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 .
In light of the amendments to the claims filed 04/22/2025 in which claims 28-31 were added, claims 19 and 26-27 were amended, and claim 25 was cancelled, claims 19-20, 22-23, and 26-31 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/US2020/020656 filed 03/02/2020 which claims priority to U.S. Provisional no. 62/813,608 filed on 03/04/2019.
Claims 19-20, 22-23, and 26-31 receive the filing date of the prior-filed Application, 03/04/2019.
Response to Arguments
Priority
Regarding the priority date of the claims, the applicant generally asserts that U.S. Provisional Application no. 62/813,608 provides support for pilocarpine as a single active agent.
The examiner acknowledges the applicant’s argument and respectfully disagrees in so far as the applicant has not provided any proof to this assertion; however, in light of the amendments to the claims to delete “as a single active agent”, priority to the Provisional Application has been restored as noted above.
Rejections of the Claims under 35 U.S.C. 103:
Applicant’s arguments, see pg. 6-7 (Priority), filed 04/22/2025, with respect to the previous rejection(s) of claim(s) 19-23 and 25-28 under 35 U.S.C. 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 Therefore, the rejection has been withdrawn.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/2014/0200211 A1 to Abad. In conclusion, the claim amendments which have disqualified some of Ivri’s disclosures as prior art have necessitated new grounds of rejection.
Applicant’s arguments, see pg. 6-7 (Response to Arguments), filed 04/22/2025 have been fully considered and they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
In the Remarks filed 11/06/2024 and referenced in the Response to Arguments filed 04/22/2025, the applicant submitted that the use of the methods disclosed in the specification and recited in the pending claims avoid certain adverse events, such as headache and brow ache, that are common symptoms of utilizing pilocarpine in the treatment of presbyopia as shown by the study in the affidavit (Rowe affidavit filed 05/10/2024) and that these results (avoidance of common adverse events) may be considered unexpected and evidentiary of nonobviousness.
In response to the applicant’s previously provided argument, the examiner acknowledges the applicant’s argument and respectfully disagrees in light of the newly provided prior art to Abad. According to MPEP 716.02, “Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)”. The prior art to Abad as utilized in the current rejection discloses that when used in the treatment of presbyopia, the methods of their invention in which an ophthalmic agent, such as pilocarpine, is delivered along at a therapeutically effective amount with a non-steroidal anti-inflammatory agent (NSAID) to an ocular location by a spray delivery device may result in a patient not experiencing the undesirable side effects of the administered ophthalmic agent: including red eyes, ocular pain, myopia, headache, and brow ache (Abad: para. 0012; para. 0027; para. 0033; para. 0071). By extension, the method of Wilkerson as usable to create a spray of an ophthalmic agent would be considered to provide the same results when utilized with pilocarpine as taught by Abad; therefore, the asserted unexpected results shown by the applicant may be considered to be expected at least in view of the disclosures of Abad and Wilkerson. According to MPEP 716.02(b)(I), “Burden on Applicant to Establish Results are Unexpected and Significant”, “The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. As it has been shown that the results are not unexpected in view of Abad and Wilkerson, the applicant has not met their burden for establishing unexpected results.
In making the determination of patentability, the evidence supporting patentability must be weighed against the evidence supporting a prima facie case of nonobviousness. See MPEP §716.01(d), “The submission of objective evidence of patentability does not mandate a conclusion of patentability in and of itself. In re Chupp, 816 F.2d 643, 2 USPQ2d 1437 (Fed. Cir. 1987). Facts established by rebuttal evidence must be evaluated along with the facts on which the conclusion of a prima facie case was reached, not against the conclusion itself. In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). In other words, each piece of rebuttal evidence should not be evaluated for its ability to knockdown the prima facie case. All of the competent rebuttal evidence taken as a whole should be weighed against the evidence supporting the prima facie case. In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984).” In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Applicant’s arguments, see pg. 7-8, filed 04/22/2025, with respect to the rejection of claim 26 under 35 U.S.C. 103 have been fully considered and they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claim 26, the applicant asserts that the spring element of Van Der Mark is different than the presently claimed lip.
In response to the applicant’s argument, the examiner acknowledges the applicant’s argument and respectfully disagrees. The applicant asserts that in the present claims, the phrase “exerts a spring-load” means that the lip is designed to dampen vibrations, which is in stark contrast to the spring element of Mark that is designed to vibrate. MPEP 2111.01 states, “"Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment." Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See also Liebel-Flarsheim Co. v. Medrad Inc., 358 F.3d 898, 906, 69 USPQ2d 1801, 1807 (Fed. Cir. 2004) “. While in the specification the lip is configured to dampen vibrations, the claim does not require this. The phrase “exerts a spring-load” may be understood by one of ordinary skill in the art to mean “applies a spring force”. It’s clear through the disclosure of Mark that the spring element applies a spring force to the generator plate in a direction of a central axis of the generator plate upon vibration by the piezoelectric actuator (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element into vertical vibratory motion at the connection to 38 membrane; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle); therefore, Mark does read on the limitation at issue.
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 26, 29, and 31 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.
Claims 26, 29, and 31 recite the limitation "a lip arranged adjacent to a generator plate" in ln. 8. This limitation is indefinite in that it is unclear whether the generator plate at ln. 8 is the same generator plate as recited in ln. 3 of the claims. For the sake of compact prosecution, the examiner is treating the claim as though it reads “a lip arranged adjacent to the generator plate”.
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.
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.
Claims 19-20, 22, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over US/2014/0336618 A1 to Wilkerson in view of US/2014/0200211 A1 to Abad.
Regarding claim 19, Wilkerson discloses a method of treating eye diseases (para. 0083), the method comprising: (a) generating droplets via a piezoelectric delivery device (Fig. 1, 1600 piezoelectric delivery device; para. 0009 ln. 5-9; para. 0136 ln. 1-6), wherein the droplets: (i) comprise an ophthalmic fluid composition (para. 0009 ln. 5-6; para. 0066); (ii) have an average diameter of 15-100 microns (para. 0074 ln. 4-9); (iii) have a volume of 0.5-10 microliters (para. 0069 ln. 9-13); (iv) have an average initial ejecting velocity of 0.5-20 m/s (para. 0074 ln. 12-15); (b) administering the droplets via the piezoelectric delivery device once-a-day to the eye of the subject (para. 0009 ln. 9-12; para. 0071 ln. 1-5).
Wilkerson differs from the instantly claimed invention in that Wilkerson fails to explicitly disclose the droplets having an average diameter of 35-100 microns, a volume of 7-10 microliters, and an average initial ejecting velocity of 2-5 m/s.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the average diameter, volume, and initial ejecting velocity of the droplets of Wilkerson from between 15-100 microns, 0.5-10 microliters, and 0.5-20 m/s to 35-100 microns, 7-10 microliters, and 2-5 m/s as applicant appears to have placed no criticality on the claimed range (see pp. [0046] indicating the average diameter “may” be within the claimed range; pp. [0010] indicating that the volume “is less than 13 microliters, less than 10 microliters, less than 5 microliters, 3-7 microliters, etc.”; pp. [0049] indicating the velocity “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Further, Wilkerson differs from the instantly claimed invention in that Wilkerson fails to disclose the droplets comprising pilocarpine at a concentration of 0.01-4.0% by weight to treat presbyopia.
Abad teaches a method of treating presbyopia in an eye of a subject in need thereof (para. 0012), the method comprising generating droplets via a delivery device (para. 0054; para. 0060), wherein the droplets comprise pilocarpine at a concentration of about 0.01% to 4.0% by weight (para. 0036) and; administering the droplets via the delivery device to the eye of the subject, thereby treating presbyopia (para. 0054; para. 0060).
Abad is considered to be analogous to the instantly claimed invention in that Abad discloses a method for treating eye diseases utilizing a spray device. It would be considered obvious to one of ordinary skill in the art to utilize the method of Wilkerson with the ophthalmic composition in the treatment of presbyopia as taught by Abad, because Wilkerson discloses their device and method for use in treating ophthalmic diseases (para. 0006; para. 0071; para. 0083), and Abad teaches an ophthalmic composition that may be provided as a spray (para. 0054) and further that delivering said ophthalmic composition comprising pilocarpine at an increased concentration in combination with a non-steroidal anti-inflammatory agent (NSAID) produces an effect to treat presbyopia without the patient experiencing the undesirable side effects normally associated with pilocarpine therapy (para. 0012; para. 0027; para. 0033; para. 0071), thereby making the treatment of presbyopia more comfortable for a patient.
The combination of the prior art differs from the instantly claimed invention in that they fail to explicitly disclose the concentration of pilocarpine being 1-3% by weight.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of pilocarpine in the droplets of Wilkerson, as modified by Abad, from between 0.01-4.0% by weight to 1-3% by weight as applicant appears to have placed no criticality on the claimed range (see pp. [0010] indicating that the concentration is “at least about 0.5% by weight, at least about 1% by weight, at least about 2 % by weight, at least about 3% by weight, at least about 4% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, from about 0.5 to about 1% by weight, from about 0.5 to about 2% by weight, from about 0.5 to about 3% by weight, from about 0.5 to about 4% by weight, from about 1% to about 2% by weight, from about 1% to about 3% by weight, from about 1% to about 4% by weight, etc.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 20, the combination of Wilkerson and Abad discloses the method of claim 19, the combination further discloses: wherein the droplets comprise pilocarpine at a concentration of about 0.01-4.0% by weight (Abad: para. 0036).
The combination of the prior art differs from the instantly claimed invention in that they fail to explicitly disclose the concentration of pilocarpine being about 2% by weight.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of pilocarpine in the droplets of Wilkerson, as modified by Abad, from between 0.01-4.0% by weight to about 2% by weight as applicant appears to have placed no criticality on the claimed range (see pp. [0010] indicating that the concentration is “at least about 0.5% by weight, at least about 1% by weight, at least about 2 % by weight, at least about 3% by weight, at least about 4% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, from about 0.5 to about 1% by weight, from about 0.5 to about 2% by weight, from about 0.5 to about 3% by weight, from about 0.5 to about 4% by weight, from about 1% to about 2% by weight, from about 1% to about 3% by weight, from about 1% to about 4% by weight, etc.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 22, the combination of Wilkerson and Abad discloses the method of claim 19, the combination further discloses: wherein the droplets have an average initial ejecting velocity of 0.5 m/s to 20 m/s (Wilkerson: para. 0074 ln. 12-15).
The combination of the prior art differs from the instantly claimed invention in that they fail to explicitly disclose the droplets having an average initial ejecting velocity of 3-4 m/s.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the average diameter, volume, and initial ejecting velocity of the droplets of Wilkerson, as modified by Abad, from between 0.5-20 m/s to 3-4 m/s as applicant appears to have placed no criticality on the claimed range (see pp. [0049] indicating the velocity “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 27, Wilkerson discloses a method of treating eye diseases (para. 0083), the method comprising: (a) generating droplets via a piezoelectric delivery device (Fig. 1, 1600 piezoelectric delivery device; para. 0009 ln. 5-9; para. 0136 ln. 1-6), wherein the droplets: (i) comprise an ophthalmic fluid composition (para. 0009 ln. 5-6; para. 0066); (ii) have an average diameter of 15-100 microns (para. 0074 ln. 4-9); (iii) have a volume of 0.5-10 microliters (para. 0069 ln. 9-13); (iv) have an average initial ejecting velocity of 0.5-20 m/s (para. 0074 ln. 12-15); (b) administering the droplets via the piezoelectric delivery device once-a-day to the eye of the subject (para. 0009 ln. 9-12; para. 0071 ln. 1-5).
Wilkerson differs from the instantly claimed invention in that Wilkerson fails to explicitly disclose the droplets having an average diameter of about 55-100 microns, a volume of about 8 microliters, and an average initial ejecting velocity of about 3-4 m/s.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the average diameter, volume, and initial ejecting velocity of the droplets of Wilkerson from between 15-100 microns, 0.5-10 microliters, and 0.5-20 m/s to about 55-100 microns, about 8 microliters, and about 3-4 m/s as applicant appears to have placed no criticality on the claimed range (see pp. [0046] indicating the average diameter “may” be within the claimed range; pp. [0010] indicating that the volume “is less than 13 microliters, less than 10 microliters, less than 5 microliters, 3-7 microliters, etc.”; pp. [0049] indicating the velocity “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Further, Wilkerson differs from the instantly claimed invention in that Wilkerson fails to disclose the droplets comprising pilocarpine at a concentration of 2% by weight to treat presbyopia.
Abad teaches a method of treating presbyopia in an eye of a subject in need thereof (para. 0012), the method comprising generating droplets via a delivery device (para. 0054; para. 0060), wherein the droplets comprise pilocarpine at a concentration of about 0.01% to 4.0% by weight (para. 0021; para. 0036) and; (b) administering the droplets via the delivery device to the eye of the subject, thereby treating presbyopia (para. 0054; para. 0060).
Abad is considered to be analogous to the instantly claimed invention in that Abad discloses a method for treating eye diseases utilizing a spray device. It would be considered obvious to one of ordinary skill in the art to utilize the method of Wilkerson with the ophthalmic composition in the treatment of presbyopia as taught by Abad, because Wilkerson discloses their device and method for use in treating ophthalmic diseases (para. 0006; para. 0071; para. 0083), and Abad teaches an ophthalmic composition that may be provided as a spray (para. 0054) and further that delivering said ophthalmic composition comprising pilocarpine at an increased concentration in combination with a non-steroidal anti-inflammatory agent (NSAID) produces an effect to treat presbyopia without the patient experiencing the undesirable side effects normally associated with pilocarpine therapy (para. 0012; para. 0027; para. 0033; para. 0071), thereby making the treatment of presbyopia more comfortable for a patient.
The combination of the prior art differs from the instantly claimed invention in that they fail to explicitly disclose the concentration of pilocarpine being 2% by weight.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of pilocarpine in the droplets of Wilkerson, as modified by Abad, from between 0.5-5% by weight to 2% by weight as applicant appears to have placed no criticality on the claimed range (see pp. [0010] indicating that the concentration is “at least about 0.5% by weight, at least about 1% by weight, at least about 2 % by weight, at least about 3% by weight, at least about 4% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, from about 0.5 to about 1% by weight, from about 0.5 to about 2% by weight, from about 0.5 to about 3% by weight, from about 0.5 to about 4% by weight, from about 1% to about 2% by weight, from about 1% to about 3% by weight, from about 1% to about 4% by weight, etc.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 30, Wilkerson discloses a method of treating eye diseases (para. 0083), the method comprising: (a) generating droplets via a piezoelectric delivery device (Fig. 1, 1600 piezoelectric delivery device; para. 0009 ln. 5-9; para. 0136 ln. 1-6), wherein the droplets: (i) comprise an ophthalmic fluid composition (para. 0009 ln. 5-6; para. 0066); (ii) have an average diameter of 15-100 microns (para. 0074 ln. 4-9); (iii) have a volume of 0.5-10 microliters (para. 0069 ln. 9-13); (iv) have an average initial ejecting velocity of 0.5-20 m/s (para. 0074 ln. 12-15); (b) administering the droplets via the piezoelectric delivery device once-a-day to the eye of the subject (para. 0009 ln. 9-12; para. 0071 ln. 1-5).
Wilkerson differs from the instantly claimed invention in that Wilkerson fails to explicitly disclose the droplets having an average diameter of about 35-100 microns, a volume of about 7-8 microliters, and an average initial ejecting velocity of about 3-5 m/s.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the average diameter, volume, and initial ejecting velocity of the droplets of Wilkerson from between 15-100 microns, 0.5-10 microliters, and 0.5-20 m/s to about 35-100 microns, about 7-8 microliters, and about 3-5 m/s as applicant appears to have placed no criticality on the claimed range (see pp. [0046] indicating the average diameter “may” be within the claimed range; pp. [0010] indicating that the volume “is less than 13 microliters, less than 10 microliters, less than 5 microliters, 3-7 microliters, etc.”; pp. [0049] indicating the velocity “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Further, Wilkerson differs from the instantly claimed invention in that Wilkerson fails to disclose the droplets comprising pilocarpine at a concentration of about 1.5-2.5% by weight to treat presbyopia.
Abad teaches a method of treating presbyopia in an eye of a subject in need thereof (para. 0012), the method comprising generating droplets via a delivery device (para. 0054; para. 0060), wherein the droplets comprise pilocarpine at a concentration of about 0.01% to 4.0% by weight (para. 0021; para. 0036) and; (b) administering the droplets via the delivery device to the eye of the subject, thereby treating presbyopia (para. 0054; para. 0060).
Abad is considered to be analogous to the instantly claimed invention in that Abad discloses a method for treating eye diseases utilizing a spray device. It would be considered obvious to one of ordinary skill in the art to utilize the method of Wilkerson with the ophthalmic composition in the treatment of presbyopia as taught by Abad, because Wilkerson discloses their device and method for use in treating ophthalmic diseases (para. 0006; para. 0071; para. 0083), and Abad teaches an ophthalmic composition that may be provided as a spray (para. 0054) and further that delivering said ophthalmic composition comprising pilocarpine at an increased concentration in combination with a non-steroidal anti-inflammatory agent (NSAID) produces an effect to treat presbyopia without the patient experiencing the undesirable side effects normally associated with pilocarpine therapy (para. 0012; para. 0027; para. 0033; para. 0071), thereby making the treatment of presbyopia more comfortable for a patient.
The combination of the prior art differs from the instantly claimed invention in that they fail to explicitly disclose the concentration of pilocarpine being 1.5-2.5% by weight.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the concentration of pilocarpine in the droplets of Wilkerson, as modified by Abad, from between 0.5-5% by weight to about 1.5-2.5% by weight as applicant appears to have placed no criticality on the claimed range (see pp. [0010] indicating that the concentration is “at least about 0.5% by weight, at least about 1% by weight, at least about 2% by weight, at least about 3% by weight, at least about 4% by weight, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, from about 0.5 to about 1% by weight, from about 0.5 to about 2% by weight, from about 0.5 to about 3% by weight, from about 0.5 to about 4% by weight, from about 1% to about 2% by weight, from about 1% to about 3% by weight, from about 1% to about 4% by weight, etc.”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 23 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkerson and Abad as applied above, and further in view of U.S. Patent 8684980 B2 to Hunter.
Regarding claim 23, the combination of Wilkerson and Abad discloses the invention of claim 19; however, the combination differs from the instantly claimed invention in that the prior art fails to disclose wherein the droplets are delivered from the piezoelectric delivery device to the eye in less than 80 ms.
Hunter teaches a stream of droplets delivered to an eye of a subject in 50-300 ms (col. 20 ln. 16-19; Fig. 16A showing 1612 droplets being delivered to 1616 eye of a subject).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method and device of Wilkerson and Abad to deliver the micro-dose stream of droplets to the eye of the subject in 50-300 ms as taught by Hunter, because Hunter teaches that the human eye takes about 300-400 ms between blinks and that delivering the ejected droplets within 50-300 ms allows for the droplets to be effectively delivered and deposited to the eye during a blinking cycle (col. 20 ln. 13-25).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery time of the stream of droplets of Wilkerson, as modified by Abad and Hunter, from between 50-300 ms to less than 80 ms as applicant appears to have placed no criticality on the claimed range ([0010] “the micro-dose stream of droplets is delivered to the eye of the subject in less than 80 ms”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Wilkerson would not operate differently with the claimed range and since the system of Wilkerson is meant to deliver the stream of droplets between blinks. Further, applicant places no criticality on the range claimed, indicating simply that the delivery time of the stream of droplets is less than 80 ms ([0010] “the micro-dose stream of droplets is delivered to the eye of the subject in less than 80 ms”).
Regarding claim 28, the combination of Wilkerson and Abad discloses the invention of claim 27; however, the combination differs from the instantly claimed invention in that the prior art fails to disclose wherein the droplets are delivered from the piezoelectric delivery device to the eye in less than 80 ms.
Hunter teaches a stream of droplets delivered to an eye of a subject in 50-300 ms (col. 20 ln. 16-19; Fig. 16A showing 1612 droplets being delivered to 1616 eye of a subject).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method and device of Wilkerson and Abad to deliver the micro-dose stream of droplets to the eye of the subject in 50-300 ms as taught by Hunter, because Hunter teaches that the human eye takes about 300-400 ms between blinks and that delivering the ejected droplets within 50-300 ms allows for the droplets to be effectively delivered and deposited to the eye during a blinking cycle (col. 20 ln. 13-25).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery time of the stream of droplets of Wilkerson, as modified by Abad and Hunter, from between 50-300 ms to less than 80 ms as applicant appears to have placed no criticality on the claimed range ([0010] “the micro-dose stream of droplets is delivered to the eye of the subject in less than 80 ms”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, Wilkerson would not operate differently with the claimed range and since the system of Wilkerson is meant to deliver the stream of droplets between blinks. Further, applicant places no criticality on the range claimed, indicating simply that the delivery time of the stream of droplets is less than 80 ms ([0010] “the micro-dose stream of droplets is delivered to the eye of the subject in less than 80 ms”).
Claims 26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkerson and Abad as applied above, and further in view of US/2012/0285446 A1 to Van Der Mark (hereinafter referred to as “Mark”).
Regarding claim 26, the combination of Wilkerson and Abad discloses the method of claim 1, the combination further discloses: wherein the piezoelectric droplet delivery device (Wilkerson: Fig. 1, 1600 piezoelectric delivery device; para. 0093) comprises: (i) an ejector mechanism (Wilkerson: Fig. 1, 1601 ejector mechanism), the ejector mechanism comprising a generator plate (Wilkerson: Fig. 3A, 1602 generator plate) and a piezoelectric actuator (Wilkerson: Fig. 3A, 1604 piezoelectric actuator), wherein the generator plate includes a plurality of openings formed through its thickness (Wilkerson: Fig. 3A, 1626 openings; para. 0093); and wherein the piezoelectric actuator is operable to directly or indirectly oscillate the generator plate, at a frequency to generate the droplets (Wilkerson: para. 0073; para. 0099-0100), and an enclosure positioned adjacent a fluid side of the generator plate (Wilkerson: Fig. 1, 1620 reservoir positioned at the fluid side of 1602 generator plate), the enclosure and the generator plate forming a chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate forming a chamber for 1610 fluid), wherein the enclosure includes a wall (Wilkerson: Fig. 1 showing 1620 reservoir bounded by 1650 reservoir wall), the enclosure and the generator plate together defining the chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate defining the chamber for 1610 fluid); however, the combination of the prior art differs from the instantly claimed invention in that they fail to disclose a lip arranged adjacent to the generator plate and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate.
Mark teaches a lip arranged adjacent a generator plate (Fig. 3, 48 spring lip arranged adjacent 38 generator plate) and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element into vertical vibratory motion at the connection to 38 membrane; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle); the lip positioned adjacent a fluid side of the generator plate (Fig. 3 showing 48 spring lip positioned adjacent 52 fluid chamber); and the lip extending around a plurality of openings (Fig. 6 showing 48 spring lip extending around entirety of 38 generator plate).
Mark is considered to be analogous to the instantly claimed invention in that Mark discloses a device for generating an aerosol composition. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the piezoelectric delivery device of Wilkerson and Abad to further comprise a lip as taught by Mark, because Mark teaches that providing a spring lip between the membrane/generator plate and piezoelectric actuator allows for the membrane to be easily replaced without the loss of oscillation of the membrane by the piezoelectric actuator (para. 0030-0032). This is advantageous as the membrane is subject to deterioration, and cleaning of the membrane is cumbersome (para. 0004).
Regarding the limitation “wherein the piezoelectric actuator oscillates the generator plate to which the spring-load is exerted by the lip”, the combined invention of Wilkerson, Abad, and Mark reads on the limitation in that Wilkerson discloses the piezoelectric actuator oscillating the generator plate (para. 0073; para. 0099-0100) and Mark teaches a lip connected between the piezoelectric actuator and the generator plate that exerts a spring-load on the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element [Arrow A] into vertical vibratory motion at the connection to 38 membrane [Arrow B]; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle).
Regarding claim 29, the combination of Wilkerson and Abad discloses the method of claim 27, the combination further discloses: wherein the piezoelectric droplet delivery device (Wilkerson: Fig. 1, 1600 piezoelectric delivery device; para. 0093) comprises: (i) an ejector mechanism (Wilkerson: Fig. 1, 1601 ejector mechanism), the ejector mechanism comprising a generator plate (Wilkerson: Fig. 3A, 1602 generator plate) and a piezoelectric actuator (Wilkerson: Fig. 3A, 1604 piezoelectric actuator), wherein the generator plate includes a plurality of openings formed through its thickness (Wilkerson: Fig. 3A, 1626 openings; para. 0093); and wherein the piezoelectric actuator is operable to directly or indirectly oscillate the generator plate, at a frequency to generate the droplets (Wilkerson: para. 0073; para. 0099-0100), and an enclosure positioned adjacent a fluid side of the generator plate (Wilkerson: Fig. 1, 1620 reservoir positioned at the fluid side of 1602 generator plate), the enclosure and the generator plate forming a chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate forming a chamber for 1610 fluid), wherein the enclosure includes a wall (Wilkerson: Fig. 1 showing 1620 reservoir bounded by 1650 reservoir wall), the enclosure and the generator plate together defining the chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate defining the chamber for 1610 fluid); however, the combination of the prior art differs from the instantly claimed invention in that they fail to disclose a lip arranged adjacent to the generator plate and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate.
Mark teaches a lip arranged adjacent a generator plate (Fig. 3, 48 spring lip arranged adjacent 38 generator plate) and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element into vertical vibratory motion at the connection to 38 membrane; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle); the lip positioned adjacent a fluid side of the generator plate (Fig. 3 showing 48 spring lip positioned adjacent 52 fluid chamber); and the lip extending around a plurality of openings (Fig. 6 showing 48 spring lip extending around entirety of 38 generator plate).
Mark is considered to be analogous to the instantly claimed invention in that Mark discloses a device for generating an aerosol composition. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the piezoelectric delivery device of Wilkerson and Abad to further comprise a lip as taught by Mark, because Mark teaches that providing a spring lip between the membrane/generator plate and piezoelectric actuator allows for the membrane to be easily replaced without the loss of oscillation of the membrane by the piezoelectric actuator (para. 0030-0032). This is advantageous as the membrane is subject to deterioration, and cleaning of the membrane is cumbersome (para. 0004).
Regarding the limitation “wherein the piezoelectric actuator oscillates the generator plate to which the spring-load is exerted by the lip”, the combined invention of Wilkerson, Abad, and Mark reads on the limitation in that Wilkerson discloses the piezoelectric actuator oscillating the generator plate (para. 0073; para. 0099-0100) and Mark teaches a lip connected between the piezoelectric actuator and the generator plate that exerts a spring-load on the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element [Arrow A] into vertical vibratory motion at the connection to 38 membrane [Arrow B]; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle).
Regarding claim 31, the combination of Wilkerson and Abad discloses the method of claim 30, the combination further discloses: wherein the piezoelectric droplet delivery device (Wilkerson: Fig. 1, 1600 piezoelectric delivery device; para. 0093) comprises: (i) an ejector mechanism (Wilkerson: Fig. 1, 1601 ejector mechanism), the ejector mechanism comprising a generator plate (Wilkerson: Fig. 3A, 1602 generator plate) and a piezoelectric actuator (Wilkerson: Fig. 3A, 1604 piezoelectric actuator), wherein the generator plate includes a plurality of openings formed through its thickness (Wilkerson: Fig. 3A, 1626 openings; para. 0093); and wherein the piezoelectric actuator is operable to directly or indirectly oscillate the generator plate, at a frequency to generate the droplets (Wilkerson: para. 0073; para. 0099-0100), and an enclosure positioned adjacent a fluid side of the generator plate (Wilkerson: Fig. 1, 1620 reservoir positioned at the fluid side of 1602 generator plate), the enclosure and the generator plate forming a chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate forming a chamber for 1610 fluid), wherein the enclosure includes a wall (Wilkerson: Fig. 1 showing 1620 reservoir bounded by 1650 reservoir wall), the enclosure and the generator plate together defining the chamber (Wilkerson: Fig. 1 showing 1620 reservoir and 1602 generator plate defining the chamber for 1610 fluid); however, the combination of the prior art differs from the instantly claimed invention in that they fail to disclose a lip arranged adjacent to the generator plate and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate.
Mark teaches a lip arranged adjacent a generator plate (Fig. 3, 48 spring lip arranged adjacent 38 generator plate) and configured to exert a spring-load to the generator plate in a direction of a central axis of the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element into vertical vibratory motion at the connection to 38 membrane; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle); the lip positioned adjacent a fluid side of the generator plate (Fig. 3 showing 48 spring lip positioned adjacent 52 fluid chamber); and the lip extending around a plurality of openings (Fig. 6 showing 48 spring lip extending around entirety of 38 generator plate).
Mark is considered to be analogous to the instantly claimed invention in that Mark discloses a device for generating an aerosol composition. It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the piezoelectric delivery device of Wilkerson and Abad to further comprise a lip as taught by Mark, because Mark teaches that providing a spring lip between the membrane/generator plate and piezoelectric actuator allows for the membrane to be easily replaced without the loss of oscillation of the membrane by the piezoelectric actuator (para. 0030-0032). This is advantageous as the membrane is subject to deterioration, and cleaning of the membrane is cumbersome (para. 0004).
Regarding the limitation “wherein the piezoelectric actuator oscillates the generator plate to which the spring-load is exerted by the lip”, the combined invention of Wilkerson, Abad, and Mark reads on the limitation in that Wilkerson discloses the piezoelectric actuator oscillating the generator plate (para. 0073; para. 0099-0100) and Mark teaches a lip connected between the piezoelectric actuator and the generator plate that exerts a spring-load on the generator plate (para. 0028; para. 0030; para. 0033; para. 0047; Fig. 3, 48 spring lip as a z-shaped spring through connection to 44 piezoelectric element changes horizontal vibratory motion created by 44 piezoelectric element [Arrow A] into vertical vibratory motion at the connection to 38 membrane [Arrow B]; therefore, as a spring it exerts a spring-load [force exerted by a spring upon compression and extension] upon 38 membrane along the central axis of 38 membrane passing vertically through the center of 38 membrane as a planar circle).
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.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781