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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 1,11 require a “means for attaching the eye shield”. This invokes 112(f). Per applicant’s specification pages 9-10 “the device includes a means for attaching to the patient. Embodiments include various temporary medical adhesives well known in the art (e.g. hydrogel,
acrylate-based hydrogel). Some of these embodiments include a nonstick backing (e.g. that can be removed by the user before placement on the patient). Some embodiments include a compliant
layer (e.g. foam layer) to provide a soft surface and/or allow the device to better contour to the patient's face. Under some embodiments, this compliant layer is a closed-cell and/or open-cell foam. Some embodiments include a strap, temple, or other component to attach the device in a
non-adhesive manner.” As such, the means for attachment may be any of the aforementioned.
Claims 2-4,6-18, and 20 are subject to this interpretation. Claims 5,19 detail specifically that a medical adhesive is used and thus are not subject to 112f.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,3,7,20,23, is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutson et al US 5588564 in view of Zmitek et al. EP 0551626 and further in view of Funk US 6098628 A, hereafter Hutson, Zmitek, and Funk.
Regarding Claim 1, Hutson discloses
An ocular and/or peri-ocular wound treatment device, comprising: a deployment system (Fig. 1,2, Dispenser (13)) initially containing a therapeutic agent (column 3 line 49-67, where the agent is a misting solution). Hutson further discloses an eye shield assembly (Fig. 1, shield (10), configured to couple with eye seen in figure 1). The examiner notes that the dispenser tube (delivery tube (21)).
The examiner notes that Hutson discloses that the eye shield comprises a connector to connect to connect to the tubing defining an aperture through the eye shield through which the agent is delivered (inner tube (24) configured to have (but not limited to) a friction fit with the nozzle, see column 4 lines 4-32). As seen in figure 2, said inner tube connects and opens directly to the eye cup. Hutson further discloses one or more passages to allow gas to escape, said passages being openings at a different location than the aperture for delivery (vent holes (26)).
Hutson, although teaching a misted solution, fails to teach a thermoreversible polymer formulation.
Zmitek teaches a liquid pharmaceutical and is thus considered analogous to the claimed invention. Zmitek teaches that the formulations in the disclosure are for application onto skin, eye, or mucous membranes (para. 0018). Zmitek teaches a thermoreversible gel as the pharmaceutical carrier for said application (para. 0019, 0020, 0036). The examiner notes that per para. 0035 and 0036, the agent of Zmitek is a solution of thermoreversible gel (containing a poloxamer per para. 0044), where, upon application thickens, and may be removed by washing. Per paragraph 0039, the application may be performed by spraying instead of a solution. Therefore, as Hutson teaches the dispensing of a mist solution to the eye, and Zmitek teaches that thermoreversible gels may be applied in a sprayed form to treat the eye, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the solution of Zmitek, containing a thermoreversible polymer with the eye shield of Hutson as a means to treat an eye. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the treatment of an eye wound, and thus a prima facie case of obviousness exists.
Hutson teaches that the rim of the cup forms a seal when placed over the eye (column 4, lines 26-29) and is thus interpreted to comprise a means for attaching to the eye. However, should the applicant disagree that this does not “attach” to the eye, the examiner provides Funk.
Funk teaches an eye shield and is thus considered analogous to the claimed invention. Funk teaches that a transparent eyeshield is sealed against the eye by an adhesives pliable foam (abstract, column 1 lines 35-40). Therefore, as Funk teaches that an eye shield that seals against the eye may do so by using a foam layer and adhesive, it would have been obvious to one having ordinary skill in the art to provide the sealing eye cup of Hutson with said foam and adhesive structure, as Funk teaches that said structure is suitable for the same purpose (of sealing around an eye). As such, doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the sealing of an eye cup around and eye.
The examiner notes that (although not required in claim 1, claim 8 requires the shield to be transparent. The examiner notes that as Funk teaches that an eyeshield may be transparent. Therefore, as Funk teaches that eye shields may be transparent (See above paragraph) it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cup of Hutson to be transparent as Funk teaches that transparent eye coverings are known to be suitable in the art. As such, doing so would merely require the simple substitution of one known element for another to obtain predictable results that being the use of an eye covering.
Regarding Claim 2, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, wherein the eyeshield is configured to be worn over a single eye (see figure 1 of Hutson).
Regarding Claim 5, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, wherein the means for attaching is a temporary medical adhesive. The examiner notes that per the rejection of claim 1, the means for attachment is an adhesive. The examiner notes that as the shield is configured to be removed, the adhesive is interpreted to be temporary.
Regarding Claim 6, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, wherein the eyeshield assembly further comprises a compliant layer to enable the device to contour to the patient’s face. The examiner notes that as detailed under the rejection of claim 1, the attachment means comprises a pliable foam and thus reads to the claimed invention.
Regarding Claim 7, Hutson, Zmitek, and Funk teach the wound treatment device of claim 6, where the compliant layer comprises a foam layer. See the rejection of claim 1 and 6.
Regarding Claim 8, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, where the eyeshield assembly comprises a transparent outer surface. See the rejection of claim 1 in view of Funk.
Regarding Claim 10, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, where the one or more passages are planar openings through the eye shield assembly. The examiner notes that as the defined openings in Hutson are seen to be through the walls of the cup and are holes (not seen to be outwardly extending past the wall) they are interpreted to be planar openings.
Regarding Claim 11, Hutson discloses a method of treating an ocular and/or periocular wound, comprising: attaching an eye shield to a patient (see figure 1, where shield (10) is seen on a patient’s eye, where the shield forms a seal on the eye per column 4, lines 26-29); causing a therapeutic agent (column 3 line 49-67, where the agent is a misting solution) to be delivered from a canister (13) to the patient through the eye shield (figure 1) via tubing (delivery tube (21) through an aperture through a connector of the eye shield connected to the tubing (inner tube (24) configured to have (but not limited to) a friction fit with the nozzle, see column 4 lines 4-32). As seen in figure 2, said inner tube connects and opens directly to the eye cup and is thus interpreted as comprising an aperture. Hutson further discloses and leaving the eye shield in place attached to the patient during and after therapeutic agent delivery such that gas is allowed to escape through one or more passages that are openings through the eye shield assembly at different locations than the aperture through which the therapeutic agent is delivered to prevent buildup of pressure in the eye shield from damaging the patient's eye (vent holes 26, column 4, lines 34-47. Hutson discloses one or more passages to allow gas to escape, said passages being openings at a different location than the aperture for delivery, and thus it is interpreted that the device is left on the eye while gases leave through the vent holes.
Hutson, although teaching a misted solution, fails to teach a thermoreversible polymer formulation.
Zmitek teaches a liquid pharmaceutical and is thus considered analogous to the claimed invention. Zmitek teaches that the formulations in the disclosure are for application onto skin, eye, or mucous membranes (para. 0018). Zmitek teaches a thermoreversible gel as the pharmaceutical carrier for said application (para. 0019, 0020, 0036). The examiner notes that per para. 0035 and 0036, the agent of Zmitek is a solution of thermoreversible gel (containing a poloxamer per para. 0044), where, upon application thickens, and may be removed by washing. Per paragraph 0039, the application may be performed by spraying instead of a solution. Therefore, as Hutson teaches the dispensing of a mist solution to the eye, and Zmitek teaches that thermoreversible gels may be applied in a sprayed form to treat the eye, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the solution of Zmitek, containing a thermoreversible polymer with the eye shield of Hutson as a means to treat an eye. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the treatment of an eye wound, and thus a prima facie case of obviousness exists.
Hutson teaches that the rim of the cup forms a seal when placed over the eye (column 4, lines 26-29) and is thus interpreted to comprise a means for attaching to the eye. However, should the applicant disagree that this does not “attach” to the eye, the examiner provides Funk.
Funk teaches an eye shield and is thus considered analogous to the claimed invention. Funk teaches that a transparent eyeshield is sealed against the eye by an adhesives pliable foam (abstract, column 1 lines 35-40). Therefore, as Funk teaches that an eye shield that seals against the eye may do so by using a foam layer and adhesive, it would have been obvious to one having ordinary skill in the art to provide the sealing eye cup of Hutson with said foam and adhesive structure, as Funk teaches that said structure is suitable for the same purpose (of sealing around an eye). As such, doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being the sealing of an eye cup around and eye.
Regarding Claim 12, Hutson, Zmitek, and Funk teach the method of claim 11, wherein the eyeshield is attached over a single eye (see figure 1 of Hutson).
Regarding Claim 14, Hutson, Zmitek, and Funk teach the method of claim 11, wherein the thermoreversible polymer formulation comprises a poloxamer. Per the rejection of claim 11 in view of Zmitek, the thermoreversible polymer contains poloxamer.
Regarding Claim 15, Hutson, Zmitek, and Funk teach the method of claim 14, wherein the poloxamer is at least one of P407 and P 188. See para. 0005 of Zmitek where Poloxamer 407 is the poloxamer used.
Regarding Claim 16, Hutson, Zmitek, and Funk teach the method of claim 11, wherein causing the therapeutic agent to be delivered from the canister includes causing the therapeutic agent to spread topically over tissue. The examiner notes as per the rejection of claim 1, Hutson discloses the mist is sprayed onto the eye and is thus interpreted as being spread topically over the tissue.
Regarding Claim 18, Hutson, Zmitek, and Funk teach the method of claim 11, wherein causing the therapeutic agent to be delivered from the canister includes pushing on a canister adapter of the canister. Hutson discloses pump activator flanges (14) to expel the mist (column 3 lines 58-67). Said flanges are interpreted as an adapter which is pushed to deliver the therapeutic.
Regarding Claim 19, Hutson, Zmitek, and Funk teach the method of claim 11, wherein attaching the eye shield to the patient includes attaching the eye shield to the patient with a temporary medical adhesive. The examiner notes that per the rejection of claim 11, the means for attachment is an adhesive. The examiner notes that as the shield is configured to be removed, the adhesive is interpreted to be temporary.
Claim(s) 4, is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutson in view of Zmitek and Funk and further in view of Kouyoumjian et al. US 2013/0245579, hereafter Kouyoumjian.
Regarding Claim 4, Hutson, Zmitek, and Funk teach the wound treatment device of claim 1, but fail to teach that the connector comprises a Luer connector.
Kouyoumjian teaches an ophthalmic drug delivery device and is thus considered analogous to the claimed invention. Kouyoumjian teaches a primary device (2) seen to be a medicament container is connected with a housing (9) which further connects to an eye cup (3) (see figures 2 and 3, para. 0029). The examiner notes that per Kouyoumjian, Luer locks are used for the connection, where the configuration allows for easy attachment and detachment of the medication container (para. 0029). The examiner notes that as the housing (9) provides an external pathway through which medication is sent from a bottle to an eyecup, it is interpreted as a tube. Therefore, as Kouyoumjian teaches that an external tube may be used to connect a dispenser and an eyecup to allow for quick and easy disconnection, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a Luer connection housing between the eyecup and dispenser of Specter. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the connection of a dispenser and eye cup, and thus a prima facie case of obviousness exists.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutson, Zmitek, and Funk and further in view of Chebli et al US 2011/0009836, hereafter Chebli.
Regarding Claim 9, Hutson, Zmitek, and Funk teach The wound treatment device of claim 1, but fail to disclose that the deployment system further comprises a cap configured to indicate if the deployment system has been previously opened.
Chebli teaches a pharmaceutical delivery device configured to be used on an eye, and is thus considered analogous to the claimed invention. Chebli further teaches that said delivery device can be provided with tamper evident features to ensure that the device has not been previously opened or
used, and that such features are well known in the art (Paragraph 0045). Chebli also teaches that the overcap is provided with the tamper evident features (See Chebli Claim 8). Therefore it would be obvious to one of ordinary skill in the art to provide the dispenser of Hutson with an overcap containing a tamper evident feature in order to notify the user if the device has been previously used or opened.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutson in view of Zmitek and Funk and further in view Rajagopalan et al. US 2017/0119785, hereafter Rajagopalan.
Regarding Claim 17, Hutson, Zmitek, and Funk method of claim 11, but fail to teach wherein the thermoreversible polymer formulation comprises an alginate configured to increase viscosity of the thermoreversible polymer formulation and/ to assist with preventing, slowing and/or stopping bleeding and/or fluid leakage.
Rajagopalan teaches a sol-gel polymer composite for ocular uses (para. 0083) and is thus considered analogous to the claimed invention. Rajagopalan teaches that the thermoreversible gel formed of the solution may include alginate (para. 0059). Therefore, as Hutson, Zmitek, and Funk teach a gel polymer composite that is thermoreversible, and Rajagopalan teaches that alginate may be used in such thermoreversible gels, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use alginate as a component of the prior art gel. Doing so would merely require combining prior art elements according to known methods to yield predictable results, that being the formation of a thermoreversible polymer gel.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutson in view of Zmitek and Funk and further in view Weiss US 4473370, hereafter Weiss.
Regarding Claim 20, Hutson, Zmitek, and Funk teach the method of claim 11, but fails to teach further comprising examining the wound without removing the eye shield through a transparent outer surface of the eye shield after therapeutic agent deployment.
Weiss teaches an eye shield and is thus considered analogous to the claimed invention. Weiss teaches that it is an object of the invention to provide a transparent eyeshield which allows for a doctor or nurse to examine the eye and medication without removal of the shield (column 1, lines 53-61). Therefore, as a means to monitor the eye being treated under the shield, without removing the shield, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shield of Hutson to be transparent. Doing so would merely require the s simple substitution of one known element for another to obtain predictable results, that being viewing of the eye during treatment, and thus a prima facie case of obviousness exists.
Allowable Subject Matter
Claim 3,13 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art previously applied teach that upon contact with the eye, the solution solidifies into a gel, not a foam. Applicant, per pages 6 and 7, differentiates between a gel and a foam. The examiner notes that while some arts use foams to treat disorders, and may alternatvielt use thermoreversible gels (See for example, US 20090297533 (para. 0018), US 20010055607 (claim 21,22), US 20100036000 (para. 0020), these prior arts use the foam as an alternative to the gel. Even so, the foams are not taught to be thermoreversible, only the gels are. Therefore, even if used, the foams of the prior art would not read to the claimed invention requiring a thermoreversible foam.
Upon a review of NPL on the subject the examiner came across
Donaldson RI, Chou E, Tanen DA, Armstrong JK, Buchanan OJ, Graham TL, Cristerna NN, Cambridge JS, Goldenberg D, Tolles J, Ross JD. Novel Thermoreversible Reverse-Phase-Shift Foam With Deployment System for Treatment of Penetrating Globe Trauma in a Newly Described Porcine Model. Mil Med. 2024 Aug 19;189(Suppl 3):254-261. doi: 10.1093/milmed/usae088. PMID: 39160838; PMCID: PMC11332267, hereafter Donaldson1, and
Donaldson, Ross & Zimmermann, Eric & Fisher, Timothy & Buchanan, Oliver & Armstrong, Jonathan & Cambridge, John & Graham, Todd & Ross, James & Ross, J. (2021). Thermoreversible Reverse-Phase-Shift Foam for Treatment of Noncompressible Torso Hemorrhage. Journal of Surgical Research. 259. 10.1016/j.jss.2020.11.039., hereafter Donaldson2.
The examiner notes while Donaldson1 specifically deals with optical uses of thermoreversible foam, the disclosure is by the instant inventor and has and effective year of 2024 and thus does not qualify as prior art. While older (2021), Donaldson2 is also by the instant inventor, and is within the grace period of one year of the effective filing date of the instant application and thus does not qualify as prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1,3,5-10,15,17-26 of U.S. Patent No. 12239572, hereafter 572. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Pending Claim Number
Corresponding Claim of 572
1
1
2
1,15
3
N/A
4
3
5
1
6
7
7
8
8
See obviousness type double patenting rejection below
9
9
10
1
11
15
12
15
13
n/a
14
20
15
20
16
19
17
15
18
See obviousness type double patenting rejection below
19
15, 5
20
See obviousness type double patenting rejection below
Regarding the claims above in the table, the claims of the 572 reference, in the examiner’s opinion read to the claims of the instant application. Claim 3 and 13 are not read to by the claim, and no obviousness type double patenting rejection is provided. Claims 8,18,and 20, although not rejected alone in view of 572, are rejection as an obviousness type rejection.
Claims 8,20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 of Patent “572” provided above in view of Weiss.
Weiss teaches an eye shield and is thus considered analogous to the claimed invention. Weiss teaches that it is an object of the invention to provide a transparent eyeshield which allows for a doctor or nurse to examine the eye and medication without removal of the shield (column 1, lines 53-61). Therefore, as a means to monitor the eye being treated under the shield, without removing the shield, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shield of 572 to be transparent. Doing so would merely require the s simple substitution of one known element for another to obtain predictable results, that being viewing of the eye during treatment, and thus a prima facie case of obviousness exists.
Claims 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 of Patent “572” provided above in view of Hutson.
Hutson teaches an eye applicator and is thus considered analogous to the claimed invention. Hutson discloses pump activator flanges (14) to expel the mist (column 3 lines 58-67). Said flanges are interpreted as an adapter which is pushed to deliver the therapeutic. Therefore, as a means to distribute medicine within an eye shield, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a means of actuation. Doing so would merely require the s simple substitution of one known element for another to obtain predictable results, that being delivering medication to the eye, and thus a prima facie case of obviousness exists.
Conclusion
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/MATTHEW WRUBLESKI/
Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
Prosecution Insights