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 .
Election/Restrictions
Applicant’s election of species D without traverse in the reply filed on 10/13/2025 is acknowledged.
Claims 3-4, 21, and 29-39 have been amended
Claims 1-2, 5-20, and 22-28 has been canceled.
Claims 3-4, 21, and 29-39 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/09/2022, 09/06/2024, and 04/10/2025 have been considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 21 and 36 are objected to because of the following informalities:
Claim 21 recites “a bottom portion disposed at other side” in line 19. This should read “a bottom portion disposed at an other side”.
Claim 36 recites “PRENCSO” in line 4. Before the use of acronyms, the word/phrase should be fully written followed by the acronym.
Appropriate correction is required.
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 3-4, 21, and 29-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, the term “substantially closed space” in line 15 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the term “container body” is rendered indefinite. Clarification is requested.
For the purposes of examination, the “substantially closed space” in claim 21 is interpreted as “at least partially closed space”.
Further regarding claim 21, the claim recites “wherein the irritant placement section is disposed on the bottom portion of the container body” in lines 22-23. The claim also recites “wherein the irritant placement section is disposed on the bottom portion” in line 25. The claim already defines that the bottom portion is included in the container body (line 19), therefore it is unclear how the second recitation of line 25 provides any further limitation to the recitations of lines 22-23. Clarification is requested.
For the purposes of examination, the limitations of lines 22-23 of claim 21 are interpreted as identical to the limitations of line 25 of claim 21.
Regarding claim 35, the claim recites “wherein the enzyme is disposed in the irritant placement section in a dry state, and wherein the substrate is added to the enzyme in a form of a solution” in lines 2-3. Based on this recitation, it is unclear whether the substrate is a part of the eye irritant that is disposed in the bottom portion or if the substrate is located elsewhere and is then added to the enzyme by a user. The claim does not recite the structure that performs the method steps of adding the substrate to the enzyme, therefore it is unclear how this functional limitation is achieved. Clarification is requested.
Also, this recitation reads as method steps in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
For the purposes of examination, the claim is interpreted as “wherein the enzyme is disposed in the irritant placement section in a dry state, and wherein enzyme is capable of being combined with the substrate in a form of a solution.”
Regarding claim 38, the claim recites “a retainer capable of retaining the one or each container body”. There is insufficient antecedent basis for the limitation “each container body”, as the claim is dependent on claim 21 where a single container body is recited. Clarification is requested.
For the purposes of examination, the claim is interpreted as being dependent on claim 37, wherein the device comprises two container bodies.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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.
Claims 3-4, 21, 29-30, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2007/0282012 by Kinoshita et al. – cited by Applicant, hereinafter “Kinoshita” in view of US Patent 4,733,802 by Sheldon, hereinafter “Sheldon” in view of US Patent 3,945,381 by Silver, hereinafter “Silver”.
Regarding claim 21, Fig. 5 of Kinoshita teaches a device for stimulating tear secretion (exposure container 1), the device comprising:
a container body including a rim capable of coming into close contact with a face in a region around an eye ([0138], “The upper circumference of the opening of the inner container 20 has concave curvature (as shown in FIG. 5) so that the mouth of the cup fits snugly on the periphery of the subject's eye”), the container body defining therein a gas-receiving space capable of being filled with gas generated by an eye irritant (The inside of inner container 20 is capable of being filled with gas); and
an irritant placement section that communicates with the gas-receiving space and in which the eye irritant is placed (Par. [0141] describes the use of the container, wherein the lacrimatory component solution is transferred to the inside of the inner container),
wherein the container body has a cup shape with an opening that opens toward one side in a first direction ([0138], “the inner container 20 has a substantially cup shape with its upper part open”. The bottom of the inner container is closed, thereby defining a cup shape. The cup extends from the bottom to the top),
wherein the rim of the container body extends continuously along an entirety of a peripheral edge of the opening (Fig. 5, the rim of the cup is continuous),
wherein the container body defines a substantially closed space between the container body and the eye when the rim of the container body is in close contact with the face in the region around the eye ([0138], “The upper circumference of the opening of the inner container 20 has concave curvature (as shown in FIG. 5) so that the mouth of the cup fits snugly on the periphery of the subject's eye.”),
wherein the container body includes
a bottom portion disposed at other side in the first direction (the bottom of inner container 11), and
a peripheral wall extending from a peripheral edge of the bottom portion toward the one side in the first direction (The wall of inner container 11 that defines the cup shape),
wherein the irritant placement section is disposed on the bottom portion of the container body (The filter paper can be placed in the inner container 11, on the bottom portion, therefore the bottom portion defines an irritant placement section), and
wherein the irritant placement section is disposed on the bottom portion (The filter paper can be placed in the inner container 11, on the bottom portion).
Kinoshita does not teach wherein the bottom portion is removably attachable to the peripheral wall.
Sheldon teaches a medicament dispensing system for introducing a substance to the eyes comprising an applicator 41 and a cup shaped member (50). The applicator and the cup shaped member are removably attachable via releasable securing means 51, such that the applicator is no longer attached to the wall of the cup shaped member when they are released. The releasable securing means allows for a variation in the applicator that is to be used (Col. 4, lines 24-34).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Kinoshita such that the bottom portion is removably attachable to the peripheral wall, such that a variation of applicators and methods of introducing substances to the eyes can be used with the same container body, as taught by Sheldon (Col. 4, lines 24-34).
Kinoshita in view of Sheldon does not teach the container body having an access opening through which an inside of the container body is accessible from an outside when the rim of the container body is in close contact with the face in the region around the eye.
Silver teaches a medicament dispensing system for introducing a substance to the eyes comprising an applicator and a cup (22). The cup is configured to be placed against the face, around the eyes (Col. 3, lines 53-57). The cup can comprise one or more access openings (58) which provide drainage holes for excess fluid (Col. 4, lines 32-35).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Kinoshita in view of Sheldon to include an access opening through which an inside of the container body is accessible from an outside when the rim of the container body is in close contact with the face in the region around the eye, to provide drainage holes for excess fluid, as taught by Silver (Col. 4, lines 32-35).
It is noted that Kinoshita, Sheldon, and Silver are in the same field of endeavor of introducing substances to the eyes. It is also noted that the Sheldon uses the method of an applicator (dropper) to introduce substances to the eyes, and the applicator is removably attachable at the bottom of the “cup”, and is analogous to the irritant placement section of Kinoshita being placed at the bottom of the cup.
Regarding claim 3, the combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, wherein the irritant placement section is disposed in at least a portion of the gas-receiving space. In the combination of Kinoshita, Sheldon, and Silver, the irritant placement section is in the bottom portion, which is within the cup. The cup defines the gas-receiving space, therefore the irritant placement section is disposed in at least a portion of the gas-receiving space.
Regarding claim 4, the combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, further comprising: a tear-fluid-receiving section that is provided in the container body and in which tear fluid produced by secretion in the eye is collected. The cup is also capable of receiving tears, therefore it defines a tear-fluid-receiving section that is provided in the container body.
Regarding claim 29, the combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein at least a portion or an entirety of the container body is made of a material having transparency characteristics that allow optical observation of an inside of the container body from an outside.
Sheldon teaches that the cone shaped member (analogous to the container body of Kinoshita, Sheldon, and Silver) may be either transparent or translucent while the bottom portion is opaque. This combination of translucent and opaque sections assists the patient in focusing his or her eye upon opening to assist in proper administration of the substance (Col. 5, lines 1-14).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that at least a portion or an entirety of the container body is made of a material having transparency characteristics that allow optical observation of an inside of the container body from an outside, to assist the patient in focusing his or her eye upon opening to assist in proper administration of the substance, as taught by Sheldon (Col. 5, lines 1-14).
Regarding claim 30, the combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, further comprising: a fiber structure that supports the eye irritant and that is disposed in the irritant placement section (Kinoshita; [0141-0143]; a circular piece of filter paper instilled with the lacrimatory component solution is transferred to the inside of the inner container).
Regarding claim 34, the combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the eye irritant comprises at least a portion of an enzyme and a substrate that react to generate the gas.
Kinoshita teaches that the lachrymatory property of onions is well known. The onion cells are rich in PRENCSO, and a lachrymatory component is generated from PRENCSO by alliinase and lacrimatory factor synthase (LFS) ([0002]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of the combination of Kinoshita, Sheldon, and Silver such that the eye irritant comprises at least a portion of an enzyme and a substrate that react to generate the gas. The device of the combination of Kinoshita, Sheldon, and Silver teaches a lachrymatory agent, therefore this modification would merely comprise simple substitution of one known element (the lachrymatory agent of Kinoshita) for another (the enzyme and a substrate that react to generate the gas) to obtain predictable results. See MPEP 2143.I.B.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita in view of Sheldon in view of Silver, as applied to claim 21, in view of US Patent Publication 2009/0182291 by Eilat, hereinafter “Eilat”.
The combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the eye irritant is liquid and sealed in a bag.
Eilat teaches a method of introducing a substance to the eye, wherein the substance to be introduced is a solution (i.e., liquid) that is hermetically sealed in a bag and attached to a dispensing valve ([0017]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that the eye irritant is liquid and sealed in a bag. It is noted that the device of the combination of Kinoshita, Sheldon, and Silver teaches the introduction of substances to the eye, and Sheldon specifically teaches a removably attachable bottom portion to allow for a variation of types of applicators for these substances. Therefore, this modification would merely comprise simple substitution of one known element for another to obtain predictable results, as the hermetically sealed bag with the dispensing valve is a type of applicator for introducing substances to the eye. See MPEP 2143.I.B.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita in view of Sheldon in view of Silver, as applied to claim 21, in view of US Patent Publication 2011/0144137 by Jordt et al., hereinafter “Jordt”.
The combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the eye irritant comprises benzyl bromide.
Jordt teaches that common lachrymatory agents that stimulate the corneal nerves in the eyes to cause tearing include benzyl bromide ([0092]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that the eye irritant comprises benzyl bromide, as taught by Jordt ([0092]). The device of the combination of Kinoshita, Sheldon, and Silver teaches a lachrymatory agent, therefore this modification would merely comprise simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I.B.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita Sheldon in view of Silver, as applied to claim 21, in view of US Patent Publication 2017/0254114 by Perrenoud et al., hereinafter “Perrenoud”.
The combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the eye irritant comprises syn-propanethial-S-oxide.
Perrenoud teaches a device comprising a chemical deterrent comprising a lachrymatory agent. One potential lachrymatory agent is syn-propanethial-S-oxide ([0010, 0042]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that the eye irritant comprises syn-propanethial-S-oxide. The device of the combination of Kinoshita, Sheldon, and Silver teaches a lachrymatory agent, therefore this modification would merely comprise simple substitution of one known element for another to obtain predictable results. See MPEP 2143.I.B.
Claims 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita in view of Sheldon in view of Silver, as applied to claim 21, in view of Japanese Patent Document 2009254344 by Kato, hereinafter “Kato”.
The combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the enzyme is disposed in the irritant placement section in a dry state, and wherein the substrate is added to the enzyme in a form of a solution, or wherein the enzyme comprises alliinase and lachrymatory factor synthase (LFS), and wherein the substrate is PRENCSO.
Kato teaches a method of separating PRENCSO and lachrymatory factor synthase (LFS) (Abstract). The dry mixed enzyme is contained in a powder form and comprises a mixture of LFS and alliinase (Page 4, 6. LFS stabilization process, par. 5). PRENSCO is maintained in an aqueous solution (Page 5, 7. PRENSCO stabilization process, pars. 1-3). Therefore, to generate the eye irritant, the enzyme (dry state enzyme mix) can be combined with a solution containing PRENCSO. Stably storing LFS (i.e., dry enzyme) and PRENCSO is useful to control when the production of the tear component is generated, so that it may be used for lacrimation examination (Page 1, Background-Art, par. 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that the enzyme is disposed in the irritant placement section in a dry state, and wherein the substrate is added to the enzyme in a form of a solution and wherein the enzyme comprises alliinase and lachrymatory factor synthase (LFS), and wherein the substrate is PRENCSO, as Kato teaches that these are stable configurations to store the components to be used for lacrimation examination (Page 1, Background-Art, par. 2).
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita in view of Sheldon in view of Silver, as applied to claim 21, in view of US Patent Publication 2008/0051741 by Grenon et al., hereinafter “Grenon”.
The combination of Kinoshita, Sheldon, and Silver teaches the device according to claim 21, but does not teach wherein the device comprises: two of the container bodies. However, according to MPEP § 2144.04-VI-B, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver to comprise two container bodies such that lacrimation examination or therapy can be administered to two eyes simultaneously. No unexpected results would occur from the duplication of the container bodies.
The combination of Kinoshita, Sheldon, and Silver does not teach the device comprising a connector that connects inner-corner end portions of the two container bodies to each other, the inner-corner end portions being adjacent to inner corners of the eyes when the rims of the two container bodies are in close contact with the face in the regions around the eyes, a retainer capable of retaining the or each container body on a head of a subject such that the rim of the container body is in close contact with the face in the region around the eye, or the retainer provided on outer-corner end portions of the two container bodies and capable of retaining the two container bodies on a head of a subject, the outer-corner end portions being adjacent to outer corners of the eyes when the rims of the two container bodies are in close contact with the face in the regions around the eyes.
Fig. 3 of Grenon teaches an apparatus for administering a substance to the eyes comprising two eyepieces 220 (i.e., container bodies). The inside edges of each of the eyepieces are joined by a nose piece or bridge 240 (i.e., connector). The outside edges of the eyepieces are connected via headband 210 (i.e., retainer). The head-worn configuration of the eyepieces allow them to be firmly and comfortably in place while using the device ([0055]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Kinoshita, Sheldon, and Silver such that the device comprises a connector that connects inner-corner end portions of the two container bodies to each other, the inner-corner end portions being adjacent to inner corners of the eyes when the rims of the two container bodies are in close contact with the face in the regions around the eyes and a retainer capable of retaining each container body on a head of a subject such that the rim of each container body is in close contact with the face in the region around the eye, wherein the retainer is provided on outer-corner end portions of the two container bodies, the outer-corner end portions being adjacent to outer corners of the eyes when the rims of the two container bodies are in close contact with the face in the regions around the eyes. This configuration of connecting the container bodies with a connector and retainer allows for a head-worn configuration of the eyepieces allow them to be firmly and comfortably in place while using the device, as taught by Grenon ([0055]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2020/0138669 by Berdahl et al. teaches a system of introducing substances to eyes of a user, comprising two container bodies connected by a connector and a retainer.
US Patent 5,578,021 by Cornish – cited by Applicant teaches a device for introducing a substance to the eye comprising a container body and a bottom portion removably attached to the container body.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/MATTHEW KREMER/ Primary Examiner, Art Unit 3791