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 .
Status of Claims
Claims 1-3, 5-13, 15-21, and 23 are pending and currently under consideration for patentability.
Response to Arguments
Applicant's arguments filed 6/9/2025 have been fully considered but they are not persuasive.
In response the to the applicant’s argument that since the invention is a syringe-type container, it would not have been obvious to compress the cartridge, the examiner respectfully disagrees. A cartridge is generally understood in the art to be “self-contained unit holding a substance or device, which is easily inserted or replaced in a larger mechanism”. This would meet the prior art unit (10) and the fact that the prior art is explicitly defined as a syringe does take away that the claim language still reads on such prior art.
Applicant’s arguments, see pages 6-9, filed 6/9/2025, with respect to the rejection(s) of claim(s) 1-3, 5-13, 15-21, and 23 under USC regarding the radial actuator 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 Therefore, the rejection has been withdrawn.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 Meshberg (US 20200269258 A1). This action is now second non-final.
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.
Claim(s) 1, 7, 10-11, 15, 17, 20-22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2) in view of Meshberg (US 20200269258 A1).
Regarding Claim 1, Schaller teaches an apparatus comprising:
a housing (115) defines at least a first receptacle that is configured to receive and support a cartridge (10) having a solution therein, the first receptacle having a central axis (figure 3); and
an actuator (705) that is coupled to the housing (115) and movable between a first position and a second position (column 6, lines 9-23) , wherein the actuator (705) comprises an engagement element (405) that is configured to contact and radially compress a circumferential outer surface of the cartridge toward the central axis of the first receptacle (FIG. 1B and FIG. 4),
wherein in the first position, the engagement element of the actuator is radially spaced from the central axis of the first receptacle by a first distance (FIG. 1B and FIG. 4) (column 7, lines 44-62), and
wherein in the second position, the engagement element of the actuator is positioned at least partly within the first receptacle and radially spaced from the central axis of the first receptacle by a second distance that is less than the first distance (FIG. 1B and FIG. 4) (column 7, lines 44-62).
Schaller fails to teach an engagement element that is configured to contact and radially compress a circumferential outer surface. Meshberg teaches a nasal spray device wherein an engagement element that is configured to contact and radially compress a circumferential outer surface (paragraph [0013])(paragraph [0053]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Schaller to have a radial actuator, similar to Meshberg in order to be compatible with a device with a non-flat surface (as motivated by Meshberg, paragraph [0053]).
Regarding Claim 7, Schaller in view of Meshberg teaches the apparatus of claim 6. Schaller further teaches wherein the frame (10) defines the first receptacle and the second receptacle (Annotated figure 4).
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Regarding Claim 10, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller further teaches, further comprising the cartridge, wherein the cartridge contains an eye drop solution (column 4, lines 41-52).
Regarding Claim 11, Schaller teaches a method comprising:
positioning a cartridge within a first receptacle of a housing of an apparatus, the cartridge containing a solution (column 4, lines 41-52), the cartridge having a circumferential outer surface, the first receptacle having a central axis, the apparatus further comprising an actuator (705) that is coupled to the housing and movable between a first position and a second position (column 6, lines 9-23), wherein the actuator comprises an engagement element, wherein in the first position, the engagement element of the actuator is radially spaced from the central axis of the first receptacle by a first distance (FIG. 1B and FIG. 4) (column 7, lines 44-62),; and
moving the actuator from the first position to the second position to contact and radially compress the circumferential outer surface of the cartridge toward the central axis of the first receptacle, wherein in the second position, the engagement element of the actuator is positioned within the first receptacle and radially spaced from the central axis of the first receptacle by a second distance that is less than the first distance (FIG. 1B and FIG. 4) (column 7, lines 44-62,
wherein in the second position, the engagement element of the actuator radially compresses the circumferential outer surface of the cartridge to dispense a quantity of the solution within the cartridge (FIG. 1B and FIG. 4) (column 7, lines 44-62. Schaller fails to teach an engagement element that is configured to contact and radially compress a circumferential outer surface. Meshberg teaches a nasal spray device wherein an engagement element that is configured to contact and radially compress a circumferential outer surface (paragraph [0013])(paragraph [0053]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Schaller to have a radial actuator, similar to Meshberg in order to be compatible with a device with a non-flat surface (as motivated by Meshberg, paragraph [0053]).
Regarding Claim 15, Schaller in view of Meshberg teaches the method of claim 11. Schaller further teaches wherein the apparatus further comprises a stop (20) that inhibits the actuator from moving beyond the second position (column 7, lines 9-24).
Regarding Claim 17, Schaller in view of Meshberg teaches the apparatus of claim 16. Schaller further teaches wherein the frame defines the first receptacle (115) and the second receptacle (117) (figure 3).
Regarding Claim 20, Schaller in view of Meshberg teaches the method of claim 11. Schaller further wherein the cartridge contains an eye drop solution, wherein the cartridge has an outlet at a distal end of the cartridge (column 4, lines 41-52) (figure 4), wherein the outlet is in alignment with the central axis of the receptacle (figure 3), wherein moving the actuator from the first position to the second position to contact and radially compress the circumferential outer surface of the cartridge toward the central axis of the first receptacle effects dispensation of the eye drop solution in a direction parallel to or in alignment with the central axis of the receptacle (FIG. 1B and FIG. 4) (column 7, lines 44-62).
Regarding Claim 21, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller further teaches wherein the actuator is configured to return from the second position to the first position by a force exerted by the cartridge as the cartridge resiliently returns from being compressed (column 8, lines 1-40).
Regarding Claim 23, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller further teaches wherein the housing comprises a main body that defines the at least a first receptacle, wherein the housing (115) further comprises a handle (605) that extends from the main body (figure 7).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2)as applied to claim 1 above, and further view of Collins (US 20090212133 A1).
Regarding Claim 5, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller further teaches wherein the housing (115) comprises an end that defines an opening of the first receptacle and wherein the engagement element (405) is positioned between the end that defines the opening of the first receptacle and the stop (20) (FIG. 1B and FIG. 4).
Though Schaller does not explicitly teach wherein housing further comprises a stop that is configured to inhibit the actuator from moving beyond the second position an O-ring that is configured to bias against the outer surface of the cartridge, Schaller teaches internal ribs (308) to support the eye drop dispenser. In the same field of endeavor, namely an eye drop apparatus, Collins teaches an O-ring (134) that is configured to bias against the outer surface of the cartridge (134) and a stop (2624) that is configured to inhibit the actuator from moving beyond the second position (paragraph [0234]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to replace the internal ribs of Schaller with an O-ring similar to that disclosed by Collins so that the frame may also include a fluid tight seal in case of leakage (as motivated by Collins, paragraph 0115)(figure 3).
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2) in view of Meshberg (US 20200269258 A1) in view of Clem (US 20150351959 A1).
Regarding Claim 3, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller fails to teach wherein the actuator comprises a rack and a pinion, wherein the rack defines the engagement element of the actuator wherein the pinion comprises a lever. Clem teaches and fluid dispensing apparatus wherein the actuator comprises a rack and a pinion , wherein the rack defines the engagement element of the actuator wherein the pinion comprises a lever (catheter) (paragraph [201]) the rack and pinion are an alternative to the rack and the elements that engage the rack in Schaller. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuation system of Schaller to include a rack and pinion similar to that disclosed by Clem so that the pinion may rotate in response to the control and the medication may be dispensed gradually in a more controlled fashion (as motivated by Clem, paragraph [0201]) as the rack and pinion are an alternative to the rack and the elements that engage the rack in Schaller.
Regarding Claim 13, Schaller in view of Meshberg teaches the apparatus of claim 11. Schaller fails to teach wherein the actuator comprises a rack and a pinion, wherein the rack defines the engagement element of the actuator wherein the pinion comprises a lever. Clem teaches and fluid dispensing apparatus wherein the actuator comprises a rack and a pinion , wherein the rack defines the engagement element of the actuator wherein the pinion comprises a lever (catheter) (paragraph [201]) the rack and pinion are an alternative to the rack and the elements that engage the rack in Schaller. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuation system of Schaller to include a rack and pinion similar to that disclosed by Clem so that the pinion may rotate in response to the control and the medication may be dispensed gradually in a more controlled fashion (as motivated by Clem, paragraph [0201]) as the rack and pinion are an alternative to the rack and the elements that engage the rack in Schaller.
Claim(s) 2, 6, 12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2) in view of Meshberg (US 20200269258 A1) and in further view of Lipchak (US 20190290486 A1).
Regarding Claim 2, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller fails to teach wherein the housing defines an alignment feature that is at least partially receivable into an eye socket of a user so that when the housing is positioned above an eye of the user and the alignment feature is received within the eye socket of the user, the alignment feature is configured to align the central axis of the first receptacle with the eye of the user, wherein the apparatus is configured to dispense the solution from the cartridge along the central axis.
Lipchak teaches wherein the alignment feature (eyedrop guide, 100)(paragraph [0027]) is configured to align the central axis of the first receptacle (left lens) with the eye of the user wherein the apparatus is configured to dispense the solution from the cartridge along the central axis (paragraph [0023]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that it is aligned with the central axis of the first receptacle and the eye of the user, similar to that disclosed by Lipchak, so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]).
Regarding Claim 6, Schaller in view of Meshberg teaches the apparatus of claim 1. Schaller fails to teach wherein the housing comprises a frame that defines at least one alignment feature, wherein the at least one alignment feature is configured to engage a face of a user to align the frame in a predetermined orientation with respect to the face of the user, wherein the first receptacle is configured to align a cartridge containing solution therein with respect to a first eye of the user, and wherein the housing further defines a second receptacle that is configured to align the cartridge containing solution therein with a second eye of the user. Lipchak teaches wherein the first receptacle (eyedrop guide, 100)(paragraph [0027]) is configured to align a cartridge containing solution therein with respect to a first eye of the user and the second receptacle being configured to align the cartridge containing solution therein with a second eye of the user (paragraph [0023]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that there are two alignment receptacles, similar to that disclosed by Lipchak , so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]) and that both eyes may receive medication at the same time (Lipchak, paragraph [0023]).
Regarding Claim 12, Schaller in view of Meshberg teaches the method of claim 11. Schaller fails to teach wherein the housing defines an alignment feature, the method further comprising: with the alignment feature of the housing positioned at least partially within an eye socket of an eye of a user, positioning the housing above the eye of the user, wherein the alignment feature aligns the central axis of the first receptacle with the eye of the user.
Lipchak teaches wherein the alignment feature (eyedrop guide, 100)(paragraph [0027]) is configured to align the central axis of the first receptacle (left lens) with the eye of the user wherein the apparatus is configured to dispense the solution from the cartridge along the central axis (paragraph [0023]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that it is aligned with the central axis of the first receptacle and the eye of the user, similar to that disclosed by Lipchak, so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]).
Regarding Claim 16, Schaller in view of Meshberg teaches the method of claim 11. Schaller fails to teach wherein the housing comprises a frame that defines at least one alignment feature, wherein the at least one alignment feature is configured to engage a face of a user to align the frame in a predetermined orientation with respect to the face of the user, wherein the first receptacle is configured to align a cartridge containing solution therein with respect to a first eye of the user, and wherein the housing further defines a second receptacle that is configured to align the cartridge containing solution therein with a second eye of the user. Lipchak teaches wherein the first receptacle (eyedrop guide, 100)(paragraph [0027]) is configured to align a cartridge containing solution therein with respect to a first eye of the user and the second receptacle being configured to align the cartridge containing solution therein with a second eye of the user (paragraph [0023]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that there are two alignment receptacles, similar to that disclosed by Lipchak , so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]) and that both eyes may receive medication at the same time (Lipchak, paragraph [0023]).
Claim(s) 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2) in view of Meshberg (US 20200269258 A1) and in further view of Lipchak (US 20190290486 A1) as applied to claims 6 and 16 above, and further in view of Chauhan (US PGPUB 2016/0354240).
Regarding Claim 8, Schaller in view of Meshberg teaches the apparatus of claim 6. However Schaller fails to teach wherein the actuator comprises a pair of calipers and a cable, wherein the pair of calipers are configured to close upon retraction of the cable. Chauhan teaches an eye drop delivery device wherein the actuator comprises a pair of calipers and a cable, wherein the pair of calipers are configured to close upon retraction of the cable (paragraph [0015]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuator of Schaller to include a pair of calipers and a cable similar to that disclosed by Chauhan so that the reaction time is almost instantaneous (as motivated by Chauhan, paragraph [0015]).
Regarding Claim 18, Schaller in view of Meshberg teaches the method of claim 16. However Schaller fail to teach wherein the actuator comprises a pair of calipers and a cable, wherein the pair of calipers are configured to close upon retraction of the cable. Chauhan teaches an eye drop delivery device wherein the actuator comprises a pair of calipers and a cable, wherein the pair of calipers are configured to close upon retraction of the cable (paragraph [0015]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the actuator of Schaller to include a pair of calipers and a cable similar to that disclosed by Chauhan so that the reaction time is almost instantaneous (as motivated by Chauhan, paragraph [0015]).
Claim(s) 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Schaller (US 9987163 B2) in view of Meshberg (US 20200269258 A1) and in further view of Lipchak (US 20190290486 A1) as applied to claims 6 and 16 above, and further in view of Yamada (US 20180168862 A1).
Regarding Claim 9, Schaller in view of Meshberg teaches the apparatus of claim 6. Schaller fails to teach wherein the frame defines the first receptacle and the second receptacle.
Lipchak teaches wherein the frame defines the first receptacle and the second receptacle (left and right receptacle, figure 7B). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that there are two alignment receptacles, similar to that disclosed by Lipchak , so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]) and that both eyes may receive medication at the same time (Lipchak, paragraph [0023]).
However all fail to teach wherein the housing further comprises a swing arm that is configured to receive the cartridge and move with the cartridge between the first receptacle and the second receptacle. Yamada teaches an ocular instillation assisting device (abstract) comprising the housing further comprises a swing arm (lever, 30) that is configured to receive the cartridge (container, 10) and move with the cartridge between the first receptacle and the second receptacle (paragraph 0052) (figure 1) . Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the housing disclosed by Schaller in view of Lipcheck to include a lever arm similar to that disclosed by Yamada so that the cartridge may be adjusted within the device (Yamada, paragraph 0051).
Regarding Claim 19, Schaller in view of Meshberg teaches the method of claim 16. However all fail to teach wherein the housing Further comprises a swing arm. Lipchak teaches wherein the frame defines the first receptacle and the second receptacle (left and right receptacle, figure 7B). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the alignment feature of Schaller so that there are two alignment receptacles, similar to that disclosed by Lipchak , so that the user may self-administer the eye drops, with limited visibility (Lipchak, paragraph [0005-0006]) and that both eyes may receive medication at the same time (Lipchak, paragraph [0023]).
Yamada teaches the method further comprising: positioning the cartridge (10) within the swing arm (30): and moving the swing arm (30) from a first rotational position to a second rotational position (paragraph 0051), wherein in the first rotational position the cartridge is positioned within the first receptacle, and wherein in the second rotational position, the cartridge is positioned within the second receptacle (paragraph 0051). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the housing disclosed by Schaller to include a lever arm similar to that disclosed by Yamada so that the cartridge may be adjusted within the device (Yamada, paragraph 0051).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/
Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781