i) a fastener (1/6) to removably secure said drug delivery device to a surface of said patient’s mouth (see Fig. 1A and Fig. 2A); (ii) a pump (2) comprising: (a) a drug reservoir (3) comprising said pharmaceutical composition, the volume of said drug reservoir being from 0.1 mL to 5 mL (see page 37 under Drug Delivery Devices second paragraph); and (b) a delivery tube (5/8) in fluidic communication with the drug reservoir for delivery of the pharmaceutical composition to the mouth of the patient (see Fig. 2B).
Heller fails to teach a removable plug comprising an elastomeric polymer for hermetically sealing the delivery tube prior to initial use by the patient, wherein, following removal of the removable plug, the device is ready to be inserted into the mouth of the patient for said intraoral administration.
However, Gelvin teaches a prefilled ocular implant and method that includes the use of a plug (160) pressed into the lumen of the delivery tube (106). See Figs. 2-3 and 5A. The plug (160) is removed immediately prior to use. It is noted that the claim term “for hermetically sealing the delivery tube prior to initial use by the patient” is functional in nature and the prior art only has to be shown to be capable of achieving that function in order to meet the claim limitation. In this case, the plug of Gelvin prevents premature fluid loss through the tube and therefore is capable of also hermetically sealing the interior of the tube prior to use.
At the time of the effective filing of the invention, it would have been obvious to incorporate the plug as taught by Gelvin into the invention of Heller. Both devices are analogous in the art of fluid delivery to structures in the human body; therefore, a combination is proper. Additionally, Gelvin discloses that the use of the plug “prevents fluid from prematurely exiting the implant 102.” See Gelvin para. [0033]. One skilled in the art would have been motivated to incorporate the structure of the plug and the functionality of preventing premature delivery of fluid before use into the invention of Heller in order to impart this feature to prevent fluid loss prior to use.
Regarding claim 25, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller in view of Gelvin teach the drug delivery device of claim 2, and further teach wherein: (c) the removable plug is configured to be removed before insertion of the drug delivery device into the mouth of the patient. Gelvin teaches a prefilled ocular implant and method that includes the use of a plug (160) pressed into the lumen of the delivery tube (106). See Figs. 2-3 and 5A. The plug (160) is removed immediately prior to use.
Regarding claim 39, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller in view of Gelvin teach the drug delivery device of claim 2, wherein: (b) the drug reservoir or the first chamber comprises a rigid housing having a port for filling the drug reservoir or chamber with said pharmaceutical composition that is hermetically sealed with an elastomeric plug comprising a fluorocarbon elastomer that is biocompatible with the oral mucosa and compatible with the pharmaceutical composition. See rejection of claim 2 above.
Regarding claim 42, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller in view of Gelvin teach the drug delivery device of claim 2, and further teach wherein: (c) the fastener is a retainer. See Heller Fig. 2A.
Regarding claim 44, Heller in view of Gelvin teach the drug delivery device of claim 42 and also teach wherein the plastic is an acrylate- containing polymer or a thermoplastic polyolefin (see Heller para [0145].
Regarding claim 58, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller in view of Gelvin teach the drug delivery device of claim 2, and further teach wherein: (c) the pump comprises at least an osmotic pump. See Heller para. [0054].
Regarding claim 63, Heller in view of Gelvin teach the drug delivery device of claim 2 and also teach wherein said pump is a propellant-driven pump (see Heller Figs. 20E-F) and the device comprises: (i) a first chamber (3) comprising the pharmaceutical composition; (ii) a second chamber (67) comprising a propellant; and (iii) a flexible and/or deformable (deformable in its movement, see Heller Fig. 20F) diaphragm (64) separating said first chamber from said second chamber.
Regarding claim 72, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b) or (c) in order to meet the claim limitations. Heller in view of Gelvin teach the drug delivery device of claim 63, wherein: (a) the second chamber comprises a propellant having a vapor pressure of about 4 atm or greater at 37 °C (see Heller para. [0017] and claim 26).
Regarding claim 75, Heller in view of Gelvin teach the drug delivery device of claim 2, and further teach wherein the pharmaceutical composition comprises the drug and one or more excipients (see Heller para. [0135]), and wherein less than about 3% (see Heller para. [0155]) of said drug and of each of said excipients is absorbed by or transported through said delivery tube when the drug delivery device is stored non-frozen for one year (see Heller para. [0153]).
Regarding claim 87, Heller in view of Gelvin discloses a method of administering a pharmaceutical composition into a mouth of a patient, the method comprising: (i) inserting the drug delivery device of claim 2 into the mouth of said patient; (ii) administering said pharmaceutical composition to said patient; and (iii} removing said device from the mouth of said patient. See Heller paras. [0001] and [0013].
Claim(s) 6, 66 and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller in view of US Pub. No. 2018/0070857 to Jones et al. (hereinafter “Jones”).
Regarding claim 6, Heller discloses a drug delivery device configured to be removably inserted in a patient's mouth and for continuous or semi-continuous intraoral administration of a pharmaceutical composition comprising a drug (see at least Figs. 1A, 1B, 2A and 2B), said device comprising: (i) a fastener (1/6) to removably secure said drug delivery device to a surface of said patient’s mouth (see Fig. 1A and Fig. 2A); (ii) a pump (2) comprising a drug reservoir (3) comprising said pharmaceutical composition, the volume of said drug reservoir being from 0.1 mL to 5 mL (see page 37 under Drug Delivery Devices second paragraph); and (b) a flow restrictor (58) in fluidic communication with the drug reservoir (see Figs. 17A-C); and (c) (b) a delivery tube (5/8) in fluidic communication with the drug reservoir for delivery of the pharmaceutical composition to the mouth of the patient (see Fig. 2B), wherein said flow restrictor and/or said delivery tube are hermetically bonded either directly or indirectly to the drug reservoir by an adhesive. It is noted that this last limitation is in the alternative and either the restrictor or delivery tube are hermetically bonded to the drug reservoir. As shown by Heller in Figs. 17A-C, the flow restrictor (58) is hermetically bonded, i.e., no leakage of fluid, as shown by the release of fluid from the flow restrictor. As stated in para. [0081], “In any of the above fluid-delivery devices, the device can include a flow restrictor that sets the infusion rate of the drug (e.g., wherein the length of the flow restrictor sets the infusion rate of the drug, or wherein the infusion rate of the drug is set by cutting the flow restrictor to a predetermined length).” Therefore, while the flow restrictor (58) is not shown in the embodiments of Figs. 1A-16, one is envisioned.
Heller meets the claim limitations as described above but fails to specifically disclose an adhesive. However, using adhesives in medical devices is well known in the art. Jones discloses using an adhesive to join two portions of a housing. See para. [0311]. The adhesive material is cyanoacrylate.
Regarding claim 66, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a) or (b) in order to meet the claim limitations. Heller in view of Jones teaches the drug delivery device of claim 6 and further teaches wherein: (a) the adhesive is acrylate, gum, epoxy, or a sealant (See Jones para. [0311].
Regarding claim 67, Heller in view of Jones teach the drug delivery device of claim 66. At the effective filing date of the invention, it would have been obvious to substitute the adhesive of Jones with an epoxy adhesive as a substitution of equivalents known for the same purpose. Additionally, it is considered inherently necessary that any epoxy comprises two components, a first component comprising compound with two or more epoxide functions and a second component comprising a compound with two or more amine functions.
Claim(s) 4 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller in view of US 6,264,921 to Johnson et al. (hereinafter “Johnson”) and US 2013/0245592 to Glaser et al. (hereafter “Glaser”).
Regarding claim 4, Heller meets the claim limitations as described above for claim 3 and further includes the drug reservoir comprises a rigid housing (4) but fails to include that the housing has a port for filling the drug reservoir with said pharmaceutical composition that is hermetically sealed with an elastomeric plug comprising a fluorocarbon elastomer that is biocompatible with the oral mucosa and compatible with the pharmaceutical composition.
However, Johnson teaches a drug reservoir (see Fig. 1) comprising a rigid housing (10) having a port (20) for filling the drug reservoir with said pharmaceutical composition (see needle 22 and column 3 lines 21-24 stating, “Drug pump 10 operates with one or more introducer needles 22 that are used to introduce fluid beyond injection port 20 and into reservoir 14.”) that is hermetically sealed, i.e., no leaking of liquid or air, with an elastomeric plug (21). At the time of the effective filing date of the invention, it would have been obvious to incorporate the plug as taught by Johnson into the invention of Heller. Filling ports/septums are well known in the medical drug delivery art and incorporating the septum of Johnson into the invention of Heller would have been done in order to provide an aseptic reservoir filling area for the device. One skilled in the art would have anticipated predictable resulting in being able to fill the reservoir before use of the device.
Heller in view of Johnson meet the claim limitations as described above but fail to include that the plug/septum is a fluorocarbon elastomer that is biocompatible with the oral mucosa and compatible with the pharmaceutical composition.
However, Viton (see para. [0051]) is disclosed in Glaser as being used as a septum and is impermeable and compatible (see para. [0029]. The motivation to incorporate the material of Glaser would have been due to its suitability as a septum. One skilled in the art would have expected predictable results in that the septum being made from Viton would allow for filling of the device and provide fluid impermeability and compatibility.
Regarding claim 51, Heller in view of Johnson and Glaser teach the drug delivery device of claim 4. It is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a) or (b) in order to meet the claim limitations. Also, the limitation of (a) is considered a product by process claim and the determination of patentability is based on the product itself. Heller in view of Johnson and Glaser teach (a) the elastomeric plug (21) is an injection molded elastomeric plug. At the effective filing date of the invention, it would have been obvious to make the elasomeric plug (21) by injection molding since this is a well known manufacturing process.
Claim(s) 5 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heller in view of US Pat. No. 5,842,860 to Funt (hereinafter “Funt”).
Regarding claim 5, Heller meets the claim limitations as described above for claim 3 but fails to teach the fastener comprising a pocket that is fabricated as an integral part of the fastener for securing the drug delivery device to a buccal side of an upper molar of the patient, and wherein the pocket is configured to position the drug delivery device coplanar with an occlusal plane of the molar.
However, Funt teaches a fastener (20) comprising a pocket (50) that is fabricated as an integral part of the fastener (see Fig. 6) for securing the drug delivery device to a buccal side of an upper molar of the patient (see column 6, lines 28-32 stating, “Formed within the buccal flange 44 are a pair of cavities or chambers 50 for holding the containers 18. The chambers 50 are located on opposite sides of the appliance 20 to locate the containers 18 between the cheek and the teeth/gums on opposite sides of the mouth.”), and wherein the pocket is configured to position the drug delivery device coplanar with an occlusal plane of the molar (see Fig. 2). As stated by Funt at column 2, lines 3-8, “it is preferable that the device adequately secures the agent yet does not cause irritation and is easy for the user to securely insert and remove from their mouth. Furthermore, it is preferable that the device can be used by patients with and without dentures.”
At the effective filing of the invention, it would have been obvious to one skilled in the art to substitute the fastener of Heller with the fastener including pocket of Funt. Both devices are analogous in the art of retainers to deliver medicament into a patient’s mouth; therefore, a combination is proper. Additionally, the motivation is provided by Funt in the desire to provide an appliance/fastener that is securely positioned within the mouth, does not cause irritation yet is easy to remove. The substitution would enable Heller to have enhanced useability.
Regarding claim 40, it is noted that the limitations after the wherein clause on line 1 are written in the alternative. Therefore, it is understood that the prior art only has to disclose one of (a), (b), (c), (d), (e) or (f) in order to meet the claim limitations. Heller in view of Funt teaches the drug delivery device of claim 5 and also includes wherein: (a) the pocket is configured to position the drug delivery device coplanar with the occlusal plane of the first or second molar (see Figs. 1 and 2); and (d) the pocket is configured such that the patient’s oral anatomy would mechanically interfere with and prevent the removal of the drug delivery device from the pocket when the fastener is attached to the surface of the patient’s mouth (see Fig. 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993